Exhibit 10.14
CONFIDENTIAL TREATMENT REQUESTED AS TO PORTIONS OF THIS DOCUMENT, WHICH PORTIONS
HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURTIES AND EXCHANGE
COMMISSION.
TERMINATION AGREEMENT
THIS TERMINATION AGREEMENT (this "Agreement") is entered into as of
February 15, 2002 (the "Effective Date"), by and 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 and BMS entered into that certain Research Collaboration and
License Agreement, dated as of December 15, 1999 (the "License Agreement").
B. By a letter dated October 24, 2001, BMS informed OXiGENE that BMS was
exercising its right under Section 15.4 of the License Agreement to terminate
the License Agreement in its entirety effective April 24, 2002 or any earlier
date upon which OXiGENE and BMS may agree.
C. In accordance with Section 15.5(a) of the License Agreement, OXiGENE and
BMS have agreed to terminate the License Agreement upon the terms and conditions
set forth herein.
NOW, THEREFORE, in consideration of the foregoing Preliminary Statements
and the mutual promises and covenants set forth herein, OXiGENE and BMS hereby
agree as follows:
1. TERMINATION OF LICENSE AGREEMENT.
1.1 Termination. The parties hereby agree that the License Agreement is
terminated as of the Effective Date.
1.2 Right to Cross-Reference. BMS shall permit OXiGENE to cross-reference
BMS' U.S. IND No. [******] in its entirety solely in connection with OXiGENE's
development of Licensed Products (or other products that would constitute
Licensed Products, but for the expiration of the relevant [*****]year period(s)
referred to in clause (i) of Section 3.1(g)) pursuant to Section 3 hereof.
Within 10 days after the Effective Date, BMS shall file with the FDA all
documents required authorize OXiGENE to cross reference BMS U.S. IND No.
[******] in its entirety for such purpose. BMS represents and warrants to
OXiGENE that such IND is the only IND, NDA or other regulatory filing made or
filed with respect to any Collaboration Compound or Covered Product.
1.3 Survival.
(a) Except to the extent provided herein,
[*****************************************] this Agreement shall not supersede,
modify or otherwise affect the provisions of the License Agreement that
expressly survive the termination, relinquishment or expiration of the License
Agreement, which provisions of the License Agreement shall continue in full
force and effect.
(b) Notwithstanding Section 1.3(a) and the parties' continuing obligations
under Section 12 of the License Agreement, OXiGENE shall be permitted to provide
Confidential Information of BMS to any third party under appropriate terms and
conditions, including confidentiality provisions equivalent to those set forth
in the License Agreement, for consulting, manufacturing development,
manufacturing, external testing, marketing trials and sublicensing or potential
sublicensing, in each case solely with respect to a Collaboration Compound(s)
and/or Licensed Product(s); provided, however, that OXiGENE shall encourage any
such third party to validate and confirm the accuracy and completeness of any
such Confidential Information of BMS that OXiGENE elects to disclose pursuant to
this Section 1.3(b); and provided, further, that BMS shall have no liability
with respect to OXiGENE or any such third party, either directly or indirectly,
in connection with the receipt, use or reliance upon any such Confidential
Information of BMS.
1.4 Representation and Warranty. BMS represents and warrants that, to the
best of BMS' knowledge, (i) the Transferred Materials, the technical information
and documentation listed on Exhibit B and the Licensed Patents constitute all of
the BMS Collaboration Technology and all of the data, reports, records,
materials and other intellectual property owned or controlled by BMS) that
relates directly and primarily (whether or not exclusively) to Collaboration
Compounds and/or Covered Products; and (ii) in the case of the Licensed Patents,
constitute all of the pending patent applications that relate directly and
primarily (whether or not exclusively) to Collaboration Compounds and/or Covered
Products as to which former and/or current BMS employees (in their capacity as
employees of BMS) are either the only inventors or co-inventors along with
former and/or current employees of OXiGENE. BMS covenants and agrees to transfer
or license to OXiGENE, without additional consideration, any additional
intellectual property (including patent applications or patents) materials,
data, reports or records that are subsequently discovered to relate directly and
primarily to Collaboration Compounds or Covered Products. This Section 1.4,
however, shall not pertain to the subject matter of Section 2.4, which shall be
governed solely by Section 2.4.
1.5 Definitions. As used in this Section 1, the terms "Collaboration
Compound," "Confidential Information," "Covered Product," and "BMS Collaboration
Technology" shall have the respective meanings set forth in the License
Agreement.
2. TRANSFER OF SUPPLIES.
2.1 Generally. OXiGENE hereby agrees to receive from BMS, and BMS hereby
agrees to transfer to OXiGENE, the quantities of the compounds set forth on the
attached Exhibit A ( "Transferred Materials"). OXiGENE shall pay BMS the sum of
[**********] (the "Transfer Payment") as a reimbursement of BMS' costs of
acquiring the Transferred Materials.
2.2 Shipment.
(a) BMS shall package and ship, in accordance with OXiGENE's written
instructions, the Transferred Materials. Risk of loss with respect to the
Transferred Materials shall shift to OXiGENE upon BMS' deposit thereof with the
common carrier selected by OXiGENE. OXiGENE shall bear, and BMS shall invoice
OXiGENE for, all costs of any special packaging required or requested by OXiGENE
and of such shipment.
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(b) Simultaneously with BMS' shipment of the Transferred Materials, BMS
shall transmit to OXiGENE a package of technical information and documentation
concerning same, the contents of which are outlined on the attached Exhibit B.
2.3 Invoicing; Payment. BMS shall be entitled to invoice OXiGENE for the
Transfer Payment and permitted costs under Section 2.2(a) after the shipment of
the Transferred Materials in accordance with Section 2.2. Payment of any such
invoice(s) shall be due within 30 days. OXiGENE shall be liable for all taxes
arising from the purchase and sale of the Transferred Materials other than taxes
imposed on the gross income of BMS or any of its Affiliates.
2.4 Future Purchases. BMS may, but shall not be required to, maintain some
or all of its current inventory of [********] [*******] that was originally
manufactured by Aerojet. OXiGENE acknowledges that the quality of such material
has previously been disclosed to OXiGENE by BMS. OXiGENE may, from time to time,
request BMS to sell OXiGENE quantities of such material upon terms and
conditions that the parties shall agree to. BMS shall not unreasonably deny any
such requests by OXiGENE, so long as BMS continues to maintain such inventory.
During the [***********] period immediately following the Effective Date, if BMS
determines to dispose of such inventory, BMS will give OXiGENE at least 30 days'
prior written notice thereof, and OXiGENE shall have the right to acquire any or
all of such inventory upon terms and conditions that the parties shall agree to.
2.5 Representations and Warranties; Disclaimer.
(a) BMS represents and warrants that it owns the Transferred Materials and
any other materials that OXiGENE may purchase pursuant to this Section 2, and
that BMS has the right to sell same to OXiGENE and that BMS will furnish to
OXiGENE all information in its possession or control concerning the safety and
quality of the Transferred Materials and such other materials.
(b) EXCEPT AS EXPRESSLY PROVIDED IN SECTIONS 1.4 AND 2.5(a), BMS EXPRESSLY
DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE
TRANSFERRED MATERIALS, 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.
3. PATENT LICENSES.
3.1 Definitions. For purposes of this Agreement, the following terms shall
have the following respective meanings unless the context dictates otherwise.
(a) "Field" shall mean the prevention, diagnosis, control or treatment of
any human or animal disease or condition by use of a Licensed Product(s), either
as a single agent or in combination with any other therapy.
(b) "First Commercial Sale" shall mean, with respect to any Licensed
Product, the first sale for use or consumption by the general public of such
Licensed Product in a country 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 Licensed
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 OXiGENE
receives remuneration for any such compassionate use or named patient sales,
OXiGENE shall pay royalties thereon in accordance with Section 3.7.
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(c) "Licensed Patents" shall mean the letters patent and patent
applications set forth on the attached Exhibit C, as well as any and all
substitutions, extensions, renewals, continuations, continuations-in-part,
divisions, patents-of-addition and/or reissues thereof and all foreign and/or
PCT counterparts thereto.
(d) "Licensed Product" shall mean any pharmaceutical product the
manufacture, sale or use of which in the jurisdiction in which it is
manufactured or sold is covered by a Valid Claim of any Licensed Patent.
(e) "Major Market" shall mean [*********************************].
(f) "Net Sales" shall mean, with respect to any Licensed Product, the gross
amount invoiced to third parties by OXiGENE, its Affiliates or its sublicensees,
as the case may be, for such Licensed Product, commencing with the First
Commercial Sale of such Licensed Product, less deductions for:
[************************************************************] Such amounts
shall be determined from the books and records of [***********], 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 Licensed 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 Licensed 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 Licensed Product, as if sold separately. In
the event no such separate sales are made by OXiGENE, its Affiliates or its
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 Licensed Product that is not a bona fide, arms length transaction
for money, or (Y) any other use of Licensed 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 Licensed Product.
OXiGENE's or any of its Affiliate's transfer of Licensed Product to another
Affiliate or a sublicensee shall not result in any Net Sales, unless such
Licensed 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 Licensed Product to a third party.
Further, the disposition of Licensed Product for, or the use of Licensed 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.
(g) "Valid Claim" shall mean (i) a pending claim in any patent application
that has not been pending for more than five years, or (ii) a claim of any
issued letters patent that, in each case, has not been held invalid or
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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.
3.2 Representations and Warranties of BMS; Disclaimer.
(a) BMS represents and warrants to OXiGENE that, as of the Effective Date:
(i) With respect to any of the Licensed Patents that BMS does not
jointly own with OXiGENE, BMS and/or its Affiliates are the owner
of, or have exclusive rights to, all of such Licensed Patents and
have the exclusive right to grant the licenses therefor granted
under this Section 3;
(ii) With respect to any of the Licensed Patents that BMS jointly owns
with OXiGENE, BMS and/or its Affiliates have the exclusive right
to grant the licenses granted under this Section 3 with respect
to BMS' interests in such Licensed Patents;
(iii)All of the Licensed 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;
(iv) BMS is not aware of any claim or demand asserted or threatened by
a third party which BMS reasonably believes can be enforced by a
third party against any Licensed Patents; and
(v) BMS has not entered into any agreement with any third party which
is in conflict with the rights granted to OXiGENE under to this
Section 3, and the execution and performance of this Agreement by
BMS do not and shall not violate any agreement or undertaking to
which BMS is a party.
(b) EXCEPT AS EXPRESSLY PROVIDED IN SECTIONS 1.4 AND 3.2(a), BMS EXPRESSLY
DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE LICENSED
PATENTS, 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.
3.3 Grant. BMS hereby grants OXiGENE an exclusive (even as to BMS, subject
to Section 3.9(b)), world-wide, royalty-bearing right and license in the Field,
with the right to grant sublicenses subject to the terms of this Agreement,
under BMS' respective interests in the Licensed Patents, to develop, make, have
made, use, sell, offer for sale, have sold, import and export Licensed Products.
3.4 Sublicensing.
(a) OXiGENE shall guarantee and be responsible for the making of all
payments due, and the making of reports required, under this Agreement by reason
of milestones achieved with respect to any Licensed Product and sales of any
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Licensed Products by its Affiliates or sublicensees and their diligent discharge
of OXiGENE's obligations under, and compliance with all applicable terms of,
this Agreement. Each Affiliate or sublicensee of OXiGENE shall agree in writing
to keep books and records, and permit BMS to review such books and records,
pursuant to the relevant provisions of, and to observe all other applicable
terms of, this Agreement. The rights of BMS under this Agreement are preserved
in connection with any such sublicensing. OXiGENE shall promptly provide BMS
with notice of any sublicense granted hereunder.
(b) OXiGENE hereby unconditionally guarantees the performance of any of its
Affiliates and its sublicensees hereunder. In the event of a breach by an
Affiliate or sublicensee of OXiGENE in the observance of applicable terms of
this Agreement, BMS shall be entitled to proceed against either such Affiliate
or sublicensee or directly against OXiGENE, as BMS may determine in its sole
discretion, to enforce this Agreement.
3.5 License Fees.
(a) In partial consideration of the rights and licenses granted to OXiGENE
under this Section 3 (collectively, the "Licenses"), within [*****] days after
the execution of this Agreement OXiGENE shall pay BMS a non-refundable,
non-creditable initial license fee in the amount of [**********]. OXiGENE
acknowledges that the amount payable under this Section 3.5(a) has been
negotiated in a manner such that BMS shall be deemed to have paid all patent
prosecution expenses payable by BMS under the License Agreement that have not
been paid as of the Effective Date.
(b) In partial consideration of the Licenses, within [****] days after the
execution of this Agreement OXiGENE shall pay BMS a non-refundable,
non-creditable additional license fee in the amount of [************].
3.6 Patent Prosecution Milestone Payments by OXiGENE. In partial
consideration of the Licenses, OXiGENE shall pay BMS the following milestone
payments upon the first occurrence of each event set forth below:
(i) [********] upon the issuance of the first notice of allowance, in
any Major Market, with respect to any claim of U.S. patent
application [********] or any substitution, continuation,
continuation-in-part, division, patent-of-addition, or foreign
counterpart to any of the foregoing that covers the [**********]
and/or any pharmaceutical composition thereof; and
(ii) [*******] upon the issuance of the first letters patent, in any
Major Market, with respect to any claim of U.S. patent
application [*******] or any substitution, continuation,
continuation-in-part, division, patent-of-addition, or foreign
counterpart to any of the foregoing that covers the [********]
and/or any pharmaceutical composition thereof.
Each of the foregoing payments shall be made within [*****] days after
achievement of such milestone. For the avoidance of doubt, after OXiGENE has
made any of the foregoing payments with respect to any claim, OXiGENE shall have
no further obligation to make such payment with respect to any other claim.
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3.7 Royalties.
(a) In partial consideration of the Licenses, OXiGENE shall pay BMS a
royalty on Net Sales of each Licensed Product, commencing on the First
Commercial Sale of each Licensed Product by OXiGENE, its Affiliates or its
sublicensees, in an amount equal to [****] percent of the [**********] Net Sales
of such Licensed Product by OXiGENE, its Affiliates and its sublicensees during
the term of this Agreement.
(b) The obligation to pay royalties to BMS under this Section 3.7 is
imposed only once with respect to the same unit of Licensed Product, regardless
of the number of Licensed Patents pertaining thereto.
3.8 Payment and Reports.
(a) Except as otherwise provided in this Agreement, all royalty and other
payments due hereunder shall be paid quarterly within [***] days after the end
of each calendar quarter. Each such payment shall be accompanied by a statement,
Licensed Product-by-Licensed Product and country-by-country, of the amount of
Net Sales during such quarter and the amount of royalties due on such Net Sales.
(b) OXiGENE shall make all payments required under this Agreement as
directed by BMS from time to time, in U.S. Dollars. All royalties due hereunder
shall first be determined in the currency of the country in which the Licensed
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.
(c) OXiGENE, its Affiliates and its sublicensees shall keep complete and
accurate records pertaining to the sale of Licensed Products and covering all
transactions from which Net Sales are derived for a period of [*****] after the
year in which such sales occurred, and in sufficient detail to permit BMS to
confirm the accuracy of royalty payments due hereunder.
(d) At the request and expense (except as provided below) of BMS, OXiGENE,
its Affiliates and its sublicensees shall permit an independent, certified
public accountant appointed by BMS and reasonably acceptable to OXiGENE, 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 OXiGENE, 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 OXiGENE, its Affiliates or its sublicensees, it is
shown that OXiGENE's royalty payments under this Agreement were less than the
amount which should have been paid, then OXiGENE shall make all payments
required to eliminate any discrepancy revealed by said inspection within [***]
days after BMS' demand therefor. Furthermore, if the aggregate royalty payments
OXiGENE made were less than [*****] of the amount which should have been paid
during the period in question, OXiGENE shall also reimburse BMS for the
reasonable out-of-pocket cost of such inspection and shall pay interest on the
deficiency pursuant to Section 3.8(g).
(e) In the event that OXiGENE is required to withhold any tax to the tax or
revenue authorities in any country in connection with any payment to BMS due to
the laws of such country, such amount shall be deducted from the royalty or
other payment to be made by OXiGENE, and OXiGENE shall notify BMS and promptly
furnish BMS 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.
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(f) If at any time legal restrictions prevent OXiGENE's prompt remittance
of part or all of the royalties due with respect to any country where a Licensed
Product is sold, OXiGENE shall convert the amount owed to BMS into U.S. funds
and shall pay BMS directly from OXiGENE's U.S. source of funds for the amount
impounded. OXiGENE shall then pay all future royalties due to BMS from OXiGENE's
U.S. source of funds so long as the legal restrictions of this Section 3.8(f)
still apply.
(g) In the event that any payment OXiGENE is required to make hereunder is
not made within [********] after such payment was originally due, OXiGENE shall
pay interest on the past due amount as follows at the rate of [*****] per annum,
until payment in full is made.
3.9 Intellectual Property Matters; Prosecution of Licensed Patents.
(a) From and after the Effective Date OXiGENE shall have sole
responsibility for preparing, filing, prosecuting, maintaining and enforcing all
Licensed Patents, at its sole cost and expense. Following the execution of this
Agreement the parties shall make arrangements for the prompt, orderly transfer
to OXiGENE of all files, papers and information in BMS' possession and control
relating to the Licensed Patents.
(b) In the event that OXiGENE wishes to abandon the prosecution,
maintenance or enforcement of any Valid Claim(s) of any Licensed Patent other
than in the ordinary course of agreeing on the language of claims with any
patent office, it shall promptly notify BMS of such wish and shall, if so
requested by BMS, execute an instrument canceling the license granted to OXiGENE
under this Section 3 with respect to such Valid Claim(s) and expressly
permitting BMS to continue such prosecution, maintenance and/or enforcement, at
BMS' sole cost and expense.
(c) OXiGENE shall have sole responsibility for defending against, or
otherwise disposing 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 OXiGENE's, or its Affiliates' or sublicensees'
exploitation of the rights granted to OXiGENE under this Agreement or by reason
of the manufacture, use or sale of any Licensed Products; provided, however,
that OXiGENE shall not have any such responsibility with respect to any claim or
action to the extent it arises from BMS' exploitation of any of its interests in
the Licensed Patents prior to or after the Effective Date.
(d) At OXiGENE's request, BMS shall provide reasonable assistance to
OXiGENE in the activities set forth in Sections 3.9(a), 3.9(c) and 3.10(a),
including by providing access to personnel and records of BMS pertaining to the
Licensed Patents, provided that the rendering of such assistance does not
unreasonably interfere with the conduct of BMS' business in the ordinary course.
3.10 Patent Enforcement.
(a) OXiGENE shall have the right, but not the duty, to institute patent
infringement actions against third parties with respect to any alleged
infringement of the Licensed Patents. BMS shall execute all reasonable,
necessary and proper documents and take such reasonable actions (other than
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allowing itself to be named as a party in any litigation or alternative dispute
resolution proceeding, and provided that the taking of such actions does not
require BMS to expend more than incidental sums of money and does not
unreasonably interfere with the conduct of BMS' business in the ordinary course)
as shall be appropriate to allow OXiGENE to institute and prosecute infringement
actions under this Section 3.10.
(b) The costs and expenses of bringing and maintaining any infringement
action under Section 3.10(a) shall be borne solely by OXiGENE. To the extent BMS
agrees to take any action pursuant to Section 3.10(a) that requires BMS to
expend more than incidental sums of money, OXiGENE shall reimburse BMS therefor,
promptly after receiving an invoice(s) from BMS.
(c) Any award or compensation (including the fair market value of any
non-monetary compensation) paid by third parties as a result of any infringement
action brought by OXiGENE under Section 3.10(a) (whether by way of settlement or
otherwise) shall be allocated first to reimbursement of OXiGENE for all expenses
incurred by it in connection with such action. Any remaining award or
compensation shall be allocated to OXiGENE; provided, however, that to the
extent any such award or compensation (including the fair market value of
non-monetary compensation) shall relate to the sale of any compounds or products
that infringe upon any Licensed Patent (and/or to lost revenue or profits with
respect to any Licensed Product), then OXiGENE shall pay BMS a royalty thereon
in substantial accordance with Section 3.7, the exact amount of such royalty to
be calculated in a manner agreed upon by the parties.
3.11 Indemnification by OXiGENE.
(a) OXiGENE shall indemnify and hold BMS 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
OXiGENE, its Affiliates or its sublicensees and their respective
directors, officers, employees and agents, in connection with
OXiGENE's exercise of any of its rights hereunder;
(ii) any and all product liability claims resulting from the
development and/or commercialization of any Licensed Product by
OXiGENE, its Affiliates or its sublicensees; or
(iii)any warranty claims, Licensed 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 Licensed Product by OXiGENE, its Affiliates or its
sublicensees due to any negligence, recklessness or intentional
misconduct by, or strict liability of, OXiGENE, 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 BMS or its Affiliates
and their respective directors, officers, employees and agents.
For the avoidance of doubt, it is acknowledged that (a) except as may be
otherwise provided in the License Agreement, OXiGENE shall have no obligation to
indemnify BMS for any claims resulting from, arising out of or relating to the
conduct of any clinical trial by BMS; and (b) BMS' obligation to indemnify
OXiGENE for any such claim under Section 14.1 of the License Agreement shall
continue in effect.
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(b) In the event that any person entitled thereto (an "indemnitee") is
seeking indemnification under Section 3.11(a), such indemnitee shall inform
OXiGENE of a claim as soon as reasonably practicable after the indemnitee
receives notice of the claim, shall permit OXiGENE to assume direction and
control of the defense of the claim (including the sole right to settle it at
the sole discretion of OXiGENE, provided that such settlement does not impose
any material obligation on the indemnitee or BMS) and shall cooperate as
requested (at the expense of OXiGENE) in the defense of the claim (including,
without limitation, granting OXiGENE limited access to pertinent records and
making persons under such indemnitee's control available for interview and
testimony).
(c) As the parties intend complete indemnification, all costs and expenses
incurred by any indemnitee to enforce this Section 3.11 shall be reimbursed by
OXiGENE.
3.12 Term; Termination.
(a) The term of the Licenses shall commence as of the Effective Date and,
unless sooner terminated as provided hereunder, shall expire as follows:
(i) As to each Licensed Product in each country, the Licenses
shall expire upon the expiration of the last of the Valid
Claims of the Licensed Patents to expire with respect to
such Licensed Product in such country.
(ii) The Licenses shall expire in their entirety upon the
termination of the all Valid Claims of all Licensed Patents
with respect to all Licensed Products in all countries.
(b) Following the expiration of the Licenses with respect to a Licensed
Product in a country pursuant to Section 3.12(a)(i), OXiGENE shall have the
royalty-free, perpetual right to continue to make, have made, use, sell, offer
for sale, have sold and export such Licensed Product in such country. Following
the expiration of all Licenses in their entirety pursuant to Section
3.12(a)(ii), OXiGENE shall have the royalty-free, perpetual right to continue to
make, have made, use, sell, offer for sale, have sold and export all Licensed
Products in all countries.
(c) Each party shall have the right to terminate the Licenses, upon notice
to the other party, in the event that such other party materially defaults with
respect to any of its material obligations under this Agreement and does not
cure such default within [********] 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 [*********] period, if
the breaching party does not commence and diligently continue actions to cure
same during such [********] period). Any termination pursuant to this Section
3.12(c) 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.
(d) Provided that OXiGENE is not in material breach of any obligation under
this Agreement at the time of any termination of the Licenses pursuant to
Section 3.12(c), OXiGENE shall have the right for one year thereafter to dispose
of all Licensed 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. OXiGENE shall pay royalties thereon, in accordance
with the provisions of this Agreement, as though this Agreement had not
terminated.
-10-
(e) Upon any termination of any of the Licenses, all relevant sublicenses
granted by OXiGENE under this Agreement shall terminate simultaneously, subject,
nevertheless, to Section 3.12(d).
(f) 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.
(g) Termination, relinquishment or expiration of this Agreement shall not
terminate a 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 1, 2.3,
2.4(b), 2.5, 3.2(b), 3.4, 3.8, 3.11, 3.12(b), (f) and (g), 4.3, 4.6, 4.12, 4.13
and 4.14 shall survive termination, relinquishment or expiration hereof.
4. MISCELLANEOUS.
4.1 Definition. For purposes of this Agreement, "Affiliate" have the
meaning set forth in the License Agreement.
4.2 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.
4.3 Guaranty. OXiGENE, Inc. hereby unconditionally guaranties the
performance of all obligations of OXiGENE Europe AB under this Agreement. 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.
4.4 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 4.4(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 4.4 shall be valid or
effective unless and until the assignee/transferee shall agree in writing to be
bound by the provisions of this Agreement.
-11-
4.5 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.
4.6 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.: 000-000-0000
(ii)In the case of OXiGENE, to:
OXiGENE Europe AB
c/o OXiGENE, Inc.
000 Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Attention: President
Facsimile No.: 000-000-0000
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.
4.7 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 for any purpose in connection with the performance of this Agreement.
4.8 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.
-12-
4.9 Compliance with Law. Nothing in this Agreement shall be deemed to
permit a party to export, re-export or otherwise transfer any Licensed Product
sold under this Agreement without compliance with applicable laws.
4.10 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.
4.11 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.
4.12 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 4.13 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 4.13, each party hereby consents to the in personam jurisdiction of any
state or federal court sitting in the State of New York 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 York 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 York.
(c) For purposes of consistency, Section 17.15 of the License Agreement is
hereby amended to replace all references therein to "New Jersey" with the words
"New York."
4.13 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 New York, New
York, 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.
-13-
(b) Section 4.13(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.
(c) For purposes of consistency, Section 17.16(a) of the License Agreement
is hereby amended to replace the reference therein to "Philadelphia,
Pennsylvania" with the words "New York, New York."
4.14 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.
4.15 Entire Agreement. Except as set forth in Section 1.3 hereof, this
Agreement (together with the Exhibits hereto) 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. 4.16 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.
4.17 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.
4.18 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.
4.19 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.
* * *
-14-
IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be
executed by its duly authorized officer as of the Effective Date.
OXIGENE EUROPE AB
By:/s/ Xxxxxxxxx X. Xxxxxxxx
----------------------------
Name: Xxxxxxxxx X. Xxxxxxxx
----------------------------
Title: President
----------------
XXXXXXX-XXXXX SQUIBB COMPANY
By:/s/ Xxxxxxx Xxxxx
--------------------
Name: Xxxxxxx Xxxxx
--------------------
Title: Senior Vice President
----------------------------
ACCEPTED AND AGREED TO WITH RESPECT
TO SECTION 4.3:
OXIGENE, INC.
By:/s/ Xxxxxxxxx X. Xxxxxxxx
----------------------------
Name: Xxxxxxxxx X. Xxxxxxxx
----------------------------
Title: President
----------------
-15-
EXHIBIT A
[*************************************************************]
Quantity
Item To Be Sold
-------------------------------------------------------------
A. API & Related Compounds
-------------------------------------------------------------
[**************************] [****]
-------------------------------------------------------------
[******] [****]
-------------------------------------------------------------
[**********************************] [****]
-------------------------------------------------------------
[**********************] [****]
-------------------------------------------------------------
[**********************] [****]
-------------------------------------------------------------
[**********************************] [****]
-------------------------------------------------------------
B. Drug Product
-------------------------------------------------------------
[**********************] [****]
-------------------------------------------------------------
[**********************] [****]
-------------------------------------------------------------
EXHIBIT B
[*********************************************************]
[***************************]
Reports:
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
Data:
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
Other Documents:
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
[***************************]
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
o [*********************************************************]
EXHIBIT C
LICENSED PATENTS
(1) [************************************************]
(2) [************************************************]
(3) [************************************************]
