Exhibit 10.72
CONFIDENTIAL TREATMENT REQUESTED
AGREEMENT FOR SUPPLY OF MATERIAL
This AGREEMENT FOR SUPPLY OF MATERIAL (the "Agreement"), among
Connaught Laboratories Limited, a Pasteur Merieux Connaught company,
incorporated under the laws of Ontario, Canada with offices at 1755
Steeles Avenue West, Toronto, Ontario, Canada M2R 3T4, ("PMC")
and
ImClone Systems Incorporated, a company existing and organized under
the laws of Delaware, USA with offices at 180 Varick Street, New York,
NY, USA 10014, ("ImClone")
and
Merck KGaA, a company incorporated under the laws of Germany with
offices at Frankfurter Strasse 250, 64271 Darmstadt, Germany, ("Merck")
is effective as of this 1st day of January, 1997 ("Effective Date"), with
respect to the following facts and circumstances:
WHEREAS PMC has a proprietary interest in and manufactures and sells a
product known as BCG vaccine, consisting of BCG in vaccine formulation with its
accompanying diluent in a 10-dose vial presentation (hereinafter the "BCG
Material"); and
WHEREAS ImClone and Merck severally have a proprietary interest in a
monoclonal anti-idiotypic antibody known as BEC2 (hereinafter "BEC2") and
jointly are performing clinical and pre-clinical research relating to the
treatment and/or prophylaxis of certain human cancers by administration of the
BEC2; and
WHEREAS ImClone and Merck intend to administer a combination therapy of
BEC2 and BCG Material to certain patients with small cell lung carcinoma
("SCLC") in a multi-national Phase III clinical trial being conducted in Europe,
Australia and the United States (hereinafter the "SILVA Trial") pursuant to the
protocol(s) and investigators' brochure(s) (hereinafter the "Clinical Trial
Protocol") attached hereto as Exhibit "A"; and
WHEREAS, ImClone and Merck may administer a combination therapy of BEC2
and BCG Material to other patients in such additional clinical trials that are
necessary or advisable in the sole discretion of ImClone and Merck in connection
with or in furtherance of the SILVA Trial (the "Additional Clinical Trials");
and
*** Confidential Treatment Requested
-2-
WHEREAS ImClone and Merck are interested in securing a supply of the
BCG Material to be administered with BEC2 in the SILVA Trial and any such
Additional Clinical Trials, and PMC is willing to supply the BCG Material to
ImClone and Merck on the terms set forth herein.
NOW THEREFORE, in consideration of the foregoing and for other good and
valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the parties hereby agree as follows:
1. Trials to be Conducted; Status of Recipient
ImClone and Merck are conducting the SILVA Trial and any Additional
Clinical Trials together, and will receive supplies of the BCG Material together
or independently for the sole purpose of conducting the SILVA Trial and the
Additional Clinical Trials (the SILVA Trial and the Additional Clinical Trials
are collectively referred to herein as the "Clinical Trials"). ImClone and Merck
shall be referred to for the purposes herein as the "Recipient" and the term so
used shall mean ImClone and Merck together or either of them. ImClone and Merck
shall be jointly and severally liable in respect of the obligations set forth in
this Agreement, except as specifically noted hereinbelow.
2. Supply and Acceptance of Delivery
2(a). Quantities of the BCG Material
Subject to the terms of this Agreement and during the [ *** ] following
the Effective Date (hereinafter the "Supply Period"), PMC shall supply to the
Recipient, and the Recipient shall accept delivery from PMC of, the BCG Material
for use in and during the Clinical Trials on the following dates, in the
following quantities and with the following expiry dating:
(i) [ *** ]
(ii) [ *** ]
(iii) [ *** ]
(iv) [ *** ]
(A) [ *** ]
(B) [ *** ]
(C) [ *** ]
(D) [ *** ]
*** Confidential Treatment Requested
-3-
[ *** ]
2(b). Cost of Supply
[ ***]
2(c). Delivery; Risk of Loss
At Recipient's cost, PMC shall deliver or arrange for the
delivery of the BCG Material to Recipient, FOB at a point or points of
destination selected by Recipient, to a reputable carrier. Prior to any
delivery, Recipient shall forward import permits or other documents, as required
for shipment, to PMC to the attention of Ms. Joy Rennick, Logistics Coordinator,
(facsimile: 416-667-2275). Upon delivery of the BCG Material, Recipient shall
assume all risk of loss or damage for the BCG Material so delivered. All
temperature monitoring devices shall be returned by Recipient to PMC to the
attention of Ms. Rennick.
2(d). Technical Services Assistance
Upon the reasonable request by Recipient, and in consideration
of payment by ImClone of PMC's costs and services fees at a rate of [ *** ] for
regulatory/logistics personnel, PMC shall make, and has made, available its
clinical/medical and regulatory/logistics personnel (at their usual place of
employment or by telephone) to provide reasonable levels of technical assistance
to the Recipient in connection with PMC's Regulatory Manufacturing Documentation
for the BCG Material or in connection with the Recipient's Regulatory Filings
required for the Clinical Trials. ImClone shall pay PMC, by no later than July
15, 1998, the amount of [ *** ], representing the sum of:
(i) [ *** ]
(ii) [ *** ]
(iii) [ *** ]
(iv) [ *** ]
ImClone agrees to pay for any further technical services
provided by PMC and tests conducted by or on behalf of PMC, in connection with
this Agreement or the Clinical Trials, at the hourly rates agreed to herein and
the costs to PMC of any such tests. The parties agree that the currency for
payment shall be Canadian dollars.
2(e). Negotiations for Future Commercial Supply
In the event that the Recipient wishes to seek registration
for the combination therapy of BEC2 and BCG Material, Recipient shall notify PMC
in writing. PMC and the Recipient agree that within sixty (60) days of said
written notice from the Recipient, the parties
*** Confidential Treatment Requested
-4-
shall initiate good faith negotiations toward the securing of a commercial
supply agreement for the purchase by Recipient of BCG Material with terms
satisfactory to both parties, including without limitation, purchase price.
Failure to reach such agreement during the Term within twelve months (12) of
initiation of negotiations, or as of such earlier time when it is clear that the
parties cannot reach such agreement, shall be grounds for termination of this
Agreement by either PMC or Recipient, upon thirty (30) days written notice to
the other.
3. Preparation and Conduct of the SILVA Trial
3(a). Regulatory Filings; Manufacturing Regulatory Documentation
At Recipient's sole cost, Recipient shall file and be the
owner of record for all Regulatory Filings developed by the Recipient relating
to the Clinical Trials. "Regulatory Filing" shall mean a filing with a
regulatory agency, for example, the US Food and Drug Administration ("FDA"),
that concerns the Clinical Trials. Recipient owns and shall retain all right,
title and interest in and to BEC2 (and any improvements, progeny, derivatives or
related materials thereof) and the Regulatory Filings. PMC shall permit the
Recipient to cross-reference PMC's Product License Application Supplement and
Drug Master File for BCG Material and/or otherwise excerpt portions of or
describe PMC's Product License Application Supplement and Drug Master File in
the Regulatory Filings, to enable the Recipient to complete Regulatory Filings
required for the Clinical Trials. Notwithstanding the foregoing, the parties
agree that despite Recipient's cross-referencing PMC's Product License
Application Supplement and Drug Master File for BCG Material and/or otherwise
excerpting portions of or describing PMC's Product License Application
Supplement and Drug Master File in the Regulatory Filings, PMC owns, and shall
retain all right, title and interest in and to the BCG Material (and any
improvements, progeny, derivatives or related materials thereof) and the
Manufacturing Regulatory Documentation. "Manufacturing Regulatory Documentation"
shall mean a Product License Application, Drug Master File or any other
regulatory filing or documentation owned, developed, submitted or prepared by or
on behalf of PMC and filed with appropriate regulatory authorities that contains
information concerning the BCG Material, including but not limited to
information concerning the BCG Material contained in the Regulatory Filings
which is excerpted from or describes PMC's Product License Application or Drug
Master File or other regulatory filing by or on behalf of PMC which concerns the
BCG Material, which information, Recipient agrees and undertakes, shall be
deemed and treated as Confidential Information. All non-public information
provided by one party to the other in preparing Regulatory Filings and the
Manufacturing Regulatory Documentation shall be deemed to be Confidential
Information of the disclosing party for the purposes of this Agreement.
3(b). Protocols for Clinical Trials; Results
At Recipient's sole cost, Recipient shall be responsible for
the design, implementation, and evaluation of any human clinical studies used to
obtain clinical data for use in preparing Regulatory Filings related to the
Clinical Trials. Recipient shall conduct the Clinical Trials in compliance with
current Good Clinical Practices ("cGCP") pursuant to FDA regulations. Recipient,
at its sole cost, shall provide PMC with a complete copy of the protocols
*** Confidential Treatment Requested
-5-
and investigators' brochures for the Clinical Trials, as well as copies of all
reports, abstracts and publications (subject to Section 5(c) herein) concerning
the data and results of the Clinical Trials. All right, title and interest in
and to the data and results of the Clinical Trials shall vest in Recipient;
provided that any information relating to the BCG Material shall remain the sole
property of PMC.
3(c). Adverse Reaction Reporting
Recipient shall promptly notify PMC of any serious adverse
reactions which result from the conduct of the Clinical Trials on the same basis
that such reporting is made to the appropriate regulatory authorities. Such
notices shall be sent by Recipient to PMC to the attention of Mrs. Doris
Rudert-Dolby, Supervisor, Regulatory Affairs (facsimile: 416-667-2912). For this
purpose, it is understood that an adverse reaction is subject to expedited
reporting to appropriate regulatory authorities if such adverse reaction
constitutes an "unexpected adverse reaction" and if the minimum criteria for
expedited reporting are met (as such criteria are set forth in the ICH Topic
E2A: Clinical Safety Data Management - Definitions and Standards for Expedited
Reporting, June 1, 1995). An "unexpected adverse reaction" is one the nature or
severity of which is not consistent with the information in the relevant source
document (i.e., the most recent version of the investigators' brochure). It is
further understood that "SCLC-related Deaths" are the end-points of the SILVA
Trial and are, therefore, not subject to expedited reporting.
3(d). PMC's Notice in Connection With Actions by Regulatory Authorities
PMC shall promptly notify Recipient of any threatened or
pending actions by regulatory authorities which may reasonably be believed to
affect the safety or efficacy claims of the BCG Material or to affect the supply
commitment contained in this Agreement. Any form of such notice that is not in
writing shall be promptly followed by notice in writing.
3(e). Recipient's Notice in Connection With Actions by Regulatory
Authorities
Recipient shall promptly notify PMC of any threatened or
pending actions by regulatory authorities which may reasonably be believed to
affect the safety or efficacy claims of BEC2 or of the combination therapy of
BEC2 and BCG Material or to affect the Clinical Trials. Any form of such notice
that is not in writing shall be promptly followed by notice in writing.
3(f). Recipient's Provision of Updated Investigators' Brochure
For the purpose of keeping PMC apprised of the status of the
Clinical Trials, Recipient shall provide to PMC a copy of all updated
investigators' brochures which Recipient is required to file with the FDA or
other regulatory agency anywhere.
*** Confidential Treatment Requested
-6-
4. Availability and Manufacture of BCG Material and of BEC2
4(a). BCG Material for Clinical Trials
During the Supply Period, PMC shall supply the BCG Material in
the quantities and according to the terms set forth in Sections 2(a)(i), (ii),
(iii) and (iv); provided, however, that with respect to the quantities and terms
set forth in Section 2(a)(iii) and (iv), PMC shall only be required to use
reasonable commercial efforts to make available to Recipient such BCG Material
as may be requested for the Additional Clinical Trials. With respect to the BCG
Material requested pursuant to Sections 2(a)(iii) and 2(a)(iv), in the event of
Force Majeure or of supply shortage or production constraint, PMC shall allocate
the available quantities of BCG Material among PMC, its affiliates, customers
and distributors, including Recipient, in a commercially reasonable manner. Each
lot of BCG Material released to the Recipient for the Clinical Trials shall be
manufactured in compliance with current Good Manufacturing Practices ("cGMP")
pursuant to FDA regulations and according to manufacturing information in the
Manufacturing Regulatory Documentation. PMC shall, or shall cause a third party
to, perform quality control testing of the BCG Material released to the
Recipient to establish compliance with any release specifications required by
the Manufacturing Regulatory Documentation.
4(b). BEC2 for Clinical Trials
During the Term, Recipient shall use reasonable commercial
efforts to have sufficient quantities of BEC2 for use in the Clinical Trials. In
the event of Force Majeure or of supply shortage or production constraint,
Recipient shall notify PMC as soon as possible so as to permit PMC to allocate
the above-noted quantities of BCG Material among PMC, its affiliates, customers
and distributors at PMC's sole discretion. Each lot of BEC2 released by
Recipient for the Clinical Trials shall be manufactured in compliance with cGMP
pursuant to FDA regulations and according to manufacturing information in the
Regulatory Filings. Recipient shall, or shall cause a third party to, perform
quality control testing of BEC2 to establish compliance with any release
specifications required by the Regulatory Filings.
4(c). BCG Material Specifications
PMC shall provide BCG Material to the Recipient in the
available vialed formulations and vial sizes specified in the then current
Manufacturing Regulatory Documentation. PMC shall have no obligation under this
Agreement to develop any other vial sizes or formulations of BCG Material for
the Recipient. PMC shall use reasonable commercial efforts to maintain the
integrity and consistency of all specifications applicable to BCG. In the event
that PMC deems it necessary to revise any specifications, procedures or
Manufacturing Regulatory Documentation applicable to BCG Material, PMC shall
provide reasonable advance notice of any such revision to the Recipient for the
sole purpose of permitting Recipient to revise the Clinical Trial Protocol or
Regulatory Filings, as required. All specification changes that result in
procedures or limits that exceed or differ from those set forth in the
Manufacturing Regulatory Documentation shall be submitted to the FDA before
being implemented to the extent the FDA so requires such submission.
*** Confidential Treatment Requested
-7-
4(d). Documentation
Upon acceptance by Recipient of delivery of the BCG Material,
PMC shall provide the Recipient with a Certificate of Analysis applicable to
each lot of BCG Material delivered to the Recipient. Complete batch records and
sufficient retention samples for the BCG Material delivered to the Recipient
shall be maintained at PMC for inspection at any time by the Recipient at PMC's
place of business upon reasonable prior written notice to PMC. Any confidential
or proprietary information of PMC or of its affiliates contained in such records
or samples shall be deemed to be Confidential Information of PMC.
4(e). PMC Facility Audits
Upon reasonable prior written notice to PMC, the Recipient may
(but shall not be required to) have its representatives, acting reasonably,
audit PMC's production of the BCG Material to be used in the Clinical Trials for
compliance with cGMP; provided however that such representatives shall have
first signed a confidentiality agreement with PMC. Recipient and its
representatives shall comply with all applicable health, safety, environmental
and security laws and with PMC's policies and procedures while present at PMC's
facilities.
4(f). Recall or Withdrawals
In the event that a party is notified of a recall or
withdrawal of BEC2 or of the BCG Material in any country, or believes such
recall or withdrawal is necessary, it shall immediately notify the other
parties. The parties will consult on the necessity of, and appropriate actions
and mutually acceptable procedures to be taken in connection with, a recall or
withdrawal. If such recall or withdrawal is undertaken, the parties shall
cooperate in taking all reasonable and appropriate action necessary to complete
such recall or withdrawal in a timely fashion.
5. Confidentiality and Disclosure
5(a). General Obligations of Confidentiality
For a period of ten (10) years following any disclosure of
Confidential Information hereunder, the Recipient and PMC shall maintain in
confidence the respective Confidential Information received or obtained from the
other, and use such Confidential Information solely for the purposes
contemplated and permitted by this Agreement. Each party shall maintain
communications to the other parties in confidence. Each party acknowledges that
all Confidential Information exchanged or developed hereunder shall be owned by
the transferor and shall continue to be owned by the transferor following
transfer. "Confidential Information" shall mean any and all confidential or
proprietary information owned by PMC (or its affiliates) or by the Recipient or
either of ImClone or Merck (or their affiliates) that is provided to the other
parties. Confidential Information shall not be deemed to include information
that:
*** Confidential Treatment Requested
-8-
(i) is or becomes known publicly through no fault of the
receiving party;
(ii) is learned by the receiving party from a third party
entitled to disclose it;
(iii) is developed by the receiving party independently of
information obtained from the disclosing party as shown by the receiving party's
written records;
(iv) is already known to the receiving party before receipt
from the disclosing party, as shown by prior written records; or
(v) is released with the prior written consent of the
disclosing party.
5(b). Permitted Disclosures
Notwithstanding Section 5(a) hereof, PMC and the Recipient
shall, upon prior written notice to the other parties and only to the extent
necessary, have the right to disclose the other parties' Confidential
Information to regulatory or government agencies for the purposes of preparing
or supplementing any Regulatory Filing or Manufacturing Regulatory
Documentation, as applicable, or of otherwise assisting in securing
institutional or government approval to clinical test the BCG Material, or as
required by law within each country where the Clinical Trials are being
conducted.
5(c). Publications
The parties acknowledge that the data and results arising from
the Clinical Trials should be published and presented except to the extent where
such publication or presentation would be reasonably expected to materially
diminish the commercial value of the BCG Material, or to affect the
patentability of the BCG Material or any improvements thereof. The parties
further acknowledge that the Clinical Trials are multi-centre studies. Recipient
undertakes and shall ensure that the data and results arising from the Clinical
Trials shall not be published or presented by Recipient, by the coordinating
investigators or by other participating individuals or entities, until such time
as the Clinical Trials are completed and the data and results are analyzed
thereafter. Upon completion of the SILVA Trial, Recipient shall ensure that a
cooperative clinical administrative body, comprising the coordinating
investigators, shall prepare a report which will include a statistical analysis
and an appraisal of the final data and results from a medical viewpoint. Interim
publication or presentation of the Clinical Trials would include only
demographic data, for publicity purposes. Any publication, abstract or
presentation, whether verbal or written, of such data, results or report, or
excerpts or interpretations thereof, shall be submitted by Recipient to PMC for
review, pursuant to the following conditions:
(i) Recipient shall ensure that any article, paper,
manuscript, report, data, results, abstract, poster or notes shall not be
published or presented until the completion of the SILVA Trial and after
analysis of the final results of the SILVA Trial;
*** Confidential Treatment Requested
-9-
(ii) Recipient shall ensure that any such publication or
presentation acknowledges the contribution of the parties and their employees,
representatives or consultants as co-authors or as otherwise appropriate; and
(iii) Recipient shall ensure that the publishing party deliver
to PMC, at least sixty (60) days in advance of any such publication or
presentation, any article, paper, manuscript, report, data, results, abstract,
poster or notes proposed to be published or presented, in order to permit PMC,
acting reasonably:
(A) to apply for patents or make such other filings or
registrations as deemed advisable,
(B) to object to any part of such proposed publication
or presentation on the basis that it would be reasonably
expected to materially diminish the value of the BCG
Material and information related thereto,
(C) to require that any Confidential Information be
deleted from any such proposed publication or presentation,
or
(D) to revise such proposed publication or
presentation accordingly.
Recipient undertakes and shall ensure that similar publication and presentation
procedures will be established for any Additional Clinical Trials.
5(d). Use of Names or Trademarks
The parties shall not originate any press release concerning
the entering into of this Agreement or the subject matter hereof without the
prior written approval of the other parties, which approval shall not be
unreasonably withheld. The parties shall not have the right to use the name or
any trade name or trademark of the other parties without prior written approval.
Reference to the existence of this Agreement may be made in the regular course
of business of the parties in informational disclosures describing the business
of the parties, upon prior written notice to the other parties.
6. Warranties and Representations
6(a). Warranties and Representations of PMC.
Subject to Section 7(a), PMC represents and warrants to the
Recipient that:
(i) PMC is a corporation duly organized, validly existing and
in good standing and has all necessary corporate power to enter into and perform
its obligations under this Agreement;
(ii) the execution, delivery and performance of this Agreement
by PMC have been duly authorized and approved by all necessary corporate action,
and the Agreement is binding
*** Confidential Treatment Requested
-10-
upon and enforceable against PMC in accordance with its terms (subject to
bankruptcy and similar laws affecting the rights of creditors generally);
(iii) each lot of the BCG Material delivered to the Recipient
for the Clinical Trials shall be manufactured, tested and released in compliance
with cGMP and the applicable Manufacturing Regulatory Documentation; and
(iv) any documentation provided to the Recipient by PMC
concerning the BCG Material or Manufacturing Regulatory Documentation shall be
accurate to the best of PMC's knowledge and ability.
6(b). Warranties and Representations of the Recipient
Recipient and each of ImClone and Merck represents and
warrants to PMC that:
(i) Recipient consist of corporations duly organized, validly
existing and in good standing and have all necessary corporate power to enter
into and perform their obligations under this Agreement;
(ii) the execution, delivery and performance of this Agreement
by the Recipient have been duly authorized and approved by all necessary
corporate action, and the Agreement is binding upon and enforceable against the
Recipient in accordance with its terms (subject to bankruptcy and similar laws
affecting the rights of creditors generally);
(iii) Recipient shall use BCG Material in compliance with all
applicable laws and regulations and shall conduct the Clinical Trials in
compliance with cGMP and cGCP;
(iv) Recipient is not aware of any special or unusual hazards
that would arise as a result of the combination of BEC2 and BCG Material for the
Clinical Trials to be conducted by Recipient;
(v) each lot of BEC2 for the Clinical Trials shall be
manufactured, tested and released in compliance with cGMP and the applicable
Regulatory Filings; provided that, in connection with such release only, each of
ImClone and Merck provides such warranty and representation with respect to the
territories in which they respectively are responsible for the conduct of the
Clinical Trials;
(vi) any documentation concerning the Clinical Trials, BEC2 or
Regulatory Filings shall be accurate to the best of Recipient's knowledge and
ability; and
(vii) Recipient does not guarantee any particular results from
the conduct of the Clinical Trials.
*** Confidential Treatment Requested
-11-
7. Limitation of Liability; Indemnification
7(a). Limitation of Liability
PMC has limited knowledge or awareness of, and has no control
over, the manner in which the Recipient intends to use the BCG Material. PMC
shall not be liable for any losses, damages, costs or expenses of any nature
incurred or suffered by the Recipient or by a third party, arising out of any
dispute or other claims or proceedings (including, without limitation, product
liability claims and claims by a third party alleging infringement of its
intellectual property rights by the use or sale of BCG Material), made or
brought as a result of the Clinical Trials or against the Recipient, nor shall
PMC be responsible in any way for dealing with any such disputes, claims or
proceedings, except to the extent that any such dispute, claim or proceeding
arises from (a) a breach by PMC of any warranty set forth in Section 6(a)
hereof, or (b) any failure by PMC to manufacture, test, document or release the
BCG Material in compliance with cGMP and the applicable Manufacturing Regulatory
Documentation. PMC shall not be responsible for any interruption in supply that
is caused by Force Majeure. EXCEPT AS SET FORTH IN SECTION 6(a) HEREOF, PMC
MAKES NO WARRANTIES, EXPRESS OR IMPLIED, WRITTEN OR ORAL, INCLUDING WITHOUT
LIMITATION ANY WARRANTIES OF MERCHANTABILITY, OF FITNESS FOR A PARTICULAR
PURPOSE OR OF NON-INFRINGEMENT OF THIRD PARTY PATENTS. PMC SHALL NOT BE LIABLE
FOR ANY LOSS, CLAIM, DAMAGE, EXPENSE OR LIABILITY, OF ANY KIND OR NATURE, WHICH
MAY ARISE FROM OR IN CONNECTION WITH THIS AGREEMENT OR WITH THE CLINICAL TRIALS
OR FROM THE USE, HANDLING OR STORAGE OF BCG MATERIAL, BEC2 OR THEIR ANCILLARY
MATERIALS BY RECIPIENT OR BY ANY AFFILIATES, EMPLOYEES, AGENTS, CONTRACTORS,
INVESTIGATORS OR REPRESENTATIVES OF RECIPIENT. NO PARTY TO THIS AGREEMENT SHALL
BE ENTITLED TO RECOVER FROM THE OTHER PARTIES ANY SPECIAL, INCIDENTAL,
CONSEQUENTIAL OR PUNITIVE DAMAGES.
7(b). Recipient's Right to Indemnification
PMC hereby agrees to indemnify, defend and hold harmless
Recipient and its affiliates, officers, directors, employees and representatives
(collectively, the "Recipient's Indemnitees") from and against any liabilities,
claims, damages, costs, expense (including reasonable attorneys' fees), and
actions (collectively, "Claims") arising out of or resulting from (i) the
failure by PMC to manufacture, test, document or release the BCG Material in
compliance with cGMP and the applicable Manufacturing Regulatory Documentation
or (ii) the breach by PMC or PMC's Indemnitees of any of its obligations or
warranties hereunder, except to the extent that any such Claims arise out of,
are based upon or result from the gross negligence or willful misconduct of
Recipient or Recipient's Indemnitees or a breach by Recipient or Recipient's
Indemnitees of any of Recipient's obligations or warranties under this Agreement
or under the Clinical Trial Protocol or Regulatory Filings. Recipient shall
promptly notify PMC of any Claims, upon becoming aware thereof, and permit PMC
at PMC's cost to defend against such Claims and shall cooperate with PMC in the
defense thereof. Recipient shall not enter into, or permit, any settlement of
any such Claims without the express written consent of PMC.
*** Confidential Treatment Requested
-12-
Recipient may, at its option and expense, have its own counsel participate in
any proceeding that is under the direction of PMC and will cooperate with PMC or
its insurer in the disposition of any such matter.
7(c). PMC's Right to Indemnification
Recipient hereby agrees to indemnify, defend and hold harmless
PMC and its affiliates, officers, directors, employees and representatives
(collectively, "PMC's Indemnitees") from and against any liabilities, claims,
damages, costs, expense (including reasonable attorneys' fees), and actions
(collectively, "Claims") arising out of or resulting from (i) the Clinical
Trials, (ii) the failure by Recipient to manufacture, test, document or release
BEC2 in compliance with cGMP and the applicable Regulatory Filings, (iii) the
breach by Recipient or Recipient's Indemnitees of any of Recipient's obligations
or warranties under this Agreement or under the Clinical Trial Protocol or
Regulatory Filings, (iv) the possession, processing, shipment, storage,
handling, administration or disposal of any BCG Material supplied to Recipient
hereunder, or (v) the possession, manufacture, sale, use, distribution,
processing, shipment, storage, handling, administration or disposal of BEC2 by
Recipient whether or not any BCG Material is combined thereto, except to the
extent that any such Claims arise out of, are based upon or result from the
gross negligence or willful misconduct of PMC or PMC's Indemnitees or a breach
by PMC or PMC's Indemnitees of any of PMC's obligations or warranties under this
Agreement. PMC shall promptly notify Recipient of any Claims, upon becoming
aware thereof, and permit Recipient at Recipient 's cost to defend against such
Claims and shall cooperate with Recipient in the defense thereof. PMC shall not
enter into, or permit, any settlement of any such Claims without the express
written consent of Recipient. PMC may, at its option and expense, have its own
counsel participate in any proceeding that is under the direction of Recipient
and will cooperate with Recipient or its insurer in the disposition of any such
matter.
7(d). Recipient's Insurance
Each of ImClone and Merck shall obtain and maintain separate
product liability insurance and clinical trial liability insurance (naming PMC
either as an additional insured or policy beneficiary), with an acceptable
insurer, in the minimum amount of US$10,000,000 per occurrence. Such insurance
may not be cancelled or terminated except upon thirty (30) days' prior written
notice to PMC. Such insurance shall be obtained and maintained at the sole cost
and expense of ImClone and Merck. From time to time, at the request of PMC,
ImClone and Merck will cause certificates of such insurance to be provided to
PMC evidencing compliance with their respective obligations set forth herein.
*** Confidential Treatment Requested
-13-
8. Term and Termination
8(a). Expiration
This Agreement shall commence on the Effective Date and shall
terminate six (6) months after the expiration of the Supply Period, unless
earlier terminated as provided in Sections 8(b), (c) and (d) hereof (the
"Term").
8(b). Termination by Any Party
Any party shall have the right to terminate this Agreement,
immediately upon written notice of termination to the other parties in the event
that:
(i) a party fails to perform or observe or otherwise breaches
any of its material obligations under this Agreement and such failure or breach
continues unremedied for a period of sixty (60) days after receipt by the
breaching party of a written notice thereof from the non-breaching party; and
(ii) a proceeding or case shall be commenced without the
application or consent of the other party and such proceeding or case shall
continue undismissed, or an order, judgment or decree approving or ordering any
of the following shall be entered and continue unstayed and in effect, for a
period of forty-five (45) days from and after the date service of process is
effected upon the other party, seeking (A) the other party's liquidation,
reorganization, dissolution or winding-up, or the composition or readjustment of
its debts, (B) the appointment of a trustee, receiver, custodian, liquidation or
the like of the other party or of all or any substantial portion of their
assets, or (C) similar relief in respect of the other party under any law
relating to bankruptcy, insolvency, reorganization, winding-up or the
composition or readjustment of debts.
8(c). Termination due to Cessation of Clinical Trials
In the event Recipient in its sole discretion ceases the
Clinical Trials, and so advises PMC in writing in advance, either Recipient or
PMC may terminate this Agreement upon thirty (30) days prior written notice to
the other parties.
8(d). Termination in Connection With Further Negotiation
This Agreement may be terminated by the Recipient or PMC in
connection with the failure, during the Term, to enter into a separate agreement
for future commercial supply of BCG Material, as further set forth in Section
2(e) hereof.
8(e). Effects of Termination
In the event of any termination of this Agreement, all amounts
previously invoiced and unpaid or owed to PMC shall be due and payable by
Recipient on the date of termination. Following termination of the Agreement,
the Recipient shall return to PMC or
*** Confidential Treatment Requested
-14-
destroy, at PMC's option, any quantities of BCG Material. The parties agree
that: (i) the provisions of Section 2(e), Article 3 and Article 6 shall survive
the termination or expiration of this Agreement; (ii) the provisions of Article
5 hereof shall survive the termination or expiration of this Agreement for the
term specified in that Article; and (iii) the provisions of Article 7 hereof
shall survive termination or expiration of this Agreement only with respect to
Claims that arose from acts or circumstances that occurred prior to termination.
9. Miscellaneous
9(a). No Implied Waivers; Rights Cumulative
No failure on the part of PMC or the Recipient to exercise,
and no delay in exercising, any right, power, remedy or privilege under this
Agreement, or provided by statute or at law or in equity or otherwise,
including, without limitation, the right or power to terminate this Agreement,
shall impair, prejudice or constitute a waiver of any such right, power, remedy
or privilege or be construed as a waiver of any breach of this Agreement or as
an acquiescence therein, nor shall any single or partial exercise of any such
right, power, remedy or privilege preclude any other or further exercise thereof
or the exercise of any other right, power, remedy or privilege.
9(b). Notices
All notices, requests and other communications to PMC or the
Recipient hereunder shall be in writing (including telecopy or similar
electronic transmissions) and shall be personally delivered or sent by telecopy
(fax) or other electronic facsimile transmission or by registered mail, or
certified mail, return receipt requested, postage prepaid, or by other form of
courier requiring receipt in each case to the respective address specified below
(or to such address as may be specified in writing to the other party hereto)
and shall be effective upon receipt thereof:
Connaught Laboratories Limited
1755 Steeles Avenue West
Toronto, Ontario, CANADA
M2R 3T4
Attn: Vice President and General Counsel
Facsimile: (416) 667-2860
with a copy to: Senior Vice President, and General Manager,
Oncology Business Unit
Facsimile: (416) 667-2990
*** Confidential Treatment Requested
-15-
Merck KGaA
Frankfurter Strasse 250
64271 Darmstadt, GERMANY
Attn: Dr. Dieter Orth, License Department
Facsimile: 61 51 72 3378
with a copies to: Dr. Jurgen Uhl, Project Manager, Facsimile: 61 51 72 7580, and
Lothar Finke, TATONZ, Facsimile: 61 51 72 6905
ImClone Systems Incorporated
180 Varick Street
New York NY 10014
U.S.A.
Attn: General Counsel
Facsimile: (212) 645-2054
9(c). Successors and Assigns
The terms and provisions of this Agreement shall inure to the
benefit of, and be binding upon, PMC, the Recipient, and their respective
successors and permitted assigns as provided in this Section. PMC and Recipient
shall have the right to assign or otherwise transfer any of its rights and
interests, or delegate any of its obligations, to an Affiliate of such party
provided that such Affiliate agrees in writing to carry out in full any
obligations that are assigned to it. PMC and Recipient shall have the right to
assign all of its rights and interests and delegate all of its obligations under
this Agreement to any entity that is the successor in interest to the assigning
party in any merger, consolidation or sale involving substantially all of the
business and assets of the assigning party. Any other assignment or delegation
shall only be valid and effective if the other parties have provided their
respective prior express written consent. Any attempt to assign or delegate any
portion of this Agreement in violation of this Section shall be null and void.
Subject to the foregoing, any reference to PMC or the Recipient hereunder shall
be deemed to include the successors thereto and permitted assigns thereof.
9(d). Force Majeure
No party shall be liable to the others, or be in default under
the terms of this Agreement, for its failure to fulfill its obligations
hereunder to the extent such failure arises for any reason or cause beyond its
control including, without limitation, strikes, lockouts, labor disputes, acts
of God, acts of nature, acts of governments or their agencies, fire, flood,
storm, power shortages or power failure, war, sabotage, inability to supply and
to obtain labor, raw materials, supplies, fuel or utilities, or inability to
obtain transportation, or any other circumstance or event beyond the reasonable
control of the party (each, "Force Majeure"), provided that the party relying on
the provisions of this Section 9(d) shall give notice to the other parties of
its inability to observe or perform the provisions of this Agreement. A party
shall notify the other parties if, at any time, it encounters a production or
manufacturing problem
*** Confidential Treatment Requested
-16-
which in its reasonable opinion could reasonably be expected to adversely affect
its ability to supply BEC2 or BCG Material, as applicable, for the Clinical
Trials. Should such production or manufacturing be so reduced, the party relying
on these provisions shall have the right to allocate such supply for its own use
and among its affiliates, customers and distributors, in such manner and on such
basis as it may reasonably determine, without compensation or penalty to the
other parties.
9(e). Governing Law
This Agreement shall be governed by the laws of the Province of
Ontario. The parties specifically agree that the International Sale of Goods Act
does not apply hereto.
9(f). Entire Agreement
This Agreement, together with its Exhibits A, B and C,
constitutes, on and as of the Effective Date hereof, the entire agreement of and
among PMC, ImClone and Merck with respect to the subject matter hereof, and all
prior or contemporaneous understandings or agreements, whether written or oral,
between or among PMC, ImClone or Merck with respect to such subject matter are
hereby superseded, as of the Effective Date.
9(g) Relationship
Each of the parties is an independent contractor. No party is,
and nothing in this Agreement shall constitute any party as the employer,
employee, principal, agent or partner of, or joint venturer with, any other
party. No party has authority to enter into any agreement on behalf of the other
parties or to bind the other parties in any other manner, and no party shall act
or omit to act so as to suggest that it has such authority. No party shall incur
any obligations or liabilities, express or implied, by reason of, or with
respect to, the actions or omissions of the other parties or of persons for whom
they are responsible.
9(h) Counterparts
This Agreement may be executed in two or more counterparts,
each of which shall be deemed an original but all of which together shall
constitute one and the same instrument.
*** Confidential Treatment Requested
-17-
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their duly authorized officers as of the Effective Date.
ImClone Systems Incorporated
By: /s/ John B. Landes
--------------------------
Name: John B. Landes
Title: VP Business Development
and General Counsel
Merck KGaA
By: /s/ Professor Schurr 18/8/98
------------------------------
Name: Professor Schurr
Title: Vice President Clin. R&D
By: /s/ Dr. Dieter Orth
---------------------------
Name: Dr. Dieter Orth
Title: Head of Corporate Licensing
Connaught Laboratories Limited
By: /s/ Dr. Pierre Meulien
----------------------
Name: Dr. Pierre Meulien
Title: Vice President
Research & Development
By: /s/ Wm. M.M. Thoms
-------------------
Name: Wm. M. Thoms
Title: VP & General Counsel
*** Confidential Treatment Requested
-18-
Exhibit "A" (Protocols, Investigators' Brochures)
to Agreement among PMC, ImClone and Merck effective as of January 1, 1997
- --------------------------------------------------------------------------------
[ *** ]
*** Confidential Treatment Requested
-19-
Exhibit "B" (Section 2(a), ImClone's labelling requirements)
to Agreement among PMC, ImClone and Merck effective as of January 1, 1997
- --------------------------------------------------------------------------------
BCG (lyophilized) 1.5 mg
(An Active Immunizing Agent)
For Intracutaneous Injection Only
Dose as per Clinical Protocol
Lot:
Exp:
For Investigational Use Only
MUST NOT BE ADMINSTERED AS A SINGLE AGENT
Mfg: Connaught Laboratories Limited
North York, ONT Canada
*** Confidential Treatment Requested
-20-
Exhibit "C" (Section 2(a), Merck's labelling requirements)
to Agreement among PMC, ImClone and Merck effective as of January 1, 1997
- --------------------------------------------------------------------------------
BCG (lyophilized) 1.5 mg
(An Active Immunizing Agent)
For Intracutaneous Injection Only
Use according to study protocol EORTC 08971 only
Lot:
Exp:
For Clinical Trial Use Only
MUST NOT BE ADMINSTERED AS A SINGLE AGENT
Mfg: Connaught Laboratories Limited
North York, ONT Canada
*** Confidential Treatment Requested