EXHIBIT 10.30
Confidential Treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designed as ****. A complete version of this exhibit has been
filed separately with the Securities and Exchange Commission.
EXCLUSIVE PATENT LICENSE AGREEMENT
between
AVENTIS BEHRING GMBH
AND
ZYMOGENETICS, INC.
This Exclusive Patent License Agreement (the "Agreement") is effective as of
December 18, 2002 ("Effective Date") by and between Aventis Behring GmbH
("Licensor"), a German corporation having a principal place of business at
Emil-von-Behring-Strasse 76, D-35041 Marburg, Germany, and ZymoGenetics, Inc.
("Licensee"), a Washington corporation having a principal place of business at
1201 Eastlake Avenue East, Seattle, Washington 98102.
WITNESSETH
WHEREAS, Licensor and Licensee are parties to Interference No. ****
relating to Factor XIII pending in the United States Patent and Trademark office
involving certain patent applications owned or controlled by Licensee and a
patent application within the "Licensed Patents" (as hereinafter defined) owned
by Licensor;
WHEREAS, Licensor is a successor to certain patent rights of Behringwerke
Aktiengesellschaft, which previously entered into a Cross License Agreement with
Hoechst Japan, Ltd. and Licensee relating to Factor XIII dated May 3, 1993
regarding certain patents and patent applications owned or controlled by
Licensee and certain patents and patent applications within the Licensed Patents
owned or controlled by Licensor ("Cross License Agreement");
WHEREAS, Licensor is the present owner or exclusive licensee of the
Licensed Patents;
WHEREAS, Licensee desires to modify certain licenses granted under the
Cross License Agreement as such licenses relate to Licensor and Licensee and
obtain from Licensor an exclusive worldwide license under the Licensed Patents
in the Field of Use for Licensed Products in accordance with the terms of this
Agreement;
**** designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the commission.
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WHEREAS, Licensor is willing to modify certain licenses granted under the
Cross License Agreement as such licenses relate to Licensor and Licensee and
grant an exclusive worldwide license under the Licensed Patents in the Field of
Use for Licensed Products to Licensee on the terms and conditions set forth
herein;
NOW THEREFORE, in consideration of the mutual covenants contained herein,
it is agreed by the parties as follows:
1. DEFINITIONS
1.1 Affiliate means any company, corporation, business or entity controlled
by, controlling, or under common control with either Licensee or Licensor.
"Control" means direct or indirect beneficial ownership of at least fifty
percent (50%) interest in the voting stock (or the equivalent) of such
corporation or other business or having the right to direct, appoint or remove a
majority or more of the members of its board of directors (or their equivalent).
1.2 Biologically Active Substance means any substance other than Recombinant
Factor XIII that has intrinsic biological or cell stimulatory activity but not
including substances or compounds whose primary function is to act as a vehicle
for the delivery of Licensed Product, including but not limited to stabilizing
agents, excipients and adjuvants.
1.3 Combination Product means a Licensed Product that includes one or more
Biologically Active Substance(s) to achieve the desired therapeutic response.
1.4 Field of Use means the prevention, diagnosis or treatment of any disease
or condition in humans or animals.
1.5 First Commercial Sale means the first sale of any Licensed Product by
Licensee or its Affiliates or Sublicensees to a bona fide independent third
party.
1.6 Licensed Patents means: (a) the patents and the patent applications set
forth in Exhibits A and B (attached hereto) and made part of this Agreement; (b)
all parent, provisional, divisional, continuation (in whole or in part) or
substitute applications with respect to any of the patent applications described
in 1.6(a); (c) any other patent applications, both U.S. and foreign, based on
the patent applications described in 1.6(a) or 1.6(b); (d) all issued or granted
patents resulting from any of the patent applications described above; and (e)
all issued or granted reissue, re-examination, renewal or extension patents,
supplementary protection certificates, and confirmation or registration patents
or patents of addition based on any of the patents described in 1.6(a) or
1.6(d).
1.7 Licensed Product(s) means any product that contains Recombinant Factor
XIII and is covered by a Valid Claim of an issued patent falling within the
Licensed Patents or that, but for this Agreement, would infringe a Valid Claim
of an issued patent falling within the Licensed Patents.
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1.8 Net Sales means the amounts invoiced by Licensee or its Affiliates or
its Sublicensees during the Term of this Agreement for the sale of Licensed
Products to bona fide independent third parties, less deductions for: (i) normal
and customary rebates, and cash and trade discounts, actually taken, including
without limitation chargebacks, retroactive price reductions or other
adjustments to pricing of sales to government agencies; (ii) sales, use and/or
other excise taxes, custom duties, surcharges or other governmental charges
(other than taxes imposed on or measured by net income) actually paid in
connection with sales of Licensed Products; (iii) the cost of any bulk packages
and packing, prepaid freight charges and insurance; (iv) amounts actually
allowed or credited due to returns paid; and (v) amounts written off for bad
debt and uncollectable receivables. Transfers of a Licensed Product among
Licensee and its Affiliates or Sublicensees for sale by such Affiliates or
Sublicensees shall not be considered a sale for purposes of calculating Net
Sales. In the event that a Licensed Product is sold as a Combination Product,
Net Sales for purposes of calculating royalty payments on the Combination
Product shall be calculated by multiplying Net Sales of the Combination Product
by the fraction C/(C+D), where C is the fully allocated cost of the Combination
Product (excluding the fully allocated cost of the other Biologically Active
Substance contained therein) and D is the fully allocated cost of the other
Biologically Active Substance. The distribution of (i) reasonable quantities of
free promotional samples of Licensed Product, or (ii) Licensed Product provided
for clinical trials or research purposes shall not be considered a sale of
Licensed Product for royalty purposes.
1.9 Recombinant Factor XIII means a protein having the amino acid sequence of
naturally occurring factor XIII and that is produced by recombinant DNA
techniques, including without limitation production in prokaryotic and
eukaryotic host cells and transgenic animals, as well as variants, derivatives,
modifications, fragments, hybrids, mutants, conjugates, fusion proteins,
analogs, orthologs and homologs thereof.
1.10 Single Agent Product means a Licensed Product that contains no additional
Biologically Active Substance(s) to achieve the desired therapeutic response.
1.11 Sublicensee means any non-Affiliate to whom Licensee grants a sublicense
of some or all of the rights granted to Licensee under this Agreement.
1.12 Territory means the entire world.
1.13 Valid Claim means a claim of an issued and unexpired patent within the
Licensed Patents that has not lapsed or become abandoned or been held
permanently revoked, unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, unappealable or unappealed within
the time allowed for appeal, and that has not been admitted to be invalid or
unenforceable through reissue or disclaimer or otherwise.
2. GRANT
2.1 Exclusive License. Licensor hereby grants to Licensee and Licensee hereby
accepts from Licensor, upon the terms and conditions herein specified, an
exclusive license under the Licensed
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Patents in the Territory, and in the Field of Use to develop, make, have made,
import, have imported, use, offer for sale, sell, have sold and otherwise
commercialize Licensed Product(s). For the avoidance of doubt, the exclusive
license granted hereby relates solely to Recombinant Factor XIII.
2.2 Sublicenses. Licensor hereby grants to Licensee and Licensee hereby
accepts from Licensor, upon the terms and conditions herein specified, the right
to grant sublicenses under the Licensed Patents. Each sublicense granted by
Licensee shall be consistent with the terms and conditions of this Agreement,
and Licensee shall remain responsible to Licensor for the compliance of each
such Sublicensee with the financial and other obligations under this Agreement.
Licensee shall promptly notify Licensor of each sublicense granted including the
identity of the Sublicensee.
3. TERM AND TERMINATION
3.1 Term. The term of this Agreement shall be for a period beginning with the
Effective Date and extending, on a country-by-country basis, until the
expiration of the last to expire Valid Claim that covers a Licensed Product in
that country. Licensee's obligation to pay royalties shall expire on a
country-by-country basis.
3.2 Termination by Licensee. This Agreement may be terminated by Licensee,
with or without cause, upon thirty (30) days written notice to Licensor.
3.3 Termination for Breach. In the event that Licensee commits any material
breach of this Agreement, unless this Agreement provides a different remedy, the
Licensor at its option, may terminate this Agreement by giving Licensee written
notice of its election to terminate as of a stated date, not less than sixty
(60) days from such stated termination date. Such notice shall state the nature
of the defaults claimed by Licensor. During said sixty (60) day period, Licensee
may cure any default stated in said notice, and if such default is cured, or, if
such default will take longer than sixty (60) days to cure and Licensee is
diligently pursuing such cure, this Agreement shall continue in full force and
effect as if such notice had not been given. Notwithstanding the foregoing, if
Licensee disputes in good faith that the claimed breach exists, such sixty (60)
day period will not start to run until such dispute has been resolved.
3.4 Effect of Termination. If this Agreement is terminated prior to its
expiration, upon such termination Licensee shall cease all production and sale
of Licensed Products except for the production and sale of Licensed Products on
which production is complete prior to receipt of the notice of such termination.
Licensee may continue to sell such Licensed Products for up to one hundred and
eighty (180) days after such notice and shall pay to Licensor any royalties or
milestones that may accrue on such sales.
3.5 Survivability. Articles 1, 6, 8, 9 and 10, and Sections 3.4, 3.5 and 5.3,
and, with respect to amounts accruing prior to expiration or termination,
Sections 4.2, 4.3, 4.4, 4.5 and 4.6 hereof shall survive termination or
expiration of this Agreement.
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4. FEES AND ROYALTIES
4.1 License Issue Fee. Upon execution and delivery of this Agreement,
Licensee will pay Licensor the sum of **** by wire transfer to an account
designated in writing by Licensor.
4.2 Royalties. Licensee shall pay or cause to be paid to Licensor a royalty
equal to **** of Net Sales of Licensed Product, the manufacure, sale or use of
which is covered by a Valid Claim of an issued patent falling within the
Licensed Patents in the country of such manufacture, sale or use. If Licensed
Product is sold by a Sublicensee, then in connection with such sales Licensee
shall pay Licensor the amount set forth in this Section 4.2 using Net Sales as
reported to Licensee by the Sublicensee as Net Sales by Licensee. Regardless of
the number of Licensed Patents covering a particular Licensed Product, only one
royalty will be due with respect to such Licensed Product.
4.3 Milestone Payments. Licensee shall provide Licensor written notice within
thirty (30) days after the achievement of the milestone event set forth below,
whether achieved by the Licensee, an Affiliate or a Sublicensee. With such
written notice, Licensee shall pay to Licensor the corresponding amount set
forth below:
-------------------------------------------------------------------------
MILESTONE AMOUNT
-------------------------------------------------------------------------
**** ****
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For the avoidance of doubt, the parties understand and agree that only a single,
one-time payment shall be due Licensor under this Section 4.3.
4.4 Schedule and Form of Payment/Taxes. Licensee shall pay royalties, if any,
on a quarterly basis commencing on the date of First Commercial Sale of a
Licensed Product and payments shall be due and payable with the reports required
by this Section 4.4 within sixty (60) days following the close of the relevant
calendar quarterly period. Each such payment shall be accompanied by a report
for the period covered showing total number or volume of Licensed Products sold
and identified as Net Sales on a country by country basis, the exchange rate
used to convert any payments into United States dollars, and total royalties
due. All amounts payable to
**** designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the commission.
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Licensor hereunder shall be payable in United States funds. Licensee, if
required by applicable law, shall be responsible for the payment of all
withholding taxes imposed by any country on any royalty payable to Licensor
hereunder and shall withhold such taxes from the amounts payable to Licensor
hereunder. Notwithstanding the foregoing, if the law of any foreign country
prevents any payment payable to Licensor hereunder to be made in the United
States of America or prevents any such payment to be made in United States
dollars, Licensor agrees to accept such royalty in form and place as permitted,
including deposits by Licensee in the applicable foreign currency in a local
bank or banks in such country designated by Licensee. If any currency conversion
is required in connection with any payment to Licensor hereunder, such
conversion shall be made at the buying rate for the transfer of such other
currency as published in the United States in The Wall Street Journal under the
caption "Currency Trading" on the last business day of the applicable accounting
period, in the case of any payment payable with respect to a specified quarterly
period.
4.5 Records. Licensee shall maintain complete and accurate records sufficient
to enable accurate calculation of royalties due Licensor under this Agreement.
Not more than once a calendar year, and not more than three (3) years following
the relevant accounting period, Licensor shall have the right to select a
certified public accountant reasonably acceptable to Licensee to inspect, on not
less than thirty (30) days prior written notice and during regular business
hours, the records of Licensee necessary to verify Licensee's statement and
royalty payments due pursuant to this Agreement. Licensee agrees to provide
reasonable access to the books, records and premises of Licensee; provided,
however, that such access shall be limited to those books and records necessary
to verify the accuracy of the payment made by Licensee to Licensor pursuant to
this Agreement. Such accountant shall not disclose to Licensee any information
other than information relating to the accuracy of the reports and the
calculation of the amounts due to Licensor made under this Agreement. All
financial information disclosed to such accountant or Licensor under this
Section 4.5 shall be considered the Confidential Information of Licensee. The
entire cost for such inspection shall be borne by Licensor unless there is a
discrepancy of greater than, or equal to, ten percent (10%) in Licensee's favor
in which case Licensee shall bear the entire cost of the inspection and audit.
Records shall be preserved by Licensee for at least three (3) years following
the relevant accounting period for inspection by Licensor.
4.6 Payments Based on Audit Results. In the event an inspection conducted in
accordance with Section 4.5 hereinabove shows an undisputed discrepancy in favor
of either party, the party benefiting from the discrepancy shall, within thirty
(30) days of receiving notice of such discrepancy, make a payment to the other
party such that the amount paid hereunder shall conform to the amount so
determined to be payable.
5. PROSECUTION AND MAINTENANCE OF PATENT RIGHTS
5.1 Right to Prosecute and Maintain Licensed Patents. During the term hereof,
Licensee, with respect to the Licensed Patents set forth in Exhibit A, and
Licensor, with respect to the Licensed Patents set forth in Exhibit B, shall
have the right, but not the obligation, at its own cost
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and expense, to file, prosecute and maintain such Licensed Patents. Each party
shall render the other party such assistance as the latter may reasonably
require to comply with said obligations. Should Licensee, with respect to the
Licensed Patents set forth in Exhibit A, or Licensor, with respect to the
Licensed Patents set forth in Exhibit B, wish to finally abandon any one or more
of such Licensed Patents or cease the maintenance thereof, it shall notify the
other party not less than sixty (60) days prior to any action required to
preserve such Licensed Patents, and shall offer the other party a right to
prosecute and maintain such Licensed Patents. The other party shall notify
Licensee or Licensor, as appropriate, within sixty (60) days of receipt of
Licensee's or Licensor's notification of its intent to assume such prosecution
and maintenance rights that Licensee or Licensor wishes to abandon or cease
maintaining. The other party shall thereafter have the right, but not the
obligation, to pursue the prosecution and maintenance of such Licensed Patents
at its sole expense, and Licensee or Licensee, as appropriate, shall provide
such assistance and execute such documents as are necessary to assist the other
party in such prosecution and maintenance. The other party shall thereafter
assume all costs and expenses related to such Licensed Patents.
5.2 Assistance and Communication. Licensee, with respect to the Licensed
Patents set forth in Exhibit A, and Licensor, with respect to the Licensed
Patents set forth in Exhibit B, shall have exclusive control over the
prosecution of such Licensed Patents before all national and international
patent offices. The other party shall cooperate with Licensee or Licensor, as
appropriate, and shall render all reasonable assistance to Licensee or Licensor
in preparing, filing and prosecuting such Licensed Patents. Licensee or
Licensor, as appropriate, agrees to provide the other party with copies of all
correspondence to and from the U.S. Patent and Trademark Office and other
national and international patent offices regarding the prosecution of such
Licensed Patents. Notwithstanding the foregoing, this Section 5.2 shall not
apply to currently pending Interference No. ****
5.3 Patent Extensions. Licensee shall have the sole right to apply for any
extensions, supplementary protection certificates and the like for any of the
Licensed Patents set forth in Exhibit A and Licensor shall render Licensee such
assistance as Licensee may reasonably require therefore.
5.4 Marking. Licensee shall comply with all applicable United States and
foreign laws, rules and regulations related to the marking of Licensed Products
and their packaging with patent pending, patent number(s), or other intellectual
property notices and legends required by law to maintain the Licensed Patent
Rights.
**** designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the commission.
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6. CONFIDENTIALITY
6.1 Confidential Information. It may be necessary for one party to disclose
to the other party certain confidential or proprietary information.
"Confidential Information" means information related to the business of Licensee
or to the business of Licensor and includes, without limitation, information
exchanged by the parties in anticipation of this Agreement, all tangible and
intangible information relating to scientific data, analyses and projections;
intellectual property, trade secrets, know how, products and product candidates,
business, strategies, operations, systems, software, ideas, financial
information, contracts, business documents, and business records together with
analysis, compilations, studies and other documents, in whatever form furnished,
prepared or stored, whether prepared by a party, its representatives or others,
which are based upon, incorporate or otherwise reflect such information.
Disclosures hereunder may be made orally and in writing, but all oral
disclosures shall be reduced to writing and forwarded to the receiving party
within thirty (30) days of such oral disclosure, and shall be designated as
confidential. During the term of this Agreement and for five (5) years
thereafter, the party receiving Confidential Information of the other party
agrees not to disclose such Confidential Information and not to use it for any
purposes except those specifically allowed in this Agreement. Confidential
Information shall not include information that:
(a) is now in the public domain or which becomes generally available to
the public through no fault of the receiving party;
(b) is already known to, or in the possession of, the receiving party
prior to disclosure by the disclosing party as can be demonstrated by written
evidence;
(c) is disclosed on a non-confidential basis to the receiving party by a
third party having no obligation of confidentiality, directly or indirectly, to
the disclosing party;
(d) is independently developed by or for the receiving party (by activity
not associated with the Licensed Patent Rights) as can be demonstrated by
written evidence; or
(e) is required to be disclosed by order of any court or governmental or
regulatory authority, but only after notification to the providing party by the
receiving party of such requirement in order to allow the providing party to
seek protection for the providing party's Confidential Information from such
court or governmental or regulatory authority.
6.2 Permitted Disclosures. Notwithstanding the foregoing, Licensee may
disclose Confidential Information of Licensor to the extent such disclosure is
reasonably required for filing and prosecuting patent applications, prosecuting
or defending litigation, complying with applicable governmental regulations and
obtaining regulatory approvals.
6.3 Terms of the Agreement. Neither party shall disclose the terms and
conditions of this Agreement to any third party without the prior written
consent of the other party, except as required by applicable law or to third
parties with whom Licensor or Licensee has entered into or
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proposes to enter into a business relationship, provided that such third party
has entered into a confidentiality agreement with the party wishing to disclose
such information.
7. INTERFERENCE, OPPOSITION, ENFORCEMENT AND DEFENSE
7.l Interference. In the event an interference is declared by the U.S. Patent
and Trademark Office involving one or more of the Licensed Patents, then the
party receiving notice of such interference shall promptly notify the other
party in writing. Licensee, with respect to the Licensed Patents set forth in
Exhibit A, and Licensor, with respect to the Licensed Patents set forth in
Exhibit B, shall have exclusive control at its own expense over the conduct of
the interference. The other party, at no out-of-pocket expense to it, shall
provide reasonable assistance to and cooperate with Licensee or Licensor, as
appropriate, in any such interference upon Licensee's or Licensor's request.
Notwithstanding the foregoing, this Section 7.1 shall not apply to currently
pending Interference No. ****.
7.2 Opposition. In the event that one or more Licensed Patents are subject to
an opposition proceeding, then the party receiving notice of such opposition
shall promptly notify the other party in writing. Licensee, with respect to the
Licensed Patents set forth in Exhibit A, and Licensor, with respect to the
Licensed Patents set forth in Exhibit B, shall have exclusive control at its own
expense over the conduct of the opposition. The other party, at no out-of-pocket
expense to it, shall provide reasonable assistance to and cooperate with
Licensee or Licensee, as appropriate, in any such opposition upon Licensee's or
Licensor's request.
7.3 Enforcement by Licensee. In the event that either party becomes aware of
any infringement relating to Licensed Products by a third party of any of the
Licensed Patent Rights set forth in Exhibit A, it shall promptly notify the
other party in writing (including evidence establishing a prima facie case of
infringement by such third party). Licensee shall have the sole right, but not
the obligation, to initiate and control the prosecution, defense and settlement
(including without limitation the right to sublicense alleged infringers), at
its own expense, of any infringements by third parties of any such Licensed
Patents. If Licensor is required to join any such legal action as a necessary
party and retain independent legal counsel because of a conflict of interest
between Licensee and Licensor, Licensee shall pay the reasonable legal fees for
such independent legal counsel selected by Licensor and reasonably acceptable to
Licensee. Licensor will cooperate fully with Licensee in all reasonable
respects, including without limitation, permitting its employees and appointees
to testify when requested and making available relevant records, papers,
information, samples, specimens and the like and Licensee will reimburse
Licensor for all reasonable out-of-pocket costs incurred at Licensee's request
in connection therewith. The total cost, including legal fees, expenses,
judgments, penalties and liabilities of such infringement action shall be borne
by Licensee, and all damages or other proceeds from any judgment or settlement
will be awarded solely to Licensee.
**** designates portions of this document that have been omitted pursuant to a
request for confidential treatment filed separately with the commission.
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7.4 Enforcement by Licensor. In the event that either party becomes aware of
any infringement related to Licensed Products by a third party of any of the
Licensed Patent Rights set forth in Exhibit B, it shall promptly notify the
other party in writing (including evidence establishing a prima facie case of
infringement by such third party). Licensor shall have the first right, but not
the obligation, to initiate and control the prosecution and defense, at its own
expense, of any infringements by third parties of any such Licensed Patents. If
Licensee is required to join any such legal action as a necessary party and
retain independent legal counsel because of a conflict of interest between
Licensee and Licensor, Licensor shall pay the reasonable legal fees for such
independent legal counsel selected by Licensee and reasonably acceptable to
Licensor. Licensee will cooperate fully with Licensor in all reasonable
respects, including without limitation, permitting its employees and appointees
to testify when requested and making available relevant records, papers,
information, samples, specimens and the like and Licensor will reimburse
Licensee for all reasonable out-of-pocket costs incurred at Licensor's request
in connection therewith. The total cost, including legal fees, expenses,
judgments, penalties and liabilities of such infringement action shall be borne
by Licensor, and all damages or other proceeds from any judgment will be awarded
solely to Licensor. Notwithstanding the foregoing, in the event that Licensor
fails to take action with respect to any such third party infringement related
solely to Recombinant Factor XIII within sixty (60) days of receiving notice of
such infringement, or desires to enter into a settlement with respect to such
third party infringement related solely to Recombinant Factor XIII, then
Licensee shall have the right to take such action and/or control such
settlement, in which event the provisions of Section 7.3 shall apply.
7.5 Declaratory Judgment Action. In the event a third party brings an action
to obtain a declaration of patent invalidity against one or more Licensed
Patents, Licensee, with respect to the Licensed Patents set forth in Exhibit A,
and Licensor, with respect to the Licensed Patents set forth in Exhibit B, shall
have the sole right to defend such action at its own cost and expense, and to
control any ensuing litigation. Notwithstanding the foregoing, in the event that
Licensor elects not to defend any such declaratory judgment action related
solely to Recombinant Factor XIII, or desires to enter into a settlement with
respect to such declaratory judgment action related solely to Recombinant Factor
XIII, it shall give timely notice to Licensee, in which event Licensee shall
have the right to defend such declaratory judgment action and/or control such
settlement, at Licensee's own cost and expense, and to control any ensuing
litigation.
8. REPRESENTATIONS AND WARRANTIES
8.1. Representations, Warranties and Covenants of Licensor and Licensee. Each
party represents and warrants to and covenants with the other party that:
(a) it is a corporation duly organized, validly existing and in
corporate good standing under the laws of the State of Washington, in the case
of Licensee, and the laws of Germany, in the case of Licensor; and
(b) it has the corporate and legal right, title, authority and power to
enter into this Agreement and to perform its obligations hereunder; and
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(c) it has taken all necessary action to authorize the execution, delivery
and performance of this Agreement; and
(d) upon the execution and delivery of this Agreement, this Agreement
shall constitute a valid and binding obligation of such party, enforceable in
accordance with its terms, except as enforceability may be limited by applicable
bankruptcy, insolvency, reorganization, moratorium or similar laws affecting
creditors' and contracting parties' rights generally; and
(e) the performance of its obligations under this Agreement will not
conflict with or result in a breach of any agreements, contracts or other
arrangements to which it is a party; and
(f) it will not during the term of this Agreement enter into any
agreements, contracts or other arrangements that would prevent it from meeting
its obligations or conflict with the other party's rights under this Agreement;
and
(g) it will comply with all applicable laws, rules, regulations and
guidelines in connection with the activities conducted by it pursuant to this
Agreement, including but not limited to all applicable product safety, product
testing, product labeling, package marking and product advertising laws and
regulations and the regulations of the United States and any other relevant
nation concerning any export or other transfer of technology, services or
products.
8.2 Representations, Warranties and Covenants of Licensor. Licensor represents
and warrants to and covenants with License that:
(a) it is the sole and current owner or exclusive licensee of the Licensed
Patents and that it has the right to grant the licenses granted hereunder; and
(b) there are no other patents or patent applications owned or controlled
by Licensor that cover the manufacture, use, importation, or sale of Recombinant
Factor XIII as a Single Agent Product or as a component of a Combination Product
other than the Licensed Patents; and
(c) according to the Joint Venture Agreement dated February 22, 1995
which formed Centeon Pharma GmbH, the predecessor corporation of Aventis
Behring GmbH), Aventis Behring GmbH with respect to its parent company and
related affiliates (including Hoechst Japan, Ltd., now Aventis Pharma Ltd.,
Japan), has jointly with Aventis Behring L.L.C. the exclusive, worldwide right
to operate in the field of therapeutics and prophylaxis for blood and blood
plasma derivative products including recombinant substitutes and synthetic
equivalents for such products, including without limitation Recombinant Factor
XIII; and
(d) Aventis Pharma Ltd., Japan has no right to develop, sell or otherwise
commercialize any of the products referred to in Section 8.2 (c) hereinabove
anywhere in the world or grant licenses or sublicenses to third parties to
develop, sell or otherwise commercialize any such products anywhere in the world
and Licensor shall not, during the term of this Agreement, enter into or modify
any agreement, contract or other arrangement to grant Aventis Pharma Japan, Ltd.
any such right for any product containing Recombinant Factor XIII.
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8.3 Certain Japanese Patent Rights. Licensor shall use commercially reasonably
efforts to have Aventis Pharma Ltd., Japan, the successor corporation of Hoechst
Japan, Ltd., assign the following patents and patent applications to Licensor:
****. Licensor shall promptly notify Licensee of the occurrence of such
assignments, whereupon, without further action on the part of Licensor or
Licensee, the patent application set forth in Section 8.3 (a) shall be added to
Exhibit A of this Agreement and the remaining patents and patent applications
set forth in this Section 8.3 shall be added to Exhibit B of this Agreement. All
such patents and patent applications shall be considered to be Licensed Patents
subject to the terms and conditions of this Agreement.
8.4 Termination of Cross License Agreement. Licensor shall use commercially
reasonable efforts to have Aventis Pharma Ltd., Japan, the successor corporation
of Hoechst Japan, Ltd., assign its interest in the Cross License Agreement to
Licensor. Licensor shall promptly notify Licensee in writing of the occurrence
of such assignment, whereupon Licensee and Licensor shall amend this Agreement
to terminate the Cross License Agreement, provided, however, the license granted
by Hoechst Japan, Ltd. to ZymoGenetics, Inc. under the Cross License Agreement
to the HJL Licensed Patent Rights (as defined in the Cross License Agreement)
shall remain in full force and effect until the patents and patent applications
set forth in Section 8.3 hereinabove have been licensed by Licensor to Licensee
as provided therein.
8.5 Representations, Warranties and Covenants of Licensee. Licensee represents
and warrants to and covenants with Licensor that it shall use commercially
reasonable efforts to develop and commercialize Licensed Product(s).
8.6 Warranty Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS
AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY WITH RESPECT TO THE LICENSED
PATENTS, GOODS, SERVICES OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY
DISCLAIMS WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND
NON-INFRINGEMENT WITH RESPECT TO ANY AND ALL OF THE FOREGOING.
9. INDEMNIFICATION
9.1 Personal Injury or Property Damage. Licensee shall indemnify and hold
Licensor and its Affiliates and their respective directors, officers, employees
and agents harmless from and against any and all claims, judgments, costs,
awards, expenses (including, but not limited to, any attorney's fees) or
liability of any kind arising out of any activities performed by Licensee and
its Affiliates or Sublicensees pursuant to this Agreement, including without
limitation personal
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injury or property damage caused or alleged to be caused by a Licensed Product.
In addition, Licensee shall assume all obligations for warranties and product
liability claims that accompany or result from the sale or use of a Licensed
Product; and shall indemnify and hold Licensor harmless from and against any and
all claims, judgments, costs, awards, expenses (including, but not limited to,
any attorney's fees) or liability of any kind arising from customers and
relating to such warranty obligations or product liability claims. Licensee's
obligation to indemnify Licensor under this Section 9.1 shall not apply to the
extent caused by the gross negligence or willful misconduct of or breach of this
agreement by Licensor.
9.2 Patent Infringement. Licensee shall indemnify and hold Licensor and its
Affiliates and their respective directors, officers, employees and agents
harmless from and against any and all claims, judgments, costs, awards, expenses
(including, but not limited to, any attorney's fees) or liability of any kind
arising out of or connected with the actual or alleged infringement of any
patent or other proprietary right of third parties by reason of Licensee's and
its Affiliates' or Sublicensee's making, having made, using, importing, offering
for sale, selling or having sold any Licensed Product, provided, however, that
in the event a suit, claim or action is brought against Licensee and its
Affiliates or Sublicensee(s) by a third party, Licensor shall render all
reasonable assistance to Licensee upon request of Licensee, at Licensee's cost
and expense in connection therewith. Licensee's obligation to indemnify Licensor
under this Section 9.2 shall not apply to the extent caused by the gross
negligence or willful misconduct of or breach of this Agreement by Licensor.
9.3 Notification. It shall be a condition precedent to Licensee's
indemnification obligations under Sections 9.1 and 9.2 hereinabove that each
person or entity seeking indemnification hereunder must (a) promptly notify
Licensee of the assertion of any claims, legal proceedings or causes of action
(collectively, "Claims") against it/him/her, (b) authorize and permit Licensee
to conduct and exercise sole control of the defense and disposition (including
all decisions relative to litigation, appeal or settlement) of such Claims, and
(c) fully cooperate with Licensee regarding any such Claims (including access to
pertinent records and documents and provision of relevant testimony) and in
determining the scope of Licensee's obligations hereunder.
10. GENERAL PROVISIONS
10.1 Severability. If any provision of this Agreement shall be found by a court
of competent jurisdiction to be void, invalid or unenforceable, the same shall
either be conformed to the extent necessary to comply with applicable law or
stricken if not so conformable, so as not to affect the validity of this
Agreement. Captions and paragraph headings are for convenience only and shall
not form an interpretive part of this Agreement.
10.2 Notices. All notices, requests, demands, waivers, consents, approvals or
other communications hereunder shall be in writing and shall be deemed to have
been duly given if delivered personally, faxed with receipt acknowledged (and
with a confirmation copy also sent by first class mail, return receipt
requested), delivered by a recognized commercial courier service with receipt
acknowledged, or mailed by registered or certified mail, return receipt
requested, postage prepaid, as follows:
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If to Licensor: Aventis Behring GmbH
Emil-von-Behring-Strasse 76,
D-35041 Marburg, Germany
Attention: Head of Patent Department
With a copy to: Aventis Behring L.L.C.
1020 First Avenue
P.O. Box 61501
King of Prussia, PA 19406
Attention: General Counsel
If to ZGI: ZymoGenetics, Inc.
1201 Eastlake Avenue East
Seattle, WA 98102
Attention: Vice President, Intellectual Property and Legal
Affairs
or to such other addresses as the addressee may have specified in a notice duly
given to the sender as provided herein. Such notice, request, demand, waiver,
consent, approval or other communication will be deemed effective as of the date
received.
10.3 Force Majeure. Neither party to this Agreement shall be liable for delay
or failure in the performance of any of its obligations hereunder if such delay
or failure is due to causes beyond its reasonable control, including, without
limitation, acts of God, fires, earthquakes, strikes and labor disputes, acts of
war, acts of terrorism, civil unrest, or intervention of any governmental
authority, but any such delay or failure shall be remedied by such party as soon
as is reasonably possible.
10.4 Assignments. This Agreement may be assigned by either party without the
written prior consent of the other party. The assigning party shall notify the
other party of such assignment within thirty (30) days of the occurrence
thereof. This Agreement shall inure to the benefit of and be binding on the
parties' assigns and successors in interest. The parties hereto agree that each
is acting as an independent contractor and not as an agent or partner of the
other by virtue of this Agreement.
10.5 Waivers and Modifications. The failure of any party to insist on the
performance of any obligation hereunder shall not act as a waiver of such
obligation. No waiver, modification, change, release, or amendment of this
Agreement or any obligation under this Agreement shall be valid or effective
unless in writing and signed by both parties hereto.
10.6 Choice of Law and Jurisdiction. This Agreement is subject to and shall be
construed and enforced in accordance with the laws of the State of Delaware
without reference to its choice of law provisions.
10.7 Entire Agreement. This Agreement constitutes the entire understanding
between the
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parties with respect to the subject matter hereof, and supercedes and replaces
all prior negotiations, representations, agreements and understandings and
writings between the parties as to said subject matter, excluding the Cross
License Agreement. Notwithstanding the foregoing:
(a) the Interference Settlement Agreement dated November 1, 1997 between
Hoechst Aktiengesellschaft and Zymogenetics, Inc. shall remain in full force and
effect in accordance with its terms; and
(b) subject to Section 10.7 (c)hereinbelow, Licensor shall have no rights
in any ZymoGenetics Patent Rights (as defined in the Cross License Agreement);
and
(c) Licensee agrees that it shall not assert the ZymoGenetics Licensed
Patent Rights (as defined in the Cross License Agreement) corresponding to
United States Serial Nos. **** set forth in Appendix A of the Cross License
Agreement, against Licensor, its Affiliates or sublicensees with respect to the
manufacture, use, importation or sale of any Factor XIII product isolated and
purified from human plasma; and
(d) the license granted by Behringwerke Aktiengesellschaft to
ZymoGenetics, Inc. under the Cross License Agreement under the Behringwerke
Licensed Patent Rights (as defined in the Cross License Agreement), and all
terms and conditions of the Cross License Agreement applicable to such license,
shall be replaced in its entirety by this Agreement.
10.8 Recording and Further Assurances. Licensee may record this Agreement in
each place necessary or convenient to perfect, protect or otherwise evidence
Licensee's rights hereunder. Each party agrees, promptly upon request, to
execute such further documents as the other party may reasonably request for the
purpose of making effective the rights of such party under this Agreement, at
the sole expense of the party so requesting.
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10.9 Publicity. The parties shall not use or permit to be used by any other
person or entity the name of the other party or any adaptation thereof, or the
name of the other party's employees in any advertising, promotional or sales
literature without the prior written permission of the other party.
IN WITNESS WHEREOF, the parties have duly executed this Agreement as of the
Effective Date.
AVENTIS BEHRING GMBH ZYMOGENETICS, INC.
By: /s/ Lauppe By: /s/ Bruce L.A. Carter, Ph.D
---------------------- ----------------------------
Name: Lauppe Name: Bruce L.A. Carter, Ph.D
---------------------- ----------------------------
Its: Senior Director Its: President and CEO
---------------------- ----------------------------
By: /s/ Matthias Runge
----------------------
Name: M. Runge
----------------------
Its: Senior Director
----------------------
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request for confidential treatment filed separately with the commission.
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