RESEARCH COLLABORATION
AND LICENSE AGREEMENT
between
OXIGENE EUROPE AB
and
XXXXXXX-XXXXX SQUIBB COMPANY
Dated as of December 15, 1999
TABLE OF CONTENTS
Page
I
DEFINITIONS
II
REPRESENTATIONS AND WARRANTIES
2.1 Representations and Warranties of Both Parties...................6
2.2 Additional Representations and Warranties of OXiGENE.............7
III
ASU LICENSE AGREEMENT
3.1 Representations and Warranties of OXiGENE........................8
3.2 OXiGENE Obligations..............................................9
3.3 Rights of, and Obligations to, ASU..............................10
IV
JOINT DEVELOPMENT COMMITTEE
4.1 Members.........................................................10
4.2 Responsibilities................................................11
4.3 Meetings........................................................12
4.4 Decisions.......................................................12
4.5 Minutes.........................................................12
4.6 Term............................................................13
4.7 Expenses........................................................13
V
COLLABORATIVE RESEARCH PROGRAM
5.1 Scope of Research Program.......................................13
5.2 Funding of Research Program.....................................13
5.3 Conduct of Research Program.....................................14
5.4 Records.........................................................15
5.5 Material Transfer...............................................15
5.6 Liability.......................................................15
5.7 Term of Research Program........................................15
5.8 Termination of Research Program; Effect.........................16
VI
OWNERSHIP; PATENT PROTECTION
6.1 Ownership of BMS Collaboration Technology.......................17
6.2 Ownership of ASU Licensed Technology, OXiGENE Licensed Technology,
OXiGENE Collaboration Technology................................17
6.3 Ownership of Joint Collaboration Technology.....................17
6.4 Patent Filing, Prosecution and Maintenance......................17
6.5 Termination of Support by BMS...................................18
VII
GRANT OF LICENSES; RESERVATION OF RIGHTS
7.1 Mutual Research Licenses........................................18
7.2 BMS Commercialization License; Limited Partial Conversion to
Non-exclusivity.................................................19
7.3 Mutual Ex-Field Licenses........................................19
7.4 ******..........................................................19
7.5 ******..........................................................19
7.6 ******..........................................................19
7.7 ******..........................................................19
VIII
DEVELOPMENT AND COMMERCIALIZATION
8.1 Development Efforts by BMS......................................20
8.2 Transfer of INDs, etc...........................................20
8.3 Ownership of Regulatory Filings.................................20
8.4 Reporting; OXiGENE Liaison......................................20
8.5 Trademarks......................................................21
8.6 ******..........................................................21
IX
MONETARY OBLIGATIONS
9.1 BMS's Reimbursement of Certain Expenses.........................21
9.2 License Fee.....................................................22
9.3 Development Milestone Payments by BMS...........................22
9.4 Additional License Fee, Milestone Payment.......................23
9.5 Royalties.......................................................23
9.6 Third Party Royalties...........................................24
9.7 Additional Royalty Indemnification..............................25
X
PAYMENTS AND REPORTS
10.1 Payment.........................................................25
10.2 Mode of Payment.................................................25
10.3 Records Retention...............................................25
10.4 Audit Request...................................................25
10.5 Taxes...........................................................26
10.6 Blocked Currency................................................26
10.7 Late Payments...................................................26
XI
MANUFACTURING
11.1 Transfer of Manufacturing Responsibility........................26
11.2 Negotiation, Execution of Supply Agreement......................27
11.3 Terms of Supply Agreement.......................................27
11.4 Cost of Manufacturing and Related Activities....................28
11.5 Manufacturing Liaisons..........................................28
11.6 U.S. Manufacture................................................28
XII
CONFIDENTIALITY
12.1 Confidentiality; Exceptions.....................................28
12.2 Exclusions to Confidentiality...................................29
12.3 Injunctive Relief...............................................29
XIII
INTELLECTUAL PROPERTY
13.1 Patent Enforcement..............................................29
13.2 Infringement Actions by Third Parties...........................30
13.3 Superior Rights of ASU..........................................31
XIV
INDEMNIFICATION
14.1 By BMS..........................................................31
14.2 By OXiGENE......................................................32
14.3 Notice..........................................................32
14.4 Complete Indemnification........................................32
14.5 Insurance.......................................................32
XV
TERM; TERMINATION
15.1 Term............................................................33
15.2 Effect of Expiration............................................33
15.3 Termination by Either Party.....................................33
15.4 Termination by BMS..............................................34
15.5 Effect of Expiration or Termination.............................34
15.6 Right to Sell Stock on Hand.....................................35
15.7 Termination of Sublicenses......................................35
15.8 Accrued Rights, Surviving Obligations...........................35
XVI
FORCE MAJEURE
16.1 Events of Force Majeure.........................................35
XVII
MISCELLANEOUS
17.1 Non-solicitation................................................36
17.2 Standstill......................................................36
17.3 Relationship of Parties.........................................37
17.4 Guaranty........................................................37
17.5 Assignment......................................................37
17.6 Disclaimer of Warranties........................................37
17.7 Further Actions.................................................38
17.8 Notice..........................................................38
17.9 Use of Name.....................................................38
17.10 Public Announcements............................................39
17.11 Waiver..........................................................39
17.12 Compliance with Law.............................................39
17.13 Severability....................................................39
17.14 Amendment.......................................................40
17.15 Governing Law; English Original; Jurisdiction...................40
17.16 Arbitration.....................................................40
17.17 No Consequential Damages........................................40
17.18 Entire Agreement................................................41
17.19 Parties in Interest.............................................41
17.20 Descriptive Headings............................................41
17.21 Counterparts....................................................41
RESEARCH COLLABORATION
AND LICENSE AGREEMENT
THIS RESEARCH COLLABORATION AND LICENSE AGREEMENT (this
"Agreement"), dated as of December 15, 1999, is between OXiGENE Europe AB, a
company duly organized and existing under the laws of Sweden and having offices
at Xxxxxxxxxxxxxxxx 0x, X-000 00 Xxxxxxxxx, Xxxxxx, for and on behalf of itself
and its Affiliates ("OXiGENE"), and Xxxxxxx-Xxxxx Squibb Company, a company duly
organized and existing under the laws of the State of Delaware and having
offices at Route 206 and Province Line Road, Princeton, New Jersey, USA
08543-4000, for and on behalf of itself and its Affiliates ("BMS").
PRELIMINARY STATEMENTS
A. OXiGENE is a leading biotechnology company.
B. BMS is an international pharmaceutical company.
C. OXiGENE has entered into that certain License Agreement with the
Arizona Board of Regents, acting on behalf of Arizona State University
(collectively, "ASU"), pursuant to which OXiGENE has been granted a license,
with the right to sublicense, certain patent rights and other know-how and
technology owned by ASU.
D. OXiGENE wishes to grant a sublicense to BMS, and BMS wishes to
take a sublicense from OXiGENE, under certain rights granted to OXiGENE under
such License Agreement and under other relevant patent rights and know-how owned
by OXiGENE, upon the terms and conditions set forth in this Agreement.
E. Furthermore, OXiGENE and BMS wish to collaborate in connection
with the research, development and commercialization of products covered by such
licensed technology, upon the terms and conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the foregoing preliminary
statements and the mutual covenants and agreements of the Parties contained in
this Agreement, the Parties hereby agree as follows:
I
DEFINITIONS
As used in this Agreement, the following terms shall have those
meanings set forth in this Section 1 unless the context dictates otherwise.
1.1 "Affiliate" with respect to either Party, shall mean any Person
controlling, controlled by, or under common control with, such Party. For these
purposes, "control" shall refer to (i) the possession, directly or indirectly,
of the power to direct the management or policies of a Person, whether through
the ownership of voting securities, by contract or otherwise, or (ii) the
beneficial ownership (as such term is defined in the 0000 Xxx) of at least 50%
of the voting securities or other ownership interest of a Person.
1.2 "ASU Advisory Committee" shall have the meaning assigned thereto
in Section 3.1(f).
1.3 "ASU License Agreement" shall mean that certain License
Agreement No. 206-01.LIC, dated August 2, 1999, by and between OXiGENE and ASU,
a redacted copy of which is attached hereto as Exhibit A.
1.4 "ASU Licensed Technology" shall mean ASU'S PATENT RIGHTS I, II,
III and IV and all related TECHNOLOGY and KNOW-HOW to which OXiGENE has been
granted a license under the ASU License Agreement, as such block capitalized
terms are defined therein. A list of all such Patents in existence on the
Effective Date is included in Exhibit B attached.
1.5 "BMS Collaboration Technology" shall mean all Inventions and
Know-How first studied, developed, reduced to practice or shown to have utility
solely by employees of BMS in connection with the performance of BMS's
obligations under the Research Program, as well as any and all Patents covering
same.
1.6 "CA4P" shall mean the chemical compound having the chemical name
Combretastatin A4 phosphate.
1.7 "Collaboration Compound" shall mean any chemical compound, the
composition of matter and/or method of use of which is, or under Section 9.4 is
deemed to be, covered by the ASU Licensed Technology, the OXiGENE Licensed
Technology and/or the OXiGENE Collaboration Technology, and that is the subject
of any of the research, development, commercialization and/or marketing
activities contemplated by this Agreement. While the Parties intend CA4P to be
the initial Collaboration Compound, other compounds may be selected as
Collaboration Compounds in addition to, or in lieu of, CA4P.
1.8 "Combretastatin" shall mean any cancer cell growth inhibitory
substance derived from the xxxx willow Combretum caffrum.
1.9 "Confidential Information" shall have the meaning assigned to
such term in Section 12.1.
1.10 "Covered Product" shall mean any pharmaceutical product the
manufacture, sale or use of which in any country in the Territory is covered by
a Valid Claim of any Patent included in the ASU Licensed Technology, the OXiGENE
Licensed Technology, the OXiGENE Collaboration Technology, the BMS Collaboration
Technology and/or the Joint Collaboration Technology.
1.11 "EEA" shall mean the countries in the European Economic Area,
or any successor thereto, from time to time.
1.12 "Effective Date" shall mean the date first set forth above.
1.13 "FDA" shall mean the United States Food and Drug
Administration, or any successor thereto.
1.14 "Field" shall mean the prevention, diagnosis, control or
treatment of any human or animal disease or condition by the Systemic Use of a
Covered Product(s), either as a single agent or in combination with any other
therapy. The Field may be modified from time to time as provided in Section 7.7"
1.15 "First Commercial Sale" shall mean, with respect to any Covered
Product, the first sale for use or consumption by the general public of such
Covered Product in a country in the Territory after all required marketing and
pricing approvals have been granted, or otherwise permitted, by the governing
health authority of such country. "First Commercial Sale" shall not include the
sale of any Covered Product for use in clinical trials or for compassionate use
prior to the approval of an NDA; provided, however, that if and to the extent
that BMS receives remuneration for any such compassionate use or named patient
sales, BMS shall pay royalties thereon in accordance with Section 9.5.
1.16 "IND" shall mean an Investigational New Drug Application to be
filed with the FDA, or the equivalent thereof in other countries or regulatory
jurisdictions.
1.17 "Invention" shall mean any new or useful method, process,
manufacture, compound or composition of matter, whether or not patentable or
copyrightable, or any improvement thereof.
1.18 "Joint Collaboration Technology" shall mean all Inventions and
Know-How first studied, developed, reduced to practice or shown to have utility
jointly by one or more employees of BMS and one or more employees of OXiGENE
during the performance of the Parties' respective obligations under the Research
Program, as well as any and all Patents covering same.
1.19 "Joint Development Committee" shall mean the entity organized
and acting pursuant to Section 4.
1.20 "Know-How" shall mean unpatented technical and other
information which is not in the public domain including information comprising
or relating to discoveries, inventions, data, designs, formulae, methods,
models, assays, research plans, procedures, designs for experiments and tests
and results of experimentation and testing (including results of research or
development), processes (including manufacturing processes, specifications and
techniques), laboratory records, chemical, pharmacological, toxicological,
clinical, analytical and quality control data, trial data, case report forms,
data analyses, reports or summaries and information contained in submissions to
and information from ethical committees and regulatory authorities. Know-How
includes rights protecting Know-How. The fact that an item is known to the
public shall not be taken to exclude the possibility that a compilation
including the item, and/or a development relating to the item, is (and remains)
not known to the public.
1.21 "Licensed Product" shall mean any pharmaceutical product the
manufacture, sale or use of which in any country in the Territory is covered by
a Valid Claim of any Patent included in the ASU Licensed Technology. For
purposes of clarification, all Licensed Products are Covered Products, but not
all Covered Products are Licensed Products.
1.22 "NDA" shall mean a New Drug Application to be filed with the
FDA, or the equivalent thereof in other countries or regulatory jurisdictions.
1.23 "Net Sales" shall mean, with respect to any Covered Product,
the gross amount invoiced to Third Parties by BMS, its Affiliates or its
Sublicensees, as the case may be, for such Covered Product, commencing with the
First Commercial Sale of such Covered Product, less deductions for: (i)
reasonable and customary trade, quantity and/or cash discounts actually granted;
(ii) reasonable and customary credits, refunds and allowances (including,
without limitation, cash, credit and free goods allowances) actually allowed or
given for chargebacks, retroactive price reductions, billing errors and rebates
(including, without limitation, government-mandated and managed healthcare
negotiated rebates); (iii) credits and refunds for Covered Product that is
rejected, spoiled, damaged, outdated or returned actually allowed or given; (iv)
freight, postage, shipping insurance and other transportation costs actually
incurred in transporting Covered Product to a Third Party; and (v) taxes,
tariffs, customs duties, surcharges and other governmental charges incurred in
connection with the sale, exportation or importation of Covered Product. Such
amounts shall be determined from the books and records of BMS, its Affiliates or
its Sublicensees, as the case may be, maintained in accordance with the
generally accepted accounting principles, consistently applied.
Notwithstanding the foregoing, in the event a Covered Product is
sold in conjunction with another proprietary active component so as to be a
combination product (whether packaged together or in the same therapeutic
formulation), Net Sales shall be calculated by multiplying the Net Sales of such
combination product by a fraction, the numerator of which shall be the fair
market value of the Covered Product as if sold separately (determined in
accordance with generally accepted accounting principles), and the denominator
of which shall be the aggregate fair market value of all the proprietary active
components of such combination product, including the Covered Product, as if
sold separately. In the event no such separate sales are made by BMS, its
Affiliates or Sublicensees, Net Sales of the combination product shall be
calculated in a manner to be negotiated and agreed upon by the Parties,
reasonably and in good faith, prior to any sale of such combination product,
which shall be based upon the respective estimated commercial values of the
proprietary active components of such combination product.
Notwithstanding the foregoing, in connection with (X) any sale or
other disposition of Covered Product that is not a bona fide, arms length
transaction for money, or (Y) any other use of Covered Product that does not
result in or give rise to sales revenue that is customary in the country in
which such use takes place (except as provided in the next paragraph), Net Sales
shall be calculated at the relevant open market price in the country in which
such sale, disposition or use takes place, or, if such price is not reasonably
ascertainable, at a reasonable price, assessed on an arms length basis, for the
goods and/or services received in consideration of the sale, disposition or use
of Covered Product.
BMS's or any of its Affiliate's transfer of Covered Product to
another Affiliate or a Sublicensee shall not result in any Net Sales, unless
such Covered Product is consumed by such Affiliate or Sublicensee in the course
of its commercial activities. In such case, Net Sales shall occur upon such
other Affiliate's or Sublicensee's sale of such Covered Product to a Third
Party. Further, the disposition of Covered Product for, or the use of Covered
Product in, pre-clinical or clinical (Phase I - III) trials or other
market-focused (Phase IV or V) trials or free samples shall not result in any
Net Sales.
1.24 "1934 Act" shall mean the Securities Exchange Act of 1934, as
amended, and all regulations promulgated pursuant thereto from time to time.
1.25 "North America" shall mean the United States and Canada and
their respective possessions.
1.26 "OXiGENE Collaboration Technology" shall mean all Inventions
and Know-How first studied, developed, reduced to practice or shown to have
utility solely by employees of OXiGENE, or of any Third Party working on behalf
of for the benefit of OXiGENE and/or in whose Inventions and Know-How OXiGENE
otherwise has rights, in connection with the performance of OXiGENE's
obligations under the Research Program, as well as any and all Patents covering
same.
1.27 "OXiGENE Licensed Technology" shall mean all Patents owned or
controlled by, or licensed to, OXiGENE, and all Know-How and Inventions
developed, owned or controlled by, or licensed to, OXiGENE, on or after the
Effective Date, other than the ASU Licensed Technology, which, in the reasonable
opinion of the Parties, is necessary for or may be useful in the development,
manufacture, use or sale of Licensed Products in the Field in the Territory, all
to the extent that OXiGENE has the right to license or otherwise make available
such Patents, Know-How and Inventions to BMS hereunder. A list of all such
Patents in existence on the Effective Date is included in Exhibit B attached.
1.28 "OXiGENE Pre-clinical Studies" shall have the meaning assigned
thereto in Section 9.1(a).
1.29 "Party" shall mean OXiGENE or BMS and, when used in the plural,
shall mean OXiGENE and BMS.
1.30 "Patents," as used in this Agreement, shall mean all of the
subject letters patent and patent applications throughout the Territory, as well
as any and all substitutions, extensions, renewals, continuations,
continuations-in-part, divisions, patents-of-addition and/or reissues thereof.
1.31 "Person" shall mean any natural person, corporation, firm,
business trust, joint venture, association, organization, company, partnership
or other business entity, or any government or any agency or political
subdivision thereof.
1.32 "Research Plan" shall have the meaning thereto in Section 5.1.
1.33 "Research Program" shall mean the research program that is
conducted by OXiGENE in collaboration with BMS pursuant to Section 5.
1.34 "Royalty Term" shall mean, with respect to each Covered Product
in a country in the Territory, the period of time commencing on the Effective
Date and ending on the later of: (i) the ****** anniversary of the First
Commercial Sale of such Covered Product in such country, or (ii) if, at the time
of the First Commercial Sale of such Covered Product in such country, the sale
of such Covered Product is covered by a Valid Claim of a Patent directed to the
composition of matter or use in the Field of the compound contained in such
Covered Product or a pharmaceutical preparation containing such compound that is
included in the ASU Licensed Technology, the OXiGENE Licensed Technology and/or
the OXiGENE Collaboration Technology, the date on which the last of such Patents
expires.
1.35 "Sublicensee" shall mean a Third Party to which BMS has granted
sublicense rights under the OXiGENE Licensed Technology, OXiGENE Collaboration
Technology, BMS Collaboration Technology and Joint Collaboration Technology and
further sublicense rights under the ASU Licensed Technology.
1.36 "Substances" shall have the meaning assigned thereto in Section
5.5.
1.37 "Supply Agreement" shall have the meaning assigned thereto in
Section 11.2.
1.38 "Systemic Use" shall mean any use of a compound or product
where the administration is by means other than topical.
1.39 "Territory" shall mean all of the countries in the entire
world.
1.40 "Third Party" shall mean any Person who or which is neither a
Party nor an Affiliate of a Party.
1.41 "Valid Claim" shall mean (i) a pending claim in any patent
application that has not been pending for more than five years, which for
purposes of Sections 1.10, 1.21 and 1.33 shall be treated as if such pending
claim were issued in then-current form, or (ii) a claim of any issued letters
patent that, in each case, has not been held invalid or unenforceable by final
decision of a court or other governmental agency of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, and that is not
admitted to be invalid or unenforceable through reissue, disclaimer or
otherwise.
II
REPRESENTATIONS AND WARRANTIES
2.1 Representations and Warranties of Both Parties. Each Party
represents and warrants to the other Party that, as of the Effective Date:
(a) Such Party is duly organized and validly existing under the laws
of the jurisdiction of its incorporation and has full corporate power and
authority to enter into this Agreement and to carry out the provisions hereof;
(b) Such Party has taken all corporate action necessary to authorize
the execution and delivery of this Agreement and the performance of its
obligations under this Agreement;
(c) This Agreement is a legal and valid obligation of such Party,
binding upon such Party and enforceable against such Party in accordance with
the terms of this Agreement, except as such enforceability may be affected by
laws affecting creditors' rights generally and general equitable principles. The
execution, delivery and performance of this Agreement by such Party do not and
shall not conflict with any agreement, instrument or understanding, oral or
written, to which such Party is a party or by which such Party may be bound, or
violate any law or regulation of any court, governmental body or administrative
or other agency having authority over such Party. All consents, approvals and
authorizations from all governmental authorities or other Third Parties required
to be obtained by such Party in connection with the execution, delivery and
performance of this Agreement have been obtained;
(d) Such Party has sufficient facilities, experienced personnel and
other capabilities to enable it to perform its obligations under this Agreement;
and
(e) No Person has or will have, as a result of the transactions
contemplated by this Agreement, any right, interest or valid claim against or
upon such Party for any commission, fee or other compensation as a finder or
broker because of any act by such Party or of any agent of such Party.
In addition, the Parties covenant with one another that if a filing under the
Xxxx Xxxxx Xxxxxx Act is necessary in connection with the transaction
contemplated by this Agreement, the Parties, in cooperation with each other,
shall take all actions reasonably necessary to make and complete such filing, as
soon as practicable after the Effective Date.
2.2 Additional Representations and Warranties of OXiGENE. OXiGENE
represents and warrants to BMS that, as of the Effective Date:
(a) OXiGENE and/or its Affiliates are the owner of, or have
exclusive rights to, all of the Patents included in the ASU Licensed Technology
(except as expressly provided in the copy of the ASU License Agreement attached
as Exhibit A) and the OXiGENE Licensed Technology in existence on the Effective
Date, and have the exclusive right to grant the licenses or sublicenses, as the
case may be, therefor granted under this Agreement;
(b) All such Patents consist of either patent applications that have
been filed and are pending and actively being prosecuted as of the Effective
Date, or issued letters patent that are in full force and effect and have been
maintained through the Effective Date;
(c) OXiGENE is not aware of any asserted or unasserted claim or
demand which it believes can be enforced by a Third Party against any such
Patents;
(d) To the best of OXiGENE's knowledge and belief, the practice of
such Patents and the performance of the Research Program as currently
contemplated by the Parties do not and shall not infringe upon or conflict with
any patent, copyright or other proprietary right of any Third Party;
(e) OXiGENE and/or its Affiliates have the right to grant the
licenses or sublicenses, as the case may be, granted under this Agreement for
all of the Know-How and Inventions included in the ASU Licensed Technology and
OXiGENE Licensed Technology in existence on the Effective Date;
(f) Such Know-How and Inventions were not obtained by OXiGENE, and
to the best of OXiGENE's knowledge and belief were not obtained by ASU, in
violation of any contractual or fiduciary obligation to which OXiGENE, ASU or
any of their respective employees or staff members are or were bound, or by the
misappropriation of the trade secrets of any Third Party.
(g) OXiGENE has not entered into any agreement with any Third Party
which is in conflict with the rights granted to BMS under to this Agreement, and
the execution and performance of this Agreement by OXiGENE do not and shall not
violate any agreement or undertaking to which OXiGENE is a party; and
(h) To the best of OXiGENE's knowledge and belief, all of the data
and information that OXiGENE has provided to BMS prior to the Effective Date
relating to such Patents, Know-How and Inventions, and to Combretastatins in
general, are reasonably accurate, and OXiGENE has not omitted therefrom any
material data or information in OXiGENE's possession or control reasonably in
advance of the Effective Date concerning same that a reasonable Person in BMS's
position would want to have examined prior to executing this Agreement.
III
ASU LICENSE AGREEMENT
3.1 Representations and Warranties of OXiGENE. OXiGENE represents
and warrants to BMS that, as of the Effective Date:
(a) The ASU License Agreement is in full force and effect and has
not been modified or amended, except that no representation or warranty is made
with respect to ASU or matters solely within the control or direction of ASU
that are not known to OXiGENE;
(b) To the best of OXiGENE's knowledge and belief, neither ASU nor
OXiGENE is in default with respect to a material obligation under, and neither
such party has claimed or has grounds upon which to claim that the other party
is in default with respect to a material obligation under, the ASU License
Agreement;
(c) To the best of OXiGENE's knowledge and belief, the rights that
ASU has licensed to OXiGENE pursuant to the ASU License Agreement were not and
are not subject to any restrictions or limitations except as set forth in the
copy of the ASU License Agreement attached as Exhibit A;
(d) OXiGENE has not waived or allowed to lapse any of its rights
under the ASU License Agreement, and no such rights have lapsed or otherwise
expired or been terminated;
(e) The portions of the ASU License Agreement that have been
redacted from the copy of the ASU License Agreement attached as Exhibit A do not
contain any provision that would materially alter, hinder or otherwise adversely
affect BMS's rights or obligations under this Agreement or BMS's ability to
realize commercial benefit from the exercise or enforcement of such rights and
performance of such obligations; and
(f) OXiGENE has previously informed BMS of all decisions and
recommendations made by the advisory committee contemplated by Section 8.6 of
the ASU License Agreement (the "ASU Advisory Committee") and has identified to
BMS any of such decisions and recommendations that have been made binding.
3.2 OXiGENE Obligations. OXiGENE agrees that during the term of this
Agreement:
(a) OXiGENE will use commercially reasonable efforts to fulfill all
of its material obligations under the ASU License Agreement (including, without
limitation, the payment of all patent costs under Section 6 thereof), to the
extent such obligations have not been delegated to BMS and to the extent that
failure to do so would adversely affect BMS or its rights hereunder;
(b) OXiGENE shall not enter into any subsequent agreement with ASU
that modifies or amends the ASU License Agreement in any way that could
potentially adversely affect BMS's rights under this Agreement without BMS's
prior written consent, and shall provide BMS with a copy of all modifications to
or amendments of the ASU :License Agreement, regardless of whether BMS's consent
was required with respect thereto (except to the limited extent any such
modification or amendment pertains solely to a portion(s) of the ASU License
Agreement that has not been disclosed to BMS);
(c) OXiGENE shall not terminate the ASU License Agreement in whole
or in part, directly or indirectly, without BMS's prior written consent;
(d) OXiGENE shall promptly furnish BMS with copies of all reports
and other communications OXiGENE receives from ASU that relate to the subject
matter of this Agreement (including, without limitation, under Section 6.6 of
the ASU License Agreement);
(e) OXiGENE shall promptly furnish BMS with copies of all reports
and other communications that OXiGENE furnishes to ASU which relate to the
subject of this Agreement, and to the extent any such reports or communications
relate to the efforts of BMS under this Agreement (including, without
limitation, those reports required under Sections 9.1 and 9.2 of the ASU License
Agreement), OXiGENE shall give BMS a reasonable opportunity to review and
comment upon such reports or communications before they are transmitted to ASU;
(f) OXiGENE shall furnish BMS with copies of all notices received by
OXiGENE relating to any alleged breach or default of any material obligation by
OXiGENE under the ASU License Agreement within three business days after
OXiGENE's receipt thereof and, if OXiGENE cannot or chooses not to cure or
otherwise resolve any such alleged breach or default, OXiGENE shall allow BMS,
in BMS's sole discretion, to cure or otherwise resolve any such alleged breach
or default;
(g) OXiGENE, acting as an intermediary between ASU and BMS, shall
allow BMS to exercise and enjoy the direct benefit of all of OXiGENE's
affirmative rights, to the extent they relate to the ASU Licensed Technology,
under Sections 2.4, 6.1 (concerning only the elimination or addition of
countries in which patent protection is to be sought or maintained), 6.2, 6.4
(concerning only the termination of rights with respect to any Patent), 6.7, 6.8
(concerning only the amendment of claims of patent applications), 6.9
(concerning only instruction to ASU to proceed with any necessary action), 6.10,
6.11, 7.5, 8.2, 8.7, 11.1, 11.2, 11.5, 14.1, 16.1 (subject, in the event of
default by OXiGENE under the ASU License Agreement, to Section 3.2(f) hereof),
16.3 (solely to prevent OXiGENE from terminating the ASU License Agreement with
respect to any LICENSED PRODUCT or ASU PATENT RIGHT (as such terms are defined
therein) that BMS wishes to sell or exploit under this Agreement) and 16.4
(solely to prevent OXiGENE from terminating the ASU License Agreement if BMS
wishes to maintain its sublicense with respect to the ASU Licensed Technology
hereunder) of the ASU License Agreement. BMS shall, to the extent practicable,
exercise such rights in consultation with OXiGENE, and OXiGENE shall take all
necessary steps to effect BMS's exercise thereof;
(h) Until a BMS representative begins to serve on the ASU Advisory
Committee, as provided in Section 3.2(i) hereof, OXiGENE shall inform BMS of all
decisions and recommendations made by such committee and shall identify to BMS
any such decisions or recommendations that are made binding; and
(i) Promptly after the Effective Date, OXiGENE shall take all
appropriate actions to have a representative selected by BMS appointed to the
ASU Advisory Committee. As contemplated by Section 8.6.1 of the ASU License
Agreement, such BMS representative shall be one of the two OXiGENE
representatives to the ASU Advisory Committee.
3.3 Rights of, and Obligations to, ASU. Pursuant to Section 3.1 of
the ASU License Agreement, BMS hereby acknowledges the rights of and obligations
to ASU thereunder, to the extent such rights and obligations are set forth in
the copy of the ASU License Agreement attached hereto as Exhibit A. Except as
otherwise contemplated by this Agreement, BMS shall use reasonable commercial
efforts to perform such obligations, to the extent they are set forth in the
copy of the ASU License Agreement attached hereto as Exhibit A.
IV
JOINT DEVELOPMENT COMMITTEE
4.1 Members. The Parties shall establish a Joint Development
Committee (the "Joint Development Committee"), which shall comprise three
representatives designated by each Party (or such other number as the Parties
may agree). The initial members of the Joint Development Committee are set forth
on Exhibit C. Members of the Joint Development Committee may be represented at
any meeting by a designee who is appointed by such member for such meeting and
who has authority to act on behalf of such member. During the term of the
Research Program, the chairperson of the Joint Development Committee shall be
designated annually on an alternating basis between the Parties; thereafter the
chairperson shall be designated by BMS . The initial chairperson shall be
selected by BMS and is designated on Exhibit C. The Party not designating the
chairperson shall designate one of its representative members as secretary to
the Joint Development Committee for such year. Each Party shall be free to
replace its representative members with new appointees who have authority to act
on behalf of such Party, on notice to the other Party.
4.2 Responsibilities. The Joint Development Committee shall be
responsible for overseeing and directing the Research Program and overseeing
BMS's development and commercialization efforts under Section 8. Its duties
shall include, without limitation:
(i)evaluating and determining scientific criteria to be
implemented under the Research Program;
(ii) proposing, approving and, from time to time, updating and
modifying the Research Plans;
(iii) providing guidance for the implementation of the Research
Plans;
(iv) determining the deliverables OXiGENE is responsible
for under the Research Plans;
(v)subject to Section 5.2, fixing the compensation that OXiGENE
is to receive from BMS in consideration of OXiGENE's performance of its
obligations under the Research Program;
(vi) allocating responsibilities and resources between the
Parties with respect to the Research Program;
(vii) determining whether to commence or terminate various
projects under the Research Program;
(viii) setting patent filing policies and making patent filing
determinations, as contemplated by Sections 6.4(a) - (d);
(ix) evaluating data from the Research Program and making
recommendations to BMS for its selection of Collaboration Compounds for
further development by BMS;
(x)reviewing the results of any clinical trials conducted by
OXiGENE pursuant to Section 8.6 and making recommendations as to BMS's
activities under Section 8 based on such results, as appropriate;
(xi) reviewing and evaluating progress, milestone achievement and
diligence under the Research Program and, with respect to BMS only, under
Section 8, provided that the Joint Development Committee shall not have
authority to make any determination that either Party is in breach of its
obligations under this Agreement or any Research Plan or other plan
created by the Joint Development Committee;
(xii) providing for the exchange of information between the
Parties relating to the Research Program and BMS's activities under
Section 8; and
(xiii) addressing issues and resolving differences that may arise
between the Parties with respect to the Research Program and BMS's
activities under Section 8.
4.3 Meetings. The Joint Development Committee shall meet at least
once every calendar quarter, and more frequently as the Parties deem
appropriate, on such dates and at such times as the Parties shall agree, on 10
days' written notice to the other Party unless such notice is waived by the
Parties. The Joint Development Committee may convene or be polled or consulted
from time to time by means of telecommunications, video conferences or
correspondence, as deemed necessary or appropriate by the Parties. To the extent
that meetings are held in person, they shall alternate between the offices of
the Parties unless the Parties otherwise agree. The chairperson shall be
responsible for sending notices of meetings to all members.
4.4 Decisions. (a) A quorum for a meeting of the Joint Development
Committee shall require the presence of at least one OXiGENE member (or
designee) and at least one BMS member (or designee) in person or by telephone.
All decisions made or actions taken by the Joint Development Committee shall be
made unanimously by its members, with the OXiGENE members cumulatively having
one vote and the BMS members cumulatively having one vote.
(b) In the event that unanimity cannot be reached by the Joint
Development Committee with respect to a matter that is a subject of its
decision-making authority, then the matter shall be referred for further review
and resolution to the President of the Pharmaceutical Research Institute at BMS,
or such other similar position designated by BMS from time to time, and the
Chief Executive Officer at OXiGENE, or such other similar position designated by
OXiGENE from time to time. The designated officers of each Party shall use
reasonable efforts to resolve the matter within 10 days after the matter is
referred to them. If the designated officers cannot resolve any such matter
within 10 days, the matter shall be decided by the designated officer of BMS in
good faith, taking into account the reasonable commercial interests of OXiGENE
and the express provisions of this Agreement.
4.5 Minutes. Within 15 days after each Joint Development Committee
meeting, the secretary of the Joint Development Committee shall prepare and
distribute minutes of the meeting, which shall provide a description in
reasonable detail of the discussions had at the meeting and a list of any
actions, decisions or determinations approved by the Joint Development
Committee. The secretary shall be responsible for circulation of all draft and
final minutes. Draft minutes shall be first circulated to the chairperson,
edited by the chairperson and then circulated in final draft form to all members
of the Joint Development Committee sufficiently in advance of the next meeting
to allow adequate review and comment prior to the meeting. Minutes shall be
approved or disapproved, and revised as necessary, at the next meeting. Final
minutes shall be distributed to the members of the Joint Development Committee.
4.6 Term. The Joint Development Committee shall exist until the
termination or expiration of the Research Program and for such longer period as
necessary to perform the responsibilities assigned to it under this Agreement.
4.7 Expenses. Each Party shall be responsible for all travel and
related costs for its representatives to attend meetings of, and otherwise
participate on, the Joint Development Committee.
V
COLLABORATIVE RESEARCH PROGRAM
5.1 Scope of Research Program. The Joint Development Committee shall
prepare and provide to each Party a detailed description, mutually acceptable to
the Parties in form and substance, of the activities to be undertaken during
each 12-month period during the Research Program, which shall include a
reasonably detailed description of the goals and scope of such research, the
allocation of responsibilities to the respective Parties and a work plan,
milestones and project target dates for such period (including the personnel,
equipment and facilities that OXiGENE is required to provide) (each such
12-month plan, as may be updated or modified from time to time, a "Research
Plan"). Each Research Plan shall be embodied in a letter agreement to be
executed by the Parties and shall include only projects ****** the ASU Licensed
Technology. The Joint Development Committee shall agree upon the Research Plan
for the first 12 months of the Research Program as promptly as possible after
the Effective Date and, in any event, no later than 90 days thereafter. The
Joint Development Committee shall regularly review, update and, as necessary,
modify each Research Plan from time to time. The Joint Development Committee
shall promptly provide each Party with any such updates or modifications.
5.2 Funding of Research Program. (a) BMS shall fund OXiGENE's
conduct of the Research Program at the rates determined by the Joint Development
Committee under each Research Plan (but not less than US $ ****** for ******
following the Effective Date). BMS shall make the payments due under this
Section 5.2(a) in equal quarterly installments (exclusive of any applicable VAT,
which shall be paid by BMS) on the first day of each calendar quarter during the
term of the Research Program; provided, however, that the payment due with
respect to the quarter in which the Effective Date falls shall be due seven days
after the Effective Date. Any payment under this Section 5.2(a) for a portion of
a calendar quarter shall be made on a pro rata basis. All payments under this
Section 5.2(a) shall be made via wire transfer to a bank account designated by
OXiGENE from time to time.
(b) BMS shall pay OXiGENE at least US$ ****** in consideration of
OXiGENE's performance of its Research Program obligations, unless the Research
Program is terminated by BMS pursuant to Section 5.8(a) or (b), or this
Agreement is terminated in its entirety by BMS pursuant to Section 15.3, prior
to the ****** anniversary of the Effective Date, in which case this Section
5.2(b) shall not apply.
5.3 Conduct of Research Program. During the term of the
Research Program, each Party shall:
(a) undertake an interactive, cooperative Research Program with the
other Party as set forth in the Research Plans, and such other activities that
the Joint Development Committee decides, from time to time, are necessary for
the scientific or commercial success of the Research Program;
(b) use all reasonable efforts and proceed diligently to perform the
work set out for such Party to perform under the Research Plan, including,
without limitation, by using personnel with sufficient skills and experience,
together with sufficient equipment and facilities;
(c) conduct the Research Program in good scientific manner, and in
compliance with all requirements of all applicable laws, rules and regulations
and all other requirements of any applicable good laboratory practices to
attempt to achieve the objectives of the Research Program efficiently and
expeditiously;
(d) within 30 days following the end of each six-month period during
the term of the Research Program and within 30 days following the expiration or
termination of each Research Program, furnish the other Party with written
reports summarizing all of the activities conducted by such Party under the
Research Program during such six-month period or the term of such Research
Program, as the case may be;
(e) promptly provide an invention disclosure report to the other
Party with respect to any Invention included in the OXiGENE Licensed Technology,
OXiGENE Collaboration Technology, BMS Collaboration Technology or
Joint Collaboration Technology;
(f) allow representatives of the other Party, upon reasonable notice
and during normal business hours, and subject to reasonable restrictions
necessary to protect the confidentiality of such Party's other programs, to
visit the facilities of such Party where the Research Program is being
conducted, and consult informally, during such visits and by telephone, with
such Party's personnel performing work on the Research Program;
(g) with respect to OXiGENE, (i) maintain worker's compensation,
employer's liability and comprehensive general liability insurance, to the
extent applicable, with respect to the work it is performing under the Research
Program in such amounts as it customarily maintains with respect to similar
research programs, which insurance shall designate BMS as an additional insured,
and pay the premiums due thereunder, and (ii) ensure that any Third Parties who
perform any of OXiGENE's obligations under the Research Program do likewise. The
terms and conditions of such insurance policies and any and all amendments
thereto, as well as the amount actually insured and the amount of coverage
OXiGENE or any such Third Party customarily maintains, shall be supplied to BMS
on request; and
(h) with respect to OXiGENE, ensure that all of its employees and
agents (including, without limitation any Third Party and the faculty, employees
and agents of any such Third Party) involved in the Research Program on
OXiGENE's behalf agree, in writing, to assign to OXiGENE, directly or
indirectly, such Person's entire interest in and to any and all Inventions
arising from such involvement, unless BMS otherwise agrees in advance.
5.4 Records. (a) OXiGENE and BMS each shall maintain records, in
sufficient detail and in good scientific manner, which shall be complete and
accurate in all material respects and shall fully and properly reflect all work
done and results achieved in the performance of the Research Program (including
all data in the form required under all applicable laws and regulations).
(b) OXiGENE and BMS shall share all information contained in such
records, and each shall have the right, during normal business hours, upon
reasonable notice and subject to such reasonable procedures as the other Party
may require, to inspect and copy all such records of the other Party relating
specifically to the Research Program to the extent reasonably required for the
performance of the inspecting Party's obligations under this Agreement. OXiGENE
and BMS each shall maintain such records and the information of the other Party
contained therein in confidence in accordance with Section 12 and shall not use
such records or information except to the extent otherwise permitted by this
Agreement.
5.5 Material Transfer. In order to facilitate the Research Program,
either Party may provide to the other Party certain biological materials or
chemical compounds (collectively, the "Substances") owned by or licensed to the
supplying Party (other than under this Agreement) for use by the other Party in
furtherance of the Research Program. Except as otherwise provided under this
Agreement, all Substances delivered to the other Party shall remain the sole
property of the supplying Party, shall be used only in furtherance of the
Research Program and solely under the control of the other Party, shall not be
used or delivered to or for the benefit of any Third Party without the prior
written consent of the supplying Party and shall not be used in research or
testing involving human subjects. The Substances supplied under this Section 5.5
must be used with prudence and appropriate caution in any experimental work,
since not all of their characteristics may be known. THE SUBSTANCES ARE PROVIDED
"AS IS" AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF
FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE
SUBSTANCES WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS
OF ANY THIRD PARTY.
5.6 Liability. Each Party shall be responsible for, and hereby
assumes, any and all risks of personal injury or property damage attributable to
the negligent or willful acts or omissions, during the term of the Research
Program, of such Party or its Affiliates, and their respective directors,
officers, employees and agents.
5.7 Term of Research Program. The term of the Research Program shall
commence on the Effective Date, and shall continue until the ****** anniversary
of the Effective Date, except as otherwise provided in this Agreement; provided,
however, that the Joint Development Committee may elect, at its discretion, to
extend the term of the Research Program for one or more additional 12-month
periods. Any such election shall be made, if at all, at least 90 days prior to
the relevant anniversary of the Effective Date.
5.8 Termination of Research Program; Effect. (a) At any time during
the term of the Research Program, BMS shall have the right to terminate the
Research Program upon 30 days' written notice to OXiGENE, in the event that:
(i) OXiGENE is acquired (whether through merger, consolidation,
acquisition (directly or indirectly) of stock representing *****% or more
of the outstanding voting stock or other of its equity securities, sale of
all or substantially all of its assets, or otherwise) by any Third Party
pharmaceutical company having a market capitalization in excess of US$
******; or
(ii) BMS has become entitled to terminate this Agreement under
clause (ii) or (iii) of Section 15.3; provided, however, that BMS's
termination of the Research Program pursuant to this Section 5.8(a)(ii)
shall not constitute termination of this Agreement in its entirety.
OXiGENE shall promptly notify BMS of the occurrence of any of the events
specified in Sections 5.8(a)(i) or (ii).
(b) At any time during the term of the Research Program, either
Party (the "terminating Party") shall have the right to terminate the Research
Program upon notice to the other Party (the "defaulting Party") in the event the
defaulting Party materially defaults with respect to any of its material
obligations in connection with the Research Program and fails to cure such
default within 30 days after the receipt of a notice from the terminating Party
specifying the nature of, and requiring the remedy of, such default.
(c) In the event of termination of the Research Program by BMS
pursuant to Section 5.8(a) or (b), OXiGENE shall (i) promptly transfer to BMS
copies, whether in written or electronic form, of all data, reports, records and
materials (including any ASU Licensed Technology, OXiGENE Licensed Technology
and/or OXIGENE Collaboration Technology necessary to allow BMS to continue to
conduct of the Research Program, all to the extent not previously disclosed to
BMS) in OXiGENE's possession or control which relate to the Research Program;
(ii) return to BMS all relevant records and materials, whether in written or
electronic form, in OXiGENE's possession or control containing Confidential
Information of BMS; and (iii) furnish to BMS all unused Substances provided to
OXiGENE by BMS in connection with the Research Program. Thereafter, BMS shall
have no further obligation to fund the Research Program.
(d) In the event of termination of the Research Program by OXiGENE
pursuant to Section 5.8(b), BMS shall (i) promptly provide OXiGENE with copies,
whether in written or electronic form, of all data, reports, records and
materials in BMS's possession or control which relate to the Research Program;
(ii) return to OXiGENE all relevant records and materials, whether in written or
electronic form, in BMS's possession or control containing Confidential
Information of OXiGENE; and (iii) furnish to OXiGENE all unused Substances
provided to BMS by OXiGENE in connection with the Research Program.
(e) Either Party's termination of the Research Program pursuant to
this Section 5.8 shall be without prejudice to, and shall not affect, any of the
Parties' respective rights and obligations under this Agreement that do not
specifically relate to the Research Program. Without limiting the generality of
the foregoing, BMS's right to exploit the licenses granted to it under Sections
7.2 and 7.3(a), and OXiGENE's right to exploit the license granted to it under
Sections 7.3(b), all in accordance with the terms of this Agreement, shall not
be affected by any such termination.
VI
OWNERSHIP; PATENT PROTECTION
6.1 Ownership of BMS Collaboration Technology. Except as otherwise
provided in this Agreement, the entire right, title and interest in and to all
BMS Collaboration Technology shall be owned solely by BMS.
6.2 Ownership of ASU Licensed Technology, OXiGENE Licensed
Technology, OXiGENE Collaboration Technology. Except as otherwise provided in
this Agreement, the entire right, title and interest in and to all OXiGENE
Licensed Technology, OXiGENE Collaboration Technology and, as between the
Parties, ASU Licensed Technology shall be owned solely by OXiGENE.
6.3 Ownership of Joint Collaboration Technology. Except as otherwise
provided in this Agreement, the right, title and interest in and to all Joint
Collaboration Technology shall be owned jointly and in undivided shares by
OXiGENE and BMS.
6.4 Patent Filing, Prosecution and Maintenance. (a) Reasonably
promptly after the Effective Date the Joint Development Committee, in
consultation with the Parties' respective patent counsel, shall agree upon a
patent filing policy with respect to Collaboration Compounds and Covered
Products. In addition, from time to time, the Joint Development Committee shall
determine, in accordance with such policy, whether and in what jurisdictions
patent applications should be filed with respect to any Know-How or Inventions
included in the OXiGENE Licensed Technology, OXiGENE Collaboration Technology,
BMS Collaboration Technology and Joint Collaboration Technology.
(b) Following a determination by the Joint Development Committee
that a patent application should be filed with respect to any Know-How or
Inventions included in the OXiGENE Licensed Technology or OXiGENE Collaboration
Technology, OXiGENE, through outside patent counsel (including, without
limitation, foreign patent counsel and agents) reasonably acceptable to BMS,
shall promptly file a patent application with respect thereto in the
jurisdiction(s) selected by the Joint Development Committee, and thereafter
OXiGENE shall prosecute such application and maintain any letters patent issuing
therefrom. OXiGENE shall take all such actions in consultation with BMS and its
patent counsel and shall keep BMS apprised as to the status of all pending
patent applications. The out-of-pocket costs of filing, prosecuting and
maintaining any Patents actually incurred by OXiGENE under this Section 6.4(b)
shall be reimbursed by BMS. OXiGENE shall invoice BMS for such costs on a
quarterly basis. Such invoices shall be payable 45 days after receipt thereof.
(c) Following a determination by the Joint Development Committee
that a patent application should be filed with respect to any Know-How or
Inventions included in the BMS Collaboration Technology, BMS shall promptly file
a patent application with respect thereto in the jurisdiction(s) selected by the
Joint Development Committee, and thereafter BMS shall prosecute such application
and maintain any letters patent issuing therefrom. BMS shall take all such
actions in consultation with OXiGENE and its patent counsel and shall keep
OXiGENE apprised as to the status of all pending patent applications. The costs
of filing, prosecuting and maintaining any Patents under this Section 6.4(c)
shall be borne solely by BMS.
(d) Following a determination by the Joint Development Committee
that a patent application should be filed with respect to a any Know-How or
Invention included in the Joint Collaboration Technology, BMS shall promptly
file a patent application with respect thereto, in the Parties' joint names, in
the jurisdiction(s) selected by the Joint Development Committee, and thereafter
BMS shall prosecute such application and maintain any letters patent issuing
therefrom. BMS shall take all such actions in consultation with OXiGENE and
shall keep OXiGENE apprised as to the status of all pending patent applications.
The costs of filing, prosecuting and maintaining any Patents under this Section
6.4(d) shall be borne solely by BMS.
(e) The preparation, filing, prosecuting and maintenance of Patents
included in the ASU Licensed Technology shall be accomplished as provided in the
ASU License Agreement, subject to Sections 3.2(g) and 9.1(c) hereof.
Furthermore, the Parties' respective rights and obligations under this Section
6.4 shall be subject, in all events, to any superior rights of ASU under the ASU
License Agreement regarding the ASU Licensed Technology.
6.5 Termination of Support by BMS. BMS shall have the right to
terminate all of its obligations, if any, under this Agreement with respect to
any Patent included in the ASU Licensed Technology, OXiGENE Licensed Technology,
OXiGENE Collaboration Technology and/or Joint Collaboration Technology, from
time to time, upon notice to OXiGENE; provided, however, that no such notice
shall be effective with respect to any such Patent if it is given fewer than 60
days prior to a deadline for taking any action that must be taken in order to
preserve the owner's rights in such Patent. Upon the delivery of any such
effective notice, all of BMS's rights, licenses and obligations under this
Agreement with respect to such Patent shall terminate, except those obligations
that shall have accrued prior to the delivery of such notice.
VII
GRANT OF LICENSES; RESERVATION OF RIGHTS
7.1 Mutual Research Licenses. (a) OXiGENE hereby grants BMS, during
the term of the Research Program, a co-exclusive (solely with OXiGENE), paid-up,
world-wide right and license under the OXiGENE Licensed Technology and OXiGENE
Collaboration Technology, and a co-exclusive (solely with OXiGENE), paid-up,
world-wide right and sublicense under the ASU Licensed Technology, to conduct
the Research Program and to make and use Collaboration Compounds and Covered
Products in connection with the Research Program, each in accordance with the
terms of this Agreement.
(b) BMS hereby grants OXiGENE, during the term of the Research
Program, a co-exclusive (solely with BMS), paid-up, world-wide right and license
under the BMS Collaboration Technology to conduct the Research Program in
accordance with the terms of this Agreement.
7.2 BMS Commercialization License; Limited Partial Conversion to
Non-exclusivity. (a) Subject to Section 7.2(c) and OXiGENE's limited right to
manufacture Collaboration Compounds and Covered Products under Section 7.4,
OXiGENE hereby grants BMS an exclusive (even as to OXiGENE), world-wide,
royalty-bearing right and sublicense in the Field throughout the Territory, with
the right to grant further sublicenses in accordance with the terms of this
Agreement, under the ASU Licensed Technology to develop, make, have made, use,
sell, offer for sale, have sold and export Covered Products.
(b) Subject to Section 7.2(c) and OXiGENE's limited right to
manufacture Collaboration Compounds and Covered Products under Section 7.4,
OXiGENE hereby grants to BMS an exclusive (even as to OXiGENE), world-wide,
royalty-bearing right and license in the Field throughout the Territory, with
the right to grant sublicenses in accordance with the terms of this Agreement,
under the OXiGENE Licensed Technology, the OXiGENE Collaboration Technology and
OXiGENE's interest in the Joint Collaboration Technology to develop, make, have
made, use, sell, offer for sale, have sold and export Covered Products.
(c) Notwithstanding the foregoing, if, on the date of the First
Commercial Sale of any Covered Product in any country in the EEA, any Know-How
or Invention used in the manufacture or use of such Covered Product is not
covered by letters patent in such country, then BMS's exclusive license with
respect to such Know-How or Invention in such country shall become
non-exclusive, for the remainder of the term of this Agreement, on the ******
anniversary of such First Commercial Sale.
7.3 Mutual Ex-Field Licenses.
(a) OXiGENE hereby grants BMS a perpetual, non-exclusive, paid-up,
world-wide right and license, with the right to grant sublicenses, under the
OXiGENE Collaboration Technology and Joint Collaboration Technology
for all purposes outside the Field.
(b) BMS hereby grants OXiGENE a perpetual, non-exclusive, paid-up,
world-wide right and license, with the right to grant sublicenses, under the BMS
Collaboration Technology and Joint Collaboration Technology for all purposes
outside the Field.
7.4 ******
7.5 ******
7.6 ******
7.7 ******
VIII
DEVELOPMENT AND COMMERCIALIZATION
8.1 Development Efforts by BMS. (a) BMS shall use commercially
reasonable efforts (including, but not limited to, conducting pre-clinical
testing (other than the OXiGENE Pre-clinical Studies) and clinical trials,
filing for regulatory approvals, diligently pursuing such approvals and, upon
the grant of regulatory approval, marketing Covered Products) to develop,
commercialize and market at least one Covered Product in the Field in each of
the United States, the European Union and Japan, and otherwise to comply with
the diligence obligations imposed upon OXiGENE under Section 8.7 of the ASU
License Agreement In connection therewith, BMS shall dedicate resources to the
development, commercialization and marketing of Covered Products that are
consistent with the resources that BMS, at all relevant times, would dedicate to
products containing compounds with similar commercial potential generated from
BMS's own research efforts that BMS decided to develop commercially and market.
Except as otherwise provided in this Agreement, BMS shall be solely responsible
for all costs and expenses of such development, commercialization and marketing
activities.
(b) The Parties acknowledge and agree that, as of the Effective
Date, BMS intends to focus primarily, if not exclusively, on the development and
commercialization of Covered Products for oncological indications in the Field.
Notwithstanding Section 9.3(b), but subject to the provisions of Section 8.6,
BMS shall not be obligated to develop or commercialize any Covered Products for
non-oncological indications in the Field.
8.2 Transfer of INDs, etc. The Parties acknowledge and agree that as
of the Effective Date OXiGENE is conducting a Phase I clinical trial of CA4P.
Promptly after the completion of such trial OXiGENE shall transfer and assign to
BMS ownership of all INDs and any other regulatory filings previously made or
filed by OXiGENE in the Territory with respect to any Collaboration Compounds or
Covered Products in the Field (or if such transfer and assignment is not
permitted under the laws of any applicable jurisdiction, OXiGENE shall take such
other permitted actions with respect to such filings as may be reasonably
requested by BMS). Promptly after the Effective Date the Parties shall begin
planning and coordinating the transfer to BMS of such clinical trial
responsibilities.
8.3 Ownership of Regulatory Filings. Except to the limited extent
expressly contemplated under Sections 8.2 and 8.6, all INDs, NDAs and other
regulatory filings made or filed by BMS with respect to any Collaboration
Compounds or Covered Products shall be in the name of, and be owned solely by,
BMS.
8.4 Reporting; OXiGENE Liaison. (a) Within 30 days after the end of
each calendar quarter during BMS's development or commercialization of a Covered
Product(s) under this Section 8, BMS shall furnish OXiGENE with written reports
summarizing all of the development and commercialization activities conducted by
BMS during such quarter. In addition, OXiGENE shall have the right to appoint
one OXiGENE employee or consultant to act as a liaison between OXiGENE and BMS's
team(s) having responsibility for such activities. BMS shall inform such liaison
regarding all significant Covered Product development or commercialization
issues that may arise from time to time.
(b) BMS shall promptly notify OXiGENE concerning any happening or
circumstance that BMS understands has a reasonable potential to result in
OXiGENE's loss of any of its rights under the ASU License Agreement, and BMS
shall reasonably cooperate with OXiGENE to prevent any such loss.
(c) Following the acquisition of OXiGENE (whether through merger,
consolidation, acquisition (directly or indirectly) of stock representing *****%
or more of the outstanding voting stock or other of its equity securities, sale
of all or substantially all of its assets, or otherwise) by any Third Party
that, in the good faith determination of BMS, is a substantial competitor of
BMS, BMS shall not be required to include in any report furnished by BMS
pursuant to this Agreement, or provide to any representative of OXiGENE (or any
successor thereto), any information that BMS, acting in good faith, determines
to be competitively sensitive or enabling information, unless such information
is required for compliance with the obligations to ASU under the ASU License
Agreement, in which event OXiGENE or its successor, as the case may be, and ASU
(if it shall receive such information) shall execute a nondisclosure agreement,
satisfactory to BMS in form and substance, concerning all such information.
8.5 Trademarks. BMS shall market the Covered Products throughout the
Territory under trademarks (collectively, the "Trademarks") selected by BMS. BMS
shall own all right, title and interest in and to such Trademarks and shall bear
all costs and expenses of registering, and maintaining the registration of,
same.
8.6 ******
IX
MONETARY OBLIGATIONS
9.1 BMS's Reimbursement of Certain Expenses. (a) The Parties
acknowledge and agree that prior to the Effective Date OXiGENE has undertaken
the conduct of certain toxicity and other animal laboratory studies with respect
to CA4P, which are identified and described on Exhibit D (collectively, the
"OXiGENE Pre-clinical Studies"). OXiGENE has incurred, and has contractually
committed to incur after the Effective Date, certain out-of-pocket costs and
expenses in connection with the conduct of the OXiGENE Pre-clinical Studies. BMS
shall reimburse OXiGENE for such costs and expenses actually incurred by
OXiGENE, to a maximum of (i) US$****** with respect to the OXiGENE Pre-clinical
Studies for toxicity, and (ii) US$****** with respect to all other OXiGENE
Pre-clinical Studies; provided, however, that any balance not applied to costs
and expenses actually incurred by OXiGENE prior to the Effective Date may be
applied as set forth in Section 9.1(b) . OXiGENE shall invoice BMS for all such
costs and expenses incurred during 1999 not later than January 15, 2000, and BMS
shall pay such invoices not later than February 29, 2000. OXiGENE shall invoice
BMS for such costs and expenses incurred during 2000 on a quarterly basis, and
BMS shall pay such invoices within 45 days after receipt thereof.
(b) The Parties acknowledge and agree that prior to the Effective
Date OXiGENE has undertaken certain manufacturing development work with respect
to the formulation and method of delivery for CA4P, which are identified and
described on Exhibit E (collectively, the "OXiGENE Manufacturing Development
Work"). OXiGENE has incurred certain out-of-pocket costs and expenses in
connection with the conduct of the OXiGENE Manufacturing Development Work and
may incur additional such costs and expenses if BMS requests that OXiGENE
conduct any further OXiGENE Manufacturing Development Work after the Effective
Date. BMS shall reimburse OXiGENE for all reasonable out-of-pocket costs and
expenses (based on customary practices and standards in the pharmaceutical
industry) actually incurred by OXiGENE in connection with any OXiGENE
Manufacturing Development Work, prior to or after the Effective Date, to a
maximum of the sum of (i) US$****** plus (ii) any portion of the US$****** that
BMS is obligated to pay under Section 9.1(a) that is not applied to the costs
and expenses of OXiGENE Pre-clinical Studies actually incurred by OXiGENE;
provided, however, that OXiGENE shall not be required to perform any OXiGENE
Manufacturing Development Work after the Effective Date for which it shall not
be entitled to reimbursement under this Section 9.1(b). OXiGENE shall invoice
BMS for all such costs and expenses incurred during 1999 not later than January
15, 2000, and BMS shall pay such invoices not later than February 29, 2000.
OXiGENE shall invoice BMS for such costs and expenses incurred during 2000 on a
quarterly basis, and BMS shall pay such invoices within 45 days after receipt
thereof.
(c) BMS shall reimburse OXiGENE for the costs of maintaining the
Patents included in the ASU Licensed Technology for which ASU invoices OXiGENE.
OXiGENE shall invoice BMS for such costs on a quarterly basis, and BMS shall pay
such invoices within 45 days after receipt thereof.
9.2 License Fee. In partial consideration of the rights and licenses
granted to BMS under this Agreement, within 30 days after the execution of this
Agreement BMS shall pay OXiGENE a non-refundable, non-creditable one-time
license fee in the amount of US$******.
9.3 Development Milestone Payments by BMS. (a) In partial
consideration of the rights and licenses granted to BMS by OXiGENE under this
Agreement, BMS shall pay OXiGENE the following milestone payments upon the first
occurrence of each event set forth below with respect to any single Covered
Product for an oncological indication in the Field, whether such occurrence is
achieved by BMS or its Affiliates or its Sublicensees:
(i) US$****** upon ****** (as prescribed by applicable FDA
regulations or corresponding statutes, rules or regulations in the
relevant jurisdiction(s)) of such a Covered Product as a single agent in
the United States, the European Union (under the centralized process or
any other process) or Japan;
(ii) US$****** upon ****** (as prescribed by applicable FDA
regulations or corresponding statutes, rules or regulations in the
relevant jurisdiction(s)) of such Covered Product in concomitant use with
any other pharmaceutical product in the United States, the European Union
(under the centralized process or any other process) or Japan;
(iii) US$****** upon ******;
(iv) US$****** upon ******;
(v) US$****** upon ******; and
(vi) US$****** upon ******.
Each of the foregoing payments shall be made within 30 days after achievement of
such milestone. For the avoidance of doubt, after BMS has made any of the
foregoing payments with respect to any one Covered Product, BMS shall have no
further obligation to make such payment with respect to any other Covered
Product.
(b) In partial consideration of the rights and licenses granted to
BMS by OXiGENE under this Agreement, BMS shall pay OXiGENE the following
milestone payments upon the first occurrence of each event set forth below with
respect to any single Covered Product for any non-oncological indication in the
Field (if BMS pursues development and commercialization of any such Covered
Product), whether such occurrence is achieved by BMS or its Affiliates or its
Sublicensees:
(i) US$****** upon ******; and
(ii) US$****** upon ******.
Each of the foregoing payments shall be made within 30 days after achievement of
such milestone. For the avoidance of doubt, after BMS has made any of the
foregoing payments with respect to any one Covered Product, BMS shall have no
further obligation to make such payment with respect to any other Covered
Product.
9.4 Additional License Fee, Milestone Payment. The Parties
acknowledge and agree that during OXiGENE's performance of its obligations under
the Research Program, OXiGENE may discover new compounds. In addition, BMS may
request from OXiGENE samples of other compounds covered by the ASU Licensed
Technology and made available to OXiGENE by ASU from time to time. OXiGENE shall
submit any such compound to BMS for its evaluation. Within a reasonable period
of time after BMS's receipt of a 30-day toxicity report with respect to any such
new compound, BMS may elect, upon notice to OXiGENE, to pursue commercial
development of such compound under this Agreement. Each time BMS exercises such
right, such compound thereafter shall be deemed to be a Collaboration Compound
for purposes of this Agreement, and BMS shall pay OXiGENE:
(i) US$****** upon the delivery of any such notice; and
(ii) US$****** upon ******.
9.5 Royalties. (a) Subject to Section 9.5(b), in partial
consideration of the rights and licenses granted to BMS under this Agreement,
BMS shall pay OXiGENE a royalty on Net Sales of each Covered Product, commencing
on the First Commercial Sale of each Covered Product by BMS, its Affiliates or
its Sublicensees in each country in the Territory, in an amount equal to the
applicable percentage of the world-wide Net Sales of such Covered Product by
BMS, its Affiliates and its Sublicensees throughout the Territory during each
calendar year (or portion thereof) during the term of this Agreement:
INCREMENT OF ANNUAL WORLD-WIDE
NET SALES OF SUBJECT COVERED ROYALTY PAYABLE
PRODUCT ACHIEVED DURING CALENDAR THEREON
YEAR
-------------------------------- -----------------
>US****** ******%
> US$****** ******%
Such incremental amounts shall be pro rated accordingly with respect to any
partial calendar year during the term of this Agreement.
(b) Notwithstanding the foregoing, BMS's obligation to pay royalties
with respect to each Covered Product in each country in the Territory shall
expire upon the expiration of the Royalty Term with respect to such Covered
Product in such country.
(c) In the event that BMS makes the milestone payment contemplated
by Section 9.3(a)(i), US$****** of such payment shall be creditable against
royalties payable under this Section 9.5; provided, however, that the
application of such credit shall not reduce the royalties payable by BMS under
this Agreement with respect to any given calendar quarter by more than ******%.
Any credit arising under this Section 9.5(c) may be carried forward indefinitely
during the term of this Agreement.
(d) The obligation to pay royalties to OXiGENE under this Section
9.5 is imposed only once with respect to the same unit of Covered Product,
regardless of the number of Patents pertaining thereto.
9.6 Third Party Royalties. (a) BMS, at its sole expense, shall pay
all earned royalties owing to any Third Party that BMS determines, in its
reasonable business judgment, are necessary in order to exercise BMS's rights
hereunder to develop, make, have made, use, sell, offer for sale, have sold or
export any Covered Product (collectively, "Third Party Royalties"). Except as
provided in Section 9.6(b), BMS shall not be entitled to any credit under this
Agreement on account of any Third Party Royalties paid by BMS.
(b) BMS shall be entitled to a credit against royalties due to
OXiGENE under this Agreement in an amount equal to ******% of the aggregate
Third Party Royalties paid by BMS in any country in the Territory with respect
to licenses for Patent rights dominating the subject matter of any claim of any
letters patent included in the ASU Licensed Technology and/or the OXiGENE
Licensed Technology; provided, however, that the application of such credit
shall not reduce the royalties payable by BMS under this Agreement with respect
to any given calendar quarter by more than ******%. Notwithstanding the
foregoing, if BMS is required to pay an award of damages or a settlement amount
in the form of a reasonable royalty based on sales during any period of previous
infringement (as opposed to the on-going payment of a running royalty), then
such payment shall be allocated to the several calendar quarters during such
period of infringement, and the limits set forth in the previous sentence shall
apply to each portion of such payment allocated to a specific quarter and not to
such payment as a whole.
9.7 Additional Royalty Indemnification. In the event that any action
taken by BMS or its Affiliates or Sublicensees with respect to any unit of
Covered Product does not give rise to an obligation of BMS to pay a royalty
under Section 9.5 with respect to such unit of Covered Product but does give
rise to an obligation of OXiGENE to pay a royalty under the copy of the ASU
License Agreement attached as Exhibit A with respect to such unit of Covered
Product in connection with any ASU Licensed Technology embodied therein, BMS
shall either indemnify OXiGENE against the amount of such royalty payment made
to ASU or pay such royalty payment directly to ASU, as OXiGENE shall so
instruct.
X
PAYMENTS AND REPORTS
10.1 Payment. Except as otherwise provided in this Agreement, all
royalty and other payments due hereunder shall be paid quarterly within 45 days
after the end of each calendar quarter. Each such payment shall be accompanied
by a statement, Covered Product-by-Covered Product and country-by-country, of
the amount of Net Sales during such quarter and the amount of royalties due on
such Net Sales.
10.2 Mode of Payment. BMS shall make all payments required under
this Agreement as directed by OXiGENE from time to time, in U.S. Dollars (except
as provided in Section 10.6). All royalties due hereunder shall first be
determined in the currency of the country in which the Covered Products in
question were sold and then converted into equivalent U.S. funds. The exchange
rate for such conversion shall be that rate quoted in The Wall Street Journal on
the last business day of the applicable reporting period.
10.3 Records Retention. BMS, its Affiliates and its Sublicensees
shall keep complete and accurate records pertaining to the sale of Covered
Products in the Territory and covering all transactions from which Net Sales are
derived for a period of three calendar years after the year in which such sales
occurred, and in sufficient detail to permit OXiGENE to confirm the accuracy of
royalty payments due hereunder.
10.4 Audit Request. At the request and expense (except as provided
below) of OXiGENE, BMS, its Affiliates and its Sublicensees shall permit an
independent, certified public accountant appointed by OXiGENE and reasonably
acceptable to BMS, at reasonable times and upon reasonable notice, to examine
those records and all other material documents relating to or relevant to Net
Sales in the possession or control of BMS, its Affiliates or its Sublicensees,
for a period of three years after such royalties have accrued. The results of
any such examination shall be made available to both Parties. If, as a result of
any inspection of the books and records of BMS, its Affiliates or its
Sublicensees, it is shown that BMS's royalty payments under this Agreement were
less than the amount which should have been paid, then BMS shall make all
payments required to eliminate any discrepancy revealed by said inspection
within 45 days after OXiGENE's demand therefor. Furthermore, if the aggregate
royalty payments BMS made were less than 95% of the amount which should have
been paid made during the period in question, BMS shall also reimburse OXiGENE
for the reasonable out-of-pocket cost of such inspection and shall pay interest
on the deficiency pursuant to Section 10.7.
10.5 Taxes. In the event that BMS is required to withhold any tax to
the tax or revenue authorities in any country in the Territory in connection
with any payment to OXiGENE due to the laws of such country, such amount shall
be deducted from the royalty or other payment to be made by BMS, and BMS shall
notify OXiGENE and promptly furnish OXiGENE with copies of any tax certificate
or other documentation evidencing such withholding. Each Party agrees to
cooperate with the other Party in claiming exemptions from such deductions or
withholdings under any agreement or treaty from time to time in effect.
10.6 Blocked Currency. If at any time legal restrictions prevent
BMS's prompt remittance of part or all of the royalties due with respect to any
country where a Covered Product is sold, BMS shall convert the amount owed to
OXiGENE into U.S. funds and shall pay OXiGENE directly from BMS's U.S. source of
funds for the amount impounded. BMS shall then pay all future royalties due to
OXiGENE from BMS's U.S. source of funds so long as the legal restrictions of
this Section 10.6 still apply.
10.7 Late Payments. In the event that any payment BMS is required to
make hereunder is not made within 30 days after such payment was originally due,
BMS shall pay interest on the past due amount as follows:
(a) If BMS's late payment pertains to a payment OXiGENE is required
to make under the ASU License Agreement and causes OXiGENE to become liable to
pay interest with respect to such payment under the ASU License Agreement, then
BMS shall pay interest on the past due amount as provided under the applicable
provision(s) of the ASU License Agreement.
(b) In all other events, BMS shall pay interest on the past due
amount at the rate of 12% per annum, until payment in full is made.
XI
MANUFACTURING
11.1 Transfer of Manufacturing Responsibility. (a) ****** after the
Effective Date the Parties shall commence, and diligently pursue, the transfer
of responsibility for manufacturing Collaboration Compounds and bulk Covered
Products from OXiGENE to BMS. Each Party shall designate a liaison to implement
such transfer process and coordinate it with the performance of such Party's
other obligations under this Agreement. The Parties shall use commercially
reasonable efforts to complete such transfer as expeditiously as possible. In
connection with such transfer OXiGENE shall assign to BMS any Third Party
contracts into which OXiGENE has entered regarding such manufacturing that BMS
requests to be assigned and that may be so assigned. OXiGENE shall use
reasonable commercial efforts to obtain any necessary Third Party consents in
connection with any such assignments.
(b) Until the completion of such transfer, OXiGENE shall use
reasonable commercial efforts to supply BMS, through OXiGENE's use of Third
Party manufacturers, with BMS's requirements for Collaboration Compounds and
bulk Covered Products for use under this Agreement, pursuant to a supply
arrangement(s) that OXiGENE has disclosed to BMS. OXiGENE shall manufacture
same, or shall cause OXiGENE's Third Party manufacturers to manufacture same, in
accordance with current Good Manufacturing Practices under 21 C.F.R. 210 and 211
and all applicable laws, rules and regulations. The cost to BMS of Collaboration
Compounds and bulk Covered Products supplied pursuant to this Section 11.1(b)
shall be ******% of the invoiced price OXiGENE pays therefor. BMS shall pay such
invoices within 45 days after receipt thereof. OXiGENE shall provide proof of
such prices paid by OXiGENE from time to time, upon BMS's request. OXiGENE shall
invoice BMS quarterly for, and BMS shall pay for, the Collaboration Compounds
and bulk Covered Products supplied pursuant to this Section 11.1(b).
(c) Upon the completion of such transfer, BMS shall have sole
responsibility for manufacturing all Collaboration Compounds and/or bulk Covered
Products for the Parties under this Agreement.
11.2 Negotiation, Execution of Supply Agreement. ****** after the
Effective Date the Parties shall negotiate, diligently and in good faith, and
execute a supply agreement (the "Supply Agreement") pursuant to which BMS shall
sell to OXiGENE, and OXiGENE shall purchase from BMS, ******% of OXiGENE's
requirements, for use outside the Field, for any Collaboration Compounds and/or
bulk Covered Products that BMS is manufacturing for its own use under this
Agreement. The commencement of the term of the Supply Agreement shall be
coordinated with the transfer of manufacturing responsibility from OXiGENE to
BMS under Section 11.1.
11.3 Terms of Supply Agreement. The Supply Agreement shall contain
commercially reasonable terms and conditions. Without limiting the generality of
the foregoing:
(a) The Supply Agreement shall call for delivery of all
Collaboration Compounds and/or bulk Covered Products to a U.S. Affiliate of
OXiGENE.
(b) The transfer price of any Collaboration Compounds and/or bulk
Covered Products that BMS manufactures for OXiGENE under the Supply Agreement
for use outside the Field during the term of this Agreement shall equal BMS's
fully burdened cost therefor, as such term shall be defined in the Supply
Agreement. BMS shall provide Collaboration Compounds and/or bulk Covered
Products to OXiGENE for use in performing OXiGENE's obligations under this
Agreement without charge.
(c) The Supply Agreement shall provide that in the event of
termination of this Agreement after all manufacturing responsibility has been
transferred to BMS pursuant to Section 11.1, BMS shall continue to manufacture
Collaboration Compounds and/or bulk Covered Products for OXiGENE for a
reasonable period of time, during which the Parties shall cooperate in
transferring back to OXiGENE responsibility for such manufacturing. The transfer
price of any Collaboration Compounds and/or bulk Covered Products that BMS
manufactures for OXiGENE under the Supply Agreement after termination of this
Agreement shall be BMS's fully burdened cost therefor (as calculated under the
Supply Agreement).
(d) Under the Supply Agreement BMS shall grant OXiGENE a
non-exclusive, paid-up, world-wide right and license under all relevant Patents,
Inventions and Know-How owned by or licensed to BMS (and as to which BMS has the
right to grant a license to OXiGENE) to manufacture: (i) any compounds that
would be Collaboration Compounds, and any bulk products that would be Covered
Products, but for the fact they are not (or no longer are) being developed,
commercialized or marketed under this Agreement, and (ii) in the event of any
termination of this Agreement or BMS's inability to supply (as defined in the
Supply Agreement), any compounds that are Collaboration Compounds, and any
products that are Covered Products, at the time of any such termination or
inability to supply.
(e) The Supply Agreement shall contain other terms and conditions
(including, without limitation, indemnification) that are customary in
agreements of such type.
11.4 Cost of Manufacturing and Related Activities. Except as
expressly provided to the contrary in this Section 11 and Section 9.1, each
Party shall be solely responsible for all of the costs and expenses it has
incurred before, or incurs after, before or after the Effective Date, in
connection with the manufacture of any Collaboration Compound or Covered Product
(including, without limitation, in connection with the transfer of manufacturing
responsibility to BMS pursuant to Section 11.1). Without limiting the generality
of the foregoing, OXiGENE shall be solely responsible for all costs and expenses
it has incurred in connection with the scale-up and process development of its
CA4P manufacturing capability, except as otherwise provided in Section 9.1.
11.5 Manufacturing Liaisons. Each Party shall have the right to
appoint one employee or consultant to act as a liaison between OXiGENE's and
BMS's relevant manufacturing teams. Each Party shall inform the other Party's
liaison regarding the status of such Party's manufacturing-related efforts
(including scale-up, process development and actual manufacturing) under this
Agreement and/or the Supply Agreement, and the two liaisons shall coordinate
such efforts with the Parties' performance of their other respective obligations
under this Agreement and/or the Supply Agreement.
11.6 U.S. Manufacture. All Covered Products embodying the TECHNOLOGY
(as such term is defined under the ASU License Agreement) shall be manufactured
substantially in the United States. The Supply Agreement also shall contain a
provision to this effect.
XII
CONFIDENTIALITY
12.1 Confidentiality; Exceptions. Except to the extent expressly
authorized by this Agreement or otherwise agreed in writing, the Parties agree
that, during the term of this Agreement and for five years thereafter each
Party, its Affiliates and its Sublicensees, if any (collectively, a "receiving
Party"), shall use their best efforts to keep completely confidential, shall not
publish or otherwise disclose and shall not use for any purpose other than the
performance of this Agreement both the financial terms of this Agreement and any
information furnished to it by the other Party, its Affiliates or its
Sublicensees, if any (collectively, a "disclosing Party"), or developed under or
in connection with the Research Program pursuant to this Agreement (and shall
ensure that its and its Affiliates' and its Sublicensees' respective directors,
officers, employees or agents do likewise), except to the extent that it can be
established by the receiving Party by competent proof that such information: (i)
is, or hereafter becomes, generally available to the public other than by reason
of any default by the receiving Party with respect to its confidentiality
obligations hereunder; (ii) was already known to the receiving Party at the time
of disclosure by the disclosing Party; (iii) was lawfully disclosed to the
receiving Party by a Third Party who was not in default of any confidentiality
obligation to the disclosing Party; or (iv) is independently developed by or for
the receiving Party without reference to or reliance upon the information
furnished by the disclosing Party (all such information to which none of the
foregoing exceptions applies, "Confidential Information").
12.2 Exclusions to Confidentiality. The restrictions contained in
Section 12.1 shall not apply to any Confidential Information in the hands of a
receiving Party that (i) is submitted by the receiving Party to governmental
authorities to facilitate the issuance of marketing approvals for a Covered
Product, provided that reasonable measures shall be taken to assure confidential
treatment of such information, if practicable; (ii) is provided by BMS to any
Third Party under appropriate terms and conditions, including confidentiality
provisions equivalent to those in this Agreement, for consulting, manufacturing
development, manufacturing, external testing, marketing trials and sublicensing
or potential sublicensing; or (iii) is otherwise required to be disclosed in
compliance with applicable laws or regulations (including, without limitation,
to comply with any governmental or stock exchange disclosure requirements) or an
order by a court or other regulatory body having competent jurisdiction;
provided, however, that if a receiving Party is required to make any such
disclosure of the disclosing Party's Confidential Information such receiving
Party shall, except where impracticable for necessary disclosures (for example
to physicians conducting studies or to health authorities), give reasonable
advance notice to the other Party of such disclosure requirement and, except to
the extent inappropriate in the case of patent applications or otherwise, will
use its best efforts to secure confidential treatment of such Confidential
Information required to be disclosed.
12.3 Injunctive Relief. The Parties acknowledge that monetary
damages alone would not adequately compensate the disclosing Party in the event
of a breach by the receiving Party of this Section 12, and that, in addition to
all other remedies available to the disclosing Party under this Agreement, at
law or in equity, it shall be entitled to injunctive relief for the enforcement
of its rights under this Section 12, without the posting of a bond or other
security, and to an accounting of profits made during the period of any breach
of the receiving Party's obligations under this Section 12.
XIII
INTELLECTUAL PROPERTY
13.1 Patent Enforcement. (a) Each Party shall notify the other
promptly after such Party becomes aware of any alleged infringement of any
Patent licensed to either Party under this Agreement in any country in the
Territory. Except as provided in Section 13.3, BMS shall have the first right,
but not the duty, to institute patent infringement actions against Third Parties
with respect to any such alleged infringement. BMS shall take all such actions
under this Section 13.1(a) (other than with respect to a Patent included solely
in the BMS Collaboration Technology) in reasonable consultation with OXiGENE and
shall keep OXiGENE apprised as to the status of any such infringement action BMS
institutes. OXiGENE shall execute all reasonable, necessary and proper documents
and take such actions as shall be appropriate to allow BMS to institute and
prosecute infringement actions under this Section 13.1(a).
(b) The costs and expenses of bringing and maintaining any
infringement action under Section 13.1(a) shall be borne solely by BMS.
(c) Any award or compensation (including the fair market value of
non-monetary compensation) paid by Third Parties as a result of any infringement
action brought by BMS under Section 13.1(a) (whether by way of settlement or
otherwise) shall be allocated first to reimbursement of BMS for all expenses
incurred by it in connection with such action. Any remaining award or
compensation shall be allocated to the Parties in the following proportions: (i)
to the extent such infringement occurred within the Field, ******% to BMS, and
******% to OXiGENE; and (ii) to the extent such infringement occurred outside
the Field, ******% to BMS, and ******% to OXiGENE.
(d) Except as provided in Section 13.3, in the event BMS elects not
to, or fails to, exercise its rights under Section 13.1(a) with respect to any
alleged infringement of a Patent licensed to BMS under this Agreement (i.e.,
excluding any Patent included solely in the BMS Collaboration Technology) within
120 days after receiving notice thereof, OXiGENE shall have the right, but not
the duty, to institute patent infringement actions against Third Parties with
respect to any such alleged infringement. OXiGENE shall take all such actions
under this Section 13.1(d) in reasonable consultation with BMS and shall keep
BMS apprised as to the status of any such infringement action OXiGENE
institutes. BMS shall execute all reasonable, necessary and proper documents and
take such actions as shall be appropriate to allow OXiGENE to institute and
prosecute infringement actions under this Section 13.1(d). The costs and
expenses of bringing and maintaining any infringement action under this Section
13.1(d) shall be borne solely by OXiGENE, and OXiGENE shall be entitled to
retain any award or compensation (including the fair market value of
non-monetary compensation) paid by Third Parties as a result of any such action.
13.2 Infringement Actions by Third Parties. (a) Each Party shall
notify the other Party promptly in writing of any claim of, or action for,
infringement of any Patents owned or licensed by Third Parties which is
threatened, made or brought against either Party by reason of either Party's
performance of its obligations under this Agreement or manufacture, use or sale
of any Covered Products in the Territory in the Field.
(b) Except as provided in Section 13.3, in the event that such an
action for infringement is commenced solely against a Party or both Parties
jointly and/or any of their respective Affiliates or Sublicensees, as the case
may be, with respect to any Covered Product developed and commercialized by BMS,
its Affiliates and/or Sublicensees, BMS shall defend such action at its own
expense, and OXiGENE hereby agrees to assist and cooperate with BMS to the
extent necessary in the defense of such suit, in accordance with Section
13.2(c). BMS shall have the right to settle any such action or consent to an
adverse judgment thereto, and OXiGENE's consent shall not be required unless
such settlement or consent: (i) imposes any material obligation on OXiGENE
(including under Section 13.2(d)), or (ii) materially impairs OXiGENE's rights
in or to any ASU Licensed Technology, OXiGENE Licensed Technology, OXiGENE
Collaboration Technology and/or Joint Collaboration Technology, in which event
OXiGENE's consent shall not be unreasonably withheld or delayed.
(c) The costs of defending any infringement action with respect to a
Covered Product developed and commercialized by BMS, its Affiliates and/or
Sublicensees shall be borne solely by BMS.
(d) During the pendency of any such action, BMS shall continue to
pay all royalties due hereunder. Subject to Section 9.6(b), BMS shall be fully
liable for the payment of any award for damages, or any amount due pursuant to
any settlement entered into by BMS, to the extent that any such action pertains
to a Covered Product developed and commercialized by BMS and/or its Affiliates
or Sublicensees.
(e) Except to the extent that the provisions of Section 13.1 shall
apply to any portion thereof, BMS shall retain any award or compensation
(including the fair market value of non-monetary compensation) received by BMS
as a result of any such action (i.e., as a result of a counterclaim).
13.3 Superior Rights of ASU. Notwithstanding any other provision of
this Agreement, the Parties' respective rights and obligations under this
Section 13 shall be subject, in all events, to any superior rights of ASU under
the ASU License Agreement regarding the ASU Licensed Technology.
XIV
INDEMNIFICATION
14.1 By BMS. BMS shall indemnify and hold OXiGENE and its Affiliates
and their respective directors, officers, employees and agents, harmless from
and against any and all liabilities, damages, losses, costs and expenses
(including the reasonable fees of attorneys and other professionals and other
reasonable litigation expenses) arising out of or resulting from:
(i)the negligence, recklessness or intentional misconduct of BMS,
its Affiliates or its Sublicensees and their respective directors,
officers, employees and agents, in connection with the work performed by
BMS under the Research Program or pursuant to Section 8 or in connection
with BMS's exercise of any of its rights hereunder;
(ii) any and all product liability claims resulting from the
development and/or commercialization of any Covered Product by BMS, its
Affiliates or its Sublicensees;
(iii) any warranty claims, Covered Product recalls or any tort
claims of personal injury (including death) or property damage relating to
or arising out of the manufacture, use, distribution or sale of any
Collaboration Compound or Covered Product by BMS, its Affiliates or its
Sublicensees due to any negligence, recklessness or intentional misconduct
by, or strict liability of, BMS, its Affiliates or its Sublicensees, and
their respective directors, officers, employees and agents, except, in
each case, to the comparative extent such claim arose out of or resulted
from the negligence, recklessness or intentional misconduct of OXiGENE or
its Affiliates and their respective directors, officers, employees and
agents; or
(iv) any breach of any representation or warranty made by BMS
pursuant to Section 2.1.
14.2 By OXiGENE. OXiGENE shall indemnify and hold BMS, its
Affiliates and its Sublicensees and their respective directors, officers,
employees and agents, harmless from and against any and all liabilities,
damages, losses, costs and expenses (including the reasonable fees of attorneys
and other professionals and other reasonable litigation expenses) arising out of
or resulting from:
(i)the negligence, recklessness or intentional misconduct of
OXiGENE or its Affiliates and their respective directors, officers,
employees and agents, in connection with the work performed by OXiGENE
under the Research Program or pursuant to Section 8.6 or in connection
with OXiGENE's exercise of any of its rights hereunder; or
(ii) any breach of any representation or warranty made by OXiGENE
pursuant to Section 2 or 3.1.
14.3 Notice. In the event that any Person entitled thereto (an
"indemnitee") is seeking indemnification under Section 14.1 or 14.2, such
indemnitee shall inform the indemnifying Party of a claim as soon as reasonably
practicable after the indemnitee receives notice of the claim, shall permit the
indemnifying Party to assume direction and control of the defense of the claim
(including the sole right to settle it at the sole discretion of the
indemnifying Party, provided that such settlement does not impose any material
obligation on the indemnitee or the other Party) and shall cooperate as
requested (at the expense of the indemnifying Party) in the defense of the claim
(including, without limitation, granting the indemnifying Party limited access
to pertinent records and making persons under such indemnitee's control
available for interview and testimony).
14.4 Complete Indemnification. As the Parties intend complete
indemnification, all costs and expenses incurred by any indemnitee to enforce
this Section 14 shall be reimbursed by the indemnifying Party.
14.5 Insurance. Each Party agrees to comply with Section 18.1 of the
ASU License Agreement with respect to such Party's performance of its
obligations under this Agreement.
XV
TERM; TERMINATION
15.1 Term. This Agreement shall commence as of the Effective Date
and, unless sooner terminated as provided hereunder, shall expire as follows:
(a) As to each Covered Product in each country in the Territory,
this Agreement shall expire upon the expiration of the Royalty Term with respect
to such Covered Product in such country.
(b) This Agreement shall expire in its entirety upon the termination
of the respective Royalty Terms with respect to all Covered Products in all
countries in the Territory.
15.2 Effect of Expiration. Following the expiration of this
Agreement with respect to a Covered Product in a country in the Territory
pursuant to Section 15.1(a), BMS shall have the royalty-free, perpetual right to
continue to make, have made, use, sell, offer for sale, have sold and export
such Covered Product in such country. Following the expiration of the term of
this Agreement in its entirety pursuant to Section 15.1(b), BMS shall have the
royalty-free, perpetual right to continue to make, have made, use, sell, offer
for sale, have sold and export all Covered Products in all countries in the
Territory.
15.3 Termination by Either Party. Each Party shall have the right to
terminate this Agreement, upon notice to the other Party, in the event that:
(i)Such other Party materially defaults with respect to any of
its material obligations under this Agreement and does not cure such
default within 60 days after the receipt of a notice from the
non-breaching Party specifying the nature of, and requiring the remedy of,
such default (or, if such default cannot be cured within such 60-day
period, if the breaching Party does not commence and diligently continue
actions to cure same during such 60-day period); provided, however, that
if any such default is limited to the breaching Party's obligations with
respect to a particular Covered Product and/or a particular country in the
Territory, then any termination of this Agreement under this clause (i)
due to such default shall be limited to the breaching Party's rights under
this Agreement with respect to such Covered Product and/or country. Any
termination pursuant to this clause (i) shall be without prejudice to any
of the non-breaching Party's other rights under this Agreement, and in
addition to any other remedies available to it by law or in equity;
(ii) The other Party shall have: (i) voluntarily commenced any
proceeding or filed any petition seeking relief under the bankruptcy,
insolvency or other similar laws of any jurisdiction, (ii) applied for, or
consented to, the appointment of a receiver, trustee, custodian,
sequestrator, conciliator, administrator or similar official for it or for
all or substantially all of its property, (iii) filed an answer admitting
the material allegations of a petition filed against or in respect of it
in any such proceeding, (iv) made a general assignment for the benefit of
creditors of all or substantially all of its assets, (v) admitted in
writing its inability to pay all or substantially all of its debts as they
become due, or (vi) taken corporate action for the purpose of effecting
any of the foregoing; or
(iii) An involuntary proceeding shall have been commenced, or any
involuntary petition shall have been filed, in a court of competent
jurisdiction seeking: (i) relief in respect of the other Party, or of its
property, under the bankruptcy, insolvency or similar laws of any
jurisdiction, (ii) the appointment of a receiver, trustee, custodian,
sequestrator, conciliator, administrator or similar official for such
other Party or for all or substantially all of its property, or (iii) the
winding-up or liquidation of such other Party; and, in each case, such
proceeding or petition shall have continued undismissed for 60 days, or an
order or decree approving or ordering any of the foregoing shall have
continued unstayed, unappealed and in effect for 30 days.
15.4 Termination by BMS. Notwithstanding any other provision of this
Agreement, BMS shall have the right to terminate this Agreement, in its entirety
or with respect to any particular Covered Product and/or country in the
Territory, at any time upon six months' notice to OXiGENE.
15.5 Effect of Expiration or Termination. (a) Subject to Section
15.5(b), upon any termination of this Agreement by OXiGENE pursuant to Section
15.3 or by BMS pursuant to Section 15.4, BMS shall (i) transfer and assign to
OXiGENE all of BMS's right, title and interest in and to any BMS Collaboration
Technology and all data, reports, records, materials and other intellectual
property owned or controlled by BMS that relates exclusively to the
Collaboration Compounds and/or the Covered Products; (ii) grant OXiGENE a
non-exclusive license, solely for the purpose of OXiGENE's developing, making,
having made, using, marketing and selling Covered Products, under any BMS
Collaboration Technology that does not exclusively relate to the Collaboration
Compounds and/or the Covered Products; and (iii) transfer and assign to OXiGENE
ownership of all INDs, NDAs and other regulatory filings made or filed with
respect to any Collaboration Compound or Covered Product (or, if such transfer
and assignment is not permitted under the laws of any applicable jurisdiction,
BMS shall take such other permitted actions with respect to such filings as may
be reasonably requested by OXiGENE), all upon commercially reasonable, arms
length financial terms and conditions that the Parties shall negotiate in good
faith and agree upon as soon as practicable after such termination of this
Agreement. In the event the Parties, despite the mutual use of good faith
efforts, are unable to agree upon such terms and conditions, the Parties shall
appoint an independent valuation expert who shall determine such terms and
conditions, which determination shall be binding upon the Parties. If the
Parties are unable to agree upon the appointment of such an expert, then each
Party shall nominate an expert (the cost of whom shall be borne by such Party),
and both experts appointed by the Parties shall jointly appoint the expert who
shall make such determination. Any expert appointed pursuant to this Section
15.5(a) shall have at least 15 years' experience in the business of
pharmaceutical development and commercialization. Except as provided above, the
costs and expenses of any expert acting under this Section 15.5(a) shall be
borne equally by the Parties.
(b) Notwithstanding the foregoing:
(i)In the event of any termination of this Agreement by OXiGENE
pursuant to Section 15.3 or by BMS pursuant to Section 15.4 with respect
to fewer than all of the Covered Products and/or fewer than all of the
countries in the Territory, the rights, licenses and other benefits to be
transferred, granted and otherwise assigned to OXiGENE under Section
15.5(a) shall be expressly limited to those pertaining to the Covered
Products and/or the countries in the Territory to which such termination
applies; and
(ii) At any time prior to any transfer, granting and assignment
of rights, licenses and benefits to OXiGENE pursuant to Section 15.5(a),
OXiGENE may elect, upon notice to BMS, to waive the application of Section
15.5(a) with respect to such rights, licenses and benefits. Following any
such waiver neither Party shall have any obligation or liability to the
other with respect to such rights, licenses and benefits.
15.6 Right to Sell Stock on Hand. Provided that BMS is not in
material breach of any obligation under this Agreement at the time of any
termination of this Agreement, in whole or in part, BMS shall have the right for
one year thereafter to dispose of all Covered Product then in its inventory and
to complete manufacture of and dispose of any work-in-progress then being
manufactured, as though this Agreement had not terminated. BMS shall pay
royalties thereon, in accordance with the provisions of this Agreement, as
though this Agreement had not terminated.
15.7 Termination of Sublicenses. Upon any termination of this
Agreement, all sublicenses granted by BMS under this Agreement shall terminate
simultaneously, subject, nevertheless, to Section 15.6.
15.8 Accrued Rights, Surviving Obligations. (a) Termination,
relinquishment or expiration of this Agreement for any reason shall be without
prejudice to any rights which shall have accrued to the benefit of either Party
prior to such termination, relinquishment or expiration. Such termination,
relinquishment or expiration shall not relieve either Party from obligations
which are expressly indicated to survive termination or expiration of this
Agreement.
(b) Termination, relinquishment or expiration of this Agreement
shall not terminate each Party's obligation to pay all royalties, milestone
payments and other monetary obligations that may have accrued hereunder prior to
such termination. All of the Parties' rights and obligations under Sections 4.7,
5.2(b) (except as otherwise provided therein), 5.5, 5.6, 6.1, 6.2, 6.3, 7.3,
8.5, 10, 11.4, 12, 13 (solely with respect to actions pending at such time), 14,
15.2, 15.5, 15.6, 15.7, 15.8, 17.1 (if in effect at such time), 17.2 (if in
effect at such time), 17.4, 17.6, 17.12, 17.15, 17.16 and 17.17 shall survive
termination, relinquishment or expiration hereof.
XVI
FORCE MAJEURE
16.1 Events of Force Majeure. Neither Party shall be held liable or
responsible to the other Party nor be deemed to be in default under or in breach
of any provision of this Agreement for failure or delay in fulfilling or
performing any obligation under this Agreement when such failure or delay is due
to force majeure, and without the fault or negligence of the Party so failing or
delaying. For purposes of this Agreement, force majeure shall be defined as
causes beyond the control of the Party, including, without limitation, acts of
God; acts, regulations, or laws of any government; war; civil commotion;
destruction of production facilities or materials by fire, flood, earthquake,
explosion or storm; labor disturbances; epidemic; and failure of public
utilities or common carriers. In such event OXiGENE or BMS, as the case may be,
shall immediately notify the other Party of such inability and of the period for
which such inability is expected to continue. The Party giving such notice shall
thereupon be excused from such of its obligations under this Agreement as it is
thereby disabled from performing for so long as it is so disabled and for 30
days thereafter. To the extent possible, each Party shall use reasonable efforts
to minimize the duration of any force majeure.
XVII
MISCELLANEOUS
17.1 Non-solicitation. During the term of the Research Program and
for a period of one year thereafter, neither Party shall solicit, induce,
encourage or attempt to induce or encourage any employee of the other Party to
terminate his or her employment with such other Party or to breach any other
obligation to such other Party.
17.2 Standstill. (a) During the Standstill Period (as defined
below), without the prior written consent of OXiGENE, neither BMS nor any of its
"affiliates" (which, for purposes of this Section 17.2 only, shall be defined as
such term is defined under the 0000 Xxx) shall, directly or indirectly:
(i)Acquire or propose to acquire, alone or in concert with any
Person, by purchase or otherwise, any beneficial interest in any voting
securities of OXiGENE, or any warrants, options or other rights to
acquire, or any securities convertible into or exchangeable for, any
voting securities of OXiGENE; provided, however, that nothing in this
Section 17.2(a)(i) shall be deemed or construed to prohibit BMS and its
affiliates from purchasing collectively less than five percent of any
class of securities of OXiGENE registered under Section 12 or 15 of the
1934 Act and exercising their respective voting rights as shareholders
with respect to such securities;
(ii) Participate in any way in any "solicitation" of "proxies"
(as such terms are defined in the regulations promulgated pursuant to
Section 14 of the 1934 Act), or seek to advise or influence in any manner
whatsoever any Person with respect to the voting of any voting securities
of OXiGENE;
(iii) Participate in a "group," within the meaning of Section
13(d)(3) of the 1934 Act, with respect to any voting securities of
OXiGENE;
(iv) Propose, either alone or in concert with any Person, to
OXiGENE or any of its shareholders any business combination of OXiGENE
with, sale of substantially all of the assets of OXiGENE to, or any other
similar transaction with or to any Person, or otherwise seek, alone or in
concert with any Person, to control, change or influence the management,
directors or policies of OXiGENE, except with respect to the subject
matter of this Agreement and/or the Supply Agreement, when executed; or
(v)Announce any intention to do, or enter into any agreement or
understanding with any Person to do, any of the activities prohibited
under Sections 17.2(a)(i)-(iv).
(b) For purposes of this Section 17.2, the "Standstill Period" shall
commence on the Effective Date and expire on the earlier to occur of: (i)
December 31, 2002; or (ii) any Third Party's or "group's" taking of any of the
actions, or announcing an intention to take any of the actions, specified in
Sections 17.2(a)(i)-(v), if OXiGENE supports same or does not, within 10
business days after such action or announcement, oppose or recommend to its
shareholders rejection of such action.
17.3 Relationship of Parties. Nothing in this Agreement is intended
or shall be deemed to constitute a partnership, agency, employment or joint
venture relationship between the Parties. Neither Party shall be entitled to, or
shall, incur any debts or make any commitments for the other, except to the
extent, if at all, specifically provided herein.
17.4 Guaranty. OXiGENE, Inc. hereby unconditionally guaranties the
performance of all obligations of OXiGENE Europe AB under this Agreement and the
Supply Agreement, when executed. In the event of a breach by OXiGENE Europe AB
in the observance of the terms of this Agreement, BMS shall be entitled to
proceed against either OXiGENE Europe AB or directly against OXiGENE, Inc., as
BMS may determine in its sole discretion, to enforce this Agreement.
17.5 Assignment. (a) Each Party shall be entitled to assign this
Agreement to any of its Affiliates upon 60 days' prior written notice to the
other Party; provided, however, that in the event of any such assignment, the
assigning Party shall remain jointly and severally liable with respect to all of
its obligations hereunder, and in the event of any default relating to any such
obligations, the other Party shall be entitled to proceed against either such
Affiliate or directly against the assigning Party, as such other Party may
determine in its sole discretion, to enforce this Agreement.
(b) Except as provided in Section 17.5(a), neither Party shall be
entitled to assign its rights hereunder without the express written consent of
the other Party, except that each Party may assign this Agreement to any
assignee of all or substantially all of such Party's business (or that portion
thereof to which this Agreement relates) or in the event of such Party's merger,
consolidation or similar transaction.
(c) No assignment contemplated by this Section 17.5 shall be valid
or effective unless and until the assignee/transferee shall agree in writing to
be bound by the provisions of this Agreement.
17.6 Disclaimer of Warranties. EXCEPT AS EXPRESSLY PROVIDED IN
SECTIONS 2 AND 3.1, THE PARTIES EXPRESSLY DISCLAIM ALL OTHER WARRANTIES, EXPRESS
OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT OF THIRD PARTY RIGHTS, OR ARISING
FROM A COURSE OF DEALING OR USAGE OF TRADE PRACTICE.
17.7 Further Actions. Each Party shall execute, acknowledge and
deliver such further instruments, and take all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
17.8 Notice. Any notice or request required or permitted to be given
under or in connection with this Agreement shall be deemed to have been
sufficiently given if in writing and personally delivered or sent by certified
mail (return receipt requested), facsimile transmission (receipt verified), or
overnight express courier service (signature required), prepaid, to the Party
for which such notice is intended, at the address set forth for such Party
below:
(i) In the case of BMS, to:
Xxxxxxx-Xxxxx Squibb Company
X.X. Xxx 0000
Xxxxx 000 & Province Line Road
Princeton, New Jersey 08543-4000
USA
Attention: Vice President & Senior Counsel,
Pharmaceutical Research Institute and
Worldwide Business Development
Facsimile No.: 0-000-000-0000
(ii) In the case of OXiGENE, to:
OXiGENE Europe AB
Xxxxxxxxxxxxxxxx 0x
X-000 00 Xxxxxxxxx
XXXXXX
Attention: Chief Executive Officer
Facsimile No.: 011-46-8-678-8605
or to such other address for such Party as it shall have specified by like
notice to the other Party, provided that notices of a change of address shall be
effective only upon actual receipt thereof. If delivered personally or by
facsimile transmission, the date of delivery shall be deemed to be the date on
which such notice or request was given. If sent by overnight express courier
service, the date of delivery shall be deemed to be the next business day after
such notice or request was deposited with such service. If sent by certified
mail, the date of delivery shall be deemed to be the fifth business day after
such notice or request was deposited with the postal service in the country of
mailing.
17.9 Use of Name. Except as otherwise provided herein, neither Party
shall have any right, express or implied, to use in any manner the name or other
designation of the other Party or any other trade name or trademark of the other
Party (including, without limitation, any Trademark) for any purpose in
connection with the performance of this Agreement.
17.10 Public Announcements. (a) Except as required by law
(including, without limitation, the applicable disclosure requirements of any
relevant regulatory authority or stock exchange) and as permitted by Section
12.2, neither Party shall make any public announcement concerning this
Agreement, any Covered Product or any other subject matter hereof without the
prior written consent of the other Party, which shall not be unreasonably
withheld or delayed. It shall not be unreasonable for a Party to withhold
consent with respect to any public announcement containing any of such Party's
Confidential Information. In the event of any required or proposed public
announcement, (i) the Parties shall consult with each other in good faith as to
the timing thereof, and (ii) the Party making such announcement shall provide
the other Party with a copy of the proposed text prior to such announcement
sufficiently in advance of the scheduled release of such announcement to afford
such other Party a reasonable opportunity to review and comment upon the
proposed text.
(b) BMS acknowledges and agrees that OXiGENE needs to communicate
with its investors regularly and keep them apprised of the development status of
the products in which OXiGENE has an interest. In order to facilitate this
communication, promptly after the Effective Date BMS shall designate, from time
to time, one BMS employee who shall have primary responsibility for reviewing
and approving all OXiGENE proposed investor communications, to the extent that
they pertain to this Agreement, any Covered Product or any other subject matter
hereof. BMS shall instruct such employee to review the content of such draft
communications as expeditiously as possible and otherwise to cooperate with and
assist OXiGENE in connection therewith, so long as the number of such
communications and the timing thereof are reasonable.
(c) Following a Party's consent to or approval of the public
announcement of any information pursuant to this Section 17.10, both Parties
shall be entitled to make subsequent public announcements of such information
without renewed compliance with this Section 17.10, unless the scope and/or
duration of such consent or approval is expressly limited.
17.11 Waiver. A waiver by either Party of any of the terms and
conditions of this Agreement in any instance shall not be deemed or construed to
be a waiver of such term or condition for the future, or of any subsequent
breach hereof. All rights, remedies, undertakings, obligations and agreements
contained in this Agreement shall be cumulative, and none of them shall be in
limitation of any other remedy, right, undertaking, obligation or agreement of
either Party.
17.12 Compliance with Law. Nothing in this Agreement shall be deemed
to permit a Party to export, re-export or otherwise transfer any Covered Product
sold under this Agreement without compliance with applicable laws.
17.13 Severability. When possible, each provision of this Agreement
will be interpreted in such manner as to be effective and valid under applicable
law, but if any provision of this Agreement is held to be prohibited by or
invalid under applicable law, such provision shall be ineffective only to the
extent of such prohibition or invalidity, without invalidating the remainder of
this Agreement.
17.14 Amendment. No amendment, modification or supplement of any
provisions of this Agreement shall be valid or effective unless made in writing
and signed by a duly authorized officer of each Party.
17.15 Governing Law; English Original; Jurisdiction. (a) This
Agreement shall be governed by and interpreted in accordance with the laws of
the State of New Jersey without regard to its choice of law principles;
provided, however, that any arbitration proceeding conducted pursuant to Section
17.16 shall be governed by the Convention on the Recognition and Enforcement of
Foreign Arbitral Awards of June 10, 1958. The English original of this Agreement
shall prevail over any translation hereof.
(b) Without prejudice to the rights and obligations of the Parties
under Section 17.16, each Party hereby consents to the in personam jurisdiction
of any state or federal court sitting in the State of New Jersey with respect to
any matter arising in connection with this Agreement and further consents to the
service of any process, notice of motion or other application to any such court
or a judge thereof outside the State of New Jersey by registered or certified
mail or personal service, provided that reasonable time is allowed for
appearance. Each Party hereby waives, to the greatest extent it may do so, any
defense it may have on the grounds of inconvenient forum with respect to any
action or proceeding maintained in any state or federal court in New Jersey.
17.16 Arbitration. (a) Any dispute arising out of or relating to any
provisions of this Agreement shall be finally settled by arbitration to be held
in Philadelphia, Pennsylvania, under the auspices and then current commercial
arbitration rules of the American Arbitration Association (the "AAA"). Such
arbitration shall be conducted by three arbitrators. Within 30 days after the
commencement of any arbitration, each Party shall appoint one arbitrator, and
these two arbitrators shall jointly appoint the third arbitrator, who shall have
significant experience in pharmaceutical drug development and commercialization;
provided, however, that if the two arbitrators appointed by the Parties are
unable to agree upon the third arbitrator within 30 days after their
appointment, then the third arbitrator shall be appointed by the AAA. The
Parties shall instruct such arbitrators to render a determination of any such
dispute within four months after their appointment. All arbitration proceedings
shall be conducted in English. Judgment upon any award rendered may be entered
in any court having jurisdiction, or application may be made to such court for a
judicial acceptance of the award and an order of enforcement, as the case may
be.
(b) Section 17.16(a) shall not prohibit a Party from seeking
injunctive relief from a court of competent jurisdiction in the event of a
breach or prospective breach of this Agreement by the other Party which would
cause irreparable harm to the first Party.
17.17 No Consequential Damages. IN NO EVENT SHALL EITHER PARTY OR
ANY OF ITS RESPECTIVE AFFILIATES OR SUBLICENSEES BE LIABLE TO THE OTHER PARTY OR
ANY OF ITS AFFILIATES OR SUBLICENSEES FOR SPECIAL, INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT
LIABILITY OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, LOSS OF PROFITS OR
REVENUE, OR CLAIMS OF CUSTOMERS OF ANY OF THEM OR OTHER THIRD PARTIES FOR SUCH
OR OTHER DAMAGES.
17.18 Entire Agreement. This Agreement (together with the Exhibits
hereto and the Research Plans, as approved and modified from time to time by the
Joint Development Committee) sets forth the entire agreement and understanding
between the Parties as to the subject matter hereof and merges all prior
discussions and negotiations between them, and neither of the Parties shall be
bound by any conditions, definitions, warranties, understandings or
representations with respect to such subject matter other than as expressly
provided herein or as duly set forth on or subsequent to the Effective Date in
writing and signed by a proper and duly authorized officer or representative of
the Party to be bound thereby. Without limiting the generality of the foregoing,
the terms and conditions of this Agreement shall supersede the terms and
conditions of any confidentiality, non-disclosure or similar such agreement that
the Parties may have executed prior to the Effective Date.
17.19 Parties in Interest. All the terms and provisions of this
Agreement shall be binding upon, inure to the benefit of and be enforceable by
the Parties hereto and their respective permitted successors and assigns.
17.20 Descriptive Headings. The descriptive headings of this
Agreement are for convenience only, and shall be of no force or effect in
construing or interpreting any of the provisions of this Agreement.
17.21 Counterparts. This Agreement may be executed simultaneously in
two counterparts, any one of which need not contain the signature of more than
one Party, but both such counterparts taken together shall constitute one and
the same agreement.
* * *
IN WITNESS WHEREOF, each of the Parties has caused this Agreement to
be executed by its duly authorized officer as of the day and year first above
written.
OXIGENE EUROPE AB
By:
___________________________________
Name:
Title:
XXXXXXX-XXXXX SQUIBB COMPANY
By:
___________________________________
Name:
Title:
ACCEPTED AND AGREED TO WITH RESPECT TO
SECTION 17.4:
OXIGENE, INC.
By:
___________________________________
Name:
Title:
