EXHIBIT 10.85
*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. Sections 200.80(b)(4),
200.83 and 240.24B-2
LICENSE AGREEMENT
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This License Agreement ("Agreement") is made as of this 28th day of March,
2001 (the "Effective Date"), by and between Nexell of California, Inc., a
Delaware corporation, having an address at 0 Xxxxxx Xx., Xxxxxx, XX 00000
("Nexell"), and Epimmune Inc., a Delaware corporation, having an address at 0000
Xxxxx Xxxxx Xxxxx, Xxx Xxxxx, XX 00000 ("Epimmune").
WITNESSETH:
WHEREAS, Epimmune owns or has a license to certain patent rights and know-how
as described herein; and
WHEREAS, Nexell desires to obtain a license under Epimmune's rights in such
patent rights and know-how to develop and commercialize products for use in the
Field in the Territory (each as defined below);
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, the parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
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For purposes of this Agreement, the terms defined in this Article 1 shall
have the respective meanings set forth below:
1.1 "Affiliate" shall mean, with respect to any Person, any other Person
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which directly or indirectly controls, is controlled by, or is under common
control with, such Person. A Person shall be regarded as in control of another
Person if it owns, or directly or indirectly controls, at least fifty percent
(50%) of the voting stock or other ownership interest of the other Person, or if
it directly or indirectly possesses the power to direct or cause the direction
of the management and policies of the other Person by any means whatsoever.
1.2 "BLA" shall mean Biologic License Application or any equivalent
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successor application.
1.3 "Dollars" or "$" means United States dollars.
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1.4 "Epimmune Future Improvements" shall mean all Improvements owned by or
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licensed to Epimmune (with the right to license or sublicense) during the term
of this Agreement, including, without limitation, Epimmune's interest in any
Joint Inventions that are
Improvements, but excluding any Improvements licensed to Epimmune by Nexell
under Section 9.1.1.
1.5 "FDA" shall mean the United States Food and Drug Administration or any
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successor entity.
1.6 "Field" shall mean ex vivo cell therapy.
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1.7 "GMP" shall mean current good manufacturing practices under FDA rules
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and regulations.
1.8 "Improvement" shall mean any invention or discovery, whether or not
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patentable, that constitutes an enhancement or improvement to the Licensed
Patent Rights or the Licensed Know-How and is owned by or licensed to Epimmune
or Nexell (with the right to license or sublicense) during the term of this
Agreement, and any and all Patent Rights covering such invention or discovery.
1.9 "Law" means any local, state or federal rule, regulation, statute or
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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.
1.10 "License" means the license granted to Nexell pursuant to Section 3.1
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hereof.
1.11 "Licensed Know-How" shall include all inventions, discoveries, trade
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secrets, experience, xxxx, xxxxxxxx information, formulas, computer models,
procedures, results, materials and assays owned by or licensed to Epimmune (with
the right to license or sublicense), which are not included in the Licensed
Patent Rights, but which are necessary or useful to the commercial exploitation
of the Licensed Patent Rights and which are not generally publicly known.
Licensed Know-How shall include, but not be limited to, reagents, peptides
manufactured in accordance with GMP and cell lines for the purpose of
immunomonitoring.
1.12 "Licensed Patent Rights" shall mean the antigens and associated
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Patent Rights listed in Appendix A hereto, including derivatives and
modifications thereof owned by or licensed to Epimmune (with the right to
license or sublicense), together with Patent Rights included in Epimmune Future
Improvements.
1.13 "Licensed Technology" shall mean, collectively, the Licensed Patent
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Rights and Licensed Know-How.
1.14 "NDA" shall mean a New Drug Application or any equivalent successor
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application.
1.15 "Net Sales" shall mean, with respect to any Product, the invoiced
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sales price of such Product billed by Nexell or its Affiliates or sublicensees
to Third-Party customers, less to the extent included in the invoiced sales
price, (a) credits, allowances, discounts and rebates to, and chargebacks from
the account of, such Third-Party customers for 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-Party customers; (c) cash,
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quantity and trade discounts; (d) charges for cell processing and related
services in an amount not to exceed the fair market value of such services; 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.
1.16 "Patent Rights" shall mean any and all patents or patent
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applications, 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
patents, together with any corresponding foreign patent applications and
patents.
1.17 "Person" shall mean an individual, corporation, partnership, trust,
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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.
1.18 "Product" shall mean any product that contains, incorporates, or uses
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any Licensed Technology.
1.19 "Territory" shall mean world-wide, except Japan.
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1.20 "Third Party" shall mean any Person other than Epimmune, Nexell and
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their respective Affiliates.
1.21 "Valid Patent Claim" shall mean either (a) a claim of an issued and
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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 or (b) a claim of a pending patent application included within the
Licensed Patent Rights, which claim has not been abandoned or finally disallowed
without the possibility of appeal or refiling of such application.
ARTICLE 2
REPRESENTATIONS AND WARRANTIES
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2.1 Each party hereby represents and warrants to the other party as
follows:
2.1.1 Corporate Existence and Power. Such party (a) is a corporation
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duly organized, validly existing and in good standing under the laws of the
state in which it is incorporated; (b) has the corporate power and authority and
the legal right to own and operate its property and assets, to lease the
property and assets it operates under lease, and to carry on its business as it
is now being conducted and (c) is in compliance with all requirements of
applicable law, except to the extent that any noncompliance would not have a
material adverse effect on the properties, business, financial or other
condition of it and would not materially adversely affect its ability to perform
its obligations under this Agreement.
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2.1.2 Authorization and Enforcement of Obligations. Such party
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(a) has the corporate power and authority and the legal right to enter into this
Agreement and to perform its obligations hereunder and (b) has taken all
necessary corporate 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.
2.1.3 No Conflict. As of the Effective Date, the execution and
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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.
2.2 Warranties by Epimmune. Epimmune represents and warrants to Nexell
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as of the Effective Date:
2.2.1 Epimmune is the sole and exclusive owner or licensee of the
Licensed Technology and has the right to grant the licenses or sublicenses
granted hereunder.
2.2.2 Epimmune represents and warrants that Appendix A hereto identifies
all Patent Rights (owned or licensed by Epimmune) associated with the ten
antigens listed therein and there exist no limitations on Epimmune's right to
sublicense such Patent Rights as contemplated hereby. Epimmune agrees that it
shall not enter into any agreement or arrangement that would limit Epimmune's
right to sublicense the Licensed Patent Rights to Nexell pursuant to this
Agreement.
2.2.3 To the best of Epimmune's knowledge, actual and constructive,
(a) there are no pending or threatened claims of litigation brought by a Third
Party under any Third Party patent, trade secret or other Third Party
intellectual property right regarding the Licensed Technology; and (b) the
Licensed Technology does not infringe any Third Party patent, trade secret or
other Third Party intellectual property right.
ARTICLE 3
LICENSE AND OPTION GRANTS
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3.1 Licensed Technology. Epimmune hereby grants to Nexell and its
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Affiliates a non-exclusive license under the Licensed Technology to make and
have made (including the right to make derivatives) and use the Licensed
Technology and to make, have made, use and sell Products in the Field in the
Territory.
3.2 Sublicenses. Nexell shall have the right to grant sublicenses under
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the License solely to corporate partners to whom Nexell also licenses its own
technology. Nexell shall deliver a copy of each sublicense under this Agreement
to Epimmune promptly after execution of the same. Each sublicense shall be
subject to the terms and conditions of this Agreement.
3.3 Third Party Licenses. ***
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3.4 Epimmune Obligations.
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3.4.1 Within fifteen (15) days following the execution of this Agreement,
Epimmune shall deliver to Nexell such Licensed Know-How as is owned by Epimmune
at such time; provided that GMP manufactured peptides included in the Licensed
Know-How will be provided to Nexell at an additional cost to be negotiated in
good faith.
3.4.2 Epimmune agrees to provide Nexell with reasonable access to its
facilities and employees at reasonable times for the purpose of demonstrating to
Nexell the assay processes included in the Licensed Know-How that may be
necessary or useful to Nexell's development, manufacture, use or sale of
Licensed Products. Consultation by Epimmune's employees at Epimmune's facilities
shall be limited to ***. In addition, consultation by Epimmune's employees by
teleconference shall be limited to ***.
3.5 Peptide License Option. Epimmune hereby grants to Nexell an option
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to include under the License any or all of the peptides listed on Appendix B
hereto, together with all associated Patent Rights and improvements thereto
owned by Epimmune or which Epimmune has the right to license (with the right to
sublicense). Epimmune represents and warrants that Appendix B hereto identifies
all Patent Rights (owned or licensed by Epimmune) associated with the peptides
listed therein and there exist no limitations on Epimmune's right to sublicense
such Patent Rights as contemplated hereby. Epimmune agrees that it shall not
enter into any agreement or arrangement that would limit Epimmune's right to
sublicense the peptides and Patent Rights and improvements to Nexell pursuant to
the option.
3.5.1 The option may be exercised at any time during the period ending on
the earlier of (a) *** from the Effective Date, or (b) *** from enrollment of
the first patient in Nexell's first clinical trial relating to a Product. Nexell
may exercise the option, in whole or in part, upon written notice to Epimmune,
together with a payment of ***. Upon the exercise of the option during such
option period and payment of the specified amount to Epimmune, the term
"Licensed Patent Rights" will include the peptides with respect to which the
option was exercised and the associated Patent Rights, including derivatives and
modifications thereof, owned or licensed by Epimmune (with the right to
sublicense).
* Confidential Treatment Requested
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ARTICLE 4
LICENSE FEES, ROYALTIES AND MILESTONE PAYMENTS
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4.1 License Fees. In consideration for the License, Nexell shall pay to
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Epimmune a non-refundable license fee of *** in cash promptly following the
Effective Date, and an additional *** following the Effective Date.
4.2 Royalty. In further consideration for the License during the term of
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this Agreement, Nexell shall pay to Epimmune a royalty of *** of Net Sales of
Products by Nexell and any of its Affiliates or sublicensees.
4.2.1 With respect to any Product in a given country where there is no
Valid Patent Claim described in Section 1.21(a) included in the Licensed Patent
Rights, the royalty on Net Sales of such Products in such country will
thereafter be reduced by ***.
4.3 Accrual of Royalties. No royalty shall be payable on a Product
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distributed to Third Parties, without payment or at cost, solely for marketing
and advertising purposes or as a sample for testing or evaluation purposes. No
multiple royalty shall be payable on a Product because the manufacture, use or
sale of such Product is covered by more than one Licensed Patent Right.
4.4 Milestone Payments. As further consideration for the license granted
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to Nexell under this Agreement, Nexell shall pay Epimmune a non-refundable
milestone payment of *** in cash upon the occurrence of each of the following
events with respect to *** developed by Nexell or its Affiliates or
sublicensees: ***.
4.4.1 In the event Nexell exercises the peptide license option described
in Section 3.5 hereof, Nexell shall pay Epimmune an additional non-refundable
milestone payment of *** in cash upon the occurrence of each of the events
described in Section 4.4. above with respect to *** developed by Nexell or its
Affiliates or sublicensees that contains, incorporates, or uses any peptide or
associated Patent Right included under the peptide license option.
ARTICLE 5
ROYALTY REPORTS AND ACCOUNTING
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5.1 Reports. Nexell and its Affiliates and sublicensees shall keep
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complete and accurate records in sufficient detail to properly reflect all gross
sales and Net Sales and to enable the royalties payable hereunder to be
determined. Nexell shall provide such a royalty report to Epimmune within ***
of the end of each fiscal quarter in which royalties are due.
5.2 Audits.
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5.2.1 Upon the written request of Epimmune, and not more than once in
each calendar year, Nexell shall permit an independent certified public
accounting firm of globally recognized standing, selected by Epimmune, at
Epimmune's expense, to have access during normal business hours to such of the
records of Nexell as may be reasonably necessary to verify the accuracy of the
royalty reports hereunder. The accounting firm 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.
5.2.2 If such accounting firm concludes that additional royalties were
owed during such period, Nexell shall pay the additional royalties within
thirty (30) days of the date Epimmune delivers to Nexell 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
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payable by Nexell for the audited period are more than *** of the royalties
actually paid for such period, then Nexell shall pay the reasonable fees and
expenses charged by such accounting firm.
5.2.3 Upon the expiration of twelve (12) months following the end of
any year, the calculation of royalties payable with respect to such year shall
be binding and conclusive upon Epimmune and Nexell and its sublicensees.
5.3 Confidential Financial Information. Epimmune shall treat all
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financial information subject to review under this Article 5 or under any
sublicense agreement as confidential, and shall cause its accounting firm to
retain all such financial information in confidence.
ARTICLE 6
PAYMENTS
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6.1 Payment Terms. Royalties shown to have accrued by each royalty report
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provided for under Article 5 above shall be due and payable upon the date such
royalty report is due. Payment of royalties in whole or in part may be made in
advance of such due date.
6.2 Payment Method. All payments by Nexell to Epimmune under this
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Agreement shall be paid in 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.
6.3 Exchange Control. If at any time legal restrictions prevent the
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prompt remittance of part or all royalties with respect to any country where the
Product is sold, payment shall be made through such lawful means or methods as
Epimmune reasonably shall request.
6.4 Withholding Taxes. All amounts owing from Nexell to Epimmune under
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this Agreement are net amounts, and shall be grossed-up to account for any
withholding taxes, value-
* Confidential Treatment Requested
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added taxes or other materially similar taxes, levies or charges with respect to
such amounts, other than United States taxes, payable by Nexell or its
sublicensees, or any taxes required to be withheld by Nexell or its sublicensees
having a permanent establishment in any country or otherwise being subject to
taxation by such country (except solely by reason of the License).
ARTICLE 7
INFRINGEMENT ACTIONS BY THIRD PARTIES
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If Nexell, or any of its Affiliates, sublicensees or customers shall be
sued by a Third Party for infringement of a Third Party's patent because of the
manufacture, use or sale of Products, Nexell shall promptly notify Epimmune in
writing of the institution of such suit. If the alleged infringing process,
method or composition is claimed under the Licensed Patent Rights, Nexell shall
promptly cease the manufacture, use, sale, offering for sale or importation of
the allegedly infringing process, method or composition claimed under the
Licensed Patent Rights and Nexell shall have the right, subject to the
reasonable approval of Epimmune, to control the defense of such suit at Nexell's
own expense, in which event Epimmune shall have the right to be represented by
advisory counsel of its own selection, at its own expense, and shall cooperate
fully in the defense of such suit and furnish to Nexell all evidence and
assistance in its control. If Nexell does not elect within thirty (30) days
after such notice to so control the defense of such suit, Epimmune may undertake
such control at its own expense, and Nexell shall then have the right to be
represented by advisory counsel of its own selection, at its own expense, and
Nexell shall cooperate fully in the defense of such suit and otherwise furnish
to Epimmune all evidence and assistance in Nexell's control. The party
controlling the suit may not settle the suit or otherwise consent to an adverse
judgment in such suit that diminishes the rights or interests of the non-
controlling party without the express written consent of the non-controlling
party. Any judgments, settlements or damages payable with respect to legal
proceedings covered by this Article 7 shall be paid by the party which controls
the litigation.
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ARTICLE 8
CONFIDENTIALITY
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8.1 Confidential Information. During the term of this Agreement, and for
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a period of *** following the expiration or earlier termination hereof, each
party shall maintain in confidence all information of the other party disclosed
by the other party and identified as, or acknowledged to be, confidential (the
"Confidential Information"), and shall not use, disclose or grant the use of the
Confidential Information except on a need-to-know basis to those directors,
officers, affiliates, employees, permitted licensees, permitted assignees and
agents, consultants, lawyers, bankers, clinical investigators or contractors, to
the extent such disclosure is reasonably necessary in connection with such
party's activities as expressly authorized by this Agreement. To the extent
that disclosure is authorized by this Agreement, prior to disclosure, each party
hereto shall obtain agreement of any such Person to hold in confidence and not
make use of the Confidential Information for any purpose other than those
permitted by this Agreement. Each party shall notify the other promptly upon
discovery of any unauthorized use or disclosure of the other party's
Confidential Information.
8.2 Permitted Disclosures. The confidentiality obligations contained in
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Section 8.1 above shall not apply to the extent that (a) any receiving party
(the "Recipient") is required (i) to disclose information by law, order or
regulation of a governmental agency or a court of competent jurisdiction, or
(ii) to disclose information to any governmental agency for purposes of
obtaining approval to test or market a product, provided in either case that the
Recipient shall provide written notice thereof to the other party and sufficient
opportunity to object to any such disclosure or to request confidential
treatment thereof, or (b) the Recipient can demonstrate that (i) the disclosed
information was public knowledge at the time of such disclosure to the
Recipient, or thereafter became public knowledge, other than as a result of
actions of the Recipient in violation hereof; (ii) the disclosed information was
rightfully known by the Recipient (as shown by its written records) prior to the
date of disclosure to the Recipient by the other party hereunder; (iii) the
disclosed information was disclosed to the Recipient on an unrestricted basis
from a source unrelated to any party to this Agreement and not under a duty of
confidentiality to the other party or (iv) the disclosed information was
independently developed by the Recipient without use of the Confidential
Information disclosed by the other party (as shown by the Recipient's written
records).
8.3 Terms of this Agreement. Except as otherwise provided in Section 8.2
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above and subject to either party's reporting obligations under applicable state
and federal laws (including the rules of any stock exchange or trading market),
Epimmune and Nexell 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.
8.4 Publication. Neither party shall submit for written or oral
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publication or presentation any manuscript, abstract, writing, printed material
or the like which includes data or any other information generated and provided
solely by the other party without first obtaining the prior written consent of
the other party, which consent shall not be unreasonably withheld or
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delayed, provided, however, that valid commercial reasons may exist for
withholding such consent. Nothing contained herein shall be construed as
precluding either party from making, in its discretion, any disclosures of
information to the extent that either party may be required by law to make
disclosures of such information.
ARTICLE 9
PATENTS
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9.1 Ownership of Inventions and Patents. All right, title and interest in
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and to (i) any new developments resulting from the practice of the Licensed
Technology and/or (ii) Improvements that are (a) made by or at the request of
Nexell shall be the sole property of Nexell, (b) made by or at the request of
Epimmune shall be the sole property of Epimmune, and (c) made jointly by Nexell
and Epimmune shall be the joint property of Nexell and Epimmune ("Joint
Inventions").
9.1.1 Nexell hereby grants to Epimmune a non-exclusive, worldwide license
to (a) any new developments resulting from the practice of the Licensed
Technology made by or at the request of Nexell that directly incorporate
peptides or cell lines included in the Licensed Know-How and/or (b) Improvements
owned by or licensed to Nexell (with the right to license or sublicense) during
the term of this Agreement for all uses. Such a license shall bear a royalty of
*** on Net Sales by Epimmune or its Affiliates or sublicensees of products that
use or incorporate such developments or Improvements. Epimmune may sublicense
its rights under the license to Third Parties to whom Epimmune also licenses its
own technology. Nexell shall promptly notify Epimmune in writing of any such
developments or Improvements licensed to Epimmune under this Section 9.1.1.
9.2 Prosecution and Maintenance. Epimmune shall be responsible for the
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preparation, filing, prosecution, maintenance and defense of its patents
included in the Licensed Patent Rights at its own expense. Nexell shall control
the prosecution, grant and maintenance of patent rights regarding Joint
Inventions, using patent counsel reasonably acceptable to Epimmune, provided
that Nexell shall provide Epimmune with the opportunity to review and comment on
filings and other actions with respect to such patent rights regarding Joint
Inventions. Nexell and Epimmune shall share equally all costs incurred in
connection therewith; provided, however, that if Epimmune disagrees with filing
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for patent rights regarding a Joint Invention in a given country, Epimmune may
elect not to share the costs incurred in connection with filing, prosecution,
maintenance and defense of patent rights regarding such Joint Invention upon
written notice to Nexell, and Nexell shall pay all such costs in such country;
provided further that Nexell will be entitled to credit such costs in such
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country incurred by Nexell against royalties payable to Epimmune under Section
4.2 on Net Sales of Products in such country. Nexell shall inform Epimmune 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 Nexell elects
not to file a patent application or decides to abandon any pending application
or granted patent regarding Joint Inventions in any country, Nexell shall
provide adequate notice to Epimmune and give Epimmune the opportunity to file or
maintain such application or patent at its own expense, and all right title
interest in such application or patent for such country shall thereupon be
assigned to Epimmune.
* Confidential Treatment Requested
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In the event that Epimmune elects not to file a patent application or
decides to abandon any pending application or granted patent under the Licensed
Patent Rights in any country, Epimmune shall provide adequate notice to Nexell
and give Nexell the opportunity to file or maintain such application or patent
at its own expense; provided, however, that except for the right to file and
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maintain such patent rights, the ownership rights of Epimmune to such patent
rights shall not be affected by reason of this paragraph.
9.3 Cooperation. Each party shall make available to the other party or
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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 inventions, as set forth in
Section 9.2 above, 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.
9.4 No Other Technology Rights. Except as otherwise provided in this
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Agreement, under no circumstances shall a party, as a result of this Agreement,
obtain any ownership interest or other right in any technology, Licensed
Technology, know-how, patents, pending patent applications, products, compounds,
materials, vaccines, antibodies, cell lines or cultures, or animals of the other
party, including items owned, controlled or developed by the other, or
transferred by the other to such party at any time pursuant to this Agreement.
9.5 Notification of Infringement. Each party shall notify the other party
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of any significant and continuing infringement known to such party of any joint
patent rights on Joint Inventions or patent rights of the other party and shall
provide the other party with the available evidence, if any, of such
infringement.
ARTICLE 10
INDEMNITY
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10.1 Indemnity.
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10.1.1 By Epimmune. Epimmune shall indemnify and hold Nexell harmless,
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and hereby forever releases and discharges Nexell, from and against all losses,
liabilities, damages and expenses (including reasonable attorneys' fees and
costs) resulting from all claims, demands, actions and other proceedings by any
Third Party to the extent arising from (a) the breach of any representation,
warranty or covenant of Epimmune under this Agreement, (b) the development,
manufacture, use or sale of products by Epimmune or its Affiliates or
sublicensees resulting from the license described in Section 9.1.1 hereof, or
(c) the gross negligence or willful misconduct of Epimmune in the performance of
its obligations and its permitted activities under this Agreement.
10.1.2 By Nexell. Nexell shall indemnify and hold Epimmune harmless,
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and hereby forever releases and discharges Epimmune, from and against all
losses, liabilities, damages and expenses (including reasonable attorneys' fees
and costs) resulting from all claims, demands, actions and other proceedings by
any Third Party to the extent arising from (a) the
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breach of any representation, warranty or covenant of Nexell under this
Agreement, (b) the development, manufacture, use or sale of Products by Nexell
or its Affiliates or sublicensees or (b) the gross negligence or willful
misconduct of Nexell or its Affiliates or sublicensees in the performance of its
or their obligations, and its or their permitted activities under this
Agreement.
10.2 Procedure. A party (the "Indemnitee") that intends to claim
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indemnification under this Article 10 shall promptly notify the other party (the
"Indemnitor") of any claim, demand, action or other proceeding for which the
Indemnitee intends to claim such indemnification, The Indemnitor shall have the
right to participate in, and to the extent the Indemnitor so desires jointly
with any other indemnitor similarly noticed, to assume the defense thereof with
counsel selected by the Indemnitor; provided, however, that the Indemnitee shall
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have the right to retain its own counsel, with the fees and expenses to be paid
by the Indemnitor, if representation of the Indemnitee by the counsel retained
by the Indemnitor would be inappropriate due to actual or potential differing
interests between the Indemnitee and any other party represented by such counsel
in such proceedings. The indemnity obligations under this Article 10 shall not
apply to amounts paid in settlement of any claim, demand, action or other
proceeding if a settlement is effected without the prior express written consent
of the Indemnitor, which consent shall not be unreasonably withheld or delayed.
The failure to deliver notice to the Indemnitor within a reasonable time after
notice of any such claim or demand, or the commencement any such action or other
proceeding, if prejudicial to its ability to defend such claim, demand, action
or other proceeding, shall relieve such Indemnitor of any liability to the
Indemnitee under this Article 10 with respect thereto, but the omission so to
deliver notice to the Indemnitor shall not relieve it of any liability that it
may have to the Indemnitee otherwise than under Article 10. The Indemnitor may
not settle or otherwise consent to an adverse judgment in such claim, demand,
action or other proceeding, that diminishes the rights or interests of
Indemnitee without the prior express written consent of the Indemnitee, which
consent shall be unreasonably withheld or delayed. The Indemnitee, its
employees and agents, shall reasonably cooperate with the Indemnitor and its
legal representatives in the investigation of any claim, demand, action or other
proceeding covered by this Article 10.
ARTICLE 11
TERMINATION
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11.1 Expiration. Subject to the provisions of Sections 11.2 and 11.3
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below, this Agreement shall expire on a Product-by-Product and country-by-
country basis on the date which is the later of (a) *** years from the first
sale of the applicable Product in the applicable country, or (b) the last to
expire of the patents included in the Licensed Patent Rights.
11.2 Termination for Cause. Except as otherwise provided in Article 12,
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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 sixty (60) days after written notice thereof by the
non-breaching party.
* Confidential Treatment Requested
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11.3 Bankruptcy. In the event of the institution by or against either
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party of insolvency, receivership or bankruptcy proceedings or any other
proceedings for the settlement of such party's debts which are not dismissed
within sixty (60) days, or upon such party's making an assignment for the
benefit of creditors, or upon such party's dissolution or ceasing to do
business, the other party shall have the right to terminate this Agreement upon
written notice to the other party.
11.4 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 Article 1, Sections 5.2
(for one year following the end of the calendar year in which such expiration or
termination occurred) 5.3, 8.1, 8.2 and 8.3, 9.1.1 (provided that the license
granted thereunder shall continue so long as Epimmune is not in breach of its
obligations to Nexell with respect to such license), Article 10 and Sections
11.4, 13.2, 13.3 and 13.4 shall survive the expiration or termination of this
Agreement.
ARTICLE 12
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 13
MISCELLANEOUS
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13.1 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 or by facsimile (and promptly
confirmed by personal delivery, U.S. first class mail or courier), U.S. 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
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.
0000 Xxxxx Xxxxx Xxxxx
Xxx Xxxxx, XX 00000
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Attention: Chief Financial Officer
with a copy to: Xxxxxx Godward LLP
0000 Xxxxxxxxx Xxxxx, 00xx Xxxxx
Xxx Xxxxx, XX 00000
Attention: L. Xxx Xxxxxxxx, Esq.
If to Nexell: Nexell of California, Inc.
0 Xxxxxx Xxxxxx
Xxxxxx, XX 00000
Attention: Xxxxxx Xxxxx, Vice President, Business Development
with a copy to: Xxxxx Xxxx LLP
000 Xxxxxxxxxx Xxxxxx, X.X.
Xxxxx 000
Xxxxxxxxxx, X.X. 00000
Attention: Xxxxxxx Xxxxxxx, Esq.
13.2 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.
13.3 Arbitration. Upon written request by at least one party that is
------------
submitted according to the applicable rules for arbitration, any claim, demand
or cause of action that arises out of or is related to this Agreement
(collectively, "Claims") shall be resolved by binding arbitration in the city of
Los Angeles, California, subject to the rules of the American Arbitration
Association. The decision of an arbitrator on any Claims submitted to
arbitration shall follow applicable substantive law and be in writing setting
forth the findings of fact and law and the reasons supporting the decision.
Such decision shall be final and binding upon the parties, subject to the right
of appeal described below. Judgment upon any arbitration award may be entered
in any court having jurisdiction. The arbitrator has exclusive authority to
resolve any dispute relating to the applicability or enforceability of this
Agreement, including the provisions of this section. Either party shall have
the right to appeal to the appropriate court any errors of law in the decision
rendered by the arbitrator. After a demand for arbitration is made, each party
may conduct a limited number of depositions (including the production of
documents) by mutual agreement or as permitted by the arbitrator.
13.4 Assignment. Neither party shall assign its rights or obligations
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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 or entity,
other than Nexell 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 thisSection 13.4 shall be
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void.
13.5 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 hereto.
13.6 Entire Agreement. This Agreement 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.
13.7 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.
13.8 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.
13.9 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.
13.10 Independent Contractors. The relationship between Epimmune and
-----------------------
Nexell 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 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.
13.11 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.
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IN WITNESS WHEREOF, the parties have executed this License Agreement by
their duly authorized representatives as of the date first set forth below.
EPIMMUNE INC.
__________________________
By:
Title:
NEXELL OF CALIFORNIA, INC.
__________________________
By:
Title:
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