Exhibit 10.1
Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
CO-PROMOTION AGREEMENT
BY AND BETWEEN
GENENTECH, COR THERAPEUTICS
AND
SCHERING SALES MANAGEMENT, INC.
TABLE OF CONTENTS
Page
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ARTICLE 1. DEFINITIONS...................................................................................................... 2
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1.1 "Affiliate"...................................................................................................... 2
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1.2 "Agreement"...................................................................................................... 2
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1.3 "Agreement Quarter".............................................................................................. 2
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1.4 "Agreement Year"................................................................................................. 2
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1.5 "Change in Control".............................................................................................. 2
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1.6 "Clinical Supplies".............................................................................................. 2
-----------------
1.7 "Competing GP IIb-IIIa Inhibitor Product"........................................................................ 2
---------------------------------------
1.8 "Competing Thrombolytic Product"................................................................................. 2
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1.9 "Confidential Information"....................................................................................... 3
------------------------
1.10 "Controlled by".................................................................................................. 3
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1.11 "Co-promotion Term".............................................................................................. 3
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1.12 "Diligent Efforts"............................................................................................... 3
----------------
1.13 "Effective Date"................................................................................................. 3
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1.14 "Execution Date"................................................................................................. 3
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1.15 "ERISA".......................................................................................................... 3
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1.16 "FDA"............................................................................................................ 3
---
1.17 "GENENTECH Baseline Annual Sales"................................................................................ 3
-------------------------------
1.18 "GENENTECH Combination Product".................................................................................. 3
-----------------------------
1.19 "GENENTECH Compounds"............................................................................................ 3
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1.20 "GENENTECH Hospitals"............................................................................................ 3
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1.21 "GENENTECH Know-How"............................................................................................. 4
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1.22 "GENENTECH Net Sales"............................................................................................ 4
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1.23 "GENENTECH Patents".............................................................................................. 5
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1.24 "GENENTECH Performance Compensation"............................................................................. 5
----------------------------------
1.25 "GENENTECH Products"............................................................................................. 5
------------------
1.26 "GENENTECH Sales Force".......................................................................................... 5
---------------------
1.27 "GENENTECH Trademarks"........................................................................................... 5
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1.28 "IND"............................................................................................................ 5
---
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
TABLE OF CONTENTS
Page
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1.29 "INTEGRILIN Baseline Annual Sales"............................................................................ 6
--------------------------------
1.30 "INTEGRILIN Combination Product".............................................................................. 6
------------------------------
1.31 "INTEGRILIN Compound"......................................................................................... 6
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1.32 "INTEGRILIN Net Sales"........................................................................................ 6
--------------------
1.33 "INTEGRILIN PARTNERS Know-How"................................................................................ 7
----------------------------
1.34 "INTEGRILIN Patents".......................................................................................... 7
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1.35 "INTEGRILIN Performance Compensation"......................................................................... 7
-----------------------------------
1.36 "INTEGRILIN Products"......................................................................................... 7
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1.37 "INTEGRILIN Reported Sales"................................................................................... 7
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1.38 "INTEGRILIN Sales Force"...................................................................................... 7
----------------------
1.39 "INTEGRILIN Trademark"........................................................................................ 8
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1.40 "Joint Hospitals"............................................................................................. 8
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1.41 "Laws"........................................................................................................ 8
----
1.42 "NDA"......................................................................................................... 8
---
1.43 "NDA Approval"................................................................................................ 8
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1.44 "Party"....................................................................................................... 8
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1.45 "Performance Compensation".................................................................................... 8
------------------------
1.46 "Person"...................................................................................................... 8
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1.47 "Products".................................................................................................... 8
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1.48 "Promotion"................................................................................................... 8
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1.49 "Regulatory Approval"......................................................................................... 8
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1.50 "Regulatory Authority"........................................................................................ 8
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1.51 "Sales Force Personnel"....................................................................................... 9
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1.52 "Serious adverse event" and "Non-serious adverse event"....................................................... 9
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1.53 "Strategic Promotional Decisions"............................................................................. 9
-------------------------------
1.54 "Target Bonus"................................................................................................ 9
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1.55 "Technology".................................................................................................. 9
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1.56 "Territory"................................................................................................... 9
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1.57 "Third Party(ies)"............................................................................................ 9
----------------
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
ii.
TABLE OF CONTENTS
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ARTICLE 2. GRANT OF RIGHTS TO THE INTEGRILIN PARTNERS; GENENTECH RESERVED RIGHTS; NON-COMPETITION; EXTENSIONS
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OF EXCLUSIVITY.................................................................................................... 10
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2.1 Engagement of the INTEGRILIN PARTNERS............................................................................. 10
-------------------------------------
2.2 GENENTECH Reserved Rights......................................................................................... 10
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2.3 Noncompetition.................................................................................................... 10
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2.4 Effect of Acquisition of Competing Product........................................................................ 11
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ARTICLE 3. GRANT OF RIGHTS TO GENENTECH; INTEGRILIN PARTNERS RESERVED RIGHTS; NON-COMPETITION; EXTENSIONS OF EXCLUSIVITY..... 12
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3.1 Engagement of GENENTECH........................................................................................... 12
-----------------------
3.2 INTEGRILIN PARTNERS Reserved Rights............................................................................... 12
-----------------------------------
3.3 Noncompetition.................................................................................................... 13
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3.4 Effect of Acquisition of Competing GP IIb-IIIa Inhibitor Product.................................................. 13
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ARTICLE 4. PROMOTION, COMMERCIALIZATION AND DISTRIBUTION OF PRODUCTS......................................................... 15
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4.1 General Diligence Obligation...................................................................................... 15
----------------------------
4.2 Strategic Promotional Decisions................................................................................... 15
-------------------------------
4.3 Sales Force Coordination.......................................................................................... 15
------------------------
4.4 Regulatory Approvals.............................................................................................. 15
--------------------
4.5 Managed Care and Formulary Relationships.......................................................................... 15
----------------------------------------
4.6 No Adverse Change to a Party's Rights Without Its Consent......................................................... 16
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4.7 Sales Force Deployment............................................................................................ 16
----------------------
4.8 Sales Forces...................................................................................................... 17
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4.9 Promotional and Advertising Responsibilities...................................................................... 24
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4.10 Medical Education Programs........................................................................................ 28
--------------------------
4.11 Clinical Trials................................................................................................... 28
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4.12 Bonus Structure of the INTEGRILIN PARTNERS Sales Force Personnel.................................................. 30
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4.13 Bonus Structure of the GENENTECH Sales Force Personnel............................................................ 30
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4.14 Management of Sales Force Personnel............................................................................... 31
-----------------------------------
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
iii.
TABLE OF CONTENTS
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4.15 Management of the Collaboration Between Genentech and the Integrilin Partners...................................... 31
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ARTICLE 5. PRODUCT PRICING; REVENUE RECOGNITION; MANUFACTURING................................................................ 32
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5.1 Product Pricing.................................................................................................... 32
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5.2 Revenue Recognition................................................................................................ 32
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5.3 Supply of GENENTECH Product........................................................................................ 33
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5.4 Supply of INTEGRILIN PRODUCT....................................................................................... 34
----------------------------
ARTICLE 6. TRADEMARKS AND COPYRIGHTS.......................................................................................... 35
-------------------------
6.1 GENENTECH Trademarks............................................................................................... 35
--------------------
6.2 INTEGRILIN Trademarks.............................................................................................. 36
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ARTICLE 7. COMMITMENT TO CERTAIN SPENDING BY INTEGRILIN PARTNERS.............................................................. 37
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7.1 NRMI and Related Programs.......................................................................................... 37
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7.2 Promotional Materials and Sales Training Reimbursement............................................................. 38
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7.3 Timing of Payments................................................................................................. 38
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ARTICLE 8. TRAINING OF SALES FORCES........................................................................................... 38
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8.1 General Training................................................................................................... 38
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8.2 GENENTECH Product Training......................................................................................... 38
--------------------------
8.3 INTEGRILIN Product Training........................................................................................ 38
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8.4 Expenses........................................................................................................... 39
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8.5 Training Materials................................................................................................. 39
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ARTICLE 9. FORCE MAJEURE...................................................................................................... 40
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ARTICLE 10. CERTAIN REGULATORY MATTERS CONCERNING GENENTECH PRODUCTS; PRODUCT RECALL........................................... 41
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10.1 General Control in GENENTECH....................................................................................... 41
----------------------------
10.2 Efficacy and Safety Information.................................................................................... 41
-------------------------------
10.3 Notification of Adverse Events; Reporting to Regulatory Authorities................................................ 42
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10.4 Response by the INTEGRILIN PARTNERS to Regulatory Inquiries........................................................ 43
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10.5 GENENTECH Product Quality Complaint................................................................................ 43
-----------------------------------
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
iv.
TABLE OF CONTENTS
Page
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10.6 Medical Inquiries.................................................................................................. 43
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10.7 Product Recall..................................................................................................... 44
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ARTICLE 11. CERTAIN REGULATORY MATTERS CONCERNING INTEGRILIN PRODUCTS; PRODUCT RECALL.......................................... 44
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11.1 General Control in INTEGRILIN PARTNERS............................................................................. 44
--------------------------------------
11.2 Efficacy and Safety Information.................................................................................... 44
-------------------------------
11.3 Notification of Adverse Events; Reporting to Regulatory Authorities................................................ 45
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11.4 Response by GENENTECH to Regulatory Inquiries...................................................................... 46
---------------------------------------------
11.5 INTEGRILIN Product Quality Complaint............................................................................... 46
------------------------------------
11.6 Medical Inquiries.................................................................................................. 47
-----------------
11.7 Product Recall..................................................................................................... 47
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ARTICLE 12. COMPLIANCE WITH LAW AND LABELING................................................................................... 47
--------------------------------
12.1 Compliance with Laws............................................................................................... 47
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12.2 Maintenance of Authorizations...................................................................................... 48
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ARTICLE 13. CO-PROMOTION PERFORMANCE COMPENSATION.............................................................................. 48
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13.1 Compensation to Genentech.......................................................................................... 48
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13.2 Compensation to INTEGRILIN PARTNERS................................................................................ 49
-----------------------------------
13.3 Shortfall in Sales Effort.......................................................................................... 49
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13.4 Currency; Bank Account; Tax Withholdings........................................................................... 50
----------------------------------------
13.5 Payment............................................................................................................ 50
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13.6 Exchange of Sales Data............................................................................................. 53
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ARTICLE 14. DISPUTE RESOLUTION................................................................................................. 53
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14.1 Dispute Resolution................................................................................................. 53
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14.2 No Limitation...................................................................................................... 53
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ARTICLE 15. CO-PROMOTION TERM AND TERMINATION.................................................................................. 53
---------------------------------
15.1 Co-promotion Term; Term of Agreement............................................................................... 53
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15.2 Termination by the INTEGRILIN PARTNERS............................................................................. 53
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15.3 Termination by GENENTECH........................................................................................... 55
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15.4 Insolvency......................................................................................................... 56
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15.5 Survival of Obligations............................................................................................ 56
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
v.
TABLE OF CONTENTS
Page
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15.6 Effect of Termination.............................................................................................. 57
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ARTICLE 16. INDEMNIFICATION AND INSURANCE; INFRINGEMENT PROCEEDINGS............................................................ 57
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16.1 Indemnification by GENENTECH....................................................................................... 57
----------------------------
16.2 Indemnification by the INTEGRILIN PARTNERS......................................................................... 58
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16.3 Indemnification Procedure.......................................................................................... 58
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16.4 Insurance.......................................................................................................... 59
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16.5 Infringement of GENENTECH Product Claimed by a Third Party......................................................... 59
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16.6 Infringement of INTEGRILIN Product Claimed by a Third Party........................................................ 60
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ARTICLE 17. CONFIDENTIALITY.................................................................................................... 60
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17.1 Confidential Information........................................................................................... 60
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17.2 Required Disclosures............................................................................................... 61
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17.3 Duration........................................................................................................... 62
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17.4 Novation........................................................................................................... 62
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ARTICLE 18. REPRESENTATIONS AND WARRANTIES..................................................................................... 62
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18.1 Mutual Representations and Warranties.............................................................................. 62
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18.2 GENENTECH's Representations and Warranties......................................................................... 63
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18.3 COR's Representations and Warranties............................................................................... 63
------------------------------------
18.4 SCHERING's Representations and Warranties.......................................................................... 64
-----------------------------------------
ARTICLE 19. NOTICES............................................................................................................ 64
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19.1 Notices............................................................................................................ 64
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ARTICLE 20. MISCELLANEOUS PROVISIONS........................................................................................... 65
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20.1 Assignment......................................................................................................... 65
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20.2 Non-Waiver......................................................................................................... 66
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20.3 Entirety of Agreement.............................................................................................. 66
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20.4 Public Announcements............................................................................................... 66
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20.5 Governing Law...................................................................................................... 66
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20.6 Relationship of the Parties........................................................................................ 66
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20.7 Collaboration Agreement............................................................................................ 66
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20.8 Counterparts....................................................................................................... 67
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with
the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
vi.
Execution Copy
CO-PROMOTION AGREEMENT
This Co-promotion Agreement is made as of January 1, 2001 (the
"Effective Date"), by and between Genentech, Inc., a Delaware corporation,
having a place of business at 1 DNA Way, South San Francisco, California 94080
("GENENTECH"), COR Therapeutics, Inc., a Delaware corporation having a place of
business at 256 East Grand Avenue, South San Francisco, California 94080 ("COR")
and Schering Sales Management, Inc., a Nevada corporation, having a place of
business at 12125 Moya Boulevard, Reno, Nevada 89506-2600 ("SCHERING").
W I T N E S S E T H:
- - - - - - - - - -
WHEREAS, COR and SCHERING (collectively, the "INTEGRILIN PARTNERS" and
each individually an "INTEGRILIN PARTNER") market and distribute INTEGRILIN(R)
(eptifibatide) Injection ("Integrilin") in the United States in accordance with
the labeling approved by the U.S. Food and Drug Administration; and
WHEREAS, GENENTECH and its Affiliates are engaged in the business of
marketing pharmaceutical products to hospitals; and
WHEREAS, the INTEGRILIN PARTNERS wish to engage GENENTECH to assist
the INTEGRILIN PARTNERS in the promotion of Integrilin in the Territory (as
defined below), and GENENTECH desires to have the right to copromote said
product, upon the terms specified in this Agreement; and
WHEREAS, GENENTECH markets and distributes TNKase(TM) (tenecteplase)
("TNK") and Activase(R) (alteplase, recombinant)("TPA") in the United States in
accordance with the labeling approved by the U.S. Food and Drug Administration;
and
WHEREAS, the INTEGRILIN PARTNERS and their Affiliates are engaged in
the business of marketing pharmaceutical products to hospitals; and
WHEREAS, GENENTECH wishes to engage the INTEGRILIN PARTNERS to assist
GENENTECH in the promotion of TNK and TPA in the Territory (as defined below),
and the INTEGRILIN PARTNERS desire to have the right to copromote said products,
upon the terms specified in this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants set forth
herein, and intending to be legally bound hereby, the Parties hereto agree as
follows:
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
1.
ARTICLE 1. Definitions
-----------
For purposes of this Agreement, the following terms, whether used in
the singular or plural, shall have the corresponding meanings set forth below:
1.1 "Affiliate" means, with respect to any Person, any other Person that
---------
directly or indirectly controls, is controlled by, or is under common control
with, such Person. A Person shall be regarded as in control of another Person
if it/he/she owns, or directly or indirectly controls, more than fifty percent
(50%) of the voting securities (or comparable equity interests) or other
ownership interests of the other Person, or if it/he/she directly or indirectly
possesses the power to direct or cause the direction of the management or
policies of the other Person, whether through the ownership of voting
securities, by contract or any other means whatsoever. Notwithstanding the
foregoing, for purposes of this Agreement, F. Hoffmann-La Roche Ltd and its
affiliates (other than wholly owned subsidiaries of Genentech) shall not be
considered Affiliates of Genentech.
1.2 "Agreement" means this agreement, together with all appendices,
---------
exhibits and schedules hereto, and as the same may be amended or supplemented
from time to time hereafter by a written agreement duly executed by authorized
representatives of each Party hereto.
1.3 "Agreement Quarter" means each three-month period commencing on the
-----------------
first day of January, April, July, or October, as the case may be, during the
Co-promotion Term, provided that the first Agreement Quarter shall commence on
--------
the Effective Date and end on March 31, 2001.
1.4 "Agreement Year" means each 12-month period commencing on January 1
---------------
and ending on December 31 during the Co-promotion Term, provided that the first
--------
Agreement Year shall commence on the Effective Date and end on December 31,
2001.
1.5 "Change in Control" means, with respect to a hospital, any sale of
-----------------
voting securities or sale of assets (whether by sale, merger, combination,
consolidation, reorganization, share exchange, or otherwise) which, directly or
indirectly, (i) transfers over 50% of the assets of such hospital to any entity
other than an Affiliate of such hospital existing as of the Effective Date, or
(ii) results in any entity, other than an Affiliate of such hospital existing as
of the Effective Date, becoming the beneficial owner, directly or indirectly, of
fifty percent (50%) or more of those securities entitled to vote for the
election of directors of such hospital.
1.6 "Clinical Supplies" means any and all [*] (whether [*] or [*]), [*]
------------------
or other similar materials used in connection with a clinical study.
1.7 "Competing GP IIb-IIIa Inhibitor Product" has the meaning set forth
---------------------------------------
in Section 3.3 hereof.
1.8 "Competing Thrombolytic Product" has the meaning set forth in Section
------------------------------
2.3 hereof.
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
2.
1.9 "Confidential Information" has the meaning set forth in Article 17
------------------------
hereof.
1.10 "Controlled by" means, with respect to any product, information or
-------------
intellectual property right, that the applicable Party or Person, in whole or in
part, owns or has a license to such product, information or intellectual
property right and has the ability to grant access or a license (or a
sublicense), as applicable, without violating the terms of any agreement or
other arrangements with any Third Party existing at the time such Party or
Person would be first required to grant such access, license or sublicense.
1.11 "Co-promotion Term" has the meaning specified in Section 15.1 hereof.
-----------------
1.12 "Diligent Efforts" means the carrying out of obligations or tasks in a
----------------
manner consistent with the efforts a Party devotes to [*] or [*] and at a [*]
resulting from its [*], based on conditions then prevailing.
1.13 "Effective Date" means January 1, 2001.
--------------
1.14 "Execution Date" means January 5, 2001.
--------------
1.15 "ERISA" means the Employee Retirement Income Security Act of 1974, as
-----
amended.
1.16 "FDA" means the U.S. Food and Drug Administration.
---
1.17 "GENENTECH Baseline Annual Sales" has the meaning set forth in Section
--------------------------------
13.2.2 hereof.
1.18 "GENENTECH Combination Product" means any GENENTECH Product that
-----------------------------
contains a GENENTECH Compound in combination with one or more other
pharmaceutically active ingredients.
1.19 "GENENTECH Compounds" means the following compounds: the glycoprotein
-------------------
developed by introducing modifications to the complementary DNA (cDNA) for
natural human Tpa such that the resulting recombinant protein contains a
substitution of threonine-103 with asparagine, and a substitution of asparagine-
117 with glutamine, both within the kringle 1 domain, and a tetra-alanine
substitution at amino acids 296-299 in the protease domain (TNK); and the 527
amino acid glycoprotein synthesized using the complementary DNA (cDNA) for
natural human tissue-type plasminogen activator obtained from a human melanoma
cell line, and whose manufacturing process involves the secretion of the enzyme
recombinant human tissue-type plasminogen activator into the culture medium by
an established mammalian cell line (Chinese Hamster ovary cells) into which the
cDNA for human tissue-type plasminogen activator has been genetically inserted.
(TPA)
1.20 "GENENTECH Hospitals" has the meaning set forth in Section 4.7.1.
-------------------
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
3.
1.21 "GENENTECH Know-How" means all proprietary information that is now
------------------
or may hereafter during the term of this Agreement be controlled by GENENTECH or
any of its Affiliates regarding the GENENTECH Compound or the GENENTECH
Products.
1.22 "GENENTECH Net Sales" means for an applicable accounting period, the
-------------------
gross amount invoiced for the GENENTECH Products for sales by GENENTECH or its
Affiliates [*] to Third Parties that are [*], less the following amounts [*]:
(i) trade, quantity and cash discounts or rebates actually and lawfully
allowed and taken and any other similar adjustments, including,
without limitation, those granted on account of price adjustments,
billing errors, rejected goods, and damaged goods;
(ii) price reductions, credits, rebates, product returns, charge-back and
prime vendor rebates, fees, reimbursements or similar payments or
adjustments actually granted or given to [*], health care insurance
carriers, pharmacy benefit management companies, health maintenance
organizations or other institutions or health care organizations;
(iii) any sales or use tax, customs duties, excise or other duties or
other governmental charge (other than an income tax) levied on the
sale, transportation or delivery of the GENENTECH Products;
(iv) price reductions, credits, rebates, charge-back and prime vendor
rebates, fees, reimbursements or similar payments or adjustments
actually granted or given in connection with GENENTECH Product sales
to any governmental or regulatory authority in respect of any state
or federal Medicare, Medicaid, Veterans Affairs, or similar
programs; and
(v) any charge for freight, insurance or other transportation costs
charged to the customer to the extent included on the same invoice
as GENENTECH Product.
With respect to sales of TPA, Net Sales shall be calculated as Net
Sales multiplied by [*] attributed to the [*] as determined in good faith by
GENENTECH using its [*] by [*] which surveys a representative sample of [*] on a
monthly basis to break out [*]. Genentech agrees not to materially change such
tracking methodology during the Co-promotion Term without the consent of the
INTEGRILIN PARTNERS.
Sales of the GENENTECH Products between GENENTECH and its Affiliates
[*] sales to Third Parties [*] sales result in such Affiliates [*] of the
GENENTECH Products) and [*] Net Sales calculations. Subject to the foregoing,
Net Sales shall be determined in accordance with U.S. generally accepted
accounting principles, consistently applied. If a GENENTECH Product is sold for
compensation other than cash, Net Sales shall be calculated based on the fair
market value of the GENENTECH Products. The fair market value of a GENENTECH
Product shall be the [*] of the GENENTECH Product for the [*]. Net Sales of
GENENTECH Products
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
4.
used in clinical trials or for promotional or sampling purposes shall be deemed
to be zero.
With respect to sales of GENENTECH Combination Products, Net Sales
shall be calculated on the basis of the [*] of the [*] of GENENTECH Compound in
the GENENTECH Products then being sold by GENENTECH without another active
ingredient in the Territory, if such exists.
For purposes of this Agreement, [*] for [*] shall [*] towards
Genentech Net Sales.
1.23 "GENENTECH Patents" means all patents and patent applications in the
-----------------
Territory which are or become Controlled by GENENTECH or any of its Affiliates
which patents generically or specifically claim the composition or use of any
GENENTECH Product in the Territory, including without limitation all
continuations, continuations-in-part, divisions, patents of addition, reissues,
renewals, substitutions, registrations, confirmations or extensions thereof.
1.24 "GENENTECH Performance Compensation" has the meaning set forth in
----------------------------------
Section 13.1.1. hereof.
1.25 "GENENTECH Products" means all pharmaceutical preparations for human
------------------
use which contain the GENENTECH Compounds ([*]) as a therapeutically active
ingredient, including GENENTECH Combination Products, and that are approved by
any Regulatory Authority in the Territory during the Co-promotion Term of this
Agreement. GENENTECH Products shall be in filled and finished (packaged) form
for use by the end-user. Notwithstanding the foregoing [*] (including, without
limitation, all [*]) shall [*] to be a GENENTECH Product.
1.26 "GENENTECH Sales Force" has the meaning set forth in Section 4.8.3.1
---------------------
hereof.
1.27 "GENENTECH Trademarks" mean the TNKase(TM) and Activase(R) trademarks
--------------------
and any other trademark or trade name (whether registered or unregistered) used
on or with the GENENTECH Products or in any promotional material related to the
GENENTECH Products in the Territory during the Co-promotion Term (other than the
name and logo of the INTEGRILIN PARTNERS or any of their Affiliates), subject to
the terms of this Agreement.
1.28 "IND" means an Investigational New Drug Application, as defined in the
---
United States Federal Food, Drug and Cosmetic Act and applicable regulations
promulgated thereunder as amended from time to time, filed in the United States.
1.29 "INTEGRILIN Baseline Annual Sales" has the meaning set forth in
---------------------------------
Section 13.1.2 hereof.
1.30 "INTEGRILIN Combination Product" means any Product that contains the
------------------------------
INTEGRILIN Compound in combination with one or more other pharmaceutically
active ingredients.
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
5.
1.31 "INTEGRILIN Compound" means the compound whose chemical formula is
-------------------
N/6/-(aminoiminomethyl)-N/2/-(3-mercapto-1-oxopropyl-L-lyslglycl-L--aspartyl-L-
tryptophyl-L-prolyl-L-cysteinamide, cyclic (1-->6)-disulfide.
1.32 "INTEGRILIN Net Sales" means for an applicable accounting period,
--------------------
the gross amount invoiced for the INTEGRILIN Products for sales by the
INTEGRILIN Partners or their Affiliates [*] to Third Parties that are [*] less
the following amounts [*]:
(i) trade, quantity and cash discounts or rebates actually and lawfully
allowed and taken and any other similar adjustments, including,
without limitation, those granted on account of price adjustments,
billing errors, rejected goods, and damaged goods;
(ii) price reductions, credits, rebates, product returns, charge-back and
prime vendor rebates, fees, reimbursements or similar payments or
adjustments actually granted or given to [*], health care insurance
carriers, pharmacy benefit management companies, health maintenance
organizations or other institutions or health care organizations;
(iii) any sales or use tax, customs duties, excise or other duties or
other governmental charge (other than an income tax) levied on the
sale, transportation or delivery of the INTEGRILIN Products;
(iv) price reductions, credits, rebates, charge-back and prime vendor
rebates, fees, reimbursements or similar payments or adjustments
actually granted or given in connection with INTEGRILIN Product
sales to any governmental or regulatory authority in respect of any
state or federal Medicare, Medicaid, Veterans Affairs, or similar
programs; and
(v) any charge for freight, insurance or other transportation costs
charged to the customer to the extent included on the same invoice
as INTEGRILIN Product.
Sales of the INTEGRILIN Products between the INTEGRILIN PARTNERS and
their Affiliates [*] sales to Third Parties [*] sales result in such Affiliates
[*] of the INTEGRILIN Products) and [*] Net Sales calculations. Subject to the
foregoing, Net Sales shall be determined in accordance with U.S. generally
accepted accounting principles, consistently applied. If an INTEGRILIN Product
is sold for compensation other than cash, Net Sales shall be calculated based on
the fair market value of the INTEGRILIN Products in cash. The fair market value
for an INTEGRILIN Product shall be the [*] for the INTEGRILIN Product for the
[*]. Net Sales of INTEGRILIN Products used in clinical trials or for
promotional or sampling purposes shall be deemed to be zero.
With respect to sales of INTEGRILIN Combination Products, Net Sales
shall be calculated on the basis of the [*] of the [*] of INTEGRILIN Compound in
the INTEGRILIN
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
6.
Products then being sold by the INTEGRILIN PARTNERS without [*] in the
Territory, if such exists.
1.33 "INTEGRILIN PARTNERS Know-How" means all proprietary information
----------------------------
regarding the Integrilin Compound or the Integrilin Products that is now or may
hereafter during the term of this Agreement be controlled by INTEGRILIN PARTNERS
or either of them or any of their Affiliates.
1.34 "INTEGRILIN Patents" means all patents and patent applications in the
------------------
Territory which are or become Controlled by either of the INTEGRILIN PARTNERS or
any of their Affiliates which patents generically or specifically claim the
composition or use of any INTEGRILIN Product in the Territory, including without
limitation all continuations, continuations-in-part, divisions, patents of
addition, reissues, renewals, substitutions, registrations, confirmations or
extensions thereof.
1.35 "INTEGRILIN Performance Compensation" has the meaning set forth in
-----------------------------------
Section 13.2.1 hereof.
1.36 "INTEGRILIN Products" means all pharmaceutical preparations for human
-------------------
use which contain the INTEGRILIN Compound (or any other parenteral GP IIb-IIIa
inhibitor compound acquired by an INTEGRILIN PARTNER not in violation of this
Agreement) as a therapeutically active ingredient, including INTEGRILIN
Combination Products, and that are approved by any Regulatory Authority in the
Territory during the Co-promotion Term of this Agreement. Products shall be in
filled and finished (packaged) form for use by the end-user.
1.37 "INTEGRILIN Reported Sales" means the sum of sales of INTEGRILIN
-------------------------
Products reported to the INTEGRILIN PARTNERS from [*]. To prevent double
counting of sales, if any of the foregoing sources begins incorporating data
into its reports that is also included in the reports of one of the other
sources, such data will be included in INTEGRILIN Reported Sales only once in
total, rather than once for each reporting entity. In the event that there is a
disruption in the receipt of data from any of the foregoing sources, the parties
will mutually agree on a method of estimation.
1.38 "INTEGRILIN Sales Force" has the meaning set forth in Section 4.8.1.1
----------------------
hereof.
1.39 "INTEGRILIN Trademark" mean the INTEGRILIN(R) trademark and any other
--------------------
trademark or trade name (whether registered or unregistered) used on or with the
INTEGRILIN Products or in any promotional material related to the INTEGRILIN
Products in the Territory during the Co-promotion Term (other than the name and
logo of GENENTECH or any of its Affiliates), subject to the terms of this
Agreement.
1.40 "Joint Hospitals" has the meaning set forth in Section 4.7.1.
---------------
1.41 "Laws" shall mean all laws, statutes, rules, regulations, ordinances
----
and other pronouncements having the effect of law of any government or
Regulatory Authority.
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
7.
1.42 "NDA" shall mean a New Drug Application (including a Supplemental New
---
Drug Application) or Biologics License Application (including amendments
thereto), as the case may be, as defined in the United States Federal Food, Drug
and Cosmetic Act and applicable regulations promulgated thereunder as amended
from time to time, filed in the United States.
1.43 "NDA Approval" shall mean the marketing clearance granted by the FDA
------------
required for the marketing and promotion of the Products in the United States.
1.44 "Party" means SCHERING, COR or GENENTECH, as the case may be.
-----
1.45 "Performance Compensation" means the GENENTECH Performance
------------------------
Compensation or the INTEGRILIN Performance Compensation
1.46 "Person" means an individual, corporation, partnership, limited
------
liability company, trust, business trust, association, joint stock company,
joint venture, pool, syndicate, sole proprietorship, unincorporated
organization, governmental authority, or any other form of entity not
specifically listed herein.
1.47 "Products" means the GENENTECH Products and the INTEGRILIN Products.
--------
1.48 "Promotion" means those activities normally undertaken by a
---------
professional sales representative of a pharmaceutical company to implement
promotion plans for a particular prescription pharmaceutical product aimed at
encouraging the appropriate use of such product by a health care professional
with actual prescribing authority. When used as a verb, "promote" shall mean to
engage in such activities.
1.49 "Regulatory Approval" means any approvals (including pricing and
-------------------
reimbursement approvals, if required in the Territory), licenses, regulatory
approvals or authorizations of any Regulatory Authority, necessary for the
manufacture, import and sale of Products in the Territory.
1.50 "Regulatory Authority" means any regulatory agency or other
--------------------
governmental instrumentality that has regulatory authority, anywhere or at any
governmental level, in the Territory over the development, marketing or
commercialization of the Products.
1.51 "Sales Force Personnel" means a Party's and/or its Affiliates' sales
---------------------
force representatives that are involved in the Promotion of the Products in the
Territory.
1.52 "Serious adverse event" and "Non-serious adverse event" shall have the
---------------------- -------------------------
following meanings: A "serious adverse event" for the Products is defined as
any untoward medical occurrence that at any dose for a Product: (i) results in
death; (ii) is life-threatening; (iii) requires inpatient hospitalization or
prolongation of existing hospitalization; (iv) results in persistent or
significant disability/incapacity; (v) is a congenital anomaly/birth defect or
(vi) does not meet any of the previous serious criteria but may jeopardize the
patient and may require medical or surgical intervention to prevent one of the
outcomes listed above. A "non-serious
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
8.
adverse event" for the Products is any untoward medical occurrence that does not
meet the aforementioned serious criteria.
1.53 "Strategic Promotional Decisions" for a Product shall mean: [*]
-------------------------------
and [*]; [*] including [*] programs; [*]; [*] of existing and new [*] including
but not limited to the [*]; development of [*] for the Product; [*]; development
of [*]; and [*] and other professional relations events of specific interest to
physicians. Strategic Promotional Decisions for a Product shall also include all
Product marketing-related issues that directly affect the commercial valuation
and/or competitive positioning of the Products in the Territory.
1.54 "Target Bonus" means the [*] incentive compensation plan payment
------------
for achievement of [*] of sales goals and/or of median sales performance. Such
incentive compensation plan will be quantitatively based (vs. activity based)
and will be intended to achieve and/or exceed the annual sales objectives
contemplated by this Agreement. The Parties acknowledge and agree that each
Party shall be responsible, at its own expense, for acquiring the data necessary
to determine the size of Target Bonuses.
1.55 "Technology" means any information, data (including without
----------
limitation pre-clinical data and clinical data), processes and other technology
relating to the Products.
1.56 "Territory" means the fifty (50) states of the United States of
---------
America and the District of Columbia. For sake of clarity, "Territory" does not
include any U.S. possession and territory or Puerto Rico.
1.57 "Third Party(ies)" means any Person other than: (1) SCHERING, COR
----------------
and GENENTECH, (2) any Affiliates of SCHERING, COR or GENENTECH and (3)
F.Hoffmann-La Roche Ltd and its Affiliates (other than wholly owned subsidiaries
of Genentech).
Article 2. Grant of Rights to the INTEGRILIN PARTNERS; GENENTECH Reserved
--------------------------------------------------------------
Rights; Non-Competition; Extensions of Exclusivity.
---------------------------------------------------
2.1 Engagement of the INTEGRILIN PARTNERS. GENENTECH hereby grants to
-------------------------------------
the INTEGRILIN PARTNERS the co-exclusive right with GENENTECH and its licensee
Actelion Ltd. to promote the GENENTECH Products during the Co-promotion Term,
within the Territory, upon the terms and conditions set forth in this Agreement.
The INTEGRILIN PARTNERS' co-promotion rights under this Agreement shall be
exclusive as to any Third Party within the Territory (other than Actelion Ltd.),
and GENENTECH may not, without the prior written consent of the INTEGRILIN
PARTNERS enter into any agreement with a Third Party (other than Actelion Ltd.)
to promote or market the GENENTECH Products in the Territory, during the Co-
promotion Term. The INTEGRILIN PARTNERS shall have the right to enter into any
written agreement with one or more of their Affiliates with respect to any
right, representation, warranty, or obligation of the INTEGRILIN PARTNERS under
this Agreement; provided, that the INTEGRILIN PARTNERS shall remain [*] and
--------
responsible with such Affiliate for the performance of any obligations,
representations or warranties delegated, contracted, assigned or otherwise
transferred. The INTEGRILIN PARTNERS shall not promote
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
9.
or market the GENENTECH Products except in accordance with the rights expressly
granted to it under, and in accordance with the terms of, this Agreement.
2.2 GENENTECH Reserved Rights. GENENTECH reserves all rights in and to
-------------------------
the GENENTECH Products not expressly granted under this Agreement. The
INTEGRILIN PARTNERS agree that they will not practice any rights reserved by
GENENTECH in and to the GENENTECH Products that are not expressly granted to the
INTEGRILIN PARTNERS under this Agreement.
2.3 Noncompetition. During the Co-promotion Term and for [*] thereafter,
--------------
the INTEGRILIN PARTNERS and their Affiliates shall not market, promote or
otherwise sell within the Territory any [*] drug product that is approved by the
FDA for marketing for the treatment of [*] of the [*] listed on Exhibit 2.3 for
-----------
which a GENENTECH Product has been approved (a "Competing Thrombolytic
Product"); provided, that
--------
2.3.1 said [*] post-Co-promotion Term restriction shall be
inapplicable if this Agreement shall have been terminated pursuant to any of
Sections 15.2.1, 15.2.2, 15.2.3 or 15.2.5, hereof; and
2.3.2 this Section 2.3 shall not apply with respect to a given [*]
for a given [*] if, prior to the submission of an NDA for such primary
indication, GENENTECH shall have given its prior written consent to that effect
(to be given or withheld in GENENTECH'S sole discretion).
For sake of clarity and avoidance of doubt, any breach by the INTEGRILIN
PARTNERS and/or their Affiliates of the terms of this Section 2.3 shall, in
addition to any remedies to which GENENTECH may have hereunder or at law or in
equity, entitle GENENTECH to terminate this Agreement upon [*] prior written
notice to the INTEGRILIN PARTNERS, unless the INTEGRILIN PARTNERS, within such
[*] cease the breaching activity (or causes their Affiliate(s) to cease such
breaching activity) and provides reasonable assurances to GENENTECH that [*]
during the Co-promotion Term. In the event that the INTEGRILIN PARTNERS or any
of their Affiliates breach this provision [*] during the Co-promotion Term,
GENENTECH shall be entitled to [*] to the INTEGRILIN PARTNERS, [*] any [*] on
the part of the INTEGRILIN PARTNERS to [*] and [*]
The Parties further agree that the [*] of [*] by the [*] and/or their
Affiliates in [*] this Section 2.3 may [*] to [*] for which [*] may not [*]. In
the event [*] shall [*], upon [*] to a [*] and [*] to any [*] as may be provided
for in this Agreement, [*], in addition to [*] it may have [*].
2.4 Effect of Acquisition of Competing Product.
-------------------------------------------
2.4.1 In the event that during the Co-promotion Term:
2.4.1.1 a Person becomes an Affiliate of a INTEGRILIN PARTNER
after the Effective Date, or
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
10.
2.4.1.2 an INTEGRILIN PARTNER or any of its Affiliates
merges or consolidates with any Third Party, (each of the foregoing, a
"Triggering Event"), and such Person or Third Party (or any Affiliate of such
Person or Third Party) is then marketing a Competing Thrombolytic Product in the
Territory, or [*] to [*] of a Competing Thrombolytic Product in the Territory
during the Co-promotion Term, then, within [*] after the applicable Triggering
Event, the applicable INTEGRILIN PARTNER shall notify GENENTECH in writing of
such circumstances, and GENENTECH shall have the right:
2.4.1.3 to terminate this Agreement by notifying the
INTEGRILIN PARTNERS in writing within [*] after the applicable Triggering Event,
in which event such termination shall be effective as of the date that is [*]
after receipt of such written notice by the INTEGRILIN PARTNER. If this
Agreement is to be terminated by GENENTECH as a result of a Triggering Event,
each Party shall continue to perform its duties under this Agreement in
accordance with the terms hereof until the actual termination date, provided,
--------
however, that any monies which would, but for such termination, otherwise be
- -------
paid to the INTEGRILIN PARTNERS pursuant to Article 13 with respect to periods
subsequent to such termination shall not be due to the INTEGRILIN PARTNERS, and
any such monies which have been paid in advance shall be promptly returned to
GENENTECH;
2.4.1.4 In the event that GENENTECH does not provide
timely notice of its intention to terminate, as set forth above, then GENENTECH
shall be deemed to have waived such termination right, and GENENTECH may not
subsequently exercise any termination remedy hereunder with respect to the
marketing of such Competing Thrombolytic Product by the INTEGRILIN PARTNERS
(with respect to the [*] such Competing Thrombolytic Product is then being
marketed but not [*] for which such Competing Thrombolytic Product may [*]).
2.4.1.5 In the event that GENENTECH notifies the
INTEGRILIN PARTNERS of its decision to terminate this Agreement pursuant to
Section 2.4.1.3 above, GENENTECH agrees to meet with the INTEGRILIN PARTNERS,
upon the request of the INTEGRILIN PARTNERS and within [*] after the Triggering
Event, to determine whether there are any mutually acceptable changes to this
Agreement that could be made that would allow GENENTECH to avoid termination of
this Agreement. In the event that the Parties are unable to agree in writing
upon such mutually acceptable changes within [*] of the Triggering Event, this
Agreement shall terminate as of the date that is thirty (30) days thereafter.
2.4.2 Nothing in this Section 2.4 is intended to affect the
INTEGRILIN PARTNERS' or GENENTECH'S obligations, covenants, warranties,
representations set forth in other sections of this Agreement.
Article 3. Grant of Rights to GENENTECH; INTEGRILIN PARTNERS Reserved Rights;
------------------------------------------------------------------
Non-Competition; Extensions of Exclusivity.
-------------------------------------------
3.1 Engagement of GENENTECH. The INTEGRILIN PARTNERS hereby grant to
-----------------------
GENENTECH the co-exclusive right with the INTEGRILIN PARTNERS to promote the
INTEGRILIN Products during the Co-promotion Term, within the Territory, upon the
terms and
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
11.
conditions set forth in this Agreement. GENENTECH's co-promotion rights under
this Agreement shall be exclusive as to any Third Party within the Territory,
and the INTEGRILIN PARTNERS may not, without the prior written consent of
GENENTECH, enter into any agreement with a Third Party to promote or market the
INTEGRILIN Products in the Territory, during the Co-promotion Term. GENENTECH
shall have the right to enter into any written agreement with one or more of its
Affiliates with respect to any right, representation, warranty, or obligation of
GENENTECH under this Agreement; provided, that GENENTECH shall remain [*] and
--------
responsible with such Affiliate for the performance of any obligations,
representations or warranties delegated, contracted, assigned or otherwise
transferred. GENENTECH shall not promote or market the INTEGRILIN Products
except in accordance with the rights expressly granted to it under, and in
accordance with the terms of, this Agreement.
3.2 INTEGRILIN PARTNERS Reserved Rights. The INTEGRILIN PARTNERS reserve
-----------------------------------
all rights in and to the INTEGRILIN Product not expressly granted under this
Agreement. GENENTECH agrees that it will not practice any rights in and to the
INTEGRILIN Products reserved by the INTEGRILIN PARTNERS that are not expressly
granted to GENENTECH under this Agreement.
3.3 Noncompetition. During the Co-promotion Term and for [*] thereafter,
--------------
GENENTECH and its Affiliates shall not market, promote or otherwise sell within
the Territory any [*] drug product that is approved by the FDA for marketing for
the treatment of [*] of the [*] listed on Exhibit 3.3 for which an INTEGRILIN
-----------
Product has been approved (a "Competing GP IIb-IIIa Inhibitor Product");
provided, that
- --------
3.3.1 said [*] post-Co-promotion Term restriction shall be
inapplicable if this Agreement shall have been terminated pursuant to any of
Sections 15.2.1, 15.2.2, 15.2.3 or 15.2.5 hereof; and
3.3.2 this Section 3.3 shall not apply with respect to a given [*]
for a given [*] if, prior to the submission of an NDA for such primary
indication, the INTEGRILIN PARTNERS shall have given their prior written consent
to that effect (to be given or withheld in their sole discretion).
For sake of clarity and avoidance of doubt, any breach by GENENTECH
and/or its Affiliates of the terms of this Section 3.3 shall, in addition to any
remedies to which the INTEGRILIN PARTNERS may have hereunder or at law or in
equity, entitle the INTEGRILIN PARTNERS to terminate this Agreement upon [*]
prior written notice to GENENTECH, unless GENENTECH, within such [*], ceases the
breaching activity (or causes its Affiliate(s) to cease such breaching activity)
and provides reasonable assurances to the INTEGRILIN PARTNERS [*] during the Co-
promotion Term. In the event that GENENTECH or any of its Affiliates breach
this provision [*] during the Co-promotion Term, the INTEGRILIN PARTNERS shall
be entitled to [*] to GENENTECH, [*] any [*] on the part of GENENTECH to [*] and
[*].
The Parties further agree that the [*] of a [*] by [*] and/or its
Affiliates in [*] this Section 3.3 may [*] to the [*] for which [*] may not [*].
In the event of [*] shall [*], upon [*] to
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
12.
a [*] and [*] to any [*] as may be provided for in this Agreement, [*], in
addition to [*] it may have [*].
3.4 Effect of Acquisition of Competing GP IIb-IIIa Inhibitor Product.
-----------------------------------------------------------------
3.4.1 In the event that during the Co-promotion Term:
3.4.1.1 a Person becomes an Affiliate of GENENTECH after the
Effective Date, or
3.4.1.2 GENENTECH or any of its Affiliates merges or
consolidates with any Third Party, (each of the foregoing, a "Triggering
Event"), and such Person or Third Party (or any Affiliate of such Person or
Third Party) is then marketing a Competing GP IIb-IIIa Inhibitor Product in the
Territory, or [*] to [*] of a Competing GP IIb-IIIa Inhibitor Product in the
Territory during the Co-promotion Term, then, within [*] after the applicable
Triggering Event, GENENTECH shall notify the INTEGRILIN PARTNERS in writing of
such circumstances, and the INTEGRILIN PARTNERS shall have the right:
3.4.1.3 to terminate this Agreement by notifying GENENTECH
in writing within [*] after the applicable Triggering Event, in which event such
termination shall be effective as of the date that is [*] after receipt of such
written notice by GENENTECH. If this Agreement is to be terminated by the
INTEGRILIN PARTNERS as a result of a Triggering Event, each Party shall continue
to perform its duties under this Agreement in accordance with the terms hereof
until the actual termination date, provided, however, that any monies which
-------- -------
would, but for such termination, otherwise be paid to GENENTECH pursuant to
Articles 7 and 13 with respect to periods subsequent to such termination shall
not be due to GENENTECH, and any such monies which have been paid in advance
shall be promptly returned to the INTEGRILIN PARTNERS;
3.4.1.4 In the event that the INTEGRILIN PARTNERS do not
provide timely notice of their intention to terminate, as set forth above, then
the INTEGRILIN PARTNERS shall be deemed to have waived such termination right,
and the INTEGRILIN PARTNERS may not subsequently exercise any termination remedy
hereunder with respect to the marketing of such Competing GP IIb-IIIa Inhibitor
Product by GENENTECH (with respect to [*] such Competing GP IIb-IIIa Inhibitor
Product is then being marketed but not [*] for which such Competing GP IIb-IIIa
Inhibitor Product may [*]).
3.4.1.5 In the event that the INTEGRILIN PARTNERS notify
GENENTECH of their decision to terminate this Agreement pursuant to Section
3.4.1.3 above, the INTEGRILIN PARTNERS agree to meet with GENENTECH, upon the
request of GENENTECH and within [*] after the Triggering Event, to determine
whether there are any mutually acceptable changes to this Agreement that could
be made that would allow the INTEGRILIN PARTNERS to avoid termination of this
Agreement. In the event that the Parties are unable to agree in writing upon
such mutually acceptable changes within [*] of the Triggering Event, this
Agreement shall terminate as of the date that is thirty (30) days thereafter.
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
13.
3.4.2 Nothing in this Section 3.4 is intended to affect
GENENTECH's or the INTEGRILIN PARTNERS' obligations, covenants, warranties,
representations set forth in other sections of this Agreement.
Article 4. Promotion, Commercialization and Distribution of Products.
---------------------------------------------------------
4.1 General Diligence Obligation. Subject to the terms and conditions of
----------------------------
this Agreement, each Party will exercise Diligent Efforts (i) to promote the
GENENTECH Products in the Territory during the Co-promotion Term in accordance
with the terms of this Agreement, and with applicable law; and (ii) to promote
the INTEGRILIN Products in the Territory during the Co-promotion Term in
accordance with the terms of this Agreement, and with applicable law. All such
activity shall occur [*] except as may otherwise be expressly provided by this
Agreement.
4.2 Strategic Promotional Decisions. Except as otherwise expressly set
-------------------------------
forth in this agreement: (i) GENENTECH will be responsible for all Strategic
Promotional Decisions regarding [*]; and (ii) the INTEGRILIN PARTNERS will be
responsible for all Strategic Promotional Decisions regarding [*]. The Parties
shall provide timely updates to any changes in Strategic Promotional Decisions
to enable the Parties to carry out their respective duties under this Agreement.
The Parties acknowledge and agree that it is a Strategic Promotional Decision
for [*] to [*] customers to [*] customers for the [*] of [*].
4.3 Sales Force Coordination. The Parties shall coordinate with each
-------------------------
other with respect to Sales Force Personnel communication activities and
training regarding the Products.
4.4 Regulatory Approvals. GENENTECH shall have [*] and [*] and [*] for
--------------------
obtaining, at [*] all Regulatory Approvals related to the GENENTECH Products and
to the use of promotional and advertising materials or programs [*] GENENTECH,
and will use Diligent Efforts to [*] same on a timely basis. The INTEGRILIN
PARTNERS shall have [*] and [*] and [*] for obtaining, at the [*] all Regulatory
Approvals related to the INTEGRILIN Products and to use of promotional and
advertising materials or programs [*] the INTEGRILIN PARTNERS, and will use
Diligent Efforts to [*] same on a timely basis.
4.5 Managed Care and Formulary Relationships. GENENTECH shall retain [*]
----------------------------------------
for all contractual relationships for the GENENTECH Products with formularies
(including managed care, group purchasing organizations and hospital), insurers,
and governmental agencies and instrumentalities (including without limitation
Medicare, Medicaid, the Veterans Administration, and military entities). The
INTEGRILIN PARTNERS shall retain [*] for all contractual relationships for the
INTEGRILIN Products with formularies (including managed care, group purchasing
organization and hospital), insurers, and governmental agencies and
instrumentalities (including without limitation Medicare, Medicaid, the Veterans
Administration, and military entities). The Parties acknowledge that it is their
intention [*] with respect to strategy for obtaining and maintaining
contractual/formulary relationships for the Products with such entities, and [*]
in obtaining entry into such entities for the sale of the Products and
subsequent pull-through sales of the Products.
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
14.
4.6 No Adverse Change to a Party's Rights Without Its Consent.
---------------------------------------------------------
Notwithstanding any term or condition of this Agreement that may state or imply
to the contrary:
4.6.1 No Party shall be required to follow the Strategic
Promotional Decisions or any Promotion decision or guideline determined or
promulgated by another Party under this Agreement, where the adversely affected
Party believes in good faith based on opinion of counsel that doing so would
conflict in any material way with its obligations under applicable Law; and
4.6.2 Each Party agrees to use Diligent Efforts not to knowingly
make a Strategic Promotional Decision that would materially adversely affect any
of another Party's obligations, duties, rights or benefits under this Agreement,
or require the adversely affected Party to spend any funds or reimburse or
absorb any costs that are not expressly provided for under this Agreement,
without the adversely affected Party's prior written consent (not to be
unreasonably withheld).
4.7 Sales Force Deployment. The following terms shall apply to promotion
----------------------
of the Products in the Territory by GENENTECH and the INTEGRILIN PARTNERS under
this Agreement:
4.7.1 Hospitals. (a) The hospitals listed in Exhibit 4.7.1(a) (the
----------
"GENENTECH Hospitals") shall be targeted and promoted to [*] Sales Force.
(b) The hospitals listed in Exhibit 4.7.1(b) (the "Joint Hospitals")
shall be targeted [*] Sales Force.
(c) All hospitals in the Territory other than the GENENTECH Hospitals
and the Joint Hospitals may be targeted by both the INTEGRILIN Sales Force and
the GENENTECH Sales Force, at each such Party's discretion.
(d) Within [*] of the end of each Agreement Quarter, at the option of
the INTEGRILIN PARTNERS and upon written notice to GENENTECH, any GENENTECH
HOSPITAL which undergoes a Change in Control after which it or the surviving
entity is, or is an Affiliate of, a Joint Hospital, shall no longer be deemed a
GENENTECH Hospital and shall become a Joint Hospital for purposes of this
Agreement. Exhibit 4.7.1(a) and Exhibit 4.7.1(b) shall be deemed to have been
amended upon the date that GENENTECH receives such notice under this Section.
(e) On the date which is [*], in the event that [*] have been made in
a given GENENTECH Hospital, at the option of [*] and upon written notice to [*],
such [*] will no longer be [*] and shall become [*] for purposes of this
Agreement. [*] and [*] shall be deemed to have been amended upon the date that
[*] receives such notice under this Section.
4.7.2 Use of Independent Contractors. Each Party agrees not to use
------------------------------
any independent contractors to [*] with respect to its Sales Force Personnel
under this Agreement,
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
15.
provided that nothing herein shall limit a Party's ability to use independent
- --------
contractors to [*] its obligations under this Agreement.
4.7.3 Percentage of Time Spent Promoting GENENTECH Products and
---------------------------------------------------------
INTEGRILIN Products. Each member of the GENENTECH Sales Force shall spend that
- -------------------
percentage of his/her business time promoting the INTEGRILIN Products that is
equal to the INTEGRILIN Product Percentage set forth in Section 4.13. Each
member of the INTEGRILIN Sales Force shall spend that percentage of his/her
business time promoting the GENENTECH Products equal to the GENENTECH Product
Percentage set forth in Section 4.12.
4.8 Sales Forces.
-------------
4.8.1 INTEGRILIN Sales Force.
----------------------
4.8.1.1 INTEGRILIN Sales Force Composition. The INTEGRILIN
----------------------------------
PARTNERS will use Diligent Efforts to deploy, on an average daily basis for each
Agreement Quarter in each Agreement Year, a sales force of [*] trained
INTEGRILIN PARTNERS representatives [*] in the field to promote the Products to
hospital-based physicians hereof (the "INTEGRILIN Sales Force"). These
representatives will be [*] of an INTEGRILIN PARTNER or an Affiliate of an
INTEGRILIN PARTNER. The relevant INTEGRILIN PARTNER will treat its Sales Force
Personnel as its employees for all purposes, including, but not limited to
federal, state and local tax and employment Laws
In the event that the INTEGRILIN PARTNERS fail on an average daily
basis for a given Agreement Quarter to meet their obligation to maintain [*] of
their [*] trained [*] in the INTEGRILIN Sales Force, they shall present to
GENENTECH a plan within [*] after the end of such Agreement Quarter as to how
the INTEGRILIN PARTNERS will correct such deficiency by the end of the
immediately succeeding Agreement Quarter. If such deficiency is not cured by
the end of the immediately succeeding Agreement Quarter (i.e., such that the
average daily number of representatives for the Agreement Quarter of such
deficiency and the immediately following Agreement Quarter do not exceed on an
average daily basis [*] of the [*] required to be maintained by the INTEGRILIN
PARTNERS in the INTEGRILIN Sales Force), and if GENENTECH does not have an
uncured breach under Section 4.8.3.1, then, for sake of clarity and avoidance of
doubt, the INTEGRILIN PARTNERS shall be deemed to have materially breached this
Agreement and GENENTECH shall be entitled to terminate this Agreement upon [*]
written notice given at any time within the [*] period after GENENTECH has
learned of such deficiency in writing from the INTEGRILIN PARTNERS.
4.8.1.2 Sales Force Tracking. In order to enforce the
--------------------
provisions of Section 4.8.1.1, within [*] of the end of each month during the
Co-promotion Term, the INTEGRILIN PARTNERS shall deliver to GENENTECH, through
the JPT, a report specifying the number of INTEGRILIN Sales Force Personnel that
were in the field to promote the Products on the last day of such month.
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
16.
4.8.2 Provisions Applicable to the INTEGRILIN Sales Force Personnel.
-------------------------------------------------------------
The following shall apply to all the INTEGRILIN Sales force Personnel:
4.8.2.1 Noncompliance by Representative. In the event that
-------------------------------
information comes to GENENTECH's attention such that GENENTECH has a reasonable
basis for believing that any INTEGRILIN Sales Force Personnel may have (i)
violated any applicable Laws, or (ii) failed to [*] comply with this Agreement,
GENENTECH shall have the right to request the INTEGRILIN PARTNERS [*] in
addition to any other rights or remedies available to GENENTECH under this
Agreement, at law or in equity. The INTEGRILIN PARTNERS shall promptly use
Diligent Efforts to evaluate and, if needed, resolve such issue in accordance
with its policies or as it may otherwise deem appropriate. The INTEGRILIN
PARTNERS shall keep GENENTECH informed of the progress of, and information
learned during, its evaluation, and shall provide GENENTECH with a reasonably
detailed written report summarizing any steps taken toward resolution of the
matter within [*] after same.
4.8.2.2 No Participation in GENENTECH Benefit Plans. The
-------------------------------------------
INTEGRILIN PARTNERS acknowledge and agree that all the INTEGRILIN Sales Force
Personnel are not, and are not intended to be or be treated as, employees of
GENENTECH or any of its Affiliates, and that such individuals are not, and are
not intended to be, eligible to participate in any benefits programs or in any
"employee benefit plans", as such term is defined in section 3(3) of ERISA, that
are sponsored by GENENTECH or any of its Affiliates or that are offered from
time to time by GENENTECH or its Affiliates to their own employees (the
"GENENTECH Benefit Plans"). All matters of compensation, benefits and other
terms of employment for any such personnel shall be solely a matter between the
employing INTEGRILIN PARTNER and such individual. The employing INTEGRILIN
PARTNER shall be solely responsible and liable for the payment of all
compensation and benefits under any such employee benefit plan to its Sales
Force Personnel.
GENENTECH shall not be responsible to the INTEGRILIN PARTNERS or to
their Sales Force Personnel used by it to promote or detail the Products for any
compensation, expense reimbursements or benefits (including, without limitation,
vacation and holiday remuneration, healthcare coverage or insurance, life
insurance, pension or profit-sharing benefits and disability benefits), payroll-
related taxes or withholdings, or any governmental charges or benefits
(including without limitation unemployment and disability insurance
contributions or benefits and workmen' compensation contributions or benefits)
that may be imposed upon or be related to the performance by the INTEGRILIN
PARTNERS and their Sales Force Personnel of their obligations under this
Agreement, all of which shall be the sole responsibility of the INTEGRILIN
PARTNERS, even if it is subsequently determined by any court, the IRS or any
other governmental agency that such individual may be a common law employee of
GENENTECH or any of its Affiliates.
4.8.2.3 INTEGRILIN PARTNER Responsibility for Acts and
----------------------------------------------
Omissions of its Personnel. The employing INTEGRILIN PARTNER shall be solely
- --------------------------
responsible for its acts and omissions and for those acts or omissions of its
Sales Force Personnel while performing any of the services to be provided by the
INTEGRILIN PARTNERS under this Agreement.
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
17.
4.8.2.4 Sole Responsibility for Disciplinary Actions of Employees.
---------------------------------------------------------
The employing INTEGRILIN PARTNER shall be solely responsible and liable for all
probationary and termination actions taken by it, as well as for the
formulation, content, and for the dissemination (including content) of all
employment policies and rules (including written probationary and termination
policies) applicable to its employees.
4.8.2.5 Reassignment/Non-solicitation.
------------------------------
4.8.2.5.1 COR will not, without the written consent of
GENENTECH, reassign in any Agreement Year [*], to other sales forces of COR or
the INTEGRILIN PARTNERS during the Co-promotion Term. GENENTECH and its
Affiliates shall not [*] (either directly or through recruiters) for employment
the INTEGRILIN PARTNERS' or their Affiliates' [*] directly involved in the
performance of the INTEGRILIN PARTNERS' obligations under this Agreement.
4.8.2.5.2 SCHERING will not, without the written consent
of GENENTECH, reassign in any Agreement Year more than [*] to other sales forces
of SCHERING or the INTEGRILIN Partners during the Co-promotion Term. GENENTECH
and its Affiliates shall not [*] (either directly or through recruiters) for
employment the INTEGRILIN PARTNERS' or their Affiliates' [*] directly involved
in the performance of the INTEGRILIN PARTNERS' obligations under this Agreement.
4.8.2.6 Indemnification for Employee Reclassification.
4.8.2.6.1 The employing INTEGRILIN PARTNER will
indemnify, defend, and hold harmless the other Parties and their respective
Affiliates, and their directors, employees and agents (collectively, the
"GENENTECH Indemnitees") from and against any damages, liability, loss and costs
that may be paid or payable by any such GENENTECH Indemnitee resulting from or
in connection with any claim or other cause of action asserted by any of the
employing INTEGRILIN PARTNER's Sales Force Personnel, or by any Third Party
(including without limitation federal, state or local governmental authorities)
arising out of the execution and/or performance of this Agreement that is based
on or with respect to:
4.8.2.6.1.1. costs, damages and losses that the
other Party or its Affiliates may incur resulting from any claims for benefits
that any of the employing INTEGRILIN PARTNER's Sales Force Personnel may make
under or with respect to any Benefit Plan of the GENENTECH Indemnitees; and
4.8.2.6.1.2. any payment or obligation to make
a payment to any of the employing INTEGRILIN PARTNER's Sales Force Personnel
relating in any way to any compensation, benefits of any type under any employee
benefit plan (as such term is defined in Section 3(3) of ERISA), and any other
bonus, stock option, stock purchase, incentive, deferred compensation,
supplemental retirement, severance and other similar fringe or employee benefit
plans, programs or arrangements that may be sponsored at any time by the
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
18.
GENENTECH Indemnitees or any of their Affiliates or by the employing INTEGRILIN
PARTNER or any of its Affiliates, even if it is subsequently determined by any
court, the IRS or any other governmental agency that any the employing
INTEGRILIN PARTNER's Sales Force Personnel may be a common law employee of the
GENENTECH Indemnitees; and
4.8.2.6.1.3. the payment or
withholding of any contributions, payroll taxes, or any other payroll-related
item by or on behalf of the employing INTEGRILIN PARTNER or any of its Sales
Force Personnel with respect to which the employing INTEGRILIN PARTNER or any of
its Sales Force Personnel may be responsible hereunder or pursuant to applicable
law to pay, make, collect, withhold or contribute, even if it is subsequently
determined by any court, the IRS or by any other governmental agency that any
such Sales Force Personnel may be a common law employee of the GENENTECH
Indemnitees or any of its Affiliates; and
4.8.2.6.1.4. failure of the employing
INTEGRILIN PARTNER to withhold or pay required taxes or failure to file required
forms with regard to compensation and benefits paid or extended by the employing
INTEGRILIN PARTNER to its Sales Force Personnel.
4.8.2.6.2 Notwithstanding anything to the
contrary in Section 4.8.2.6.1 above, the employing INTEGRILIN PARTNER shall have
no liability to any GENENTECH Indemnitee to the extent attributable to any
discriminatory, harassing or retaliatory acts of any GENENTECH Indemnitee, or
any tortious acts (including without limitation acts constituting assault,
battery or defamation) by any GENENTECH Indemnitee with respect to any the
employing INTEGRILIN PARTNER's Sales Force Personnel.
4.8.2.6.3 Nothing contained in this Section
4.8.2 is intended to affect or limit any Performance Compensation payable by
GENENTECH to the INTEGRILIN PARTNERS for the services rendered by the INTEGRILIN
PARTNERS pursuant to this Agreement.
4.8.3 GENENTECH Sales Force.
---------------------
4.8.3.1 GENENTECH Sales Force Composition. GENENTECH will use
---------------------------------
Diligent Efforts to deploy, on an average daily basis for each Agreement Quarter
in each Agreement Year, a sales force of [*] trained GENENTECH representatives
[*] in the field to promote the Products to hospital-based physicians hereof
(the "GENENTECH Sales Force"). These representatives will be [*]. GENENTECH will
treat its Sales Force Personnel as employees of GENENTECH for all purposes,
including, but not limited to federal, state and local tax and employment.
In the event that GENENTECH fails on an average daily basis for a
given Agreement Quarter to meet its obligation to maintain [*] of its one
hundred sixty-five (165) trained [*] in the GENENTECH Sales Force, it shall
present to the INTEGRILIN PARTNERS a plan within [*] after the end of such
Agreement Quarter as to how GENENTECH will correct
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
19.
such deficiency by the end of the immediately succeeding Agreement Quarter,
except as such period may be extended pursuant to the last sentence of this
paragraph. If such deficiency is not cured by the end of the immediately
succeeding Agreement Quarter (i.e., such that the average daily number of
representatives for the Agreement Quarter of such deficiency and the immediately
following Agreement Quarter do not exceed on an average daily basis [*] of the
representatives required to be maintained by GENENTECH in the GENENTECH Sales
Force), and if the INTEGRILIN PARTNERS do not have an uncured breach under
Section 4.8.1.1, then, for sake of clarity and avoidance of doubt, GENENTECH
shall be deemed to have materially breached this Agreement and the INTEGRILIN
PARTNERS shall be entitled to terminate this Agreement upon [*] written notice
given at any time within the [*] period after the INTEGRILIN PARTNERS has
learned of such deficiency in writing from GENENTECH.
4.8.3.2 Sales Force Tracking. In order to enforce the
--------------------
provisions of Section 4.8.3.1, within [*] of the end of each month during the
Co-promotion Term, GENENTECH shall deliver to the INTEGRILIN PARTNERS, through
the JPT, a report specifying the number of GENENTECH Sales Force Personnel that
were in the field to promote the Products on the last day of such month.
4.8.4 Provisions Applicable to the GENENTECH Sales Force Personnel.
------------------------------------------------------------
The following shall apply to all GENENTECH Sales Force Personnel:
4.8.4.1 Noncompliance by Representative. In the event that
-------------------------------
information comes to an INTEGRILIN PARTNERS' attention such that the INTEGRILIN
PARTNER has a reasonable basis for believing that any GENENTECH Sales Force
Personnel may have (i) violated any applicable Laws, or (ii) failed to [*]
comply with this Agreement, the INTEGRILIN PARTNER shall have the right to
request GENENTECH immediately to address the performance of such individual(s),
in addition to any other rights or remedies available to the INTEGRILIN PARTNERS
under this Agreement, at law or in equity. GENENTECH shall promptly use
Diligent Efforts to evaluate and, if needed, resolve such issue in accordance
with GENENTECH policies or as it may otherwise deem appropriate. GENENTECH shall
keep the INTEGRILIN PARTNERS informed of the progress of, and information
learned during, its evaluation, and shall provide the INTEGRILIN PARTNERS with a
reasonably detailed written report summarizing any steps taken toward resolution
of the matter within [*] after same.
4.8.4.2 No Participation in the INTEGRILIN PARTNERS' Benefit
----------------------------------------------------
Plans. GENENTECH acknowledges and agrees that all GENENTECH Sales Force
- -----
Personnel are not, and are not intended to be or be treated as, employees of
either INTEGRILIN PARTNER or any of its Affiliates, and that such individuals
are not, and are not intended to be, eligible to participate in any benefits
programs or in any "employee benefit plans", as such term is defined in section
3(3) of ERISA, that are sponsored by either INTEGRILIN PARTNER or any of its
Affiliates or that are offered from time to time by either INTEGRILIN PARTNER or
its Affiliates to their own employees (the "INTEGRILIN PARTNERS Benefit Plans").
All matters of compensation, benefits and other terms of employment for any such
personnel shall be solely a matter between GENENTECH and such individual.
GENENTECH shall be solely responsible
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
20.
and liable for the payment of all compensation and benefits under any such
employee benefit plan to its Sales Force Personnel.
The INTEGRILIN PARTNERS shall not be responsible to GENENTECH or to
its Sales Force Personnel used by it to promote or detail the Products for any
compensation, expense reimbursements or benefits (including, without limitation,
vacation and holiday remuneration, healthcare coverage or insurance, life
insurance, pension or profit-sharing benefits and disability benefits), payroll-
related taxes or withholdings, or any governmental charges or benefits
(including without limitation unemployment and disability insurance
contributions or benefits and workmen' compensation contributions or benefits)
that may be imposed upon or be related to the performance by GENENTECH and its
Sales Force Personnel of its obligations under this Agreement, all of which
shall be the sole responsibility of GENENTECH, even if it is subsequently
determined by any court, the IRS or any other governmental agency that such
individual may be a common law employee of an INTEGRILIN PARTNERS or any of its
Affiliates .
4.8.4.3 GENENTECH Responsibility for Acts and Omissions of its
------------------------------------------------------
Personnel. GENENTECH shall be solely responsible for its acts and omissions and
- ---------
for those acts or omissions of its Sales Force Personnel while performing any of
the services to be provided by GENENTECH under this Agreement.
4.8.4.4 GENENTECH Sole Responsibility for Disciplinary Actions
-------------------------------------------------------
of Its Employees. GENENTECH shall be solely responsible and liable for all
- ----------------
probationary and termination actions taken by it, as well as for the
formulation, content, and for the dissemination (including content) of all
employment policies and rules (including written probationary and termination
policies) applicable to its employees.
4.8.4.5 Reassignment/Nonsolicitation. GENENTECH will not,
----------------------------
without the written consent of the INTEGRILIN PARTNERS, reassign in any
Agreement Year [*] to other GENENTECH sales forces During the Co-promotion Term.
Neither COR nor SCHERING or its Affiliates shall [*] (either directly or through
recruiters) for employment GENENTECH's or its Affiliates' [*] directly involved
in the performance of GENENTECH's obligations under this Agreement.
4.8.4.6 Indemnification for Employee Reclassification.
---------------------------------------------
4.8.4.6.1 GENENTECH will indemnify, defend, and
hold harmless each INTEGRILIN PARTNER and its Affiliates, and its and their
directors, employees and agents (collectively, the "INTEGRILIN PARTNERS
Indemnitees") from and against any damages, liability, loss and costs that may
be paid or payable by any such INTEGRILIN PARTNERS Indemnitee resulting from or
in connection with any claim or other cause of action asserted by any GENENTECH
Sales Force Personnel, or by any Third Party (including without limitation
federal, state or local governmental authorities) arising out of the execution
and/or performance of this Agreement that is based on or with respect to:
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
21.
4.8.4.6.1.1. costs, damages and losses that the
INTEGRILIN PARTNER or its Affiliates may incur resulting from any claims for
benefits that any GENENTECH Sales Force Personnel may make under or with respect
to the INTEGRILIN PARTNER's Benefit Plan; and
4.8.4.6.1.2. any payment or obligation to make a
payment to any GENENTECH Sales Force Personnel relating in any way to any
compensation, benefits of any type under any employee benefit plan (as such term
is defined in Section 3(3) of ERISA), and any other bonus, stock option, stock
purchase, incentive, deferred compensation, supplemental retirement, severance
and other similar fringe or employee benefit plans, programs or arrangements
that may be sponsored at any time by GENENTECH or any of its Affiliates or by
the INTEGRILIN PARTNER or any of its Affiliates, even if it is subsequently
determined by any court, the IRS or any other governmental agency that any
GENENTECH Sales Force Personnel may be a common law employee of the INTEGRILIN
PARTNER or any of its Affiliates; and
4.8.4.6.1.3. the payment or withholding of any
contributions, payroll taxes, or any other payroll-related item by or on behalf
of GENENTECH or any of its Sales Force Personnel with respect to which GENENTECH
or any of its Sales Force Personnel may be responsible hereunder or pursuant to
applicable law to pay, make, collect, withhold or contribute, even if it is
subsequently determined by any court, the IRS or by any other governmental
agency that any such GENENTECH Sales Force Personnel may be a common law
employee of the INTEGRILIN PARTNER or any of its Affiliates; and
4.8.4.6.1.4. failure of GENENTECH to withhold or
pay required taxes or failure to file required forms with regard to compensation
and benefits paid or extended by GENENTECH to its Sales Force Personnel.
4.8.4.6.2 Notwithstanding anything to the contrary in
Section 4.8.4.6.1, GENENTECH shall have no liability to any INTEGRILIN PARTNERS
Indemnitee to the extent attributable to any discriminatory, harassing or
retaliatory acts of the INTEGRILIN PARTNERS or any INTEGRILIN PARTNERS
Indemnitee, or any tortious acts (including without limitation acts constituting
assault, battery or defamation) by the INTEGRILIN PARTNERS or any INTEGRILIN
PARTNERS Indemnitee, with respect to any GENENTECH Sales Force Personnel.
4.8.4.6.3 Nothing contained in this Section 4.8.4 is
intended to affect or limit any Performance Compensation payable by the
INTEGRILIN PARTNERS to GENENTECH for the services rendered by GENENTECH pursuant
to this Agreement.
4.9 Promotional and Advertising Responsibilities.
--------------------------------------------
4.9.1 Overall Responsibility. All advertising and promotional
----------------------
materials and literature to be used by the Parties in the Territory in
connection with the promotion of the GENENTECH Products in the field shall be
developed and provided to the INTEGRILIN
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
22.
PARTNERS or approved by GENENTECH, and the INTEGRILIN PARTNERS shall use only
those materials and literature provided or approved by GENENTECH in the
Promotion of the GENENTECH Products by them. All advertising and promotional
materials and literature to be used by the Parties in the Territory in
connection with the promotion of the INTEGRILIN Products in the field shall be
developed and provided to GENENTECH or approved by the INTEGRILIN PARTNERS, and
GENENTECH shall use only those materials and literature provided or approved by
the INTEGRILIN PARTNERS in the Promotion of the INTEGRILIN Products by it.
4.9.2 Duties of the INTEGRILIN PARTNERS. During the Co-promotion Term:
---------------------------------
4.9.2.1 the INTEGRILIN PARTNERS agree to instruct the INTEGRILIN
Sales Force Personnel to use, and to use Diligent Efforts to monitor the
INTEGRILIN Sales Force Personnel to ensure that such Sales Force Personnel use,
only promotional materials, and literature provided or approved by GENENTECH
under this Agreement for the promotion of the GENENTECH Products in the
Territory.
4.9.2.2 All materials and literature supplied by GENENTECH and
promoting the GENENTECH Products which are not used during the Co-promotion Term
and are in the INTEGRILIN PARTNERS' possession at the end of the Co-promotion
Term shall be returned to GENENTECH as soon as reasonably practicable after the
expiration or termination of the Co-promotion Term, to a site designated by
GENENTECH, at [*] expense. All materials and literature prepared by the
INTEGRILIN PARTNERS and promoting the GENENTECH Products which are not used
during the Co-promotion Term and are in the INTEGRILIN PARTNERS's possession at
the end of the Co-promotion Term shall be destroyed by the INTEGRILIN PARTNERS
and shall not be used by them for any purpose after the end of the Co-promotion
Term.
4.9.2.3 Any promotional material and promotional literature
supplied by GENENTECH shall not be misbranded, changed, altered or adulterated
prior to their distribution or use by the INTEGRILIN PARTNERS or its Sales Force
Personnel; and
4.9.2.4 the INTEGRILIN PARTNERS will instruct the INTEGRILIN
Sales Force Personnel to, and will use Diligent Efforts to monitor the
INTEGRILIN Sales Force Personnel so that such personnel do:
4.9.2.4.1 limit claims of efficacy and safety for
GENENTECH Products in the Territory to those that are consistent with
GENENTECH's approved promotional claims and that are consistent in all material
respects with the FDA-approved prescribing information for the GENENTECH
Products in the Territory and with applicable Law;
4.9.2.4.2 not add, delete or modify claims of efficacy
and safety in the Promotion of the GENENTECH Products under this Agreement in
any respect from those claims of efficacy and safety that are approved by
GENENTECH and in any manner that
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
23.
would be inconsistent in any material respect with the FDA-approved prescribing
information and with applicable Law;
4.9.2.4.3 not make any changes in promotional
materials and literature provided by GENENTECH;
4.9.2.4.4 use promotional materials and literature
only in furtherance of this Agreement;
4.9.2.4.5 promote the GENENTECH Products under this
Agreement in adherence to applicable legal requirements, as well as the American
Medical Association Gifts to Physicians From Industry Guidelines; and
4.9.2.4.6 assist in obtaining hospital formulary
acceptance for the GENENTECH Products and promote the GENENTECH Products to
hospital-based physicians in accordance with the terms of this Agreement.
4.9.2.5 The INTEGRILIN PARTNERS will use Diligent Efforts to
ensure that promotional and education materials and literature developed or used
by it or its Affiliates for the INTEGRILIN Products in the Territory during the
Co-promotion Term, and all INTEGRILIN Product advertising in the Territory
during the Co-promotion Term (whether in print, radio, television, Internet, or
otherwise) developed or used by it or its Affiliates, comply in all material
respects with the FDA-approved labeling for the INTEGRILIN Products and with
applicable Law. All promotional and educational materials and literature
developed and provided by the INTEGRILIN PARTNERS shall be of a nature and
quality that are consistent with materials and literature for the other key
products of the INTEGRILIN PARTNERS and shall be provided on a timely basis as
needed by each Party in the Territory. The quantity of promotional and
educational materials and literature provided to GENENTECH by the INTEGRILIN
PARTNERS shall be determined in good faith by the Parties taking into account
the level of sales and sales force effort to be generated.
4.9.2.6 The INTEGRILIN PARTNERS shall [*] to [*] of the GENENTECH
Products [*] by the INTEGRILIN PARTNERS.
4.9.2.7 Market Research Data. During the Co-promotion Term, the
--------------------
INTEGRILIN PARTNERS shall provide GENENTECH with [*] for the INTEGRILIN
Products, reasonably promptly if and after the same are made available to the
INTEGRILIN PARTNERS and so long as the INTEGRILIN PARTNERS have the lawful right
to provide same; provided, that GENENTECH shall distribute such information
--------
within GENENTECH only to such individuals as are necessary for GENENTECH to
perform its obligations under this Agreement, and GENENTECH shall hold such
information in confidence until made publicly available by the INTEGRILIN
PARTNERS or by the Third Party source providing same, and shall have [*] by such
Third Party with respect to such disclosure of such information to GENENTECH.
4.9.3 GENENTECH Duties. During the Co-promotion Term:
----------------
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
24.
4.9.3.1 GENENTECH agrees to instruct its Sales Force Personnel to
use, and to use Diligent Efforts to monitor its Sales Force Personnel to ensure
that such personnel use, only promotional materials and literature provided or
approved by the INTEGRILIN PARTNERS under this Agreement for the promotion of
the INTEGRILIN Products in the Territory.
4.9.3.2 All materials and literature supplied by the INTEGRILIN
PARTNERS and promoting the INTEGRILIN Products which are not used during the Co-
promotion Term and are in GENENTECH's possession at the end of the Co-promotion
Term shall be returned to the INTEGRILIN PARTNERS as soon as reasonably
practicable after the expiration or termination of the Co-promotion Term, to a
site designated by the INTEGRILIN PARTNERS, [*] All materials and literature
prepared by GENENTECH and promoting the INTEGRILIN Products which are not used
during the Co-promotion Term and are in GENENTECH's possession at the end of the
Co-promotion Term shall be destroyed by GENENTECH and shall not be used by it
for any purpose after the end of the Co-promotion Term.
4.9.3.3 Any promotional material and promotional literature used by
GENENTECH shall not be misbranded, changed, altered or adulterated prior to
their distribution or use by GENENTECH or its Sales Force Personnel; and
4.9.3.4 GENENTECH will instruct its sales force to, and will use
Diligent Efforts to monitor its Sales Force Personnel so that such personnel do:
4.9.3.4.1 limit claims of efficacy and safety for
INTEGRILIN Products in the Territory to those that are consistent with
promotional claims approved by the INTEGRILIN PARTNERS and that are consistent
in all material respects with the FDA-approved prescribing information for the
INTEGRILIN Products in the Territory and with applicable Law;
4.9.3.4.2 not add, delete or modify claims of efficacy
and safety in the Promotion of the INTEGRILIN Products under this Agreement in
any material respect from those claims of efficacy and safety would be
inconsistent in any material respect with the FDA-approved prescribing
information and with applicable Law;
4.9.3.4.3 not make any changes in promotional materials
and literature provided by the INTEGRILIN PARTNERS;
4.9.3.4.4 use promotional materials and literature only
in furtherance of this Agreement;
4.9.3.4.5 promote the INTEGRILIN Products under this
Agreement in adherence in all material respects to applicable legal
requirements, as well as the American Medical Association Gifts to Physicians
From Industry Guidelines; and
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
25.
4.9.3.4.6 assist in obtaining hospital formulary
acceptance for the INTEGRILIN Products and promote the INTEGRILIN Products to
hospital-based physicians in accordance with the terms of this Agreement.
4.9.3.5 GENENTECH will use Diligent Efforts to ensure that
promotional and education materials and literature developed or used by it or
its Affiliates for the GENENTECH Products in the Territory during the Co-
promotion Term, and all GENENTECH Product advertising in the Territory during
the Co-promotion Term (whether in print, radio, television, Internet, or
otherwise) developed or used by it or its Affiliates, comply in all material
respects with the FDA-approved labeling for the GENENTECH Products and with
applicable Law. All promotional and educational materials and literature
developed and provided by GENENTECH shall be of a nature and quality that are
consistent with GENENTECH's materials and literature for its other key products
and shall be provided on a timely basis as needed by each Party in the
Territory. The quantity of promotional and educational materials and literature
provided to the INTEGRILIN PARTNERS by GENENTECH shall be determined in good
faith by the Parties taking into account the level of sales and sales force
effort to be generated.
4.9.3.6 GENENTECH shall [*] to [*] of the INTEGRILIN Products [*]
by GENENTECH.
4.9.3.7 Market Research Data. During the Co-promotion Term,
--------------------
GENENTECH shall provide the INTEGRILIN PARTNERS with access to [*] for the
GENENTECH Products, reasonably promptly if and after the same are made available
to GENENTECH and so long as GENENTECH has the lawful right to provide same;
provided, that the INTEGRILIN PARTNERS shall distribute such information within
- --------
the INTEGRILIN PARTNERS only to such individuals as are necessary for the
INTEGRILIN PARTNERS to perform their obligations under this Agreement, and the
INTEGRILIN PARTNERS shall hold such information in confidence until made
publicly available by GENENTECH or by the Third Party source providing same, and
shall have [*] such Third Party with respect to such disclosure of such
information to the INTEGRILIN PARTNERS.
4.9.4 Responsibility for Costs. Subject to Section 7.2 hereof,
------------------------
each Party shall [*] and [*] for [*] and [*].
4.9.5 Approval of Product Positioning Messages. All written, electronic
----------------------------------------
and visual communications provided by a Party to a majority of the INTEGRILIN
Sales Force Personnel and GENENTECH Sales Force Personnel, respectively, for use
by such personnel regarding Product strategy, positioning or selling messages
will be [*]; provided, that a message, once [*], need not be [*] prior to its
--------
re-use unless the Product labeling applicable to such message has been changed
since such prior approval date. All Product direction to the GENENTECH Sales
Force shall be made by GENENTECH. All Product direction to the INTEGRILIN Sales
Force shall be made by the INTEGRILIN PARTNERS.
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
26.
4.10 Medical Education Programs. Medical education programs for the
--------------------------
Products in the Territory shall be coordinated by the Parties. Each Party shall
[*] to [*] medical education programs and symposia for the Products [*] by all
the Parties.
4.11 Clinical Trials.
---------------
4.11.1 The Parties are contemplating conducting a Phase [*]
clinical trial combining [*] with [*] for the [*] (the "[*] Trial").
4.11.2 In the event that the Parties have enrolled patients by [*]
in the [*], GENENTECH will not, and will cause [*], to [*] or [*] (including [*]
or [*] or other forms of [*]) for [*] combining a [*]) with [*] where the
primary endpoint is a clinical outcome in patients [*], until the earlier of the
date on which the [*] or [*] after the end of the Co-promotion Term.
Notwithstanding the foregoing, in the event that patients are not enrolled in
the [*] Trial by [*] for reasons [*] of the [*] then the prohibitions on
GENENTECH's rights to conduct trials set forth herein shall be [*].
4.11.3 During the Co-promotion Term, GENENTECH will not, and will
cause its Affiliates not to, [*] or [*] (including [*] or [*] or other forms of
[*]) for [*] combining a [*]) with [*] unless the Parties determine in good
faith that the results of the [*] do not [*] of the combination of [*].
4.11.4 During the Co-promotion Term, GENENTECH will not, and will
cause its Affiliates not to, [*] or [*] (including [*] or [*] or other forms of
[*]) for any [*] conducted on [*] which combines a [*] and [*] without [*] the
INTEGRILIN PARTNERS [*] in such trial [*].
4.11.5 During the Co-promotion Term, the INTEGRILIN PARTNERS will
not, and will cause their Affiliates not to, [*] or [*] (including [*] or [*] or
other forms of [*]) for any [*] combining [*] with any [*] (other than [*])
unless the Parties determine in good faith that the results of the [*] Trial do
not [*] of the combination of [*].
4.11.6 During the Co-promotion Term, the INTEGRILIN PARTNERS will
not, and will cause their Affiliates not to, [*] or [*] (including [*] or [*] or
other forms of [*]) for any [*] conducted on [*] which combines [*] (other than
[*]) without [*] GENENTECH [*] in such trial [*]
4.11.7 Nothing in this Section 4.11 shall preclude [*] from
completing [*] set forth in [*], or [*] from completing [*] set forth in [*].
4.11.8 The Parties acknowledge that [*], or [*], shall sponsor and
fund any clinical studies initiated during the Co-promotion Term by the
INTEGRILIN PARTNERS or GENENTECH which combine [*], including the [*] Trial, and
that [*] shall provide [*] and Clinical Supplies for all patients enrolled in
such studies at [*]; provided, however, that [*] shall [*], and [*] shall not be
[*] for, any clinical study that includes the use of [*] at a dose [*] of that
contained in the product inserts for [*]. The Parties acknowledge it is their
intention to use the
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
27.
Clinical Research Collaboration Agreement dated as of November 5, 1999 among
Genentech, COR and Schering Corporation, where applicable, as a model for
contracts for any clinical studies initiated by the INTEGRILIN PARTNERS or
GENENTECH which combine [*].
4.11.9 Protocol of [*] Trial. [*] shall have the right to review
---------------------
and provide comments regarding the trial protocols for the [*] Trial or other
trial contemplated by Section 4.11.8, and the [*] agree to consider such
comments in good faith. In addition, [*] agree that [*] not implement any trial
protocol for the [*] or other trial contemplated by Section 4.11.8 that includes
the use of [*] at a dose [*] of that contained in the product inserts for [*].
4.11.10 Trial Results. Each Party shall provide the other Parties
-------------
with the right to review any contents of public disclosures, prepared by or
otherwise under the control of such Party, to the extent that they are
contractually permitted to do so, regarding the results of [*] pursuant to this
Section 4.11. Each Party shall consider in good faith incorporating any comments
or amendments that the other Parties propose to such contents.
4.12 Bonus Structure of the INTEGRILIN PARTNERS Sales Force Personnel.
----------------------------------------------------------------
During the Co-promotion Term, a portion of the Target Bonus for each member of
the INTEGRILIN Sales Force shall be based on market performance of the GENENTECH
Products (the "GENENTECH Product Percentage"). During the first Agreement Year,
the GENENTECH Product Percentage shall be [*] of the total Target Bonus for each
member of the INTEGRILIN Sales Force. During the second Agreement Year, the
GENENTECH Product Percentage shall be [*] of the total Target Bonus for each
member of the INTEGRILIN Sales Force. The Target Bonus structure for the
INTEGRILIN Sales Force Personnel shall be consistent with the Target Bonus
structure historically in effect for the INTEGRILIN PARTNERS in connection with
the promotion and sale of a product. The INTEGRILIN PARTNERS shall provide to
GENENTECH sufficient details on the Target Bonus and benefits expected to be
provided to the INTEGRILIN Sales Force Personnel upon the Effective Date and
annually thereafter, so that GENENTECH may make a reasonable determination of
the compliance of the INTEGRILIN PARTNERS with their obligations under this
Section. In the event that GENENTECH is concerned that the GENENTECH Product
Percentage does not meet the above requirements, then the Parties will promptly
discuss the issue in a good faith attempt to help resolve any of the perceived
noncompliance. Subject to the foregoing, the INTEGRILIN PARTNERS shall retain
final control over all decisions relating to compensation and bonuses for their
respective Sales Force Personnel.
4.13 Bonus Structure of the GENENTECH Sales Force Personnel. During the Co-
------------------------------------------------------
promotion Term, a portion of the Target Bonus for each member of the GENENTECH
Sales Force shall be based on market performance of the INTEGRILIN Products (the
"INTEGRILIN Product Percentage"). During the first Agreement Year the INTEGRILIN
Product Percentage shall be [*] of the Target Bonus for each member of the
GENENTECH Sales Force. During the second Agreement Year the INTEGRILIN Product
Percentage shall be [*] of the Target Bonus for each member of the GENENTECH
Sales Force. The Target Bonus structure for GENENTECH's Sales Force Personnel
shall be consistent with the Target Bonus structure historically in effect for
GENENTECH in connection with the promotion and sale of a product.
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
28.
GENENTECH shall provide to the INTEGRILIN PARTNERS sufficient details on the
Target Bonus and benefits expected to be provided to the GENENTECH Sales Force
Personnel upon the Effective Date and on the first anniversary thereof, so that
the INTEGRILIN PARTNERS may make a reasonable determination of the compliance of
GENENTECH with their obligations under this Section. In the event that the
INTEGRILIN PARTNERS are concerned that the INTEGRILIN Product Percentage does
not meet the above requirements, then the Parties will promptly discuss the
issue in a good faith attempt to help resolve any of the perceived
noncompliance. Subject to the foregoing, GENENTECH shall retain final control
over all decisions relating to compensation and bonuses for their respective
Sales Force Personnel.
4.14 Management of Sales Force Personnel. During the Co-promotion Term,
-----------------------------------
each of the Parties shall ensure that the management of its Sales Force
Personnel shall reflect a diligent commitment to the Promotion of the Products
in accordance with its obligations hereunder.
4.15 Management of the Collaboration Between Genentech and the Integrilin
--------------------------------------------------------------------
Partners.
- --------
4.15.1 Formation of Joint Project Team. (a) Within thirty (30)
-------------------------------
days of the Effective Date, the Parties shall establish a joint project team
(the "Joint Project Team" or "JPT") to coordinate and implement all activities
for the commercialization of the Products pursuant to, and as contemplated by,
this Agreement.
4.15.1.1 Each Party shall appoint a sufficient number of
authorized representatives (but no more than [*], unless otherwise determined by
the JPT), as members of the JPT respectively and notify the other Parties as to
the name of the individuals so appointed. Such representatives will include
individuals with expertise and responsibilities in the areas of clinical
affairs, marketing and sales, as applicable to the stage of development and
commercialization of the Product. Each party may replace its representatives at
any time, upon written notice to the other party. The JPT shall meet at regular
intervals, but no less than once per calendar quarter, at times and locations to
be agreed upon by the members of the JPT. In addition, the members of the JPT
from each Party shall designate two senior officers from their respective
organizations who are not members of the JPT, and who have sufficient cross-
functional expertise, and are empowered, to resolve disputes that may occur
within the JPT.
4.15.1.2 The Joint Project Team shall make all respective
decisions by consensus, with [*]. In the event the JPT is unable to reach a
decision by consensus, the matter(s) in dispute shall be referred to the
designees appointed pursuant to the last sentence of Section 4.15.1.1 above for
decision. Notwithstanding the foregoing, nothing in this Section 4.15 shall
alter the rights, responsibilities or authority of any Party that are expressly
provided for elsewhere in this Agreement, and issues falling within such express
grants of authority shall not be subject to the dispute resolution provisions of
this Agreement.
Article 5. Product Pricing; Revenue Recognition; Manufacturing.
----------------------------------------------------
5.1 Product Pricing. (a) GENENTECH shall have the sole right and
---------------
responsibility for establishing and modifying the terms and conditions with
respect to the sale of the
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
29.
GENENTECH Products in the Territory, including any terms and conditions relating
to or affecting the price at which GENENTECH Products will be sold; any discount
attributable to payments on receivables; distribution of GENENTECH Products;
credit, price adjustments, discounts and allowances to be granted or refused;
and price increases or decreases and the timing thereof. GENENTECH has sole
authority and discretion to implement pricing changes. GENENTECH shall notify
the INTEGRILIN PARTNERS in writing of such changes at the same time as GENENTECH
notifies its own sales force representatives.
(b) The INTEGRILIN PARTNERS shall have the sole right and
responsibility for establishing and modifying the terms and conditions with
respect to the sale of the INTEGRILIN Products in the Territory, including any
terms and conditions relating to or affecting the price at which INTEGRILIN
Products will be sold; any discount attributable to payments on receivables;
distribution of INTEGRILIN Products; credit, price adjustments, discounts and
allowances to be granted or refused; and price increases or decreases and the
timing thereof. INTEGRILIN Partners have sole authority and discretion to
implement pricing changes. INTEGRILIN Partners shall notify GENENTECH in writing
of such changes at the same time as INTEGRILIN PARTNERS notify their own sales
force representatives.
5.2 Revenue Recognition. (a) GENENTECH will book all sales of the
-------------------
GENENTECH Products in the Territory. GENENTECH shall be exclusively responsible
for accepting and filling purchase orders, billing, and returns with respect to
GENENTECH Products. If INTEGRILIN PARTNERS receive an order for GENENTECH
Product, they shall promptly transmit such order to GENENTECH for acceptance or
rejection, which acceptance or rejection shall be at GENENTECH's sole
discretion. GENENTECH shall have the sole responsibility, at its sole cost and
expense, for GENENTECH Product shipping, distribution and warehousing in a
timely manner, for the invoicing and billing of purchasers of the GENENTECH
Products, for order confirmation (if any) in accordance with GENENTECH's
customary practices, and for the collection of receivables resulting from sales
of the GENENTECH Products.
(b) The INTEGRILIN PARTNERS will book all sales of the INTEGRILIN
Products in the Territory. The INTEGRILIN PARTNERS shall be exclusively
responsible for accepting and filling purchase orders, billing, and returns with
respect to INTEGRILIN Products. If GENENTECH receives an order for INTEGRILIN
Products, it shall promptly transmit such order to the INTEGRILIN PARTNERS for
acceptance or rejection, which acceptance or rejection shall be at the
INTEGRILIN PARTNERS' sole discretion. The INTEGRILIN PARTNERS shall have the
sole responsibility, at their sole cost and expense, for INTEGRILIN Product
shipping, distribution and warehousing in a timely manner, for the invoicing and
billing of purchasers of the INTEGRILIN Products, for order confirmation (if
any) in accordance with their customary practices, and for the collection of
receivables resulting from sales of the INTEGRILIN Products.
5.3 Supply of GENENTECH Product.
----------------------------
5.3.1 GENENTECH Responsibility. Subject to Article 9, or as otherwise
------------------------
expressly provided in this Agreement, GENENTECH shall manufacture, finish,
package, label,
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
30.
and supply, or cause to be manufactured, finished, labeled, packaged, and
supplied, at its sole cost and expense, all requirements for GENENTECH Products
in the Territory during the Co-promotion Term. GENENTECH shall be solely
responsible at its sole expense for the distribution of GENENTECH Products in
the Territory during the term of the Agreement to Third Party purchasers
(including without limitation distributors and wholesalers) of the GENENTECH
Products.
5.3.2 Change of Product Specifications and/or Source of Supply.
--------------------------------------------------------
GENENTECH shall have the right, at its sole discretion and expense, to change
the GENENTECH Products specifications from time to time at any time during the
term of this Agreement or if it is required to do so by any Regulatory Authority
having jurisdiction over the GENENTECH Products. In the event of any such
change, GENENTECH shall be responsible, at its sole cost and expense, for
ensuring that any such change is approved by each such applicable Regulatory
Authority. If a change requires prior approval by FDA, such change shall not be
implemented until such change has been so approved. As between GENENTECH and the
INTEGRILIN PARTNERS, GENENTECH shall determine in its sole discretion, and may
from time to time change, the source of supply of the GENENTECH Products without
the consent of the INTEGRILIN PARTNERS; and GENENTECH shall be responsible for
securing all Regulatory Approvals at GENENTECH's expense that may be required to
effect such change.
5.3.3 Product Returns. Any GENENTECH Product or GENENTECH Product-
---------------
related items returned to the INTEGRILIN PARTNERS shall be shipped by the
INTEGRILIN PARTNERS to GENENTECH's facility identified by GENENTECH as the point
for receiving returned goods, with any reasonable or authorized shipping or
other documented direct cost to be paid or reimbursed by GENENTECH to the
INTEGRILIN PARTNERS.
5.3.4 Timely Supply. GENENTECH will [*] adequate supplies of
-------------
GENENTECH Product are available to meet the requirements of Third Party
purchasers in the Territory. GENENTECH shall be responsible for [*] for
GENENTECH Products, and the INTEGRILIN PARTNERS shall provide input and
assistance as reasonably necessary for GENENTECH to do so. The INTEGRILIN
PARTNERS shall have the opportunity [*] as necessary to perform their
obligations under this Agreement. In addition, in the event that GENENTECH has
reason to believe that it may not be able to produce adequate supplies of
GENENTECH Product to meet the requirements of Third Party purchasers in the
Territory, it shall promptly notify the INTEGRILIN PARTNERS, and the Parties
shall discuss in good faith the measures that should be taken to address the
shortfall and to allocate available GENENTECH Product fairly among all of the
Parties' customers.
5.4 Supply of INTEGRILIN PRODUCT
----------------------------
5.4.1 INTEGRILIN PARTNERS Responsibility. Subject to Article 9, or as
----------------------------------
otherwise expressly provided in this Agreement, the INTEGRILIN PARTNERS shall
manufacture, finish, package, label, and supply, or cause to be manufactured,
finished, labeled, packaged, and supplied, at its sole cost and expense, all
requirements for INTEGRILIN Products in the Territory during the Co-promotion
Term. The INTEGRILIN PARTNERS shall be solely
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
31.
responsible at its sole expense for the distribution of INTEGRILIN Products in
the Territory during the term of the Agreement to Third Party purchasers
(including without limitation distributors and wholesalers) of the INTEGRILIN
Products.
5.4.2 Change of Product Specifications and/or Source of Supply. The
--------------------------------------------------------
INTEGRILIN PARTNERS shall have the right, at their sole discretion and expense,
to change the INTEGRILIN Products specifications from time to time at any time
during the term of this Agreement or if they are required to do so by any
Regulatory Authority having jurisdiction over the INTEGRILIN Products. In the
event of any such change, the INTEGRILIN PARTNERS shall be responsible, at their
sole cost and expense, for ensuring that any such change is approved by each
such applicable Regulatory Authority. If a change requires prior approval by
FDA, such change shall not be implemented until such change has been so
approved. As between GENENTECH and the INTEGRILIN PARTNERS, the INTEGRILIN
PARTNERS shall determine in their sole discretion, and may from time to time
change, the source of supply of the INTEGRILIN Products without the consent of
GENENTECH; and the INTEGRILIN PARTNERS shall be responsible for securing all
Regulatory Approvals at their expense that may be required to effect such
change.
5.4.3 Product Returns. Any INTEGRILIN Product or INTEGRILIN Product-
---------------
related items returned to GENENTECH shall be shipped by GENENTECH to the
INTEGRILIN PARTNERS' facility identified by the INTEGRILIN PARTNERS as the point
for receiving returned goods, with any reasonable or authorized shipping or
other documented direct cost to be paid or reimbursed by the INTEGRILIN PARTNERS
to GENENTECH.
5.4.4 Timely Supply. The INTEGRILIN PARTNERS [*] adequate supplies of
-------------
INTEGRILIN Product are available to meet the requirements of Third Party
purchasers in the Territory. The INTEGRILIN PARTNERS shall be responsible for
[*] for INTEGRILIN Products, and GENENTECH shall provide input and assistance as
reasonably necessary for the INTEGRILIN PARTNERS to do so. GENENTECH shall have
the opportunity [*] as necessary to perform its obligations under this
Agreement. In addition, in the event that the INTEGRILIN PARTNERS have reason to
believe that they may not be able to produce adequate supplies of INTEGRILIN
Product to meet the requirements of Third Party purchasers in the Territory, it
shall promptly notify GENENTECH, and the Parties shall discuss in good faith the
measures that should be taken to address the shortfall and to allocate available
INTEGRILIN Product fairly among all of the Parties' customers.
Article 6. Trademarks and Copyrights.
-------------------------
6.1 GENENTECH Trademarks
--------------------
6.1.1 Trademark. GENENTECH shall own all rights, title and
---------
interests, and be solely entitled to all goodwill developed, in and to the
GENENTECH Trademarks.
6.1.2 Use of GENENTECH and INTEGRILIN PARTNERS Names on Promotional
-------------------------------------------------------------
Material. All GENENTECH Product promotional materials shall contain the
- --------
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
32.
GENENTECH name and logo, and where permitted by and in accordance with
applicable Law, a reference to the COR and SCHERING company names (and logo) as
a co-promotion partner of the GENENTECH Products; provided, that the [*] will
--------
not [*] until the [*] following the Effective Date.
6.1.3 Trademark Maintenance. GENENTECH shall maintain a registration
---------------------
for the GENENTECH Trademarks in the Territory at its expense. The GENENTECH
Trademarks shall be owned solely by GENENTECH. Except as set forth in Section
6.1.4, this Agreement does not and is not intended to create a grant to the
INTEGRILIN PARTNERS of any property right or interest in any trademark of
GENENTECH or any of its Affiliates. All promotional materials and advertising
for the GENENTECH Products in the Territory will clearly indicate that the
GENENTECH Trademarks are owned by GENENTECH or its Affiliates.
6.1.4 Use of GENENTECH Trademark by the INTEGRILIN PARTNERS. GENENTECH
-----------------------------------------------------
and its Affiliates consent to the use by the INTEGRILIN PARTNERS of the
GENENTECH Trademark solely in connection with the performance of the INTEGRILIN
PARTNERS obligations under this Agreement; provided, that any such use is
--------
approved in writing by GENENTECH in advance. The INTEGRILIN PARTNERS agree that
all use of the GENENTECH Trademarks by the INTEGRILIN PARTNERS as provided in
this Agreement shall inure to the benefit of GENENTECH and its Affiliates. The
INTEGRILIN PARTNERS' right to use the GENENTECH Trademarks with respect to a
given GENENTECH Products shall terminate at such time as the INTEGRILIN
PARTNERS' rights to promote such GENENTECH Products are terminated in accordance
with this Agreement.
6.1.5 Copyrighted Works. All rights, title and interests in and to
-----------------
copyrighted works authored or otherwise created or developed for use on or as
promotional materials, advertisements, packaging or labeling, whether singly or
jointly, by the INTEGRILIN PARTNERS's or GENENTECH's employees, agents, or other
persons acting under their authority in the conduct of this Agreement, shall, to
the extent [*] be owned by GENENTECH ("GENENTECH Works"). The INTEGRILIN
PARTNERS shall retain all rights to its sole works to the extent that they are
[*], and shall retain co-ownership with GENENTECH in any joint works to the
extent that they are [*]. The INTEGRILIN PARTNERS agree to execute such
instruments as may be reasonably requested by GENENTECH to confirm the
assignment and/or ownership of GENENTECH Works in GENENTECH, free and clear of
liens, claims and encumbrances. GENENTECH and its Affiliates shall be free to
use the GENENTECH Works as GENENTECH deems fit. Nothing herein shall be
construed as giving the INTEGRILIN PARTNERS any right or license to use any
GENENTECH Works for any purpose other than for purposes of carrying out its
obligations under this Agreement.
6.1.5.1 With respect to any of the INTEGRILIN PARTNERS's sole
works that are [*] and that are provided by the INTEGRILIN PARTNERS for use with
the GENENTECH Products, GENENTECH shall have a nonexclusive, worldwide,
sublicensable, fully paid-up right and license, under any intellectual property
rights owned or controlled by the INTEGRILIN PARTNERS or its Affiliates covering
such sole works, to use same in connection
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
33.
with the use, sale, marketing or Promotion of the GENENTECH Products, but not
any other product.
6.2 INTEGRILIN Trademarks
---------------------
6.2.1 Determination of Trademark. COR shall own all rights, title
---------------------------
and interests, and be solely entitled to all goodwill developed, in and to the
INTEGRILIN Trademarks.
6.2.2 Use of INTEGRILIN PARTNERS and GENENTECH Names on Promotional
-------------------------------------------------------------
Materials. All INTEGRILIN Product promotional materials shall contain the
- ---------
INTEGRILIN PARTNERS' name and logo, and where permitted by and in accordance
with applicable Law, a reference to the GENENTECH company name (and logo) as a
co-promotion partner of the INTEGRILIN Products; provided, that the [*] will not
--------
[*] until the [*] following the Effective Date.
6.2.3 Trademark Maintenance. COR shall maintain a registration for
---------------------
the INTEGRILIN Trademark in the Territory at its expense. The INTEGRILIN
Trademark shall be owned solely by COR. Except as set forth in Section 6.2.4,
this Agreement does not and is not intended to create a grant to GENENTECH of
any property right or interest in any trademark of the INTEGRILIN PARTNERS or
any of their Affiliates. All promotional materials and advertising for the
INTEGRILIN Products in the Territory will clearly indicate that the INTEGRILIN
Trademarks are owned by COR.
6.2.4 Use of INTEGRILIN Trademark by GENENTECH. COR consents to the
----------------------------------------
use by GENENTECH and SCHERING of the INTEGRILIN Trademark solely in connection
with the performance of such Party's obligations under this Agreement; provided,
--------
that any such use is approved in writing by COR in advance. The Parties agree
that all use of the INTEGRILIN Trademarks by the Parties as provided in this
Agreement shall inure to the benefit of COR. GENENTECH's and SCHERING's right to
use the INTEGRILIN Trademarks with respect to a given INTEGRILIN Product shall
terminate at such time as that Party's rights to promote such INTEGRILIN Product
are terminated in accordance with this Agreement.
6.2.5 Copyrighted Works. All rights, title and interests in and to
-----------------
copyrighted works authored or otherwise created or developed for use on or as
promotional materials, advertisements, packaging or labeling, whether singly or
jointly, by GENENTECH's or the INTEGRILIN PARTNERS's employees, agents, or other
persons acting under their authority in the conduct of this Agreement, shall, to
the extent [*] be owned [*] ("INTEGRILIN Works"). GENENTECH shall retain all
rights to its sole works to the extent that they are [*], and shall retain co-
ownership with the INTEGRILIN PARTNERS in any joint works to the extent that
they are [*]. GENENTECH agrees to execute such instruments as may be reasonably
requested by the INTEGRILIN PARTNERS to confirm the assignment and/or ownership
of INTEGRILIN Works in the INTEGRILIN PARTNERS, free and clear of liens, claims
and encumbrances. The INTEGRILIN PARTNERS and their Affiliates shall be free to
use the INTEGRILIN Works as they deem fit. Nothing herein shall be construed as
giving GENENTECH any right or license to
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
34.
use any INTEGRILIN Works for any purpose other than for purposes of carrying out
its obligations under this Agreement.
6.2.5.1 With respect to any of GENENTECH's sole works that are
[*] and that are provided by GENENTECH for use with the INTEGRILIN Products,
each of the INTEGRILIN PARTNERS shall have a nonexclusive, worldwide,
sublicensable, fully paid-up right and license, under any intellectual property
rights owned or controlled by GENENTECH or its Affiliates covering such sole
works, to use same in connection with the use, sale, marketing or Promotion of
the INTEGRILIN Product, but not any other product.
Article 7. Commitment to Certain Spending by INTEGRILIN PARTNERS.
------------------------------------------------------
7.1 NRMI and Related Programs. (a) During each Agreement Year, the
-------------------------
INTEGRILIN PARTNERS shall provide GENENTECH [*] to support the National Registry
of Myocardial Infarction ("NRMI"). In consideration of such payments by the
INTEGRILIN PARTNERS, the INTEGRILIN PARTNERS will have the right, during the Co-
promotion Term, to query [*] NRMI data at the [*] and use these analyses to
support the promotion of the INTEGRILIN Products, provided, however, that the
costs of such analyses shall not exceed [*] in any Agreement Year. This use
shall include but shall not be limited to publications and medical education
programs. [*] data, if any, shall be in aggregate form, and [*] shall remain
confidential unless disclosed by [*]. In addition, the INTEGRILIN PARTNERS shall
have the right, during the Co-promotion Term, to [*] approved by the JPT and by
[*], but shall not have the right to [*]. Further, GENENTECH shall use Diligent
Efforts to include a member of the INTEGRILIN Sales Force when [*]. The
INTEGRILIN PARTNERS shall also have the right, during the Co-promotion Term, to
select [*] reasonably acceptable to GENENTECH to serve as [*]. Any actions taken
by the INTEGRILIN PARTNERS relating in any way to NRMI or data therefrom shall
be taken in accordance with, and pursuant to, the provisions of the NRMI
reference binder [*].
(b) The INTEGRILIN Partners will also have the right to [*] to
address questions relevant to GP IIb-IIIa inhibitors, in ways reasonably
acceptable to GENENTECH, in the event that GENENTECH [*], and GENENTECH agrees
to consider in good faith [*] suggested by the INTEGRILIN PARTNERS.
7.2 Promotional Materials and Sales Training Reimbursement. During the
------------------------------------------------------
first Agreement Year, the INTEGRILIN PARTNERS shall reimburse GENENTECH in the
amount of [*] (the "Promotional Materials Reimbursement Payment") in
consideration for documented costs actually incurred by GENENTECH in connection
with providing promotional materials and sales training to the INTEGRILIN Sales
Force.
7.3 Timing of Payments. Payments due under Section 7.1 and 7.2 shall be
------------------
made in quarterly installments of [*] and [*] respectively and shall be [*] at
[*], provided that, in the case of payments due under Section 7.2, such payments
shall [*] has been [*].
[*]=Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
35.
ARTICLE 8. Training of Sales Forces.
-------------------------
8.1 General Training. Subject to Section 7.2, each of the Parties shall
----------------
be solely responsible at its expense for general sales training of its Sales
Force Personnel.
8.2 GENENTECH Product Training. GENENTECH shall have primary
--------------------------
responsibility for training, at a location to be jointly agreed upon, the
GENENTECH Sales Force Personnel and INTEGRILIN Sales Force Personnel, in
consultation with the other Parties, with respect to the promotion of the
GENENTECH Products in the Territory. Training of the INTEGRILIN Sales Force
shall be consistent with the GENENTECH Product training materials and program
developed by GENENTECH for training its own sales forces for the promotion of
the GENENTECH Products in the Territory, and that such training shall include
training on the proper handling and reporting of adverse drug experiences
encountered for the GENENTECH Products and on timely reporting to GENENTECH of
GENENTECH Product inquiries and other requests for information related to
GENENTECH Product.
8.3 INTEGRILIN Product Training. The INTEGRILIN PARTNERS shall have
---------------------------
primary responsibility for training, at a location to be jointly agreed upon,
the GENENTECH Sales Force Personnel and INTEGRILIN Sales Force Personnel, in
consultation with GENENTECH, with respect to the promotion of the INTEGRILIN
Products in the Territory. Training of the GENENTECH Sales Force shall be
consistent with the INTEGRILIN Product training materials and program developed
by the INTEGRILIN PARTNERS for training its own sales forces for the promotion
of the INTEGRILIN Products in the Territory, and that such training shall
include training on the proper handling and reporting of adverse drug
experiences encountered for the INTEGRILIN Products and on timely reporting to
the INTEGRILIN PARTNERS of INTEGRILIN Product inquiries and other requests for
information related to INTEGRILIN Product.
8.4 Expenses. Each Party shall be responsible for all expenses incurred
--------
by it and its personnel associated with any training meetings for the Products
for such Party's own Sales Force Personnel and for any expenses incurred by it
and its personnel in participating at another Party's training sessions.
8.5 Training Materials.
-------------------
8.5.1 (a) GENENTECH will determine the content of the GENENTECH
Product-specific training materials. Promptly after the Execution Date,
GENENTECH will provide to the INTEGRILIN PARTNERS, [*], reasonable quantities of
training materials to enable the INTEGRILIN PARTNERS to provide the initial
training of its Sales Force Personnel. GENENTECH shall [*] the content,
development, and associated cost of all GENENTECH Product-specific training
materials. The contents and strategic direction of any training provided by the
INTEGRILIN PARTNERS that relates to the GENENTECH Products shall be [*].
(b) GENENTECH agrees to provide the INTEGRILIN PARTNERS with
reasonable quantities of training materials for GENENTECH Product-specific
training in the
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
36.
Territory which are revised or developed by GENENTECH from time to time after
the Effective Date during the term of this Agreement. Subject to Article 17,
such materials may be distributed by the INTEGRILIN PARTNERS to its Sales Force
Personnel and to such other employees, agents or contractors who have a need to
know such materials for purposes of the INTEGRILIN PARTNERS's performance of its
obligations under this Agreement. The INTEGRILIN PARTNERS may copy the training
materials provided by GENENTECH for such purpose; provided that all copyright
--------
and trademark notices are retained as in the original provided by GENENTECH.
(c) All GENENTECH Product-specific training materials may only be
used by the INTEGRILIN PARTNERS for training in connection with the GENENTECH
Products and may not be used, copied or adapted for any other product or
purpose.
(d) During the term of this Agreement, GENENTECH shall make available
to the INTEGRILIN PARTNERS, [*] a reasonable number of, and for a reasonable
amount of time, GENENTECH sales training personnel who will assist the
INTEGRILIN Product promotion management team in training the INTEGRILIN Sales
Force Personnel with respect to the GENENTECH Product-specific training and the
Promotion of the GENENTECH Products in the Territory to help ensure that such
training will be consistent with the training provided to GENENTECH Sale Force
Personnel who will be promoting GENENTECH Products in the Territory.
8.5.2 The INTEGRILIN PARTNERS will determine the content of the
INTEGRILIN Product-specific training materials. Promptly after the Execution
Date, the INTEGRILIN PARTNERS will provide to GENENTECH [*] reasonable
quantities of training materials to enable GENENTECH to provide the initial
training of its Sales Force Personnel. The INTEGRILIN PARTNERS shall [*] the
content, development, and associated cost of all INTEGRILIN Product-specific
training materials. The contents and strategic direction of any training
provided by GENENTECH that relates to the INTEGRILIN Products shall be [*].
(a) The INTEGRILIN PARTNERS agree to provide GENENTECH with
reasonable quantities of training materials for INTEGRILIN Product-specific
training in the Territory which are revised or developed by the INTEGRILIN
PARTNERS from time to time after the Effective Date during the term of this
Agreement. Subject to Article 17, such materials may be distributed by GENENTECH
to its Sales Force Personnel and to such other employees, agents or contractors
who have a need to know such materials for purposes of GENENTECH's performance
of its obligations under this Agreement. GENENTECH may copy the training
materials provided by the INTEGRILIN PARTNERS for such purpose; provided that
--------
all copyright and trademark notices are retained as in the original provided by
the INTEGRILIN PARTNERS.
(b) All INTEGRILIN Product-specific training materials may only be
used by GENENTECH for training in connection with the INTEGRILIN Products and
may not be used, copied or adapted for any other product or purpose.
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
37.
(c) During the term of this Agreement, the INTEGRILIN PARTNERS
shall make available to GENENTECH, [*] a reasonable number of, and for a
reasonable amount of time, INTEGRILIN sales training personnel who will assist
the GENENTECH Product promotion management team in training the GENENTECH Sales
Force Personnel with respect to the INTEGRILIN Product-specific training and the
Promotion of the INTEGRILIN Products in the Territory to help ensure that such
training will be consistent with the training provided to INTEGRILIN Sale Force
Personnel who will be promoting INTEGRILIN Product in the Territory.
ARTICLE 9. Force Majeure.
--------------
If the performance of any obligation under this Agreement by any
Party is prevented, restricted, interfered with or delayed by reason of any
cause beyond the reasonable control of the Party unable to perform (including
without limitation, as a result of acts of God, civil disorders or commotions,
acts of aggression, earthquake, fire, explosions, floods, drought, war,
sabotage, embargo, utility failures, material shortages, mycoplasmal
contamination, failure of supply of Product on the part of another Party, labor
disturbances, a national health emergency, or appropriations of property), then,
unless the other Party can demonstrate to the contrary in accordance with the
standards of proof for the court, tribunal or arbitration in which such evidence
is offered, the Party so affected shall, upon giving written notice to the other
Parties, be excused from such performance to the extent of, and for the period
of time reasonably occasioned by, such prevention, restriction, interference or
delay; provided, that the affected Party shall use Diligent Efforts to avoid or
--------
remove such causes of non-performance and to ameliorate the effects of such
nonperformance as promptly as practicable thereafter and shall continue
performance of this Agreement whenever such causes are removed; provided,
--------
further that nothing contained herein shall require any Party to settle on terms
- -------
unsatisfactory to such Party any strike, lock-out or other labor difficulty, any
investigation or proceeding by any public authority, or any litigation by any
Third Party. When such circumstances arise, the Parties shall discuss what, if
any, modification of the terms of this Agreement may be required in order to
arrive at an equitable solution.
ARTICLE 10. Certain Regulatory Matters Concerning Genentech Products; Product
-----------------------------------------------------------------
Recall.
-------
10.1 General Control in GENENTECH. All regulatory matters regarding the
----------------------------
GENENTECH Products shall remain under the exclusive control and responsibility
of GENENTECH. GENENTECH will have the sole responsibility, [*] to respond to
GENENTECH Product and medical complaints and to handle all returns and recalls
of the GENENTECH Products.
10.2 Efficacy and Safety Information. GENENTECH shall furnish the
-------------------------------
INTEGRILIN PARTNERS with efficacy and safety information reasonably requested by
the INTEGRILIN PARTNERS to assist it in promoting the GENENTECH Products in the
Territory, including, without limitation, summaries of relevant clinical and
safety data [*] for the GENENTECH
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
38.
Products and summaries of information related to the efficacy and safety profile
of the GENENTECH Products since its approval by the FDA.
Subject to the terms of this Agreement, within three (3) months of the
Execution Date, GENENTECH and the INTEGRILIN PARTNERS shall discuss and develop
mutually acceptable guidelines and procedures (in the form of a safety agreement
(the "Safety Agreement") to be executed by each of the Parties) for the receipt,
recordation, communication (as between the Parties) and exchange of adverse
event information. It is anticipated that such guidelines and procedures will
include provisions for the direct reporting to GENENTECH of adverse events by
the INTEGRILIN Sales Force Personnel. The Parties shall bear their respective
costs incurred in connection with receiving, recording, reviewing,
communicating, and exchanging with each other regarding and, as applicable,
reporting and responding to adverse events. The Safety Agreement shall
supercede the adverse reporting procedures set forth in this Agreement.
The Parties hereby agree that adverse event reporting procedures in
connection with clinical trials involving [*] shall be handled in a separate
Clinical Trial Research Agreement among the Parties, if applicable.
10.3 Notification of Adverse Events; Reporting to Regulatory Authorities.
-------------------------------------------------------------------
"Serious adverse events" for the GENENTECH Products (as defined in Section 1.52)
learned by the INTEGRILIN PARTNERS shall be submitted to GENENTECH within [*]
from the receipt date by the INTEGRILIN PARTNERS. The "receipt date" is defined
as the date the INTEGRILIN PARTNER first receives notification of an adverse
event report that contains at least: (i) an identifiable patient; (ii) an
identifiable reporter; (iii) a suspect GENENTECH Product; and (iv) an adverse
event or fatal outcome. "Non-serious adverse events" for the GENENTECH
Products (as defined in Section 1.52) that are spontaneously reported to the
INTEGRILIN PARTNERS shall be submitted to GENENTECH no more than [*] from the
date received by the INTEGRILIN PARTNERS; provided, however, that medical and
--------
scientific judgment should be exercised in deciding whether expedited reporting
is appropriate in other situations, such as important medical events that may
not be immediately life-threatening or result in death or hospitalization but
may jeopardize the patient or may require intervention to prevent a serious
adverse event outcome.
GENENTECH shall have the reporting responsibility for all adverse
events associated with use of GENENTECH Products to applicable Regulatory
Authorities anywhere in the world. GENENTECH shall inform the INTEGRILIN
PARTNERS of all adverse events reported by it to FDA at the same time as
GENENTECH reports same to FDA.
The INTEGRILIN PARTNERS shall report all such adverse events involving
the GENENTECH Products learned by it to:
Genentech Drug Safety
1 DNA Way, MS# 84
South San Francisco, CA 94080-4990
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
39.
Attention: Director - Drug Safety
Facsimile No.: (650) 225-4683
Telephone No.: (888) 835-2555 (Toll free adverse event reporting
line)
The INTEGRILIN PARTNERS will inform GENENTECH of the adverse event, as
well as the reporter's name, address and contact information.
Adverse events concerning the GENENTECH Products learned by GENENTECH
shall be reported by GENENTECH to the INTEGRILIN PARTNERS at the time that
GENENTECH reports such events to FDA, and shall be sent to:
Schering Corporation.
Drug Safety Surveillance
50 Lawrence Road
Springfield, NJ 07081-3121
Telephone No.: (973) 921-7412
Facsimile No.: (973) 921-7424
COR Therapeutics, Inc.
256 E. Grand Avenue
South San Francisco, CA 94080
Attention: Manager, Medical Safety
Telephone No.: (650) 244-7303;
Facsimile No.: (650) 246-7776
A Party may change its contact at any time for future notices upon
written notice given to the other.
10.4 Response by the INTEGRILIN PARTNERS to Regulatory Inquiries. Upon
-----------------------------------------------------------
being contacted by the FDA or any other applicable Regulatory Authority for any
regulatory purpose directly related to the GENENTECH Products, the INTEGRILIN
PARTNERS shall [*] notify GENENTECH. To the extent permitted by applicable Law,
the INTEGRILIN PARTNERS will allow GENENTECH to assume control over the timing
and content of the response to such Regulatory Authority and will not respond to
the agency until consulting with GENENTECH; provided, that the foregoing shall
--------
not be construed to prevent the INTEGRILIN PARTNERS in any way from complying
with their obligations under applicable Law, including, without limitation, by
permitting unannounced FDA or similar inspections and responding to requests by
FDA inspectors in connection therewith.
10.5 GENENTECH Product Quality Complaint. The INTEGRILIN PARTNERS shall
-----------------------------------
inform GENENTECH of any GENENTECH Product Quality Complaint received within [*]
from the receipt date by the INTEGRILIN PARTNERS. The "GENENTECH Product
Quality Complaint" is defined as any complaint that questions the purity,
identity, potency or quality of any GENENTECH Product, its packaging, or
labeling, or any complaint that concerns any
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
40.
incident that causes the drug product or its labeling to be mistaken for, or
applied to, another article or any bacteriological contamination, or any
significant chemical, physical, or other change or deterioration in the
distributed drug product, or any failure of one or more distributed batches of
the drug product to meet the specifications therefor in the NDA for the
GENENTECH Products. Such information shall be sent to the Product Complaints
department at Genentech, to the attention of the Director of Product Complaints
at the same address as set forth in Section 10.3 above. GENENTECH shall be
solely responsible for responding to any such GENENTECH Product Quality
Complaints.
10.6 Medical Inquiries. GENENTECH's Medical Information Department shall
-----------------
be responsible for and shall handle all medical inquiries concerning the
GENENTECH Products in accordance with its normal procedures therefor. The
INTEGRILIN PARTNERS shall refer all routine medical information requests by
telephone to:
Genentech Medical Information
Telephone No.: (800) 821-8590
A Party may change its contact at any time for future notices under
this Section upon written notice given to the other.
GENENTECH shall provide the INTEGRILIN PARTNERS with one copy of all
medical documents, including but not limited to medical responses, written,
phone and person contact inquiries and published literature which GENENTECH
believes is useful or necessary in connection with the activities and duties
contemplated of the INTEGRILIN PARTNERS under this Agreement.
10.7 Product Recall. Beginning as of the Effective Date of this
--------------
Agreement, each Party shall promptly notify the other Parties in writing of any
order, request or directive of a court or Regulatory Authority to recall or
withdraw the GENENTECH Products in the Territory. GENENTECH shall be solely
responsible for handling all recalls of the GENENTECH Products in the Territory,
including those initiated by it or that are required by any Regulatory Authority
in the Territory. Prior to making a decision to implement any such recall,
GENENTECH will, where it is reasonably able to do so, consult with the
INTEGRILIN PARTNERS as to same, but GENENTECH shall have total discretion with
respect to any decision concerning any recall. GENENTECH shall be [*] any recall
or withdrawal of the GENENTECH Products and for [*] Third Parties as a result of
such GENENTECH Product recall, except to the extent caused by the negligence or
willful misconduct of, or breach of this Agreement by, the INTEGRILIN PARTNERS.
At GENENTECH's request, the INTEGRILIN PARTNERS will assist GENENTECH in
effecting any such GENENTECH Product recall and in obtaining and receiving any
GENENTECH Product-related items that have been recalled, [*] by the [*] incurred
in connection therewith [*].
ARTICLE 11. Certain Regulatory Matters Concerning INTEGRILIN Products;
----------------------------------------------------------
Product Recall.
--------------
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
41.
11.1 General Control in INTEGRILIN PARTNERS. All regulatory matters
--------------------------------------
regarding the INTEGRILIN Products shall remain under the exclusive control and
responsibility of the INTEGRILIN PARTNERS. The INTEGRILIN PARTNERS will have
the sole responsibility, [*], to respond to INTEGRILIN Product and medical
complaints and to handle all returns and recalls of the INTEGRILIN Products.
11.2 Efficacy and Safety Information. The INTEGRILIN PARTNERS shall
-------------------------------
furnish GENENTECH with efficacy and safety information reasonably requested by
GENENTECH to assist it in promoting the INTEGRILIN Products in the Territory,
including, without limitation, summaries of relevant clinical and safety data
included in the NDA for the INTEGRILIN Products and summaries of information
related to the efficacy and safety profile of the INTEGRILIN Products since its
approval by the FDA.
Subject to the terms of this Agreement, within [*] of the Execution
Date, GENENTECH and the INTEGRILIN PARTNERS shall discuss and develop mutually
acceptable guidelines and procedures (in the form of a safety agreement (the
"Safety Agreement") to be executed by each of the Parties) for the receipt,
recordation, communication (as between the Parties) and exchange of adverse
event information. It is anticipated that such guidelines and procedures will
include provisions for the direct reporting to the INTEGRILIN PARTNERS of
adverse events by the GENENTECH Sales Force Personnel. The Parties shall bear
their respective costs incurred in connection with receiving, recording,
reviewing, communicating, and exchanging with each other regarding and, as
applicable, reporting and responding to adverse events. The Safety Agreement
shall supercede the adverse reporting procedures set forth in this Agreement.
The Parties hereby agree that adverse event reporting procedures in
connection with clinical trials involving [*] shall be handled in a separate
Clinical Trial Research Agreement among the Parties, if applicable.
11.3 Notification of Adverse Events; Reporting to Regulatory Authorities.
-------------------------------------------------------------------
"Serious adverse events" for the INTEGRILIN Products (as defined in Section
1.52) learned by GENENTECH shall be submitted to the INTEGRILIN PARTNERS within
[*] from the receipt date by GENENTECH. The "receipt date" is defined as the
date GENENTECH first receives notification of an adverse event report that
contains at least: (i) an identifiable patient; (ii) an identifiable reporter;
(iii) a suspect INTEGRILIN Product; and (iv) an adverse event or fatal outcome.
"Non-serious adverse events" for the INTEGRILIN Products (as defined in Section
1.52) that are spontaneously reported to GENENTECH shall be submitted to the
INTEGRILIN PARTNERS no more than [*] from the date received by GENENTECH;
provided, however, that medical and scientific judgment should be exercised in
- --------
deciding whether expedited reporting is appropriate in other situations, such as
important medical events that may not be immediately life-threatening or result
in death or hospitalization but may jeopardize the patient or may require
intervention to prevent a serious adverse event outcome.
The INTEGRILIN PARTNERS shall have the reporting responsibility for
all adverse events associated with use of INTEGRILIN Products to applicable
Regulatory
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
42.
Authorities anywhere in the world. The INTEGRILIN PARTNERS shall inform
GENENTECH of all adverse events reported by it to FDA at the same time as the
INTEGRILIN PARTNERS report same to FDA.
GENENTECH shall report all such adverse events involving the
INTEGRILIN Products learned by it to both:
COR Therapeutics, Inc.
256 E. Grand Avenue
South San Francisco, CA 94080
Attention: Manager, Medical Safety
Telephone No.: (650) 244-7303;
Facsimile No.: (650) 246-7776
AND
Schering Corporation
Drug Safety Surveillance
50 Lawrence Road
Springfield, NJ 07081-3121
Telephone No.: (973) 921-7412
Facsimile No.: (973) 921-7424
GENENTECH will inform the INTEGRILIN PARTNERS of the adverse event, as
well as the reporter's name, address and contact information.
Adverse events concerning the INTEGRILIN Products learned by the
INTEGRILIN PARTNERS shall be reported by the INTEGRILIN PARTNERS to GENENTECH at
the time that the INTEGRILIN PARTNERS report such events to FDA, and shall be
sent to:
Genentech Drug Safety
1 DNA Way, MS# 84
South San Francisco, CA 94080-4990
Attention: Director - Drug Safety
Facsimile No.: (650) 225-4683
Telephone No.: (888) 835-2555 (Toll free adverse event reporting line)
A Party may change its contact at any time for future notices upon
written notice given to the other.
11.4 Response by GENENTECH to Regulatory Inquiries. Upon being contacted
---------------------------------------------
by the FDA or any other applicable Regulatory Authority for any regulatory
purpose directly related to the INTEGRILIN Products, GENENTECH shall [*] notify
the INTEGRILIN PARTNERS. To the extent permitted by applicable Law, GENENTECH
will allow the INTEGRILIN PARTNERS to assume control over the timing and content
of the response to such Regulatory Authority and will not respond to the agency
until consulting with the INTEGRILIN PARTNERS; provided,
--------
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
43.
that the foregoing shall not be construed to prevent GENENTECH in any way from
complying with their obligations under applicable Law, including, without
limitation, by permitting unannounced FDA or similar inspections and responding
to requests by FDA inspectors in connection therewith.
11.5 INTEGRILIN Product Quality Complaint. GENENTECH shall inform the
------------------------------------
INTEGRILIN PARTNERS of any INTEGRILIN Product Quality Complaint received within
[*] from the receipt date by GENENTECH. The "INTEGRILIN Product Quality
Complaint" is defined as any complaint that questions the purity, identity,
potency or quality of any INTEGRILIN Product, its packaging, or labeling, or any
complaint that concerns any incident that causes the drug product or its
labeling to be mistaken for, or applied to, another article or any
bacteriological contamination, or any significant chemical, physical, or other
change or deterioration in the distributed drug product, or any failure of one
or more distributed batches of the drug product to meet the specifications
therefor in the NDA for the INTEGRILIN Products. Such information shall be sent
to the same address as set forth in Section 11.3 above. The INTEGRILIN PARTNERS
shall be solely responsible for responding to any such INTEGRILIN Product
Quality Complaints.
11.6 Medical Inquiries. COR's Medical Information Department shall be
-----------------
responsible for and shall handle all medical inquiries concerning the INTEGRILIN
Products in accordance with its normal procedures therefor. GENENTECH shall
refer all routine medical information requests by telephone to:
MedCom
Telephone Number: (888) 267-4633
A Party may change its contact at any time for future notices under
this Section upon written notice given to the other.
The INTEGRILIN PARTNERS shall provide GENENTECH with one copy of all
medical documents, including but not limited to medical responses, written,
phone and person contact inquiries and published literature which the INTEGRILIN
PARTNERS believes is useful or necessary in connection with the activities and
duties contemplated of GENENTECH under this Agreement.
11.7 Product Recall. Beginning as of the Effective Date of this
--------------
Agreement, each Party shall promptly notify the other Parties in writing of any
order, request or directive of a court or Regulatory Authority to recall or
withdraw the INTEGRILIN Products in the Territory. The INTEGRILIN PARTNERS shall
be solely responsible for handling all recalls of the INTEGRILIN Products in the
Territory, including those initiated by it or that are required by any
Regulatory Authority in the Territory. Prior to making a decision to implement
any such recall, the INTEGRILIN PARTNERS will, where it is reasonably able to do
so, consult with GENENTECH as to same, but the INTEGRILIN PARTNERS shall have
total discretion with respect to any decision concerning any recall. The
INTEGRILIN PARTNERS shall [*] any recall or withdrawal of the INTEGRILIN
Products and for any [*] Third Parties as a result of such INTEGRILIN
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
44.
Product recall, except to the extent caused by the negligence or willful
misconduct of, or breach of this Agreement by, GENENTECH. At the INTEGRILIN
PARTNERS's request, GENENTECH will assist the INTEGRILIN PARTNERS in effecting
any such INTEGRILIN Product recall and in obtaining and receiving any INTEGRILIN
Product-related items that have been recalled, and any out-of-pocket costs
incurred by GENENTECH or any of its Affiliates incurred in connection therewith
shall be promptly reimbursed by the INTEGRILIN PARTNERS.
ARTICLE 12. Compliance with Law and Labeling.
--------------------------------
12.1 Compliance with Laws. Each Party shall comply in all material
--------------------
respects with all Laws applicable to its activities under this Agreement,
including without limitation, any requirements of any product license applicable
to the Products in the Territory. The Parties will reasonably cooperate with one
another with the goal of ensuring full compliance with Laws.
12.2 Maintenance of Authorizations. Each Party shall maintain in full
-----------------------------
force and effect at its expense all necessary licenses, permits, approvals,
consents, registrations, and other authorizations required by law to carry out
its duties and obligations under this Agreement.
ARTICLE 13. Co-promotion Performance Compensation.
--------------------------------------
13.1 Compensation to Genentech.
-------------------------
13.1.1 Generally. Subject to Section 13.3, as compensation for
---------
GENENTECH's performance of its Promotion obligations under this Agreement, the
INTEGRILIN Partners shall pay GENENTECH compensation ("Genentech Performance
Compensation"), for each Agreement Year, in the amount equal to the sum of:
(i) [*] of INTEGRILIN Reported Sales in GENENTECH
Hospitals, plus
(ii) [*] of INTEGRILIN Net Sales that are [*].
Notwithstanding the foregoing, in the event that there
are [*] for the INTEGRILIN Product during the Co-
promotion Term [*] effective as of [*], then the amount
calculated to equal the Net Sales that [*] shall be [*]
for the purpose [*].
13.1.2 Baseline Annual Sales. For the purposes of this Agreement,
---------------------
"INTEGRILIN Baseline Annual Sales" shall equal, with respect to each Agreement
Year:
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
45.
===============================================================================================
Agreement Year Agreement Quarter Baseline Sales in Cumulative Year to
Territory Date Baseline Sales
-----------------------------------------------------------------------------------------------
[*] [*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*]
-----------------------------------------------------------------------------------------------
[*] [*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*]
===============================================================================================
For any partial Agreement Year, the figure for such Agreement Year
shall be adjusted by a fraction equal to the number of days in such Agreement
Year divided by 365.
13.2 Compensation to INTEGRILIN PARTNERS.
-----------------------------------
13.2.1 Generally. Subject to Section 13.3, as compensation for
---------
the INTEGRILIN PARTNERS' performance of its Promotion obligations under this
Agreement, GENENTECH shall pay the INTEGRILIN PARTNERS compensation ("INTEGRILIN
Performance Compensation") equal to [*] of those GENENTECH Net Sales that are
[*] for such Agreement Year. Notwithstanding the foregoing, in the event that
there are [*] for the GENENTECH Products during the Co-promotion Term, then the
amount calculated [*] that arise from [*] shall be [*] for the purpose [*].
13.2.2 Baseline Annual Sales. For the purposes of this
---------------------
Agreement, "GENENTECH Baseline Annual Sales" shall equal, with respect to each
Agreement Year:
===============================================================================================
Agreement Year Agreement Quarter Baseline Sales in Cumulative Year to
Territory Date Baseline Sales
-----------------------------------------------------------------------------------------------
[*] [*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*]
-----------------------------------------------------------------------------------------------
[*] [*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*] [*]
[*] [*]
===============================================================================================
For any partial Agreement Year, the figure for such Agreement Year shall be
adjusted by a
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
46.
fraction equal to the number of days in such Agreement Year divided by 365.
13.3 Shortfall in Sales Effort. In the event that a Party fails on an
-------------------------
average daily basis for a given Agreement Quarter to meet their obligation to
maintain [*] of the trained full-time employees (or full-time employee
equivalents) in its Sales Force required by Section 4.8, then that Party shall
[*] that it would otherwise [*]. The [*] that a Party [*], as compared to [*]
that such Party [*] pursuant to this Article 13, is set forth in the schedule
below. For purposes of this Section 13.3, the percentage of full-time employees
maintained by a Party shall be [*].
---------------------------------------------------
Percentage of trained [*]
full-time employees maintained
---------------------------------------------------
[*] [*]
---------------------------------------------------
[*] [*]
---------------------------------------------------
[*] [*]
---------------------------------------------------
[*] [*]
---------------------------------------------------
[*] [*]
---------------------------------------------------
[*] [*]
---------------------------------------------------
[*] [*]
---------------------------------------------------
[*] [*]
---------------------------------------------------
[*] [*]
---------------------------------------------------
[*] [*]
---------------------------------------------------
[*] [*]
---------------------------------------------------
[*] [*]
---------------------------------------------------
13.4 Currency; Bank Account; Tax Withholdings. All payments to a Party
----------------------------------------
under this Agreement shall be made by wire transfer in immediately available
funds in legal currency of the United States and shall be delivered to the
account of such Party designated by such Party in writing from time to time. All
payments shall be made in U.S. dollars.
13.5 Payment.
-------
13.5.1 Quarterly Payments. During the Co-promotion Term, the
------------------------------------------------------
Parties shall make quarterly payments as follows:
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
47.
13.5.1.1 The INTEGRILIN PARTNERS shall pay to GENENTECH, on a
quarterly basis for each of the first three quarters in any Agreement Year, an
amount [*] of those INTEGRILIN Reported Sales in GENENTECH Hospitals for the
Agreement Year-to-date, plus [*] of the INTEGRILIN Net Sales for the Agreement
Year-to-date that are [*] for such Agreement Quarter (as set forth in Section
13.1.2).
13.5.1.2 GENENTECH shall pay to the INTEGRILIN PARTNERS an
amount [*] of the GENENTECH Net Sales for the Agreement Year-to-date that are
[*] such Agreement Quarter (as set forth in Section 13.2.2).
13.5.1.3 Cumulative quarterly payments due in any Agreement
Quarter in accordance with this Section shall [*] previously paid by a Party on
account of previous Agreement Quarters in such Agreement Year.
13.5.1.4 Within [*] after the end of an Agreement Quarter,
GENENTECH and the INTEGRILIN PARTNERS shall provide each other with a detailed
written report setting forth the calculation of the amount to be paid by each of
them respectively under this Article 13 for such Agreement Quarter. Amounts owed
under this Article 13 for any Agreement Quarter shall be paid within [*] of the
end of such quarter.
13.5.2 Final Reconciliation of Payments.
---------------------------------
Since certain deductions required to calculate Net Sales take [*] being
confirmed with Third Parties (e.g., Medicare and Medicaid rebates), a final
reconciliation of the Performance Compensation due under Section 13.1 and 13.2
with respect to the second Agreement Year will be completed [*] after the end of
such second Agreement Year and reconciled against all amounts previously paid
with respect to such Agreement Year. If the final annual reconciliation shows an
amount due by either Party to the other, the amount due shall be paid [*] after
the receipt of such final reconciliation report.
13.5.2.1 Books and Records. (a) GENENTECH will maintain
-----------------
complete and accurate books and records in sufficient detail to enable
verification of GENENTECH Net Sales. Not more than [*], the INTEGRILIN PARTNERS
may demand an audit of GENENTECH's and its Affiliates' relevant books and
records in order to verify GENENTECH's reports on the aforesaid matters. Upon
reasonable prior notice [*] to GENENTECH and during GENENTECH's normal business
hours, the INTEGRILIN PARTNERS' independent public accountants shall have access
to the relevant books and records of Genentech in order to conduct a review or
audit thereof. Such review and access shall be permitted only with respect to
[*] prior to the Agreement Year in which the audit occurs. The accountants shall
report its conclusions and calculations to both Parties at the same time. The
accountants shall execute an appropriate confidentiality agreement with
GENENTECH prior to having access to any GENENTECH books and records.
(b) The INTEGRILIN PARTNERS will maintain complete and accurate books
and records in sufficient detail to enable verification of INTEGRILIN Net Sales.
Not
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
48.
more than [*], GENENTECH may demand an audit of the INTEGRILIN PARTNERS' and its
Affiliates' relevant books and records in order to verify the INTEGRILIN
PARTNERS' reports on the aforesaid matters. Upon reasonable prior notice [*] to
the INTEGRILIN PARTNERS and during their normal business hours, GENENTECH's
independent public accountants shall have access to the relevant books and
records of the INTEGRILIN PARTNERS in order to conduct a review or audit
thereof. Such review and access shall be permitted only with respect to [*]
comprising the Co-promotion Term. The accountants shall report its conclusions
and calculations to both Parties at the same time. The accountants shall execute
an appropriate confidentiality agreement with the INTEGRILIN PARTNERS prior to
having access to any of their books and records.
13.5.2.2 Costs of Audit. (a) The INTEGRILIN PARTNERS shall
--------------
bear the full cost of the performance of any such audit except as hereinafter
set forth. If, as a result of any inspection of the books and records of
GENENTECH, it is shown that GENENTECH's Performance Compensation payments to the
INTEGRILIN PARTNERS under this Agreement were less than the amount which should
have been paid, then GENENTECH shall make all payments required to be made to
eliminate any discrepancy revealed by said inspection, [*] the INTEGRILIN
PARTNERS' demand therefor. If, as a result of any inspection of the books and
records of the INTEGRILIN PARTNERS, it is shown that GENENTECH's reimbursements
for costs to the INTEGRILIN PARTNERS under this Agreement were more than the
amount which should have been paid, then the INTEGRILIN PARTNERS shall reimburse
GENENTECH for the discrepancy revealed by said inspection, [*] after GENENTECH's
demand therefor. Furthermore, if the Performance Compensation payments were less
than the amount which should have been paid by an amount in excess of [*] of the
payments actually made during the period in question, GENENTECH shall also
reimburse the INTEGRILIN PARTNERS for [*] due from [*] as part of [*] at [*], as
well as [*]. For purposes of the foregoing, [*] shall mean [*] during the
relevant period in question .
(b) GENENTECH shall bear the full cost of the performance of any such
audit except as hereinafter set forth. If, as a result of any inspection of the
books and records of the INTEGRILIN PARTNERS, it is shown that the INTEGRILIN
PARTNERS' Performance Compensation payments to GENENTECH under this Agreement
were less than the amount which should have been paid, then the INTEGRILIN
PARTNERS shall make all payments required to be made to eliminate any
discrepancy revealed by said inspection, [*] after GENENTECH's demand therefor.
If, as a result of any inspection of the books and records of GENENTECH, it is
shown that the INTEGRILIN PARTNERS's reimbursements for costs to GENENTECH under
this Agreement were more than the amount which should have been paid, then
GENENTECH shall reimburse the INTEGRILIN PARTNERS for the discrepancy revealed
by said inspection, [*] after the INTEGRILIN PARTNERS' demand therefor.
Furthermore, if the Performance Compensation payments were less than the amount
which should have been paid by an amount in excess of [*] of the payments
actually made during the period in question, the INTEGRILIN PARTNERS shall also
reimburse GENENTECH for [*] due from [*]as part of [*] at [*] as well as [*].
For purposes of the foregoing, [*] shall mean [*] during the relevant period in
question.
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act Of 1934, As
Amended.
49.
13.6 Exchange of Sales Data. The Parties agree to exchange factory
----------------------
sales data [*]. Such information shall be provided to individuals within the
recipient's organizations only on a need to know basis and according to a
procedure to be decided upon by the JPT
ARTICLE 14. Dispute Resolution.
-------------------
14.1 Dispute Resolution. In the event of any controversy, claim or
------------------
dispute arising out of or relating to this Agreement, the Parties shall try to
settle their differences amicably between themselves, first by the members of
the JPT, second by referring the disputed matter to the designees contemplated
by Section 4.15.1.1, and third by referring the disputed matter to the Chief
Operating Officer of GENENTECH, the President of COR and the President of
Schering Corporation for resolution. Either Party may initiate such informal
dispute resolution by sending written notice of the dispute to the other Parties
requesting attempted resolution by such designees or said officers, as the case
may be, and, within [*] after such notice, such representatives of the Parties
shall meet for the purpose of attempting in good faith to resolve such dispute.
Following completion of the procedures set forth above, neither Party shall be
precluded from using a court of competent jurisdiction to resolve any dispute
arising under this Agreement.
14.2 No Limitation. Notwithstanding the foregoing, nothing in this
-------------
Article 14 shall be construed as limiting in any way the right of a Party to
seek injunctive or other equitable relief from a court of competent jurisdiction
with respect to any actual or threatened breach of this Agreement or to prevent
infringement of its intellectual property rights.
ARTICLE 15. Co-promotion Term and Termination.
----------------------------------
15.1 Co-promotion Term; Term of Agreement.
-------------------------------------
15.1.1 Co-promotion Term. The Co-promotion Term shall begin on
-----------------
the Effective Date and shall continue until [*]. (the "Co-promotion Term");
provided, that the Co-promotion Term is subject to earlier termination in
- --------
accordance with Section 15.2, 15.3, 15.4, or 15.5 below or by the Parties'
mutual agreement.
15.1.2 Term of Agreement. Notwithstanding the termination or
-----------------
expiration of the Co-promotion Term, this Agreement shall continue until any
obligations of the Parties that survive termination of the Co-promotion Term
shall have expired in accordance with their terms or shall have been terminated
by mutual written agreement of the Parties.
15.2 Termination by the INTEGRILIN PARTNERS. The INTEGRILIN PARTNERS
--------------------------------------
may terminate the Co-promotion Term upon the occurrence of any of the following:
15.2.1 Upon written notice to GENENTECH, if GENENTECH and/or
its Third Party manufacturer has permanently ceased manufacturing and marketing
a GENENTECH Products because of a significant safety problem related to the
GENENTECH Product; or
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
Amended.
50.
15.2.2 immediately upon written notice of termination given to
GENENTECH, if GENENTECH has breached a material obligation, covenant, or duty
under this Agreement, unless, where such breach is curable, either GENENTECH has
cured such default within [*] after the INTEGRILIN PARTNERS have advised
GENENTECH in writing of the nature of the breach or default, or, if such breach
is not curable within said [*] period, GENENTECH has taken substantial steps to
remedy such breach and continues to take diligent steps to cure same as promptly
as reasonably practicable thereafter; or
15.2.3 immediately upon written notice of termination given to
GENENTECH, if any of GENENTECH's representations and warranties set forth in
Article 18 were untrue in any material respect provided, that such notice of
termination is given [*] after the INTEGRILIN PARTNERS has learned of the
circumstance(s) giving rise to this right of termination; or
15.2.4 pursuant to Section 3.4.1.3 hereof; or
15.2.5 upon [*] written notice, (i) if GENENTECH has been found by
an unappealable order of a court of competent jurisdiction to have acted
illegally in the manner in which it is Promoting an INTEGRILIN Product in the
Territory or to have otherwise not complied in any material respect with
applicable Law relating to the Promotion of an INTEGRILIN Product, or (ii) if
GENENTECH has materially breached this Agreement in its Promotion of an
INTEGRILIN Product, such that GENENTECH materially jeopardizes or harms the NDA
for, or materially harms the commercial value, Net Sales, or the commercial
reputation of, the INTEGRILIN Product. The phrase "jeopardizes or harms" an NDA
includes, but is not limited to, the following serious types of issues:
15.2.5.1 a government seizure of INTEGRILIN Product;
15.2.5.2 a government injunction upon the sale of INTEGRILIN
Product;
15.2.5.3 a government indictment of GENENTECH or its employees
based upon Promotion or other conduct of GENENTECH or its employees involving
the INTEGRILIN Product; or
15.2.5.4 a consent decree or assurance of voluntary
discontinuance or similar civil and/or criminal settlement agreement entered
into between GENENTECH and the federal or state government which involves the
INTEGRILIN Product and relates to conduct of GENENTECH or its employees which is
not in compliance with or alleged by such government not to be in compliance
with federal and/or state laws and regulations impacting drug labeling,
advertising and promotion including, without limitation the Prescription Drug
Marketing Act, the Antifraud and Abuse Amendments, the Omnibus Budget
Reconciliation Act, and the Veteran's Administration Bill, and other similar
laws enacted in the future in the U.S.
15.3 Termination by GENENTECH. GENENTECH may terminate the Co-promotion
------------------------
Term upon the occurrence of any of the following:
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
51.
15.3.1 Upon written notice to the INTEGRILIN PARTNERS, if the
INTEGRILIN PARTNERS and/or its Third Party manufacturer has permanently ceased
manufacturing and marketing the INTEGRILIN Products because of a significant
safety problem related to the INTEGRILIN Products; or
15.3.2 immediately upon written notice of termination given to the
INTEGRILIN PARTNERS, if the INTEGRILIN PARTNERS have breached a material
obligation, covenant, or duty under this Agreement, unless, where such breach is
curable, either the INTEGRILIN PARTNERS have cured such default within [*] after
GENENTECH has advised the INTEGRILIN PARTNERS in writing of the nature of the
breach or default, or, if such breach is not curable within said [*] period, the
INTEGRILIN PARTNERS has taken substantial steps to remedy such breach and
continues to take diligent steps to cure same as promptly as reasonably
practicable thereafter; or
15.3.3 immediately upon written notice of termination given to the
INTEGRILIN PARTNERS, if any of the INTEGRILIN PARTNERS's representations and
warranties set forth in Article 18 were untrue in any material respect,
provided, that such notice of termination is given not later than [*] after
GENENTECH has learned of the circumstance(s) giving rise to this right of
termination; or
15.3.4 pursuant to Section 2.4.1.3; or
15.3.5 upon [*] written notice, (i) if either of the INTEGRILIN
PARTNERS have been found by an unappealable order of a court of competent
jurisdiction to have acted illegally in the manner in which they are Promoting a
GENENTECH Product in the Territory or has otherwise not complied in any material
respect with applicable Law relating to the Promotion of a GENENTECH Product, or
(ii) if the INTEGRILIN PARTNERS have materially breached this Agreement in their
Promotion of a GENENTECH Product, such that the INTEGRILIN PARTNERS materially
jeopardizes or harms GENENTECH's NDA for, or materially harms the commercial
value, Net Sales, or the commercial reputation of, the GENENTECH Product. The
phrase "jeopardizes or harms" an NDA includes, but is not limited to, the
following serious types of issues:
15.3.5.1 a government seizure of GENENTECH Product;
15.3.5.2 a government injunction upon the sale of GENENTECH
Product;
15.3.5.3 a government indictment of the INTEGRILIN PARTNERS or
its employees based upon Promotion or other conduct of the INTEGRILIN PARTNERS
or its employees involving a GENENTECH Product; or
15.3.5.4 a consent decree or assurance of voluntary
discontinuance or similar civil and/or criminal settlement agreement entered
into between the INTEGRILIN PARTNER and the federal or state government which
involves a GENENTECH Product and
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
52.
relates to conduct of the INTEGRILIN PARTNERS or their employees which is not in
compliance with or alleged by such government not to be in compliance with
federal and/or state laws and regulations impacting drug labeling, advertising
and promotion including, without limitation the Prescription Drug Marketing Act,
the Antifraud and Abuse Amendments, the Omnibus Budget Reconciliation Act, and
the Veteran's Administration Bill, and other similar laws enacted in the future
in the U.S.
15.4 Insolvency. Any Party may terminate this Agreement if, at any time,
----------
another Party shall file in any court or agency pursuant to any statute or
regulation of any state or country, a petition in bankruptcy or insolvency or
for reorganization or for an arrangement or for the appointment of a receiver or
trustee of the Party or of its assets, or if the other Party proposes a written
agreement of composition or extension of its debts, or if the other Party shall
be served with an involuntary petition against it, filed in any insolvency
proceeding, and such petition shall not be dismissed within [*] after the filing
thereof, or if the other Party shall propose or be a party to any dissolution or
liquidation, or if the other Party shall make an assignment for the benefit of
creditors. In the event that this Agreement is terminated or rejected by a
Party or its receiver or trustee under applicable bankruptcy laws due to such
Party's bankruptcy, then all rights and licenses granted under or pursuant to
this Agreement by such Party to another Party are, and shall otherwise be deemed
to be, for purposes of Section 365(n) of the Bankruptcy Code and any similar law
or regulation in any other country, licenses of rights to "intellectual
property" as defined under Section 101(52) of the Bankruptcy Code. The Parties
agree that all intellectual property rights licensed hereunder, including,
without limitation, any patents or patent applications in any country of a party
covered by the license grants under this Agreement, are part of the
"intellectual property" as defined under Section 101(52) of the Bankruptcy Code
subject to the protections afforded the non-terminating Party under Section
365(n) of the Bankruptcy Code, and any similar law or regulation in any other
country.
15.5 Survival of Obligations.
------------------------
15.5.1 Neither the termination nor expiration of the Co-promotion
Term shall release or operate to discharge any Party from any liability or
obligation that may have accrued prior to such termination or expiration or
constitute a waiver or relinquishment of any cause of action or claim that a
Party may have based on events, acts or omissions occurring prior to such
termination date. Any termination of the Co-promotion Term by a Party shall not
be an exclusive remedy, but shall be in addition to any legal or equitable
remedies that may be available to a Party and shall not affect a Party's rights
to indemnification that are expressly set forth in this Agreement. The mere
termination of this Agreement in accordance with its terms shall not, in and of
itself, give rise to any damages or liability on the part of the terminating
Party.
15.5.2 The following provisions shall survive any termination of this
Agreement: Articles 16 and 17 and Sections 4.8.2.6, 4.8.4.6, 6.1.1, 6.1.5,
6.2.1 and 6.2.5, as well as any other provisions, which, by their intent or
meaning, are intended to so survive.
15.6 Effect of Termination.
----------------------
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
53.
15.6.1 Upon the termination or expiration of the Co-promotion
Term, the INTEGRILIN PARTNERS shall promptly (i) cease all of its promotion
activities for the GENENTECH Products pursuant to this Agreement, (ii)
discontinue any use of the GENENTECH Trademarks, and (iii) return to GENENTECH
at GENENTECH's expense all sales training, promotional and marketing material
for the GENENTECH Product, and GENENTECH Confidential Information (in accordance
with Article 17 hereof).
15.6.2 Upon the termination or expiration of the Co-promotion
Term, GENENTECH shall promptly (i) cease all of its promotion activities for the
INTEGRILIN Product pursuant to this Agreement, (ii) discontinue any use of the
INTEGRILIN Trademark, and (iii) return to the INTEGRILIN PARTNERS at the
INTEGRILIN PARTNERS' expense all sales training, promotional and marketing
material for the INTEGRILIN Product, and INTEGRILIN Confidential Information (in
accordance with Article 17 hereof).
15.6.3 During any period after receipt of notice of termination
but preceding the effective date of termination, each Party shall continue to
diligently fulfill all obligations of this Agreement as apply to it during such
period in accordance with the provisions of this Agreement.
ARTICLE 16. Indemnification and Insurance; Infringement Proceedings.
--------------------------------------------------------
16.1 Indemnification by GENENTECH. Subject to Section 16.3, GENENTECH
----------------------------
shall defend, indemnify and hold the INTEGRILIN PARTNERS, their Affiliates and
their respective employees, agents, officers and directors (collectively, the
"INTEGRILIN PARTNERS Indemnitees") harmless from and against any and all losses,
liabilities, obligations, claims, fees (including, without limitation,
reasonable attorneys fees and fees of other professionals), expenses and
lawsuits brought against or incurred by a the INTEGRILIN PARTNERS Indemnitee
that are claimed by any Third Party and that result from or arise in connection
with: (i) the breach of any covenant, obligation, representation or warranty of
GENENTECH contained in this Agreement; (ii) the manufacture, importation, sale
or distribution of the GENENTECH Products by GENENTECH, its Affiliates, or any
licensees, distributors, wholesalers or retailers of the Products; (iii) any
claim of patent, copyright, trade secret or other intellectual property
infringement arising out of or in connection with any manufacture, use, sale,
offer for sale, importation, or use of the GENENTECH Products; (iv) any product
liability claim arising out of or in connection with the use of the GENENTECH
Products by any Third Party; (v) any contamination, adulteration, mislabeling,
or other defect in or of the GENENTECH Products; (vi) injury to any person
(including death) arising out of the use of the GENENTECH Products; (vii)
negligence or willful misconduct by any employee, representative, contractor
(other than the INTEGRILIN PARTNERS) or agent of GENENTECH; (viii) use or
dissemination by the INTEGRILIN PARTNERS or GENENTECH, or any of their Sales
Force Personnel, of any educational, promotional or advertising materials
developed or provided by GENENTECH; (ix) subject to Section 10.7, any recall,
withdrawal or similar action with respect to the GENENTECH Products in the
Territory; (x) claims by Third Parties arising out of any shortfall of the
GENENTECH Product in the Territory.
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
54.
16.2 Indemnification by the INTEGRILIN PARTNERS. Subject to Section 16.3,
------------------------------------------
the INTEGRILIN PARTNERS shall defend, indemnify and hold GENENTECH, its
Affiliates and their respective employees, agents, officers and directors
(collectively, the "GENENTECH Indemnitees") harmless from and against any and
all losses, liabilities, obligations, claims, fees (including, without
limitation, reasonable attorneys fees and fees of other professionals), expenses
and lawsuits brought against or incurred by a the GENENTECH Indemnitee that are
claimed by any Third Party and that result from or arise in connection with: (i)
the breach of any covenant, obligation, representation or warranty of the
INTEGRILIN PARTNERS contained in this Agreement; (ii) the manufacture,
importation, sale or distribution of the INTEGRILIN Product by the INTEGRILIN
PARTNERS, their Affiliates, or any licensees, distributors, wholesalers or
retailers of the INTEGRILIN Product; (iii) any claim of patent, copyright, trade
secret or other intellectual property infringement arising out of or in
connection with any manufacture, use, sale, offer for sale, importation, or use
of the INTEGRILIN Products; (iv) any product liability claim arising out of or
in connection with the use of the INTEGRILIN Products by any Third Party; (v)
any contamination, adulteration, mislabeling, or other defect in or of the
INTEGRILIN Products; (vi) injury to any person (including death) arising out of
the use of the INTEGRILIN Products; (vii) negligence or willful misconduct by
any employee, representative, contractor (other than GENENTECH) or agent of the
INTEGRILIN PARTNERS; (viii) use or dissemination by GENENTECH or the INTEGRILIN
PARTNERS or any of their Sales Force Personnel, of any educational, promotional
or advertising materials developed or provided by INTEGRILIN PARTNERS; (ix)
subject to Section 11.7, any recall, withdrawal or similar action with respect
to the INTEGRILIN Products in the Territory; (x) claims by Third Parties arising
out of any shortfall of the INTEGRILIN Product in the Territory.
16.3 Indemnification Procedure. In order to receive the benefits of the
-------------------------
indemnity under Sections 16.1, or 16.2, as applicable, the INTEGRILIN PARTNERS
Indemnitee or the GENENTECH Indemnitee (either, an "Indemnitee") must:
(i) give the indemnifying Party or Parties (the "Indemnitor") written
notice of any claim or potential claim promptly after the
Indemnitee receives notice thereof; provided that failure of the
--------
Indemnitee to provide such notice shall not constitute a waiver of,
or result in the loss of, such party's right to indemnification
under this Agreement, except in the event that the Indemnitor's
rights, and/or its ability to defend against or settle such claim
or potential claim, are materially prejudiced by such failure to
notify;
(ii) allow the Indemnitor to assume the control of the defense and
settlement (including all decisions relating to litigation, defense
and appeal) of any such claim, provided, that: (a) the Indemnitor
has confirmed its indemnification obligation to the Indemnitee
under this Article 16, and (b) no such settlement may materially
adversely affect the rights or obligations of the Indemnitee under
this Agreement without the Indemnitee's prior written consent; and
(iii) reasonably cooperate with the Indemnitor in its defense of the
claim (including, without limitation, making documents and records
available for review and
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
55.
copying and making persons within the Indemnitee's control
available for pertinent interview and testimony), so long as such
cooperation does not vitiate any legal privilege to which such
Indemnitee is entitled.
If the Indemnitor defends the claim, the Indemnitee may at its expense and using
attorneys of its choice, participate in, but shall not have any control of, the
defense of such claim. An Indemnitor shall have no liability under this Article
16 as to any claim for which settlement or compromise of such claim, or an offer
of settlement or compromise of such claim, is made by an Indemnitee without the
prior written consent of the Indemnitor.
16.4 Insurance. Each of the Parties shall maintain an adequate self-
---------
insurance and/or insurance program to protect against potential liabilities and
risk arising out of activities to be performed under this Agreement and upon
such terms (including coverages, deductible limits and self-insured retentions)
as are customary for the activities to be conducted by such Parties under this
Agreement and are appropriate to cover the Parties' respective indemnification
obligations hereunder. Each Party shall furnish to the others evidence of such
insurance and/or self-insurance, upon request. Such insurance information shall
be kept in confidence in the same manner as any other confidential information
disclosed by one Party to another hereunder.
16.5 Infringement of GENENTECH Product Claimed by a Third Party. In the
----------------------------------------------------------
event of the institution of any suit by a Third Party against the INTEGRILIN
PARTNERS or its Affiliates for patent, copyright or trademark infringement
involving the manufacture, use, sale, license or marketing of the GENENTECH
Products in the Territory, the INTEGRILIN PARTNERS shall promptly notify
GENENTECH in writing. GENENTECH shall defend the INTEGRILIN PARTNERS in any
such suit with counsel reasonably satisfactory to the INTEGRILIN PARTNERS at
GENENTECH's own expense. GENENTECH may settle any such action in its sole and
absolute discretion through the payment of damages, royalties, milestones or
other fees to such Third Party. Provided that GENENTECH has acknowledged its
indemnification obligations to the INTEGRILIN PARTNERS under Section 16.1 in
writing, the INTEGRILIN PARTNERS shall render, at their expense all assistance
reasonably requested in connection with any action taken by GENENTECH in such
suit and permit GENENTECH to use their name in connection therewith, and the
control of such action, including whether to initiate any legal proceeding
and/or the settlement thereof, shall solely be under the control of GENENTECH;
provided, that GENENTECH or its Affiliates shall not, without the INTEGRILIN
- --------
PARTNERS' prior written consent (not to be unreasonably withheld), settle any
such claim or proceeding in a manner that (a) materially adversely affects the
INTEGRILIN PARTNERS's rights, benefits or obligations under this Agreement (it
being understood that the payment of monies by GENENTECH or the continuing
payment of any monies by GENENTECH under the previous sentence shall not require
the INTEGRILIN PARTNERS's consent, even though it may have an effect on
Performance Compensation), or (b) admits liability on the part of the INTEGRILIN
PARTNERS, or (c) results in any damages payable by the INTEGRILIN PARTNERS that
are not covered by GENENTECH's indemnification herein. GENENTECH shall
reimburse the INTEGRILIN PARTNERS for reasonable out-of-pocket expenses
(including attorney's fees and costs of litigation) incurred by the INTEGRILIN
PARTNERS in any such proceeding or at the specific written request of GENENTECH.
GENENTECH shall indemnify and hold the
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
56.
INTEGRILIN PARTNERS and their Affiliates harmless from and against any claims,
damages, liabilities, costs and expenses that may be incurred by or levied upon
the INTEGRILIN PARTNERS or any of its Affiliates as a result of providing such
cooperation or of using their respective name(s) in any such action or related
proceeding.
16.6 Infringement of INTEGRILIN Product Claimed by a Third Party. In the
-----------------------------------------------------------
event of the institution of any suit by a Third Party against GENENTECH or its
Affiliates for patent, copyright or trademark infringement involving the
manufacture, use, sale, license or marketing of the INTEGRILIN Product in the
Territory, GENENTECH shall promptly notify the INTEGRILIN PARTNERS in writing.
The INTEGRILIN PARTNERS shall defend GENENTECH in any such suit with counsel
reasonably satisfactory to GENENTECH at the INTEGRILIN PARTNERS' own expense.
The INTEGRILIN PARTNERS may settle any such action in its sole and absolute
discretion through the payment of damages, royalties, milestones or other fees
to such Third Party. Provided that the INTEGRILIN PARTNERS have acknowledged
their indemnification obligations to GENENTECH under Section 16.2 in writing,
GENENTECH shall render, at its expense all assistance reasonably requested in
connection with any action taken by the INTEGRILIN PARTNERS in such suit and
permit the INTEGRILIN PARTNERS to use their name in connection therewith, and
the control of such action, including whether to initiate any legal proceeding
and/or the settlement thereof, shall solely be under the control of the
INTEGRILIN PARTNERS; provided, that the INTEGRILIN PARTNERS or theirs Affiliates
--------
shall not, without GENENTECH's prior written consent (not to be unreasonably
withheld), settle any such claim or proceeding in a manner that (a) materially
adversely affects GENENTECH's rights, benefits or obligations under this
Agreement (it being understood that the payment of monies by the INTEGRILIN
PARTNERS or the continuing payment of any monies by the INTEGRILIN PARTNERS
under the previous sentence shall not require GENENTECH's consent, even though
it may have an effect on Performance Compensation), or (b) admits liability on
the part of GENENTECH, or (c) results in any damages payable by GENENTECH that
are not covered by the INTEGRILIN PARTNERS' indemnification herein. The
INTEGRILIN Partners shall reimburse GENENTECH for reasonable out-of-pocket
expenses (including attorney's fees and costs of litigation) incurred by
GENENTECH in any such proceeding or at the specific written request of the
INTEGRILIN PARTNERS. The INTEGRILIN PARTNERS shall indemnify and hold GENENTECH
and its Affiliates harmless from and against any claims, damages, liabilities,
costs and expenses that may be incurred by or levied upon GENENTECH or any of
its Affiliates as a result of providing such cooperation or of using their
respective name(s) in any such action or related proceeding.
ARTICLE 17. Confidentiality.
----------------
17.1 Confidential Information. Each Party acknowledges that it may
------------------------
receive Confidential Information (as defined below) of the other Parties in the
performance of or in furtherance of this Agreement. Each Party shall use
Diligent Efforts to hold confidential and not to, directly or indirectly,
disclose or publish to any Third Party or use for the benefit of a Third Party
or itself or its Affiliates, except in carrying out its duties hereunder, any
Confidential Information of the another Party, without first having obtained the
furnishing Party's written consent to such disclosure or use. "Confidential
Information" shall mean know-how, scientific
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
57.
information, pre-clinical and clinical data, adverse event information,
formulas, methods and processes, specifications, pricing information (including
discounts, rebates and other price adjustments) and other terms and conditions
of sales, customer information, business plans, and all other intellectual
property which is not publicly available and is owned or controlled by a Party.
These restrictions shall not apply to any Confidential Information which:
17.1.1 is known to the receiving Party or its Affiliates prior to the
time of disclosure to it; or
17.1.2 is independently developed by employees, agents, or
independent contractors of the receiving Party or its Affiliates without aid or
use of the disclosing Party's Confidential Information (and such independent
development can be demonstrated by the receiving Party); or
17.1.3 is disclosed, without restriction as to confidentiality, to
the receiving Party or its Affiliates by a Third Party that has a right to make
such disclosure; or
17.1.4 becomes part of the public domain through no breach by the
receiving Party of its obligations under this Agreement (including without
limitation information that is contained in any written promotional material
prepared by a Party that is distributed for use in connection with the
Products).
Each receiving Party shall disclose Confidential Information of the
disclosing Party only to those employees and contractors of such Party and of
its Affiliates who have reason to know same in furtherance of a Party's duties
under this agreement and who are bound by a written obligation of
confidentiality to the receiving Party (or its Affiliate) that is no less
stringent than the confidentiality obligations set forth in this Article 17.
17.2 Required Disclosures. The receiving Party shall also be entitled to
--------------------
disclose the other Party's Confidential Information that is required to be
disclosed (i) to or by Regulatory Authorities; (ii) to comply with applicable
Laws (including, without limitation, to comply with SEC, NASDAQ or stock
exchange disclosure requirements), (iii) to comply with judicial process or an
order of any governmental body or a court of competent jurisdiction, or (iv) to
defend or prosecute litigation; provided, however, that in each case the Party
-------- -------
required to disclose such Confidential Information shall use Diligent Efforts to
notify the other Party in advance of such disclosure and shall provide the
disclosing Party with reasonable assistance to obtain a protective order and/or
confidential treatment of such Confidential Information, to the extent
available, and thereafter only discloses the minimum Confidential Information
required to be disclosed in order to ensure legal compliance.
17.3 Duration. This obligations set forth in this Article 17 shall survive
--------
the termination or expiration of this Agreement for [*]. Upon expiration or
termination of this Agreement, a receiving Party shall return to the disclosing
Party or destroy all Confidential Information provided to it by the disclosing
Party, including all copies, notes and extracts thereof or other written records
containing such Confidential Information, except for one (1) copy that it may
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
58.
keep in its archives for the sole purpose of verifying its continuing
confidentiality obligations hereunder.
17.4 Novation. The confidentiality obligations described above shall
--------
supersede the Mutual Confidentiality Agreement dated as of September 19, 2000
between the Parties with respect to the disclosure by either Party to the other
of any Confidential Information hereafter that may fall within the terms of this
Agreement and the terms of such Confidential Disclosure Agreement. Further,
said prior Confidential Disclosure Agreement is hereby amended to incorporate
the terms of Section 17.3 hereof.
ARTICLE 18. Representations and Warranties.
-------------------------------
18.1 Mutual Representations and Warranties. COR, SCHERING and
-------------------------------------
GENENTECH each represent and warrant to the other Parties that, as of the
Execution Date:
18.1.1 Representations of Authority. It (as well as such Party's
----------------------------
Affiliates with which such Party may agree, contract or otherwise arrange with
to assume or perform any of such Party's rights, obligations, representations,
or warranties hereunder) has full corporate right, power and authority to enter
into this Agreement and to perform its respective obligations under this
Agreement and, subject to Section 18.1.2 hereof, that it has the right to grant
to the other the licenses granted pursuant to this Agreement.
18.1.2 Consents. All necessary consents, approvals and
--------
authorizations of all government authorities and other persons required to be
obtained by it as of the Execution Date in connection with the execution,
delivery and performance of this Agreement have been or, to the extent that such
consents, approvals and/or authorizations can not reasonably obtained prior to
the Execution Date, shall be obtained.
18.1.3 No Conflict. Notwithstanding anything to the contrary in
-----------
this Agreement, the execution and delivery of this Agreement, the performance of
such Party's obligations in the conduct of this Agreement and the licenses and
sublicenses to be granted pursuant to this Agreement (a) do not and will not
conflict with or violate any requirement of applicable laws or regulations
existing as of the Execution Date, and (b) do not and will not conflict with,
violate, breach or constitute a default or require any consent under, any
contractual obligations of such Party or any of its Affiliates existing as of
the Execution Date, except for such consents as shall have been obtained prior
to the Execution Date.
18.1.4 Enforceability. This Agreement has been duly executed by
--------------
it, has been authorized by all necessary corporate action, and is a legal and
valid obligation binding upon it and is enforceable in accordance with its
terms.
18.2 GENENTECH's Representations and Warranties. GENENTECH represents
------------------------------------------
and warrants to the INTEGRILIN PARTNERS, as of the Execution Date, that:
18.2.1 There are no actions, suits, proceedings, investigations,
or claims relating to the GENENTECH Patents or to the GENENTECH Products, at law
or in equity, that are
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
59.
pending in the Territory against GENENTECH or any of its Affiliates before or by
any court or governmental or Regulatory Authority, or that, to the actual
knowledge of GENENTECH, have been threatened against GENENTECH or any of its
Affiliates in writing, which, if adversely determined, would have a material
adverse effect on the rights granted to the INTEGRILIN PARTNERS under this
Agreement.
18.2.2 To the actual knowledge of GENENTECH, neither GENENTECH nor
any of its Affiliates have previously assigned, transferred, conveyed or
otherwise encumbered its right, title and interest in and to the Compound, the
GENENTECH Products, the GENENTECH Patents, or the GENENTECH Trademark in any
manner that would have a material adverse effect on the rights granted to the
INTEGRILIN PARTNERS under this Agreement.
18.2.3 Other than the agreement with Actelion Ltd. relating to the
promotion of TNK, to the actual knowledge of GENENTECH as of the Execution Date,
GENENTECH and its Affiliates have not entered into any licensing,
distributorship or marketing agreements relating to the GENENTECH Compound,
GENENTECH Products, the GENENTECH Patents or the GENENTECH Trademark, in each
case in the Territory, that materially adversely effect the rights granted to
the INTEGRILIN PARTNERS under this Agreement.
18.3 COR's Representations and Warranties. SCHERING represents and
------------------------------------
warrants to GENENTECH, as of the Execution Date, that:
18.3.1 There are no actions, suits, proceedings, investigations, or
claims relating to the INTEGRILIN Patents or to the INTEGRILIN Products, at law
or in equity, that are pending in the Territory against COR or any of its
Affiliates before or by any court or governmental or Regulatory Authority, or
that, to the actual knowledge of COR, have been threatened against COR in
writing, and which, if adversely determined, would have a material adverse
effect on the rights granted to GENENTECH under this Agreement.
18.3.2 To the actual knowledge of COR, COR has not previously
assigned, transferred, conveyed or otherwise encumbered its right, title and
interest in and to the INTEGRILIN Compound, the INTEGRILIN Products, the
INTEGRILIN Patents, or the INTEGRILIN Trademark in any manner that would have a
material adverse effect on the rights granted to GENENTECH under this Agreement.
18.3.3 To the actual knowledge of COR as of the Execution Date, COR
has not entered into any licensing, distributorship or marketing agreements
relating to the INTEGRILIN Compound, INTEGRILIN Products, the INTEGRILIN Patents
or the INTEGRILIN Trademark, in the Territory, that materially adversely effect
the rights granted to GENENTECH under this Agreement.
18.4 SCHERING's Representations and Warranties. SCHERING represents and
-----------------------------------------
warrants to GENENTECH, as of the Execution Date, that:
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
60.
18.4.1 There are no actions, suits, proceedings, investigations, or
claims relating to the INTEGRILIN Patents or to the INTEGRILIN Products, at law
or in equity, that are pending in the Territory against SCHERING or any of its
Affiliates before or by any court or governmental or Regulatory Authority, or
that, to the actual knowledge of SCHERING, have been threatened against SCHERING
in writing, and which, if adversely determined, would have a material adverse
effect on the rights granted to GENENTECH under this Agreement.
18.4.2 To the actual knowledge of SCHERING, SCHERING or its
Affiliates have not previously assigned, transferred, conveyed or otherwise
encumbered its right, title and interest in and to the INTEGRILIN Compound, the
INTEGRILIN Products, the INTEGRILIN Patents, or the INTEGRILIN Trademark in any
manner that would have a material adverse effect on the rights granted to
GENENTECH under this Agreement.
18.4.3 To the actual knowledge of SCHERING as of the Execution Date,
SCHERING or its Affiliates have not entered into any licensing, distributorship
or marketing agreements relating to the INTEGRILIN Compound, INTEGRILIN
Products, the INTEGRILIN Patents or the INTEGRILIN Trademark, in the Territory,
that materially adversely effect the rights granted to GENENTECH under this
Agreement.
ARTICLE 19. Notices.
--------
19.1 Notices. Unless otherwise explicitly set forth herein, any notice
-------
required or permitted to be given hereunder shall be in writing and shall be
delivered personally by hand, or sent by reputable overnight courier, signature
required, to the addresses of each Party set forth below or to such other
address or addresses as shall be designated in writing in the same matter:
(a) If to GENENTECH:
Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080
Attn: Corporate Secretary
Fax: 650.952.9881
with a copy to the attention of the "Vice President, Business Development" at
the same address.
(b) If to SCHERING:
Schering Sales Management, Inc.
12125 Moya Boulevard
Reno, NV 89506-2600
Attn: President
Fax: (775) 677-7861
with a copy to:
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
61.
Schering Corporation
2000 Galloping Hill Road
Kenilworth, NJ 07033
Attn: Staff Vice President - Licensing
Fax: (908) 298-2739 and
Schering Corporation
2000 Galloping Hill Road
Kenilworth, NJ 07033
Attn: Vice President Business Development
Fax: (908) 298-5379
(c) If to COR:
COR Therapeutics, Inc.,
256 E. Grand Avenue
South San Francisco, CA 94080
Attn: General Counsel
with a copy to the attention of the "Senior Vice President, Business
Development" at the same address.
All notices shall be deemed given when received by the addressee.
ARTICLE 20. Miscellaneous Provisions.
-------------------------
20.1 Assignment.
----------
20.1.1 No Party shall assign or otherwise transfer this Agreement or
any interest herein or right hereunder without the prior written consent of the
other Parties, and any such purported assignment, transfer or attempt to assign
or transfer any interest herein or right hereunder shall be void and of no
effect; except that each Party (i) may assign its rights and obligations
hereunder to an Affiliate (in the case of Schering, to a wholly owned subsidiary
of Schering Plough Corporation) without the prior consent of the other Parties
(although, in such event, the assigning Party shall remain [*] with such
Affiliate for the performance of all of representations, warranties, obligations
and agreements of the assigning Party set forth herein) and (ii), except as set
forth in Sections 2.4 and 3.4, may assign its rights and obligations to a
successor (whether by merger, consolidation, reorganization or other similar
event) or purchaser of all or substantially all of its business assets relating
to the Products; provided, that such successor or purchaser has agreed in
--------
writing to assume all of such Party's rights and obligations hereunder and a
copy of such assumption is provided to the other Party hereunder.
20.2 Non-Waiver. Any failure on the part of a Party to enforce at any
----------
time or for any period of time any of the provisions of this Agreement shall not
be deemed or construed to be a waiver of such provisions or of any right of such
Party thereafter to enforce each and every such provision on any succeeding
occasion or breach thereof.
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
62.
20.3 Entirety of Agreement. This Agreement contains the entire
---------------------
understanding of the Parties with respect to the subject matter hereof and
thereof and supersedes all previous and contemporaneous verbal and written
understandings, agreements, representations and warranties with respect to such
subject matter or on which the Parties may have relied. This Agreement (and any
provision or term hereof) may be released, waived, changed or supplemented only
by a written agreement signed by an officer or other authorized representative
of the Party or Parties against whom enforcement of any release, waiver, change
or supplement is sought. This Agreement shall not be strictly construed against
any Party hereto. Paragraph headings are for convenience only and shall not be
considered in interpreting this Agreement.
20.4 Public Announcements. The form and content of any public
--------------------
announcement to be made by one Party regarding this Agreement, or the subject
matter contained herein, shall be subject to the prior written consent of the
other Parties (which consent may not be unreasonably withheld), except as may be
required by applicable law (including, without limitation, disclosure
requirements of the SEC, NASDAQ, or any other stock exchange) in which event the
disclosing Parties shall endeavor to give the other Parties reasonable advance
notice and review of any such disclosure.
20.5 Governing Law. This Agreement shall be governed by and construed in
-------------
accordance with the internal laws of the State of California, without regard or
giving effect to its conflicts of law principles.
20.6 Relationship of the Parties. In making and performing this
---------------------------
Agreement, the Parties are acting, and intend to be treated, as independent
entities and nothing contained in this Agreement shall be construed or implied
to create an agency, partnership, joint venture, or employer and employee
relationship between GENENTECH, COR and SCHERING. The relationship of the
Parties under this AGREEMENT is, and is intended to be, one of independent
contractors hereunder.
20.7 Collaboration Agreement. SCHERING and COR are parties to that
-----------------------
Collaboration Agreement dated April 10, 1995 as amended on December 23, 1998 and
as further amended on November 5, 1999 (as amended, the "INTEGRILIN
Collaboration Agreement"). The INTEGRILIN Collaboration Agreement shall govern
the relationship between SCHERING and COR with respect to the subject matter of
this Agreement, including the apportionment of duties, rights and
responsibilities between the two Parties, provided that nothing in the
INTEGRILIN Collaboration Agreement shall relieve either SCHERING or COR of any
individual or joint responsibility they have to GENENTECH under this Agreement.
No Party shall have any responsibility for the hiring, firing,
compensation or benefits of another Party's employees, and all compensation and
benefits to be paid to any employee or representative of a Party (including
without limitation all Sales Force Personnel engaged by a Party) shall be the
responsibility of the Party engaging such individual.
20.8 Counterparts. This Agreement shall become binding when any one or
------------
more counterparts hereof, individually or taken together, shall bear the
signatures of each of the Parties
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
63.
hereto. This Agreement may be executed in any number of counterparts, each of
which shall be deemed an original as against the Party whose signature appears
thereon, but all of which taken together shall constitute but one and the same
instrument.
*****************************
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
64.
IN WITNESS WHEREOF, the Parties hereto have duly executed this Agreement as
of the day and year first above written.
COR THERAPEUTICS, INC. SCHERING SALES MANAGEMENT, INC.
By: /s/ Vaughn M. Kailian By: /s/ David Poorvin
-------------------------------- ---------------------------
Vaughn M. Kailian Dr. David Poorvin
President and CEO Vice President
GENENTECH, INC.
By: /s/ Arthur D. Levinson
--------------------------------
Arthur D. Levinson
Chief Executive Officer
By: /s/ Myrtle S. Potter
--------------------------------
Myrtle S. Potter
Executive Vice President, Commercial
Operations and Chief Operating Officer
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
65.
EXHIBITS
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
66.
Exhibit 2.3
-----------
Thrombolytic Drug Product [*]
-----------------------------
[*]
---
[*] (one page omitted)
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
67.
Exhibit 3.3
-----------
GP IIb-IIIa Inhibitor Drug [*]
------------------------------
[*]
---
[*] (one page omitted)
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
68
Exhibit 4.7.1(a)
----------------
GENENTECH HOSPITALS
-------------------
Number NDC ID GNE ID GNE AcctName GNE Address GNE City GNE GNE
State Zip
================================================================================
[*] (51 pages omitted)
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
69.
Exhibit 4.7.1(b)
- ----------------
JOINT HOSPITALS
---------------
Number NDC GNE ID C/K Name C/K Address C/K City C/K C/K
REL# ST Zip
================================================================================
[*] (44 pages omitted)
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
70.
Exhibit 4.11.7 Part I
---------------------
Genentech Trials
----------------
[*] (one page omitted)
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
71.
Exhibit 4.11.7 Part II
----------------------
Integrilin Partner Trials
-------------------------
[*] (one page omitted)
[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.
72.