LICENSE AGREEMENT
THIS LICENSE AGREEMENT (the "Agreement") effective as of the 22nd day
of September 1998, between HOECHST XXXXXX XXXXXXX, INC., a corporation organized
under the laws of the State of Delaware with offices at Xxxxx 000-000, X.X. Xxx
0000, Xxxxxxxxxxx, XX 00000-0000 ("HMR") and MATRIX PHARMACEUTICAL, INC., a
corporation organized under the laws of the State of Delaware and having its
principal office at 00000 Xxxxxx Xxxxx, Xxxxxxx, XX 00000 ("Matrix," and
together the "Parties"),
RECITALS
WHEREAS, HMR is the owner of all right, title and interest in certain
patents and patent applications, identified in Appendix A hereto, and know-how
relating to a compound known as MDL 101,731; and
WHEREAS, Matrix desires to obtain certain exclusive worldwide licenses
from HMR under such patents and patent applications and know-how, and HMR, is
willing to grant to Matrix such licenses;
NOW, THEREFORE, THE PARTIES AGREE AS FOLLOWS:
1. DEFINITIONS
1.1 "Affiliate" means any corporation, firm, partnership or other
entity, whether de jure or de facto, which directly or indirectly owns, is owned
by or is under common ownership with a party to this Agreement to the extent of
at least fifty percent (50%) of the equity (or such lesser percentage which is
the maximum allowed to be owned by a foreign corporation in a particular
jurisdiction) having the power to vote on or direct the affairs of the entity
and any person, firm, partnership, corporation or other entity actually
controlled by, controlling or under common control with a party to this
Agreement.
1.2 "Compound" means the composition of matter known as MDL 101,731
whose more specific chemical name is 2'- Fluoromethylene-2'-Deoxycytidine,
including any salts, hydrates, solvates, and/or stereoisomers thereof, including
any salts, hydrates, solvates and/or stereoisomers of such compounds, the
intellectual property rights to which are owned in whole or in part by HMR in
accordance with Article 2 of this Agreement as of the Effective Date or acquires
such right during the term of this Agreement.
1.3 "Development" means preclinical, clinical, pharmaceutical, and
chemical research on a Compound or Product conducted primarily with the intent,
and for the purpose, of generating data for submission to a regulatory authority
in the Territory in support of an application for governmental approval required
for commercializing Product for any indication.
1.4 "Effective Date" means the date as of which this Agreement is
effective and shall be the date of this Agreement first written above.
1.5 "Enforceable Patent" as used in this Agreement means an issued,
unexpired Patent in a particular country within the Territory, where such Patent
contains a claim or claims which: (a) have not been held invalid or
unenforceable by a court or other legal or administrative tribunal from which no
appeal is or can be taken, and (b) is or are infringed by: (i) the sale of
Product, or (ii) the use of Compound or Product for any approved indication in
such country for Compound or Product.
1.6 "Field" means any and all fields in which a Product may have
application, including, without limitation, the prevention, treatment and/or
diagnosis of any disease or disorder.
1.7 "FDA" means the United States Food and Drug Administration.
1.8 "Know-How" means all technical information and know-how presently
developed and owned or controlled by HMR and its Affiliates, or developed and
owned or controlled by HMR and its Affiliates after the date hereof, which
relates to Compound or Product in the Field and which constitutes a proprietary
"trade secret" or other valid intellectual property right under U.S. or other
applicable law which is substantial, secret and identifiable, including, without
limitation, all biological, chemical, pharmacological, toxicological, clinical,
regulatory, analytical, quality control and manufacturing data and any other
information (whether technical or commercial) relating to Compound or Product
that may be useful for the Development, regulatory approval, manufacture and
commercialization of that Compound or Product.
1.9 "Liabilities" means liabilities of any kind or nature, primary or
secondary, direct or indirect, absolute or contingent, known or unknown, which
are caused by or allegedly caused by the manufacture, marketing, promotion,
distribution, use or sale of the Product, including without limitation, any
liabilities for claims of personal injury or death, and all reasonable
attorneys' fees incurred in connection with the defense of any such claims.
1.10 "MAA Approval" means Marketing Authorization Application approval
by the appropriate regulatory agency(ies) for commercialization of a Compound or
Product in a Major European Country.
1.11 "Major Country" means any one of [*].
1.12 "NDA" means a New Drug Application in accordance with the
requirements of the FDA.
1.13 "Net Sales" means gross sales of Products sold by Matrix, its
Affiliates and licensees to unaffiliated third parties in the Territory, less
the total of: (a) trade, cash and/or quantity discounts; (b) excise, sales and
other consumption taxes and customs duties to the extent included in the invoice
price; (c) freight, insurance and other transportation charges to the extent
included in the invoice price; (d) amounts repaid or credited by reason of
rejections and defects; (e) returns, or retroactive price reductions; and (f)
compulsory payments and rebates, accrued, paid or deducted pursuant to
agreements (including, but not limited to, managed care agreements) or
governmental regulations.
* Indicates that material has been omitted and confidential treatment has been
requested therefore. All such omitted material has been filed separately with
the Commissioner pursuant to Rule 24b-2.
2
The computation of Net Sales shall not include sales between or among a
party and its Affiliates or Sublicensees, except where such Affiliates or
Sublicensees are end users. For purposes of this License Agreement, sales of
Product to independent distributors, wholesalers or other parties who purchase
and take title to Product are considered to be sales to Third Parties. If
Product is sold through intermediaries such as agents or co-promoters who do not
purchase and take title to Product, royalties shall be due on Net Sales to Third
Parties who purchase Product through such intermediaries.
1.14 "Patents" means all patents and patent applications which are or
become owned by or licensed to HMR, or to which HMR otherwise has, now or in the
future, the right to grant licenses during the term of this Agreement, which
generically or specifically claim Compound or Product, a process for
manufacturing Compound or Product, an intermediate used in such process, a
method to formulate or deliver Compound or Product or a use of Compound or
Product. Included within the definition of Patents are any continuations,
continuations-in-part, divisions, patents of addition, reissues, renewals or
extensions thereof. Also included within the definition of Patents are any
patents or patent applications which generically or specifically claim any
improvements on Compound or Product or intermediates or manufacturing processes
required or useful for production of Compound or Product which are developed by
HMR, or which HMR otherwise has the right to grant licenses, now or in the
future, during the term of this Agreement. The current list of patent
applications and patents encompassed within Patents is set forth in Appendix A
attached hereto. Appendix A shall be updated by HMR on an annual basis.
1.15 "Product" means any bulk active ingredient or finished
pharmaceutical composition containing Compound as a pharmaceutically active
ingredient (either alone or in combination with one or more other
pharmaceutically active ingredients), for use in the Field.
1.16 "Sublicensee" means a Third Party (as defined below) to whom
Matrix sublicenses rights to manufacture and sell (or have manufactured and
sold) Product under Patents.
1.17 "Territory" means all the countries of the world except Japan [*].
1.18 "Third Party(ies)" means any party other than a party to this
Agreement or an Affiliate of Matrix or HMR.
2. GRANT [*]
2.1 HMR hereby grants to Matrix an exclusive license in the Field and
in the Territory, with the right to grant sublicenses, under Patents and
Know-How to develop, have developed, make, have made, use and sell Compound and
Product in the Territory, subject to the other terms and conditions of this
Agreement. [*]
* Indicates that material has been omitted and confidential treatment has been
requested therefore. All such omitted material has been filed separately with
the Commissioner pursuant to Rule 24b-2.
3
3. PAYMENTS AND ROYALTIES
3.1 In consideration for the exclusive license to Patents and Know-How
granted to Matrix under Section 2.1 hereof, Matrix shall pay HMR within thirty
(30) days of the first time Compound or Product reaches each of the following
milestones:
Effective Date [*]
[*] [*]
[*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
Such payments shall be paid once by Matrix, even if multiple formulations or
other variations of Compound or Product achieve such milestones. As used in this
Section 3.1, the term "Initiation of pivotal trials to be used for registration"
means the first patient treated in a large scale, multi-center, pivotal efficacy
trial. The term "Notice of NDA or MAA Approval" means the first notification
from the FDA or equivalent regulatory agency, that Product is approved for
marketing and commercialization (and including pricing approval, if applicable)
by Matrix, its Affiliate or Sublicensee in the United States or Major European
Country. In any country where pricing approval is required and product launch is
permitted pending such pricing approval, payment under this Section 3.1 pursuant
to Notice of NDA or MAA Approval shall be triggered upon such launch.
3.2 Subject to Sections 8.1 and 3.4, as a consideration for the license
under Patents and Know-How granted to Matrix under this Agreement, Matrix shall
pay to HMR royalties in the following manner provided that, for purposes of this
Section 3.2, the Product sold is covered by an Enforceable Patent:
o [*]
- The first [*] of Annual Sales : [*] royalty on Net Sales
- All Annual Sales greater than [*]: [*] royalty on Net Sales
o [*]: [*] royalty on Net Sales.
3.3 Royalty obligations for a particular Product under Section 3.2
shall become effective in each country in the Territory at such time as an
Enforceable Patent is granted in such
* Indicates that material has been omitted and confidential treatment has been
requested therefore. All such omitted material has been filed separately with
the Commissioner pursuant to Rule 24b-2.
4
country. In the event that any legal or administrative proceeding is initiated
challenging the validity, scope or enforceability of such Enforceable Patent in
any country in the Territory, which, if successful, would relieve Matrix of its
royalty obligations under Section 3.2 in such country, Matrix shall continue to
pay royalties. However, upon the imposition of a final judgement in any such
proceeding, HMR shall promptly refund to Matrix any royalties paid during the
pendency of the proceeding in the event and to the extent that such judgement
invalidates the patent coverage for the Matrix Product in the relevant
country(ies); however, in no event shall the amount refunded result in an
effective royalty to HMR less than or equal to the minimum amounts set forth in
Section 3.4. In the event of any judgement requiring the payment by Matrix of
royalties or other damages ("Infringement Damages") to any Third Party as a
result of such judgement, Matrix shall be entitled to deduct such Infringement
Damages from payment otherwise owing to HMR, and HMR shall reimburse to Matrix
or pay the Third Party from amounts already collected from Matrix any
Infringement Damages for past infringement; provided, however, subject to
Section 3.4, the royalties payable to HMR shall not [*] Net Sales during the
term of this Agreement, unless such judgment includes an injunction against the
further sale of Product and the Infringement Damages equal or exceed Matrix's
net profit on the sale of Product in such country.
3.4 In those countries were no Enforceable Patents have issued during
the term of this Agreement, the royalty rate shall be [*] percent ([*]%) of Net
Sales; provided however, if a generic version of the Product is marketed in such
countries, the royalty rate in such country shall be reduced to [*] percent
([*]%) of Net Sales. In those countries were Enforceable Patents have expired or
have been held invalid during the term of this Agreement, the royalty rate shall
be [*] percent ([*]%) of Net Sales; provided however, if a generic version of
the Product is marketed in such countries, the royalty rate in such countries
shall be reduced to [*] percent ([*]%) of Net Sales.
3.5 For the purpose of calculating payments, the currency exchange
rates for converting any currency to US dollars shall be the exchange rate in
the key currency cross rates table in the final edition of The Wall Street
Journal (US Eastern Edition) or in the case the currency exchange rate is not
published in the Wall Street Journal, the midpoint of the closing bid and the
ask price of "Xxxxxx'x 2000 Information Service" historical databases, on the
last business day of each calendar quarter to which such payment relates. A
"business day" is a day on which banks are open for business in the country of
the currency to be translated.
Account information:
Citibank, New York
Hoechst Xxxxxx Xxxxxxx, Inc.
ABA# 000000000
Account # [*]
4. COMPULSORY LICENSES AND THIRD PARTY LICENSES
4.1 In the event that a governmental agency in any country within the
Territory grants or compels HMR to grant a license to any Third Party for
Compound or Product, Matrix shall
* Indicates that material has been omitted and confidential treatment has been
requested therefore. All such omitted material has been filed separately with
the Commissioner pursuant to Rule 24b-2.
5
have the benefit in such country of the terms granted to such Third Party to the
extent that such terms, taken as a whole, are more favorable to the Third Party
than those of this Agreement, provided that such Third Party commercializes such
Product in such country.
4.2 If a governmental authority in a country in the Territory imposes a
maximum royalty rate, such that lower royalty rates than would otherwise apply
under this Agreement are mandated in such country, then the royalty rates
provided for herein shall be reduced to equal such lower rates for sales of
Product in such country for the period such lower royalty rate is required by
any governmental authority and shall cease when Matrix's royalty payment
obligations to HMR cease under this Agreement.
4.3 If, during the term of this Agreement after consultation with HMR,
Matrix, in Matrix's sole discretion, determines that patent(s) of a Third Party
exists in the Territory covering the manufacture, use or sale of Compound or
Product, and it is impractical or impossible for Matrix or its Affiliates or
Sublicensees to continue the activity or activities licensed hereunder in the
Field without obtaining a royalty-bearing license from such Third Party under
such patent(s), then Matrix shall be entitled to enter into a license with such
Third Party and deduct from any royalties payable hereunder the royalties paid
to such Third Party or account of the Net Sales on which such royalties are
paid. Subject to Section 3.4, the royalties payable to HMR shall not be [*] Net
Sales during the term of this Agreement.
5. DEVELOPMENT
5.1 Matrix shall have full legal and financial responsibility for all
costs that are incurred and all activities that are undertaken after the signing
of this Agreement, which are related to Development, safety, and required
periodic reporting to the FDA and such equivalent regulatory agency, marketing,
regulatory approvals, price registrations, compliance with all applicable laws
and regulations, and other activities required by or of Matrix or its
Sublicensee(s) (or their respective agents or distributors) elsewhere in the
Territory to obtain appropriate government approvals for, and to commercialize,
Product in the Territory. Other than as expressly provided for herein Matrix
shall not assume, nor shall Matrix be liable for, any costs or activities
(whether scientific, financial or otherwise) relating to the Compound or Product
that were incurred or undertaken prior to the signing, of this Agreement
(including without limitation any costs, expenses, damages, losses, fines,
penalties or the like that may be awarded or assessed after the signing of this
Agreement, but which arise out of events and activities that occurred prior to
the signing of this Agreement).
5.2 Provided that the Affiliates, Sublicensees and other Third Parties
agree to substantially the same terms of confidentiality in Article 10 hereof,
Matrix may appoint such Affiliates, Sublicensee(s) and other Third Parties to
perform any and all Development activities necessary to obtain government
approvals for Product in the Territory.
5.3 Matrix shall, in a manner consistent with the effort Matrix devotes
to its own products having the same or similar potential value as Product,
exercise its reasonable commercial efforts and diligence in developing and
commercializing Product, and in undertaking those investigations and actions
required to obtain appropriate governmental approvals to market
* Indicates that material has been omitted and confidential treatment has been
requested therefore. All such omitted material has been filed separately with
the Commissioner pursuant to Rule 24b-2.
6
Product in the Territory. HMR shall use reasonable efforts to assist or provide
consultation at Matrix's expense in support of the Development of Compound or
Product, but in its discretion may limit its resources and assistance; provided,
however, that such limitation shall not apply to the HMR's obligation to provide
information and assistance as set forth in Sections 6.2, 10.1, and 10.2.
5.4 Development of the Product shall be governed by a separate written
plan attached as Appendix C ("Development Plan"), which shall be prepared by
Matrix and submitted to HMR for its information. The Development Plan will
describe the proposed overall program of Development for the Compound or
Product, including, process development, clinical studies and regulatory plans
and other elements of obtaining Regulatory Approval. The Development Plan will
be updated annually by Matrix and, together with any updates thereto, be
provided to HMR solely for its information.
5.5 If Product is not launched [*] by Matrix, its Affiliates and/or
Sublicensee within [*] after the date of receiving the approvals necessary to
commercialize Product (including, without limitation, pricing approval in those
jurisdictions wherein pricing approval is required) [*] HMR and Matrix shall
review the progress of launch efforts. Matrix shall keep HMR informed on a
regular basis of the status of its launch efforts after receiving the approvals
necessary to commercialize Product [*] until such time that launch is achieved
[*]. If other than for reasons beyond the reasonable control of Matrix, launch
[*] is not achieved within [*] after the date of receiving such approvals
necessary to commercialize Product in such country(ies), then the license
granted by this Agreement shall terminate, but only with respect to the
particular country where launch was not achieved within such [*] time frame, as
the case may be, unless the Parties agree in writing to extend such time frame.
If, upon receipt of any such notification HMR determines that it desires to
itself or through an Affiliate commercialize such Product in a country in which
Matrix foresees difficulty, then HMR shall discuss with Matrix appropriate
compensation for Matrix's efforts in bringing such Product to market.
5.6 Any inventions or discoveries or improvements which arise from
Matrix's, its Affiliate's or Sublicensee's work relating to the Development
and/or manufacture of the Compound and/or Product shall be owned by Matrix. HMR
shall have the right of first negotiation to license any such invention,
discovery or improvement.
6. COMPOUND & PRODUCT SUPPLY
6.1 HMR shall deliver its entire existing supply of Product to Matrix
and at least one (1) Product lot that is fully conforming with the Compound
specifications as defined in the IND ("Compound Specifications") under the
following conditions:
(a) Within sixty (60) days with respect to bulk active
ingredient and within thirty (30) days with respect to finished product, of
written notice by Matrix to HMR, HMR shall, at its own cost (including without
limitation, duties, tariffs and the like), ship to Matrix or its designee [*]
all existing quantities of Product.
* Indicates that material has been omitted and confidential treatment has been
requested therefore. All such omitted material has been filed separately with
the Commissioner pursuant to Rule 24b-2.
7
(b) Title to, and risk of loss with respect to, all Product
supplied by HMR to Matrix under this Section 6.1 shall pass to Matrix upon the
receipt of such Product by Matrix or its designee at their point of delivery.
(c) HMR shall provide available existing testing information
on the Product, and shall transfer the analytical methods. Prior to shipment of
Product to Matrix, HMR shall test an agreed upon lot of bulk active ingredient
for conformance with the Compound Specifications and provide such test data to
Matrix. HMR shall test an agreed upon stability time point for the drug products
which are on stability.
(d) Matrix agrees to inspect each shipment of Product within
thirty (30) days of receipt to determine whether such shipment is in conformity
with the Compound Specifications or whether there exists any defects which can
be detected upon ordinary diligent examination of the shipment. If any portion
of the shipment is not in conformity with the foregoing, Matrix may reject the
non conforming shipment by giving notice of rejection to HMR as follows: i) in
case of any defects arising out of a breach by HMR which could be detected upon
ordinary diligent examination when the shipment was received, within six (6)
days after the date of receipt of the shipment by Matrix; and ii) in the case of
other defects (except any defect arising out of a breach by Matrix), within
thirty (30) days after the date of receipt of the shipment by Matrix.
(e) If Matrix notifies HMR of any non-conformance of Product
with the Compound Specifications therefor, the Parties shall discuss in good
faith such non-conformance and if it cannot be resolved within thirty (30) days,
the Parties shall have an independent reputable laboratory, reasonably
acceptable to both Parties, test representative samples from such shipment, and
the results of such laboratory shall be final and binding on the Parties. The
Party whose determination is not upheld by the laboratory's results shall bear
the costs of such testing.
(f) The Parties shall continue to perform the testing and
verification steps on HMR's existing supply of bulk active ingredient as set
forth in Sections 6.1(c)-(e) until a bulk active ingredient lot is delivered to
Matrix that is fully conforming with the Compound Specifications. In the event
that no such existing lot is fully conforming with Compound Specifications, HMR
shall provide Matrix, at HMR's expense, with one (1) lot of twenty (20)
kilograms of bulk active ingredient fully conforming with Compound
Specifications.
6.2 HMR shall provide information and assistance to Matrix with respect
to Product as follows:
(a) Upon the signing of this Agreement, HMR shall deliver to
Matrix any and all Know-How, documentation, data, and other information owned or
controlled by HMR and its Affiliates, that Matrix may reasonably require for the
manufacture of Product in the Territory, such information and technology
transfer to be accomplished within three (3) months after the Agreement is
signed. Such information and technology transfer shall include without
limitation the specifications for Product and methods of analysis for testing
Product, as currently described within the IND regulatory documentation
including Chemistry/Manufacturing/Controls (CMC) information amendments and the
technology transfer file, and all manufacturing records for the
8
Product generated by contract manufacturers. At the end of such three (3) month
period, the parties shall discuss in good faith whether the information and
technology transfer process has been satisfactorily completed. In the event that
Matrix feels it has not appropriately received such information or related
assistance, then the parties shall in good faith determine an alternative
procedure to properly complete such transition process, and the Parties shall
implement such procedure during the three (3) months immediately following such
determination. Thereafter and for the remaining term of this Agreement, HMR
shall be obligated to provide only such assistance to Matrix which is limited to
material historical information and technology.
(b) HMR shall provide to Matrix or its designated Third Party
assistance for the transfer of manufacturing technology, through documentation,
consultation and face-to-face meetings, to enable Matrix or Third Party to
proceed with development of commercial-scale manufacturing. If requested by
Matrix or the Third Party, HMR shall designate appropriate personnel reasonably
acceptable to Matrix, who shall visit the designated manufacturing facility,
with the limitation of three (3) visits, not to exceed a total of ten (10)
business days, within one (1) year after the Agreement is signed, for which
Matrix shall bear all the costs of travel and other out-of-pocket expenses.
(c) To the extent that Matrix from time to time requires
materials contained in laboratory notebooks of HMR employees (past or present)
with respect to the manufacture, use in clinical trials, governmental approvals
or otherwise of Compound or Product, HMR shall make either such laboratory
notebooks or appropriate excerpts therefrom (excerpting unrelated information
dealing with other products) available to Matrix as promptly as possible.
6.3 HMR represents and warrants that:
(a) all Product supplied hereunder shall meet the Compound
Specifications therefor at the time Product are delivered to Matrix or its
designee;
(b) all Product supplied hereunder shall be manufactured,
stored and shipped in accordance with GMPs and all other applicable laws and
regulations;
(c) none of the Product supplied hereunder shall be
adulterated or misbranded as provided for under applicable laws and regulations.
6.4 Matrix represents and warrants that all Product supplied hereunder
for use in humans shall be manufactured, stored and shipped in accordance with
GMPs and all other applicable laws and regulations.
6.5 Upon the Effective Date, Matrix shall be solely responsible for
handling Product complaints, and reporting Product complaints as required by the
authorities in the Territory. However, HMR will cooperate to provide data in its
possession which may be necessary in connection with such matters.
9
7. REGULATORY AND LEGAL REQUIREMENTS
7.1 Upon the Effective Date, Matrix shall be responsible for
maintaining the global drug surveillance database for the Product, and shall
support any other HMR licensee of the Compound or Product to the extent such
licensees are willing to enter into an agreement with Matrix whereby any such
licensee (a) assumes reporting obligations from the database for its own
territory; and (b) agrees to provide and provides Matrix with all required
information from its own territory to add to the database. Matrix shall be
responsible for adverse event reporting only in its own Territory.
7.2 Matrix agrees throughout the duration of this Agreement to maintain
records and otherwise establish procedures to assure compliance with all
regulatory, professional, or other legal requirements which apply to the
Development, manufacturing, promotion and marketing of Compound or Product.
8. TERM AND TERMINATION
8.1 Matrix's royalty obligations for a particular Product under Section
3.2 in each country of the Territory shall be [*] upon the expiration or
invalidation of the last remaining Enforceable Patent in such country.
Expiration of this Agreement or Matrix's royalty or payment obligations with
respect to a particular Product under this Article 8 shall not preclude Matrix
from continuing to market any Product and to use Know-How anywhere in the
Territory without further royalty or other payments.
8.2 [RESERVED]
8.3 Unless otherwise terminated, this Agreement shall expire fifteen
(15) years from the date of first marketing in the last country in the Territory
in which a Product is marketed by Matrix.
8.4 In the event the Development of Compound or Product is terminated
altogether by Matrix for reasons of toxicology, safety, efficacy, product
stability or the like deemed unacceptable by the FDA or its equivalent non-U.S.
regulatory agency to commercialize Product, then this Agreement shall terminate
in its entirety and the license granted hereunder shall revert back to HMR. HMR
shall retain all upfront license fees and milestone payments it had received up
to the date of termination if, and only if, termination was not due to any
misrepresentations, omissions (of information owned or controlled by HMR or its
Affiliates as of the date hereof) or falsifications with respect to such
Know-How, information or data or fraud by HMR or its Affiliates, in which case
HMR shall repay in full to Matrix within ninety (90) days of such termination,
the upfront license fee and milestone payments HMR had received from Matrix up
to the date of such termination.
8.5 If either party materially fails or neglects to perform its
obligations set forth in this Agreement and if such default is not corrected
within sixty (60) days after receiving written notice from the other party with
respect to such default, such other party shall have the right to
* Indicates that material has been omitted and confidential treatment has been
requested therefore. All such omitted material has been filed separately with
the Commissioner pursuant to Rule 24b-2.
10
terminate this Agreement by giving written notice to the party in default
provided the notice of termination is given within six (6) months of the default
and prior to correction of the default.
8.6 Matrix may terminate this Agreement in its entirety or with respect
to any country in the Territory by giving HMR at least thirty (30) days written
notice thereof based on a reasonable determination, using the same standards
Matrix would use in assessing whether or not to continue Development and
marketing of a product of its own making, that the patent, medical/scientific,
technical, regulatory or commercial profile of Compound or Product does not
justify continued Development or marketing of Compound or Product. Termination
of this Agreement with respect to any country in the Territory under this
provision shall terminate all licenses granted to Matrix in such country under
Article 2 with full reversion to HMR of all HMR's interest and rights in Patents
and Know-How in such country.
8.7 Either party may terminate this Agreement if, at any time, the
other party shall file in any court or agency pursuant to any statute or
regulation of any state or country, a petition in bankruptcy or insolvency or
for reorganization or for an arrangement or for the appointment of a receiver or
trustee of the party or of its assets, or if the other party proposes a written
agreement of composition or extension of its debts, or if the other party shall
be served with an involuntary petition against it, filed in any insolvency
proceeding, and such petition shall not be dismissed within sixty (60) days
after the filing thereof, or if the other party shall propose or be a party to
any dissolution or liquidation, or if the other party shall make a general
assignment for the benefit of creditors.
8.8 All rights and licenses granted under or pursuant to this Agreement
by HMR to Matrix are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to "intellectual
property" as defined under Section 101(52) of the U.S. Bankruptcy Code. The
Parties agree that Matrix, as a licensee of such rights under this Agreement,
shall retain and may fully exercise all of its rights and elections under the
U.S. Bankruptcy Code, subject to performance by Matrix of its preexisting
obligations under this Agreement. The Parties further agree that, in the event
of the commencement of a bankruptcy proceeding by or against HMR under the U.S.
Bankruptcy Code, Matrix shall be entitled to a complete duplicate of (or
complete access to, as appropriate) any such intellectual property and all
embodiments of such intellectual property, and same, if not already in its
possession, shall be promptly delivered to Matrix (i) upon any such commencement
of a bankruptcy proceeding upon written request therefor by Matrix, unless HMR
elects to continue to perform all of its obligations under this Agreement, or
(ii) if not delivered under (i) above, upon the rejection of this Agreement by
or on behalf of HMR upon written request therefor by Matrix, provided, however,
that upon HMR's (or its successor's) written notification to Matrix that it is
again willing and able to perform all of its obligations under this Agreement,
Matrix shall promptly return all such tangible materials to HMR, but only to the
extent that Matrix does not require continued access to such materials to enable
Matrix to perform its obligations under this Agreement.
11
9. RIGHTS AND DUTIES UPON TERMINATION
9.1 Upon termination of this Agreement, HMR shall (except as otherwise
provided herein) have the right to retain any sums already paid by Matrix
hereunder, and Matrix shall pay all sums accrued hereunder which are then due.
9.2 Termination of this Agreement shall terminate all future
obligations and rights between the Parties arising from this Agreement,
including but not limited to the payment obligations outlined in Article 3,
except those described in Sections 8.1, 8.3, 9.1, 9.2, 9.4, 10.3, 10.4, 10.5,
10.6, 10.7, 10.8, for data or other information generated or provided by either
Party during the term of the Agreement, and the rights and obligations of the
Parties pursuant to Sections 10.9, 12.1, 12.3, 12.4 and Articles 11, 13, 14, 15,
18, 19, 20, 21, 22, and 23 and except existing rights against the other Party
for a breach by that Party.
9.3 Termination of this Agreement under Section 8.5 for a default by
HMR shall terminate Matrix's obligation to make any remaining payments required
by Article 3 for the period effective as of the date HMR received written notice
from Matrix with respect to such default if after the elapse of sixty (60) days
from receipt of such notice such default is not corrected. Termination of this
Agreement with respect to all countries of the Territory under Section 8.6 shall
terminate Matrix's obligation to make any remaining payments required by Article
3 for periods after the effective date of termination.
9.4 All rights to terminate, and rights upon termination provided for
either Party in this Agreement are in addition to other remedies in law or
equity which may be available to either Party.
9.5 Upon early partial or entire termination of this license Agreement
pursuant to Sections 8.4, 8.5 (as to Matrix defaults), or 8.6, HMR shall receive
an exclusive (even as to Matrix, but subject to any Third Party's then-existing
rights) right and license, with the right to grant sublicense, to all data, know
how, results and other information related to the Compound or Product and
generated by Matrix, its Affiliates and Sublicensees, to import, use, sell,
offer for sale, and have sold Product in the countries of the Territory where
the Agreement was terminated. Any IND or other regulatory filing effected prior
to termination (for each country in which such termination is effective) shall
be assigned by Matrix to HMR (or its designees). Matrix shall provide to HMR
within one (1) month of HMR's request, copies of all regulatory correspondence,
including, but not limited to, IND Information Amendments, IND Reports, IND
Safety Reports, NDA Submission, NDA Post-marketing Reports, and reports of
written/phone contacts to/from regulatory agencies, as well as the safety
database (as applicable). In addition, Matrix shall provide reasonable
assistance to HMR, at Matrix's expense if such termination is pursuant to
Sections 8.5 or 8.6, otherwise at HMR's expense, for the transfer of such data,
know how, results and other information related to the Compound or Product and
generated by Matrix, its Affiliates, and Sublicensees prior to such termination,
such transfer to be completed by Matrix within one (1) month of such
termination.
12
10. EXCHANGE OF INFORMATION AND CONFIDENTIALITY
10.1 Upon the signing of this Agreement, HMR shall deliver to Matrix
all available Know-How through documentation, consultation, and face-to-face
meetings, which is owned or controlled by it and its Affiliates, and which may
be reasonably expected to assist Matrix in developing, registering, and
manufacturing Compound and Product in the Territory ("HMR Information"). After
the execution of this Agreement, there shall be a three (3) months transition
during which HMR shall provide, reasonable resources, expertise, Know-How and
documents to effectively transfer the Development activity to Matrix with the
limitations as described in this Agreement. At the end of such three (3) month
period, the parties shall discuss in good faith whether the information and
technology transfer process has been satisfactorily completed. In the event that
Matrix feels it has not appropriately received such information or related
assistance, then the parties shall in good faith determine an alternative
procedure to properly complete such transition process, and the Parties shall
implement such procedure during the three (3) months immediately following such
determination. Thereafter and for the remaining term of this Agreement, HMR
shall be obligated to provide only such assistance to Matrix which is limited to
material historical information and technology.
10.2 Within ten (10) days after the date of the receipt of written
notification, HMR shall transfer the U.S. IND, including without limitation, the
drug master file ("DMF"), for Compound or Product to Matrix. Until such transfer
is made, Matrix shall have the right to make reference to such Compound or
Product owned or controlled by HMR or its Affiliate.
10.3 HMR may not, during the term of this Agreement and for a period of
[*] after the date of termination of this Agreement, disclose or reveal to Third
Parties any confidential information received from Matrix or otherwise developed
by Matrix in the performance of activities in furtherance of this Agreement
which relates substantially to a Compound or Product that Matrix has in
Development or is commercializing, except in the event that rights granted under
this Agreement shall revert to HMR pursuant to Section 9.5 and solely for the
purpose of finding a licensee to such reverted rights. This confidentiality
obligation shall not apply to such information which is or becomes a matter of
public knowledge, or came or comes into the possession of HMR independently of
this Agreement (unless otherwise disclosed confidentially at any time by Matrix
to HMR), or is disclosed to HMR by a Third Party having the right to do so, or
is subsequently and independently developed by employees of HMR or Affiliates
thereof who had no knowledge of the confidential information disclosed. The
Parties shall take reasonable measures to ensure that no unauthorized use or
disclosure is made by others to whom access to such information is granted.
10.4 Matrix may not, upon the termination of this Agreement and for a
period of [*] after the date of termination of this Agreement, disclose or
reveal to Third Parties any confidential information received from HMR or
otherwise developed by HMR in the performance of activities in furtherance of
this Agreement which relates to a Compound or Product that HMR has in
Development or is commercializing. Matrix shall bind any Sublicensee to the same
terms of confidentiality relating to the Compound or Product. This
confidentiality obligation shall not apply to such information which is or
becomes a matter of public knowledge,
* Indicates that material has been omitted and confidential treatment has been
requested therefore. All such omitted material has been filed separately with
the Commissioner pursuant to Rule 24b-2.
13
or came or comes into the possession of Matrix independently of this Agreement
(unless otherwise disclosed confidentially at any time by HMR to Matrix), or is
disclosed to Matrix by a Third Party having the right to do so, or is
subsequently and independently developed by employees of Matrix or Affiliates
thereof who had no knowledge of the confidential information disclosed. The
Parties shall take reasonable measures to ensure that no unauthorized use or
disclosure is made by others to whom access to such information is granted.
10.5 Nothing herein shall be construed as preventing either party from
disclosing any information received from the other party to an Affiliate or
Sublicensee of the receiving party, provided such Affiliate or Sublicensee has
undertaken a similar obligation of confidentiality with respect to the
confidential information.
10.6 Nothing herein shall be construed as preventing Matrix or HMR from
disclosing information received from the disclosing Party for the purposes of
investigating, developing, manufacturing, or marketing Compound or Product or
for securing essential or desirable authorizations, privileges or rights from
governmental agencies, or as is required to be disclosed to a governmental
agency or as is necessary to file or prosecute patent applications concerning
Compound or Product or to carry out any litigation concerning Compound or
Product.
10.7 All confidential information disclosed by one party to the other
shall remain the intellectual property of the disclosing party. In the event
that a court or other legal or administrative tribunal, directly or through an
appointed master, trustee or receiver, assumes partial or complete control over
the assets of a party to this Agreement based on the insolvency or bankruptcy of
such party, the bankrupt or insolvent party shall promptly notify the court or
other tribunal (i) that confidential information received from the other party
under this Agreement remains the property of the other party and (ii) of the
confidentiality obligations under this Agreement. In addition, the bankrupt or
insolvent party shall, to the extent permitted by law, take all steps necessary
or desirable to maintain the confidentiality of the other party's confidential
information and to insure that the court, other tribunal or appointee maintains
such information in confidence in accordance with the terms of this Agreement.
10.8 No public announcement or other disclosure to Third Parties
concerning the existence of or terms of this Agreement shall be made, either
directly or indirectly, by either party to this Agreement, except as may be
legally required or as may be required for recording purposes, without first
obtaining the written approval of the other party and agreement upon the nature
and text of such announcement or disclosure, provided that such approval shall
not be unreasonably withheld.
The party desiring to make any such public announcement or other
disclosure shall use reasonable efforts to inform the other party of the
proposed announcement or disclosure in reasonably sufficient time prior to
public release, and shall use reasonable efforts to provide the other party with
a written copy thereof, in order to allow such other party to comment upon such
announcement or disclosure.
10.9 HMR shall not submit for written or oral publication any
manuscript, abstract or the like which includes data or other information
generated or provided by either party in the
14
course of, or otherwise as a result of Development or otherwise related to
Compound or Product, without first obtaining the prior written consent of
Matrix. The contribution of each party shall be noted in all publications or
presentations by acknowledgment or coauthorship, whichever is appropriate.
10.10 Nothing in this Agreement shall be construed as preventing or in
any way inhibiting either party from complying with statutory and regulatory
requirements governing the manufacture, use and sale or other distribution of
Compound or Product in the Territory in any manner it reasonably deems
appropriate, including, for example, by disclosing to regulatory authorities
confidential or other information received from each other or Third Parties.
11. INVENTIONS, PATENTS AND PATENT PROSECUTION
11.1 HMR shall provide Matrix with a copy of the complete texts of all
Patents filed by HMR prior to the Effective Date which relate to Compound or
Product as well as all information received concerning the institution or
possible institution of any interference, opposition, re-examination, reissue,
revocation, nullification or any official proceeding involving a Patent anywhere
in the Territory. Matrix shall have the right to review all such Patents and all
proceedings related thereto and make recommendations to HMR concerning material
aspects of their conduct. HMR agrees to copy Matrix on all aspects of the
prosecution or other proceedings of such Patents including by providing Matrix
with copies of substantive communications, search reports and third party
observations submitted to or received from patent offices within the Territory.
Matrix shall provide such patent consultation to HMR related to such Patents at
no cost to HMR. Matrix shall have the right to assume responsibility for any
such Patent or any part of any such Patent which HMR intends to abandon or
otherwise cause or allow to be forfeited provided that the claims of such Patent
covers Compound or Product.
12. PATENT LITIGATION
12.1 In the event of the institution of any suit by a Third Party
against HMR, Matrix and/or its Sublicensee for patent infringement involving the
manufacture, use, sale, distribution or marketing of Compound or Product
anywhere in the Territory, the party sued shall promptly notify the other party
in writing. Matrix shall have the right but not the obligation to defend such
suit at its own expense. HMR and Matrix shall assist one another and cooperate
in any such litigation at the other's request without expense to the requesting
party.
12.2 In the event that HMR or Matrix becomes aware of actual or
threatened infringement of a Patent related to Compound or Product, anywhere in
the Territory, or any alleged patent invalidity or non-infringement of patent or
patents pursuant to a paragraph IV patent certification by a party filing an
Abbreviated New Drug Application ("ANDA"), that party shall promptly notify the
other party in writing, but in any event no later than ten (10) business days
after receipt of notice of such action. HMR shall have the first right but not
the obligation to bring, at its own expense, an infringement action or file any
other appropriate action or claim directly, related to infringement of a Patent
owned in whole or in part by HMR, wherein such infringement relates to Compound
or Product, against any Third Party and to use Matrix's name in connection
therewith. If HMR does not commence a particular infringement action within
15
ninety (90) days after it received such written notice, Matrix, after notifying
HMR in writing, shall be entitled to bring such infringement action or any other
appropriate action or claim at its own expense. The party conducting such action
shall have full control over its conduct, including settlement thereof. In any
event, HMR and Matrix shall assist one another and cooperate in any such
litigation at the other's request without expense to the requesting party.
12.3 HMR and Matrix shall recover their respective actual out-of-pocket
expenses, or equitable proportions thereof, associated with any litigation or
settlement thereof from any recovery made by any party. Any excess amount shall
be shared between Matrix and HMR, with each party receiving an amount
proportional to the amount spent by such party on such litigation or settlement
thereof relative to the total amount spent by both Parties on such litigation or
settlement thereof.
12.4 The Parties shall keep one another informed of the status of and
of their respective activities regarding any litigation or settlement thereof
concerning Compound or Product.
12.5 HMR shall authorize Matrix to act as HMR's agent for the purpose
of making any application for any extensions of the term of Patents or
application for Supplementary Protection Certificate or any other application
for equivalent right of which HMR is entitled to act as such an agent in any
country of the Territory in which such extensions are or become available, and
shall provide reasonable assistance therefor to Matrix, at HMR's expense.
12.6 Each party shall provide prompt notice to the other of any
inquiries as to any Patent which have claims to manufacturing processes, which
inquiries are provided pursuant to 35 USC ss. 271(g), and shall cooperate with
respect to responses thereto.
12.7 Each party shall provide (i) notice of patents relevant to a US
NDA, prior to the time the NDA is filed, and (ii) immediate notice of the
issuance of any other patents relevant to a US NDA and the parties shall jointly
decide within thirty (30) days of the patent issue date, if the patent is to be
listed pursuant to any Drug Approval Application (particularly in Canada) and
any pending or approved Health Registration or NDA in the United States for
Product.
13. TRADEMARKS AND TRADE NAMES
13.1 Matrix, at its expense, shall be responsible for the selection,
registration and maintenance of all trademarks and trade names which it employs
in connection with any Product. Nothing in this Agreement shall be construed as
a grant of rights, by license or otherwise, to HMR to use such trademarks and
trade names or any other trademarks and trade names owned by Matrix for any
purpose. Matrix shall own such trade names and trademarks and shall retain such
ownership upon termination of this Agreement.
13.2 Nothing in this Agreement shall be construed as a grant of rights,
by license or otherwise, to either party, to use the name of the other party or
any entity affiliated therewith for any purpose whatsoever except as may
otherwise be expressly provided for in this Agreement.
16
13.3 If rights granted to Matrix under this Agreement in a country
shall revert to HMR pursuant to Sections 8.4 and 8.6 above, HMR shall have the
option to obtain a royalty free license to any Matrix trademark relating to the
Product in such country.
14. STATEMENTS AND REMITTANCES
14.1 Matrix shall keep and require its Affiliates and Sublicensees to
keep complete and accurate records of all sales of Product under the licenses
granted herein. HMR shall have the right, at HMR's expense, through a certified
public accountant or like person reasonably acceptable to Matrix, to examine
such records during regular business hours during the life of this Agreement and
for six (6) months after the later of its termination or the last sale of
Product by Matrix subject to the royalty obligations outlined in Section 3.2;
provided, however, that such examination shall not take place more often than
once a year and shall not cover such records for more than the preceding two (2)
years and provided further that such accountant shall report to HMR only as to
the accuracy of the royalty statements and payments. However, if the
accountant's report results in finding an error which resulted in an under or
overpayment of royalties on Net Sales more than [*] then the expense of the
examination shall be borne by Matrix (provided HMR shall first refund to Matrix
any overpayment reflected by such audit). The new Net Sales calculations shall
apply.
14.2 Within sixty (60) days after the close of each calendar quarter,
Matrix shall deliver to HMR a true accounting of all Product sold by Matrix and
its Sublicensees during such quarter and shall at the same time pay all
royalties due. Such accounting shall show gross sales and Net Sales on a
country-by-country and Product-by-Product basis.
14.3 Any tax paid or required to be withheld by Matrix on account of
royalties payable to HMR under this Agreement shall be deducted from the amount
of royalties otherwise due. Matrix shall secure and send to HMR written proof of
any such taxes withheld and paid by Matrix or its Sublicensees for the benefit
of HMR in a form sufficient to satisfy the United States Internal Revenue
Service.
14.4 All payments due under this Agreement shall be payable in U.S.
dollars. In each country where the local currency is blocked or cannot be
removed from such country, Matrix will pay the royalty owed on sales in that
country in U.S. dollars to HMR at the exchange rate set forth in Section 3.5.
15. WARRANTIES, REPRESENTATIONS, INSURANCE, AND INDEMNIFICATIONS
15.1 As of the Effective Date, HMR warrants that, to the best of its
belief and knowledge, it owns the entire right and title to the extent of its
ownership interest in Patents and Know-How, has the right to grant the license
outlined in Article 2 with respect to Patents and Know-How, and has the right to
enter into this Agreement.
15.2 HMR warrants that, as of the Effective Date, it has disclosed to
Matrix the complete texts of all Patents as well as all information received
concerning the institution or possible institution of any interference,
opposition, re-examination, reissue, revocation,
* Indicates that material has been omitted and confidential treatment has been
requested therefore. All such omitted material has been filed separately with
the Commissioner pursuant to Rule 24b-2.
17
nullification or any official proceeding involving a Patent anywhere in the
Territory. Nothing in this Agreement shall be construed as a warranty that
Patents are valid or enforceable or that their exercise does not infringe any
valid patent rights of Third Parties. HMR hereby represents that it has no
present knowledge from which it can be inferred that Patents are invalid or that
their exercise would infringe valid patent rights of Third Parties. A holding of
invalidity or unenforceability of any Patent, from which no further appeal is or
can be taken, shall not affect any obligation already accrued hereunder.
15.3 HMR acknowledges that, in entering into this Agreement, Matrix has
relied or will rely upon information supplied by HMR, information to be supplied
by HMR, and information which HMR has caused or will cause to be supplied to
Matrix by HMR's agents and/or representatives, pursuant to Articles 6 and 10 of
this Agreement and HMR warrants and represents that, to the best of its belief
and knowledge, all such information is and will be timely and accurate in all
material respects. HMR further warrants and represents that it has not, up
through and including the Effective Date, omitted to furnish Matrix with any
information requested by Matrix concerning the Compound or Product or the
transactions contemplated by this Agreement, which would be material to Matrix's
decision to enter into this Agreement and to undertake the commitments and
obligations set forth herein.
15.4 HMR warrants and represents that it has no present knowledge of
the existence of any pre-clinical or clinical data or information concerning the
Compound or Product which suggests that there may exist toxicity, safety and/or
efficacy concerns which may materially impair the utility and/or safety of the
Compound or Product, other than as has already been disclosed to Matrix.
15.5 Subject to Section 15.8, Matrix shall indemnify and hold harmless
HMR, its officers, directors, shareholders, employees, successors and assigns
from any loss, damage, or liability, including reasonable attorney's fees,
resulting from any claim, complaint, suit, proceeding or cause of action against
any of them alleging physical or other injury, including death, brought by or on
behalf of an injured party; loss of service or consortium or a similar such
claim, complaint, suit, proceeding or cause of action brought by a friend,
spouse, relative or companion of an injured party due to such physical injury or
death and rising out of the administration, utilization and/or ingestion of
Compound or Product manufactured, sold or otherwise provided to the injured
party by Matrix (or its permitted Sublicensee or other third parties such as
contract manufacturers), except to the extent such damages, claims, costs,
losses, liabilities or expenses are directly and proximately caused by HMR's
negligent or wrongful actions and provided:
(a) Matrix shall not be obligated under this Section if it is
shown by evidence acceptable in a court of law having jurisdiction over the
subject matter and meeting the appropriate degree of proof for such action, that
the injury was the result of the negligence or willful misconduct of any
employee or agent of HMR;
(b) Matrix shall have no obligation under this Section unless
HMR (i) gives Matrix prompt written notice of any claim or lawsuit or other
action for which it seeks to be
18
indemnified under this Agreement, (ii) Matrix is granted full authority and
control over the defense, including settlement, against such claim or lawsuit or
other action, and (iii) HMR cooperates fully with Matrix and its agents in
defense of the claims or lawsuit or other action; and
(c) HMR shall have the right to participate in the defense of
any such claim, complaint, suit, proceeding or cause of action referred to in
this Section utilizing attorneys of its choice, provided, however, that Matrix
shall have full authority and control to handle any such claim, complaint, suit,
proceeding or cause of action, including any settlement or other disposition
thereof, for which HMR seeks indemnification under this Section.
15.6 Subject to Section 15.8, HMR shall defend, indemnify and hold
harmless Matrix and its officers, directors, shareholders, employees, successors
and assigns from and against any and all damages, claims, costs, losses,
liabilities or expenses (including reasonable attorneys' fees) arising out of,
or resulting from or in connection with HMR's activities under this Agreement
including, but not limited to HMR's activities related to Development, HMR's
transfer of Know-How to Matrix, and any breach of a representation or warranty
made to Matrix by HMR under this Agreement, except such damages, claims, costs,
losses, liabilities or expenses which are directly and proximately caused by
Matrix's negligent or wrongful actions, provided Matrix shall have the right to
participate in the defense of any such claim, complaint, suit, proceeding or
cause of action referred to in this Section utilizing attorneys of its choice,
provided, however, that HMR shall have full authority and control to handle any
such claim, complaint, suit, proceeding or cause of action, including any
settlement or other disposition thereof, for which Matrix seeks indemnification
under this Section. HMR shall have no obligation under this Section unless
Matrix (i) gives HMR prompt written notice of any claim or lawsuit or other
action for which it seeks to be indemnified under this Agreement, and (ii)
Matrix cooperates fully with HMR and its agents in defense of the claims or
lawsuit or other action.
15.7 Subject to Section 15.8, Matrix shall defend, indemnify and hold
harmless HMR and its officers, directors, shareholders, employees, successors
and assigns from and against any and all damages, claims, costs, losses
liabilities or expenses (including reasonable attorneys' fees) arising out of,
or resulting from or in connection with Matrix's activities under this
Agreement, including, but not limited to Matrix's activities related to
Development, or any breach of a representation or warranty made to HMR by Matrix
under this Agreement, except such damages, claims, costs, losses, liabilities or
expenses which are directly and proximately caused by HMR's negligent or
wrongful actions, provided HMR shall have the right to participate in the
defense of any such claim, complaint, suit, proceeding or cause of action
referred to in this Section utilizing attorneys of its choice, provided,
however, that Matrix shall have full authority and control to handle any such
claim, complaint, suit, proceeding or cause of action, including any settlement
or other disposition thereof, for which HMR seeks indemnification under this
Section. Matrix shall have no obligation under this Section unless HMR (i) gives
Matrix prompt written notice of any claim or lawsuit or other action for which
it seeks to be indemnified under this Agreement, and (ii) HMR cooperates fully
with Matrix and its agents in defense of the claims or lawsuit or other action.
19
15.8 As between Matrix and HMR, Matrix shall be solely responsible for
any Liabilities ("Matrix Liabilities") on or after the Effective Date during the
term of this Agreement caused in a country where Matrix held the rights granted
in this Agreement at the time the Matrix Liabilities were caused; provided
however, in the event that the rights granted in this Agreement shall revert to
HMR in any country for any reason, HMR shall be solely responsible for any
Liabilities ("HMR Liabilities") caused in any such country where HMR held such
reverted rights at the time the HMR Liabilities were caused. These obligations
shall survive the termination of this Agreement.
15.9 During the term of this Agreement and for a period of five (5)
years after its expiration or earlier termination, each party shall obtain
and/or maintain, respectively, at its sole cost and expense, product liability
insurance in amounts, respectively, which are reasonable and customary in the
U.S. pharmaceutical industry for companies of comparable size and activities.
Such product liability insurance shall insure against all liability, including
product liability, personal liability, physical injury or property damage. Each
party shall provide written proof of the existence of such insurance to the
other party upon request therefor.
16. FORCE MAJEURE
16.1 If the performance of any part of this Agreement by either party,
or of any obligation under this Agreement, is prevented, restricted, interfered
with or delayed by reason of any cause beyond the reasonable control of the
party liable to perform, unless conclusive evidence to the contrary is provided,
the party so affected shall, upon giving written notice to the other party, be
excused from such performance to the extent of such prevention, restriction,
interference or delay, provided that the affected party shall use its reasonable
best efforts to avoid or remove such causes of non-performance and shall
continue performance with the utmost dispatch whenever such causes are removed.
When such circumstances arise, the Parties shall discuss what, if any,
modification of the terms of this Agreement may be required in order to arrive
at an equitable solution.
17. GOVERNING LAW
17.1 This Agreement shall be construed and governed in accordance with
the law of the State of Delaware and the United States of America, without
giving effect to conflict of law provisions.
18. DISPUTE RESOLUTION
18.1 Any dispute, controversy or claim (except as to any issue relating
to intellectual property owned in whole or in part by HMR) arising out of or
relating to this Agreement, or the breach, termination, or invalidity thereof,
shall be settled by arbitration in accordance with the Commercial Arbitration
Rules of the American Arbitration Association, except as modified by this
Section 18.1. The number of arbitrators shall be three (3). The arbitration
decision shall be binding and not be appealable to any court in any
jurisdiction. No arbitrator (nor the panel of arbitrators) shall have the power
to award punitive damages under this Agreement and such award is expressly
prohibited. The prevailing party may enter such decision in any court having
20
competent jurisdiction. The arbitration proceeding shall be conducted in the
English language in New York, New York unless the Parties agree in writing to
conduct the arbitration in another location.
19. SEPARABILITY
19.1 In the event any portion of this Agreement shall be held illegal,
void or ineffective, the remaining portions hereof shall remain in full force
and effect.
19.2 If any of the terms or provisions of this Agreement are in
conflict with any applicable statute or rule of law, then such terms or
provisions shall be deemed inoperative to the extent that they may conflict
therewith and shall be deemed to be modified to conform with such statute or
rule of law.
19.3 In the event that the terms and conditions of this Agreement are
materially altered as a result of Sections 19.1 or 19.2, the Parties will
renegotiate the terms and conditions of this Agreement to resolve any
inequities.
20. ENTIRE AGREEMENT
20.1 This Agreement, entered into as of the Effective Date, constitutes
the entire agreement between the Parties relating to the subject matter hereof
and supersedes all previous writings and understandings. No terms or provisions
of this Agreement shall be varied or modified by any prior or subsequent
statement, conduct or act of either of the Parties, except that the Parties may
amend this Agreement by written instruments specifically referring to and
executed in the same manner as this Agreement.
21. NOTICES
21.1 Any notice required or permitted under this Agreement shall be
sent by certified mail or overnight courier service, postage pre-paid to the
following addresses of the Parties:
If to HMR: Hoechst Xxxxxx Xxxxxxx
Xxxxx 000-000
X.X. Xxx 0000
Xxxxxxxxxxx, XX 00000-0000
Attention: General Counsel
Telephone: (000) 000 0000
Facsimile: (000) 000 0000
21
With copies to: Hoechst Xxxxxx Xxxxxxx
Xxxxx 000-000
X.X. Xxx 0000
Xxxxxxxxxxx, XX 00000-0000
Attention: Vice President, Licensing & Alliances
Telephone: (000) 000 0000
Facsimile: (000) 000-0000
If to Matrix: Matrix Pharmaceutical, Inc.
00000 Xxxxxx Xxxxx
Xxxxxxx, XX 00000
Attention: Xxxxx X. Xxxxxxxx, Vice President
Telephone:(000) 000-0000
Facsimile:(000) 000-0000
With copies to: Xxxxxxx Phleger & Xxxxxxxx LLP
Two Embarcadero Place
0000 Xxxx Xxxx
Xxxx Xxxx, XX 00000-0000
Attention: J. Xxxxxxx Xxxxxxxxx, Esq.
Telephone:(000) 000-0000
Facsimile:(000) 000-0000
21.2 Any notice required or permitted to be given concerning this
Agreement shall be effective upon receipt by the party to whom it is addressed.
22. ASSIGNMENT
22.1 This Agreement and the licenses herein granted shall be binding
upon and inure to the benefit of the successors in interest of the respective
Parties. Neither this Agreement nor any interest hereunder shall be assignable
by either party without the written consent of the other provided, however, that
either party may assign this Agreement or any Patent owned by it to any
Affiliate or to any corporation with which it may merge or consolidate, or to
which it may transfer all or substantially all of its assets to which this
Agreement relates, without obtaining the consent of the other party.
23. EXECUTION IN COUNTERPARTS
23.1 This Agreement may be executed in any number of counterparts, each
of which shall be deemed an original, but all of which together shall constitute
one and the same instrument.
22
23.2 IN WITNESS WHEREOF, the Parties, through their authorized
officers, have executed this Agreement as of the date first written above.
HOECHST XXXXXX XXXXXXX INC. MATRIX PHARMACEUTICAL, INC.
By: ________________________________ By: ________________________________
Name: ______________________________ Name: _______________________________
Title: _____________________________ Title: ______________________________
23
APPENDIX A-PATENTS
[*]
* Indicates that material has been omitted and confidential treatment has been
requested therefore. All such omitted material has been filed separately with
the Commissioner pursuant to Rule 24b-2.
APPENDIX B
[*]
* Indicates that material has been omitted and confidential treatment has been
requested therefore. All such omitted material has been filed separately with
the Commissioner pursuant to Rule 24b-2.
APPENDIX C DEVELOPMENT PLAN
[*]
* Indicates that material has been omitted and confidential treatment has been
requested therefore. All such omitted material has been filed separately with
the Commissioner pursuant to Rule 24b-2.
