Exhibit 10.14
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 Blasieholmsgatan 2c, S-111 48 Stockholm, Sweden, for and on behalf of itself
and its Affiliates ("OXiGENE"), and Bristol-Myers 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. 61,112 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 five-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. 61,112
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, and except for Section 15.2, 15.5 and
15.6 of the License Agreement, which shall terminate notwithstanding Section
15.8(b) of the License Agreement and irrespective of Section 4.15 hereof, 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
US$169,950 (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.
(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 cis-CA4P wet cake 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 12-month 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.
(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 the United States, France, Germany, the United
Kingdom, the European Union (as a whole) or Japan.
(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: (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 erros and rebates
(including, without limitation, government-mandated and managed healthcare
negotiated rebates); (iii) credits and refunds for Licensed 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 Licensed Product to a Third Party; and (v) taxes,
tariffs, customs duties, sucharges and other governmental charges incurred in
connection with the sale, exportation or importation of Licensed Product. Such
amounts shall be determined from the books and records of OXiGENE, 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 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
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 10 days after the
execution of this Agreement OXiGENE shall pay BMS a non-refundable,
non-creditable initial license fee in the amount of US$180,000. 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 180 days after the
execution of this Agreement OXiGENE shall pay BMS a non-refundable,
non-creditable additional license fee in the amount of US$200,000.
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) US$300,000 upon the issuance of the first notice of allowance, in any Major
Market, with respect to any claim of U.S. patent application 09/950,500 or
any substitution, continuation, continuation-in-part, division,
patent-of-addition, or foreign counterpart to any of the foregoing that
covers the CA4P TRIS salt and/or any pharmaceutical composition thereof;
and
(ii) US$400,000 upon the issuance of the first letters patent, in any Major
Market, with respect to any claim of U.S. patent application 09/950,500 or
any substitution, continuation, continuation-in-part, division,
patent-of-addition, or foreign counterpart to any of the foregoing that
covers the CA4P TRIS salt and/or any pharmaceutical composition thereof.
Each of the foregoing payments shall be made within 30 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.
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 two percent of the world-wide 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 45 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 three calendar
years 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 45 days
after BMS' demand therefor. Furthermore, if the aggregate royalty payments
OXiGENE made were less than 95% 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.
(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 30 days after such payment was originally due, OXiGENE shall pay
interest on the past due amount as follows at the rate of 12% 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
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.
(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 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). 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.
(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.
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:
Bristol-Myers Squibb Company
P.O. Box 4000
Route 206 & Province Line Road
Princeton, New Jersey 08543-4000
USA
Attention: Vice President & Senior Counsel,
Pharmaceutical Research Institute and
Worldwide Business Development
Facsimile No.: 609-252-4232
(ii) In the case of OXiGENE, to:
OXiGENE Europe AB
c/o OXiGENE, Inc.
321 Arsenal Street
Watertown, Massachusetts 02472
Attention: President
Facsimile No.: 617-924-9229
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.
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.
(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.
* * *
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/ Frederick W. Driscoll
----------------------------
Name: Frederick W. Driscoll
----------------------------
Title: President
----------------
BRISTOL-MYERS SQUIBB COMPANY
By:/s/ Elliott Sigal
--------------------
Name: Elliott Sigal
--------------------
Title: Senior Vice President
----------------------------
ACCEPTED AND AGREED TO WITH RESPECT TO SECTION 4.3:
OXIGENE, INC.
By:/s/ Frederick W. Driscoll
----------------------------
Name: Frederick W. Driscoll
----------------------------
Title: President
----------------
EXHIBIT A
COMPOUNDS AND DRUG PRODUCT
TO BE SOLD
Item Quantity To Be Sold
- --------------------------------------------------------------------------------
A. API & Related Compounds
CA4P Disodium Salt - Process B (Batch 3) 245 g
Trans-CA4 4.5 g
CA4P Disodium Salt Reference Standard (100 mg /vial) 65 vials
CA4P Mono Tris Salt 60 g
Trans-CA4P Tris Salt 5 g
CA4P Mono Tris Salt (Reference Standard) (100 mg/vial) 60 vials
- --------------------------------------------------------------------------------
B. Drug Product
Batch C00160 (Old Batch) 906 vials
Batch C01291 (New Batch) 1311 vials
- --------------------------------------------------------------------------------
EXHIBIT B
TECHNICAL INFORMATION AND
DOCUMENTATION TO BE PROVIDED BY BMS
BMS-186527-02 (Disodium salt)
Reports:
o Report on BMS-186527-02 Lyophilized/Reconstituted Solution Use-Time
Study
o Report on BMS-186527-02 for Injection, (90 mg/vial as Free Acid) Use
Time/Compatibility Study (BMS lab study)
o Report on characterization of the unknown degradant
(CA4-pyrophosphate) in drug product stability samples o
Physicochemical properties of the CA4P disodium salt (PDSO input for
IND amendment)
Data:
o Data Table:BMS-186527-02 drug substance 52-week IND stability
o Data Table: BMS-186527-02 drug product 52-week IND stability (Two
investigations relating to the 52-week KF and Particulate matter still
ongoing).
o Data Table: Lyophile stability under high intensity light
o Data Table: Compatibility of batching solution with manufacturing and
packaging components.
o Data Table: Clinical reassay data on clinical batch C00160 up to 12
months
o Data Table: Accelerated stability of the lyophile prepared using drug
substance lot 2042.E.00.3 o Miscellaneous Data:
o X-ray diffraction on drug product from Oxigene (Batch ILA003) and
BMS-Lab batches o Comparison of physicochemical properties of diNa
salt- process A vs. process B o Solubility of cis-CA4 in presence of
cis-CA4P o Density of the batching solution
Other Documents:
o Formula Manufacturing Document
o Drug substance specifications
o Drug product specifications
o Certificate of Analysis for Clinical Lots
o Manufacturing Batch Records for Clinical Lots
BMS-186527-03 (Monotris salt)
o FORM team report for the TRIS salt
o Physicochemical properties of the TRIS salt (a compilation of the
existing data generated during form selection process will be
provided)
o Formulation Development Interim Report
o Formula Manufacturing Document (draft copy)
EXHIBIT C
LICENSED PATENTS
(1) U.S. Patent Application Serial No. 10/054,746, filed December 26, 2001 by
Ronald W. Pero et al., entitled "USE OF COMBRETASTATIN A4 AND ITS PRODRUGS
AS AN IMMUNE ENHANCING THERAPY" (Dkt. 1964/63596-A CCD)
(2) U.S. Patent Application Serial No. 10/027,186, filed December 20, 2001 by
Francis Y. Lee et al., entitled "METHODS FOR MODULATING TUMOR GROWTH AND
METASTASIS" (Dkt. LD0251NP BMS)
(3) U.S. Patent Application Serial No. 09/950,500, filed September 11, 2001 by
Venit et al., entitled "COMBRETASTATIN A-4 PHOSPHATE PRODRUG MONO- AND
DI-ORGANIC AMINE SALTS, MONO- AND DI-AMINO ACID SALTS, AND MONO- AND
DI-AMINO ACID ESTER SALTS" (Dkt. LD0232NP BMS)