Exhibit 10.50
*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(B)(4),
AND 240.24B-2
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this "AGREEMENT") is made as of this 7th day of
July, 2003 (the "EFFECTIVE DATE"), by and between I.D.M. Immuno-Designed
Molecules S.A., a company organized under the laws of France ("IDM") with a
capital of [...***...] euros, and Epimmune Inc., a corporation organized under
the laws of DelawaRE ("EPIMMUNE"). Epimmune and IDM may each be referred to
herein individually as a "PARTY" and collectively, as the "PARTIES."
WHEREAS, Epimmune owns certain patent rights and know-how as described
herein; and
WHEREAS, IDM desires to obtain a license under Epimmune's rights in such
patent rights and know-how on the terms and subject to the conditions of this
Agreement.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, the Parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
For purposes of this Agreement, the terms defined in this Article 1 shall
have the respective meanings set forth below:
1.1 "AAA" shall have the meaning set forth in Section 12.3.
1.2 "ADDITIONAL RIGHTS" shall have the meaning set forth in Section 2.2.1.
1.3 "AFFILIATE" shall mean, with respect to either Party, any other Person
that directly or indirectly controls, is controlled by, or is under common
control with, such Party. For purposes of this Section 1.3, "control" of another
Person means possession, directly or indirectly, of more than 50% of the voting
stock or other ownership interest of such Person or the power to direct or cause
the direction of the management and policies of such Person.
1.4 "BLA" shall mean Biologic License Application or any equivalent
successor application or equivalent application in other countries or
jurisdictions in the Territory.
1.5 "COMMERCIAL LAUNCH" shall mean, with respect to a Licensed Product and
a given country, the first sale of such Licensed Product to a Third Party in
such country once Regulatory Approval therefore and therein has been obtained.
1.6 "CONFIDENTIAL INFORMATION" shall mean any confidential or proprietary
information of a Party or its Affiliates, including, without limitation, any
information relating to
*CONFIDENTIAL TREATMENT REQUESTED
any compound, research project, work in process, future development, scientific,
engineering, manufacturing, marketing, business plan, financial or personnel
matter relating to such Party or its Affiliates, its present or future products,
sales, suppliers, customers, employees, investors or business, whether in oral,
written, graphic or electronic form, including, without limitation, trade
secrets, processes, formulae, data and know-how, improvements, inventions,
techniques, biological materials, marketing plans, strategies, forecasts and
customer and contact lists. Without limiting the generality of the foregoing,
and notwithstanding any other provision of this Agreement to the contrary, the
Licensed Technology and the Epimmune Improvements shall be deemed the
Confidential Information of Epimmune, the IDM Improvements shall be deemed the
Confidential Information of IDM and the Joint Improvements shall be deemed the
Confidential Information of both Epimmune and IDM.
1.7 "EPIMMUNE IMPROVEMENTS" shall have the meaning set forth in Section
7.1.2.
1.8 "FDA" shall mean the United States Food and Drug Administration or any
successor entity.
1.9 "FIELD OF USE" shall mean (i) ex vivo cell therapy and (ii) ex vivo
cell therapy for the prevention and treatment of cancer for the peptides for
which Epimmune is a licensee.
1.10 "GMP" shall mean current good manufacturing practices under FDA rules
and regulations.
1.11 "GROSS SALES" means the gross amount invoiced by IDM, its Affiliates
and/or its Sublicensees for sales of a Licensed Product to Third Parties.
1.12 "IDM IMPROVEMENTS" shall have the meaning set forth in Section 7.1.2.
1.13 "IMPROVEMENT" shall mean any patentable invention or discovery that
constitutes an enhancement, improvement or modification to the Licensed Patent
Rights (or, if the Peptide Option is exercised, the Additional Rights) and is
owned by or licensed to a Party (with the right to license or sublicense) during
the term of this Agreement, and any and all patents and patent applications
covering such invention or discovery, and any corresponding foreign counterparts
thereof, and all patents issuing thereon (including utility, model and design
patents and certificates of invention), including any division, continuation,
continuation-in-part or substitution of any such patent application, and any
reissue, extension, confirmation, registration, re-examination or inventor's
certificate of any such patent, together with any corresponding foreign
counterparts of the foregoing.
1.14 "JAPAN OPTION" shall have the meaning set forth in Section 2.3.
1.15 "JOINT IMPROVEMENTS" shall have the meaning set forth in Section
7.1.2.
1.16 "LICENSE" shall have the meaning set forth in Section 2.1.
1.17 "LICENSED KNOW-HOW" shall mean all inventions, discoveries, trade
secrets, experience, xxxx, xxxxxxxx information, formulas, computer models,
procedures, results, Licensed Materials and assays, and any Epimmune
Improvements, owned by or licensed to
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Epimmune (with the right to license or sublicense) as of the Effective Date or
during the Option Period, that are not included in the Licensed Patent Rights,
but which are necessary or useful to IDM for the commercial exploitation of the
Licensed Patent Rights in the Field of Use and which are not generally publicly
known. Licensed Know-How shall specifically include, but not be limited to,
reagents, peptides manufactured in accordance with GMP and cell lines for the
purpose of immunomonitoring.
1.18 "LICENSED MATERIALS" shall mean the antigens listed on Appendix A
hereto.
1.19 "LICENSED PATENT RIGHTS" shall mean the patents and patent
applications listed on Appendix B hereto and any patent or patent applications
included in the Epimmune Improvements owned by or licensed to Epimmune (with the
right to license or sublicense) and Epimmune's interest in any Joint
Improvements as of the Effective Date or during the Option Period, including,
but not limited to, all provisional applications, substitutions, continuations,
continuations-in-part, patents of addition, divisions and renewals of the
foregoing, all letters patent granted thereon, and all reissues, confirmations,
counterparts, reexaminations and extensions thereof and if the Peptide Option is
exercised, the Additional Rights for which the Peptide Option has been
exercised.
1.20 "LICENSED PRODUCT" shall mean any product that contains, incorporates
or uses any Specified Peptide(s) or Licensed Know-How or the manufacture, use or
sale of which would, but for the License, infringe the Licensed Patent Rights.
1.21 "LICENSED TECHNOLOGY" shall mean, collectively, the Licensed Patent
Rights and Licensed Know-How.
1.22 "LOSSES" shall have the meaning set forth in Section 8.1.1.
1.23 "NET SALES" shall mean the invoiced sales price of any Licensed
Product billed by IDM or its Affiliates or Sublicensees to Third Parties, less
the following amounts to the extent included in the invoiced sales price: (a)
credits, discounts and rebates to, and chargebacks from the account of, such
Third Parties for any spoiled, damaged, out-dated, rejected or returned product;
(b) actual shipping and handling, freight and insurance costs incurred in
transporting such product in final form to such Third Parties; (c) quantity and
trade discounts; [...***...] and (e) sales, use, value-added and other taxes or
governmental chargeS incurred in connection with the exportation or importation
of such product in final form.
1.24 "OPTION PERIOD" shall have the meaning set forth in Section 2.2.2.
1.25 "PHASE III CLINICAL TRIALS" shall mean those trials on sufficient
numbers of patients that are designed to establish that a drug is safe and
efficacious for its intended use, and to define warnings, precautions and
adverse reactions that are associated with the drug in the dosage range to be
prescribed, and supporting Regulatory Approval of such drug or label expansion
of such drug, as further defined in Federal Regulation 21 C.F.R. 312.21.
1.26 "PEPTIDE OPTION" shall have the meaning set forth in Section 2.2.1.
*CONFIDENTIAL TREATMENT REQUESTED
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1.27 "PERSON" shall mean an individual, corporation, partnership, trust,
business trust, association, joint stock company, joint venture, pool,
syndicate, sole proprietorship, unincorporated organization, governmental
authority or any other form of entity not specifically listed herein.
1.28 "PHS" shall have the meaning set forth in Section 2.1.
1.29 "PHS EPITOPE" shall have the meaning set forth in Section 2.1.
1.30 "PHS LICENSE AGREEMENT" shall have the meaning set forth in Section
2.1.
1.31 "PHS LICENSE PROVISIONS" shall mean Paragraphs 5.01-5.02, 8.01,
10.01-10.02, 12.05 and 13.07-13.08 of the PHS License Agreement, such provisions
being attached as Appendix E hereto.
1.32 "RECEIVING PARTY" shall have the meaning set forth in Section 6.2.
1.33 "REGULATORY APPROVAL " shall mean any and all approvals (including
price and reimbursement approvals), licenses, registrations, or authorizations
of health/regulatory authorities or any country, federal, state or local
regulatory agency, department, bureau or other government entity that is legally
required or necessary from an economic point of view for the manufacture, use,
storage, import, transport and/or sale of a Licensed Product in such
jurisdiction.
1.34 "SPECIFIED PEPTIDES" shall have the meaning set forth in Section
2.2.1.
1.35 "SUBLICENSEE" shall have the meaning set forth in Section 2.5.1.
1.36 "TERRITORY" shall mean worldwide, except Japan, but subject to
Section 2.3.
1.37 "THIRD PARTY" shall mean any Person other than Epimmune, IDM and
their respective Affiliates.
1.38 "Transfer Price" shall mean the invoiced sales price of any Licensed
Product billed by IDM or its Affiliates to Sublicensees.
1.39 "VALID PATENT CLAIM" shall mean a claim of an issued and unexpired
patent included within the Licensed Patent Rights, which has not been held
permanently revoked, unenforceable, unpatentable 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 which has not been admitted
to be invalid or unenforceable through reissue or disclaimer or otherwise.
ARTICLE 2
LICENSE AND OPTION GRANT
2.1 LICENSE GRANT. Epimmune hereby grants to IDM a non-exclusive, royalty
bearing license to make and have made (including the right to make derivatives)
and to use the Licensed Technology and to make, have made, use, sell, offer for
sale and import Licensed
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Products in the Field of Use in the Territory during the term of this Agreement
(the "LICENSE"). The License shall be sublicensable as provided in Section 2.5.
IDM acknowledges that the License includes rights with respect to an epitope
(the "PHS Epitope") licensed by Epimmune from the National Institutes of Health,
the Centers for Disease Control and Prevention, or the
Food and Drug Administration (collectively, "PHS") pursuant to a Patent License
Agreement dated February 1, 2002, as may be amended (the "PHS LICENSE
AGREEMENT"). IDM agrees that with respect to the PHS Epitope, the obligations of
Epimmune under the PHS License Provisions shall be binding upon IDM as if IDM
were a party to the PHS License Agreement. Upon termination or expiration of the
PHS License Agreement pursuant to the terms of Article 13 of the PHS License
Agreement, Epimmune shall provide IDM notice of such termination or expiration.
Upon receipt of such notice of expiration or termination of the PHS License
Agreement, IDM may (i) elect to become a direct licensee of PHS with respect to
the PHS Epitope by providing notice to PHS, subject to approval by PHS and
contingent upon IDM's acceptance of the remaining provisions under the PHS
License Agreement or (ii) terminate only the portion of the License with respect
to the PHS Epitope and, in either case, the PHS Epitope and all patents and
applications included in the PHS License Agreement shall cease to be Licensed
Materials and Licensed Patent Rights under this Agreement.
2.2 PEPTIDE LICENSE OPTION.
2.2.1 Epimmune hereby grants to IDM a non-exclusive option (the
"PEPTIDE OPTION") to include under the License any or all of the peptides listed
on APPENDIX C hereto (the "SPECIFIED PEPTIDES"), together with all associated
patents and patent applications listed on APPENDIX D, as applicable, and any
corresponding foreign counterparts thereof, and all patents issuing thereon
(including utility, model and design patents and certificates of invention),
including any division, continuation, continuation-in-part or substitution of
any such patent application, and any reissue, extension, confirmation,
registration, re-examination or inventor's certificate of any such patent,
together with any corresponding foreign counterparts of the foregoing
(collectively, the "ADDITIONAL RIGHTS"). Epimmune agrees that it shall not enter
into any agreement or arrangement that would limit Epimmune's right to
sublicense the Additional Rights to IDM pursuant to the Peptide Option.
2.2.2 IDM may exercise a Peptide Option at any time during the
period beginning on the Effective Date and ending on the earlier of (a) the date
that is [...***...] from the Effective Date or (b) [...***...] from enrollment
of the first patient in IDM's first clinical trial relating to a Licensed
Product (collectively, the "OPTION PERIOD"). IDM may exercise the Peptide Option
on a peptide-by-peptide basis with respect to one or more Specified Peptides by
providing written notice to Epimmune describing the Specified Peptides together
with the payment described in Section 2.2.3. Upon the exercise of the Peptide
Option during such Option Period and payment of the specified amount to
Epimmune, the term "LICENSED PATENT RIGHTS" will include the Additional Rights
for which the Peptide Option has been exercised.
2.2.3 Upon exercise of a Peptide Option, IDM shall pay to Epimmune a
non-refundable license fee of [...***...] for each Specified Peptide, payable
within 30 days of the date on which the applicable option notice is delivered to
Epimmune.
*CONFIDENTIAL TREATMENT REQUESTED
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2.3 JAPAN OPTION. Epimmune hereby grants to IDM an irrevocable option (the
"JAPAN OPTION") to include Japan in the Territory. The Japan Option may be
exercised at any time during the [...***...] by providing written notice to
Epimmune together with payment of [...***...]. Upon the exercise of the Japan
Option and payment of the specified amount to Epimmune, the term "Territory"
will automatically include Japan.
2.4 NEW PEPTIDE SEQUENCES. Epimmune may upon its sole discretion offer for
license to IDM any new peptide sequence together with all associated patents and
patent applications owned or licensed by Epimmune. The terms and conditions of
such license shall be negotiated in good faith by the Parties if and when IDM is
interested.
2.5 SUBLICENSES.
2.5.1 Subject to this Section 2.5, IDM shall have the right to grant
sublicenses (without the right to further sublicense) under the License to
Affiliates and corporate partners (e.g. Sanofi Synthelabo S.A.) or licensees to
whom IDM has licensed or also licenses its own technology for use in conjunction
with such sublicense (a "SUBLICENSEE"). IDM shall deliver an unredacted copy of
each sublicense agreement to Epimmune promptly after execution of the sublicense
agreement. Each sublicense agreement shall be consistent with the terms and
conditions of this Agreement. Furthermore, any sublicense agreement shall not
relieve IDM of its obligations to Epimmune under this Agreement.
2.5.2 In the event that the sublicense agreement between IDM and a
Sublicensee includes a license of the PHS Epitope, IDM agrees that the
sublicense agreement shall:
(a) Provide that the obligations to PHS under the Applicable
PHS License Provisions shall be binding upon such Sublicensee, with respect to
the PHS Epitope, as if such Sublicensee were a party to the PHS License
Agreement; and
(b) Have attached as an appendix the PHS License Provisions.
2.5.3 If this Agreement terminates for any reason, any Sublicensee
shall automatically become a direct licensee of Epimmune with respect to the
rights originally sublicensed to it by IDM, provided such Sublicensee did not
cause the termination of this Agreement and assumes the responsibilities of IDM
hereunder, including, without limitation, the making of payments and reports
directly to Epimmune and the remedying of any breach by IDM of this Agreement,
to the extent reasonably practicable.
ARTICLE 3
LICENSE FEES AND ROYALTIES
3.1 LICENSE FEES. In consideration for the License, IDM shall pay to
Epimmune non-refundable license fees as follows:
3.1.1 [...***...] upon execution of the term sheet related to this
Agreement (Epimmune hereby acknowledges that it has already received such
payment); and
*CONFIDENTIAL TREATMENT REQUESTED
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3.1.2 [...***...] upon the sooner of (i) execution of this Agreement
or (ii) February 7th 2003 (Epimmune hereby acknowledges that it has
already received such payment).
3.2 MILESTONE PAYMENTS.
3.2.1 As further consideration for the License, IDM shall pay
Epimmune non-refundable milestone payments in cash in the following amounts upon
the occurrence of each of the following events with respect to any Licensed
Product developed by IDM or its Affiliates or Sublicensees; provided, that each
milestone payment shall be made only once and upon the first occurrence of such
milestone for the first Licensed Product for which such milestone is achieved:
MILESTONE MILESTONE PAYMENT
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
[...***...] [...***...]
3.2.2 IDM shall notify Epimmune within 30 days of the occurrence of
any milestone event and Epimmune shall provide IDM with an invoice requesting
payment. IDM shall make sure milestone payment within 30 days of receipt of such
invoice from Epimmune.
3.3 SUCCESS FEE. In further consideration of the License, at the end of
the [...***...] following Commercial Launch of a Licensed Product, IDM shall pay
Epimmune, the greater of the following (a) [...***...] or (b) [...***...] of
each Licensed Product for the [...***...] and [...***...] complete calendar
years following COMMERCIAL Launch of a Licensed Product. Such payment shall be
made within 60 days of the end of the fourth complete calendar year following
Commercial Launch of a Licensed Product.
3.4 ROYALTIES.
3.4.1 Percentage / Audit :
(a) In further consideration for the License, during the term
of the Agreement and subject to IDM marketing the Licensed Product, IDM shall
pay to Epimmune a royalty of [...***...] of Net Sales for each Licensed Product.
(b) In further consideration for the License, during the term
of the Agreement and subject to IDM licensing the marketing and sale of the
Licensed Product to a Sublicensee, IDM shall pay to Epimmune a royalty based on
[...***...] and equivalent to [...***...] of Net Sales of each LiceNSEd Product.
Epimmune shall be entitled to verify each [...***...] that such royalty on IDM's
Transfer Price for ThE Licensed Product is equivalent to [...***...] of Net
Sales of the Licensed Product.
*CONFIDENTIAL TREATMENT REQUESTED
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(c) Epimmune shall be entitled to payments from IDM, according
to section 3.4.1 (a) and (b) on a [...***...] basis. Payments shall occur on the
last business day of [...***...] and [...***...], by wire transfer to a bank
account specified by Epimmune. A statement of Transfer Price payments received
by IDM during a given [...***...] shall be attached to the corresponding royalty
payment from IDM to Epimmune. IDM shall maintain accurate books and records
which enable the calculation of all amounts payable the previous [...***...] to
be verified. IDM shall keep a specific accounting, with all corresponding
evidences, of all necessary documents to evaluate due amounts. Upon thirty days'
prior notice to the other party, independent accountants selected jointly by the
parties may have access to IDM's books and records during normal business hours
to conduct a review and audit, for the purpose of verifying the accuracy of
IDM's payments in compliance with the Agreement. Audits and reviews shall be at
Epimmune's expense; however, in the event an inspection reveals underpayment of
[...***...] percent [...***...] or more in any [...***...], IDM shall pay tHE
COSTS OF the inspection and promptly pay to Epimmune any underpayment with
interest from the date such amounts were due, at the prime rate reported by the
Chase Manhattan Bank, New York.
3.4.2 In the event IDM becomes obligated to pay royalties to a Third
Party for patent rights or technology utilized in or with a Licensed Product,
IDM may deduct [...***...] of the royalties paid TO such Third Party from the
royalties owing to Epimmune under Section 3.4.1 for such Licensed Product;
provided, however, the royalty amounts paid to Epimmune pursuant to Section
3.4.1 may not be reduced by more than an aggregate of [...***...] pursuant to
the reductions permitted in this Section 3.4.2.
3.5 ISSUANCE OF PATENT RIGHTS. The Parties agree that, in the event that
the scope of the issued claims of any patent(s) resulting from a pending patent
application(s) included in the Licensed Patent Rights are significantly less
protective than the scope of the claims of such pending patent application(s),
i.e. do not protect the Licensed Material used in any Licensed Product, as of
the Effective Date, the Parties shall in good faith negotiate to determine
whether [...***...] for any Licensed Product which is covered by suCH patent(s),
and not by any other Licensed Technology then included under the License, are
appropriate under the circumstances (taking into account the provisions of
Section 3.4.2).
ARTICLE 4
ROYALTY REPORTS AND ACCOUNTING
4.1 REPORTS. IDM and its Affiliates shall keep complete and accurate
records in sufficient detail to properly reflect all Gross Sales, Net Sales and
Transfer Price of IDM and its Affiliates to Sublicensees and Third Parties and
to enable the royalties payable hereunder to be determined. IDM shall provide
such a royalty report to Epimmune within 30 days of the end of each [...***...]
in which royalties are due to EpimmunE hereunder.
4.2 AUDITS.
4.2.1 Upon the written request of Epimmune, and not more than once
in each [...***...], IDM and its AffiliaTES shall permit a reasonably acceptable
independent certified
*CONFIDENTIAL TREATMENT REQUESTED
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public accounting firm selected by Epimmune, at Epimmune's expense, to have
access during normal business hours to such of the records of IDM and its
Affiliates as may be reasonably necessary to verify the accuracy of the royalty
reports hereunder. In addition, IDM will include in each sublicense agreement
with a Sublicensee a requirement that, upon the written request of IDM, and not
more than once in each [...***...], such Sublicensee shall permit a reasonably
acceptable independent certified public accounting firm selected by IDM, to have
access during normal business hours to such of the records of such Sublicensee
as may be reasonably necessary to verify the accuracy of the royalty reports
hereunder and under such sublicense agreement; provided that, if IDM does not
exercise its rights under such sublicense agreement with a Sublicensee, Epimmune
shall have the rights set forth in the first sentence of this Section 4.2.1 to
audit the records of such Sublicensee. The accounting firm (and any accounting
firm used by IDM to audit Sublicensee records) shall disclose to Epimmune only
whether the records are correct or not and the specific details concerning any
discrepancies. No other information shall be shared.
4.2.2 If such accounting firm concludes that additional royalties
were owed during such period, IDM shall pay the additional royalties, together
with interest thereon in accordance with Section 5.5, within 30 days of the date
Epimmune delivers to IDM such accounting firm's written report so concluding.
The fees charged by such accounting firm shall be paid by Epimmune; provided
however, if the audit discloses that the royalties payable by IDM for the
audited period are more than [...***...] of the royalties actually paid for sUCH
period, then IDM shall pay the reasonable fees and expenses charged by such
accounting firm.
ARTICLE 5
PAYMENTS
5.1 PAYMENT TERMS. Royalties shown to have accrued by each royalty report
provided for under Article 4 above shall be due and payable within 30 days of
IDM's receipt of an invoice from Epimmune for payment of such royalties. Payment
of royalties in whole or in part may be made in advance of such due date.
Milestone payments shall be due and payable in accordance with Section 3.2.
5.2 PAYMENT METHOD. All payments by IDM to Epimmune under this Agreement
shall be paid in United States dollars, and all such payments shall be made by
check or bank wire transfer in immediately available funds to such account as
Epimmune shall designate before such payment is due. All amounts payable under
this Agreement will first be calculated in the currency of sale and then
converted into United States dollars and all reports submitted pursuant to
Section 4.1 shall include both calculations. The buying rates involved for the
currency of the United States into which the currencies involved are being
exchanged shall be the arithmetic averages of the rates quoted by the Western
Edition of the Wall Street Journal at the close of business on the last business
day of each calendar month of the applicable royalty period. In the event that
such publication no longer publishes such rates, another financial publication
mutually agreed upon by the Parties shall be substituted or one shall be chosen
by an investment banker/analyst mutually agreed upon by the Parties.
*CONFIDENTIAL TREATMENT REQUESTED
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5.3 EXCHANGE CONTROL. If at any time legal restrictions prevent the prompt
remittance of part or all royalties with respect to any country where a Licensed
Product is sold, payment shall be made through such lawful means or methods as
Epimmune shall request.
5.4 WITHHOLDING TAXES. In the event that IDM is required to withhold any
tax to the tax or revenue authorities in any country in the Territory regarding
any payment to Epimmune due to the laws of such country or collect and/or pay
any sales, use, excise or value added taxes, such amount shall be deducted from
the payment to be made by IDM, and IDM shall notify Epimmune and promptly
furnish Epimmune with copies of any tax certificate or other documentation
evidencing such withholding. Each Party agrees to cooperate with the other Party
in claiming exemptions from such deductions or withholdings under any agreement
or treaty from time to time in effect.
5.5 LATE PAYMENT. In the event that any payment under this Agreement is
not made when due, the payment shall accrue interest from the date due at the
rate of 1.0% per month; provided, however, that in no event shall such rate
exceed the maximum legal annual interest rate. The payment of such interest
shall not limit Epimmune from exercising any other rights it may have as a
consequence of the lateness of such payment.
ARTICLE 6
CONFIDENTIALITY
6.1 CONFIDENTIAL INFORMATION. During the term of this Agreement and for a
period of [...***...] thereafter, each Party will maintain in confidence all
Confidential Information of the other Party. Neither Party will use, disclose or
grant use of the other Party's Confidential Information except as expressly
authorized by this Agreement. To the extent that disclosure is authorized by
this Agreement, the disclosing Party will obtain prior agreement from its
employees, agents and consultants to whom disclosure is to be made to hold in
confidence and not make use of such information for any purpose other than those
permitted by this Agreement. Each Party will use at least the same standard of
care as it uses to protect its own Confidential Information to obligate such
employees, agents and consultants not to disclose or make any unauthorized use
of the other Party's Confidential Information. Each Party will promptly notify
the other upon discovery of any unauthorized use or disclosure of the other
Party's Confidential Information.
6.2 EXCEPTIONS. Confidential Information shall not include any information
which the receiving Party (the "Receiving Party") can prove by competent written
evidence:
6.2.1 is now, or hereafter becomes, through no act or failure to act
on the part of the Receiving Party, generally known or available;
6.2.2 is known by the Receiving Party at the time of receiving such
information, as evidenced by its records;
6.2.3 is hereafter furnished to the Receiving Party by a Third
Party, as a matter of right and without restriction on disclosure;
*CONFIDENTIAL TREATMENT REQUESTED
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6.2.4 is independently discovered or developed by the Receiving
Party without the use of Confidential Information belonging to the disclosing
Party; or
6.2.5 is the subject of a written permission to disclose provided by
the disclosing Party.
6.3 AUTHORIZED DISCLOSURE. Each Party may disclose Confidential
Information belonging to the other Party to the extent such disclosure is
reasonably necessary in the following instances:
6.3.1 regulatory filings;
6.3.2 prosecuting or defending litigation;
6.3.3 complying with applicable court orders or governmental
regulations;
6.3.4 conducting research and development as permitted by this
Agreement; and
6.3.5 disclosure to Affiliates, Sublicensees, employees,
consultants, agents or other Third Parties in connection with due diligence or
similar investigations by such Third Parties, in each case who agree to be bound
by similar terms of confidentiality and non-use at least equivalent in scope to
those set forth in this Article 6.
Notwithstanding the foregoing, in the event a Party is required to make a
disclosure of the other Party's Confidential Information pursuant to this
Section 6.3, it will, except where impracticable, give reasonable advance notice
to the other Party of such disclosure and use efforts to secure confidential
treatment of such information at least as diligent as such Party would use to
protect its own Confidential Information, but in no event less than reasonable
efforts. In any event, the Parties agree to take all reasonable action to avoid
disclosure of Confidential Information hereunder. The Parties will consult with
each other on the provisions of this Agreement to be redacted in any filings
made by the parties with the Securities and Exchange Commission or its local
equivalent or as otherwise required by law.
6.4 TERMS OF THIS AGREEMENT. Except as otherwise provided in Section 6.2
or 6.3 above, Epimmune and IDM shall not disclose any terms or conditions of
this Agreement to any Third Party without the prior consent of the other Party,
which consent shall not be unreasonably withheld or delayed. However, each Party
may disclose the existence and terms of this Agreement without the other Party's
approval to the extent such Party concludes, after consulting with its legal
advisors, that it is required by any local, state or federal rule, regulation,
statute or law relevant to the activities undertaken pursuant to this Agreement
or applicable to either of the Parties with respect to any matters set forth
herein or by any applicable stock exchange or trading market to disclose this
Agreement or the terms hereof.
6.5 PRESS RELEASE. Notwithstanding the provisions of this Article 6, the
Parties agree that a press release announcing the matters covered by this
Agreement shall be issued in a form agreed upon by the Parties on a date and at
a time mutually agreed upon by the Parties, and either
11
Party may publicize the existence and general subject matter of this Agreement
consistent with such press release without the other Party's approval.
ARTICLE 7
INTELLECTUAL PROPERTY RIGHTS
7.1 Ownership of Inventions.
7.1.1 Inventorship of inventions shall be determined in accordance
with the rules of inventorship under United States patent law.
7.1.2 All right, title and interest in and to any Improvements that
are (a) authorized or made by, on behalf of or at the request of IDM shall be
the sole property of IDM ("IDM IMPROVEMENTS"), (b) authorized or made by, on
behalf of or at the request of Epimmune shall be the sole property of Epimmune
("EPIMMUNE IMPROVEMENTS"), and (c) made jointly by IDM and Epimmune shall be the
joint property of IDM and Epimmune ("JOINT IMPROVEMENTS"). Each Party may freely
practice any Joint Improvements outside the Field of Use.
7.1.3 IDM shall grant to Epimmune a [...***...], worldwide,
[...***...] license to any IDM Improvements thaT directly incorporate any
peptides or cell lines that are included in the Licensed Know-How and/or
patentable improvements or modifications to the Licensed Patents Rights for all
uses. Such license shall be negotiated in good faith by the Parties. Epimmune
may sublicense its rights under the license to its Affiliates and Third Parties
to whom Epimmune also licenses its own technology in conjunction with such
sublicense. IDM shall promptly notify Epimmune in writing of any IDM
Improvements licensed to Epimmune under this Section. For clarification, this
Section 7.1.3 does not apply to any IDM proprietary technology and improvements
thereto that are owned or licensed by IDM other than pursuant to the terms of
this Agreement. In particular this section 7.1.3 does not apply to any IDM
Improvements that constitute a product and/or process and/or an application
using the Licensed Materials.
7.1.4 Except as provided in Section 7.1.2, ownership of inventions,
discoveries, developments and improvements conceived or reduced to practice in
the course of activities conducted under this Agreement, and all patent
applications, patents and other intellectual property rights with respect to the
foregoing shall be determined in accordance with inventorship (i.e., a Party
shall solely own all inventions, discoveries, developments and improvements
conceived or reduced to practice solely by its employees or agents, and the
Parties shall jointly own all such inventions, discoveries, developments and
improvements conceived or reduced to practice jointly by their respective
employees or agents).
7.2 Prosecution and Maintenance.
7.2.1 Epimmune shall own all right, title and interest in, and shall
have the sole right to control the preparation, filing, prosecution and
maintenance of the patents and patent applications included in the Licensed
Patent Rights at its own expense. Epimmune shall keep IDM advised on a yearly
basis of the status of the actual and prospective patent filings included in the
Licensed Patent Rights, including, without limitation, the filing of any patent
application or
*CONFIDENTIAL TREATMENT REQUESTED
12
grant of any patent. Epimmune undertakes to use [...***...] efforts for the
prosecution and maintenance of the patents and patent applications included in
the Licensed Patent Rights.
7.2.2 IDM shall own all right, title and interest in, and shall have
the sole right to control the preparation, filing, prosecution and maintenance
of the patents and patent applications included in the IDM Improvements at its
own expense. IDM shall keep Epimmune advised on a regular basis of the status of
the actual and prospective patent filings included in the IDM Improvements,
including, without limitation, the filing of any patent application or grant of
any patent.
7.2.3 In case of Joint Improvements, the Parties shall negotiate in
good faith which Party is in charge of controlling the prosecution, grant and
maintenance of patents and patent applications included in the Joint
Improvements, using patent counsel reasonably acceptable to the other Party,
provided that the controlling Party shall provide the other Party with the
opportunity to review and comment on filings and other actions with respect to
such patents and patent applications included in Joint Improvements. IDM and
Epimmune shall share equally all costs incurred in connection therewith. The
controlling Party shall inform the other Party at regular intervals, or on
request, about the status of joint patent applications or joint patents for
which it is responsible. In the event that the controlling Party elects not to
file a patent application or decides to abandon any pending application or
granted patent included in Joint Improvements in any country, the controlling
Party shall provide adequate notice to the other Party and give the other Party
the opportunity to file or maintain such application or patent at its own
expense, and all rights, title and interest in such application or patent for
such country shall thereupon be assigned to the other Party.
7.3 COOPERATION. Each Party shall make available to the other Party or its
authorized attorneys, agents, consultants or representatives, if available, such
information necessary or appropriate to enable the appropriate Party (at the
appropriate Party's cost and expense) to file, prosecute and maintain patent
applications and resulting patents with respect to Epimmune Improvements, IDM
Improvements and any Joint Improvements, for a period of time reasonably
sufficient for such Party to obtain the assistance it needs from such personnel.
Where appropriate, each Party shall sign or cause to have signed all documents
relating to said patent applications or patents at no charge to the other.
7.4 INFRINGEMENT BY A THIRD PARTY.
7.4.1 Each Party shall notify the other Party of any infringement by
a Third Party known to such Party of any patent rights included in the Licensed
Patent Rights or any Joint Improvements and shall provide the other Party with
the available evidence, if any, of such infringement.
7.4.2 Epimmune shall have the sole right, at its discretion, to
prosecute any and all infringements of any Licensed Patent Rights or Joint
Improvements in or outside the Field of Use.
7.5 INFRINGEMENT OF A THIRD PARTY'S RIGHTS. Each Party shall promptly
notify the other in writing of any allegation by a Third Party that the activity
of either of the Parties pursuant to this Agreement infringes or may infringe
the intellectual property rights of such Third
*CONFIDENTIAL TREATMENT REQUESTED
13
Party. IDM shall have the sole right to control any defense of any such claim
involving alleged infringement of Third Party rights by IDM's activities at its
own expense and by counsel of its own choice, and Epimmune shall have the right,
at its own expense, to be represented in any such action by counsel of its own
choice. Epimmune shall have the sole right to control any defense of any such
claim involving alleged infringement of Third Party rights by Epimmune's
activities at its own expense (subject to Section 8.1.1) and by counsel of its
own choice, and IDM shall have the right, at its own expense, to be represented
in any such action by counsel of its own choice. Neither Party shall have the
right to settle any patent infringement litigation under this Section 7.5 in a
manner that diminishes the rights or interests of the other Party without the
written consent of such other Party (which shall not be unreasonably withheld).
7.6 INSURANCE. During the term of this Agreement, IDM, at its own expense,
shall maintain product liability insurance in amounts consistent with industry
standards for claims and actions which might be taken against it in connection
with this Agreement. IDM shall provide upon Epimmune written request a
certificate of insurance evidencing such coverage.
ARTICLE 8
INDEMNITY
8.1 INDEMNITY.
8.1.1 IDM hereby agrees to save, defend, indemnify and hold harmless
Epimmune and its officers, directors, employees, consultants and agents from and
against any and all losses, damages, liabilities, expenses and costs, including
reasonable legal expense and attorneys' fees ("LOSSES"), to which any of them
may become subject as a result of any claim, demand, action or proceeding by any
Third Party to the extent such Losses arise out of (i) the research,
development, manufacture, use or sale by IDM, its Affiliates or Sublicensees of
Licensed Products, (ii) the conduct of any research and development by IDM, its
Affiliates or Sublicensees, including, without limitation, clinical trials,
conducted with respect to the Licensed Products, (iii) a breach by IDM of any of
its representations and warranties contained in Article 9, (iv) any material
breach by IDM of this Agreement, (v) any Licensed Product, or (vi) the gross
negligence or willful misconduct of IDM, its Affiliates or Sublicensees in
performance of this Agreement, except to the extent such Losses result from the
negligence or willful misconduct of Epimmune. In the event a party entitled to
indemnification under this Section 8.1.1 seeks indemnification hereunder, it
shall inform IDM of a claim as soon as reasonably practicable after it receives
notice of the claim, shall permit IDM to assume direction and control of the
defense of the claim (including the right to settle the claim solely for
monetary consideration), and shall cooperate as requested (at the expense of
IDM) in the defense of the claim.
8.1.2 Epimmune hereby agrees to save, defend, indemnify and hold
harmless IDM and its respective officers, directors, employees, consultants and
agents from and against any and all Losses to which any of them may become
subject as a result of any claim, demand, action or proceeding by any Third
Party to the extent such Losses arise out of (i) a breach by Epimmune of any of
its representations and warranties contained in Article 9, (ii) any material
breach by Epimmune of this Agreement, or (iii) the gross negligence or willful
misconduct of Epimmune or its Affiliates in performance of this Agreement,
except to the extent such Losses
14
result from the negligence or willful misconduct of IDM. In the event a party
entitled to indemnification under this Section 8.1.2 seeks indemnification
hereunder, it shall inform Epimmune of a claim as soon as reasonably practicable
after it receives notice of the claim, shall permit Epimmune to assume direction
and control of the defense of the claim (including the right to settle the claim
solely for monetary consideration), and shall cooperate as requested (at the
expense of Epimmune) in the defense of the claim.
ARTICLE 9
REPRESENTATIONS AND WARRANTIES
9.1 REPRESENTATIONS AND WARRANTIES OF EACH PARTY. Each Party hereby
represents and warrants to the other Party as follows:
9.1.1 Such Party is duly organized, validly existing and in good
standing under the laws of the jurisdiction in which it is organized.
9.1.2 Such Party (a) has the power and authority and the legal right
to enter into this Agreement and to perform its obligations hereunder and (b)
has taken all necessary action on its part to authorize the execution and
delivery of this Agreement and the performance of its obligations hereunder.
This Agreement has been duly executed and delivered on behalf of such Party, and
constitutes a legal, valid, binding obligation, enforceable against such Party
in accordance with its terms.
9.1.3 As of the Effective Date, the execution and delivery of this
Agreement and the performance of such Party's obligations hereunder (a) do not
conflict with or violate any requirement of applicable laws or regulations, and
(b) do not conflict with, or constitute a default under, any contractual
obligation of such Party.
9.2 REPRESENTATIONS AND WARRANTIES OF EPIMMUNE. Epimmune represents and
warrants to IDM as of the Effective Date that, to its knowledge it is the sole
and exclusive owner or licensee of the Licensed Technology in the Field of Use,
and it has the right to grant the License hereunder.
9.3 DISCLAIMER OF WARRANTIES. EXCEPT AS EXPRESSLY SET FORTH IN THIS
AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY TO ANY OTHER PARTY
OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF
TITLE, NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
ARTICLE 10
TERMINATION
10.1 TERM. The term of this Agreement shall commence of the Effective Date
and, unless earlier terminated pursuant to Section 10.2, 10.3 or 10.4, shall
expire on a Licensed Product-by-Licensed Product and country-by-country basis on
the date which is the later of (a) [...***...] from the first sale of the
applicabLE Licensed Product in the applicable country, or (b) the [...***...] of
the Licensed Patent Rights, in such country.
*CONFIDENTIAL TREATMENT REQUESTED
15
10.2 TERMINATION FOR CAUSE. Except as otherwise provided in Article 11,
either Party may terminate this Agreement upon or after the breach of any
material provision of this Agreement by the other Party if the other Party has
not cured such breach within [...***...] after written notice thereof by the
non-breaching Party.
10.3 BANKRUPTCY. In the event of the institution by or against either
Party of insolvency, receivership or bankruptcy proceedings or any other
proceedings for the settlement of such Party's debts which are not dismissed
within [...***...], or upon such Party's making an assignment for the benefit of
creditors, or upon such Party's dissolution, winding up or ceasing to do
business, the other Party shall have the right to terminate this Agreement upon
written notice to such Party.
10.4 TERMINATION BY IDM. By providing written notice to Epimmune at least
[...***...] before the occurrence of any of the following events with respect to
any Licensed Product developed by IDM or its Affiliates or Sublicensees, IDM may
terminate this Agreement provided that such terminate right shall occur only
once and upon the first occurrence of such milestone event for the first
Licensed Product for which such milestone is achieved: [...***...].
10.5 EFFECT OF EXPIRATION OR TERMINATION. Expiration or termination of
this Agreement shall not relieve the Parties of any obligation accruing prior to
such expiration or termination, and the provisions of Articles 1, 4, 6, 8, and
12 and Sections 2.4.2, 7.1, 9.3, and 10.5 shall survive the expiration or
termination of this Agreement. Within 30 days following the expiration or
termination of this Agreement, each Party shall return to the other Party, or
destroy, upon the written request of the other Party, any and all Confidential
Information of the other Party in its possession.
ARTICLE 11
FORCE MAJEURE
Neither Party shall be held liable or responsible to the other Party nor
be deemed to have defaulted under or breached this Agreement for failure or
delay in fulfilling or performing any term of this Agreement (other than failure
or delay in making any payment when due) to the extent, and for so long as, such
failure or delay is caused by or results from causes beyond the reasonable
control of the affected Party including but not limited to fire, floods,
embargoes, war, acts of war (whether war be declared or not), insurrections,
riots, commotions, strikes, lockouts or other labor disturbances, acts of God or
acts, omissions or delays in acting by any governmental authority or other
Party.
ARTICLE 12
MISCELLANEOUS
12.1 NOTICES. Any consent, notice or report required or permitted to be
given or made under this Agreement by one of the Parties hereto to the other
Party shall be in writing, delivered personally, by facsimile (and promptly
confirmed by personal delivery, United States first class mail or courier),
United States first class mail or courier, postage prepaid (where applicable),
addressed to such other Party at its address indicated below, or to such other
address as the
*CONFIDENTIAL TREATMENT REQUESTED
16
addressee shall have last furnished in writing to the addressor and (except as
otherwise provided in this Agreement) shall be effective upon receipt by the
addressee.
If to Epimmune: Epimmune Inc.
5820 Xxxxx Xxxxx Xxxxx
Xxx Xxxxx, XX 00000
Xxxxxx Xxxxxx
Attention: Vice President, Business Development
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
with a copy to: Xxxxxx Godward LLP
0000 Xxxxxxxxx Xxxxx, Xxxxx 0000
Xxx Xxxxx, XX 00000
Attention: L. Xxx Xxxxxxxx, Esq.
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
If to IDM: Immuno-Designed Molecules S.A.
000 xxx xx Xxxxxxxx
00000 Xxxxx, Xxxxxx
Attn: President & CEO
Telephone: 00 (0) 000000000
Facsimile: 00 (0) 000000000
12.2 GOVERNING LAW. This Agreement shall be governed by and construed in
accordance with the laws of the State of California, without regard to the
conflicts of law principles thereof.
12.3 DISPUTE RESOLUTION/ARBITRATION. If a dispute arises between the
Parties relating to the interpretation or performance of this Agreement or the
grounds for the termination thereof (but not as to the enforceability or
validity or interpretation of any claims within the Licensed Patent Rights), and
the Parties cannot resolve the dispute within [...***...] of a written request
by either Party to the other Party, the Parties agree to hold a meeting,
attended by individuals with decision-making authority regarding the dispute, to
attempt in good faith to negotiate a resolution of the dispute prior to pursuing
other available remedies. If, within [...***...] after such meeting, the Parties
have not succeeded in negotiating a resolution of the dispute, such dispute
shall be submitted to final and binding arbitration under the then current
commercial rules and regulations of the American Arbitration Association (the
"AAA") relating to voluntary arbitrations in San Diego, California. The
arbitration shall be conducted by one arbitrator, who is knowledgeable in the
subject matter at issue in the dispute and who will be selected by mutual
agreement of the Parties or, failing such agreement, shall be selected in
accordance with the AAA rules. Each Party shall initially bear its own costs and
legal fees associated with such arbitration. The prevailing Party in any such
arbitration shall be entitled to recover from the other Party reasonable
attorneys' fees, costs and expenses incurred by such prevailing Party in
connection with such arbitration. The decision of the arbitrator shall be final
and binding and may be sued on or enforced by the Party in whose favor it runs
in any court of competent
*CONFIDENTIAL TREATMENT REQUESTED
17
jurisdiction. The arbitrator shall prepare and deliver a written, reasoned
opinion conferring its decision within [...***...] following the final
arbitration hearing. The Parties agree that thE entire arbitration proceedings
shall be completed (including the opinion of the arbitrator) within [...***...]
from the date on which such dispute is submitted to arbitration. Notwithstanding
the foregoing, either Party shall have the right to pursue an action in a court
of competent jurisdiction to obtain injunctive or other equitable remedy, in
order to preserve the status quo during the resolution of any dispute under this
provision.
12.4 ASSIGNMENT. Neither Party shall assign its rights or obligations
under this Agreement, in whole or in part, by operation of law or otherwise,
without the prior written consent of the other Party; provided however, that
either Party may, without such consent, assign this Agreement and its rights and
obligations thereunder in connection with the transfer or sale of all or
substantially all of its business, or in the event of its merger, consolidation,
change in control or similar transaction; provided further, that, in the event
of any such transaction, intellectual property rights of any Person, other than
IDM or Epimmune or their Affiliates, that is an acquiring party in such
transaction shall not be included in the intellectual property licensed
hereunder. Any purported assignment in violation of this Section 12.4 shall be
void.
12.5 WAIVERS AND AMENDMENTS. No change, modification, extension,
termination or waiver of this Agreement, or any of the provisions herein
contained, shall be valid unless made in writing and signed by duly authorized
representatives of the Parties.
12.6 ENTIRE AGREEMENT. This Agreement (including the appendices) embodies
the entire understanding between the Parties and supersedes any prior
understanding and agreements between and among them respecting the subject
matter hereof. There are no representations, agreements, arrangements or
understandings, oral or written, between the Parties hereto relating to the
subject matter of this Agreement which are not fully expressed herein.
12.7 SEVERABILITY. Any of the provisions of this Agreement which are
determined to be invalid or unenforceable in any jurisdiction shall be
ineffective to the extent of such invalidity or unenforceability in such
jurisdiction, without rendering invalid or unenforceable the remaining
provisions hereof and without affecting the validity or enforceability of any of
the terms of this Agreement in any other jurisdiction.
12.8 WAIVER. The waiver by either Party hereto of any right hereunder or
the failure to perform or of a breach by the other Party shall not be deemed a
waiver of any other right hereunder or of any other breach or failure by said
other Party whether of a similar nature or otherwise.
12.9 CONSTRUCTION. The Parties have participated jointly in the
negotiation and drafting of this Agreement. In the event an ambiguity or
question of intent or interpretation arises, this Agreement shall be construed
as if drafted jointly by the Parties and no presumption or burden of proof shall
arise favoring or disfavoring any Party by virtue of the authorship of any of
the provisions of this Agreement.
12.10 INDEPENDENT CONTRACTORS. The relationship between Epimmune and IDM
is that of independent contractors. Neither Party has any actual or apparent
authority, express or implied, to act on behalf of the other Party or to bind
the other Party to any obligations. Neither
*CONFIDENTIAL TREATMENT REQUESTED
18
Party shall be deemed to be an agent or servant of the other Party or a partner
or venturer with the other Party. Neither Party shall control, or have any right
to control, the manner, method and means by which the other Party makes, has
made, uses, sells, leases or otherwise provides or markets its products and
services.
12.11 COUNTERPARTS. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the Parties have executed this Option and License
Agreement by their duly authorized representatives as of the date first set
forth below.
EPIMMUNE INC. IDM IMMUNO-DESIGNED MOLECULES S.A.
By: /s/ Xxxxx Xxxxx By: /s/ Xxxx-Loup Romet-Lemone
------------------------------- ----------------------------------
Print Name: Xxxxx Xxxxx Print Name: Xxxx-Loup Romet-Lemone
----------------------- --------------------------
Title:President & CEO Title: President & CEO
---------------------------- ------------------------------
19
APPENDIX A
[...***...]
*CONFIDENTIAL TREATMENT REQUESTED
APPENDIX B
[...***...]
*CONFIDENTIAL TREATMENT REQUESTED
APPENDIX C
[...***...]
*CONFIDENTIAL TREATMENT REQUESTED
APPENDIX D
[...***...]
*CONFIDENTIAL TREATMENT REQUESTED
APPENDIX E
[...***...]
*CONFIDENTIAL TREATMENT REQUESTED
