LICENSE AGREEMENT between VITAE PHARMACEUTICALS, INC. and QUEST GROUP INTERNATIONAL, INC. May 11, 2007
EXECUTION
COPY
between
VITAE
PHARMACEUTICALS, INC.
and
QUEST
GROUP INTERNATIONAL, INC.
May
11,
2007
TABLE
OF CONTENTS
Page
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1.
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DEFINITIONS
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2
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2.
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GRANT
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8
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3.
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TECHNOLOGY
TRANSFER AND INVENTORIES
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9
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4.
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PAYMENTS
AND ROYALTIES
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9
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5.
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DEVELOPMENT
AND COMMERCIALIZATION
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13
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6.
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MANUFACTURING
AND SUPPLY
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14
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7.
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CONFIDENTIALITY
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15
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8.
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PATENT
PROSECUTION AND LITIGATION
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16
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9.
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TRADEMARKS
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18
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10.
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RECORDS
AND REPORTING
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18
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11.
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TERM
AND TERMINATION
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19
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12.
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WARRANTIES,
REPRESENTATIONS AND INDEMNIFICATIONS
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22
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13.
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GENERAL
PROVISIONS
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24
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APPENDIX
A - ALLERGAN PATENTS
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X-0
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XXXXXXXX
X - EXCLUDED PATENTS
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B-1
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APPENDIX
C - VITAE RETINOID PATENTS
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C-1
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APPENDIX
D - [* * *] INVENTORY
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D-1
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APPENDIX
E - EXEMPLARY EXCLUDED COMPOUNDS
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E-1
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APPENDIX
F - ALLERGAN AGREEMENT
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F-1
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i
Text
marked by [ * * *] has been omitted pursuant to a Request for Confidential
Treatment and
was
filed separately with the Securities and Exchange
Commission.
THIS
LICENSE AGREEMENT (hereinafter, this “AGREEMENT”), is entered into as of the
11th day of May 2007 (the “EFFECTIVE DATE”), between Vitae Pharmaceuticals, Inc.
(formerly known as “Concurrent Pharmaceuticals, Inc.”), a Delaware corporation
having a principal place of business at 000 Xxxx Xxxxxx Xxxxxx Xxxxx, Xxxx
Xxxxxxxxxx, XX 00000 (hereinafter, “VITAE”) and Quest Group International, Inc.,
a Nevada corporation having its principal place of business at 000 Xxxx Xxxxxx,
Xxxx, XX 00000 (hereinafter “QUEST”).
RECITALS
WHEREAS,
VITAE is a party to the Master Technology Ownership and License Agreement,
dated
May 10, 2004, by and among Allergan, Inc. and Allergan Sales, LLC, on the one
hand (collectively, “ALLERGAN”), and VITAE, on the other hand, as amended by the
letter agreement, dated December 15, 2006, among ALLERGAN and VITAE (as so
amended, the “ALLERGAN AGREEMENT”);
WHEREAS,
by virtue of the ALLERGAN AGREEMENT, VITAE is the exclusive licensee of all
right, title and interest in certain patents (identified in Appendix A hereto)
relating to certain retinoid and rexinoid compounds, including the compounds
designated [* * *] (hereinafter, the “ALLERGAN PATENTS”);
WHEREAS,
VITAE is the assignee and owner of all right, title and interest to certain
patents relating to methods of using retinoid compounds (hereinafter, the “VITAE
RETINOID PATENTS”);
WHEREAS,
VITAE is the owner of all right, title and interest in know-how, data and other
confidential information relating to certain compounds from the Allergan
retinoid library (hereinafter, the “TRANSFERRED COMPOUNDS”) (as defined in
Section 1.51);
WHEREAS,
the TRANSFERRED COMPOUNDS include [* * *], and VITAE wishes to retain all rights
to the EXCLUDED COMPOUNDS (as defined in Section 1.16);
WHEREAS,
Allergan, Inc., Allergan Ligand Retinoid Therapeutics, Inc. and Ligand
Pharmaceuticals Incorporated (hereinafter, “LIGAND”) are parties to an Amended
and Restated Technology Cross-License Agreement, dated September 24, 1997
(hereinafter, the “LIGAND AGREEMENT”);
WHEREAS,
by virtue of the LIGAND AGREEMENT, Allergan, Inc. is the exclusive, even as
to
LIGAND, licensee of certain patents owned by LIGAND, and by virtue of the
ALLERGAN AGREEMENT, VITAE is an exclusive sublicensee of such
patents;
WHEREAS,
VITAE is the owner of all right, title and interest to retinoid/rexinoid
compound library, drug substance, drug product, clinical and other data, and
know-how relating to the TRANSFERRED COMPOUNDS, including all backups, analogs,
metabolites, isomers and enantiomers thereof; and
WHEREAS,
QUEST desires to obtain an exclusive license from VITAE to develop and
commercialize the TRANSFERRED COMPOUNDS other than the EXCLUDED COMPOUNDS under
the aforesaid patents and know-how, and VITAE is willing to grant to QUEST
such
a license;
NOW,
THEREFORE, in consideration of the covenants and promises expressed herein,
intending to be legally bound, the parties agree as follows:
1. DEFINITIONS
When
used
herein, the following capitalized terms shall have the meanings
indicated:
1.01 “AAA”
shall mean the American Arbitration Association.
1.02 “ALLERGAN
AGREEMENT” shall have the meaning ascribed in the Recitals. A copy of the
ALLERGAN AGREEMENT is attached hereto as Appendix F.
1.03 “ALLERGAN
COMPOUNDS” shall mean the TRANSFERRED COMPOUNDS other than the EXCLUDED
COMPOUNDS.
1.04 “ALLERGAN
PATENTS” shall mean those patents and patent applications, identified on
Appendix A hereto, licensed to VITAE pursuant to the ALLERGAN AGREEMENT.
For clarity, the ALLERGAN PATENTS do not include the EXCLUDED
PATENTS.
1.05 “AFFILIATE”
shall mean any company or other entity controlled by, controlling, or under
common control with a party to this AGREEMENT. For purposes of this definition,
“control” shall mean direct or indirect ownership of fifty percent (50%) or more
of the voting stock or profit interest in a company or entity.
1.06 “ARBITRATOR”
shall have the meaning ascribed in Section 13.03.
1.07 "CHANGE
IN CONTROL" of VITAE means the occurrence of any of the following: (i) a sale
of
assets representing more than fifty percent (50%) of the net book value or
fair
market value of VITAE's consolidated assets (in a single transaction or in
a
series of related transactions) other than to an AFFILIATE of VITAE; (ii) a
merger or consolidation of VITAE with a third party, whether or not VITAE or
the
THIRD PARTY is the surviving entity; or (iii) an acquisition, other than in
a
merger or consolidation of the type referred to in clause (ii), of beneficial
ownership of outstanding voting securities of VITAE representing at least fifty
percent (50%) of the combined voting power of VITAE or otherwise giving the
acquirer the authority to appoint a majority of directors on VITAE’s Board,
whether such acquisition is effectuated in a single transaction or series of
related transactions.
1.08 “COMBINATION
PRODUCT” shall mean a product that contains or uses a LICENSED PRODUCT and at
least one other PRODUCT COMPONENT, or a LICENSED PRODUCT sold in combination
with a PRODUCT COMPONENT even if not co-formulated with such other PRODUCT
COMPONENT.
2
1.09 “COMMERCIALLY
REASONABLE EFFORTS” of a party shall mean the carrying out of obligations in a
manner consistent with efforts that such party would devote to a product of
similar market potential and strategic value resulting from its own research
efforts, but in no event shall such efforts be less than what a pharmaceutical
company of similar size and resources would devote to a product of similar
market potential and strategic value.
1.10 “COVER”
or “COVERING” shall mean, with respect to a patent or patent application, that
at least one claim would be infringed by the product, method or device, as
applicable.
1.11 “CYTOCHROMA
AGREEMENT” shall mean the Collaborative Research, Development and License
Agreement between Allergan, Inc. and Cytochroma, Inc., dated May 31, 1999,
as
amended on June 25, 2001.
1.12 ‘DEBLOCKING
LICENSE” shall have the meaning ascribed in Section 2.01.
1.13 “DEVELOPMENT”
shall mean those activities undertaken with respect to a LICENSED PRODUCT which
are devoted to the exploration of a potential pharmaceutical product in human
clinical trials and/or the conduct of any other studies, including clinical
trials, regulatory affairs and other activities directed toward REGULATORY
APPROVAL of such LICENSED PRODUCT.
1.14 “DISPUTE”
shall
have the meaning ascribed in Section 13.03.
1.15 “EFFECTIVE
DATE” shall have the meaning ascribed in the introductory paragraph
hereof.
1.16 “EXCLUDED
COMPOUNDS” shall mean any compounds COVERED by the EXCLUDED PATENTS or [* * *];
for clarity, EXCLUDED COMPOUNDS include [* * *]. A list of certain EXCLUDED
COMPOUNDS is provided in Appendix E attached hereto.
1.17 “EXCLUDED
PATENTS” shall mean those patents and patent applications, identified in
Appendix B hereto, licensed to VITAE pursuant to the ALLERGAN AGREEMENT
that are excluded from the LICENSED PATENTS under this AGREEMENT.
1.18 “EXISTING
LICENSORS” shall mean ALLERGAN and LIGAND.
1.19 “FDA”
shall mean the United States Food and Drug Administration or its successor
entity.
1.20 “FIELD”
shall mean all human or veterinary use, subject only to the retained rights
of
the EXISTING LICENSORS under the ALLERGAN AGREEMENT and LIGAND
AGREEMENT.
1.21 “FIRST
COMMERCIAL SALE” of a LICENSED PRODUCT shall mean the first sale for use or
consumption of such LICENSED PRODUCT to a THIRD PARTY in a country after
REGULATORY APPROVAL has been granted by the governing health regulatory
authority of such country. Sale to or consumption by an AFFILIATE or permitted
sublicense shall not constitute a FIRST COMMERCIAL SALE unless the AFFILIATE
or
permitted sublicense is the end user of the LICENSED PRODUCT.
3
1.22 “FOUNDING
SHAREHOLDERS” shall have the meaning ascribed in Section 4.03.
1.23 “GENERIC
COMPETITION” shall have the meaning ascribed in Section 4.04(f).
1.24 “GENERIC
PRODUCT” shall mean with respect to a LICENSED PRODUCT any pharmaceutical
product (other than such LICENSED PRODUCT) that contains the same active
ingredient(s) as such LICENSED PRODUCT, has substantially the same formulation,
mode of administration and duration of release as such LICENSED PRODUCT, and
is
approved for the same indications as such LICENSED PRODUCT.
1.25 “IND”
shall mean an Investigational New Drug Application filed with the FDA, or the
equivalent application or filing necessary to commence human clinical trials
in
a country other than the USA, as applicable.
1.26 “IND
APPROVAL” shall mean the acceptance of an IND by the FDA for clinical
testing.
1.27 “INITIATION”
shall mean, with respect to a clinical trial, the date that the first patient
is
dosed in such clinical trial.
1.28 “INVENTORY”
has the meaning ascribed in Section 3.02.
1.29 “LICENSED
COMPOUNDS” shall mean the ALLERGAN COMPOUNDS and any compounds for which
royalties would be due to ALLERGAN or LIGAND under the ALLERGAN AGREEMENT or
LIGAND AGREEMENT respectively, other than the EXCLUDED COMPOUNDS.
1.30 “LICENSED
KNOW-HOW” shall mean all technical information and know-how which relates to a
LICENSED PRODUCT which is owned by VITAE or its AFFILIATES as of the EFFECTIVE
DATE, and to which VITAE or its AFFILIATES otherwise has, as of the EFFECTIVE
DATE, the right to grant rights or licenses, and shall include, without
limitation, all biological, chemical, pharmacological, toxicological, clinical,
assay, control, formulation and manufacturing data and any other information
relating to a LICENSED PRODUCT and useful for the research, development,
manufacture, and commercialization of a LICENSED PRODUCT, including, without
limitation, all such information and know-how relating to each EXISTING
IND.
1.31 “LICENSED
PATENTS” shall mean all patents and patent applications, including any
continuations, continuations-in-part, divisionals, reissues, reexamination
certificates, and/or SPCs, owned or controlled by VITAE or its AFFILIATES as
of
the EFFECTIVE DATE, or to which VITAE or its AFFILIATES otherwise has, as of
the
EFFECTIVE DATE, the right to grant rights or licenses, that COVER (i) the
manufacture, use, import, export, development of, marketing, distribution,
offer
for sale, sale or other disposition of a LICENSED PRODUCT, or (ii) any processes
or intermediates necessary for the manufacture, use, import, export, research,
development, marketing, distribution, offer for sale, sale or other disposition
of a LICENSED PRODUCT. For clarity, the LICENSED PATENTS include, without
limitation, the ALLERGAN PATENTS, the LIGAND PATENTS and the VITAE RETINOID
PATENTS.
4
1.32 “LICENSED
PRODUCT” shall mean any pharmaceutical product (in any form, strength or package
size) containing one or more LICENSED COMPOUNDS as an active
ingredient.
1.33 “LIGAND
AGREEMENT” shall have the meaning ascribed in the Recitals.
1.34 “LIGAND
PATENTS” shall mean those patents and patent applications licensed to ALLERGAN
pursuant to the LIGAND AGREEMENT and sublicensed to VITAE pursuant to the
ALLERGAN AGREEMENT. A list of the LIGAND PATENTS is provided in Exhibit B-2
of
the ALLERGAN AGREEMENT.
1.35 “LOW
ROYALTY PRODUCT” shall have the meaning set forth in section 5.1(b) of the
ALLERGAN AGREEMENT.
1.36 “NDA”
shall mean a New Drug Application filed with the FDA, or the equivalent
community application filed in the European Union, or the equivalent application
filed as a national application.
1.37 “NDA
ACCEPTANCE” shall mean the earlier of (i) receipt by QUEST of written notice of
acceptance from the FDA of an NDA filed by or on behalf of QUEST under this
AGREEMENT necessary for commercialization of LICENSED PRODUCT in the USA, or
(ii) sixty (60) days following filing of such NDA with the FDA, assuming QUEST
has not received a “Notice of Refusal to File” from the FDA with respect to such
NDA.
1.38 “NET
SALES” shall mean the total consideration, including the gross amount invoiced
or received from THIRD PARTIES by QUEST, its AFFILIATES and its permitted
sublicensees for all LICENSED PRODUCTS (including any COMBINATION PRODUCTS)
sold, after deduction for the following items (i) trade, quantity and cash
discounts or rebates actually allowed, paid or taken; (ii) credits, rebates,
charge-back rebates, reimbursements or similar payments actually granted or
given to wholesalers and other distributors, buying groups, health care
insurance carriers, governmental agencies and other institutions; (iii) credits
or allowances actually granted or given for rejection or return of such LICENSED
PRODUCT previously sold; (iv) any tax, tariff, duty or other governmental charge
(other than an income tax) levied on the sale, transportation or delivery of
LICENSED PRODUCT and actually borne by QUEST; (v) payments or rebates actually
paid in connection with state or federal Medicare, Medicaid or similar programs;
and (vi) any charge for freight or insurance actually borne by QUEST to the
extent included in the gross amount invoiced. All such NET SALES shall be
determined in accordance with U.S. Generally Accepted Accounting Principles
(“GAAP”). NET SALES shall include the fair market value of all consideration
received by QUEST, its AFFILIATES and its permitted sublicensees, whether such
consideration is in the form of cash, barter or counter-trade.
5
1.39 “PHASE
II
CLINICAL TRIAL” shall mean those tests and studies (as more fully defined in 21
CFR § 312.21(b)) of a LICENSED PRODUCT that the FDA requires to be performed on
a sufficient number of patients to generate sufficient data to establish the
safety, dose ranging and biological activity of that LICENSED PRODUCT for its
intended use and to permit commencement of a PHASE III CLINICAL
TRIAL.
1.40 “PHASE
III CLINICAL TRIAL” shall mean those tests and studies (as more fully defined in
21 CFR § 312.21(c)) of a LICENSED PRODUCT that the FDA requires to be performed
on sufficient numbers of patients designed to establish the safety and efficacy
of such LICENSED PRODUCT for obtaining REGULATORY APPROVAL with the desired
claims and for the desired indications.
1.41 “PRIMARY
INDICATIONS” shall mean [* * *].
1.42 “PRIVATE
PLACEMENT” shall have the meaning ascribed in Section 4.03.
1.43 “PRODUCT
COMPONENT” shall mean one or more products that (i) are not themselves a
LICENSED PRODUCT; (ii) when combined with a LICENSED PRODUCT, the market value
of such combined product is materially higher than the market value for such
LICENSED PRODUCT (if sold separately) as a result of such combined product
containing or using such PRODUCT COMPONENT; and (iii) is a separate functional
device or active ingredient. For clarity, the term “PRODUCT COMPONENT” shall not
include excipients, buffers or other similar substances that are typically
formulated with the drug product contained in the LICENSED PRODUCT to form
the
final product for sale, nor standard, off-the-shelf components to delivery
devices such as syringes, but may include specialized drug delivery devices,
other active drug substances or other proprietary materials intended to deliver
the drug contained in the LICENSED PRODUCT.
1.44 “PRODUCT
TRADEMARKS” shall mean any word, phrase, slogan, design, symbol or product
packaging used or intended to be used to identify a LICENSED PRODUCT or
distinguish them from competitive or related products, including any registered
trademark, common law trademark, trademark application (whether a use
application or an intent-to-use application) and trade dress.
1.45 “QUEST
KNOW-HOW” shall mean all present and future technical information and know-how
which relates to a LICENSED PRODUCT which is or becomes owned by QUEST, or
to
which QUEST otherwise has, now or in the future, the right to grant licenses
and
shall include, without limitation, all biological, chemical, pharmacological,
toxicological, clinical, assay, control, formulation and manufacturing data
and
any other information relating to a LICENSED PRODUCT and useful for the
development, manufacture, and commercialization of a LICENSED
PRODUCT.
1.46 “QUEST
PATENTS” shall mean all patents and patent applications which are or become
owned by QUEST, or to which QUEST otherwise has, now or in the future during
the
term of this AGREEMENT, the right to grant licenses, which generically or
specifically claim a LICENSED PRODUCT, a process for manufacturing LICENSED
PRODUCT, an intermediate used in such process, a process for manufacturing
such
an intermediate, a use of LICENSED PRODUCT, a method of using LICENSED PRODUCT,
or a composition or formulation comprising LICENSED PRODUCT (including any
COMBINATION PRODUCTS). Included within the definition of QUEST PATENTS are
all
continuations, continuations-in-part, divisions, patents of addition, patents
of
importation, reissues, pipeline cases, registrations, revalidations, renewals
and extensions thereof, all SPCs, all utility models, and all rights equivalent
or similar to any of the foregoing, including all such rights applied for after
the EFFECTIVE DATE. Also included within the definition of QUEST PATENTS are
any
patents or patent applications which generically or specifically claim any
improvements of LICENSED PRODUCT (e.g., improvements related to the essential
technical features of LICENSED PRODUCT, including essential chemical structural
features, an intermediate, a use of LICENSED PRODUCT, a method of using LICENSED
PRODUCT, or a composition or formulation comprising LICENSED PRODUCT),
intermediates or manufacturing processes required or useful for production
of
LICENSED PRODUCT, uses of LICENSED PRODUCT, methods of using LICENSED PRODUCT,
or compositions or formulations comprising LICENSED PRODUCT (including any
COMBINATION PRODUCTS) which are developed by QUEST, or which QUEST otherwise
has
the right to grant licenses, now or in the future, during the term of this
AGREEMENT.
6
1.47 “REGULATORY
APPROVAL” shall mean all approvals, licenses, registrations or authorizations of
any country, federal, state or local regulatory agency, department, bureau
or
other government entity that are necessary for the manufacture, use, storage,
import, transport and/or sale of a LICENSED PRODUCT in a given
jurisdiction.
1.48 “SPC”
shall mean a right based upon a LICENSED PATENT or QUEST PATENT (depending
upon
context) to exclude others from making, using or selling LICENSED PRODUCTS,
such
as a Supplementary Protection Certificate.
1.49 “TERRITORY”
shall
mean all the countries and territories of the world.
1.50 “THIRD
PARTY” shall mean any party other than the EXISTING LICENSORS, QUEST, VITAE and
their respective AFFILIATES.
1.51 “TRANSFERRED
COMPOUNDS” shall have the meaning ascribed in Article 1 of the ALLERGAN
AGREEMENT.
1.52 “USA”
shall mean the United States of America, including all of its territories and
possessions.
1.53 “VALID
CLAIM” shall mean any claim issued in an unexpired patent (or pending in an
unabandoned patent application if such claim has not been pending for more
than
seven (7) years and QUEST has diligently prosecuted such claim with the
objective of obtaining prompt allowance of such claim) which has not been held
unenforceable, unpatentable or invalid by a decision of a court or other
governmental agency of competent jurisdiction following exhaustion of all
possible appeal processes, and which has not been admitted to be invalid or
unenforceable through reissue, reexamination or disclaimer.
7
1.54 “VITAE
RETINOID PATENTS” shall mean the patent applications owned directly by VITAE
that COVER methods of using certain ALLERGAN COMPOUNDS, as listed in Appendix
C.
1.55 “VITAE
SHARES” shall have the meaning ascribed in Section 4.03.
2. GRANT
2.01 VITAE
hereby grants to QUEST an exclusive (even as to VITAE) license, with the right
to grant sublicenses, under LICENSED PATENTS and LICENSED KNOW-HOW to conduct
research in the FIELD, develop, make, have made, use, sell, offer for sale,
and
import LICENSED PRODUCT, in the TERRITORY, in the FIELD, subject to the terms
and conditions of this AGREEMENT and subject to any retained rights by the
EXISTING LICENSORS pursuant to the ALLERGAN AGREEMENT and the LIGAND AGREEMENT.
VITAE shall also grant to QUEST a non-exclusive, royalty free license to any
patents (other than LICENSED PATENTS) COVERING a LICENSED PRODUCT where such
patent was filed by and is owned by VITAE or its AFFILIATE (other than an entity
which became an AFFILIATE through a CHANGE IN CONTROL of VITAE) and where such
license is necessary for DEVELOPMENT or commercialization of such LICENSED
PRODUCT in the jurisdiction in which such patent was granted (hereinafter,
referred to as a “DEBLOCKING LICENSE”).
VITAE or
its acquirer or successor-in-interest in a merger shall not be required to
grant
to QUEST a DEBLOCKING LICENSE where the patent-at-issue was owned by the
acquirer or merger partner prior to the acquisition or merger.
2.02 Limitations
on VITAE.
[*
*
*].
2.03 QUEST
may
grant sublicenses under the LICENSED PATENTS and LICENSED KNOW-HOW to its
AFFILIATES and THIRD PARTIES (including, without limitation, the right of those
AFFILIATES and THIRD PARTIES to grant further sublicenses); provided, that
any
such sublicense shall be subject to and consistent in all material respects
with
the material terms and provisions of this AGREEMENT. Within ten (10) days of
the
effective date of each sublicense granted by QUEST or its AFFILIATES, QUEST
shall provide VITAE with a copy of such sublicense, with redactions for
provisions that do not pertain to the licensed rights granted hereunder. Within
ten (10) days of the effective date of each sublicense granted by VITAE’s or its
AFFILIATES’ sublicenses to a further sublicensee, QUEST shall provide VITAE with
notice of the identity of each further sublicensee, a summary of each such
sublicense (such summary to include the scope and restrictions of the
sublicensed rights, the term of the sublicensed rights, confirmation that the
reporting, audit and indemnification obligations are consistent with the
requirements of this AGREEMENT, evidence that the definition of net sales in
such sublicense is consistent with the definition of NET SALES in this
AGREEMENT. The performance or satisfaction of any obligation of QUEST under
this
AGREEMENT by any of its AFFILIATES or sublicensees shall be deemed performance
or satisfaction of such obligation by QUEST. In no event, however, shall any
such sublicense relieve QUEST of its obligations hereunder. In the event of
any
termination of this AGREEMENT, all sublicenses hereunder shall be assigned
to
VITAE, and VITAE agrees to accept such assignment; provided, such sublicense
is
not then in breach of its sublicense agreement and its sublicense agreement
is
consistent with the provisions hereof; and provided further, in the case where
such sublicense would include obligations to be performed by VITAE, that the
foregoing assignment shall be subject to VITAE’s consent, such consent not to be
unreasonably withheld.
8
3. TECHNOLOGY
TRANSFER AND INVENTORIES
3.01 Within
sixty (60) days after the EFFECTIVE DATE, VITAE shall transfer the LICENSED
KNOW-HOW, including without limitation the LICENSED KNOW-HOW relating to the
manufacture and DEVELOPMENT of [* * *], subject to QUEST’s reimbursement of
VITAE’s documented, reasonable out-of-pocket expenses, including reasonable
travel expenses, if any, necessary to accomplish the transfer. VITAE shall
within ten (10) business days after the Effective Date, provide copies of all
regulatory dossiers to QUEST.
3.02 As
soon
as is practicable, and in any event within thirty (30) days, after the EFFECTIVE
DATE, VITAE shall transfer title to QUEST of all inventories and supplies in
VITAE’s or its AFFILIATES’ possession, or in possession by THIRD PARTIES under
VITAE’s or its AFFILIATES’ control, of LICENSED COMPOUNDS, intermediates used to
manufacture LICENSED COMPOUNDS, and other materials useful for the DEVELOPMENT
or manufacture of LICENSED PRODUCT (the “INVENTORY”), subject to QUEST’s payment
obligation under Section 4.02. Appendix D lists VITAE’s inventory of drug
substance and drug product for [* * *]. The information in Appendix D is
believed to be accurate as of the EFFECTIVE DATE based on VITAE’s knowledge.
However, QUEST acknowledges and agrees that the information may be inaccurate
and there shall be no adjustment to the inventory payment (or any other payment)
due to VITAE in the event that the information in Appendix D is later determined
to be inaccurate.
3.03 Notwithstanding
the above, QUEST acknowledges that the transfer of the compound library and
certain electronic databases may take longer than sixty (60) days because of
technical difficulties in segregating EXCLUDED COMPOUNDS from the compound
library and the electronic databases. VITAE shall use its best efforts to
transfer the compound library and the electronic databases
promptly.
4. PAYMENTS
AND ROYALTIES
4.01 Upfront
Payment.
In
consideration for the acquisition of license rights under LICENSED PATENTS
and
LICENSED KNOW-HOW granted to QUEST in this AGREEMENT, upon execution of this
AGREEMENT, QUEST
shall pay VITAE two million one hundred thousand dollars ($2,100,000). This
payment shall be made by wire transfer to an account to be designated by
VITAE.
4.02 Inventory
Payment.
Within
thirty (30) days of transfer and delivery of the INVENTORY under Section 3.02,
QUEST shall pay VITAE fifty
thousand dollars ($50,000).
QUEST
also shall bear, or reimburse VITAE, as the case may be, the reasonable cost
of
shipping and handling relating to transfer of the INVENTORY. This payment shall
be made promptly by wire transfer to an account to be designated by
VITAE.
4.03 Equity
Milestone Payment.
QUEST
shall issue to VITAE six million six hundred fifty thousand six hundred
fifty-two (6,650,652) shares of common stock of QUEST (the “VITAE SHARES”) upon
the first to occur of the following milestone events:[ * * *]. The number of
shares of QUEST common stock issued to VITAE shall equal 5.66% of the shares
of
QUEST common stock outstanding as of the EFFECTIVE DATE as determined on a
fully
diluted basis (counting the VITAE SHARES as outstanding shares. QUEST represents
and warrants that the capitalization table provided by QUEST to VITAE are
complete and accurate as of the EFFECTIVE DATE, and agrees that if there are
any
errors in QUEST’s favor, then QUEST shall issue additional sufficient shares to
VITAE to result in VITAE receiving 5.66% of the shares of QUEST common stock
outstanding as of the EFFECTIVE DATE. In the event that at any time after the
EFFECTIVE DATE until the issuance of the VITAE SHARES, the number of shares
of
QUEST common stock outstanding on a fully diluted basis is increased, whether
by
way of a stock split, stock dividend or otherwise, the number of VITAE SHARES
to
be issued upon achievement of the above milestone shall be adjusted upward
proportionately. VITAE shall have the same benefits and obligations with respect
to the VITAE SHARES as the FOUNDING SHAREHOLDERS (as hereinafter
defined),including [* * *]. “FOUNDING SHAREHOLDERS” means Santa Xxxxxx Capital
Partners II, LLC, Xxxxxxx Xxxx, Ph.D., and the other shareholders of QUEST
as of
the EFFECTIVE DATE. For clarity, the FOUNDING SHAREHOLDERS include all of the
persons and entities listed as investors in the “First Funding” on the Form 8-K
filed by QUEST on April 27, 2007. For further clarity, the FOUNDING SHAREHOLDERS
do not include the investors in the PRIVATE PLACEMENT. For further clarity,
only
one equity milestone payment shall be payable to VITAE, and the milestone
payment shall be triggered whether the LICENSED PRODUCT involved is a single
agent product or as a COMBINATION PRODUCT that incorporates one of the
above-identified LICENSED COMPOUNDS. QUEST shall use commercially reasonable
efforts to achieve at least one of the above milestones. Upon issuance to VITAE
of QUEST common stock pursuant to this Section 4.03,
and as
a condition thereto, VITAE shall execute and deliver to QUEST an appropriate
form investment representation letter with respect to such common
stock.
9
4.04 Royalties.
In
further consideration for the license under LICENSED PATENTS and LICENSED
KNOW-HOW granted to QUEST under this AGREEMENT, QUEST shall pay VITAE a royalty
in accordance with the following schedule based on annual NET
SALES:
LICENSED
COMPOUND
|
ROYALTY
RATE
|
[*
* *]
|
[*
* *]%
|
[*
* *]
|
[*
* *]%
|
[*
* *]
|
[*
* *]%
|
Other
|
See
below.
|
(a) [*
*
*]
(b) If
a
LICENSED PRODUCT contains more than one LICENSED COMPOUND, then the higher
royalty rate shall apply.
(c) If
VITAE
or QUEST is able to negotiate a lower royalty rate with the EXISTING LICENSORS,
VITAE and QUEST shall share equally in the benefit of such reduction, except
if
QUEST must provide monetary consideration (e.g.,
cash,
equity in QUEST or other consideration) to the EXISTING LICENSORS and VITAE
does
not contribute equally to the consideration provided. For example, [* *
*].
10
(d) [*
*
*]
(e) QUEST
will make royalty payments based on NET SALES, on a country-by-country basis,
from the date of the FIRST COMMERCIAL SALE in such country until the later
of
(i) the expiry of the last-to-expire LICENSED PATENT which has at least one
VALID CLAIM COVERING the LICENSED PRODUCT in such country (including the term
of
any applicable SPC covering such LICENSED PRODUCT), and (ii) [* * *] from
the date of FIRST COMMERCIAL SALE in such country.
(f) Reduction
for Generic Competition.
The
royalty payment due to VITAE for sales of a particular LICENSED PRODUCT in
a
particular country shall be reduced by [* * *] during any calendar quarter
in
which such LICENSED PRODUCT faces GENERIC COMPETITION. GENERIC COMPETITION
shall
be deemed to exist in a particular country in the TERRITORY during a given
calendar quarter with respect to a particular LICENSED PRODUCT if during such
calendar quarter, one or more GENERIC PRODUCTS were sold commercially in such
country, and the GENERIC PRODUCTS in the aggregate have a market share of [*
*
*] or more in that country (as measured by gross sales revenue based on data
provided by IMS International, or if such data is not available, such other
reliable data source as reasonably agreed upon by VITAE and QUEST). If no data
is commercially available, then the parties shall agree upon a methodology
for
estimating the percentage market share of GENERIC PRODUCTS in such
country.
(g) For
clarity, royalties shall be due during any extended or adjusted term of a
LICENSED PATENT or during the term of any applicable SPC. Even if there is
no
LICENSED PATENT in a given country, royalties shall be due for sales in such
country for ten (10) years from the date of FIRST COMMERCIAL SALE.
(h) All
royalty payments shall be made on a quarterly basis within thirty (30) days
after the end of each calendar quarter.
4.05 Sublicense
Revenue.
QUEST
shall pay VITAE as provided below a portion of all non-royalty sublicense income
received from a THIRD PARTY relating to any of the three lead LICENSED
COMPOUNDS, [* * *], except for payments directly related to research and
development cost reimbursement. Specifically, if QUEST enters into a license
agreement or other partnering arrangement with a THIRD PARTY prior to [* *
*]
for the LICENSED COMPOUND that is the subject of the licensing agreement or
partnering arrangement, then QUEST shall pay VITAE [* * *] of all non-royalty
income. If QUEST enters into a license agreement or other partnering arrangement
with a THIRD PARTY after [* * *] for the LICENSED COMPOUND that is the subject
of the licensing agreement or partnering arrangement, then QUEST shall pay
VITAE
[* * *] of all non-royalty income.
For
clarity, VITAE, and not QUEST, shall be solely and fully liable for any payments
that may be due to ALLERGAN pursuant to section 5.3 (Sublicense Up-Front
Consideration) of the ALLERGAN AGREEMENT relating to Sublicense Revenue (as
that
term is defined in the ALLERGAN AGREEMENT) payments. VITAE agrees to indemnify,
defend and hold harmless QUEST with respect to all such payments pursuant to
section 5.3 of the ALLERGAN AGREEMENT.
11
4.06 Third
Party License Payments.
QUEST
shall be responsible for all royalties and milestone payments to EXISTING
LICENSORS, as well as for any THIRD PARTY license payments that may be required,
arising for periods after the EFFECTIVE DATE. For clarity, VITAE shall be
responsible for any license payments to EXISTING LICENSORS and THIRD PARTIES
accrued or owing for any period ending on or prior to the EFFECTIVE DATE, and
VITAE shall have no responsibility or liability for any such license payments
arising for periods after the EFFECTIVE DATE.
4.07 Late
Payments.
Any
unexcused late payments by QUEST to VITAE hereunder shall accrue interest at
an
annual interest rate equal to the average prime rate (as reported in
The
Wall Street Journal
or other
reliable source) from the date the payment was originally due until the actual
date that the payment was received and credited to VITAE’s account.
4.08 Bundled
Products.
In the
event that a LICENSED PRODUCT is sold as part of a bundle of products and/or
services, QUEST may discount the bona fide list price of a LICENSED PRODUCT
by
no more than the average percentage discount of all products and services in
a
particular bundle. QUEST shall not use a LICENSED PRODUCT as a “loss leader.” If
QUEST cannot establish the average discount of a bundle (e.g., because certain
products or services included within the bundle are not sold separately), then
NET SALES for the LICENSED PRODUCT included within the bundle shall be based
on
the undiscounted list price of the LICENSED PRODUCT in the bundle. If no bona
fide list price exists for a LICENSED PRODUCT that is part of the bundle (e.g.,
because such LICENSED PRODUCT is not sold separately), then the parties shall
negotiate in good faith to establish an imputed list price for such LICENSED
PRODUCT, and NET SALES shall be calculated based on such imputed list
price.
4.09 Combination
Products.
NET
SALES of LICENSED PRODUCTS formulated in combination with one or more additional
therapeutically active ingredients shall be included in the calculation of
royalties and milestone payments based on NET SALES of LICENSED PRODUCTS. The
parties shall agree upon a formula for allocating the portion of NET SALES
of
COMBINATION PRODUCT attributable to the LICENSED PRODUCT component of the
COMBINATION PRODUCT. If the parties are unable to agree upon a formula, then
the
following formula shall apply:
(a) If
the
LICENSED PRODUCT and the other PRODUCT COMPONENT both have bona fide commercial
sales on a stand-alone basis, then the following shall apply: NET SALES of
LICENSED PRODUCT sold as part of the COMBINATION PRODUCT shall be equal to
the
NET SALES of the COMBINATION PRODUCT multiplied by the formula, A/(A+B), where
“A” is the median selling price of the LICENSED PRODUCT over the previous
calendar quarter, and “B” is the median selling price of the other PRODUCT
COMPONENT over the previous calendar quarter.
(b) If
the
LICENSED PRODUCT has bona fide commercial sales on a stand-alone basis but
the
other PRODUCT COMPONENT does not, then the following shall apply: NET SALES
of
LICENSED PRODUCT sold as part of the COMBINATION PRODUCT shall be equal to
the
NET SALES of the COMBINATION PRODUCT multiplied by the formula, A/C, where
“A”
is the median selling price of the LICENSED PRODUCT over the previous calendar
quarter, and “C” is the median selling price of the COMBINATION PRODUCT over the
previous calendar quarter.
12
(c) If
the
other PRODUCT COMPONENT has bona fide commercial sales on a stand-alone basis
but the LICENSED PRODUCT does not, then the following shall apply: NET SALES
of
LICENSED PRODUCT sold as part of the COMBINATION PRODUCT shall be equal to
the
NET SALES of the COMBINATION PRODUCT multiplied by the formula, 1-(B/C), where
“B” is the median selling price of the other PRODUCT COMPONENT over the previous
calendar quarter, and “C” is the median selling price of the COMBINATION PRODUCT
over the previous calendar quarter, provided that B is less than C.
(d) If
the
other PRODUCT COMPONENT in the COMBINATION PRODUCT is available as a generic
product and as a branded product, the median selling price of the version of
the
PRODUCT COMPONENT actually used in the COMBINATION PRODUCT, be it generic or
branded, shall be used in the calculation outlined above.
5. DEVELOPMENT
AND COMMERCIALIZATION
5.01 Sole
Responsibility.
As of
the EFFECTIVE DATE, QUEST shall have full control, authority and responsibility
for research, DEVELOPMENT, registration and commercialization of LICENSED
PRODUCTS in the TERRITORY, including preclinical work (e.g.,
safety
assessment, chemical, or pharmaceutical development work on the final
formulation), all clinical studies, and all regulatory filings, and all such
activity shall be undertaken at QUEST’s sole expense. QUEST shall be solely
responsible for developing LICENSED PRODUCTS.
5.02 Notice
and Information.
QUEST
shall keep VITAE, at VITAE’s request, reasonably informed of the progress of
QUEST’s efforts to develop and commercialize the LICENSED PRODUCTS in the
TERRITORY; QUEST shall notify VITAE of all significant developments in writing
as soon as reasonably practicable. For example, QUEST will so notify VITAE
in
the event that QUEST decides that a recall, field alert, product withdrawal
or
field correction is necessary due to any defect in any LICENSED
PRODUCT.
5.03 Certain
QUEST Covenants.
QUEST
shall give due consideration to VITAE’s input, if any, on DEVELOPMENT and
commercialization issues; however, all DEVELOPMENT and commercialization matters
shall be determined exclusively by QUEST, in its sole discretion, as provided
in
Section 5.01. Notwithstanding the above, QUEST agrees not to take any action
(without VITAE’s express written agreement) that will result (i) in a breach of
VITAE’s obligations under the ALLERGAN AGREEMENT or the LIGAND AGREEMENT; (ii)
in a waiver of VITAE’s material rights under the ALLERGAN AGREEMENT or LIGAND
AGREEMENT; or (iii) in VITAE incurring any material expenses or other
obligations that it would otherwise not have incurred. For clarity, QUEST has
no
authority to amend this AGREEMENT unilaterally or to waive any rights on behalf
of VITAE under this AGREEMENT.
13
5.04 Certain
VITAE Covenants.
(a) VITAE
shall promptly notify QUEST if it becomes reasonably likely that VITAE will
be
or become in material breach of the ALLERGAN AGREEMENT. QUEST acknowledges
that
VITAE has no obligation to develop or commercialize [* * *] or any other
TRANSFERRED COMPOUND, and QUEST has no expectation that VITAE will do
so.
(b) VITAE
agrees that it and its AFFILIATES shall not agree to amend the ALLERGAN
AGREEMENT or the LIGAND AGREEMENT in any way that would adversely affect QUEST’s
rights under the ALLERGAN AGREEMENT and the LIGAND AGREEMENT as they relate
to
the LICENSED COMPOUNDS. For clarity, VITAE has no authority to amend this
AGREEMENT unilaterally or waive or modify any rights or obligations on behalf
of
QUEST under this AGREEMENT, or under the ALLERGAN AGREEMENT or the LIGAND
AGREEMENT as they relate to the LICENSED COMPOUNDS.
5.05 Regulatory
Activities.
Subject
to, and in accordance with, the terms and conditions of this AGREEMENT, and
all
requirements of applicable laws, rules, and regulations, QUEST shall be solely
responsible, at its sole cost, for filing and obtaining REGULATORY APPROVALS
for
the LICENSED PRODUCTS in the TERRITORY.
5.06 Diligence.
QUEST
shall use COMMERCIALLY REASONABLE EFFORTS (i) to develop and commercialize
a
LICENSED PRODUCT; (ii) to obtain REGULATORY APPROVALS for LICENSED PRODUCTS;
and
(iii) to market, promote, sell and distribute a LICENSED PRODUCT. For avoidance
of doubt, QUEST shall use COMMERCIALLY REASONABLE EFFORTS to comply with all
diligence requirements in the ALLERGAN AGREEMENT. QUEST may sublicense or
subcontract the marketing or co-marketing of LICENSED PRODUCTS.
5.07 Direct
License Agreement.
VITAE
and QUEST contemplate that QUEST may enter into a licensing agreement directly
with ALLERGAN relating to the LICENSED COMPOUNDS which would replace and
supersede this Agreement as it relates to the EXISTING LICENSORS. VITAE agrees
to cooperate with QUEST in connection with the negotiation and preparation
of
any such licensing agreement. In the event QUEST and ALLERGAN enter into such
a
licensing agreement, VITAE and QUEST shall enter into an appropriate amendment,
or amendment and restatement, of this AGREEMENT. If the parties enter into
an
amendment, assignment or any other new licensing arrangement, VITAE shall retain
all financial and other benefits due under this AGREEMENT (e.g., upfront
payment, equity milestone payment, inventory payment, royalties). In addition,
if ALLERGAN terminates the ALLERGAN AGREEMENT with respect to VITAE (but not
with respect to QUEST), VITAE shall also retain all payments received under
this
AGREEMENT and shall continue to be entitled to any and all payments due under
this AGREEMENT.
6. MANUFACTURING
AND SUPPLY
6.01 Clinical
and Pre-Clinical Supply.
On or
after the EFFECTIVE DATE, QUEST shall be solely responsible, at its sole
expense, for manufacturing drug substance and drug product for any pre-clinical
studies/tests or for any clinical trials for any LICENSED PRODUCT. QUEST may
sublicense or subcontract the preclinical or clinical supplies for any LICENSED
PRODUCT as permitted under, and in accordance with, Section 2.03.
14
6.02 Commercial
Supply.
QUEST
shall be solely responsible, at its sole expense, for commercial manufacture
of
all LICENSED PRODUCTS. QUEST may sublicense or subcontract the commercial
manufacture of LICENSED PRODUCTS as permitted under, and in accordance with,
Section 2.03.
7. CONFIDENTIALITY
7.01 Confidential
Information.
Except
to the extent expressly authorized by this AGREEMENT or otherwise agreed to
in
writing by the parties, the parties agree that, during the term of this
AGREEMENT and for five (5) years thereafter, the receiving party shall not
(i)
publish or otherwise disclose to THIRD PARTIES, or (ii) use for any purpose
other than as provided or contemplated in this AGREEMENT any confidential
information received from the other party or otherwise developed by either
party
in the performance of activities in furtherance of this AGREEMENT. This
confidentiality obligation shall not apply to such information that the
receiving party can demonstrate by competent proof that such information: (i)
was already rightfully known to the receiving party, other than under an
obligation of confidentiality, at the time of disclosure by the other party;
(ii) was generally available to the public at the time of its disclosure to
the
receiving party; (iii) became generally available to the public other than
through any act or omission of the receiving party; (iv) was independently
developed by the receiving party without the aid or use of any confidential
information from the disclosing party; or (v) was disclosed to the receiving
party by a THIRD PARTY who was not under an obligation not to disclose such
information.
7.02 Authorized
Disclosures.
Notwithstanding the above, (1) QUEST may use LICENSED COMPOUNDS or LICENSED
KNOW-HOW as provided and contemplated in this AGREEMENT and may disclose
confidential information of VITAE or its AFFILIATES to the extent that such
disclosure is reasonably necessary for: (i) manufacture or DEVELOPMENT of
LICENSED PRODUCTS; (ii) filing or prosecuting patent applications relating
to the LICENSED COMPOUNDS or their use; (iii) regulatory filings relating to
the
LICENSED COMPOUNDS; (iv) prosecuting or defending litigation relating to the
LICENSED COMPOUNDS or this AGREEMENT; or (v) conducting preclinical or
clinical trials of the LICENSED COMPOUNDS; and (2) each party may disclose
confidential information of the other party to the extent such disclosure is
reasonably necessary for (i) complying with applicable laws, rules or other
governmental regulations or orders of any court or other governmental authority;
or (ii) disclosure to AFFILIATES, sublicensees, employees, consultants, agents,
investors or potential investors or merger partners, provided, however, that
such AFFILIATE, sublicensee, employee, consultant, agent, investor or potential
investor or merger partner has undertaken a similar obligation of
confidentiality with respect to the confidential information as those undertaken
by the parties hereunder. In the event that a party is required to make a
disclosure of the other party’s confidential information pursuant to Subsection
(2)(i), the receiving party shall, except where impracticable, give reasonable
advance notice to the disclosing party of such required disclosure and use
reasonable efforts to secure confidential treatment of such
information.
15
7.03 Press
Release; Publicity.
The
parties shall agree upon a joint press release, which shall be issued after
execution of this AGREEMENT.
7.04 Publications.
Except
as provided in Section 7.03, VITAE may not issue any press release or submit
any
publication or make any presentation that includes data or other information
relating to LICENSED COMPOUNDS, LICENSED KNOW-HOW or LICENSED PRODUCTS without
first obtaining the prior written consent of QUEST. The contribution, if any,
of
each party shall be acknowledged in all publications and presentations by either
party.
8. PATENT
PROSECUTION AND LITIGATION
8.01 Ownership.
QUEST
shall have and retain sole and exclusive title to all inventions, discoveries
and know-how which are made, conceived, reduced to practice or generated by
its
employees, agents, or other persons acting under its authority in the course
of
or as a result of this AGREEMENT. Each party shall own a fifty percent (50%)
undivided interest in all such inventions, discoveries and know-how made,
conceived, reduced to practice or generated jointly by employees, agents, or
other persons acting under the authority of both parties in the course of as
a
result of this AGREEMENT. The parties acknowledge and agree that as of the
EFFECTIVE DATE, the parties have no intention of entering into a joint research
collaboration; and neither party is required to enter into such a collaboration
or to contribute any efforts to any joint research. Any such joint collaboration
shall be undertaken, if at all, only pursuant to a written collaboration
agreement signed by the parties.
8.02 Prosecution
and Maintenance.
During
the term of this AGREEMENT, QUEST shall comply with Section 7.1 of the ALLERGAN
AGREEMENT as it relates to the LICENSED PATENTS, including the ALLERGAN PATENTS
and the VITAE RETINOID PATENTS, at QUEST’s sole expense. Subject to the rights
of the EXISTING LICENSORS pursuant to the ALLERGAN AGREEMENT and LIGAND
AGREEMENT to assume responsibility for any LICENSED PATENT which QUEST intends
to abandon, VITAE shall have the right, but not the obligation, to assume
responsibility for and/or take assignment of any LICENSED PATENT which QUEST
intends to abandon or otherwise cause or allow to be forfeited. QUEST shall
give
VITAE at least sixty (60) days written notice prior to abandonment or other
forfeiture of any PATENT or any part of a PATENT so as to permit VITAE to
exercise its rights under this section. In addition, QUEST shall provide notice
to ALLERGAN and any other co-owners of the LICENSED PATENT to be abandoned
in
the form and manner necessary to satisfy any legal obligations to such parties.
8.03 Litigation.
(a) In
the
event of the institution of any suit by a THIRD PARTY against VITAE, QUEST
or
its sublicensees or distributors for patent infringement involving the
manufacture, use, sale, distribution or marketing of LICENSED PRODUCT anywhere
in the TERRITORY, the party sued shall promptly notify the other party in
writing. QUEST shall have the right, but not the obligation, to defend such
suit
at its own expense. If QUEST chooses not to exercise its right to defend such
suit, then VITAE shall have the right, but not the obligation, to defend such
suit at its own expense. VITAE and QUEST shall assist one another and cooperate
in any such litigation at the other’s request without expense to the requesting
party.
16
(b) In
the
event that VITAE or QUEST becomes aware of actual or threatened infringement
of
a LICENSED PATENT anywhere in the TERRITORY, that party shall promptly notify
the other party in writing. Subject to the rights of the EXISTING LICENSORS
pursuant to the ALLERGAN AGREEMENT and LIGAND AGREEMENT, QUEST shall have the
right, but not the obligation, to bring, at its own expense, an infringement
action against any THIRD PARTY. If QUEST does not commence a particular
infringement action within ninety (90) days of receipt of the notice of
infringement, then VITAE, after notifying QUEST in writing, shall be entitled
to
bring such infringement action at its own expense. The party conducting such
action shall have full control over its conduct, including settlement thereof
subject to Section 8.03(e). In any event, VITAE and QUEST shall assist one
another and cooperate in any such litigation at the other’s request without
expense to the requesting party.
(c) In
any
action brought pursuant to this Section 8.03, the party bringing the action
shall indemnify the other party, its officers, directors, shareholders,
employees, agents, successors and assigns from any loss, damage or liability,
including for reasonable attorney’s fees and costs, which may result from
claims, counterclaims or cross-claims asserted by a defendant, except to the
extent that such losses, damages or liabilities result from the negligence
or
willful misconduct of the other party.
(d) Subject
to the rights of the EXISTING LICENSORS pursuant to the ALLERGAN AGREEMENT
and
LIGAND AGREEMENT, VITAE and QUEST shall recover their respective actual
out-of-pocket expenses, or equitable proportions thereof, associated with any
litigation or settlement thereof from any recovery made by any party. Any excess
amount shall be treated as NET SALES for purposes of the royalty provisions
of
this Agreement.
(e) The
parties shall keep one another informed of the status of and of their respective
activities regarding any litigation or settlement thereof concerning LICENSED
PRODUCT, provided however that no settlement or consent judgment or other
voluntary final disposition of any suit defended or action brought by a party
pursuant to this Article 8 may be entered into without the consent of the other
party if such settlement would require the other party to be subject to an
injunction or to make a monetary payment or would otherwise adversely affect
the
other party’s rights under this AGREEMENT.
8.04 Patent
Term Extension.
QUEST,
in its sole discretion, may seek extensions of the terms of LICENSED PATENTS
at
QUEST’s sole expense. If QUEST chooses not to seek a patent term extension where
such an extension would likely have been granted, then QUEST’s royalty
obligations to VITAE shall continue as if the term of such LICENSED PATENT
had
been extended.
8.05 Supplementary
Protection Certificates.
QUEST,
in its sole discretion, may seek to obtain, and maintain until expiry, any
SPCs
based on the LICENSED PATENTS at QUEST’s sole expense. If QUEST chooses not to
seek an SPC where such SPC likely would have been granted, then QUEST’s royalty
obligations to VITAE shall continue as if the term of such LICENSED PATENT
had
been extended.
17
9. TRADEMARKS
9.01 QUEST
shall be solely responsible, at its sole expense, for the selection of all
PRODUCT TRADEMARKS used in connection with the marketing or promotion of a
LICENSED PRODUCT in the TERRITORY, and shall own and control such PRODUCT
TRADEMARKS. QUEST shall be responsible for registration and maintenance of
all
such PRODUCT TRADEMARKS.
9.02 QUEST,
at
its sole expense, shall be responsible for the selection and registration of
non-proprietary names for any LICENSED PRODUCT throughout the
TERRITORY.
10. RECORDS
AND REPORTING
10.01 Records.
QUEST
shall keep, and require its AFFILIATES and sublicensees to keep complete and
accurate records of all sales of LICENSED PRODUCTS under the licenses granted
herein. VITAE shall have the right, at VITAE’s expense, through a certified
public accountant or like person reasonably acceptable to QUEST, to examine
such
records during regular business hours during the life of this AGREEMENT and
for
[* * *] after its termination; provided, however, that such examination shall
not take place more often than once a year and shall not cover such records
for
more than the preceding [* * *]. In the event such audit reveals an underpayment
of the amount actually due, QUEST shall promptly remit the amount of any
underpayment to VITAE. In the event such audit reveals an underpayment of [*
*
*] or more of the amount actually due, or [* * *], whichever is greater, QUEST
shall reimburse VITAE’s reasonable audit expenses and shall also promptly remit
interest on such underpayment, such interest to be calculated beginning upon
the
first day following the end of the time period within which such payment was
due, calculated at the average annual prime rate (in the USA) as reported by
The
Wall Street Journal for
the
applicable time period.
10.02 Accounting.
Within
thirty (30) days after the end of each calendar quarter, QUEST shall provide
a
true accounting of all LICENSED PRODUCTS sold by QUEST, its AFFILIATES and
its
sublicensees during such quarter in the TERRITORY, and QUEST shall, at the
same
time pay, any royalties due for such quarter. Such accounting shall show total
invoiced and net sales on a country-by-country and product-by-product basis.
10.03 Taxes.
Any
tax, duty or other levy paid or required to be withheld by QUEST on account
of
royalties or other payments payable to VITAE under this AGREEMENT shall be
deducted from the amount of royalties or payments otherwise due, provided that
QUEST shall make such deductions only to the minimum extent required by the
relevant jurisdiction. QUEST shall secure and send to VITAE proof of any such
taxes, duties or other levies withheld and paid by QUEST or its sublicensees
for
the benefit of VITAE
10.04 Payment
in U.S. Dollars; Blocked Currency.
All
royalties and milestone payments due under this AGREEMENT shall be payable
in
U.S. Dollars by bank wire transfer in immediately available funds to such bank
account(s) as VITAE shall designate. QUEST shall notify VITAE as to the date
and
amount of any such wire transfer at least two (2) business days prior to such
transfer. Except as otherwise set forth herein, all payments due hereunder
shall
be paid within thirty (30) days following receipt of VITAE’s invoice. If
governmental regulations prevent remittances from a foreign country with respect
to sales made in that country, the obligation of QUEST to pay royalties on
sales
in that country shall be suspended until such remittances are possible. VITAE
shall have the right, upon giving written notice to QUEST, to receive payment
in
that country in local currency.
18
10.05 Foreign
Exchange Conversion.
Monetary conversion from the currency of a foreign country in which LICENSED
PRODUCT is sold into U.S. Dollars shall be calculated at the actual average
rates of exchange for the quarterly period to which such royalty payment relates
as used by QUEST in producing its quarterly accounts.
10.06 Other
Reports.
QUEST
shall satisfy all reporting obligations of VITAE required by the ALLERGAN
AGREEMENT and the LIGAND AGREEMENT as they relate to LICENSED PRODUCTS,
including providing semi-annual progress reports in accordance with Section
3.5(b) of the ALLERGAN AGREEMENT.
11. TERM
AND TERMINATION
11.01 Term.
Unless
otherwise terminated earlier, this AGREEMENT shall expire upon the expiration
of
QUEST’s royalty obligations under this AGREEMENT in all countries of the
TERRITORY.
11.02 Material
Breach.
If
either party fails to perform any covenants or provisions of this AGREEMENT
and
if such default is not corrected within sixty (60) days after receiving written
notice from the other party with respect to such default, such other party
shall
have the right to terminate this AGREEMENT by giving written notice to the
party
in default.
11.03 Bankruptcy/Insolvency.
Either
party may terminate this AGREEMENT if, at any time, the other party shall file
in any court or agency pursuant to any statute or regulation of any state or
country, a petition in bankruptcy or insolvency or for reorganization or for
an
arrangement or for the appointment of a receiver or trustee of the party or
of
its assets, or if the other party proposes a written agreement of composition
or
extension of its debts, or if the other party shall be served with an
involuntary petition against it, filed in any insolvency proceeding, and such
petition shall not be dismissed with sixty (60) days after the filing thereof,
or if the other party shall propose or be a party to any dissolution or
liquidation, or if the other party shall make an assignment for the benefit
of
creditors. All rights and licenses granted under or pursuant to this AGREEMENT
by VITAE to QUEST are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of the U.S. Bankruptcy Code and other similar
international laws, licenses of rights to “intellectual property” as defined in
Section 101 of the U.S. Bankruptcy Code or such international laws.
VITAE agrees that, notwithstanding the bankruptcy of VITAE, QUEST, as a licensee
of such rights under this AGREEMENT, shall retain and may fully exercise all
of
its rights and elections under the U.S. Bankruptcy Code and other similar
international laws. VITAE further agrees that, in the event of the commencement
of a bankruptcy proceeding by or against VITAE under the U.S. Bankruptcy
Code, QUEST shall be entitled to a complete duplicate of (or complete access
to,
as appropriate) any such intellectual property and all embodiments of such
intellectual property, and the same, if not already in Licensee’s possession,
shall be promptly delivered to it (i) upon any such commencement of a
bankruptcy proceeding upon its written request therefore, unless VITAE elects
to
continue to perform all of its obligations under this AGREEMENT, or (ii) if
not delivered under (i) above, upon the rejection of this AGREEMENT by or
on behalf of VITAE upon written request therefore by QUEST.
19
11.04 Termination
by QUEST.
(a) QUEST
may
terminate this AGREEMENT by giving VITAE at least thirty (30) days written
notice thereof upon the earlier to occur of the following events: (i) the
date two (2) years after the EFFECTIVE DATE; or (ii) QUEST’s reasonable
determination that preclinical or clinical trials of all three lead LICENSED
COMPOUNDS, [* * *], fail to meet the study objectives or indicate that such
LICENSED COMPOUNDS are not safe or effective. If the parties do not agree as
to
whether the clinical and preclinical trials of all three lead LICENSED COMPOUNDS
fail to meet study objectives or indicate that such LICENSED COMPOUNDS are
not
safe or effective, then such dispute shall be resolved in accordance with
Section 13.03.
(b) Other
than as provided in this Article, QUEST shall not have the right to terminate
this AGREEMENT unilaterally. For clarity, QUEST may not unilaterally terminate
this AGREEMENT within two years of the EFFECTIVE DATE, except pursuant to
Sections 11.02 and 11.03.
11.05 Termination
by VITAE.
(a) QUEST
shall undertake to raise at least twenty million dollars ($20,000,000) in
financing through the PRIVATE PLACEMENT for purposes of funding QUEST’s initial
business and operations, including the DEVELOPMENT of the LICENSED COMPOUNDS.
If
QUEST fails to complete the PRIVATE PLACEMENT and raise such amount on or before
May 31, 2007, VITAE shall have the right to terminate this AGREEMENT by
returning all sums received from QUEST except that it may retain [* * *],
representing liquidated damages for the costs incurred by VITAE during
negotiation of this AGREEMENT, including patent prosecution and maintenance
costs.
(b) Upon
such
termination, QUEST shall return all know-how, INVENTORY, and any other assets
assigned or transferred to QUEST by VITAE in connection with this
AGREEMENT.
11.06 Consequences
of Termination.
(a) Upon
termination of this AGREEMENT, VITAE shall have the right to retain any sums
already paid by QUEST hereunder (except as specified in Section 11.05(a)),
and
QUEST shall pay all sums accrued hereunder which are then due.
(b) Upon
termination of this AGREEMENT, all licenses granted to QUEST hereunder shall
automatically terminate; provided, however, that, except as provided in
Section 2.03,
no
termination of this AGREEMENT shall affect the rights of QUEST’s AFFILIATES and
sublicensees (or their sublicensees) under any sublicense agreement previously
entered into in accordance with this AGREEMENT.
20
(c) Upon
termination of this AGREEMENT other than if QUEST terminates this AGREEMENT
because of VITAE’s uncured breach of a material provision pursuant to Section
11.02, VITAE shall automatically be granted, and hereby is granted, an exclusive
license, with the right to grant sublicense, under the QUEST PATENTS and QUEST
KNOW-HOW held by QUEST at the time of termination, to make, have made, use,
sell, offer for sale and import any LICENSED PRODUCTS in the TERRITORY, provided
that QUEST shall retain all rights and interests in such QUEST PATENTS and
QUEST
KNOW-HOW to the extent that such are not related to any LICENSED PRODUCT. In
addition, QUEST shall transfer to VITAE, at VITAE’s cost, all QUEST KNOW-HOW
reasonably required by VITAE to manufacture, market, promote and distribute
LICENSED PRODUCTS.
(d) Furthermore,
QUEST shall, within thirty (30) days after the effective date of a termination
other than a termination by QUEST pursuant to Section 11.02, use all reasonable
endeavors to take all steps and execute all documents reasonably necessary
to
assign and/or transfer (to the extent legally permissible in the relevant
country) all REGULATORY APPROVALS in QUEST’s name or in the name of QUEST’s
AFFILIATES, sublicensees or distributors related to LICENSED PRODUCTS to VITAE
or its designee, provided that VITAE shall be responsible for any reasonable
associated out-of-pocket costs related to such transfer. In the event that
no
such assignment and/or transfer pursuant to this Paragraph may legally be made,
then upon the request of VITAE, QUEST shall forthwith surrender such REGULATORY
APPROVALS or applications for cancellation. In addition, upon VITAE’s request,
QUEST shall, within the same time period, deliver to VITAE or its designee
any
documents relating to applications for REGULATORY APPROVALS in its possession,
provided that VITAE shall be responsible for any reasonable associated
out-of-pocket costs of transfer.
(e) Upon
termination of this AGREEMENT other than if QUEST terminates this AGREEMENT
because of VITAE’s uncured breach of a material provision pursuant to Section
11.02, QUEST shall assign all PRODUCT TRADEMARKS to VITAE. For clarity, QUEST
need not assign any housemarks or other trademarks that are not specifically
associated with a LICENSED PRODUCT.
(f) Upon
termination of this AGREEMENT other than if VITAE terminates this AGREEMENT
because of QUEST’s uncured breach of a material provision pursuant to Section
11.02, QUEST shall have the right to sell its inventory of LICENSED PRODUCTS,
subject to payment of applicable royalties and milestone payments to VITAE.
Within [* * *] after the effective date of termination of this AGREEMENT, QUEST
shall notify VITAE of the amount of LICENSED PRODUCTS that QUEST, its
AFFILIATES, sublicensees and distributors then have on hand, the sale of which
would, but for the termination, be subject to royalty, and QUEST, its
AFFILIATES, sublicensees and distributors shall thereupon be permitted to sell
that amount of LICENSED PRODUCTS for a period of [* * *] following the effective
date of such termination, provided that QUEST shall pay the royalty thereon
at
the time herein provided for, as well as any sales milestones that are achieved
as a result of such sales.
11.07 Survival.
Termination of this AGREEMENT in its entirety shall terminate all outstanding
obligations and liabilities between the parties arising from this AGREEMENT,
except those described in Sections 2.02
(to the
extent provided in that section), 2.03,
11.05,
11.06,
12.03,
12.04,
and
12.05
and in
Articles 7
and
13.
In
addition, any other provision required to interpret and enforce the parties’
rights and obligations under this AGREEMENT shall also survive, but only to
the
extent required for the full observation and performance of this
AGREEMENT.
21
11.08 No
Limitation on Remedies.
Subject
to Sections 12.03
and
12.04,
termination of the AGREEMENT in accordance with the provisions hereof shall
not
limit remedies which may be otherwise available in law or equity.
12. WARRANTIES,
REPRESENTATIONS AND INDEMNIFICATIONS
12.01 Each
Party.
Each
party represents and warrants to the other party that: (i) it is duly organized
and validly existing under laws of its jurisdiction of incorporation, and has
full corporate power and authority to enter into this AGREEMENT and to carry
out
the provisions hereof; (ii) it is duly authorized to execute and deliver this
AGREEMENT and to perform its obligations hereunder, and the person or persons
executing this AGREEMENT on its behalf has been duly authorized to do so by
all
requisite corporate action; (iii) the execution, delivery and performance of
this AGREEMENT by it does not conflict with the ALLERGAN AGREEMENT or any other
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 agency having jurisdiction over it; and
it
has not, and will not during the term of this AGREEMENT, grant any right to
any
THIRD PARTY that would conflict with the rights granted to the other party
hereunder.
12.02 VITAE.
VITAE
warrants and represents to QUEST as follows:
(a) VITAE
has
the right to license the LICENSED PATENTS and the LICENSED KNOW-HOW to QUEST
under this AGREEMENT, and as of the EFFECTIVE DATE, VITAE has not received
notice from ALLERGAN that it is in breach of any of the provisions of the
ALLERGAN AGREEMENT.
(b) The
copies of the ALLERGAN AGREEMENT and the LIGAND AGREEMENT furnished to QUEST
by
VITAE are true and complete in all respects, and there are no amendments or
modifications thereof that have not been furnished to QUEST by VITAE. QUEST
acknowledges that it may not have received certain electronic files that were
included as appendices to the ALLERGAN AGREEMENT. To VITAE’s knowledge as of the
EFFECTIVE DATE, neither of the EXISTING LICENSORS is in breach or default of
any
material term or provision of the ALLERGAN AGREEMENT or the LIGAND AGREEMENT.
(c) In
accordance with VITAE’s understanding and interpretation of the ALLERGAN and
LIGAND AGREEMENTS and as of the EFFECTIVE DATE, VITAE has satisfied in all
material respects its obligations under the ALLERGAN AGREEMENT and the LIGAND
AGREEMENT with respect to all periods ending on or prior to the date hereof,
and
has fulfilled as of the EFFECTIVE DATE its obligations under
Section 3.5(a)(i) of the ALLERGAN AGREEMENT.
(d) As
of the
EFFECTIVE DATE, the ALLERGAN AGREEMENT and the LIGAND AGREEMENT are in full
force and effect, and, to VITAE’s knowledge, there has not occurred any event or
circumstance that, upon notice or otherwise, would entitle ALLERGAN or LIGAND
to
terminate the ALLERGAN AGREEMENT or the LIGAND AGREEMENT respectively.
22
(e) Neither
VITAE nor, to its knowledge, ALLERGAN has received any written notice that
the
LICENSED COMPOUNDS may infringe the patent rights, trade secret rights or other
intellectual property or proprietary rights of any third party or any written
notice of threats, claims or litigation made or filed challenging the ownership,
scope, validity or enforceability of any of the LICENSED PATENTS.
(f) VITAE
and
its employees and agents have responded accurately and completely, in all
material respects, to the requests for information from QUEST and its agents
and
representatives in connection with the due diligence conducted by QUEST. VITAE
has not withheld material information, of which it is aware, that would
otherwise be responsive to the requests for information from QUEST as understood
by VITAE, except to the extent that a failure to do any of the foregoing would
not have a materially adverse impact on the rights and benefits of QUEST
hereunder.
12.03 DISCLAIMER.
Nothing
in this AGREEMENT shall be construed as a warranty that the LICENSED PATENTS
are
valid or enforceable. Except for the express warranties set forth in this
Article 12,
QUEST
acknowledges and agrees that it is relying solely on its own due diligence
in
entering into this transaction, and that it is not relying upon any
representations by VITAE, its employees or its agents. EXCEPT FOR THE EXPRESS
WARRANTIES SET FORTH IN THIS ARTICLE 12,
VITAE
DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR
A
PARTICULAR PURPOSE, OR NONINFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY
RIGHTS. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, VITAE FURTHER
DISCLAIMS ANY WARRANTY AS TO THE VALIDITY OR ENFORCEABILITY OF THE LICENSED
PATENTS OR LICENSED KNOW-HOW. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN
THIS ARTICLE 12, QUEST ACKNOWLEDGES AND AGREES THAT ALL PATENTS, KNOW-HOW AND
ANY OTHER INFORMATION OR MATERIALS LICENSED OR PROVIDED HEREUNDER (INCLUDING
THE
INVENTORY) ARE LICENSED OR PROVIDED ON AN “AS IS” BASIS.
12.04 LIMITATION
OF LIABILITY.
IN NO
EVENT SHALL EITHER PARTY, ITS AFFILIATES OR THEIR OFFICERS, EMPLOYEES OR AGENTS
BE LIABLE TO THE OTHER PARTY, ITS AFFILIATES OR THEIR OFFICERS, EMPLOYEES OR
AGENTS FOR ANY SPECIAL, CONSEQUENTIAL, INDIRECT, INCIDENTAL OR PUNITIVE DAMAGES,
OR FOR LOST PROFITS, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY (WHETHER
BASED ON TORT OR CONTRACT) ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER
OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, EXCEPT
TO
THE EXTENT THAT SUCH DAMAGES ARE THE DIRECT RESULT OF VITAE’S INTENTIONAL
FRAUDULENT MISREPRESENTATIONS. VITAE SHALL NOT BE SHALL NOT BE LIABLE WITH
RESPECT TO ANY DAMAGES ARISING OUT OF OR RELATED TO MATTERS WITHIN THE ACTUAL
KNOWLEDGE OF QUEST, ITS INVESTORS, AND THEIR ADVISORS AND AGENTS. FURTHERMORE,
VITAE’S TOTAL LIABILITY ARISING OUT OF OR RELATING TO THIS AGREEMENT SHALL BE
LIMITED TO THE SUM OF THE PAYMENTS AND THE VALUE OF THE OTHER CONSIDERATION
RECEIVED BY VITAE PURSUANT TO THIS AGREEMENT EXCEPT TO THE EXTENT THAT SUCH
DAMAGES ARE THE DIRECT RESULT OF VITAE’S INTENTIONAL FRAUDULENT
MISREPRESENTATIONS.
23
12.05 Indemnification.
(a) Subject
to paragraphs (c)-(e) of this Section 12.05, QUEST shall defend, indemnify
and
hold harmless VITAE, its AFFILIATES, and its and their respective officers,
directors, employees, agents, successors and assigns from any and all suits,
claims, actions, demands, liabilities, expenses and/or loss, including
reasonable legal expenses and reasonable attorney’s fees (collectively,
“LOSSES”), resulting from QUEST’s negligence or misconduct in connection with
the manufacture, use, handling, storage, sale or other disposition from and
after the EFFECTIVE DATE of LICENSED PRODUCTS or LICENSED
COMPOUNDS.
(b) Subject
to paragraphs (c)-(e) of this Section 12.05, VITAE shall defend, indemnify
and
hold harmless QUEST, its AFFILIATES, and its and their respective officers,
directors, employees, agents, successors and assigns from any and all LOSSES
resulting from a breach by VITAE of the ALLERGAN AGREEMENT or the LIGAND
AGREEMENT, whether arising before or after the EFFECTIVE DATE, or VITAE’s
negligence or misconduct in connection with activities relating to the EXCLUDED
COMPOUNDS.
(c) No
party
shall be obligated under this Section 12.05 for LOSSES if it is shown by
evidence acceptable in a court of law having jurisdiction over the subject
matter and meeting the appropriate degree of proof for such action, that such
LOSSES were primarily the result of the gross negligence or willful misconduct
of the other party or its employees or agents.
(d) No
party
shall have any obligation under this Section 12.05 for any LOSSES with respect
to any claim, lawsuit or other action unless the other party (i) gives such
party prompt written notice of any claim or lawsuit or other action for which
it
seeks to be indemnified under this AGREEMENT, (ii) such party is granted full
authority and control over the defense, including settlement, against such
claim, lawsuit or other action, and (iii) the other party cooperates fully
with
such party and its agents in defense of the claims, lawsuit or other
action.
(e) The
indemnified party shall have the right to participate in the defense of any
claim, complaint, suit, proceeding or cause of action referred to in this
Section 12.05, utilizing attorneys of its choice, at its own expense; provided,
however, that the indemnifying party shall have full authority and control
to
handle any such claim, complaint, suit, proceeding or cause of action, including
any settlement or other disposition thereof, for which the indemnified party
seeks indemnification under this Section 12.05.
13. GENERAL
PROVISIONS
13.01 Force
Majeure.
If the
performance of any part of this AGREEMENT by either party, or of any obligation
under this AGREEMENT, is prevented, restricted, interfered with or delayed
by
reason of any cause beyond the reasonable control of the party liable to
perform, unless conclusive evidence to the contrary is provided, the party
so
affected shall, upon giving written notice to the other party, be excused from
such performance to the extent of such prevention, restriction, interference
or
delay, provided that the affected party shall use its reasonable best efforts
to
avoid or remove such causes of non-performance and shall continue performance
with the utmost dispatch whenever such causes are removed. When such
circumstances arise, the parties shall discuss what, if any, modification of
the
terms of this AGREEMENT may be required in order to arrive at an equitable
solution.
24
13.02 Governing
Law.
This
AGREEMENT shall be deemed to have been made in the State of California, and
its
form, execution, validity, construction and effect shall be determined in
accordance with the laws of the State of California without regard to its
conflicts of laws principles.
13.03 Dispute
Resolution.
(a) Any
dispute, controversy or claim arising out of or relating to this AGREEMENT
(hereinafter, referred to as a “DISPUTE”) shall be attempted to be settled by
the parties, without litigation, in good faith, by submitting each such DISPUTE
to appropriate senior management representatives of each party in an effort
to
effect a mutually acceptable resolution thereof.
(b) In
the
event no mutually acceptable resolution of such DISPUTE is achieved within
thirty (30) days as a result of Section 13.03(a) then, at either party’s
request, such DISPUTE may be submitted to binding arbitration by a mutually
acceptable, independent THIRD PARTY arbitrator (the “ARBITRATOR”) for resolution
under the then-current American Arbitration Association (“AAA”) rules. In such
event, the parties shall select a mutually acceptable ARBITRATOR within twenty
(20) days of the request of the party invoking this dispute resolution
procedure. If the parties are unable to agree upon an ARBITRATOR, the AAA shall
select a qualified, independent arbitrator. The venue for the arbitration shall
be New York, New York, or some other location agreed upon by the parties. The
decision of the ARBITRATOR may be enforced in any jurisdiction having
jurisdiction over the parties.
13.04 Waiver.
The
failure of either party at any time or times to require performance of any
provision hereof shall in no manner affect its rights at a later time to enforce
the same. No waiver by either party of any condition or term in any one or
more
instances shall be construed as a further or continuing waiver of such condition
or term or of another condition or term.
13.05 Severability.
(a) In
the
event any portion of this AGREEMENT shall be held illegal, void or ineffective,
the remaining portions hereof shall remain in full force and
effect.
(b) If
any of
the terms or provisions of this AGREEMENT are in conflict with any applicable
statute or rule of law, then such terms or provisions shall be deemed
inoperative to the extent that they may conflict therewith and shall be deemed
to be modified to conform with such statute or rule of law.
25
(c) In
the
event that the terms and conditions of this AGREEMENT are materially altered
as
a result of this Section 13.05, the parties will renegotiate the terms and
conditions of this AGREEMENT to resolve any inequities.
13.06 Entire
Agreement.
This
AGREEMENT, entered into as of the date written above, constitutes the entire
agreement between the parties relating to the subject matter hereof and
supersedes all previous writings and understandings. No modifications or waiver
of any terms or conditions hereof shall be effective unless made in writing
and
signed by a duly authorized officer of the party against which enforcement
is
sought.
13.07 Notices.
Notices
required or permitted under this AGREEMENT shall be in writing and sent by
prepaid registered or certified air mail or by overnight express mail (e.g.,
FedEx), or by facsimile confirmed by prepaid registered or certified air mail
letter or by overnight express mail (e.g.,
FedEx), and shall be deemed to have been properly served to the addressee upon
receipt of such written communication, to the following addresses of the
parties:
If
to VITAE:
|
|
Vitae
Pharmaceuticals, Inc.
000
Xxxx Xxxxxx Xxxxxx Xxxxx
Xxxx
Xxxxxxxxxx, XX 00000
Attn:
Legal Department
|
|
copy
to:
|
|
Xxxxxxx
Xxxxxx, Esq.
Xxxxxx
Godward
5
Palo Alto Square
0000
Xx Xxxxxx Xxxx
Xxxx
Xxxx, XX 00000-0000
|
|
If
to QUEST:
|
|
Quest
Group International, Inc.
000
Xxxx Xxxxxx
Xxxx,
XX 00000
|
|
copy
to:
|
Xxxx
& Xxxxx Professional Corporation
0000
Xxxxxxx Xxxx Xxxx, 00xx
Xxxxx
Xxx
Xxxxxxx, Xxxxxxxxxx 00000
Attention:
Xxxxx X. Xxxxxxxx, Esq.
|
13.08 Assignment.
This
AGREEMENT and the licenses herein granted shall be binding upon and inure to
the
benefit of the successors-in-interest of the respective parties. Neither this
AGREEMENT nor any interest hereunder shall be assignable by either party without
the written consent of the other; provided, however, that either may assign
this
AGREEMENT, or any part of its rights and obligations hereunder, to any AFFILIATE
or to any corporation or entity with which such party may merge or consolidate,
or to which it may transfer all or substantially all of its assets to which
this
AGREEMENT relates, without obtaining the consent of the other
party.
26
13.09 No
Third-Party Beneficiaries.
Nothing
in this AGREEMENT, express or implied, is intended to confer on any person
other
than the parties hereto, or their respective permitted successors and assigns,
any benefits, rights or remedies.
13.10 Ambiguities.
This
AGREEMENT is to be deemed drafted by both parties; and ambiguities, if any,
shall not be construed against either party, irrespective of which party may
have actually drafted the ambiguous provision.
13.11 Headings.
The
headings contained in this AGREEMENT have been added for convenience and shall
not be construed as limiting.
13.12 Counterparts.
This
AGREEMENT may be executed in any number of counterparts, each of which shall
be
deemed an original but all of which together shall constitute one and the same
instrument. Execution of a facsimile copy shall have the same force and effect
as execution of an original, and a facsimile signature shall be deemed an
original and valid signature.
13.13 Further
Assurances.
Each
party agrees that it shall, upon the request of the other, execute and deliver
such further documents and do such other acts and things as are reasonably
necessary and appropriate to effectuate the terms and conditions of this
AGREEMENT.
13.14 No
Debarred Personnel.
QUEST
shall not use during the term of this AGREEMENT the services of any employee,
consultant, contractor or clinical investigator that has been debarred by the
FDA or any other regulatory authority or that is the subject of debarment
proceedings by the FDA or any other regulatory authority.
13.15 No
Finder’s Fee.
QUEST
agrees that VITAE shall not be responsible for paying any commissions or fees
to
any THIRD PARTY in connection with this transaction.
THE
REMAINDER OF THIS PAGE IS LEFT BLANK INTENTIONALLY
27
IN
WITNESS WHEREOF, the parties, through their authorized officers, have executed
this AGREEMENT as of the date first written above.
QUEST
GROUP INTERNATIONAL, INC.
/s/
Xxxx Xxxxxxxxxxx
|
|
BY: Xxxx
Xxxxxxxxxxx
|
|
TITLE: Director
|
|
VITAE
PHARMACEUTICALS, INC.
/s/
Xxxxxxx Xxxxxxxx
|
|
BY: Xxxxxxx
Xxxxxxxx
|
|
TITLE: Chief
Executive Officer
|
28
Text
marked by [ * * *] has been omitted pursuant to a Request for Confidential
Treatment and
was
filed separately with the Securities and Exchange
Commission.
APPENDIX
A
ALLERGAN
PATENTS
[*
*
*]
A-1
Text
marked by [ * * *] has been omitted pursuant to a Request for Confidential
Treatment and
was
filed separately with the Securities and Exchange
Commission.
APPENDIX
B
EXCLUDED
PATENTS
[*
*
*]
B-1
Text
marked by [ * * *] has been omitted pursuant to a Request for Confidential
Treatment and
was
filed separately with the Securities and Exchange
Commission.
APPENDIX
C
VITAE
RETINOID PATENTS
[*
*
*]
C-1
Text
marked by [ * * *] has been omitted pursuant to a Request for Confidential
Treatment and
was
filed separately with the Securities and Exchange
Commission.
APPENDIX
D
INVENTORY
[*
*
*]
D-1
Text
marked by [ * * *] has been omitted pursuant to a Request for Confidential
Treatment and
was
filed separately with the Securities and Exchange
Commission.
APPENDIX
E
EXEMPLARY
EXCLUDED COMPOUNDS
[*
*
*]
E-1
Text
marked by [ * * *] has been omitted pursuant to a Request for Confidential
Treatment and
was
filed separately with the Securities and Exchange
Commission.
APPENDIX
F
ALLERGAN
AGREEMENT
[*
*
*]
F-1