MANUFACTURING AGREEMENT
* Confidential portions omitted and filed separately with the Commission.
Pharmacia & Upjohn
Oncology Division
Albuquerque, New Mexico
and
Immunomedics, Inc.
Morris Plains, New Jersey
June, 1996
TABLE OF CONTENTS
ARTICLE I. DEFINITIONS. . . . . . . . . . . . . . . . . . . . . 1
1.01 Bulk Solution . . . . . . . . . . . . . . . . . . 1
1.02 Product(s). . . . . . . . . . . . . . . . . . . . 1
1.03 Finished. . . . . . . . . . . . . . . . . . . . . 1
1.04 Specifications. . . . . . . . . . . . . . . . . . 1
1.05 Master Batch Record . . . . . . . . . . . . . . . 1
1.06 PLA . . . . . . . . . . . . . . . . . . . . . . . 1
1.07 Calendar Year . . . . . . . . . . . . . . . . . . 2
1.08 Effective Date. . . . . . . . . . . . . . . . . . 2
1.09 Affiliate . . . . . . . . . . . . . . . . . . . . 2
1.10 Person. . . . . . . . . . . . . . . . . . . . . . 2
1.11 Schedules . . . . . . . . . . . . . . . . . . . . 2
ARTICLE II. THE WORK. . . . . . . . . . . . . . . . . . . . . . 2
2.01 Statement of Work . . . . . . . . . . . . . . . . 2
2.02 Amendments to Statement of Work . . . . . . . . . 2
2.03 Addition of Other Products to the Agreement . . . 2
2.04 Work Performed by POD . . . . . . . . . . . . . . 3
2.05 Preparation of Bulk Solution. . . . . . . . . . . 3
2.06 Use of POD Facilities by IMMUN. . . . . . . . . . 3
2.07 Equipment Provided by IMMUN . . . . . . . . . . . 3
2.08 Compliance With Applicable Rules at the POD
Facility . . . . . . . . . . . . . . . . . . . . 3
2.09 Responsibility for Bulk Solution. . . . . . . . . 4
2.10 Endotoxin Testing . . . . . . . . . . . . . . . . 4
2.11 Availability of POD Facilities. . . . . . . . . . 4
2.12 Processing of Product in Quarantine . . . . . . . 4
2.13 Regulatory Support. . . . . . . . . . . . . . . . 4
2.14 Facilities Inspection . . . . . . . . . . . . . . 5
ARTICLE III. FORECAST OF REQUIREMENTS . . . . . . . . . . . . . 5
3.01 Forecast. . . . . . . . . . . . . . . . . . . . . 5
3.02 POD Obligation to Meet Requirements . . . . . . . 5
3.03 Placement of an Order . . . . . . . . . . . . . . 5
ARTICLE IV. SHIPMENT & STORAGE OF, & PAYMENT FOR PRODUCT . . . . 5
4.01 Storage . . . . . . . . . . . . . . . . . . . . . 5
4.02 Transfer of Product to IMMUN. . . . . . . . . . . 6
4.03 Payment for Product . . . . . . . . . . . . . . . 6
4.04 Cancellation Fee. . . . . . . . . . . . . . . . . 6
4.05 Component Fee . . . . . . . . . . . . . . . . . . 6
4.06 Late Payment Penalty. . . . . . . . . . . . . . . 6
(i)
ARTICLE V. PRICE OF MANUFACTURE. . . . . . . . . . . . . . . . . 6
5.01 Price . . . . . . . . . . . . . . . . . . . . . . 6
5.02 Price Increase. . . . . . . . . . . . . . . . . . 7
5.03 Notification of Price Increase. . . . . . . . . . 7
5.04 Verification of Increase by Accountant. . . . . . 7
5.05 Accountant's Report . . . . . . . . . . . . . . . 7
5.06 Determination that Increase is Unjustified. . . . 7
5.07 Price Decrease. . . . . . . . . . . . . . . . . . 7
ARTICLE VI. WARRANTIES OF POD . . . . . . . . . . . . . . . . . 8
6.01 The POD Facility. . . . . . . . . . . . . . . . . 8
6.02 Aseptic Processing Environment. . . . . . . . . . 8
6.03 Failure to Comply with Sections 6.01 and 6.02 . . 8
ARTICLE VII. OWNERSHIP OF COMPONENTS AND RISK OF LOSS. . . . . . 8
7.01 Ownership of Components . . . . . . . . . . . . . 8
7.02 Ownership of Finished Product . . . . . . . . . . 8
7.03 Ownership of Bulk Solution. . . . . . . . . . . . 8
7.04 Ownership of Equipment. . . . . . . . . . . . . . 8
ARTICLE VIII. TERM AND TERMINATION . . . . . . . . . . . . . . . 9
8.01 Term. . . . . . . . . . . . . . . . . . . . . . . 9
8.02 Voluntary Termination . . . . . . . . . . . . . . 9
8.03 Termination for Material Breach . . . . . . . . . 9
8.04 Termination for Insolvency. . . . . . . . . . . . 9
8.05 Effect of Expiration or Termination . . . . . . . 9
8.06 POD Obligations Upon Expiration or Termination. . 9
ARTICLE IX. INDEMNIFICATION. . . . . . . . . . . . . . . . . . . 10
9.01 POD Indemnity . . . . . . . . . . . . . . . . . . 10
9.02 IMMUN Indemnity . . . . . . . . . . . . . . . . . 10
ARTICLE X. POD LIABILITY TO IMMUN FOR PRODUCT LOSSES . . . . . . 11
10.01 Liability for Loss of Product, Bulk
Solution, Equipment and Components. . . . . . . 11
10.02 Parties Disagree Whether Product Out of
Specification . . . . . . . . . . . . . . . . . 11
ARTICLE XI. CONFIDENTIALITY. . . . . . . . . . . . . . . . . . . 11
11.01 Confidential Information. . . . . . . . . . . . 11
11.02 Limitations on Confidentiality. . . . . . . . . 12
11.03 Disclosure Required by Law. . . . . . . . . . . 12
11.04 Equitable Remedies for Breach of
Confidentiality . . . . . . . . . . . . . . . . 12
(ii)
ARTICLE XII. MISCELLANEOUS . . . . . . . . . . . . . . . . . . . 12
12.01 Force Majeure . . . . . . . . . . . . . . . . . 12
12.02 New Mexico Gross Receipts & Compensating Tax. . 13
12.03 Relationship. . . . . . . . . . . . . . . . . . 13
12.04 Governing Law . . . . . . . . . . . . . . . . . 13
12.05 Notice. . . . . . . . . . . . . . . . . . . . . 13
12.06 Legal Construction. . . . . . . . . . . . . . . 14
12.07 Entire Agreement, Modifications, Consents,
Waivers . . . . . . . . . . . . . . . . . . . . 14
12.08 Section Headings; Construction. . . . . . . . . 15
12.09 Execution Counterparts. . . . . . . . . . . . . 15
12.10 Product Manufactured Prior to Effective Date. . 15
ARTICLE XIII. BINDING EFFECT, ASSIGNMENT . . . . . . . . . . . . 15
SIGNATURE PAGE . . . . . . . . . . . . . . . . . . . . . . . . . 16
ATTACHMENTS TO AGREEMENT
SCHEDULE 1.04 - Specifications
SCHEDULE 2.01 - Statement of Work
SCHEDULE 2.07 - Equipment List
SCHEDULE 5.01 - Product Pricing Schedule
(iii)
MANUFACTURING AGREEMENT
THIS AGREEMENT entered into this__14 th__day of June, 1996, between
Pharmacia & Upjohn Oncology Division, 4272 Balloon Park Road, N.E.
Albuquerque, New Mexico 87109 (hereinafter referred to as "POD"), and
IMMUNOMEDICS, INC., 300 American Road, Morris Plains, New Jersey 07950
(hereinafter referred to as "IMMUN").
WHEREAS, IMMUN is a biotechnology company which, using its
proprietary technology and know-how, has developed in vivo cancer imaging
products known as "CEA-Scan " and LeukoScan (the Products); and
WHEREAS, POD has expertise in the finishing of pharmaceutical
products and has the necessary and proper facilities and employees to
undertake such finishing services and is willing to do so;
NOW, THEREFORE, in consideration of the mutual covenants exchanged
herein, the parties agree as follows:
ARTICLE I. DEFINITIONS
1.01 Bulk Solution. As used herein the term "Bulk Solution"
refers to the formulated solution of Injectable grade in vivo imaging
agent solution prepared at the POD facility by IMMUN personnel.
1.02 Product(s). As used herein the term "Product(s)" shall mean
"finished" Bulk Solutions which are final pharmaceutical dosage forms
having the trade names "CEA-Scan " or LeukoScan and which are useful as
in vivo imaging agents.
1.03 Finished. The term "finish" or "finished" refers to Bulk
Solution which has been filled into vials, lyophilized, inspected, and
packaged by POD in order to produce finished pharmaceutical dosage forms
of the Product(s). The term "finishing" refers to the process of filling,
lyophilization, and packaging of the Bulk Solution.
1.04 Specifications. As used herein the term "Specification"
shall mean the "Master Batch Record" for each Product and the standards
set forth in Schedule 1.04 attached hereto.
1.05 Master Batch Record. The term "Master Batch Record" as used
herein shall mean the master production and control records required by
the FDA to be kept for each Product pursuant to 21 CFR 600.12.
1.06 PLA. The term "PLA" is used herein to mean the Product
License Application No. 91-0209 for CEA-Scan and the Product License
Application No. _________________for LeukoScan covering the Product(s)
filed with the United States Food and Drug Administration ("FDA").
1.07 Calendar Year. The term "Calendar Year" shall mean the
consecutive twelve (12) month period beginning January 1 of a year and
ending December 31 of such year.
1.08 Effective Date. The "Effective Date" of this Agreement shall
be the date first written hereinabove.
1.09 Affiliate. The term "Affiliate" as used herein shall mean
with respect to any specified Person, any other Person that directly or
indirectly through one or more intermediaries, controls, or is controlled
by, or is under common control with, the Person specified. For purposes
of this definition, "control" including, with correlative meanings, the
terms "controlled by" and "under common control with" means ownership
directly or indirectly of more than thirty percent (30%) of the equity
capital having the right to vote for election of directors in the case of
a corporation and more than thirty percent (30%) of the beneficial
interest in the case of a business entity other than a corporation.
1.10 Person. As used herein the term "Person" shall mean any
individual, corporation, partnership, business trust, business
association, governmental entity, governmental authority or other legal
entity.
1.11 Schedules. The Schedules to this Agreement are listed below
and are an integral part of this Agreement and are incorporated herein.
Schedule Description
________ _________________
1.04 Specifications
2.01 Statement of Work
2.07 Equipment List
5.01 Price
ARTICLE II. THE WORK
2.01 Statement of Work. The work to be performed by POD pursuant
to the terms of this Agreement shall be as set forth in the Statement of
Work attached hereto as Schedule 2.01 and as such may be amended from time
to time.
2.02 Amendments to Statement of Work. Any amendments made to the
Statement of Work must be mutually agreed to by the parties in writing and
must be attached to Schedule 2.01 whereupon such amendment shall become
part of this Agreement.
2.03 Addition of Other Products to the Agreement. With the
written consent of POD, IMMUN may add additional products to the Agreement
to be finished by POD; provided, however, that POD shall have the
unilateral right to decide whether it wishes to finish such additional
products pursuant to this Agreement. Any additional products added to the
Agreement will require their own Specifications, Statements of Work and
determination of "cost" in order to set the price pursuant to Section 5.01.
2.04 Work Performed by POD. POD shall be responsible for
"finishing" the formulated bulk Solution supplied to it by IMMUN in
accordance with the Statement of Work to produce Product which meets the
Specifications set forth in Schedule 1.04 attached hereto.
2.05 Preparation of Bulk Solution. IMMUN shall be responsible for
the preparation of the Bulk Solution according to the PLA and shall be
responsible for providing such Bulk Solution to POD, at POD's facilities
at such time and in such quantities as to enable POD to produce Product
in accordance with the Statement of Work.
2.06 Use of POD Facilities by IMMUN. POD shall make its
facilities (including all equipment reasonably required for the
preparation of Bulk Solution) available for IMMUN personnel to prepare
Bulk Solution in the quantity required for the manufacture of lots of
Product scheduled for production in accordance with the scheduling
procedures of Section 3.03.
2.07 Equipment provided by IMMUN. IMMUN, where possible, shall
provide all equipment and spare parts for such equipment which will come
in contact with the Bulk Solution for each Product and which shall be
suitable and sufficient for the preparation, holding and filling of each
of the Bulk Solutions. Such equipment shall be provided to POD new and
in good working order. POD agrees to clean, maintain and store such
equipment and use it solely for the purpose of manufacturing the IMMUN
product for which it is dedicated. IMMUN shall be responsible for the
repair or replacement of all equipment that becomes inoperative because
of normal wear and tear or improper use by IMMUN employees. POD shall be
responsible for the replacement of such equipment that becomes inoperative
because of improper use by POD employees. A list of the equipment to be
provided by IMMUN is attached as Schedule 2.07.
2.08 Compliance With Applicable Rules at the POD Facility. While
performing the formulation activities at the POD facilities described in
Section 2.05, IMMUN personnel shall comply with applicable current Good
Manufacturing Practice as set forth in 21 CFR Part 211, as amended from
time to time ("FDA GMP") and POD's written Standard Operating Procedures
("SOPs") as disclosed to IMMUN prior to the date hereof. IMMUN agrees to
assume any and all risks of its personnel entering and being in POD's
facilities for such formulation activities and releases POD from any and
all claims which may arise due to any injury, damage or loss which may be
suffered by such personnel on such premises; provided, however, that such
assumption and release shall not apply to any risk, injury, damage or loss
caused by or resulting substantially from the negligence of POD, its
employees and agents.
2.09 Responsibility for Bulk Solution. Except as otherwise
provided herein, IMMUN shall be solely liable for any damage to or loss
of the Bulk Solution prepared by IMMUN at the POD facility. POD shall
have no obligation or responsibility to IMMUN for any damage to or loss
of such Bulk Solution until IMMUN provides such Bulk Solution to POD
personnel to begin finishing the Bulk Solution into Product, unless such
loss or damage is due to the negligence of POD.
2.10 Endotoxin Testing. Unless otherwise agreed to by the
parties, POD shall retain a sample of each batch of final formulated Bulk
Solution provided to it by IMMUN for finishing and POD shall assay the
retained sample of final formulated Bulk Solution for presence of
endotoxin to provide a baseline endotoxin measurement to be used to
determine whether endotoxin was introduced into the Product during the
finishing process. If the results of the endotoxin test indicates that
endotoxin was introduced into the Product after compounding and during
finishing then failure of the Product to meet the Endotoxin Specifications
shall be presumed to be the fault of POD and the provisions of Section
10.01 shall apply.
2.11 Availability of POD Facilities. In the event that the POD
facilities should become unavailable for any reason and for any period of
time resulting in IMMUN being unable to use such facilities to prepare the
Bulk Solution, POD shall promptly notify IMMUN, in writing, and shall use
its best efforts to promptly restore the availability of the facilities
for the use of IMMUN. In the event the POD facilities become unavailable
to IMMUN for use through no fault of POD, POD shall have no liability to
IMMUN either direct or indirect, consequential or inconsequential for any
loss or damage suffered by IMMUN as a result of the unavailability of the
POD facilities.
2.12 Processing of Product in Quarantine. In the event POD elects
to process "in quarantine" as set forth in Paragraph 11 of Schedule 2.01,
if a batch or lot of product so processed is rejected, POD shall be
responsible for additional labor and materials costs associated with
reworking of the batch or lot; provided, however, that if IMMUN requests
that the batch or lot be further processed in quarantine, then IMMUN shall
be responsible for the additional labor and material costs if the batch
or lot so processed is rejected and must be reworked.
2.13 Regulatory Support. POD shall provide IMMUN at no additional
charge, with regulatory support for the Drug Master File and for the POD
facilities inspections by the FDA or equivalent foreign health care
regulatory authorities. In the event regulatory support additional to
that just described is required by IMMUN, POD shall provide such support
and shall charge IMMUN for the labor and materials used. Labor shall be
charged at the rate specified in Schedule 5.01 herein and materials shall
be charged at cost.
2.14 Facilities Inspection. IMMUN shall have the right to audit
POD's facilities for Good Manufacturing Practices compliance during each
year of the term of the Agreement; provided IMMUN gives POD reasonable
prior notice and the date of the audit is mutually agreed to by the
parties. IMMUN agrees that its employees or agents which inspect POD
facilities will comply with POD rules, regulations and GMP's. IMMUN
specifically assumes liability for any injuries, damages or delays in
production resulting solely from the action of its employees or agents at
POD facilities. There shall be no charge to IMMUN for POD's cooperation
unless more than one audit per year is scheduled on IMMUN's behalf.
ARTICLE III. FORECAST OF REQUIREMENTS
3.01 Forecast. Within fifteen (15) days after the Effective Date,
IMMUN shall deliver to POD a forecast of the quantity (by batch size) of
Product to be produced by POD for the period from the Effective Date until
December 31, 1996 (the "Initial Forecast"). The first three months of the
forecast will be considered a firm commitment for production quantities
and the remainder of the forecast shall be advisory only. Beginning on
June 1, 1996, and thereafter on June 1 of each calendar year of the
Agreement, IMMUN shall deliver to POD a forecast of its requirements for
Product for the Calendar Year and shall thereafter update such Calendar
Year forecasts on a monthly basis in order to allow POD to plan its
production schedule for the batch size of Product to be produced. In the
event that IMMUN anticipates a material deviation from the forecast at any
time, IMMUN shall promptly notify POD.
3.02 POD Obligation to Meet Requirements. POD agrees to supply,
in each Calendar Year, all orders placed by IMMUN up to one hundred
percent (100%) of IMMUN's Calendar Year forecast. POD shall use
reasonable efforts to supply any quantity ordered by IMMUN of Product in
excess of the forecast subject to POD's production scheduling capabilities
and commitments to other customers.
3.03 Placement of an Order. IMMUN shall initiate an order for
Product by sending to POD a specific purchase order for Product. Once POD
takes possession of the Bulk Solution and begins to finish such Bulk
Solution pursuant to the Statement of Work, IMMUN shall be obligated to
accept delivery of and pay for the Product produced from such Bulk
Solution, provided such Product meets the Specifications. Purchase orders
shall be submitted to the attention of Contract Manufacturing.
ARTICLE IV. SHIPMENT & STORAGE OF, & PAYMENT FOR PRODUCT
4.01 Storage. Finished vials will be stored at the recommended
controlled temperature until shipped as instructed by IMMUN. POD will
store the finished dosage form at no cost up to two weeks after the lots
are released to IMMUN by POD's Quality Assurance Department. Beyond two
weeks an additional charge will be incurred as noted in Schedule 5.01.
The parties agree that the storage of the finished product by POD shall
not create or constitute an agency relationship between the parties.
Title to all Product whether approved or unapproved shall remain with
IMMUN and subject to the Provisions of 10.01, risk of loss of such product
shall rest with IMMUN.
4.02 Transfer of Product to IMMUN. Product shall be shipped to
IMMUN by POD F.O.B. Albuquerque; any deviation from this Section 4.02 must
be in writing and agreed to by POD. There shall be only one shipment per
lot of Product.
4.03 Payment for Product. POD shall invoice IMMUN for approved
Product which is "released" in accordance with applicable FDA rules and
regulations. The invoice date shall be either the date of shipment of
Product or the date the lot is released by POD's Quality Department (in
the event the lot is not shipped following release in quarantine to IMMUN
by POD's Quality Department). Payment terms are [*]% in advance with the
payment and purchase order received prior to the manufacture of each lot
(F.O.B. Albuquerque). The remaining [*]% of the price shall be due within
ten (10) working days of completion of batch record review by POD and
receipt of the lot(s) by IMMUN if the lots are shipped to IMMUN or an
IMMUN designated location or, if POD stores the lot(s) of Product, payment
of the remaining [*]% will be due ten (10) days after completion of batch
record review by POD.
4.04 Cancellation Fee. A cancellation fee of [*]
Dollars [*], plus an additional charge for labor and
materials if applicable, shall be billed to IMMUN if cancellation or
rescheduling by IMMUN of any scheduled batch production occurs within one
(1) week (7 days) of the scheduled manufacture date.
4.05 Component Fee. A component fee equal to [*] times the
cost of POD's components used plus [*] times the costs associated
with component preparation shall be billed to IMMUN if IMMUN fails to
cancel a lot one week (7 days) prior to the scheduled manufacture date.
4.06 Late Payment Penalty. All invoices paid later than ten (10)
days from completion of batch record review by POD will be charged 1.5%
interest per month.
ARTICLE V. PRICE OF MANUFACTURE
5.01 Price. IMMUN shall pay POD for Product in accordance with
the price set forth in Schedule 5.01 attached hereto.
5.02 Price Increase. The price charged by POD for the manufacture
of Product as specified in Section 5.01 shall remain in effect until
December 31, 1996. On January 1, of each Calendar Year thereafter, POD
shall have the right to increase the price set forth in Schedule 5.01 to
reflect increased manufacturing costs and increased fixed costs incurred
by POD during the previous twelve (12) month period. Any such price
increase shall not exceed ten percent (10%) of the sum of the
manufacturing cost and fixed cost for the Product determined for the
previous twelve (12) month period.
5.03 Notification of Price Increase. POD must notify IMMUN no
later than December 1, 1996 that POD intends to take a price increase and
the amount of the increase (hereinafter the "Increased Cost Notice"). At
the time POD provides IMMUN with the Increased Cost Notice, POD shall
provide IMMUN with a statement which sets forth, in reasonable detail, the
increased costs and the computation thereof.
5.04 Verification of Increase by Accountant. Within forty-five
(45) days after receipt of the Increased Cost Notice from POD, IMMUN shall
have the right to have any such increase in cost verified by an
independent certified public accountant of its choosing who shall be
reasonably acceptable to POD and who shall execute such nondisclosure
agreement with respect to POD's confidential information as may reasonably
be required by POD (a "Nondisclosure Agreement").
5.05 Accountant's Report. The independent accountant described
in Section 5.05 shall issue a report within thirty (30) days of the
completion of the audit, and copies of such report shall be delivered to
IMMUN and POD. IMMUN shall be obligated to pay the increased price for
the Product during the period of the audit and completion of the report.
5.06 Determination that Increase is Unjustified. In the event the
audit of the increased costs shows that such increase is not based on
reasonable evidence of increased costs to POD, the parties shall negotiate
in good faith to determine an acceptable price increase, if any. If the
independent auditor determines that the price increase requested by POD
is more than 1.5 times the increase the independent auditor finds to be
supported, POD shall pay for the cost of such audit.
5.07 Price Decrease. If, as a result of a cooperative effort
between POD and IMMUN relating to the manufacture of IMMUN's products, POD
experiences a decrease in cost of manufacture of Product, e.g., materials,
direct labor and the like or overhead related to the services to be
performed by POD under this Agreement, POD shall notify IMMUN of such
decrease and grant IMMUN a reduction in price equal to the related cost
reduction. IMMUN shall have the right, upon reasonable notice to POD, to
have an independent certified public accountant reasonably acceptable to
POD (who shall execute a Nondisclosure Agreement) review the books and
records of POD once every Calendar Year to verify if any such cost
reductions resulting from the joint efforts of IMMUN and POD have
occurred.
ARTICLE VI. WARRANTIES OF POD
6.01 The POD Facility. POD represents and warrants that it shall
use its best efforts to maintain its facilities in such a fashion as to
be in compliance with all applicable federal, state and local rules and
regulations. POD agrees that it will maintain a Type I Drug Master File
("DMF") for the POD facility.
6.02 Aseptic Processing Environment. POD represents and warrants
that it shall use its best efforts to insure that all filtration, filling
and lyophilization of the Product by POD shall be done in an aseptic
processing environment and in accordance with the Statement of Work.
6.03 Failure to Comply with Sections 6.01 and 6.02. In the event
that POD determines that it is unable to comply with its obligations as
specified in Section 6.01 and Section 6.02, it shall promptly notify IMMUN
of its inability to comply and shall advise IMMUN of what actions POD
shall take in order to be in compliance.
ARTICLE VII. OWNERSHIP OF COMPONENTS AND RISK OF LOSS
7.01 Ownership of Components. All raw materials, active and
inactive ingredients, and secondary components supplied by IMMUN to POD,
as between POD and IMMUN, shall be owned by IMMUN, who shall retain title
thereto at all times and subject to the provisions of Section 10.01, IMMUN
shall bear all risk of loss therefore.
7.02 Ownership of Finished Product. The finished Product shall
be owned by IMMUN, and subject to the provisions of Section 10.01, IMMUN
shall bear the risk of loss for such product while stored at POD's
manufacturing or warehouse facility.
7.03 Ownership of Bulk Solution. IMMUN shall own the Bulk
Solution prepared by IMMUN at POD's facilities pursuant to the provisions
of Section 2.04 and subject to the provisions of Section 10.01, IMMUN
shall bear the risk of loss for such Bulk Solution.
7.04 Ownership of Equipment. IMMUN shall own the product contact
equipment IMMUN purchases and provides to POD for use only on the
Products. Subject to the provisions of Section 10.01, IMMUN shall bear
the risk of loss for such equipment while stored at POD's manufacturing
or warehouse facility. POD shall take steps necessary to identify all
equipment belonging to IMMUN sufficient to differentiate such equipment
from POD's own equipment.
ARTICLE VIII. TERM AND TERMINATION
8.01 Term. Upon execution by both parties, this Agreement shall
be effective as of the date first set forth above and shall expire on
December 31, 1998. IMMUN may renew this Agreement for successive one (1)
year periods by giving notice to POD of IMMUN's intent to renew at least
ninety (90) days prior to the expiration of the term; provided however,
that POD must consent to the renewal. POD shall notify IMMUN no later
than fifteen (15) days after receipt of the notice whether it consents to
the renewal.
8.02 Voluntary Termination. IMMUN or POD may terminate this
Agreement for any reason, provided that the terminating party first serves
written notice of such termination on the other party no later than one
hundred eighty (180) days prior to the date of such termination.
8.03 Termination for Material Breach. Either party may terminate
this Agreement in the event of a material breach by the other, provided
that the party asserting such breach first serves written notice of the
alleged breach on the offending party and such alleged breach is not cured
within thirty (30) days of said notice.
8.04 Termination for Insolvency. In the event that either party
shall admit in writing that it can not pay its debts, or shall suspend its
business, or shall file a voluntary petition or any answer admitting the
jurisdiction of the court and the material allegations of, or shall
consent to, an involuntary petition pursuant to or purporting to be
pursuant to any reorganization or insolvency law of any jurisdiction, or
shall make an assignment for the benefit of creditors, or shall apply for
or consent to the appointment of a receiver or trustee of all or a
substantial part of its property (such party, upon the occurrence of any
such event, a "Bankrupt Party"), then to the extent permitted by the law
the other party hereto may thereafter immediately terminate this Agreement
by giving notice of termination to the Bankrupt Party.
8.05 Effect of Expiration or Termination. Expiration or earlier
termination of this Agreement shall not extinguish rights or obligations
previously accrued or vested.
8.06 POD Obligations Upon Expiration or Termination. Upon the
expiration of this Agreement or its earlier termination, POD shall:
a) at the request of IMMUN, and at IMMUN's expense,
return or dispose of all raw materials, ingredients,
components, equipment, packaging and finished Product
to IMMUN or to a third party pursuant to the
instructions of IMMUN; and
b) use its best efforts to assist IMMUN in the transfer
of relevant manufacturing technology and information
not considered to be proprietary to POD to another
qualified manufacturing site; IMMUN shall pay POD for
such efforts in an amount to be determined by the
parties.
ARTICLE IX. INDEMNIFICATION
9.01 POD Indemnity. POD agrees to indemnify, protect and defend
IMMUN and hold IMMUN harmless from and against any claims, damages,
liability, harm, loss, costs, penalties, lawsuits, threats of lawsuit,
recalls or other governmental action, including reasonable attorneys'
fees, brought or claimed by any third party which (i) arise as the result
of POD's breach of this Agreement or of any warranty or representation
made to IMMUN under this Agreement; or, (ii) which result from any claim
made against IMMUN in connection with POD's manufacture of defective
Product for IMMUN. Upon the filing of any such legal claim or lawsuit
against IMMUN, IMMUN shall promptly notify POD, in writing, of any such
claim and POD shall, at its expense, with attorneys reasonably acceptable
to IMMUN, handle, defend and control such claim or lawsuit. Failure to
notify POD promptly of the commencement of any such action, if prejudicial
to the ability to defend such action, shall relieve POD of any liability
to IMMUN under this Section 9.01. IMMUN shall have the right to
participate in the defense of such action at its expense with counsel of
its choosing.
9.02 IMMUN Indemnity. IMMUN agrees to indemnify, protect, and
defend POD and hold POD harmless from and against any claims, damages,
liabilities, harm, loss, costs, penalties, lawsuits, threats of lawsuit,
recalls or other governmental action, including reasonable attorneys'
fees, brought or claimed by any third party, which (i) arise out of
IMMUN's breach of this Agreement or of any warranty or representation to
POD under this Agreement; or, (ii) result from the negligent acts or
willful malfeasance on the part of IMMUN or employees or agents, in
connection with IMMUN's sale, marketing or distribution of Product
manufactured by POD or other activities or actions in connection with the
Product. Upon the filing of any such legal claim or lawsuit against POD,
POD shall promptly notify IMMUN, in writing, of any such claim and IMMUN
shall, at its expense, with attorneys reasonably acceptable to POD,
handle, defend, and control such claim or lawsuit. Failure to notify
IMMUN promptly of the commencement of any such action, if prejudicial to
the ability to defend such action, shall relieve IMMUN of any liability
to POD under this Section 9.02. POD shall have the right to participate
in the defense of such action at its expense with counsel of its choosing.
ARTICLE X. POD LIABILITY TO IMMUN FOR PRODUCT LOSSES
10.01 Liability for Loss of Product, Bulk Solution, Equipment, and
Components. POD's liability to IMMUN for loss of Product, Bulk Solution,
equipment, component parts of said Product (for example, active drug
substance, excipients), or for out of Specification Product which cannot
be reworked, occurring during the manufacturing process due to the fault
of POD shall be limited to the lesser of the following:
a) [*] per batch or lot of Product; or
b) The actual cost of the Product, Bulk Solution,
equipment or components of the Product.
In the event of a third-party claim, the provisions of Article IX shall
govern and shall supersede the provisions of this Article X. The parties
specifically agree that the limitation of liability set forth in this
Section 10.01 shall apply to the following Sections: Section 2.09,
Section 4.01, Section 4.02, Section 7.01, Section 7.02, Section 7.03 and
Section 7.04.
10.02 Parties Disagree Whether Product Out of Specification. In
the case of a disagreement between the parties as to whether the Product
meets the Specifications, a third party laboratory which is reasonably
acceptable to both parties shall be chosen to act as a neutral referee.
The decision of the neutral referee shall be binding on the parties. The
cost of such testing performed by the laboratory shall be borne by the
party found to be in error.
ARTICLE XI. CONFIDENTIALITY
11.01 Confidential Information. Each party ("Receiving Party")
shall maintain in confidence all information heretofore or hereafter
disclosed by the other ("Disclosing Party") which such party knows or has
reason to know are trade secret and other proprietary information owned
by or licensed to the other, including, but not limited to, information
relating to the Product (including without limitation, information
developed in preclinical and clinical studies), and licenses, patents,
patent applications, technology or processes and business plans of the
other party, including, without limitation, information designated as
confidential in writing from one party to the other (all of the foregoing
hereinafter referred to as "Confidential Information"), and shall not use
such Confidential Information except as permitted by this Agreement or
disclose the same to anyone other than those of its officers, directors
or employees as are necessary in connection with such party's activities
as contemplated by this Agreement. Each party shall use the same efforts
such party would use to protect its own information to ensure that its
officers, directors and employees do not disclose or make any unauthorized
use of such Confidential Information. Each party shall notify the other
promptly upon discovery of any unauthorized use or disclosure of the
other's Confidential Information.
11.02 Limitations on Confidentiality. The obligation of
confidentiality contained in this Article XI shall not apply to the extent
that: i) the Receiving Party is required to disclose information by
applicable law, regulation or order of a governmental agency or a court
of competent jurisdiction; ii) the Receiving Party can demonstrate that
the disclosed information was at the time of disclosure already in the
public domain other than as a result of actions or failure to act of the
Receiving Party, its officers, directors or employees, in violation
hereof; iii) the disclosed information was rightfully known by the
Receiving Party (as shown by its written records) prior to the date of
disclosure to the Receiving Party in connection with this Agreement; or
iv) the disclosed information was received by the Receiving Party on an
unrestricted basis from a source which is not under a duty of
confidentiality to the other party.
11.03 Disclosure Required by Law. In the event that the Receiving
Party shall be required to make disclosure pursuant to the provisions of
Section 11.02 (i) as a result of the issuance of a court order or other
government process, the Receiving Party shall promptly, but in no event
more than forty-eight (48) hours after learning of such court order or
other government process, notify, by personal delivery or facsimile, all
pursuant to Section 12.04 hereof, the Disclosing Party and, at the
Disclosing Party's expense, the Receiving Party shall: a) take all
reasonably necessary steps requested by the Disclosing Party to defend
against the enforcement of such court order or other government process,
and b) permit the Disclosing Party to intervene and participate with
counsel of its choice in any proceeding relating to the enforcement
thereof.
11.04 Equitable Remedies for Breach of Confidentiality. The
parties acknowledge that their failure to comply with the provisions of
Section 11.01 of this Article XI may cause irreparable harm and damage to
the name and reputation of the other party for which no adequate remedy
may be available at law. Accordingly, the parties agree that upon a
breach by a party of such provisions, the non-breaching party may, at its
option, enforce the obligations of the breaching party under those
provisions by seeking equitable remedies in a court of competent
jurisdiction.
ARTICLE XII. MISCELLANEOUS
12.01 Force Majeure. Neither of the parties to this Agreement
shall be liable to the other party for any loss, injury, delay, damage or
other casualty suffered or incurred by such other party due to strikes,
lockouts, accidents, fire, delays in manufacture, transportation or
delivery of material, embargoes, inability to ship, explosions, floods,
war, governmental action or any other cause similar thereto which is
beyond the reasonable control of such other party and any failure or delay
by a party in the performance of any of its obligations under this
Agreement shall not be considered as a breach of this Agreement due to,
but only so long as there exists, one or more of the foregoing causes;
provided, however, that if POD cannot complete an order within ninety (90)
days due to any such cause, IMMUN may cancel the order without liability
to POD.
12.02 New Mexico Gross Receipts & Compensating Tax. IMMUN hereby
agrees to be liable for and to pay to POD any sales, use, gross receipts
or any other taxes, licenses or fees (excluding income and franchise
taxes) legally incurred by POD from the State of New Mexico or any other
state or tax jurisdiction as a result of purchasing materials, rendering
services, transferring property or any other action necessary to be taken
by POD in order to fulfill the terms of this Agreement.
12.03 Relationship. This Agreement shall not be construed to
create between the parties hereto or their respective successors or
permitted assignees the relationship of principal and agent, joint
venturers, co-partners or any other similar relationship, the existence
of which is hereby expressly denied by each party. Neither party shall
be liable to any third party in any way for engagement, obligation,
contract, representation or transaction or for any negligent act or
omission to act of the other except as expressly provided.
12.04 Governing Law. The provisions of this Agreement shall be
governed in all respects by the laws of the State of New York.
12.05 Notice. All notices, proposals, submissions, offers,
approvals, agreements, elections, consents, acceptances, waivers, reports,
plans, requests, instructions and other communications required or
permitted to be made or given hereunder (all of the foregoing hereinafter
collectively referred to as "Communications") shall be in writing, and
shall be deemed to have been duly made or given when: a) delivered
personally with receipt acknowledged; b) sent by registered or certified
mail or equivalent, return receipt requested, or c) sent by facsimile or
telex (which shall promptly be confirmed by a writing sent by registered
or certified mail or equivalent, return receipt requested), or d) sent by
recognized overnight courier for delivery within twenty-four (24) hours,
in each case addressed or sent to the parties at the following addresses
and facsimile numbers or to such other or additional address or facsimile
as any party shall hereafter specify by Communication to the other
parties:
To POD: H. Joseph Larsen
Sr. Vice President/General Manager
Pharmacia & Upjohn Oncology Division
4272 Balloon Park Road, N.E.
Albuquerque, New Mexico 87109
Fax No. (505) 345-7513
For All Issues to POD: Jan Holland Hickey
Director of Contract Manufacturing
Pharmacia & Upjohn Oncology Division
4272 Balloon Park Road, N.E.
Albuquerque, New Mexico 87109
Fax No. (505) 345-7513
For Quality Issues to POD: Donald E. Hagman. Ph.D.
Vice President, Development/Quality Assurance
Pharmacia & Upjohn Oncology Division
4272 Balloon Park Road, N.E.
Albuquerque, New Mexico 87109
Fax No. (505) 345-7513
To IMMUN: David M. Goldenberg, Sc.D., M.D.
Chairman and CEO
Immunomedics, Inc.
300 American Road
Morris Plains, New Jersey 07950
Fax No.: 201-605-8282
With a Copy to: Cynthia L. Sullivan
Executive Director, Operations
Immunomedics, Inc.
300 American Road
Morris Plains, New Jersey 07950
Fax No.: 201-605-8282
Notice of change of address shall be deemed given when actually received,
all other Communications shall be deemed to have been given, received and
dated on the earlier of: (i) when actually received, or on the date when
delivered personally; (ii) one (1) day after being sent by facsimile,
cable, telex (each promptly confirmed by a writing as aforesaid) or
overnight courier; or four (4) business days after mailing (except that
in the case of any communication given to a person with an address outside
the United States, then ten (10) business days after mailing).
12.06 Legal Construction. In case any one or more of the
provisions contained in this Agreement shall be invalid or unenforceable
in any respect, the validity and enforceability of the remaining
provisions contained herein shall not in any way be affected or impaired
thereby and the parties will attempt to agree upon a valid and enforceable
provision which shall be a reasonable substitute for such invalid and
unenforceable provision in light of the tenor of this Agreement, and, upon
so agreeing, shall incorporate such substitute provision in this
Agreement.
12.07 Entire Agreement, Modifications, Consents, Waivers. This
Agreement together with the Schedules hereto contains the entire agreement
of the parties with respect to the subject matter hereof. This Agreement
may not be modified or amended except by an instrument or instruments in
writing signed by the party against whom enforcement of any such
modification or amendment is sought. Each party hereto may, by an
instrument in writing, waive compliance by the other party hereto with any
term or provision of this Agreement on the part of such other party to be
performed or complied with. The waiver by either party hereto of a breach
of any term or provision of this Agreement shall not be construed as a
waiver of any subsequent breach. Neither anything in this Agreement nor
the execution or performance hereof shall be deemed to prejudice in any
way, and each party hereto expressly reserves, any and all rights,
remedies, and claims which each party may now or hereafter have against
or with respect to the other party or any of such other party's
Affiliates, relating to any matter which is not expressly covered by this
Agreement.
12.08 Section Headings; Construction. The section headings and
titles contained herein are each for reference only and shall not be
deemed to affect the meaning or interpretation of this Agreement. The
words "hereby", "herein", "hereinabove", "hereinafter", "hereof" and
"hereunder", when used anywhere in this Agreement, refer to this Agreement
as a whole and not merely to a subdivision in which such words appear,
unless the context otherwise requires. The singular shall include the
plural, the conjunctive shall include the disjunctive and the masculine
gender shall include the feminine and neuter, and vice versa, unless the
context otherwise requires.
12.09 Execution Counterparts. This Agreement may be executed in any
number of counterparts and each such duplicate counterpart shall
constitute an original, any one of which may be introduced in evidence or
used for any other purpose without the production of its duplicate
counterpart. Moreover, notwithstanding that any of the parties did not
execute the same counterpart, each counterpart shall be deemed for all
purposes to be an original, and all such counterparts shall constitute one
and the same instrument, binding on all of the parties hereto.
12.10 Product Manufactured Prior to Effective Date. The parties
specifically acknowledge that only Product manufactured by POD upon or
after the Effective date is covered by this Agreement and Product
manufactured by POD for IMMUN prior to the Effective Date is not covered
by this Agreement.
ARTICLE XIII. BINDING EFFECT, ASSIGNMENT
In entering into this Agreement, each party hereto has relied upon
the expertise and capabilities of the other. Accordingly, neither party
may directly or indirectly assign, delegate, encumber or in any other
manner transfer any of its rights, remedies, obligations, liabilities or
interests in or arising under this Agreement, without the prior consent
of the other, which consent shall not be unreasonably withheld or delayed,
except that either party may directly or indirectly assign, delegate,
encumber or in any other manner transfer any of its rights, remedies,
obligations, liabilities or interests in or arising under this Agreement,
upon prior notice to the other party but without obtaining the prior
consent of such party to:
a) any affiliate of a party; or
b) to any entity which succeeds, by purchasing stock or assets,
by merger or otherwise, to all or substantially all of the
assets of a party or in the case of IMMUN, to any right,
title and interest of IMMUN's to the Product.
Any attempted assignment, delegation, encumbrance or other transfer in
violation of this Agreement shall be void and of no effect, and shall be
a material breach hereof.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed as of the day and year first written above.
IMMUNOMEDICS, INC. PHARMACIA & UPJOHN
ONCOLOGY DIVISION
By: /s/ D M Goldenberg By: /s/ H J Larsen
___________________ _________________
D. M. Goldenberg H. Joseph Larsen
Title: __Chairman & CEO__ Title: __Sr. Vice President/General Manager__
Date: __June 14, 1996__ Date: __6/12/96__
Schedule 1.04
SPECIFICATIONS
Current revisions of the Master Batch Record, Document No. 10-228, and
Packaging Batch Record, Document No. PL-IMR, for CEA-Scan and current
revisions of the Master Batch Record, Document No. 10-290, and Packaging
Batch Record, Document No. PL-IMM, for LeukoScan and the standards set
forth on this page constitute the Specifications.
POD is responsible for the Products meeting the following standards:
[ * ]
Schedule 2.01
STATEMENT OF WORK
[ * ]
SCHEDULE 2.07
EQUIPMENT LIST
Quantity Description
[ * ]
SCHEDULE 5.01
PRODUCT PRICE SCHEDULE
FIRM UNTIL DECEMBER 31, 1996
[ * ]