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EXHIBIT 10.78
*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4),
200.83 AND 240.24B-2
NON-EXCLUSIVE LICENSE AGREEMENT
THIS NON-EXCLUSIVE LICENSE AGREEMENT (the "Agreement") is entered into
as of November __, 2000 (the "Effective Date"), by and between EPIMMUNE INC., a
Delaware corporation, having offices at 0000 Xxxxx Xxxxx Xxxxx, Xxx Xxxxx,
Xxxxxxxxxx 00000 ("Epimmune"), and VALENTIS, INC., a Delaware corporation,
having offices at 000X Xxxxxx Xxxx, Xxxxxxxxxx, Xxxxxxxxxx 00000 ("Valentis").
WHEREAS, Valentis has developed and owns the Patent Rights and
Biological Material (as defined below);
WHEREAS, Valentis has previously transferred the Biological Material to
Epimmune pursuant to the Material Transfer Agreement between the parties dated
August 31, 1999 (the "Prior Agreement"); and
WHEREAS, Epimmune wishes to obtain, and Valentis is willing to grant, a
non-exclusive, worldwide license under the Patent Rights to develop and
commercialize Products in the HCV Field and the HIV Field (as such terms are
defined below), on the terms and subject to the conditions set forth herein.
NOW, THEREFORE, in consideration of the mutual covenants and promises
hereinafter set forth, the parties hereto hereby agree as follows:
ARTICLE 1
DEFINITIONS
1.1 "AFFILIATE" shall mean any corporation or other entity which controls,
is controlled by, or is under common control with, a party. A
corporation or other entity shall be regarded as in control of another
corporation or entity if it owns or directly or indirectly controls 100%
of the voting securities or other ownership interest of the other
corporation or entity, or if it possesses, directly or indirectly, the
power to direct or cause the direction of the management and policies of
the corporation or other entity.
1.2 "BIOLOGICAL MATERIAL" shall mean Valentis' proprietary plasmid backbone,
designated pMB75.6, all information, maps or data relating to such
plasmid backbone supplied by Valentis to Epimmune, and all derivatives
or modifications thereof.
1.3 "BLA" shall mean a Biological License Application filed pursuant to the
requirements of the FDA.
1.4 "CONFIDENTIAL INFORMATION" shall mean any confidential or proprietary
information of a party, including information related to the Patent
Rights or Biological Material, and any other information relating to any
compound, research project, work in process, future development,
scientific, engineering, manufacturing, marketing, business plan,
financial or personnel matter relating to such party, its present or
future products, sales, suppliers, customers, employees, investors or
business, whether in oral, written, graphic or electronic form.
Notwithstanding the foregoing, Confidential Information shall not
include any information which the receiving party can prove by competent
written evidence:
(a) is now, or hereafter becomes, through no act or failure to act on the
part of the receiving party, generally known or available;
(b) is known by the receiving party at the time of receiving such
information, as evidenced by its records;
(c) is hereafter furnished to the receiving party by a Third Party, as a
matter of right and without restriction on disclosure;
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(d) is independently developed by the receiving party, as evidenced by its
records, without knowledge of, and without the aid, application or use
of, the Confidential Information of the disclosing party; or
(e) is the subject of a written permission to disclose provided by the
disclosing party.
1.5 "CONTROL" shall mean possession of the ability to grant a license or
sublicense without violating the terms of any agreement or other
arrangement with any Third Party.
1.6 "FDA" shall mean the United States Food and Drug Administration or
equivalent regulatory agency in any of the following countries: Canada,
China, France, Germany, Italy, Japan, Mexico, Spain, Australia or the
United Kingdom.
1.7 "FIELD" shall mean the HCV Field and/or the HIV Field, as applicable.
1.8 "FIRST COMMERCIAL SALE" of a Product means the first sale for use or
consumption of such Product in a country after required marketing
approval has been granted by the governing health regulatory authority
of such country. Sale to an Affiliate or sublicensee shall not
constitute a First Commercial Sale unless the Affiliate or sublicensee
is the end user of the Product.
1.9 "HCV FIELD" shall mean the prophylactic and/or therapeutic treatment of
hepatitis C virus infection in humans.
1.10 "HIV FIELD" shall mean the prophylactic and/or therapeutic treatment of
human immunodeficiency virus infection in humans.
1.11 "NDA" shall mean a New Drug Application or Product License Application,
as appropriate, filed pursuant to the requirements of the FDA.
1.12 "NET SALES" shall mean the gross amounts received by Epimmune, its
Affiliates and its sublicensees for the sale of Products to Third
Parties, less the following: (a) discounts actually granted, (b)
credits, rebates or allowances actually granted upon claims, damaged
goods, rejections or returns of Products, including recalls, (c)
freight, postage, shipping and insurance charges actually allowed or
paid for delivery of Products, to the extent billed, and (d) taxes,
duties or other governmental charges (other than income taxes) levied
on, absorbed or otherwise imposed on sales of Products. Amounts received
by Epimmune or its Affiliates for the sale of Products between Epimmune
and its Affiliates or sublicensees, whether for their own use or for
resale or other disposition, will not be included in the computation of
Net Sales hereunder.
With regard to a product sold by Epimmune or its Affiliates or
sublicensees that is comprised in part of a Product and in part of one
or more other products (a "Combination Product"), Net Sales shall be
determined by multiplying the amounts received by Epimmune or its
Affiliates or sublicensees for the sale of such Combination Product by a
fraction determined by dividing (i) the fair market value of the Product
included in the Combination Product, by (ii) the sum of the fair market
value of such Product and the fair market value of the other product(s)
included in the Combination Product. As used herein, "fair market value"
shall be equal to the average selling price, where such Product is sold
on a stand-alone basis. If such Product is not sold on a stand-alone
basis, "fair market value" shall be determined by mutual written
agreement of the parties in good faith.
1.13 "PATENT RIGHTS" shall mean (a) the patents and patent applications
listed on Exhibit A attached hereto, (b) any and all corresponding
foreign patents and patent applications, whether now existing or
hereafter filed, (c) any provisionals, substitutions, divisionals,
reissues, renewals, continuations, continuations-in-part, substitute
applications and inventors' certificates arising from, or based upon,
any of the foregoing patents or patent applications, and (d) any patents
issuing from any of the foregoing patent applications.
1.14 "PHASE I CLINICAL TRIALS" shall mean that portion of the clinical
development program with respect to a pharmaceutical product which
generally provides for the first introduction into humans of the product
with the primary purpose of determining safety, metabolism and
pharmacokinetic properties and clinical pharmacology of the product, as
more specifically defined by the rules and regulations of the FDA and
corresponding rules and regulations in other countries or jurisdictions.
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1.15 "PHASE III CLINICAL TRIALS" shall mean that portion of the clinical
development program which provides for the continued trials of a
pharmaceutical product on sufficient numbers of patients to establish
the safety and efficacy of such product for the desired claims and
indications, as more specifically defined by the rules and regulations
of the FDA and corresponding rules and regulations in other countries or
jurisdictions. Notwithstanding the foregoing, if Phase III Clinical
Trials are not conducted, but Epimmune, its Affiliate or sublicensee
nonetheless pursues regulatory approval of a Product based upon Phase II
trial results, such Phase II trial shall be deemed to be a Phase III
Clinical Trial.
1.16 "PRODUCT" shall mean a plasmid-based therapeutic or prophylactic vaccine
developed by Epimmune, its Affiliates or its sublicensees the
manufacture, use, importation, offer for sale, or sale of which is
covered by a Valid Claim or is based upon or incorporates the Biological
Material.
1.17 "ROYALTY TERM" shall mean, on a country-by-country basis, the longer of:
(a) the period of time commencing on the First Commercial Sale and
ending upon the expiration of the last to expire Valid Claim covering
such Product in such country; and (b) the period of time commencing on
the First Commercial Sale in such country and ending *** years from the
date of First Commercial Sale in such country.
1.18 "THIRD PARTY" shall mean any entity other than Epimmune or Valentis or
an Affiliate of Epimmune or Valentis.
1.19 "VALID CLAIM" shall mean a claim of an issued patent included within the
Patent Rights, which claim has not lapsed, been canceled or become
abandoned and has not been declared invalid or unenforceable by an
unreversed and unappealable decision or judgment of a court or other
appropriate body of competent jurisdiction, and which has not been
admitted to be invalid or unenforceable through reissue, disclaimer or
otherwise.
ARTICLE 2
GRANT OF LICENSE
2.1 LICENSE GRANT. Subject to the terms and conditions of this Agreement,
Valentis hereby grants to Epimmune and its Affiliates a non-exclusive,
worldwide, non-transferable (except as provided in Section 10.1)
royalty-bearing license, with the right to sublicense in accordance with
Section 2.2, under the Patent Rights to develop, make, have made, use,
offer for sale, sell, have sold and import Products solely for use in
the HCV Field and the HIV Field and to use the Biological Material for
such purposes.
2.2 SUBLICENSES. Epimmune and its Affiliates shall have the right to grant
sublicenses solely to bona fide strategic or collaborative partners of
Epimmune or an Affiliate of Epimmune for use solely in such strategic or
collaborative partners' collaborative research, development or
commercialization program with Epimmune or such Affiliate and to
transfer Biological Material to such partners for use in connection with
such purposes, provided that such collaborative or strategic partner is
also granted, at the same time as the sublicense, rights to
substantially all other intellectual property Controlled by Epimmune or
its Affiliates relating to a Product. Epimmune shall notify any
sublicensee hereunder of all rights and obligations of Epimmune under
this Agreement which are sublicensed to such sublicensee and shall
notify Valentis within thirty (30) days of the grant of any sublicense
hereunder, and provide a copy of such sublicense to Valentis.
2.3 NEGATIVE COVENANT. Epimmune hereby covenants that neither it nor any of
its Affiliates shall practice any invention claimed in the Patent Rights
or use the Biological Material outside the HCV Field or the HIV Field.
Epimmune further covenants that neither it nor its Affiliates shall
transfer the Biological Material to any Third Party except as permitted
under Section 2.2 above, or otherwise for purposes of developing,
manufacturing or commercializing Products.
2.4 REASONABLE ACCESS. Valentis will provide Epimmune with access to
appropriate personnel of Valentis via telephone, facsimile or electronic
mail during Valentis' regular business hours in order to discuss
questions
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relating to the use of the Biological Material and the Patent Rights in
connection with the Products, provided that such access is limited to
six (6) days per year.
ARTICLE 3
PAYMENT OBLIGATIONS
3.1 LICENSE FEE. In partial consideration of the license granted to Epimmune
by Valentis, Epimmune shall pay to Valentis a license fee of *** within
ten (10) days of the Effective Date.
3.2 ROYALTIES.
(a) With regard to any Product the manufacture, use, importation, offer for
sale or sale of which is covered by a Valid Claim, Epimmune shall pay to
Valentis a royalty of (i) *** on that portion of annual Net Sales of
such Product that is less than or equal to ***, and (ii) *** on that
portion of annual Net Sales of such Product that is greater than ***;
provided, however, that, if Epimmune or its Affiliate enters into a
collaborative or strategic relationship with a Third Party with respect
to such Product prior to initiation of Phase III Clinical Trials of such
Product, then, with respect to such Product, Epimmune shall pay to
Valentis a royalty equal to the greater of (A) *** of royalty payments
received by Epimmune and its Affiliates from such Third Party with
respect to sales of such Product or (B) the royalty on Net Sales of such
Product specified in Section 3.2(a)(i) and (ii) above.
(b) With regard to any Product the manufacture, use, importation, offer for
sale or sale of which is not covered by a Valid Claim, Epimmune shall
pay to Valentis a royalty of (i) *** on that portion of annual Net Sales
of such Product that is less than or equal to ***, and (ii) *** on that
portion of annual Net Sales of such Product that is greater than ***;
provided, however, that, if Epimmune or its Affiliate enters into a
collaborative or strategic relationship with a Third Party with respect
to such Product prior to initiation of Phase III Clinical Trials of such
Product, then, with respect to such Product, Epimmune shall pay to
Valentis a royalty equal to the greater of (A) *** of royalty payments
received by Epimmune and its Affiliates from such Third Party with
respect to sales of such Product or (B) the royalty on Net Sales of such
Product specified in Section 3.2(b)(i) and (ii) above.
(c) Royalties under this Section 3.2 shall be paid, on a country-by-country
and Product-by-Product basis, during the Royalty Term.
3.3 MILESTONES. At any time following initiation of Phase I Clinical Trials
of the first Product to enter Phase I Clinical Trials in each of the HIV
Field and the HCV Field, as applicable, Valentis shall have the right,
exercisable upon written notice to Epimmune (the "Milestone Notice"), to
cause the applicable milestone payment set forth below to become payable
to Valentis by Epimmune with respect to a Product, which payment may be
made, at Epimmune's option, either in cash or in Common Stock of
Epimmune:
(a) If Valentis delivers the Milestone Notice with respect to a Product in a
Field after initiation of Phase I Clinical Trials of the first Product
to enter Phase I Clinical Trials in such Field and before initiation of
Phase III Clinical Trials of any Product in such Field, Epimmune shall
pay to Valentis (i) *** in cash or (ii) *** of Common Stock (determined
as set forth below). The milestone payment set forth in this Section
3.3(a) shall be payable with respect to one (1) Product in each of the
HIV Field and the HCV Field, provided that the applicable Milestone
Notice is given during the specified period.
(b) If Valentis delivers the Milestone Notice with respect to a Product in a
Field after initiation of Phase III Clinical Trials of a Product in such
Field and before FDA approval of an NDA or BLA (as applicable) of such
Product in such Field, Epimmune shall pay to Valentis (i) *** in cash or
(ii) *** of Common Stock (determined as set forth below).
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The milestone payment set forth in this Section 3.3(b) shall be payable
with respect to one (1) Product in each of the HIV Field and the HCV
Field, provided that the applicable Milestone Notice is given during the
specified period.
(c) If Valentis delivers the Milestone Notice with respect to a Product in a
Field after FDA approval of an NDA or BLA (as applicable) of such
Product in such Field, Epimmune shall pay to Valentis (i) *** in cash or
(ii) *** of Common Stock (determined as set forth below). The milestone
payment set forth in this Section 3.3(c) shall be payable with respect
to one (1) Product in each of the HIV Field and the HCV Field, provided
that the applicable Milestone Notice is given during the specified
period.
The number of shares of Common Stock that may be issuable to Valentis
under this Section 3.3 shall be determined by dividing the dollar amount
set forth in Section 3.3(a)(ii), 3.3(b)(ii) or 3.3(c)(ii), as
applicable, by a per share price equal to the average of the closing
prices per share of the Common Stock on the Nasdaq National Market (or
any other national securities exchange on which the Common Stock is then
traded) for the thirty (30) consecutive trading days ending on the
trading day immediately preceding the Epimmune Notice (as defined
below). In the event that the per share price of Common Stock to be
issued to Valentis under this Section 3.3 as determined above is below
***, then Epimmune will be obligated to deliver the applicable milestone
payment in cash. Notwithstanding the foregoing, in no event will
Epimmune be obligated to issue shares of Common Stock under this
Agreement to the extent such issuance would require approval of
Epimmune's stockholders under the rules and regulations of the Nasdaq
Stock Market (or any other national securities exchange on which the
Common Stock is then traded). In such event, Epimmune would be obligated
to deliver to Valentis the applicable milestone payment in cash.
Epimmune shall make each milestone payment for which it has received a
Milestone Notice hereunder and for which it elects to pay cash within
twenty (20) days following receipt of such Milestone Notice. If Epimmune
elects to make any milestone payment under this Section 3.3 in Common
Stock, Epimmune shall provide Valentis with written notice of such
election (the "Epimmune Notice") within ten (10) days following receipt
of the applicable Milestone Notice. Such Common Stock shall be delivered
to Valentis within sixty (60) days of the Epimmune Notice.
On the Effective Date, the parties shall enter into an agreement in the
form attached hereto as EXHIBIT B with respect to such shares of Common
Stock that may be issued to Valentis.
ARTICLE 4
PAYMENTS; RECORDS; AUDITS
4.1 PAYMENT; REPORTS. Royalty payments and reports for the sale of Products
shall be calculated and reported for each calendar quarter. All royalty
payments due to Valentis under this Agreement shall be paid within sixty
(60) days of the end of each calendar quarter. Each payment of royalties
shall be accompanied by a report of Net Sales of Products (and, if
applicable under Section 3.2, royalties received by Epimmune and its
Affiliates) in sufficient detail to permit confirmation of the accuracy
of the royalty payment made, including, without limitation, the number
of Products sold, the gross sales and Net Sales of Products, the
royalties payable and the method used to calculate the royalty.
4.2 EXCHANGE RATE; MANNER AND PLACE OF PAYMENT. All payments hereunder shall
be payable in U.S. dollars. With respect to each quarter, for countries
other than the United States, whenever conversion of royalty payments
from any foreign currency shall be required, such conversion shall be
made at the rate of exchange reported in The Wall Street Journal
(Western Edition) on the last business day of such quarter. All payments
owed under this Agreement shall be made by wire transfer to a bank and
account designated in writing by Valentis, unless otherwise specified in
writing by Valentis.
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4.3 LATE PAYMENTS. Any amounts not paid by Epimmune when due under this
Agreement shall be subject to interest from the date payment is due
through the date payment is received by Valentis at a rate equal to the
sum of two percent (2%) plus the prime rate of interest quoted in the
Money Rates section of The Wall Street Journal (Western Edition),
calculated daily on the basis of a 360-day year, or similar reputable
data source, or, if lower, the highest rate permitted under applicable
law.
4.4 RECORDS AND AUDITS. Epimmune shall keep for a period covering at least
the preceding *** years complete and accurate records pertaining to the
development and sale or other disposition of Products in sufficient
detail to permit Valentis to confirm the accuracy of all payments due
hereunder. Valentis shall have the right to cause an independent,
certified public accountant reasonably acceptable to Epimmune to audit
such records for the purpose of verifying any amounts payable, or
information provided, under this Agreement. Such audits may be exercised
during normal business hours upon reasonable prior written notice to
Epimmune. Prompt adjustments shall be made by the parties to reflect the
results of such audit. Valentis shall bear the full cost of such audit,
unless such audit discloses a variance of more than *** from the amounts
actually due, in which case Epimmune shall bear the full cost of such
audit.
4.5 TAXES. All taxes levied on account of the royalties and other payments
accruing to Valentis under this Agreement shall be paid by Valentis for
its own account, including taxes levied thereon as income to Valentis.
If provision is made in law or regulation for withholding, such tax
shall be deducted by Epimmune from the sums otherwise payable by it
hereunder for payment to the proper taxing authority on behalf of
Valentis and a receipt of payment of the tax secured and promptly
delivered to Valentis. Each party agrees to assist the other party in
claiming exemption from such deductions or withholdings under any double
taxation or similar agreement or treaty from time to time in force.
4.6 PROHIBITED PAYMENTS. Notwithstanding any other provision of this
Agreement, if Epimmune is prevented from paying any royalty payment
hereunder by virtue of the statutes, laws, codes or governmental
regulations of the country from which the payment is to be made, then
such royalty may be paid by depositing funds in the currency in which
accrued to Valentis' account in a bank acceptable to Valentis in the
country whose currency is involved.
ARTICLE 5
CONFIDENTIALITY; PUBLICATION
5.1 CONFIDENTIALITY. During the term of this Agreement, and for a period of
*** years thereafter, each party hereto will maintain in confidence all
Confidential Information disclosed by the other party hereto. Neither
party will use, disclose or grant use of such 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 or 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 ensure that such
employees, agents or consultants do not disclose or make any
unauthorized use of such Confidential Information. Each party will
promptly notify the other upon discovery of any unauthorized use or
disclosure of the Confidential Information.
5.2 AUTHORIZED DISCLOSURE. Each party may disclose the Confidential
Information to the extent such disclosure is reasonably necessary in
filing or prosecuting patent applications, prosecuting or defending
litigation or complying with applicable governmental regulations,
provided that if such party is required to make any such disclosure of
the Confidential Information it will to the extent practicable give
reasonable advance notice to the other party of such disclosure
requirement and, except to the extent inappropriate in the case of
patent applications, will use its best efforts to secure confidential
treatment of such information required to be disclosed.
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ARTICLE 6
INTELLECTUAL PROPERTY RIGHTS
6.1 FILING, PROSECUTION AND MAINTENANCE OF THE PATENT RIGHTS. Valentis shall
own all right, title and interest in, and shall have the sole right to
control the filing, prosecution and maintenance of, all patent
applications and patents included in the Patent Rights, at Valentis'
expense.
6.2 INFRINGEMENT ACTIONS. Valentis shall have the sole right to prosecute,
at its discretion, any and all infringements of any Patent Rights, and
to defend all charges of infringement arising as a result of such Patent
Rights, and to enter all settlements, judgments or other arrangements
with respect to the same, all at its own expense and by counsel of its
own choice. Any damages or other recovery from such infringement actions
in excess of the expenses and costs incurred by Valentis in connection
with such action shall belong solely Valentis.
6.3 PATENT MARKING. Epimmune and its Affiliates and sublicensees shall xxxx
Products with appropriate patent numbers in those countries where
markings have notice value as against infringers.
6.4 INFRINGEMENT OF THIRD PARTY RIGHTS. If the sale of any Product is
determined or alleged to infringe, or if Epimmune receives notice of or
is sued for infringement of, a patent owned or licensed by Third Party,
Valentis and Epimmune shall meet to discuss what action should be taken
if such claim involves the Patent Rights. Epimmune or its Affiliate or
sublicensee, as applicable, shall be solely responsible for the defense
or settlement of any patent infringement claim or lawsuit brought by any
Third Party involving the sale of any Product, including all expenses
and amounts payable as damages or in settlement.
ARTICLE 7
REPRESENTATIONS; WARRANTIES; COVENANTS
7.1 CORPORATE POWER. Each party hereby represents and warrants that it is
duly organized, validly existing and in good standing under the laws of
the state or jurisdiction of its incorporation or formation and has full
corporate power and authority to enter into this Agreement and to carry
out the provisions hereof.
7.2 DUE AUTHORIZATION. Each party hereby represents and warrants that such
party is duly authorized to execute and deliver this Agreement and to
perform its obligations hereunder.
7.3 BINDING AGREEMENT. Each party hereby represents and warrants that this
Agreement is a legal and valid obligation binding upon it and is
enforceable in accordance with its terms. The execution, delivery and
performance of this Agreement by such party does not conflict with any
agreement, instrument or understanding, oral or written, to which it is
a party or by which it may be bound, nor violate any law or regulation
of any court, governmental body or administrative or other agency having
authority over it.
7.4 PATENT PROCEEDINGS. Valentis represents and warrants that to the best of
its knowledge, no patent or patent application within the Patent Rights
is the subject of any pending interference, opposition, cancellation or
other protest proceeding.
7.5 DISCLAIMER OF WARRANTIES. EXCEPT AS EXPRESSLY SET FORTH IN THIS
AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY TO THE
OTHER PARTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, ANY WARRANTY OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
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7.6 INDEMNIFICATION.
(a) Epimmune and its Affiliates (each an "Indemnifying Party") shall
indemnify, hold harmless and defend Valentis, its officers, directors
and employees and/or agents (the "Indemnitees") against any and all
Third Party claims, suits, losses, damage, costs, fees (including
reasonable attorney's fees) and expenses resulting from or arising out
of Epimmune's or its Affiliates', or its or their sublicensees'
development, testing, distribution, marketing, promotion or sale of any
Product; provided that no Indemnitee shall be entitled to
indemnification hereunder to the extent that any such claims, suits,
losses, damage, costs, fees and expenses result from the gross
negligence or willful misconduct of any Indemnitee.
(b) Any Indemnitee, as the case may be, shall notify the Indemnifying Party
promptly in writing of an indemnifiable claim or cause of action under
Section 7.6(a) upon receiving notice or being informed of the existence
thereof. The Indemnifying Party shall assume, at its cost and expense,
the sole defense of such claim or cause of action through counsel
selected by the Indemnifying Party and reasonably acceptable to the
Indemnitee. The Indemnifying Party shall maintain control of such
defense, including any decision as to settlement; provided that, in the
event that the Indemnifying Party does not maintain control of such
defense on a timely basis, then, without prejudice to any other rights
and remedies available to the Indemnitee under this Agreement, the
Indemnitee may take over such defense with counsel of its choosing, at
the Indemnifying Party's cost and expense. The Indemnitee may, at its
option and expense, participate in the Indemnifying Party's defense, and
if the Indemnitee so participates, the Indemnifying Party and the
Indemnitee shall cooperate with one another in such defense.
7.7 INSURANCE. Epimmune represents and warrants that it is covered and will
continue to be covered by a comprehensive general liability insurance
program which covers all Epimmune's activities and obligations
hereunder. Epimmune shall provide Valentis with written notice at least
fifteen (15) days prior to any cancellation or material change in such
insurance program. Epimmune shall maintain such insurance program, or
other program with comparable coverage, beyond the expiration or
termination of this Agreement during (i) the period that any Product is
being commercially distributed or sold by Epimmune, its Affiliates or a
sublicensee, and (ii) a commercially reasonable period thereafter.
7.8 LIMITATION OF LIABILITY. EXCEPT FOR AMOUNTS PAYABLE UNDER ARTICLE 3 AND
EXCEPT AS REQUIRED FOR EPIMMUNE TO SATISFY ITS INDEMNIFICATION
OBLIGATIONS UNDER SECTION 7.6, NEITHER EPIMMUNE NOR ANY OF ITS
AFFILIATES SHALL BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL OR
CONSEQUENTIAL DAMAGES SUFFERED BY VALENTIS IN CONNECTION WITH THIS
AGREEMENT, EVEN IF EPIMMUNE OR ANY OF ITS AFFILIATES HAS BEEN ADVISED OF
THE POSSIBILITY OF SUCH DAMAGES.
ARTICLE 8
TERM; TERMINATION
8.1 TERM. This Agreement shall commence as of the Effective Date and shall
continue, on a country-by-country basis, until the last day of the
Royalty Term, unless terminated earlier as provided herein (the "Term").
Following the expiration of this Agreement, Epimmune shall have a
license on the same terms as set forth in Section 2.1, except that the
license shall be a fully-paid, irrevocable license.
8.2 TERMINATION FOR BREACH. A party may terminate this Agreement prior to
the expiration of the Term upon or after the breach of any material
provision of this Agreement by the other party if the breaching party
has not cured such breach within sixty (60) days after written notice
thereof by the non-breaching party.
8.3 TERMINATION BY EPIMMUNE. Epimmune may terminate this Agreement prior to
the expiration of the Term at any time upon thirty (30) days' written
notice to Valentis.
8.4 TERMINATION FOR PATENT CHALLENGE. Valentis shall have the right to
terminate this Agreement if Epimmune, its Affiliate or sublicensee
challenges the validity of any patent included in the Patent Rights
within any country effective thirty (30) days after Epimmune's receipt
of written notice of such termination by Valentis.
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8.5 EFFECT OF TERMINATION.
(a) Upon termination of this Agreement (i) all rights to the Patent Rights
and Biological Material shall revert to Valentis, and (ii) any
sublicense granted hereunder by Epimmune shall remain in full force and
effect, but shall be assigned to Valentis.
(b) Within thirty (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. Epimmune shall return
or destroy all Biological Material in its possession.
(c) Expiration or termination of this Agreement shall not relieve the
parties of any obligation accruing prior to such expiration or
termination. The provisions of Sections 4.3, 7.5, 7.8 and 8.4 and
Articles 1, 5, 9 and 10 shall survive termination or expiration of this
Agreement.
ARTICLE 9
DISPUTE RESOLUTION
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 Patent Rights), and the parties cannot resolve
the dispute within thirty (30) days 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 thirty (30) days 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 Francisco, 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
jurisdiction. The arbitrator shall prepare and deliver a written,
reasoned opinion conferring its decision within thirty (30) days
following the final arbitration hearing.
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.
ARTICLE 10
MISCELLANEOUS
10.1 ASSIGNMENT. Except as expressly provided hereunder, neither this
Agreement nor any rights or obligations hereunder may be assigned or
otherwise transferred by either party without the prior written consent
of the other party (which consent shall not be unreasonably withheld);
provided, however, that either party may assign this Agreement and its
rights and obligations hereunder without the other party's consent (a)
in connection with the transfer or sale of all or substantially all of
the business of such party to which this Agreement relates to a Third
Party, whether by merger, sale of stock, sale of assets or otherwise, or
(b) to any Affiliate. Notwithstanding the foregoing, any such assignment
to an Affiliate shall not relieve the assigning party of its
responsibilities for performance of its obligations under this
Agreement. The rights and obligations of the parties under this
Agreement shall be binding upon and inure to the benefit of the
successors and permitted assigns of the parties. Any assignment not in
accordance with this Agreement shall be void.
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10.2 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 when such failure or delay is caused by or results from
causes beyond the reasonable control of the affected party, including,
without limitation, fire, floods, earthquakes, natural disasters,
embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other party.
10.3 GOVERNING LAW. This Agreement shall be governed by, and construed and
enforced in accordance with, the laws of the State of California,
without regard to its choice of law provisions.
10.4 WAIVER. Except as specifically provided for herein, the waiver from time
to time by either party of any right or failure to exercise any remedy
shall not operate or be construed as a continuing waiver of the same
right or remedy or of any other of such party's rights or remedies
provided under this Agreement.
10.5 SEVERABILITY. In case any provision of this Agreement shall be invalid,
illegal or unenforceable, the validity, legality and enforceability of
the remaining provisions shall not in any way be affected or impaired
thereby.
10.6 INDEPENDENT CONTRACTORS. It is expressly agreed that Epimmune and
Valentis shall be independent contractors and that the relationship
between the two parties shall not constitute a partnership, joint
venture or agency of any kind. Neither party shall have the authority to
make any statements, representations or commitments of any kind, or to
take any action, which shall be binding on the other party, without the
prior written consent of the other party.
10.7 NOTICES. All notices and other communications provided for hereunder
shall be in writing and shall be mailed by first-class, registered or
certified mail, postage paid, or delivered personally, by overnight
delivery service or by facsimile, with confirmation of receipt,
addressed as follows:
IF TO EPIMMUNE: EPIMMUNE INC.
0000 Xxxxx Xxxxx Xxxxx
Xxx Xxxxx, XX 00000
Attention: President
Facsimile: (000) 000-0000
IF TO VALENTIS: VALENTIS, INC.
000X Xxxxxx Xxxx
Xxxxxxxxxx, Xxxxxxxxxx 00000
Attention: CEO
Facsimile: (000) 000-0000
Either party may by like notice specify or change an address to which
notices and communications shall thereafter be sent. Notices sent by
facsimile shall be effective upon confirmation of receipt, notices sent
by mail or overnight delivery service shall be effective upon receipt,
and notices given personally shall be effective when delivered.
10.8 ENTIRE AGREEMENT; AMENDMENT. This Agreement (including the Exhibits
attached hereto) sets forth all of the agreements and understandings
between the parties hereto with respect to the subject matter hereof,
and supersedes and terminates all prior agreements and understandings
between the parties with respect to the subject matter hereof, except
for the Prior Agreement, which shall remain in full force and effect to
the extent not expressly superceded by this Agreement. There are no
agreements or understandings with respect to the subject matter hereof,
either oral or written, between the parties other than as set forth
herein or in the Prior Agreement. Except as expressly set forth in this
Agreement, no subsequent amendment, modification or addition to this
Agreement shall be binding upon the parties hereto unless reduced to
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writing and signed by the respective authorized officers of the parties.
10.9 HEADINGS. The captions contained in this Agreement are not a part of
this Agreement, but are merely guides or labels to assist in locating
and reading the several Articles hereof.
10.10 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 Agreement as of the
date first set forth above.
EPIMMUNE INC. VALENTIS, INC.
By: /s/ Xxxxxxx X. Xxxxx By: /s/ Xxxxxxxx X. Xxxxxxx
---------------------------------------- ------------------------------------------------------
Name: Xxxxxxx X. Xxxxx Name: Xxxxxxxx X. Xxxxxxx
-------------------------------------- ---------------------------------------------------
Title: Vice President, Corporate Development Title: Vice Pres., Intellectual Property & Legal Affairs
-------------------------------------- --------------------------------------------------
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EXHIBIT A
PATENT RIGHTS
***
* CONFIDENTIAL TREATMENT REQUESTED
14
EXHIBIT B
FORM OF COMMON STOCK ISSUANCE AGREEMENT
