1
Portions of this Exhibit 10.1 have be redacted and are the subject
of a confidential treatment request filed with the Secretary of the Securities
and Exchange Commission.
2
AGREEMENT
This Agreement ("Agreement") dated as of March 19, 1999 between OSI
Pharmaceuticals, Inc. (formerly named Oncogene Science, Inc.), a Delaware
corporation, having its principal place of business at 000 Xxxxxxx Xxxxxxxxx
Xxxxxxxxx, Xxxxxxxxx, Xxx Xxxx 00000 ("OSI"), and BioChem Pharma Inc., a
corporation incorporated under the laws of Canada, having its registered office
at 000 Xxxx. Xxxxxx-Xxxxxxxx, Xxxxx, Xxxxxx, Xxxxxx X0X 0X0 ("BioChem")
(formerly BioChem Pharma International Inc.).
WITNESSETH:
WHEREAS, BioChem and OSI are parties to a Collaborative Research,
Development and Commercialization Agreement, with an effective date of May 1,
1996, as amended on October 29, 1996 and February 1997 (as amended, the "CRDC
Agreement"); and
WHEREAS, BioChem and OSI intend to terminate the CRDC Agreement and by
this Agreement to change the relationship between them provided for in the CRDC
Agreement; and WHEREAS, BioChem and OSI are parties to a Technology Transfer
Agreement, with an effective date of August 25, 1996; and
WHEREAS, BioChem and OSI intend by this Agreement to amend the terms of
the Technology Transfer Agreement; and
WHEREAS, commencing as of November 30, 1998 (the "Effective Date"),
this Agreement between OSI and BioChem will be effective.
NOW, THEREFORE, the Parties agree as follows:
3
ARTICLE I
INTERPRETATION
1.1. DEFINED TERMS. In this Agreement, unless the context or subject
matter is inconsistent therewith, the following terms and expressions shall have
the following meanings:
1.1.1. "Affiliate" shall mean, with respect to any Person
(including a Party), any other Person which directly or indirectly controls or
is controlled by, or is under direct or indirect common control with, such first
mentioned Person or any Person which is directly or indirectly controlled by a
Person which controls the first mentioned Person; for the purpose of this
definition, "control" shall mean, with respect to any Person (including any
Party), the ownership of more than 50% of the voting shares or other voting
equity of that Person.
1.1.2. "Analogue" shall mean a derivative or modification of a
Lead Compound which is structurally similar to such Lead Compound but differs
from it with respect to at least one component.
1.1.3. "BioChem Confidential Information" shall mean all
confidential information disclosed to OSI as "confidential" or designated as
"confidential" to OSI, to the extent that such information as of the date of
disclosure to OSI was not (a) demonstrably known to OSI as evidenced by written
documentation other than by virtue of a prior confidential disclosure to OSI by
BioChem or its Affiliates, or (b) disclosed in the published literature or
otherwise to the public through no fault of OSI, its Affiliates, employees or
consultants, or (c) obtained from a third party without binder of secrecy;
provided that such third party has no obligation of confidentiality to BioChem
or its Affiliates.
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1.1.4. "BioChem Patent Rights" shall mean Patent Rights, as
set forth on Exhibit A hereto, claiming inventions that are conceived and
reduced to practice solely by employees of BioChem or its Affiliates.
1.1.5. "BioChem Technology" shall mean and include all
technology and technical information, including all inventions, chemical
structures and methods for synthesis, structure-activity relationships, assay
methodology, methods, processes, formulae, plans, specifications,
characteristics, equipment and equipment designs, know how, trade secrets,
discoveries, results, formulations and biological, toxicological and clinical
data and physical, chemical or biological material, which are developed by
employees of, or consultants to, BioChem and/or its Affiliates, prior to or
during the term of the CRDC Agreement or acquired by purchase, license,
assignment or other means from third parties prior to or during the term of the
CRDC Agreement that is not Joint Technology, but only to the extent that BioChem
or its Affiliates is legally entitled to disclose such technology and technical
information.
1.1.6. "Confidential Information" shall have the meaning set
forth in Section 7.1 hereof.
1.1.7. "Effective Date" shall mean November 30, 1998.
1.1.8. "Exclusive Field" shall mean ** for which an exclusive
license has been granted by OSI to BioChem pursuant to Article IV hereof
----------
** This portion has been redacted pursuant to a request for confidential
treatment.
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1.1.9. "FDA" shall mean the United States Food and Drug
Administration.
1.1.10. "Field" shall mean the Exclusive Field and the
Non-Exclusive Field.
1.1.11. "Independent Third Party" shall mean any Person other
than BioChem, OSI and/or any of their respective Affiliates.
1.1.12. "Joint Patent Rights" shall mean Patent Rights,
including those set forth on Exhibit B hereto, claiming inventions that are
conceived and reduced to practice jointly, solely in respect of the Field during
the term of the CRDC Agreement, by employees or consultants of OSI and employees
or consultants of BioChem and of their respective Affiliates.
1.1.13. "Joint Technology" shall mean and include all
technology and information, including all inventions, chemical structures and
methods for synthesis, structure-activity relationships, assay methodology,
methods, processes, fortnulae, plans, specifications, characteristics, equipment
and equipment designs, know how, trade secrets, discoveries, formulations and
biological, toxicological and clinical data, that were developed jointly by
employees of, or consultants to, BioChem and OSI solely in respect of the Field,
described on Exhibit C hereto, such that BioChem and OSI, each having
contributed to the development of such technology and technical information,
owns an undivided interest therein.
1.1.14. "Lead Compound" shall mean any compound as set forth
on Exhibit D hereto.
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1.1.15. "NDA" shall mean a new drug application filed with the
FDA with respect to a Product.
1.1.16. "Net Sales" shall mean the gross amounts actually
received by BioChem and its Affiliates and Sublicensees from arms' length sales
of Product(s) to third parties, whether invoiced or not, less:
(a) Trade, quantity and cash discounts allowed;
(b) Refunds, rebates, chargebacks, retroactive
price adjustments, and any other allowances
which effectively reduce the net selling
price;
(c) Product returns and allowances;
(d) Any tax imposed on the Product other than
income tax that is appropriately deducted
from sales; and
(e) Allowance for distribution expenses.
Such amounts shall be determined from the books and records of BioChem and its
Affiliates and sublicensees, as appropriate, maintained in accordance with
generally accepted accounting principles ("GAAP"), consistently applied.
In the event a Product is sold in combination with another product(s),
the Net Sales from the combination product, for the purposes of determining
royalty payments, shall be determined by multiplying the Net Sales of the
combination product by the fraction A/(A+B), where A is the average sale price
of the Product when sold separately and B is the average sale price of the other
product(s) when sold separately in finished form.
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1.1.17. "Non-Exclusive Field" shall mean Hepatitis B Virus
("HBV") and Human Immunodeficiency Virus ("HIV") for which non-exclusive cross
licenses have been granted pursuant to Article V hereof.
1.1.18. "OSI Confidential Information" shall mean all
confidential information disclosed to BioChem as "confidential" or designated as
"confidential" to BioChem, to the extent that such information as of the date of
disclosure to BioChem is not (a) demonstrably known to BioChem as evidenced by
written documentation other than by virtue of a prior confidential disclosure to
BioChem by OSI or its Affiliates, or (b) disclosed in the published literature
or otherwise to the public through no fault of BioChem, its Affiliates,
employees or consultants, or (c) obtained from a third party without binder of
secrecy; provided that such third party has no obligation of confidentiality to
OSI or its Affiliates.
1.1.19. "OSI Patent Rights" shall mean Patent Rights, as set
forth on Exhibit E hereto, claiming inventions that are conceived and reduced to
practice solely by employees of OSI or its Affiliates.
1.1.20. "OSI Technology" shall mean and include all technology
and technical information, including all inventions, chemical structures and
methods for synthesis, structure-activity relationships, assay methodology,
methods, processes, formulae, plans, specifications, characteristics, equipment
and equipment designs, know how, trade secrets, discoveries, results,
formulations and biological, toxicological and clinical data and physical,
chemical or biological material, which are developed by employees of, or
consultants to, OSI and/or its Affiliates, prior to or during the term of the
CRDC Agreement or acquired by purchase, license, assignment or other means from
third parties prior to or during the term of
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the CRDC Agreement that is not Joint Technology, but only to the extent that OSI
or its Affiliates is legally entitled to disclose such technology and technical
information.
1.1.21. "Patent Rights" shall mean all patents and patent
applications, including any divisional, continuation, continuation-in-part,
reissue, renewal or extension thereof, or substitute therefor, and the letters
patent that may be issued thereon, any registration or confirmation of such
letters patent, relating to Joint Technology, Lead Compounds or Products, their
methods of manufacture or uses of intermediates therefor, or formulations
thereof.
1.1.22. "Product" shall mean any and all products in final,
approved, packaged and labeled pharmaceutical dosage form suitable for sale to
and use by an end user containing a Lead Compound or Analogue emanating from the
Joint Technology in the Exclusive Field and any and all formulations, mixtures
or compositions thereof. Product shall include all of its indications.
1.1.23. "Technology Transfer Agreement" shall mean the
Technology Transfer Agreement, dated August 26, 1996, between OSI and BioChem.
1.2. Any capitalized terms used but not defined herein shall have the
same meanings as in the CRDC Agreement.
ARTICLE II
TERMINATION OF CRDC AGREEMENT
2.1. OSI and BioChem hereby agree that the CRDC Agreement is terminated
as of the Effective Date and is of no further force and effect. Subject to the
obligations set forth in this Agreement, each of the Parties hereto hereby
releases the other Party and its respective
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officers, directors, stockholders, employees, agents, successors and assigns
from and against any and all claims of any nature, in law or equity, past,
present or future, known or unknown, fixed or contingent, which they may have
under or in respect of the CRDC Agreement.
2.2. Upon termination of the CRDC Agreement, and save and except for
any Confidential Information with respect to Joint Technology relating to the
license rights referred to in Articles IV and V hereof, OSI and BioChem shall
each promptly return to the other party all of the other party's Confidential
Information and all copies thereof; none of OSI, BioChem or any of their
respective Affiliates shall have any further obligations thereunder except as
provided in this Agreement.
2.3. Each Party confirms that the other Party and its Affiliates shall,
on and after the Effective Date, be free to conduct research activities within
the Field, subject to the terms and conditions of this Agreement.
ARTICLE III
PAYMENT; DELIVERY OF MATERIALS
3.1. PAYMENT. Upon the execution of this Agreement, BioChem agrees to
pay the sum of Two Million US Dollars (US $2,000,000) to OSI, which amount
includes license fees for license rights referred to in Article IV hereof and
valuable consideration for amending the value of the Licensed Technology in the
Technology Transfer Agreement referred to in Article VIII hereof. Upon such
payment from BioChem to OSI and subject to any payments provided for in Sections
4.3 and 4.4 hereof, BioChem and OSI have settled all costs and expenses owing to
each other pursuant to the CRDC Agreement.
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3.2. DELIVERIES OF MATERIALS.
3.2.1. OSI shall deliver to BioChem the materials constituting
Joint Technology, as listed on Exhibit F hereto, no later than 30 days following
the date of execution of this Agreement, to allow BioChem to exercise its
license rights in the Exclusive Field, as set forth in Section 4.1.1 hereto.
3.2.2. BioChem shall deliver to OSI the materials constituting
Joint Technology, as listed on Exhibit F hereto, no later than 30 days following
the date of execution of this Agreement, to allow OSI to carry out research and
development activities in the Non-Exclusive Field, as set forth in Section 5.2
hereto.
3.2.3. OSI shall deliver to BioChem the materials constituting
Joint Technology, as listed on Exhibit F hereto, no later than 30 days following
the date of execution of this Agreement, to allow BioChem to carry out research
and development activities in the Non-Exclusive Field, as set forth in Section
5.1 hereto.
ARTICLE IV
**
4.1. LICENSES.
4.1.1. License to BioChem. For good and valuable
consideration, OSI
----------
** This portion has been redacted pursuant to a request for confidential
treatment.
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hereby grants to BioChem a worldwide, irrevocable, exclusive license, in
perpetuity, including the right to grant sublicenses, under the Joint Patent
Rights and Joint Technology in the Exclusive Field to conduct research and to
develop, make, have made, use, sell and have sold Products. OSI agrees that it
shall have no rights to use the Joint Patent Rights and Joint Technology for any
purpose whatsoever, including research activities, in the Exclusive Field.
4.1.2. Sublicenses. If BioChem grants a sublicense pursuant to
Section 4.1.1 hereof, BioChem shall guarantee that any sublicensee fulfills all
of its obligations under this Agreement. In the event BioChem grants sublicenses
under Section 4.1.1 to others to make, have made, use, sell or have sold
Products, such sublicenses shall include an obligation of the sublicensees to
account for and report all Net Sales of Products to BioChem on the same basis as
if such sales were Net Sales of Products by BioChem, in accordance with Section
4.4 hereof.
4.2. REPORTING REQUIREMENTS.
4.2.1. BioChem shall prepare and submit to OSI, on or about
each anniversary of the Effective Date hereof, a written report which shall (a)
list the Lead Compounds or Analogues that are, or may be considered to be
BioChem, candidates for Phase I clinical trials, and (b) briefly describe
BioChem's progress during the previous calendar year with respect to the Lead
Compounds or Analogues previously identified as candidates for Phase I clinical
trials. Such report may be general in nature and shall not include any BioChem
proprietary information.
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4.2.2. Within 30 days after the first sale of any Product,
BioChem shall prepare and submit to OSI a concise written report which shall
include the name of such Product and the locations were the Product is sold or
to be sold.
4.3. MILESTONE PAYMENTS.
4.3.1. BioChem shall make a milestone payment to OSI of **
upon the successful completion of Phase I clinical trials for each Lead Compound
or Analogue. Each Lead Compound or Analogue can give rise to only one such
milestone payment.
4.3.2. Upon the filing of an NDA with the FDA or an equivalent
filing with appropriate regulatory authorities in Europe or in Asian countries
for each Product, BioChem shall make a milestone payment to OSI of **. Each
Product can give rise to only one such milestone payment.
4.3.3. Upon approval of an NDA by the FDA or receipt of an
equivalent approval in Europe or in an Asian country for marketing approval for
each Product, BioChem shall pay OSI the sum of **. Each Product can give rise to
only one such milestone payment.
4.4. ROYALTIES, PAYMENTS OF ROYALTIES, ACCOUNTING FOR ROYALTIES,
RECORDS.
4.4.1. Royalties - Lead Compounds. BioChem shall pay OSI a
royalty at the rate of ** of the Net Sales by BioChem and its Affiliates of each
Product containing a Lead Compound. BioChem shall continue to pay such royalty
on Net Sales of each Product in
----------
** This portion has been redacted pursuant to a request for confidential
treatment.
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each country (a) so long as the manufacture, use or sale of which is covered by
a valid claim under the Joint Patent Rights with respect to such Product in such
country or (b) if not covered by a valid claim under the Joint Patent Rights,
for 10 years from the date of first commercial sale of such Product in each such
country. If BioChem sublicenses its rights to a Lead Compound under this
Agreement to a third party, BioChem shall pay to OSI an amount equal to the
greater of (i) ** of the applicable royalty payment due to BioChem under such
sublicense arrangement or (ii) ** of sublicensee's Net Sales; provided, however,
that in no event shall such royalty to OSI exceed ** of the sublicensee's Net
Sales.
4.4.2. Royalties - Analogues. BioChem shall pay OSI a royalty
at the rate of ** of the Net Sales by BioChem and its Affiliates of each Product
containing an Analogue. BioChem shall continue to pay such royalty on Net Sales
of each Analogue in each country (a) so long as the manufacture, use or sale of
which is covered by a valid claim under the Joint Patent Rights with respect to
such Analogue in such country or (b) if not covered by a valid claim under the
Joint Patent Rights, for 10 years from the date of first commercial sale of such
Analogue in each such country. If BioChem sublicenses its rights to an Analogue
under this Agreement to a third party, BioChem shall pay to OSI an amount equal
to the greater of (i) ** of the applicable royalty payment due to BioChem under
such sublicense arrangement or (ii) ** of the sublicensee's Net Sales; provided,
however, that in no event shall such royalty to OSI exceed ** of the
sublicensee's Net Sales.
----------
** This portion has been redacted pursuant to a request for confidential
treatment.
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4.4.3. Patent Dates. Royalties shall be paid by BioChem on Net
Sales made by BioChem within 90 days after the end of each calendar quarter in
which such Net Sales are made. Such payments shall be accompanied by a statement
showing the Net Sales of each Product or Analogue in each country and a
calculation of the amount of royalty due. With respect to Net Sales made by
sublicensees, BioChem shall pay to OSI the amounts specified in Sections 4.4.1
and 4.4.2 within 30 days following receipt by BioChem of royalty payments due to
BioChem from its sublicensees.
4.4.4. Accounting. The Net Sales used for computing the
royalties payable to OSI by BioChem shall be computed and paid in U.S. Dollars.
For purposes of determining the amount of royalties due with respect to Net
Sales in any foreign currency, the amount shall be computed generally by
converting the foreign currency amount into U.S. Dollars using for each month's
calculation the foreign currency exchange rate on the last day of the preceding
month or such other method as is consistent with internal foreign currency
translation procedures of BioChem or the sublicensee paying the royalties, as
actually used by such party on a consistent basis in preparing its audited
financial statements.
4.4.5. Records. BioChem shall keep for three years from the
date of each payment of royalties complete and accurate records of Net Sales by
BioChem, its Affiliates and sublicensees of each Product in sufficient detail to
allow the accruing royalties to be determined accurately. OSI shall have the
right for a period of three years after receiving any report or statement with
respect to royalties due and payable to obtain at OSI's expense from the
independent certified public accountant used by BioChem for public reporting an
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audit of the relevant records of BioChem to verify such report or statement.
BioChem shall make its records available for inspection by such independent
certified public accountant during regular business hours at such place or
places where such records are customarily kept, upon reasonable notice from OSI,
to the extent reasonably necessary to verify the accuracy of the reports and
payments. Such inspection right shall not be exercised more than once in any
calendar year nor more than once with respect to sales in any given period,
unless a subsequent inspection reveals discrepancies which may have also
occurred during such period. Such independent certified public accountant shall
report to OSI only as to the accuracy of the Net Sales computation and royalty
payments. OSI agrees to hold in strict confidence all information concerning
royalty payments and reports, and all information learned in the course of any
audit or inspection, except to the extent necessary for such party to reveal
such information in order to enforce its rights under this Agreement or
disclosure is required by law. The failure of OSI to request verification of any
report or statement during the three-year period shall be considered acceptance
of the accuracy of such report, and BioChem shall have no obligation to maintain
records pertaining to such report or statement beyond the three-year period. The
results of the inspection shall be binding on both parties.
4.4.6. Withholding Taxes. All amounts owing to OSI as
specified in this Agreement shall be paid net of all applicable taxes, fees, and
other charges excluding only taxes on the income of BioChem. BioChem will assist
OSI in minimizing the withholding tax applicable to any payment made by BioChem
hereunder and in claiming tax refunds at OSI's reasonable request.
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ARTICLE V
HEPATITIS B VIRUS ("HBV") AND
HUMAN IMMUNODEFICIENCY VIRUS ("HIV")
5.1. LICENSE TO BIOCHEM. OSI hereby grants to BioChem a
royalty-free worldwide, irrevocable non-exclusive license in the Non-Exclusive
Field, including the right to grant sublicenses hereunder, under the Joint
Patent Rights and Joint Technology, to research, develop, make, have made, use,
sell, have sold and commercialize antiviral agents against HBV and HIV.
5.2. LICENSE TO OSI. BioChem hereby grants to OSI a
royalty-free worldwide, irrevocable non-exclusive license in the Non-Exclusive
Field, including the right to grant sublicenses hereunder, under the Joint
Patent Rights and Joint Technology, to research, develop, make, have made, use,
sell, have sold and commercialize antiviral agents against HBV and HIV.
ARTICLE VI
PATENT RIGHTS
6.1. JOINT PATENT RIGHTS RELATING TO THE EXCLUSIVE FIELD. BioChem shall
have the exclusive right, at its own expense, to take all necessary actions to
obtain, sustain and enforce patent protection for Joint Patent Rights relating
to the Exclusive Field, including the following:
(a) filing applications for patents on any patentable
inventions included within Joint Patent Rights relating to the Exclusive Field;
(b) prosecuting all pending and new patent applications
included with Joint Patent Rights relating to the Exclusive Field and responding
to opposition or any other form of
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action for invalidity or revocation of patent rights filed by Independent Third
Parties against the grant of patents for such applications; and
(c) maintaining in force any patents included within Joint
Patent Rights relating to the Exclusive Field by duly filing all necessary
papers and paying any fees required by the patent laws of the particular country
in which such patents were granted.
OSI shall provide reasonable assistance to BioChem to achieve the
objectives of this Article. BioChem shall keep OSI informed as to all
developments with respect to Joint Patent Rights by copying OSI on all documents
and correspondence related to such protection and maintenance.
6.2. PATENT RIGHTS RELATING TO THE NON-EXCLUSIVE FIELD. Upon the
reasonable request of a Party, each Party agrees to provide assistance to the
other Party with respect to the filing of patent application(s) in or relating
to the Non-Exclusive Field.
ARTICLE VII
CONFIDENTIAL INFORMATION AND PUBLICATION
7.1. GENERAL. Each of BioChem and OSI recognizes that the other Party's
Confidential Information, BioChem Technology, OSI Technology, Joint Technology,
BioChem Patents, OSI Patents, Joint Patent Rights and the results of research
pursuant to the CRDC Agreement (collectively, the "Confidential Information")
constitute highly valuable proprietary confidential information.
7.2. TREATMENT OF CONFIDENTIAL INFORMATION.
7.2.1. Subject to the disclosure obligations set forth in this
Article, each of BioChem and OSI agree that, during the term of this Agreement
and for a period of 10
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years thereafter, each Party will maintain, and shall cause its Affiliates to
maintain, the Confidential Information in confidence and shall not disclose,
divulge or otherwise communicate such Confidential Information to Independent
Third Parties (except its own Confidential Information, its own Technology or
its own Patents). Notwithstanding any provision of this Agreement, BioChem and
OSI hereby agree that they shall, together with their Affiliates, be entitled to
use, outside of the Field, know how obtained during the term of this Agreement.
7.2.2. Each Party further agrees to exercise, and shall cause
its Affiliates to exercise, every reasonable precaution to prevent and restrain
the unauthorized disclosure of such Confidential Information by any of its
directors, officers, employees, consultants, subcontractors, sublicensees or
agents or those of its Affiliates.
7.3. PRESS RELEASES AND ANNOUNCEMENTS.
7.3.1. Neither OSI nor BioChem shall, and OSI and BioChem
shall cause their Affiliates not to, issue any press release or other public
announcement disclosing any Confidential Information (other than its own
Confidential Information, its own Technology or its own Patents) without the
prior written consent of the other Party, which consent shall not be
unreasonably withheld or delayed, except where such announcements or press
releases are required by law for the purposes of securing the registration of,
and/or governmental approval to market, in accordance with this Agreement, any
Products, or for the procurement of patent protection of Joint Patent Rights.
Notwithstanding the foregoing, each Party shall have the right to disclose the
existence of this Agreement in any prospectus, offering memorandum or
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other document or filing required by applicable securities laws or other
applicable law or regulation.
7.3.2. Where a press release or public announcement is
required by law, the Party required to disclose Confidential Information shall
inform the other Party and provide it with a copy of any such press release or
public announcement.
7.3.3. Each of BioChem and OSI shall inform the other Party of
any Confidential Information which it is required to disclose.
7.4. PUBLICATIONS. Notwithstanding the provisions of Sections 7.1, 7.2
and 7.3 hereof, any results arising from research pursuant to the CRDC Agreement
may be published, subject to the following applicable restrictions:
7.4.1. The Party intending to publish, directly or indirectly,
shall provide the other Party with a copy of the manuscript (including any
abstract) for any proposed publication or presentation no later than 30 days
prior to the submission of such proposed publication or presentation to a
journal, editor or other Independent Third Party for the purpose of review and
comment. The other Party shall have the right to comment on the authorship of
the publication or presentation and to request modifications of any manuscript
to be published or presented, if such manuscript will jeopardize a Patent Right,
patent, trade secret, or other proprietary right related to this Agreement. If
the Party intending to publish does not agree with the authorship or any
modifications, the Parties shall consult independent patent counsel satisfactory
to both Parties whose determination shall be final and binding on the Parties.
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7.4.2. If the other Party informs the publishing Party within
30 days of receipt of an advance copy of a proposed publication that such
publication in its reasonable judgment could be expected to have material
adverse effect on Joint Patent Rights or Confidential Information, the
publishing Party shall delay or prevent such publication as proposed. In the
case of inventions, such Party shall delay or cause the author to delay
submission of the work for publication or other public disclosure for up to six
months after filing of a patent application.
ARTICLE VIII
AMENDMENT TO TECHNOLOGY TRANSFER AGREEMENT
8.1. The Technology Transfer Agreement is hereby amended as follows:
8.1.1. Article VI is hereby amended to delete the final
sentence of Section 6.2.
8.1.2. Article VII, Royalty, is hereby deleted in its
entirety.
8.2. The Technology Transfer Agreement, as amended hereby, shall remain
in full force and effect.
ARTICLE IX
NOTICES
9.1. All notices shall be taxed, or mailed via certified mail, return
receipt requested, or courier, addressed as follows, or to such other address as
may be designated from time to time:
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If to OSI: At its address as set forth at the beginning of
this Agreement
Attn.: Xxxxx Xxxxxxx, Ph.D., President &
Chief Executive Officer
Fax : 000-000-0000
If to BioChem: At its address as set forth at the beginning of
this Agreement
Attn.: VP Legal Affairs & Corporate Secretary
Fax : 000-000-0000
Notices shall be deemed given as of the date of receipt.
ARTICLE X
REPRESENTATIONS AND WARRANTIES
10.1. GOOD STANDING. Each of BioChem and OSI represents and warrants
that it is a corporation duly organized, validly existing and in good standing
under the laws of its jurisdiction of incorporation and that it has all
requisite power and authority, corporate or otherwise, to conduct its business
as now being conducted, to own, lease and operate its properties and to execute,
deliver and perform this Agreement.
10.2. PROPER AUTHORIZATION. Each of BioChem and OSI represents and
warrants that the execution, delivery and performance of this Agreement have
been duly authorized by all necessary corporate action and do not and will not
(a) require any consent or approval of each Party's stockholders, (b) violate
any provision of any law, rule, regulation, order, writ, judgment, injunction,
decree, determination or award presently in effect having applicability to each
Party or any provision of its charter or by-laws or (c) result in a breach of or
constitute a default under any material agreement, mortgage, lease, license,
permit or other instrument or
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obligation to which BioChem or OSI is a party or by which BioChem or OSI or
their respective properties may be bound or affected.
10.3. BINDING AGREEMENT. Each of BioChem and OSI represents and
warrants that this Agreement is a legal, valid and binding obligation of each
party, enforceable against the other in accordance with its terms and
conditions, except as such enforceability may be limited by applicable
bankruptcy, insolvency, moratorium, reorganization or similar laws, from time to
time in effect, affecting creditors' rights generally.
10.4. TITLE. Each of BioChem and OSI for itself represents that it has
good and marketable title to all of its properties, rights and assets to be used
in the fulfillment of its responsibilities under this Agreement, subject to no
claim of any third party.
ARTICLE XI
MISCELLANEOUS
11.1. BINDING EFFECT. This Agreement shall be binding upon and inure to
the benefit of the Parties hereto and their respective legal representatives,
successors and permitted assigns.
11.2. HEADINGS. The headings contained in this Agreement are for
convenience of reference only and do not form a part of this Agreement, and no
construction or inference shall be derived therefrom.
11.3. ENTIRE AGREEMENT. This Agreement and the documents and other
agreements referred to herein set forth the entire agreement and understanding
of the Parties.
11.4. SEVERABILITY. In the event that any provision of this Agreement
is held by a court of competent jurisdiction to be unenforceable because it is
invalid or in conflict with any
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law of any relevant jurisdiction, the validity of the remaining provisions shall
be construed and enforced as if the Agreement did not contain the particular
provisions held to be unenforceable.
11.5. COUNTERPARTS. This Agreement may be executed simultaneously 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.
11.6. AMENDMENT, WAIVER, ETC. This Agreement may be amended, modified,
superseded or canceled, and any of the terms hereof may be waived, only by a
written instrument executed by each party hereto or, in the case of waiver, by
the party or parties waiving compliance. The delay or failure of any party at
any time or times to require performance of any provision hereof shall in no
manner affect the rights at a later time to enforce the same. No waiver by any
party of any condition or of the breach of any term contained in this Agreement,
whether by conduct or otherwise, in any one or more instance, shall be deemed to
be, or construed as, a further or continuing waiver of any such condition or of
the breach of such term or any other term of this Agreement.
11.7. ASSIGNMENT AND SUCCESSORS. This Agreement and the rights and
interests hereunder may not be assigned by either party in whole or in part
except to an Affiliate, a purchaser of all or substantially all of the assets of
a party or to any successor corporation resulting from any merger or
consolidation of either party with or into such corporation.
11.8. GOVERNING LAW. This Agreement shall be construed and interpreted
in accordance with the laws of the State of New York.
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11.9. DISPUTE RESOLUTION. In the event BioChem and OSI cannot agree on
any matter requiring agreement between the Parties, the matter of differences
shall be determined by arbitration. Arbitration shall be conducted under the
Commercial Arbitration Rules of the American Arbitration Association by one
person appointed by the Parties or, if the Parties cannot agree within 30 days
following notification by one Party that it wishes to refer a matter to
arbitration, by such person empowered by the American Arbitration Association to
so appoint an arbitrator. Arbitration shall take place in a location agreed to
by the Parties, or absent such agreement, chosen by the arbitrator. The decision
of the arbitrator shall be final and binding on both Parties. The fees and
expenses of the arbitrator shall be borne equally by the Parties.
11.10. INDEMNIFICATION. BioChem shall indemnify, defend and hold
harmless OSI, its officers and their respective successors, heirs and assigns
(the "Indemnitees") against any liability, damage, loss or expense (including
reasonable attorneys' fees and expenses of litigation) incurred by or imposed
upon the Indemnitees or any one of them in connection with any claims, suits,
actions, demands or judgments arising out of any infringement (including, but
not limited to, actions in the form of tort, warranty or strict liability)
arising out of any claim by a third party relating to the manufacture, use or
sale of a Product. Except as provided above, the parties agree that all
warranties, express or implied, are excluded.
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IN WITNESS WHEREOF, the Parties hereto have caused this
Agreement to be executed as a sealed instrument in their names by their properly
and duly authorized representatives as of the date first written above.
BIOCHEM PHARMA INC.
By: /s/ Xxxxxxx XxXxxxxx
----------------------------------
Name: Xxxxxxx XxXxxxxx
Title: President and C.O.O.
By: /s/ Xxxxxxxx Xxxxxxx
----------------------------------
Name: Xxxxxxxx Xxxxxxx
Title: Executive Vice President
Corporate Development
OSI PHARMACEUTICALS, INC.
By: /s/ Xxxxx Xxxxxxx
----------------------------------
Name: Xxxxx Xxxxxxx
Title: President and CEO
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EXHIBIT A
BIOCHEM PATENT RIGHTS
**
----------
** This portion has been redacted pursuant to a request for confidential
treatment.
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EXHIBIT B
JOINT PATENT RIGHTS
**
----------
** This portion has been redacted pursuant to a request for confidential
treatment.
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EXHIBIT C
JOINT TECHNOLOGY
**
----------
** This portion has been redacted pursuant to a request for confidential
treatment.
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EXHIBIT D
LEAD COMPOUNDS
**
----------
** This portion has been redacted pursuant to a request for confidential
treatment.
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EXHIBIT E
OSI PATENT RIGHTS
**
----------
** This portion has been redacted pursuant to a request for confidential
treatment.
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EXHIBIT F
MATERIALS
1) As per Section 3.2, OSI to BioChem: **
2) As per Section 3.3, BioChem to OSI: **
3) As per Section 3.4, OSI to BioChem: **
----------
** This portion has been redacted pursuant to a request for confidential
treatment.
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