Exhibit 10.1
***TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
LICENSE AGREEMENT
Effective: July 9, 2001 ("Effective Date")
This License Agreement is by and between EPIMMUNE INC., having a
principal place of business at 0000 Xxxxx Xxxxx Xxxxx, Xxx Xxxxx, XX 00000
(hereinafter referred to as "EPMN"), and GENENCOR INTERNATIONAL, INC., having a
principal place of business at 000 Xxxx Xxxx Xxxx, Xxxx Xxxx, XX 00000-0000
(hereinafter referred to as "GCOR").
WHEREAS, the Parties have signed a certain Letter Agreement dated March
30, 2001 (the "Letter") regarding a license, research and development
collaboration in the Licensed Field (as defined) and certain equity investments
in EPMN (the "Definitive Agreements"); and
WHEREAS, concurrent with the execution of this License Agreement the
Parties will execute such other Definitive Agreements as deemed appropriate to
conclude the contemplated transaction; and
WHEREAS, the Parties intend for this License Agreement to constitute
the definitive license agreement.
NOW, THEREFORE, the Parties hereby agree as follows:
ARTICLE I
DEFINITIONS
The following definitions shall control the construction of
each of the following terms wherever they appear in this Agreement:
1.1 "Affiliate" shall mean any corporation or other entity that directly,
or indirectly through one or more intermediaries, controls, is
controlled by, or is under common control with the designated party but
only for so long as such relationship exists. Solely for purposes of
this Section 1.1, "Control" shall mean ownership of fifty percent (50%)
or greater of the shares of stock entitled to vote for directors in the
case of a corporation and fifty percent (50%) or greater of the
interests in profits in the case of a business entity other than a
corporation.
1.2 "Biological License Application" ("BLA") shall mean a Biological
License Application or equivalent application filed with the FDA or the
equivalent application filed with regulatory authorities in other
countries.
1.3 "Collaboration" shall mean the program of collaborative research and
development in the Licensed Field conducted pursuant to the
Collaboration Agreement during the Collaboration Term as described in
Article IX.
1.4 "Collaboration Agreement" shall mean that certain Collaboration
Agreement between the Parties of even date herewith.
1.5 "Collaboration Patent Rights" shall mean any Sole Collaboration Patent
Rights or Joint Collaboration Patent Rights.
1.6 "Collaboration Term" shall mean the two and one-half (2.5) year period
from April 2, 2001 through September 1, 2003 unless extended by mutual
agreement or terminated early as provided for in the Collaboration
Agreement.
1.7 "Combination Product" shall mean any Licensed Product that combines
[...***...], at least one (1) of which components is a Licensed Product
or EPMN Product, as applicable, and at least one (1) of which
components is not a Licensed Product or EPMN Product, as applicable,
where either (a) [...***...] (a "Type A Combination Product"), or (b)
[...***...] (a "Type B Combination Product"). For illustrative
purposes, certain examples are set forth in Appendix A hereof.
1.8 "Control" shall mean, with respect to any intellectual property rights,
the ability to grant licenses or sublicenses to and/or disclose such
intellectual property without violating the terms of any bona fide
agreement with a third party to which such intellectual property is
subject.
1.9 "Date of First Commercial Sale" ("DFCS") shall mean in respect of each
Licensed Product the first arms length transaction with a willing buyer
for the sale of such Licensed Product into the market place by GCOR or
any of its sublicensees.
1.10 "Diligence Period" shall mean the period commencing at the expiration
of the Collaboration Term and continuing until the earlier of (a)
[...***...] after the last day of the Collaboration Term, or (b) the
date GCOR or any of its sublicensees has filed in any of the Major
Geographies an IND for at least [...***...] Licensed Product directed
to each Virus.
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1.11 "EPMN Know-How" shall mean any Know-How that is or may be necessary or
useful for the development or commercialization of vaccines for
treating or preventing diseases associated with HPV, HBV or HCV,
including any such Know-How pertaining to the PADRE(R) Technology,
other than any Know-How disclosed or claimed in any EPMN Patent Rights
or Collaboration Patent Rights, which Know-How is Controlled by EPMN on
the Effective Date or during the Collaboration Term.
1.12 "EPMN Patent Rights" shall mean Patent Rights that are useful for the
development or commercialization of vaccines for treating or preventing
diseases associated with HPV, HBV or HCV, including any such Patent
Rights pertaining to the PADRE(R) Technology, which Patent Rights are
Controlled by EPMN on the Effective Date or during the Collaboration
Term, but excluding Collaboration Patent Rights.
1.13 "EPMN Product" shall mean a product, developed, made, used or sold by
EPMN the manufacture, use or sale of which, but for the license granted
in Section 2.3.2, would infringe a Valid Claim of one (1) or more Joint
Collaboration Patent Rights.
1.14 "EPMN Technology" shall mean collectively EPMN Know-How and EPMN Patent
Rights.
1.15 "First HPV Indication" shall mean treatment or prevention of
[...***...].
1.16 "First Licensed Product" shall mean the first product developed by GCOR
or any of its sublicensees for either the prevention or treatment of a
disease associated with each Virus; provided, however, that an IND
relating to such product has been submitted and become effective, by
GCOR or any of its sublicensees.
1.17 "Food and Drug Administration" ("FDA") shall mean the U.S. Food and
Drug Administration.
1.18 "HBV" shall mean Hepatitis B Virus.
1.19 "HCV" shall mean Hepatitis C Virus.
1.20 "HPV" shall mean Human Papilloma Virus.
1.21 "Investigational New Drug Application" ("IND") shall mean a request for
authorization from the FDA or applicable regulatory authorities in
other countries to administer an investigational drug or biological
product to humans.
1.22 "Joint Collaboration Patent Rights" shall mean any Patent Rights
covering inventions conceived or reduced to practice jointly by
employees, consultants or
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agents of EPMN and GCOR during the course of or arising from the
Collaboration.
1.23 "Know-How" shall mean proprietary and confidential know-how, including
technical data, experimental results, specifications, techniques,
methods, technology, processes, recipes and written materials.
1.24 "Licensed Field" shall mean the research, development and
commercialization of Licensed Product(s) for treating or preventing
diseases associated with the following viruses: HPV, HBV and HCV.
1.25 "Licensed Product" shall mean a therapeutic or prophylactic vaccine (a)
the manufacture, use or sale of which, but for any license granted to
GCOR herein, would infringe a Valid Claim of one (1) or more EPMN
Patent Rights or one (1) or more Collaboration Patent Rights, or (b)
was developed or manufactured using EPMN Know-How.
1.26 "Major Geographies" shall mean [...***...].
1.27 "Net Sales" shall mean (a) with respect to a Licensed Product, the
gross amount invoiced by GCOR or its sublicensees to unrelated third
parties for such Licensed Product, and (b) with respect to an EPMN
Product, the gross amount invoiced by EPMN or its sublicensees to
unrelated third parties for such EPMN Product, in either case less:
(i) Trade, quantity and cash discounts actually allowed;
(ii) Discounts, refunds, rebates, chargebacks, retroactive price
adjustments, and any other allowances, which effectively
reduce the net selling price;
(iii) Actual product returns and allowances;
(iv) Any tariffs, duties and/or taxes (excluding withholding tax)
imposed on the production, sale, delivery or use of the
product;
(v) That portion of the sales value associated with
non-pharmaceutical drug delivery devices in an amount not to
exceed the fair market value of such devices, as documented in
writing;
(vi) Freight charges paid for delivery; and
(VII) [...***...]
In the event the Licensed Product(s) or EPMN Product(s), as applicable,
is sold as part of a Type A Combination Product, Net Sales for purposes
of determining the applicable royalty for such Licensed Product(s) or
EPMN Product(s), as applicable, shall be determined by [...***...]. In
the event that such [...***...] cannot be determined for both the
Licensed Product(s) or EPMN Product(s), as applicable,
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[...***...] of the Type A Combination Product in combination, Net Sales
of the Type A Combination Product shall be [...***...].
In the event the Licensed Product(s) or EPMN Product(s), as applicable,
is sold as part of a Type B Combination Product, Net Sales for purposes
of determining the applicable royalty for such Licensed Product(s) or
EPMN Product(s), as applicable, shall be determined by [...***...]. In
the event that such [...***...] cannot be determined for [...***...] of
the Type B Combination Product, Net Sales of the Type B Combination
Product shall be [...***...].
1.28 "Non-Patented Countries" shall have the meaning set forth in Section
3.3.
1.29 "PADRE(R) Technology" shall mean a family of immunostimulatory
molecules which when combined with cytotoxic T cell epitopes increase
the magnitude and duration of the immune response.
1.30 "Party" shall mean either EPMN or GCOR, as appropriate, whereas the
term "Parties" shall mean EPMN and GCOR jointly.
1.31 "Patent Rights" shall mean all rights associated with all United States
and foreign patents (including all reissues, extensions, confirmations,
registrations, re-examinations, and inventor's certificates) and patent
applications (including, without limitation, all substitutions,
continuations, continuations-in-part, divisionals and provisionals
thereof).
1.32 "Phase I Clinical Trial" shall mean that portion of the clinical
development program which generally provides for the first introduction
of a product into a small number of humans with the primary purpose of
evaluating safety of the product and preliminary activity of the
product, as more specifically defined by the rules and regulations of
the FDA and corresponding rules and regulations in other countries.
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1.33 "Phase III Clinical Trial" shall mean that portion of the clinical
development program which provides for the continued trials of a
product on sufficient numbers of patients to establish the safety and
efficacy of a product for the desired claims and indications to provide
adequate basis for physician labeling, as more specifically defined by
the rules and regulations of the FDA and corresponding rules and
regulations in other countries.
1.34 "Pivotal Trial" shall mean the clinical trial of a product (which may
be, for example, a Phase II or Phase III trial) that is deemed by the
FDA or appropriate regulatory agency in other countries to be
sufficient to support the filing of a BLA or other application for
marketing approval of such product.
1.35 "Royalty Period" shall mean, with respect to a given Licensed Product
on a country-by-country basis, the longer of (a) [...***...] from the
DFCS of such Licensed Product in such country, or (b) the last to
expire EPMN Patent Right or Collaboration Patent Right licensed
hereunder in such country.
1.36 "Second HPV Indication" shall mean treatment or prevention of
[...***...].
1.37 "Second Licensed Product" shall mean the second product developed by or
for GCOR or any of its sublicensees for either the prevention or
treatment of a disease associated with each Virus; provided, however,
that an IND relating to each product has been submitted and becomes
effective, by GCOR or any of its sublicensees.
1.38 "Sole Collaboration Patent Rights" shall mean any Patent Rights
covering inventions conceived or reduced to practice solely by
employees, consultants or agents of EPMN during the course of or
arising from the Collaboration.
1.39 "Successful Completion" shall mean a decision made by GCOR that the
Licensed Product being evaluated in that phase of the clinical trial
will proceed to the next phase; provided that GCOR will be deemed to
have made a decision to proceed to the next phase with respect to a
Licensed Product if GCOR has not notified EPMN in writing that it has
decided not to proceed to the next phase with respect to such Licensed
Product within [...***...] (which period may be extended by mutual
agreement which agreement will not be unreasonably withheld) after
completion of the statistical analysis report on "clean data" ("clean
data" means all case report forms have been reviewed and cleaned up and
all outstanding queries have been resolved).
1.40 "Term" shall have the meaning given such term in Section 10.1.
1.41 "Third Party License Agreements" shall mean the agreements between EPMN
and certain third parties with respect to Third Party Technology as
listed in Appendix B hereto.
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1.42 "Third Party Technology" shall mean collectively any Patent Rights or
Know-How included in the EPMN Technology that are owned in whole or in
part by a third party, licensed to EPMN and sublicensed to GCOR by EPMN
pursuant to Section 2.2 and listed in Appendix B hereto.
1.43 "Valid Claim" shall mean any claim in (a) an unexpired patent which has
not been held unenforceable, unpatentable or invalid by a final
decision of a court or other governmental agency of competent
jurisdiction from which no appeal may be or is taken, and which has not
been admitted to be invalid or unenforceable through reissue or
disclaimer, or (b) a pending patent application; excluding from Section
1.43(b) (i) any patent application filed in the [...***...], any
country in [...***...] or the [...***...] that has been pending for
more than six (6) years following the earliest priority date of filing
of such application, and (ii) any patent application filed in
[...***...] that has been pending for more than eight (8) years
following the earliest priority date of filing of such application.
1.44 "Virus" shall mean one of HPV, HBV or HCV.
ARTICLE II
LICENSE GRANT
2.1 Grant of License in EPMN Technology from EPMN to GCOR. EPMN hereby
grants to GCOR and GCOR hereby accepts a worldwide, exclusive,
royalty-bearing and sublicensable right and license to practice the
EPMN Technology (other than the Third Party Technology) and all of
EPMN's rights in Collaboration Patent Rights to make, have made, use,
import, promote, market, distribute or sell Licensed Product(s) in the
Licensed Field.
2.2 Grant of Sublicense in Third Party Technology from EPMN to GCOR.
Subject to the terms and conditions of applicable Third Party License
Agreements, EPMN hereby grants to GCOR and GCOR hereby accepts a
worldwide, exclusive or non-exclusive (as the case may be),
royalty-bearing and sublicensable (subject to the terms of the Third
Party License Agreement) right and license to practice the Third Party
Technology to make, have made, use, import, promote, market, distribute
or sell Licensed Product(s) in the Licensed Field.
2.3 Grant of License to Joint Collaboration Patent Rights Outside the
Licensed Field.
2.3.1 EPMN Grant. EPMN hereby grants to GCOR and GCOR hereby accepts a
worldwide, non-exclusive, [...***...] and sublicenseable right and
license to practice EPMN's rights in Joint Collaboration Patent Rights
to make, have made, import, promote, market, distribute or sell
products or processes outside the Licensed Field.
2.3.2 GCOR Grant. GCOR hereby grants to EPMN and EPMN hereby accepts a
worldwide, non-exclusive, [...***...] and sublicenseable right and
license to practice GCOR's rights in Joint Collaboration Patent Rights
to make, have made,
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import, promote, market, distribute or sell EPMN Products outside the
Licensed Field.
ARTICLE III
UPFRONT FEES AND ROYALTIES
3.1 License Fee. Upon the Effective Date, GCOR shall pay EPMN a lump sum
payment of [...***...]. Such payment shall be non-creditable and
non-refundable.
3.2 GCOR Royalty Rates. Subject to Sections 3.2.1, 3.2.2, 3.2.3 and 3.2.4
hereof, GCOR shall during the Royalty Period pay EPMN a royalty of
[...***...] of Net Sales of Licensed Product.
3.2.1 Third Party Technology Sublicense. In addition to the royalty
rate set forth above, GCOR will make any royalty payments due to a
third party under any Third Party License Agreement due to the sale of
Licensed Product; provided that GCOR will be entitled to credit
[...***...] of any such third party royalty payments under such Third
Party License Agreement against the earned royalties due to EPMN
hereunder. EPMN shall be solely responsible for any other payment due
under any Third Party License Agreement. [...***...].
3.2.2 Royalty Credits. If total royalty payments made by GCOR to make,
have made, import, use or sell a Licensed Product (including all
royalties paid to non-Affiliated third parties, royalties paid to third
parties based on Third Party License Agreements, and royalties paid to
EPMN) exceed [...***...] of Net Sales of such Licensed Product in a
given calendar quarter, then GCOR shall have the right to credit
[...***...] of the amount by which such total royalty payments in such
quarter exceed [...***...] of Net Sales of such Licensed Product in
such quarter against the earned royalties due to EPMN hereunder;
provided that this Section 3.2.2 shall not apply to any Licensed
Product that is a Combination Product. For illustrative purposes,
certain royalty calculation scenarios are set forth in Appendix C
hereof.
3.2.3 Minimum Royalty. Except as provided in Section 3.2.4, in no event
will royalties payable to EPMN as a result of royalty credits under
this Section 3.2 be less than [...***...] of Net Sales of Licensed
Product.
3.2.4 HCV. In the event GCOR must obtain a license from [...***...] (or
its successor in interest) to Patent Rights in order to commercialize
an HCV Licensed Product, EPMN's minimum royalty as result of royalty
credits under this Section 3.2 will be reduced to [...***...] of Net
Sales of such HCV Licensed Product.
3.3 Sales in Non-Patented Countries. In the event EPMN Patent Rights or
Collaboration Patent Rights cover the manufacture, use or sale of a
Licensed
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Product in the Major Geographies, then in any other geography where
GCOR or any of its sublicensees sells such Licensed Product but where
no EPMN Patent Rights or Collaboration Patent Rights cover the
manufacture, use or sale of such Licensed Product (the "Non-Patented
Countries"), and subject to permissible credits pursuant to Section 3.2
above, the applicable royalty on Net Sales of Licensed Product in the
Non-Patented Countries will be [...***...] of The applicable royalty
payable on Net Sales of such Licensed Product in the Major Geographies,
subject to further reduction in the Non-Patented Countries as mutually
agreed by the Parties in writing in the event of [...***...]. For
illustrative purposes only, if EPMN or Collaboration Patent Rights
covering the manufacture, use or sale of a Licensed Product exist in
the [...***...] but not in [...***...] and GCOR sells the Licensed
Product in [...***...], [...***...] is a Non-Patented Country and
applicable royalties payable on Net Sales in [...***...] will be
determined according to this Section 3.3.
3.4 Minimum Annual Royalty. Following the Date of First Commercial Sale of
a Licensed Product in a country within the Major Geographies and during
the Royalty Period, GCOR will pay EPMN a minimum royalty of [...***...]
per calendar year (the "Minimum Annual Royalty"); provided that actual
earned royalties paid To EPMN pursuant to Section 3.2 above in a given
calendar year shall be credited against the Minimum Annual Royalty for
such calendar year.
3.5 [...***...]
ARTICLE IV
PAYMENT AND ACCOUNTING FOR ROYALTIES
4.1 Keeping of Records. Each Party shall keep, and impose on its
sublicensees to keep, complete and correct records of Net Sales of
Licensed Products or EPMN Product for a period of three (3) years from
the making of a royalty payment with respect to such Net Sales under
this Agreement.
4.2 Payment Term. All royalty payments (other than the Minimum Annual
Royalty) under this Agreement shall become due and payable [...***...]
after the last day of the [...***...] in which the corresponding sales
of Licensed Product or EPMN Product were made. Payment shall be
accompanied by a report on a country-by-country basis, showing the
gross receipts from sales of Licensed Product or EPMN Product less the
deductions permitted in Section 1.27 and the resulting calculation of
the Net Sales used in the computation of the royalty payments.
4.2.1 Minimum Annual Royalty. Notwithstanding the above provision
relating to [...***...] royalty payments, the Minimum Annual Royalty
payments by GCOR will be due and payable only at the end of each
calendar year period in which corresponding sales of Licensed Product
were made. For any calendar year period, if the earned royalties paid
to EPMN in such period are less than the Minimum Annual Royalty payment
set forth above in Section 3.4, GCOR will
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within [...***...] of the end of the relevant calendar year period, pay
EPMN the difference.
4.3 Currency and Exchange Rate. Payments under this Agreement will be made
in U.S. Dollars by wire transfer to a bank account to be designated by
the receiving Party. Net Sales in currency other than U.S. Dollars
shall be converted into Net Sales in U.S. Dollars on a monthly basis
using the rate of exchange as quoted by the Wall Street Journal
(Eastern Edition) on the last business day of the applicable month in
which the corresponding sales of Licensed Products or EPMN Products
were made.
4.4 Audit of Records. Each Party will allow the other to appoint a firm of
independent certified public accountants to whom the non-appointing
Party has no reasonable objection. The non-appointing Party shall give
such accountants access, during ordinary business hours and subject to
reasonable advance notice, to such records as are necessary to verify
the accuracy of any royalty payments made or payable under this
Agreement for a period covering not more than the preceding one (1)
year. Such access shall be granted no more than once in a calendar
year, at the requesting Party's expense. The independent certified
public accountants shall be under a confidentiality obligation to the
non-appointing Party to disclose to the appointing Party in its report
only the amount of royalties payable under this Agreement. In the event
it is determined that the records indicate that the amount of royalties
payable under this Agreement by the non-appointing Party is more than
the amount actually paid, the non-appointing Party shall pay such
difference within [...***...] of such accountant's report (together
wIth any interest thereon pursuant to Section 4.5), and if that
difference is greater than [...***...] of the amounts actually paid,
then the costs and expenses of said independent certified public
accountants shall be borne by the non-appointing Party.
4.5 Late Payments. In the event that any payment due hereunder is not made
when due, the payment shall accrue interest from the date due at the
rate of [...***...]; provided, however, that in no event shall sUch
rate exceed the maximum legal annual interest rate. The payment of such
interest shall not limit a Party from exercising any other rights it
may have as a consequence of the lateness of any payment.
4.6 Withholding. Any withholding of taxes levied by tax authorities on the
payments hereunder shall be borne by the Party receiving the payment
and deducted by the Party making the payment from the sums otherwise
payable by it hereunder for payment to the proper tax authorities on
behalf of the Party receiving the payment. The Party making the payment
agrees to cooperate with the Party receiving the payment in the event
that the receiving Party claims exemption from such withholding or
seeks credits or deductions under any double taxation or similar treaty
or agreement from time to time in force, such cooperation to consist of
providing receipts of payment of such withheld tax or other documents
reasonably available to the Party making the payment.
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ARTICLE V
MILESTONE PAYMENTS
5.1 Commercial Milestones for the First Licensed Product. During the Term
and subject to Section 5.6 below, GCOR will pay EPMN certain milestone
payments (the "Milestone Payments") for the First Licensed Product
developed for each Virus within the Licensed Field as detailed below:
5.1.1 Effective IND. [...***...] after an IND covering the First
Licensed Product for a Virus has become effective, GCOR shall pay EPMN
[...***...]; provided that, if there is a clinical hold with respect to
such IND at the time that such payment becomes due, such payment shall
instead be due and payable when such clinical hold is lifted.
5.1.2 Completion of Phase I. Within [...***...] after Successful
Completion of the first Phase I Clinical Trial for the First Licensed
Product for a Virus, GCOR shall pay EPMN [...***...];
5.1.3 Initiation of Pivotal Trial. Upon treatment of the first patient
in the first Pivotal Trial for the First Licensed Product for a Virus,
GCOR shall pay EPMN [...***...];
5.1.4 Completion of Phase III. Within [...***...] after Successful
Completion of the first Phase III Clinical Trial for the First Licensed
Product for a Virus, GCOR shall pay EPMN [...***...];
5.1.5 Submission of BLA. Within [...***...] from the submission of the
first BLA covering the First Licensed Product for a Virus, GCOR shall
pay EPMN [...***...];
5.1.6 Approval. Within [...***...] from written marketing approval of
the First Licensed Product for a Virus in the geographic market
designated below by the appropriate regulatory agency, GCOR shall pay
EPMN the following payments:
5.1.6.1 For approval to market in the [...***...], GCOR shall
pay EPMN [...***...];
5.1.6.2 For approval to market in [...***...] or in the first
of any of [...***...], GCOR shall pay EPMN [...***...];
5.1.6.3 For approval to market in [...***...], GCOR shall pay
EPMN [...***...].
5.2 Commercial Milestones for a Second Licensed Product. Except as set
forth in Section 5.3 for a Licensed Product useful against the Second
HPV Indication, during the Term, GCOR will pay EPMN certain additional
milestone payments (the "Additional Milestone Payments") for any Second
Licensed Product developed for each Virus within the Licensed Field as
detailed below:
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5.2.1 Second Licensed Product requiring new IND. For a Second Licensed
Product, which requires the filing of a new IND, GCOR shall pay EPMN
Additional Milestone Payments equal to [...***...] of each of the
MilestonE Payments set forth above in Sections 5.1.1 through 5.1.6 upon
achievement of the indicated milestone-triggering event. For the
avoidance of doubt, if the Second Licensed Product does not require the
filing of a new IND for clinical evaluation, approval or marketing such
as for example, Second Licensed Products, which are line extensions,
formulation changes, expanded labeling or the like, GCOR shall pay EPMN
no Additional Milestone Payments.
5.3 Second HPV Indication Milestones. In the event GCOR or any of its
sublicensees develops a Licensed Product for treatment or prevention of
the Second HPV Indication (the "Second HPV Product"), which Second HPV
Product requires the filing of a new IND, GCOR shall pay EPMN
Additional Milestone Payments equal to [...***...] of each of the
Milestone Payments set forth above in Sections 5.1.1 through 5.1.6 upON
achievement of the indicated milestone-triggering event.
5.4 Discontinued Development. In the event GCOR or any of its sublicensees
develops a Licensed Product for a Virus as a replacement for the First
Licensed Product or Second Licensed Product for such Virus after
development of such First Licensed Product or Second Licensed Product,
as applicable, has been discontinued, such Licensed Product shall be
deemed a replacement First Licensed Product (if it replaces a First
Licensed Product) or replacement Second Licensed Product (if it
replaces a Second Licensed Product), as applicable; provided that GCOR
shall pay EPMN only those Milestone Payments for a replacement First
Licensed Product or Additional Milestone Payments for a replacement
Second Licensed Product, as applicable, set forth in Sections 5.1.4
through 5.1.6 upon achievement of the indicated milestone-triggering
event.
5.5 Know-How Based Licensed Product Milestones. In the event GCOR or any of
its sublicensees develops a Licensed Product and no EPMN Patent Rights
or Collaboration Patent Rights cover the manufacture, use or sale of
such Licensed Product but EPMN Know-How is used in the development or
manufacture of such Licensed Product, GCOR shall pay EPMN [...***...]
of each of the Milestone Payments or Additional MilestoNE Payments that
would otherwise be payable under this Article V.
5.6 Location of Occurrence of Milestone Events. If a milestone-triggering
event under this Article V (other than Section 5.1.6 or any provision
based upon Section 5.1.6) first occurs (a) in any of the Major
Geographies, then one hundred percent (100%) of the applicable
Milestone Payment or Additional Milestone Payment determined in
accordance with the applicable provision of Article V shall be due and
payable in connection with the occurrence of such milestone-triggering
event, and (b) in any country other than any of the Major
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Geographies, then [...***...] of the applicable Milestone Payment or
Additional Milestone Payment determined in accordance with the
applicable provision of Article V shall be due and payable upon the
occurrence of such milestone-triggering event, and the remaining
[...***...] of the applicable Milestone Payment or Additional Milestone
Payment determined in accordance with the applicable provision of
Article V shall be due and payable upon the occurrence of such
milestone-triggering event in any of the Major Geographies.
ARTICLE VI
DILIGENT EFFORTS
6.1 Diligence. During the Diligence Period GCOR and its sublicensees will
use commercially reasonable efforts to develop Licensed Products. As
used herein "commercially reasonable efforts" means, unless the Parties
agree otherwise, those efforts consistent with the exercise of prudent
scientific and business judgment, as applied to other products of
similar scientific and commercial potential. Specifically, the Parties
agree that GCOR will have used commercially reasonable efforts during
the Diligence Period if GCOR continues to invest, internally or
otherwise (including Milestone Payments paid hereunder), a minimum of
[...***...] as may be reduced pursuant to Section 6.2 hereof
("Investment Commitment") for the development of Licensed Products.
GCOR will provide to EPMN on each [...***...] durING the Diligence
Period a report describing GCOR and its sublicensees' investment in
developing Licensed Products in sufficient detail for EPMN to determine
whether the Investment Commitment is being satisfied. [...***...],
during the Diligence Period, upon request by EPMN, GCOR will provide to
EPMN a general report on the development status of Licensed Products,
including for example, information on where a Licensed Product is in
research or pre-clinical development or whether an IND has been filed
and the like.
6.2 IND Filing. In the event GCOR or its sublicensee files an IND at any
time during the Collaboration Term or the Diligence Period on
[...***...] or more Licensed Product(s), the Investment Commitment will
be reduced by [...***...] for each IND filed. Accordingly the
Investment Commitment will be reduced by [...***...] upon filing of the
first IND, [...***...] upon filing of a second IND and [...***...] upon
filing of a thIRD IND filed by GCOR or its sublicensee.
6.3 Remedy. If (i) during the Diligence Period GCOR has failed to maintain
the relevant Investment Commitment, or otherwise use commercially
reasonable efforts to develop Licensed Products, or (ii) by the end of
the Diligence Period, neither GCOR nor any of its sublicensees has
filed in any of the Major Geographies an IND for at least [...***...]
Licensed [...***...] in an Affected Program (as defined in SeCTION 6.4
below), EPMN shall have the right, subject to Section 6.4, in its sole
discretion to (a) reduce GCOR's exclusive license in the Affected
Program to a non-exclusive license, or (b) terminate GCOR's license as
to the Affected Program, unless, in either case, GCOR provides evidence
*CONFIDENTIAL TREATMENT REQUESTED
13.
reasonably satisfactory to EPMN that such failure was beyond its
control. If GCOR or any of its sublicensees has filed an IND for a
Licensed Product in an Affected Program in any geography other than one
of the Major Geographies prior to the end of the Diligence Period, EPMN
may only exercise the remedy provided under this Section 6.3 with
regard to the license in the Affected Program outside that geography,
and within that geography GCOR shall maintain its exclusive license
subject to the terms and conditions of this Agreement.
6.4 Notice of Lack of Diligence. EPMN shall give GCOR written notice of its
intention to reduce the license to a non-exclusive license or to
terminate the license for lack of diligence. Such notice shall include
an indication by EPMN whether the alleged failure relates to the lack
of development of a Licensed Product for [...***...] or more of the
HPV, HCV or HBV programs (the "Affected Program(s)") and the evideNCE
on which EPMN bases its opinion. GCOR and its sublicensees shall have
[...***...] (which period shall be IN place of, and not in addition to,
the period under Section 10.2) to cure the deficiency or to provide
reasons satisfactory to EPMN for their inability to do so. Should EPMN
reduce GCOR's exclusive license in an Affected Program to a
non-exclusive license, GCOR shall have no further obligation under
Article V of this Agreement and GCOR's royalty obligation upon
commercialization of a Licensed Product from the Affected Program shall
be reduced to [...***...] of Net Sales under Section 3.2 (and the
provisions of Section 3.2.1, 3.2.2 and 3.2.3 shall no longer apply).
Should EPMN terminate GCOR's exclusive license in an Affected Program,
the provisions of Section 10.5.2 shall apply.
ARTICLE VII
REPRESENTATIONS AND WARRANTIES
7.1 By EPMN. EPMN represents and warrants to GCOR that:
7.1.1 Corporate Power. As of the Effective Date, EPMN is duly organized
and validly existing under the laws of Delaware and has full corporate
power and authority to enter into this Agreement and carry out the
provisions hereof;
7.1.2 Due Authorization. As of the Effective Date, EPMN is duly
authorized to execute and deliver this Agreement and to perform its
obligations hereunder. The person executing this Agreement on EPMN's
behalf has been duly authorized to do so by all requisite corporate
action;
7.1.3 Binding Agreement. This Agreement is a legal and valid obligation
binding upon EPMN and enforceable in accordance with its terms. As of
the Effective Date, the execution, delivery and performance of this
Agreement by EPMN 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 material law or regulation of any court,
governmental body or administrative or other agency having jurisdiction
over it;
*CONFIDENTIAL TREATMENT REQUESTED
14.
7.1.4 Technology Ownership. EPMN owns the EPMN Technology (other than
the Third Party Technology) and has the right to grant to GCOR the
exclusive license granted under Section 2.1 hereof and that said
license does not conflict with or violate the terms of any agreement
between EPMN and any third party;
7.1.5 Third Party Technology. Appendix B is a true and complete list of
all Third Party Technology Controlled by EPMN as of the Effective Date
which is sublicenseable to GCOR in the Licensed Field; EPMN has
disclosed to GCOR all the terms and conditions relating to EPMN's
rights in said Third Party Technology; EPMN has the right to grant to
GCOR the sublicense in said Third Party Technology granted under
Section 2.2 hereof; and said sublicense does not conflict with or
violate the terms of any agreement between EPMN and any third party;
7.1.6 Validity. As of the Effective Date, EPMN is aware of no action,
suit or inquiry or investigation instituted by any federal or state
governmental agency which questions the validity of this Agreement;
7.1.7 Proceedings. EPMN has duly informed GCOR of administrative or
judicial proceedings, if any, contesting the inventorship, ownership,
validity or enforceability of any element of the EPMN Technology;
7.1.8 Prior Agreement. EPMN has not, as of the Effective Date, licensed
the EPMN Technology to any third party in the Licensed Field;
7.1.9 Disclosure. As of the Effective Date, EPMN has no third party
agreements which would be violated by the disclosure to GCOR of EPMN
Know-How;
7.1.10 Non-Infringement. As of the Effective Date, to EPMN's knowledge,
the practice of EPMN Technology to develop or commercialize Licensed
Products does not infringe any Patent Rights of any third party nor has
EPMN received any notice of any alleged infringement of or conflict
with Patent Rights of any third party arising from the practice of EPMN
Technology.
7.2 By GCOR. GCOR represents and warrants to EPMN that:
7.2.1 Corporate Power. As of the Effective Date, GCOR is duly organized
and validly existing under the laws of Delaware and has full corporate
power and authority to enter into this Agreement and carry out the
provisions hereof;
7.2.2 Due Authorization. As of the Effective Date, GCOR is duly
authorized to execute and deliver this Agreement and to perform its
obligations hereunder. The person executing this Agreement on GCOR's
behalf has been duly authorized to do so by all requisite corporate
action;
15.
7.2.3 Binding Agreement. This Agreement is a legal and valid obligation
binding upon GCOR and enforceable in accordance with its terms. As of
the Effective Date, the execution, delivery and performance of this
Agreement by GCOR 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 material law or regulation of any court,
governmental body or administrative or other agency having jurisdiction
over it;
7.2.4 Validity. As of the Effective Date, GCOR is aware of no action,
suit or inquiry or investigation instituted by any federal or state
governmental agency which questions the validity of this Agreement.
7.3 Disclaimer. NEITHER PARTY GUARANTEES THE SAFETY OR USEFULNESS OF ANY
PRODUCT. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE
COLLABORATION AGREEMENT OR THE SECURITIES PURCHASE AGREEMENT, NEITHER
PARTY MAKES ANY REPRESENTATION OR WARRANTY TO THE OTHER PARTY OF ANY
NATURE, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY
OF NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE.
ARTICLE VIII
PATENT PROSECUTION/ENFORCEMENT
8.1 Prosecution of EPMN Patent Rights. Subject to the terms of any Third
Party License Agreement with respect to the Third Party Technology,
EPMN will be responsible for filing, prosecuting and maintaining, at
its own expense, all patents and patent applications included in the
EPMN Patent Rights. EPMN shall routinely and at least [...***...]
provide GCOR with information on the status of said EPMN Patent Rights
including reports on the prosecution and issuance of the EPMN Patent
Rights. To the extent practicable and subject to the terms of any Third
Party License Agreement with respect to the Third Party Technology, for
so long as GCOR maintains an exclusive license under this Agreement,
EPMN will provide GCOR an opportunity to discuss and will consider in
good faith GCOR's suggestions regarding major prosecution events with
respect to the exclusively licensed EPMN Patent Rights. Such major
prosecution events shall include substantive amendments to claims,
response to final rejections and notices of allowance, filing decisions
in the US as well as foreign patent offices, oppositions, revocations,
re-examination or other substantive prosecution matters with respect to
the EPMN Patent Rights. In the event that EPMN desires to abandon any
patent application or patent included within the EPMN Patent Rights,
and if GCOR then has an exclusive license to the relevant EPMN Patent
Rights, EPMN shall provide reasonable prior written notice to GCOR of
such intention to abandon, and at GCOR's request assign or otherwise
transfer to GCOR all of EPMN's right, title and interest in and to the
EPMN Patent Rights
*CONFIDENTIAL TREATMENT REQUESTED
16.
designated in such notice and shall execute all documents necessary to
effect such assignment or transfer.
8.2 Enforcement of EPMN Patent Rights and Collaboration Patent Rights.
8.2.1 Notice. In the event that either Party becomes aware of any
alleged or threatened infringement of any EPMN Patent Rights or
Collaboration Patent Right by any third party, it shall provide the
other Party with written notice of and evidence establishing such
infringement. The Parties agree to cooperate in taking commercially
reasonable legal action to protect the commercial interests of the
Parties in the applicable EPMN Patent Rights or Collaboration Patent
Rights against infringement by third parties.
8.2.2 GCOR Enforcement Within the Licensed Field. In the event that
either Party provides the other with written notice of and evidence
establishing infringement of an EPMN Patent Right or Collaboration
Patent Right by a third party with a product made, used or sold in the
Licensed Field, the Parties shall promptly meet and agree on the
necessary action to xxxxx such infringement. Principally, for
infringing conduct within the Licensed Field if GCOR then has an
exclusive license as to the allegedly infringed Patent Rights under
this Agreement, GCOR shall take the lead role and absent agreement to
the contrary shall have the first right to take any necessary action
against such infringement or alleged infringement. In no event will
either Party take action to enforce a Joint Collaboration Patent
without the consent of the other Party. If GCOR elects to take action
against such infringement alone or if the Parties agree to take such
action together, both Parties shall render all reasonable assistance to
the enforcing party in connection therewith including being named as a
party, if necessary. In such an event, each party shall have the right
to be represented in that action by counsel of its own choice and at
its expense. If GCOR fails to bring an action or proceeding with
respect to any infringement of EPMN Patent Rights or Sole Collaboration
Patent Rights under this Section 8.2.2 within (i) [...***...] followiNG
the notice of alleged infringement or (ii) [...***...] before the time
limit, if any, set forth in the appropriate laws and regulations for
the filing of such actions, whichever comes first, EPMN shall have the
right to take any action necessary against such infringement or alleged
infringement. In such event, GCOR shall have the right to be
represented by counsel of its own choice and at its expense. In no
event shall either Party settle or xxxxx such infringement pursuant to
this Section 8.2.2 in a manner that would diminish the rights or
interests of the other Party or obligate the other Party to make any
payment or take any action without written approval of such other
Party. Except as otherwise agreed to by the Parties as part of a
cost-sharing arrangement, any recovery realized as a result of such
action involving any EPMN Patent Rights or Collaboration Patent Rights
under this Section 8.2.2, after reimbursement of any litigation
expenses of the Parties, shall [...***...]. With respect to any
recovery received by GCOR, to the extent compensatory damages are
awarded based on
*CONFIDENTIAL TREATMENT REQUESTED
17.
lost sales, such lost sales damages (unless otherwise shared with EPMN)
shall be treated as Net Sales for purposes of the royalty provisions of
this Agreement.
8.2.3 Enforcement by EPMN. In the event that either Party provides the
other with written notice of infringement of an EPMN Patent Right or
Sole Collaboration Patent Rights (a) by a third party with a product
made, used or sold outside the Licensed Field, or (b) by a third party
with a product made, used or sold in the Licensed Field if GCOR's
exclusive license as to the allegedly infringed Patent Rights has been
reduced to a non-exclusive license pursuant to Section 6.3, EPMN shall
have the sole right, at its sole discretion, to take any necessary
action against such infringement or alleged infringement. EPMN will
keep GCOR informed of the status of any action arising from such
infringement and to the extent permissible allow GCOR to be a party in
such proceeding, represented by its own counsel at its own cost. Any
recovery realized as a result of such action involving any EPMN Patent
Rights or Sole Collaboration Patent Rights under this Section 8.2.3,
after reimbursement of any litigation expenses of the Parties, shall
[...***...]. In no event may EPMN settle or xxxxx such infringement
under EPMN Patent Rights or Sole Collaboration Patent Rights outside
the Licensed Field in a manner which would diminish the rights or
interests of GCOR within the Licensed Field, except with GCOR's written
consent, which shall not be unreasonably withheld.
8.2.4 Joint Collaboration Patent Rights. In no event will either Party
take action to enforce a Joint Collaboration Patent without the written
consent of the other Party.
8.3 Defense of Third Party Infringement Claim. Each Party shall promptly
notify the other Party of any suit, claim or demand based on actual or
alleged infringement of a third party Patent Right through the making,
having made, using, selling, offering for sale or importing of Licensed
Products by GCOR or its sublicensees. GCOR shall have the first right
to defend such suit at its own cost, and EPMN shall have the right to
be represented in that action by counsel of its own choice and at
EPMN's expense. In the event such suit, claim or demand is determined
to arise from a material breach of any EPMN representation and
warranty, EPMN shall indemnify GCOR pursuant to Article XII. EPMN will
provide reasonable and necessary assistance in any defense undertaken
by GCOR, at GCOR's expense. The Parties shall keep one another informed
of the status of any of their respective activities regarding any
litigation concerning the foregoing. Neither Party shall have the right
to settle any patent infringement action under this Section 8.3 in a
manner that would diminish the rights or interests of the other Party
or obligate the other Party to make any payment or take any action
without written approval of such other Party.
8.4 Royalty Payments During any Third Party Infringement Claims. During the
pendency of any suit, claim or demand alleging infringement of a third
party Patent Right through the making, having made, using, selling,
offering for sale or
*CONFIDENTIAL TREATMENT REQUESTED
18.
importing of Licensed Product by GCOR or its sublicensees, if GCOR and
its sublicensees are required to cease making, having made, using,
selling, offering for sale or importing of Licensed Product and
provided that such suit, claim or demand is not attributable to the
practice of Patent Rights or Know-How other than the EPMN Patent Rights
and EPMN Know-How, GCOR's royalty payments due under this Agreement for
sale of the relevant Licensed Product shall be stayed until sales
resume (if at all). If GCOR and its sublicensees are not required to
cease the making, having made, using, selling, offering for sale or
importing of Licensed Product during the pendency of any such suit,
claim or demand, GCOR shall pay applicable royalty payments on Net
Sales of Licensed Product to EPMN in accordance with the terms of this
Agreement. In the event a final unappealable judgment with respect to
such suit, claim or demand requires GCOR or its sublicensees to pay to
any third party damages based on sales of Licensed Products on which
royalty payments were made to EPMN pursuant to the preceding sentence,
then EPMN shall return to GCOR the amount of such royalty payments made
that were based on such sales of Licensed Products, together with
interest thereon in accordance with Section 4.5.
ARTICLE IX
COLLABORATION
9.1 Collaboration Agreement. Concurrently herewith, the Parties have
concluded a Collaboration Agreement including the Work Plan detailing
the efforts to be undertaken pursuant to the Collaboration Agreement.
All Collaboration Patent Rights shall be licensed in accordance with
the terms of this Agreement.
ARTICLE X
TERM AND TERMINATION
10.1 Term. This Agreement shall become effective on the Effective Date and
shall expire at the end of the last Royalty Period for any Licensed
Product, unless earlier terminated under Section 10.2, 10.3 or 10.4
(the "Term"); provided that the licenses granted under Section 2.3 and
the royalty provisions of Section 3.5 and any other provisions to the
extent that they pertain to such licenses or royalty provisions shall
become effective on the Effective Date and shall expire upon expiration
of the last to expire of the Joint Collaboration Patent Rights, unless
earlier terminated under Section 10.2, 10.3 or 10.4.
10.2 Termination Due to Material Breach. If a Party to this Agreement
commits a material breach of any provision of this Agreement (including
but not limited to payment due under Article III or V, diligence under
Article VI, warranties under Article VII, Patent Prosecution,
Enforcement or Defense under Article VIII or Confidentiality under
Article XI) and fails to remedy such breach within [...***...] with
respect to breach of any payment obligation) after written notice
thereof from the other Party stating the intent to terminate, the Party
not in default may, at its option, terminate this Agreement by giving
written notice to the Party in default.
*CONFIDENTIAL TREATMENT REQUESTED
19.
10.3 Termination due to Bankruptcy. In the event that a Party becomes
subject to bankruptcy, insolvency, liquidation or similar proceedings,
the other Party shall be entitled to terminate this Agreement upon
written notice to such Party.
10.4 Termination by Licensee. Either Party may terminate this Agreement with
respect to the licenses granted hereunder to such Party at any time
after the expiration or termination of the Collaboration Term upon
[...***...] prior written notice to the other Party.
10.5 Effect of Termination; Survival of Provisions.
10.5.1 Termination by EPMN. Upon termination of this Agreement by EPMN
pursuant to Section 10.2 or 10.3 or termination by GCOR pursuant to
Section 10.4: (i) all rights under the licenses granted by EPMN to GCOR
hereunder shall automatically terminate and revert to EPMN except that
GCOR shall have the right to sell off any existing inventory of
Licensed Product subject to its obligations to pay applicable royalties
as provided in Article III; (ii) any permitted sublicenses granted
hereunder by GCOR shall remain in effect, but shall be assigned to
EPMN; (iii) the licenses granted by GCOR to EPMN hereunder shall remain
in effect in accordance with their terms, subject to compliance by EPMN
with all applicable provisions of this Agreement; and (iv) GCOR shall,
upon request by EPMN, deliver to EPMN any and all confidential
information of EPMN then in its possession.
10.5.2 Termination as to Affected Program. Upon termination of this
Agreement by EPMN as to one (1) or more Affected Program in any
geographies pursuant to Section 6.3(b): (i) all rights under the
licenses granted by EPMN to GCOR hereunder as to the Affected
Program(s) in such geographies shall automatically terminate and revert
to EPMN; (ii) any permitted sublicenses granted hereunder by GCOR in
the Affected Program(s) in such geographies shall remain in effect, but
shall be assigned to EPMN; (iii) the licenses granted by EPMN to GCOR
hereunder other than those described in Section 10.5.2(i) shall remain
in effect in accordance with their terms, subject to compliance by GCOR
with all applicable provisions of this Agreement; (iv) the licenses
granted by GCOR to EPMN hereunder shall remain in effect in accordance
with their terms, subject to compliance by EPMN with all applicable
provisions of this Agreement; and (v) GCOR shall, upon request by EPMN,
deliver to EPMN any and all confidential information of EPMN with
respect to the Affected Program(s) then in its possession, except to
the extent needed in connection with any licenses remaining in effect
as described in Section 10.5.2(iii).
10.5.3 Termination by GCOR. Upon termination of this Agreement by GCOR
pursuant to Section 10.2 or 10.3 or termination by EPMN pursuant to
Section 10.4: (i) all rights under the licenses granted by GCOR to EPMN
hereunder shall automatically terminate and revert to GCOR; (ii) any
permitted
*CONFIDENTIAL TREATMENT REQUESTED
20.
sublicenses granted hereunder by EPMN shall remain in effect, but shall
be assigned to GCOR; (iii) the licenses granted by EPMN to GCOR
hereunder shall remain in effect in accordance with their terms,
subject to compliance by GCOR with all applicable provisions of this
Agreement; and (iv) EPMN shall upon request by GCOR, deliver to GCOR
any and all confidential information of GCOR then in its possession.
10.5.4 Survival. Expiration or termination of this Agreement shall not
terminate any obligation of either Party to the other Party, including
any payment obligation, that has accrued prior to the date of
expiration or termination. The provisions contained in Sections 4.1,
4.4, 7.3, 10.5, 11.1 and 11.2 and Articles I, XII and XIII of this
Agreement shall survive its expiration or earlier termination.
10.5.5 Remedies. In the event of any breach of any provision of this
Agreement, in addition to the termination rights set forth herein, each
Party shall have all other rights and remedies at law or equity to
enforce this Agreement.
ARTICLE XI
CONFIDENTIALITY
11.1 Confidentiality Obligation. In consideration of disclosure by either
Party (the "disclosing Party") to the other (the "Recipient") of
confidential information in written or oral form or in the form of
samples, the Recipient and the Recipient's Affiliates undertake for a
period of [...***...] from the end OF the Term to treat received
confidential information as confidential and therefore not to disclose
it to any third party except as permitted hereunder and to use such
confidential information only for the purposes of this Agreement. Each
Recipient will use at least the same standard of care as it uses to
protect proprietary or confidential information of its own to ensure
that its employees, agents, consultants and other representatives do
not disclose or make any unauthorized use of the confidential
information of the disclosing Party. Each Recipient will promptly
notify the other upon discovery of any unauthorized disclosure of the
confidential information of the disclosing Party. This obligation does
not apply to:
(a) information which, at the time of disclosure, is already
in the public domain;
(b) information which, after disclosure, becomes a part of the
public domain by publication through no violation of this
Agreement;
(c) information which the Recipient is able to prove by
competent written evidence to have been in possession of
prior to any disclosure;
(d) information which is hereafter lawfully disclosed to the
Recipient by a third party, which third party did not
acquire the information under a still effective obligation
of confidentiality to the disclosing Party;
*CONFIDENTIAL TREATMENT REQUESTED
21.
(e) information the Recipient is able to prove by competent
written evidence to have been is independently developed
by or for the Recipient without use of the confidential
information of the disclosing Party; and
(f) information disclosed upon approval of the disclosing
Party.
11.2 Authorized Disclosures. Confidential information of the disclosing
Party may be disclosed to employees, agents, consultants or
sublicensees of the Recipient or its Affiliates, but only to the extent
required to accomplish the purposes of this Agreement and only if the
Recipient's and its Affiliates' employees, agents, consultants and
sublicensees to whom disclosure is to be made are bound by
confidentiality obligations at least as stringent as those herein.
Notwithstanding any other provision of this Agreement, disclosure of
confidential information shall not be precluded if such disclosure: (a)
is in response to a valid order of a court or other governmental body
of the United States or any political subdivision thereof; or (b) is
required by law or regulation; provided, however, that the Recipient
shall first have given reasonable prior notice to the disclosing Party
and shall have made a reasonable effort to obtain a protective order,
or to cooperate with the disclosing Party's efforts, as applicable, to
obtain a protective order limiting the extent of such disclosure and
requiring that the confidential information so disclosed be used only
for the purposes for which such order was issued or as required by such
law or regulation. 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 as otherwise
required by law.
11.3 Press Release. Neither Party shall issue any press release or other
public statement concerning the existence or terms of this Agreement or
any activities related hereto without consulting and agreeing with the
other Party. However, each Party may disclose the existence of this
Agreement without the other Party's approval if such approval has been
requested but not received within forty-eight (48) hours and such party
concludes, after consulting with its legal advisors, that it is
required by law or regulatory or listing agency to disclose the
transaction or part thereof. In addition, following the initial joint
press release announcing this Agreement, either Party shall be free to
disclose, without the other Party's prior written consent, the
existence of this Agreement, the identity of the other Party and those
terms of the Agreement which have already been publicly disclosed in
accordance herewith.
ARTICLE XII
INDEMNIFICATION
12.1 By EPMN. EPMN shall defend, indemnify and hold GCOR and its Affiliates
and their respective officers, directors, employees, agents or
representatives (the
22.
"GCOR Indemnitees") harmless against any liability, damage, loss, cost
or expense, including legal fees (collectively, "Liability"), incurred
by any GCOR Indemnitee arising out of our resulting from: (i) EPMN's
breach of a material term of this Agreement, including any material
breach of any representation or warranty of EPMN set forth in Section
7.1; and (ii) any third party claims or suits made or brought against
any GCOR Indemnitee to the extent such Liability arises out of or
relates to EPMN's research and development of the Licensed Product or
EPMN's use of the EPMN Technology or the Collaboration Patent Rights,
except to the extent such Liability results from the negligence or
willful misconduct of GCOR.
12.2 By GCOR. GCOR shall defend, indemnify and hold EPMN and its Affiliates
and their respective officers, directors, employees, agents or
representatives (the "EPMN Indemnitees") harmless against any Liability
incurred by any EPMN Indemnitee arising out of or resulting from: (i)
GCOR's breach of a material term of this Agreement, including any
material breach of a representation or warranty of GCOR set forth in
Section 7.2; and (ii) any third party claims or suits made or brought
against any EPMN Indemnitee to the extent such Liability arises out of
or relates to GCOR's research, development, manufacture, use or sale of
the Licensed Product or GCOR's use of the EPMN Technology or
Collaboration Patent Rights, except to the extent such Liability
results from the negligence or willful misconduct of EPMN.
12.3 Notice and Cooperation. If either Party hereunder receives notice of
any claim or of the commencement of any action, administrative or legal
proceeding, or investigation as to which the indemnity provided for in
Section 12.1 or 12.2 hereof may apply:
12.3.1 The party seeking indemnification shall notify the indemnifying
party of such fact within fourteen (14) days at the address noted in
Section 13.7; provided that the failure to so notify shall not release
an indemnifying party of its obligation hereunder unless such failure
shall be materially detrimental to the defense of any such action,
proceeding or investigation; and
12.3.2 The party seeking indemnification shall cooperate with and
assist the indemnifying party and its representatives in the
investigation and defense of any claim and/or suit for which
indemnification is provided.
12.4 Defense and Settlement. The indemnifying party shall control the
defense of any claim and/or suit for which indemnification is provided
under this Article XII. This agreement of indemnity shall not be valid
as to any settlement of a claim or suit or offer of settlement or
compromise without the prior written approval of the indemnifying
party.
12.5 Limitation of Liability. EXCEPT FOR AMOUNTS PAYABLE UNDER ARTICLES III,
V and VIII AND LIABILITY FOR BREACH OF ARTICLE XX,
00.
NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY
SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION
WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER.
ARTICLE XIII
MISCELLANEOUS
13.1 Force Majeure. Each of the Parties hereto shall be excused from the
performance of its obligations hereunder (other than payment
obligations) and shall not be liable for damages to the other in the
event that such performance is prevented by circumstances beyond its
effective control. Such excuse from performance shall continue for as
long as the condition responsible for such excuse continues and for a
period of thirty (30) days thereafter, provided that if such excuse
continues for a period of one hundred and eighty (180) days, the Party
whose performance is not being prevented shall be entitled to terminate
this Agreement. For the purpose of this Agreement circumstances beyond
the effective control of the Party which excuse said Party from
performance shall include, without limitation, acts of God, enactments,
regulations or laws of any government, injunctions or judgment of any
court, war, civil commotion, destruction of facility or materials by
fire, earthquake, storm or other casualty, plague of epic proportions,
famine, labor disturbances and failure of public utilities or common
carrier.
13.2 Independent Contractors. Nothing in this Agreement is intended or shall
be deemed to constitute a partnership, agency, employment or joint
venture relationship between the Parties. All activities by the Parties
hereunder shall be performed by the Parties as independent parties.
Neither Party shall incur any debts or make any commitment for or on
behalf of the other Party except to the extent, if at all, specifically
provided herein or subsequently agreed upon.
13.3 Assignment. This Agreement shall not be assignable by either Party
without the prior written consent of the other Party, such consent not
to be unreasonably withheld or delayed, except a Party may make such an
assignment without the other Party's consent to Affiliates or to a
successor to substantially all of the business assets relating to the
Licensed Field of such Party, whether by merger, sale of stock, sale or
transfer of assets or other transaction; provided, however, that in the
event of such transaction, no intellectual property rights of any
Affiliate or third party that is an acquiring party shall be included
in the technology licensed hereunder. This Agreement shall be binding
upon and inure to the benefit of the Parties' successors, legal
representatives and assigns.
13.4 Amendments of Agreement. This Agreement may be amended or modified or
one or more provisions hereof waived only by a written instrument
signed by both Parties.
24.
13.5 Severability. In the event that any one or more of the provisions of
this Agreement should for any reason be held by any court or authority
having jurisdiction over this Agreement and the Parties to be invalid,
illegal or unenforceable, such provisions shall be deleted in such
jurisdiction; elsewhere this Agreement shall not be affected.
13.6 Article Headings. The section headings contained in this Agreement are
for convenience only and are to be of no force or effect in construing
and interpreting this Agreement.
13.7 Notices. Any notice, report, request, approval, payment, consent or
other communication required or permitted to be given under this
Agreement shall be in writing and shall for all purposes be deemed to
be fully given and received, if delivered in person or sent by
registered mail, postage prepaid or by facsimile transmission to the
respective parties at the following addresses:
If to EPMN: EPIMMUNE INC.
0000 Xxxxx Xxxxx Xxxxx
Xxx Xxxxx, XX 00000
Attention: Chief Executive Officer
Fax No.: 000-000-0000
If to GCOR: GENENCOR INTERNATIONAL, INC.
000 Xxxx Xxxx Xxxx
Xxxx Xxxx, XX 00000
Attention: General Counsel
Fax No.: 000-000-0000
Either party may change its address for the purpose of this Agreement
by giving the other Party written notice of its new address.
13.8 Non-Waiver For Failure To Enforce Compliance. The express or implied
waiver by either Party of a breach of any provision of this Agreement
shall not constitute a continuing waiver of other breaches of the same
or other provisions of this Agreement.
13.9 Applicable Law. This Agreement shall be construed and interpreted in
accordance with the laws of the State of California without regard to
conflict of law provisions.
13.10 Counterparts. This Agreement may be executed in one or more
counterparts, each of which is an original but all of which, taken
together, shall constitute one and the same instrument.
25.
IN WITNESS WHEREOF, this License Agreement has been entered into on the
Effective Date signed by the Parties.
GENENCOR INTERNATIONAL, INC.
By: /s/ Xxxxx Xx Xxxxx
-----------------------------------
Name: Xxxxx Xx Xxxxx
---------------------------------
Title: CBO
--------------------------------
EPIMMUNE INC.
By: /s/ Xxxxxx X. De Vaere
-----------------------------------
Xxxxxx X. De Vaere
Vice President Finance, and
Chief Financial Officer
SIGNATURE PAGE TO LICENSE AGREEMENT
APPENDIX A
COMBINATION PRODUCT EXAMPLES
[...***...]
*CONFIDENTIAL TREATMENT REQUESTED
APPENDIX B
THIRD PARTY TECHNOLOGY
[...***...]
*CONFIDENTIAL TREATMENT REQUESTED
APPENDIX C
SAMPLE ROYALTY CALCULATION
[...***...]
*CONFIDENTIAL TREATMENT REQUESTED
