COLLABORATION AND LICENSE AGREEMENT
DATED JANUARY 1, 1999
BETWEEN
AMERICAN HOME PRODUCTS CORPORATION
acting through its
WYETH-AYERST LABORATORIES DIVISION
AND
NEUROCRINE BIOSCIENCES, INC.
TABLE OF CONTENTS
ARTICLE ONE - DEFINITIONS................................................................................1
1.1 "ACQUISITION".................................................................................1
1.2 "AFFILIATE"...................................................................................1
1.3 "COLLABORATION PRODUCTS"......................................................................2
1.4 "COLLABORATION TECHNOLOGY"....................................................................2
1.5 "COMBINATION PRODUCT".........................................................................2
1.6 "COMMERCIALLY REASONABLE EFFORTS".............................................................2
1.7 "COMPETITION".................................................................................3
1.8 "COMPETITIVE PRODUCTS"........................................................................3
1.9 "COMPOUND"....................................................................................3
1.10 "CONFIDENTIALINFORMATION".....................................................................3
1.11 "CONTROLS" OR "CONTROLLED".....................................................................4
1.12 "DEFAULT".....................................................................................4
1.13 [***}.........................................................................................4
1.14 "EFFECTIVE DATE"..............................................................................4
1.15 "EUROPEAN UNION"..............................................................................4
1.16 "FDA".........................................................................................4
1.17 "FIELD OF USE"................................................................................4
1.18 "FTE".........................................................................................4
1.19 "FIRST COMMERCIAL SALE".......................................................................4
1.20 "FORCE MAJEURE"...............................................................................4
1.21 "HIT(S)"......................................................................................5
1.22 "INTERIM CLINICAL EVALUATION POINT" OR "ICE"...................................................5
1.23 "IND".........................................................................................5
1.24 "JOINT CONFIDENTIAL INFORMATION"..............................................................5
1.25 "JOINT INVENTIONS"............................................................................5
1.26 "JOINT TECHNOLOGY"............................................................................5
1.27 "LEAD COMPOUND(S)"............................................................................6
1.28 "LICENSE FEES"................................................................................6
1.29 "MAJOR EUROPEAN COUNTRY"......................................................................6
1.30 "NDA".........................................................................................6
1.31 "NET SALES"...................................................................................6
1.32 "NEUROCRINE ANCILLARY TRANSPORTERS"...........................................................9
1.33 "NEUROCRINE COMPOUND".........................................................................9
1.34 "NEUROCRINE CONFIDENTIAL INFORMATION".........................................................9
1.35 "NEUROCRINE INVENTION"........................................................................9
1.36 "NEUROCRINE MATERIALS"........................................................................9
1.37 "NEUROCRINE PROPRIETARY CHEMICAL LIBRARY".....................................................9
1.38 "NEUROCRINE RESEARCHER".......................................................................9
1.39 "NEUROCRINE TECHNOLOGY"......................................................................10
(a) "Neurocrine Compound Technology".............................................................10
(b) "Neurocrine Ancillary Transporter Technology"................................................10
(c) "Neurocrine Transporter Technology"..........................................................10
1.40 "NEUROCRINE TRANSPORTERS"....................................................................10
1.41 "OHSU AGREEMENT".............................................................................10
1.42 "PARTY"......................................................................................10
1.43 "PATENT RIGHTS"..............................................................................11
1.44 "PERSON".....................................................................................11
1.45 "PIVOTAL TRIAL"..............................................................................11
1.46 "PRIOR AGREEMENT"............................................................................11
1.47 "PROOF OF CONCEPT"...........................................................................11
1.48 "REGULATORY APPROVAL"........................................................................11
1.49 "REGULATORY AUTHORITY".......................................................................11
1.50 "REGULATORY FILINGS".........................................................................12
1.51 "RESEARCH PLAN"..............................................................................12
1.52 "RESEARCH PROGRAM"...........................................................................12
1.53 "RESEARCH PROGRAMFUNDING"....................................................................12
1.54 "RESEARCH PROGRAM MATERIALS".................................................................12
1.55 "ROYALTIES"..................................................................................12
1.56 "STEERING COMMITTEE".........................................................................12
1.57 "TECHNOLOGY".................................................................................12
1.58 "THIRD PARTY(IES)"...........................................................................12
1.59 "THIRD PARTY ROYALTIES"......................................................................12
1.60 "UNPATENTED PRODUCT".........................................................................12
1.61 "VALID CLAIM"................................................................................13
1.62 "WYETH-AYERST COMPOUND"......................................................................13
1.63 "WYETH-AYERST CONFIDENTIAL INFORMATION"......................................................13
1.64 "WYETH-AYERST INVENTION".....................................................................13
1.65 "WYETH-AYERSTMATERIALS"......................................................................13
1.66 "WYETH-AYERST PROPRIETARY CHEMICAL LIBRARY"..................................................13
1.67 "WYETH-AYERST TECHNOLOGY"....................................................................13
ARTICLE TWO -- REPRESENTATIONS AND WARRANTIES...........................................................14
2.1 MUTUAL REPRESENTATIONS AND WARRANTIES........................................................14
2.2 ADDITIONAL NEUROCRINE REPRESENTATIONS, WARRANTIES AND COVENANTS..............................15
2.3 REPRESENTATION BY LEGAL COUNSEL..............................................................17
2.4 NEUROCRINE DISCLAIMER........................................................................17
2.5 WYETH-AYERST DISCLAIMER......................................................................17
ARTICLE THREE -- LICENSES...............................................................................18
3.1 LICENSE GRANT TO WYETH-AYERST................................................................18
3.2 LICENSE GRANT TO NEUROCRINE..................................................................19
3.3 NEUROCRINE RETAINED RIGHTS...................................................................19
3.4 PRIOR AGREEMENT..............................................................................20
3.5 OHSU AGREEMENT...............................................................................20
ARTICLE FOUR -- STEERING COMMITTEE......................................................................21
4.1 CREATION; AUTHORITY..........................................................................21
4.2 CHAIRPERSON..................................................................................21
4.3 MEETINGS.....................................................................................21
4.4 DECISIONS OF THE COMMITTEE...................................................................22
ARTICLE FIVE -- COLLABORATIVE RESEARCH PROGRAM AND RESEARCH FUNDING.....................................22
5.1 RESEARCH PROGRAM.............................................................................22
5.2 TERM.........................................................................................22
5.3 RESEARCH PLAN................................................................................23
5.4 CONDUCT OF THE RESEARCH PROGRAM..............................................................23
5.5 FUNDING OF THE RESEARCH PROGRAM..............................................................23
(a) Funding by Wyeth-Ayerst......................................................................24
(b) Reporting and Reconciliation..............................................................24
(c) Records and Audits...........................................................................25
5.6 INVENTION ASSIGNMENT AGREEMENTS..............................................................26
5.7 REPORTING AND DISCLOSURE.....................................................................26
(a) Reports......................................................................................26
(b) Quarterly Meetings........................................................................26
(c) Disclosure...................................................................................26
5.8 DATA.........................................................................................26
(a) Neurocrine Data..............................................................................26
(b) Wyeth-Ayerst Data............................................................................27
(c) Other Research Program Data..................................................................27
(d) Wyeth-Ayerst Research, Clinical Development and Commercialization Data....................27
5.9 MATERIALS....................................................................................27
(a) Research Program Materials...................................................................27
(b) Neurocrine Materials.........................................................................27
(c) Wyeth-Ayerst Materials.......................................................................28
ARTICLE SIX -- SELECTION OF LEAD COMPOUNDS AND COLLABORATION PRODUCTS...................................28
6.1 SELECTION OF LEAD COMPOUNDS DURING TERM RESEARCH PROGRAM.....................................28
6.2 SELECTION OF LEAD COMPOUNDS AFTER TERM RESEARCH PROGRAM......................................29
6.3 SELECTION OF COLLABORATION PRODUCTS..........................................................29
6.4 DESIGNATION OF LEAD COMPOUNDS AND COLLABORATION PRODUCTS.....................................29
ARTICLE SEVEN - DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION........................................30
7.1 WYETH-AYERST DEVELOPMENT.....................................................................30
7.2 PROGRESS REPORTS.............................................................................30
7.3 MANUFACTURING................................................................................30
7.4 COMMERCIALIZATION OF COLLABORATION PRODUCTS..................................................30
7.5 CO-PROMOTION.................................................................................31
ARTICLE EIGHT - LICENSE FEES............................................................................31
8.1 LICENSE FEES.................................................................................31
8.2 ADDITIONAL LICENSE FEES......................................................................33
ARTICLE NINE - ROYALTIES................................................................................37
9.1 ROYALTY RATES................................................................................37
9.2 ROYALTY ADJUSTMENTS..........................................................................39
(a) Royalty Adjustment for Unpatented Products...................................................39
(b) Competition..................................................................................39
9.3 TERM OF ROYALTY..............................................................................40
9.4 REPORTS AND PAYMENTS.........................................................................40
(a) Cumulative Royalties.........................................................................40
(b) Statements and Payments...................................................................40
(c) Taxes and Withholding........................................................................41
(d) Currency..................................................................................41
(e) Maintenance of Records; Audit................................................................41
9.5 THIRD PARTY PAYMENTS.........................................................................42
(a) OHSU Agreement...............................................................................42
(b) Neurocrine Technology........................................................................43
(c) Collaboration Products.......................................................................43
(d) Third Party Licenses........................................................................44
ARTICLE TEN -- CONFIDENTIALITY, PUBLICATION AND PUBLIC ANNOUNCEMENTS....................................44
10.1 CONFIDENTIALITY..............................................................................44
10.2 AUTHORIZED DISCLOSURE........................................................................45
(a) Each Party...................................................................................45
(b) Use.......................................................................................46
10.3 SEC FILINGS..................................................................................46
10.4 PUBLICATIONS.................................................................................46
10.5 PUBLIC ANNOUNCEMENTS.........................................................................46
(a) Coordination.................................................................................46
(b) Announcements................................................................................47
ARTICLE ELEVEN - INDEMNIFICATION........................................................................47
11.1 INDEMNIFICATION BY WYETH-AYERST..............................................................47
11.2 INDEMNIFICATION BY NEUROCRINE................................................................47
11.3 PROCEDURE....................................................................................48
11.4 INSURANCE....................................................................................49
ARTICLE TWELVE - TERM AND TERMINATION...................................................................49
12.1 GOVERNMENT APPROVALS.........................................................................49
(a) Government Approvals.........................................................................49
(b) Co-operation..............................................................................49
12.2 TERM.........................................................................................49
12.3 EARLY TERMINATION FOR FAILURE TO DEMONSTRATE PROOF OF CONCEPT...............................49
12.4 TERMINATION OF COLLABORATION PRODUCT DEVELOPMENT AND COMMERCIALIZATION.......................50
12.5 DEFAULT......................................................................................54
(a) Wyeth-Ayerst.................................................................................54
(b) Neurocrine...................................................................................57
12.6 BANKRUPTCY...................................................................................58
(a) Neurocrine...................................................................................59
(b) Wyeth-Ayerst.................................................................................59
12.7 ACQUISITION..................................................................................60
12.8 LIABILITIES..................................................................................61
12.9 DISCLAIMER...................................................................................61
ARTICLE THIRTEEN - INTELLECTUAL PROPERTY................................................................61
13.1 INVENTIONS...................................................................................61
13.2 PATENT PROSECUTION...........................................................................62
(a) Wyeth-Ayerst Inventions and Collaboration Products..........................................62
(b) OHSU Licensed Patent Rights..................................................................62
(c) Neurocrine Inventions.......................................................................62
(d) Joint Inventions............................................................................62
13.3 ENFORCEMENT OF PATENT RIGHTS.................................................................62
(a) Wyeth-Ayerst Inventions......................................................................62
(b) Neurocrine Inventions and Joint Inventions................................................63
(c) OHSU Licensed Patent Rights..................................................................63
(d) Neurocrine Technology.....................................................................64
EXHIBITS
Exhibit A -- TRANSPORTERS
Exhibit B -- LEAD COMPOUND AND PROOF OF CONCEPT
Exhibit C -- PATENT RIGHTS
Exhibit D -- OHSU AGREEMENT
Exhibit E -- THIRD PARTY PATENTS
Exhibit F -- OTHER NEUROCRINE OBLIGATIONS
COLLABORATION AND LICENSE AGREEMENT
THIS COLLABORATION AND LICENSE AGREEMENT (the "Agreement"), dated as of
January 1, 1999, is made by and between Neurocrine Biosciences, Inc., a Delaware
corporation with its principal place of business at ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇, ▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇ ("Neurocrine") and American Home Products
Corporation, acting through its Wyeth-Ayerst Laboratories Division, a Delaware
corporation, with a place of business at ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇. ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("Wyeth-Ayerst").
WHEREAS, Wyeth-Ayerst is engaged in the research, development and
commercialization of human pharmaceutical products;
WHEREAS, Neurocrine is the owner or licensee of certain patent rights
relating to [***] which may be useful in the discovery and development of human
pharmaceutical products;
WHEREAS, Wyeth-Ayerst and Neurocrine have agreed to collaborate, on the
terms and conditions set forth herein, in the research, development and
commercialization of compounds [***] (each as defined below);
NOW, THEREFORE, in consideration of the mutual representations,
warranties and covenants contained herein and other good and valuable
consideration, the Parties agree as follows:
ARTICLE ONE
DEFINITIONS
When used in this Agreement, each of the following capitalized terms
shall have the meanings set forth in this Article One. Any terms defined
elsewhere in this Agreement shall be given equal weight and importance as though
set forth in this Article One.
1.1 "Acquisition" shall mean with respect to Neurocrine, the acquisition,
directly or indirectly, by any Third Party of (i) securities authorized
to cast fifty percent (50%) or more of the votes in any election of
directors and/or (ii) the sale or other transfer of all or
substantially all of its assets. Notwithstanding the foregoing, the
sale or other transfer of substantially all of the assets of Neurocrine
to another direct or indirect wholly-owned subsidiary of Neurocrine
shall not constitute an Acquisition.
1.2 "Affiliate" shall mean a Person that, directly or indirectly, through
one or more intermediates, controls, is controlled by, or is under
common control with the Person specified. For the purposes of this
definition, control shall mean the direct or indirect ownership of, (a)
in the case of corporate entities, securities authorized to cast more
than fifty percent (50%) of the votes in any election for directors or
(b) in the case of non-corporate entities, more than fifty percent
(50%) ownership interest with the power to direct the management and
policies of such non-corporate entity. Notwithstanding the foregoing,
the term "Affiliate" shall not include subsidiaries in which a Party or
its Affiliates owns a majority of the ordinary voting power to elect a
majority of the board of directors, but is restricted from electing
such majority by contract or otherwise, until such time as such
restrictions are no longer in effect.
1.3 "Collaboration Products" shall mean products containing one or more
Lead Compounds as an active ingredient(s), provided, however, that if
(i) none of the Compounds contained in a product are encompassed within
the Collaboration Technology and (ii) such product is not developed by
Wyeth-Ayerst, its Affiliates or sublicensees for any indication in
which the [***] and (iii) identification, development and
commercialization of such product does not utilize Collaboration
Technology, then such product shall not be a Collaboration Product for
purposes of this Agreement. For the purposes of License Fees under
Article Eight below and Royalty payments under Article Nine below, all
formulations (e.g., tablets, gel caps, topical formulations, parenteral
formulations, sustained release formulations, etc.) of a Collaboration
Product will be considered to be the same Collaboration Product,
regardless of the indications for which such Collaboration Product may
be used.
1.4 "Collaboration Technology" shall mean all Technology encompassed by the
Neurocrine Technology, Wyeth-Ayerst Technology and Joint Technology.
1.5 "Combination Product" shall mean a product that contains, as active
ingredients one or more Lead Compounds (or Collaboration Products) and
one or more other Compounds that are not Lead Compounds (or
Collaboration Products).
1.6 "Commercially Reasonable Efforts" shall mean efforts and resources
commonly used by a Party (which efforts will be no less than those used
by such Party in the research and development of its products, as
described below, in the one year period preceding the Effective Date)
for a product owned by it or to which it has rights, which product is
at a similar stage in its development or product life and is of similar
market potential taking into account efficacy, safety, Regulatory
Authority approved labeling, the competitiveness of alternative
products in the marketplace, the patent and other proprietary position
of the product, the likelihood of Regulatory Approval given the
regulatory structure involved, the profitability of the product
including the royalties payable to licensors of patent rights,
alternative products and other relevant factors. Commercially
Reasonable Efforts shall be determined on a market-by-market basis for
a particular product, and it is anticipated that the level of effort
will change over time, reflecting changes in the status of the
Collaboration Product and the market involved.
1.7 "Competition" shall exist during a given calendar quarter with respect
to a Collaboration Product in a county if, during such calendar
quarter, one or more Competitive Products shall be commercially
available in such country and shall have in the aggregate a [***] or
greater share of the total market (based on data provided by IMS
International, or if such data are not available, based on such other
data mutually agreed to by Wyeth-Ayerst and Neurocrine) in that country
as measured by unit sales. For purposes of this agreement, the "total
market" in a country shall be the sum of (x) the number of units of the
affected Collaboration Product sold during such calendar quarter in
such country by Wyeth-Ayerst, its Affiliates and sublicensees and (y)
the number of units of Competitive Products sold in such country during
such calendar quarter.
1.8 "Competitive Products" shall mean and include products (other than
Collaboration Products developed and commercialized by Wyeth-Ayerst
pursuant to this Agreement) that contain principally the same active
chemical entity(ies) as a Collaboration Product and which (a) act
through the same mechanism as a Collaboration Product and (b) can
reasonably be or are reasonably used for the same indication as a
Collaboration Product. Without limitation of the foregoing, compounds
that are of the same general formulation type (i.e., oral vs.
parenteral vs. topical) as a Collaboration Product would generally be
considered Competitive Products while compounds of a different general
formulation type from a Collaboration Product would generally not be
considered Competitive Products unless the compound and Collaboration
Product are reasonably used (other than de minimis usage) for the
treatment of the same indication.
1.9 "Compound" shall mean a chemical compound or substance together with
all complexes, mixtures and other combinations, prodrugs, metabolites,
enantiomers, salt forms, racemates, and isomers thereof.
1.10 "Confidential Information" shall mean with respect to each Party,
non-public proprietary data or information which belong in whole or in
part to such Party and/or information designated as Confidential
Information of such Party hereunder.
1.11 "Controls" or "Controlled" shall mean with respect to Technology, the
possession of the ability to grant licenses or sublicenses without
violating the terms of any agreement or other arrangement with, or the
rights of, any Third Party.
1.12 "Default" shall mean with respect to a Party that (i) any
representation or warranty of such Party set forth herein shall have
been untrue in any material respect when made or (ii) such Party shall
have failed to perform any material obligation set forth in this
Agreement.
1.13 [***] shall be as defined in Exhibit A.
1.14 "Effective Date" shall mean January 1, 1999.
1.15 "European Union" shall mean, from time to time, those countries that
are members of the European Union.
1.16 "FDA" shall mean the Federal Food and Drug Administration of the United
States Department of Health and Human Services or any successor agency
thereof.
1.17 "Field of Use" shall mean all therapeutic, prophylactic and diagnostic
uses.
1.18 "FTE" shall mean full time equivalent scientific person year consisting
of a minimum of a total [***] per year of scientific work on or
directly related to the Research Program. Work on or directly related
to the Research Program can include, but is not limited to,
experimental laboratory work, recording and writing up results,
reviewing literature and references, holding scientific discussions,
managing and leading scientific staff, carrying out management duties
related to the Research Program, and to the extent specifically
approved by Wyeth-Ayerst, writing up results for publications or
presentation and attending or presenting appropriate seminars and
symposia.
1.19 "First Commercial Sale" shall mean with respect to any Collaboration
Product approved for commercial sale, the first transfer by
Wyeth-Ayerst, its Affiliates and/or its sublicensees of the
Collaboration Product to a non-Affiliate Third Party in exchange for
cash or some equivalent to which value can be assigned.
1.20 "Force Majeure" shall mean any occurrence beyond the reasonable control
of a Party that prevents or substantially interferes with the
performance by the Party of any of its obligations hereunder, if such
occurs by reason of any act of God, flood, fire, explosion, earthquake,
strike, lockout, labor dispute, casualty or accident; or war,
revolution, civil commotion, acts of public enemies, blockage or
embargo; or any injunction, law, order, proclamation, regulation,
ordinance, demand or requirement of any government or of any
subdivision, authority or representative of any such government; or
breakdown of plant, inability to procure or use materials, labor,
equipment, transportation, or energy sufficient to meet manufacturing
needs without the necessity of allocation; or any other cause
whatsoever, whether similar or dissimilar to those above enumerated,
beyond the reasonable control of such Party, if and only if the Party
affected shall have used reasonable efforts to avoid such occurrence
and to remedy it promptly if it shall have occurred.
1.21 "Hit(s)" shall mean Compounds derived from the Neurocrine Proprietary
Chemical Library, the Wyeth-Ayerst Proprietary Chemical Library or any
other library selected by the Parties, which are screened in the
conduct of the Research Program and test positive in screening assays
[***]. For the purposes of this definition, the Steering Committee will
determine what shall constitute a positive test with respect to any
screening assays selected for the Research Program and it is
anticipated that, depending on results obtained in the course of the
Research Program, what constitutes a positive test may change from time
to time.
1.22 "Interim Clinical Evaluation Point" or "ICE" shall mean, with respect
to any Collaboration Product, the development milestone indicating
[***], as decided by Wyeth-Ayerst's Development Operating Committee.
[***]. In addition, [***]. Notwithstanding the foregoing, in the event
Wyeth-Ayerst shall make the decision [***], ICE shall be deemed to have
been met.
1.23 "IND" shall mean an Investigational New Drug Application covering a
Collaboration Product filed with the FDA pursuant to 21 CFR 312.20 or
an equivalent foreign filing required for the clinical testing of a
pharmaceutical product.
1.24 "Joint Confidential Information" shall mean Confidential Information
owned jointly by Wyeth-Ayerst and Neurocrine or otherwise designated as
Joint Confidential Information hereunder.
1.25 "Joint Inventions" shall be as defined in Section 13.1 hereof.
1.26 "Joint Technology" shall mean Technology, which is discovered or
invented jointly by Neurocrine personnel and Wyeth-Ayerst personnel
during the term of this Agreement.
1.27 "Lead Compound(s)" shall mean those Compounds (i) [***], (ii) that meet
the criteria set forth on Exhibit B hereto and (iii) that are selected
by the Steering Committee or Wyeth-Ayerst in accordance with Article
Six, provided, however, that Lead Compounds shall specifically exclude
any Compounds [***]. Notwithstanding the foregoing, for purposes of
calculating Net Sales and determining License Fees and Royalty payments
under this Agreement, a Lead Compound together with all complexes,
mixtures and other combinations, prodrugs, metabolites, enantiomers,
salt forms, racemates, isomers, and derivatives thereof, shall be
considered to be a single Lead Compound.
1.28 "License Fees" shall mean the payments to be made by Wyeth-Ayerst to
Neurocrine upon occurrence of certain events as set forth in Article
Eight.
1.29 "Major European Country" shall mean France, Germany, Italy or the
United Kingdom.
1.30 "NDA" shall mean a New Drug Application (or Biologics License
Application, if applicable) covering a Collaboration Product filed with
the FDA pursuant to 21 CFR 314 or an equivalent foreign filing required
for marketing approval of a pharmaceutical product.
1.31 "Net Sales" shall mean, with respect to a Collaboration Product, all
proceeds actually received from the sale or other disposition of a
Collaboration Product by Wyeth-Ayerst, its Affiliates or sublicensees
to unrelated Third Parties, less the reasonable and customary
deductions from such gross amounts actually paid by or charged to the
account of Wyeth-Ayerst, including, without limitation,
(a) trade, cash and quantity discounts actually allowed
and taken directly with respect to such sales;
(b) amounts repaid, credits or allowances actually
granted for damaged goods, defects, recalls, returns
or rejections of Collaboration Product and
retroactive price reductions;
(c) sales or similar taxes actually paid by or charged to
the account of Wyeth-Ayerst, its Affiliates or
sublicensees without offset (including, without
limitation, duties or other governmental charges
levied on, absorbed or otherwise imposed on the sale
of Collaboration Product, value added taxes or other
governmental charges otherwise measured by the
billing amount, when included in billing, but not
including national, state or local taxes based on
income);
(d) charge back payments and rebates granted to (i)
managed health care organizations, (ii) federal,
state and/or local governments or their agencies,
(iii) purchasers and reimbursers, or (iv) trade
customers, including, without limitation, wholesalers
and chain and pharmacy buying groups; and
(e) freight, postage, shipping, customs duties and
insurance charges to the extent included in the
proceeds actually received from the customer.
For the purposes of determining Net Sales hereunder, a sublicensee
shall include a Third Party who, pursuant to an agreement with
Wyeth-Ayerst, distributes Collaboration Products, provided, such Third
Party also, as required by such agreement, conducts promotion and/or
marketing activities in the applicable territory. Net Sales shall be
determined in accordance with United States generally accepted
accounting principles consistently applied. A "sale" shall also include
the transfer or other disposition of a Collaboration Product for
consideration other than cash, in which case such consideration will be
valued at the fair market value thereof. In the event that a
Collaboration Product is sold either for consideration other than cash
or as part of a bundled product, the Net Sales of such Collaboration
Product will be calculated based on the average unit price of such
Collaboration Product when sold (other than as part of a bundle) in
cash transactions in such country. In the event that, on a
country-by-country basis, a Collaboration Product is sold in the form
of a Combination Product, the Net Sales for such Combination Product
will be calculated as follows:
(i) If Wyeth-Ayerst, its Affiliates and/or sublicensees
separately sells, in such country, (x) Collaboration
Products containing as their sole active
ingredient(s) the same Lead Compound(s) as are
contained in such Combination Product and (y) other
products containing as their sole active
ingredient(s) the other active component or
components in such Combination Product, the Net
Sales attributable to such Combination Product shall
be calculated by multiplying actual Net Sales of the
Combination Product by the [***], which
Collaboration Product contains, as the sole active
ingredient(s), the same Lead Compound(s) as are in
such Combination Product and [***], which product(s)
contain, as their sole active ingredient(s) any
other active component or components in the
Combination Product.
(ii) If Wyeth-Ayerst, its Affiliates and/or sublicensees
separately sells, in such country, Collaboration
Products containing as their sole active
ingredient(s) the same Lead Compound(s) as are
contained in such Combination Product but do not
separately sell, in such country, other products
containing as their sole active ingredient(s) the
other active component or components in such
Combination Product, the Net Sales attributable to
such Combination Product shall be calculated by
multiplying the Net Sales of such Combination
Product by the [***], which Collaboration Product
contains, as the sole active ingredient(s), the same
Lead Compound(s) as are in such Combination Product,
[***].
(iii) If Wyeth-Ayerst, its Affiliates and/or sublicensees
do not separately sell, in such country,
Collaboration Products containing as their sole
active ingredient(s) the same Lead Compound(s) as are
contained in such Combination Product, the Net Sales
attributable to such Combination Product shall be
calculated by multiplying the Net Sales of such
Combination Product by the [***].
Notwithstanding the foregoing, Net Sales shall not include any
consideration received by Wyeth-Ayerst, its Affiliates or sublicensees
in respect of the sale, use or other disposition of a Collaboration
Product in a country as part of a clinical trial prior to the receipt
of all Regulatory Approvals required to commence full commercial sales
of such Collaboration Product in such country.
1.32 "Neurocrine Ancillary Transporters" shall mean [***] as defined on
Exhibit A.
1.33 "Neurocrine Compound" shall mean any Compound, which is (a) within the
Neurocrine Proprietary Chemical Library, and (b) is screened under the
Research Program for activity against the Neurocrine Transporters
together with all complexes, mixtures and other combinations, prodrugs,
metabolites, enantiomers, salt forms, racemates, and isomers thereof.
1.34 "Neurocrine Confidential Information" shall mean Confidential
Information owned by Neurocrine or otherwise designated as Neurocrine
Confidential Information hereunder but shall not include Joint
Confidential Information.
1.35 "Neurocrine Invention" shall have the meaning set forth in Section 13.1
hereof.
1.36 "Neurocrine Materials" shall mean Neurocrine proprietary research
materials including, but not limited to, Neurocrine Compounds, the
Neurocrine Proprietary Chemical Library, assays, physical databases of
chemical structures of Compounds in the Neurocrine Proprietary Chemical
Library, reagents and materials derived therefrom. Neurocrine Materials
will not include Research Program Materials. Neurocrine will own
Neurocrine Materials supplied by Neurocrine to Wyeth-Ayerst hereunder.
1.37 "Neurocrine Proprietary Chemical Library" shall mean those Compounds
that Neurocrine, as of the Effective Date owns or Controls, or that
come into Neurocrine's Control during the term of the Research Program.
1.38 "Neurocrine Researcher" shall mean professional researchers and
scientists employed by Neurocrine and having at least a Bachelors
Degree in science and other academic and/or professional credentials
demonstrating reasonably appropriate expertise for the task to be
performed by such Neurocrine Researcher in carrying out the Research
Plan.
1.39 "Neurocrine Technology" shall mean the Neurocrine Compound Technology,
Neurocrine Ancillary Transporter Technology and the Neurocrine
Transporter Technology, each as defined below.
(a) "Neurocrine Compound Technology" shall mean all
Technology (other than Joint Technology) owned or
Controlled by Neurocrine on the Effective Date and/or
during the term of this Agreement, which (i) claims
or describes Lead Compounds and/or Collaboration
Products and/or (ii) is developed, discovered or
invented by Neurocrine in the conduct of the Research
Program and/or (iii) is necessary or useful to
develop, make, use or sell Lead Compounds and/or
Collaboration Products.
(b) "Neurocrine Ancillary Transporter Technology" shall
mean all Technology (other than Joint Technology)
owned or Controlled by Neurocrine on the Effective
Date or during the term of the Research Program that
claims, describes or relates to the use of the
Neurocrine Ancillary Transporters.
(c) "Neurocrine Transporter Technology" shall mean all
Technology (other than Joint Technology) owned or
Controlled by Neurocrine on the Effective Date or
during the term of the Research Program that claims,
describes or relates to the use of the Neurocrine
Transporters. Neurocrine Transporter Technology will
specifically include, without limitation, the Patent
Rights set forth on Exhibit C hereto.
1.40 "Neurocrine Transporters" shall mean [***] as defined on Exhibit A.
1.41 "OHSU Agreement" shall mean the Amended and Restated License Agreement
dated January 1, 1999 by and between Oregon Health Sciences University
("OHSU") and Neurocrine (a complete copy of which has been provided to
and approved by Wyeth-Ayerst prior to the date this Agreement was
signed by the Parties and which is attached hereto as Exhibit D), as
such agreement may be amended from time to time (subject to the consent
of Wyeth-Ayerst to the extent required under the Agreement dated
January 1, 1999 by and among OHSU, Wyeth-Ayerst and Neurocrine.)
1.42 "Party" shall mean Wyeth-Ayerst or Neurocrine, as the case may be, and
"Parties" shall mean Wyeth-Ayerst and Neurocrine.
1.43 "Patent Rights" shall mean the rights and interests in and to all
issued patents and pending patent applications in any country,
including, without limitation, all provisional applications,
substitutions, continuations, continuations-in-part, divisions, and
renewals, all letters patent granted thereon, and all
patents-of-addition, reissues, reexaminations and extensions or
restorations by existing or future extension or restoration mechanisms,
including, without limitation Supplementary Protection Certificates or
the equivalent thereof.
1.44 "Person" shall mean any individual, firm, corporation, partnership,
limited liability company, trust, unincorporated organization or other
entity or a government agency or political subdivision thereto, and
shall include any successor (by merger or otherwise) of such Person.
1.45 "Pivotal Trial" shall mean clinical trial which, if the pre-defined
endpoints are met, is intended to be submitted as part of an
application for marketing approval as statistically significant data in
support of the product's safety and efficacy for the intended
indication.
1.46 "Prior Agreement" shall mean the agreement dated August 15, 1996 by and
between Northwest NeuroLogic, Inc. and Wyeth-Ayerst, as amended.
1.47 "Proof of Concept" shall mean, with respect to either of the Neurocrine
Transporters, the successful achievement of both the in vitro Proof of
Concept and the in vivo Proof of Concept criteria for such Neurocrine
Transporter, as set forth in Exhibit B.
1.48 "Regulatory Approval" shall mean the technical, medical and scientific
licenses, registrations, authorizations and approvals (including,
without limitation, approvals of NDAs, supplements and amendments, pre-
and post- approvals, pricing and third party reimbursement approvals,
and labeling approvals) of any national, supra-national, regional,
state or local regulatory agency, department, bureau, commission,
council or other governmental entity, necessary for the development,
manufacture, distribution, marketing, promotion, offer for sale, use,
import, export or sale of Lead Compounds or Collaboration Product(s) in
a regulatory jurisdiction.
1.49 "Regulatory Authority" shall mean any national (e.g., the FDA),
supra-national (e.g., the European Commission, the Council of the
European Union, or the European Agency for the Evaluation of Medicinal
Products), regional, state or local regulatory agency, department,
bureau, commission, council or other governmental entity in each
country of the Territory involved in the granting of Regulatory
Approval for a Lead Compound or a Collaboration Product.
1.50 "Regulatory Filings" shall mean, collectively, INDs, Biologics License
Applications, Drug Master Files, NDAs and/or any other comparable
filings as may be required by Regulatory Authorities to obtain
Regulatory Approvals.
1.51 "Research Plan" will be as defined in Section 5.3 below.
1.52 "Research Program" shall mean the collaborative research program
conducted by Neurocrine and Wyeth-Ayerst and funded, in part, by
Wyeth-Ayerst in accordance with the provisions of Article Five below.
1.53 "Research Program Funding" will be as defined in Section 5.5 below.
1.54 "Research Program Materials" shall mean and include clones, cell lines,
Compounds, assays, databases, electronic and physical databases of
chemical structures which, in each case, are developed by Neurocrine
and/or Wyeth-Ayerst during the course of conduct of the Research
Program. Research Program Materials also will include the Neurocrine
Transporters and Neurocrine Ancillary Transporters and clones, cell
lines and other materials encompassing, expressing, and/or containing
the Neurocrine Transporters and/or Neurocrine Ancillary Transporters.
1.55 "Royalties" shall mean those royalties payable by Wyeth-Ayerst to
Neurocrine pursuant to Article Nine of this Agreement.
1.56 "Steering Committee" shall have the meaning set forth in Section 4.1
hereof.
1.57 "Technology" shall mean proprietary data, information and all
intellectual property, including but not limited to, trade secrets,
know-how, inventions and technology, whether patentable or not, and
Patent Rights directed to products, processes, formulations and/or
methods.
1.58 "Third Party(ies)" shall mean any Person other than Neurocrine,
Wyeth-Ayerst and their respective Affiliates.
1.59 "Third Party Royalties" shall mean royalties payable by Neurocrine,
Wyeth-Ayerst, its Affiliates or sublicensees to a non-Affiliate Third
Party (or multiple non-Affiliate Third Parties) to make, have made,
use, sell, offer for sale or import Collaboration Products where the
royalty payable to such non-Affiliate Third Party is based on Patent
Rights owned or Controlled by such Third Party.
1.60 "Unpatented Product" shall mean a Collaboration Product the making,
using or sale of which is not claimed or described in at least one
Valid Claim included in the Collaboration Technology.
1.61 "Valid Claim" shall mean a claim of an issued and unexpired patent or a
claim of a pending patent application which has not been held invalid
or unenforceable by a court or other government agency of competent
jurisdiction from which no appeal can be or has been taken and has not
been admitted to be invalid or unenforceable through re-examination or
disclaimer or otherwise, provided, however, that if a claim of a
pending patent application shall not have issued within [***] after the
filing date from which such claim takes priority such claim shall not
constitute a Valid Claim for the purposes of this Agreement.
1.62 "Wyeth-Ayerst Compound" shall mean any Compound (a) which is within the
Wyeth-Ayerst Proprietary Chemical Library and (b) which is screened
under the Research Program or by Wyeth-Ayerst under this Agreement for
activity against a Neurocrine Transporter together with all complexes,
mixtures and other combinations, prodrugs, metabolites, enantiomers,
salt forms, racemates, and isomers thereof.
1.63 "Wyeth-Ayerst Confidential Information" shall mean Confidential
Information owned by Wyeth-Ayerst or otherwise designated as
Wyeth-Ayerst Confidential Information hereunder but shall not include
Joint Confidential Information.
1.64 "Wyeth-Ayerst Invention" shall have the meaning set forth in Section
13.1 hereof.
1.65 "Wyeth-Ayerst Materials" shall mean Wyeth-Ayerst proprietary research
materials including, but not limited to, Wyeth-Ayerst Compounds, the
Wyeth-Ayerst Proprietary Chemical Library, assays, physical databases
of chemical structures of Compounds in the Wyeth-Ayerst Proprietary
Chemical Library, reagents and materials derived therefrom.
Wyeth-Ayerst Materials will not include Research Program Materials.
Wyeth-Ayerst will own Wyeth-Ayerst Materials provided to Neurocrine
hereunder.
1.66 "Wyeth-Ayerst Proprietary Chemical Library" shall mean those Compounds
that Wyeth-Ayerst, as of the Effective Date, owns or Controls, or that
come into Wyeth-Ayerst's Control during the term of this Agreement, and
any other Compounds not Controlled by Wyeth-Ayerst, but which
Wyeth-Ayerst has the right to develop and commercialize, including,
without limitation, the right to screen such Compounds for activity
against the Neurocrine Transporters without violating the terms of any
agreement between Wyeth-Ayerst and a Third Party.
1.67 "Wyeth-Ayerst Technology" shall mean all Technology (other than Joint
Technology) owned or Controlled by Wyeth-Ayerst on the Effective Date
and/or during the term of this Agreement (a) which relates specifically
to, claims or describes Lead Compounds and/or Collaboration Products
and/or (b) is developed, discovered or invented by Wyeth-Ayerst in the
conduct of the Research Program, (c) is developed, discovered or
invented by Wyeth-Ayerst personnel directly resulting from the use of
Neurocrine Technology or Joint Technology and/or (d) is necessary or
useful to make, use or sell Lead Compounds and/or Collaboration
Products.
ARTICLE TWO
REPRESENTATIONS AND WARRANTIES
2.1 Mutual Representations and Warranties. Each Party hereby represents,
warrants and covenants to the other Party that:
(a) the execution, delivery to the other Party and performance by
it of this Agreement and its compliance with the terms and
provisions of this Agreement does not and will not conflict,
in any material respect, with or result in a breach of any of
the terms or provisions of (x) any other contractual
obligations of such Party, (y) the provisions of its charter,
operating documents or bylaws, or (z) any order, writ,
injunction or decree of any court or governmental authority
entered against it or by which it or any of its property is
bound except where such breach or conflict would not
materially impact the Party's ability to meet its obligations
hereunder, and (ii) it has not granted to any Third Party any
right which would conflict in any material respect with the
rights granted by it to the other Party hereunder;
(b) this Agreement is a legal and valid obligation binding upon
such Party and enforceable in accordance with its terms except
as (i) enforceability may be limited by bankruptcy,
insolvency, reorganization, moratorium or similar laws
affecting the enforcement of creditors' rights and (ii)
equitable principles of general applicability;
(c) such Party is a corporation duly organized, validly existing
and in good standing under the laws of the state or other
jurisdiction of incorporation or formation and has full
corporate power and authority to enter into this Agreement and
to carry out the provisions hereof except where failure to be
in good standing would not materially impact the Party's
ability to meet its obligations hereunder;
(d) such Party is duly authorized, by all requisite corporate
action, to execute and deliver this Agreement and the
execution, delivery and performance of this Agreement by such
Party does not require any shareholder action or approval, and
the Person executing this Agreement on behalf of such Party is
duly authorized to so by all requisite corporate action; and
(e) no consent, approval, order or authorization of, or
registration, qualification, designation, declaration or
filing with, any federal, state or local governmental
authority is required on the part of such Party in connection
with the valid execution, delivery and performance of this
Agreement, except for any filings under any applicable
securities laws and except where the failure to obtain any of
the foregoing would not have a material adverse impact on the
ability of such Party to meets its obligations hereunder.
2.2 Additional Neurocrine Representations, Warranties and Covenants.
Neurocrine represents, warrants and covenants to Wyeth-Ayerst that:
(a) it has the full right, power and authority to grant the
licenses granted to Wyeth-Ayerst under Article Three hereof;
(b) all Patent Rights included within the Neurocrine Transporter
Technology and/or the Neurocrine Ancillary Transporter
Technology which are existing as of the Effective Date are
listed on Exhibit C attached hereto and, as of the Effective
Date, the Patent Rights included within the Neurocrine
Technology are existing and, to its knowledge, are not invalid
or unenforceable, in whole or in part;
(c) except as disclosed to Wyeth-Ayerst in writing and except for
the nonexclusive licenses granted to Neurocrine pursuant to
Article Three of the OHSU Agreement or retained by OHSU,
▇▇▇▇▇▇ ▇▇▇▇▇▇ Medical Institute and the United States
Government pursuant to Article Five of the OHSU License
Agreement, to its knowledge (i) it is the sole and exclusive
owner or the exclusive licensee of the Neurocrine Technology,
including, without limitation, all Patent Rights included
therein, and (ii) no Person (except OHSU, the ▇▇▇▇▇▇ ▇▇▇▇▇▇
Medical Institute and the United States Government with
respect to those Patent Rights licensed to Neurocrine under
the OHSU Agreement), has any right, title or interest in or to
the Neurocrine Technology;
(d) except as disclosed to Wyeth-Ayerst in writing, to its
knowledge (i) all inventors (who are known as of the date this
Agreement is signed by each of the Parties) of any inventions
included within the Neurocrine Technology have assigned their
entire right, title and interest in and to such inventions and
the corresponding Patent Rights to Neurocrine or, in the case
of inventions and Patent Rights licensed by Oregon Health
Sciences University to Neurocrine, to Oregon Health Sciences
University, and (ii) no Person, other than those Persons named
as inventors on any patent or patent application included
within the Neurocrine Technology, is an inventor of the
invention(s) claimed in such patent or patent application;
(e) except as disclosed to Wyeth-Ayerst in writing, to
Neurocrine's knowledge, OHSU has (i) complied with all of its
obligations under applicable United States Government laws and
regulations with respect to any inventions included within the
Neurocrine Technology which inventions are subject inventions
of a funding agreement between OHSU and the United States
Government or any agency thereof and (ii) elected to retain
title to any such invention as provided in 37 CFR Part 401;
(f) as of the date this Agreement is signed by each of the
Parties, there are no claims, judgments or settlements against
or owed by Neurocrine or, to its knowledge, pending or
threatened claims or litigation relating to the Neurocrine
Technology and during the term of this Agreement Neurocrine
shall promptly notify Wyeth-Ayerst in writing, upon learning
of any such actual or threatened claim, judgment or
settlement;
(g) during the term of this Agreement Neurocrine will use
Commercially Reasonable Efforts not to diminish the rights
under the Neurocrine Technology provided, however, that
termination of the OHSU Agreement (i) by reason of the failure
by Wyeth-Ayerst, as a sublicensee thereunder, to meet
obligations set forth in Articles Nine and Ten thereof or any
other obligations of a sublicensee thereunder or (ii) by
reason of any default by Wyeth-Ayerst hereunder, shall not, in
either instance, constitute a breach of this subparagraph (g);
(h) except as set forth on Exhibit E, as of the date this
Agreement is signed by each of the Parties, it is not aware of
any patent, patent application or other intellectual property
right of any Third Party which could materially adversely
affect the ability of either Party to carry out its respective
obligations hereunder or the ability of Wyeth-Ayerst to
exercise or exploit any of the rights or licenses granted to
it under this Agreement;
(i) except as set forth on Exhibit F hereof, the terms of this
Agreement do not conflict in any material respect with the
terms of any other Neurocrine obligations; and
(j) it has no knowledge of any material information, other than
information provided to Wyeth-Ayerst in writing prior to the
signing of this Agreement, which would negatively affect the
ability of Wyeth-Ayerst to use the Neurocrine Transporters or
the Neurocrine Ancillary Transporters.
2.3 Representation by Legal Counsel. Each Party hereto represents that it
has been represented by legal counsel in connection with this Agreement
and acknowledges that it has participated in the drafting hereof. In
interpreting and applying the terms and provisions of this Agreement,
the Parties agree that no presumption shall exist or be implied against
the Party which drafted such terms and provisions.
2.4 Neurocrine Disclaimer. EXCEPT AS EXPRESSLY PROVIDED IN SECTIONS 2.1 AND
2.2 HEREOF, NEUROCRINE MAKES NO OTHER REPRESENTATION OR WARRANTY,
EITHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH
RESPECT TO ANY NEUROCRINE MATERIALS, INCLUDING WITHOUT LIMITATION, THE
NEUROCRINE TRANSPORTERS AND NEUROCRINE ANCILLARY TRANSPORTERS.
ADDITIONALLY, NEUROCRINE MAKES NO REPRESENTATION OR WARRANTY, EITHER
EXPRESS OR IMPLIED, THAT THE MANUFACTURE, USE OR SALE OF ANY LEAD
COMPOUND OR COLLABORATION PRODUCT WILL NOT INFRINGE THE INTELLECTUAL
PROPERTY RIGHTS OF ANY THIRD PARTY.
2.5 Wyeth-Ayerst Disclaimer. EXCEPT AS EXPRESSLY PROVIDED IN SECTION 2.1
HEREOF, WYETH-AYERST MAKES NO OTHER REPRESENTATION OR WARRANTY, EITHER
EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO ANY
WYETH-AYERST MATERIALS, ANY LEAD COMPOUND OR ANY COLLABORATION PRODUCT.
ADDITIONALLY, WYETH-AYERST MAKES NO REPRESENTATION OR WARRANTY, EITHER
EXPRESS OR IMPLIED THAT THE DISCOVERY, DEVELOPMENT, MANUFACTURE, USE OR
SALE OF ANY LEAD COMPOUND OR COLLABORATION PRODUCT WILL NOT INFRINGE
THE INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.
ARTICLE THREE
LICENSES
3.1 License Grant to Wyeth-Ayerst. Except as set forth in Section 3.3
below, Neurocrine hereby grants to Wyeth-Ayerst:
(a) the sole and exclusive worldwide right and license, with no
right to sublicense (except (i) to Wyeth-Ayerst's Affiliates
and (ii) to any sublicensee of a Lead Compound and/or
Collaboration Product in so far as reasonably necessary for
such sublicensee to develop such Lead Compound and/or
Collaboration Product), under both the Neurocrine Technology
and Neurocrine's interest in any Joint Technology, to use the
Neurocrine Transporters for the identification and/or
development of Lead Compounds and Collaboration Products in
the Field of Use;
(b) the sole and exclusive worldwide right and license, with the
right to sublicense to Affiliates of Wyeth-Ayerst and/or one
or more Third Parties, under both the Neurocrine Technology
and Neurocrine's interest in any Joint Technology, to make,
have made, use, import, market, offer for sale and sell Lead
Compounds and Collaboration Products in the Field of Use;
(c) during the term of the Research Program, the sole and
exclusive right and license, with no right to sublicense
(except to Wyeth-Ayerst's Affiliates), under both the
Neurocrine Ancillary Transporter Technology and Neurocrine's
interest in any Joint Technology, to use the Neurocrine
Ancillary Transporters for the [***] of Lead Compounds and
Collaboration Products;
(d) after the term of the Research Program, a non-exclusive right
and license, with no right to sublicense (except to
Wyeth-Ayerst's Affiliates), under the Neurocrine Ancillary
Transporter Technology to use the Neurocrine Ancillary
Transporters for the [***] of Lead Compounds and Collaboration
Products;
(e) during the term of this Agreement, a nonexclusive right and
license, with no right to sublicense (except (i) to
Wyeth-Ayerst Affiliates and (ii) to any sublicensee of a Lead
Compound and/or Collaboration Product in so far as reasonably
necessary for such sublicensee to develop such Lead Compound
and/or Collaboration Product), to use all data and information
generated by or on behalf of Neurocrine in the conduct of the
Research Program, including data relating to Hits in the
Neurocrine Proprietary Chemical Library, but only as shall be
reasonably necessary for Wyeth-Ayerst to conduct research to
identify and develop Lead Compounds and Collaboration
Products, provided, however, that such license shall become
sole and exclusive when a Compound is designated a Lead
Compound in accordance with Article Six and shall revert to a
non-exclusive license upon determination of the Steering
Committee or Wyeth-Ayerst that such Lead Compound will not
become a Collaboration Product;
(f) during the term of this Agreement, an exclusive right and
license, with the right to sublicense, to use all data and
information generated by or on behalf of Neurocrine in the
conduct of the Research Program relating to Lead Compounds
and/or Collaboration Products in the Neurocrine Proprietary
Chemical Library, but only as shall be reasonably necessary
for Wyeth-Ayerst to conduct research to identify and develop
Lead Compounds and Collaboration Products; and
(g) during the term of this Agreement, a non-exclusive right and
license, with no right to sublicense (except (i) to
Wyeth-Ayerst's Affiliates and (ii) to any sublicensee of a
Lead Compound and/or Collaboration Product in so far as
reasonably necessary for such sublicensee to develop such Lead
Compound and/or Collaboration Product), to use the Neurocrine
Materials but only to the extent that such right and license
shall be necessary for Wyeth-Ayerst to identify and develop
Lead Compounds and Collaboration Products.
3.2 License Grant to Neurocrine. Wyeth-Ayerst hereby grants to Neurocrine
for the term of the Research Program (i) a non-exclusive right and
license, with no right to sublicense, under the Wyeth-Ayerst Technology
to the extent that such right and license shall be necessary for
Neurocrine to perform its obligations under the Research Program, and
(ii) a non-exclusive right and license, with no right to sublicense, to
use the Wyeth-Ayerst Materials but only to the extent that such right
and license shall be necessary for Neurocrine to perform its
obligations under the Research Program and (iii) a nonexclusive right
and license to use all data and information generated in the conduct of
the Research Program, including data relating to Hits in the
Wyeth-Ayerst Proprietary Chemical Library, but only as shall be
reasonably necessary for Neurocrine to perform its obligations under
the Research Program.
3.3 Neurocrine Retained Rights. The exclusive licenses granted to
Wyeth-Ayerst in Section 3.1 above, shall be subject to the retention by
Neurocrine of a nonexclusive right and license, with no right to
sublicense, in each case, to the extent necessary for Neurocrine to
perform its obligations under the Research Program hereunder. Subject
to the licenses granted to Wyeth-Ayerst in Section 3.1 above, nothing
herein shall be deemed to restrict Neurocrine's right to otherwise
exploit the Neurocrine Technology to develop products other than Lead
Compounds and Collaboration Products including, without limitation,
Neurocrine's right to use and sublicense the use of the Neurocrine
Transporters to conduct selectivity testing with respect to products
(other than Lead Compounds and Collaboration Products) being developed
by Neurocrine or is corporate partners or sublicensees.
3.4 Prior Agreement. This Agreement supersedes the Prior Agreement and all
Compounds which may have been identified under the Prior Agreement will
be governed solely by the terms and conditions of this Agreement.
3.5 OHSU Agreement. Patent Rights licensed to Neurocrine pursuant to the
OHSU Agreement (the "Sublicensed Rights") are included in the
Neurocrine Technology licensed to Wyeth-Ayerst hereunder. Wyeth-Ayerst
has approved the terms of the OHSU Agreement and the Parties agree that
the terms of the OHSU Agreement are consistent with the terms of this
Agreement and no conflict exist with respect to Neurocrine's
obligations under this Agreement and Neurocrine's obligations under the
OHSU Agreement. Wyeth-Ayerst will have all of the rights set forth in
that agreement to be afforded to Neurocrine's sublicensee of any
technology licensed thereunder including, without limitation, in the
event of a termination of the OHSU Agreement, the right under Section
4.03 thereof, to enter into a license, with respect to the Sublicensed
Rights, directly with OHSU which license would be on the same terms and
conditions as the OHSU Agreement. In the event that Wyeth-Ayerst enters
into such a license with OHSU, (i) [***] of any payments made by
Wyeth-Ayerst to OHSU under Paragraph 6.02 thereof (including payments
creditable against payments owed under Section 6.02 thereof) and (ii)
[***] of other payments thereunder shall in each case be deducted from
any payments that Wyeth-Ayerst remains obligated or thereafter becomes
obligated to make to Neurocrine under this Agreement. Neurocrine agrees
that it will not modify or amend the OHSU Agreement, insofar as any
such amendment or modification will have any impact on any of the
rights or obligations of Wyeth-Ayerst under this Agreement or any
agreement entered into between Wyeth-Ayerst and OHSU in accordance with
this Section 3.5, without Wyeth-Ayerst's prior written consent which
consent (i) may be provided or withheld by Wyeth-Ayerst in
Wyeth-Ayerst's sole discretion in the case of any modification that
would negatively impact any such rights or obligations of Wyeth-Ayerst,
including, without limitation, any increase in payments to be made by
Wyeth-Ayerst, any increase in diligence obligations, or any
modification of the exclusivity of the Sublicensed Rights, or (ii) will
not be unreasonably withheld by Wyeth-Ayerst in the case of any
modification that would not negatively impact any such rights or
obligations of Wyeth-Ayerst. Neurocrine further agrees that it will
promptly provide Wyeth-Ayerst with copies of any notices it receives
from or gives to OHSU pertaining to any termination or threatened
termination of the OHSU Agreement.
ARTICLE FOUR
STEERING COMMITTEE
4.1 Creation; Authority. Immediately following the signing of this
Agreement, Wyeth-Ayerst and Neurocrine will establish a steering
committee (the "Steering Committee") consisting of at least three (3)
members from each of Wyeth-Ayerst and Neurocrine with Wyeth-Ayerst and
Neurocrine having equal representation at all times. The Steering
Committee will be responsible for monitoring and reviewing the
implementation of the Research Plan by the Parties and for determining
the mechanisms for exchange of information and materials between the
Parties. From time to time, the Steering Committee may establish
subcommittees to oversee specific projects or activities and such
subcommittees shall be constituted as the Steering Committee shall
determine. The Steering Committee will exist until the termination of
the Research Program unless the Parties otherwise agree in writing.
4.2 Chairperson. The chairperson of the Steering Committee shall be
designated by Wyeth-Ayerst. The chairperson will be responsible for
scheduling meetings of the Steering Committee, preparing agendas for
meetings, sending to all Steering Committee members notices of all
regular meetings and agendas for such meetings. The chairperson shall
appoint a secretary for each meeting who will record the minutes of the
meeting, circulate copies of meeting minutes to the Parties and each
Steering Committee member promptly following the meeting for review,
comment and approval and finalize approved meeting minutes.
4.3 Meetings. The Steering Committee shall meet at least once each calendar
quarter and may meet at additional times as the Parties shall agree.
Either Party may call a special meeting of the Steering Committee two
(2) times per year, on fifteen(15) days written notice to the other
Party. The Party convening a special meeting shall send notices and
agenda for such meetings to the other Party and to each Steering
Committee member. Meetings will alternate between the offices of the
Parties, unless otherwise agreed, or may be held telephonically or by
video-conference. Members of the Committee shall have the right to
participate in and vote at meetings by telephone and to vote at
meetings by proxy. Each Party shall be responsible for expenses
incurred by its employees and its members of the Steering Committee
incurred in attending or otherwise participating in Steering Committee
meetings.
4.4 Decisions of the Committee. The goal of the Parties' collaboration
shall be the timely identification and development of Lead Compounds
and Collaboration Products for commercialization in the Field of Use.
All decisions of the Steering Committee shall be made by majority vote,
with at least one (1) member from each Party voting with the majority,
in the exercise of good faith to further the goal of the Collaboration.
In the event that a decision cannot be reached by the Steering
Committee, the matter shall be referred to further review and
resolution by the Chief Executive Officer of Neurocrine and President
of Wyeth-Ayerst Research as set forth in Section 14.1.
ARTICLE FIVE
COLLABORATIVE RESEARCH PROGRAM AND RESEARCH FUNDING
5.1 Research Program. Under the terms and conditions set forth herein,
Wyeth-Ayerst and Neurocrine will exclusively collaborate in the conduct
of a collaborative pre-clinical research program (the "Research
Program") to discover, identify and develop modulators of the
Neurocrine Transporters for the treatment of central nervous system
disorders, [***]. The Research Program will be focused on the screening
of the Wyeth-Ayerst Proprietary Chemical Library and Neurocrine
Proprietary Chemical Library and any other library selected by mutual
agreement of the Parties for the identification of Hits, a medicinal
chemistry program for the development of Lead Compound candidates,
screening and testing of Lead Compound candidates to identify Lead
Compounds and further preclinical research and screening of Lead
Compounds to select Collaboration Products for development and
commercialization by Wyeth-Ayerst.
5.2 Term. The initial term of the Research Program will be three (3) years
unless earlier terminated in accordance with Article Twelve hereof. The
initial term of the Research Program will begin on January 1, 1999.
Upon the expiration of the initial three (3) year term, the term of the
Research Program may, upon mutual written agreement of the Parties, be
extended for [***] extension terms on substantially the same terms as
those set forth herein. Notwithstanding the foregoing, in the event
that at the end of the initial term of the Research Program, [***] and
the Steering Committee or Wyeth-Ayerst has determined that significant
additional [***] should be conducted and the Steering Committee
determines that such additional [***] justifies extending the Research
Program by an additional [***], the Parties will extend the term of the
Research Program [***], provided, however, that in no event will
Wyeth-Ayerst be obligated to fund more than [***] Neurocrine Researcher
FTEs (at a rate of [***]) during [***].
5.3 Research Plan. Within thirty (30) days following the date this
Agreement is signed by each of the Parties and on an annual basis on or
before October 31 of each year thereafter, the Steering Committee shall
develop and approve, a research plan and budget for the collaborative
Research Program (the "Research Plan"). The Research Plan will be
updated on an annual basis and shall specifically include both detailed
plans for the following year including staffing levels, activities and
estimated expenditures as well as more general plans for the remaining
term of the Research Program. The Research Plan may only be modified or
amended upon the written approval of the Steering Committee. Except as
expressly set forth in Section 5.5 below, each Party shall be
responsible for its own costs and expenses incurred in their conduct of
the Research Program.
5.4 Conduct of the Research Program. Neurocrine and Wyeth-Ayerst shall each
use Commercially Reasonable Efforts to perform its obligations under
the Research Program in accordance with the Research Plan.
Notwithstanding, the foregoing, during the term of the Research
Program, Neurocrine shall apply an average of at least [***] Neurocrine
Researcher FTEs per year in performing its obligations under the
Research Program, which minimum number of Neurocrine Researcher FTEs
shall be increased to [***] upon the successful completion of the first
[***] (according to the criteria set forth in Exhibit B, Part 2(a))
[***] Lead Compound (as defined in Exhibit B attached hereto) and to
[***] upon the successful completion of the first [***] (according to
the criteria set forth in Exhibit B, Part 2(b)) of [***] Lead Compound,
provided, however, that neither increase shall become effective prior
to the beginning of the [***] of the Research Program. While it is
anticipated that Neurocrine and Wyeth-Ayerst will each devote to the
Research Program efforts consistent with the goals set forth in the
Research Plan, in no event will Neurocrine's failure to devote to the
Research Program more than the number of Neurocrine Researcher FTEs
funded by Wyeth-Ayerst pursuant to Section 5.5 below, in and of itself,
constitute a failure by Neurocrine to use Commercially Reasonable
Efforts to conduct the Research Program. In addition, the Parties have
agreed that the Research Plan will at all times allocate to Neurocrine
sufficient responsibilities to allow Neurocrine to devote to the
Research Program, the number of Neurocrine Researcher FTEs funded by
Wyeth-Ayerst hereunder.
5.5 Funding of the Research Program.
(a) Funding by Wyeth-Ayerst. During the initial term of the
Research Program, Wyeth-Ayerst will provide to Neurocrine the
funds in the amount of [***] per calendar quarter, which funds
are to be used by Neurocrine solely to fund the conduct of the
Research Program by [***] Neurocrine Researcher FTEs. The
funding amount set forth in the preceding sentence shall be
increased to [***] per calendar quarter upon the successful
completion of the first [***] (according to the criteria set
forth in Exhibit B, Part 2(a)) [***] Lead Compound which funds
are to be used by Neurocrine solely to fund the conduct of the
Research Program by [***] Neurocrine Researcher FTEs and to
[***] per calendar quarter upon the successful completion of
the [***] (according to the criteria set forth in Exhibit B,
Part 2(b)) of [***] Lead Compound [***] which funds are to be
used by Neurocrine solely to fund the conduct of the Research
Program by [***] Neurocrine Researcher FTEs, provided,
however, that (i) neither increase shall become effective
prior to [***] of the Research Program and (ii) subject to
clause (i) above, each such increase shall become effective on
the first day of the calendar quarter following the calendar
quarter in which the event resulting in such increase occurs.
Wyeth-Ayerst will provide the funding set forth in this
Section 5.5(a) to Neurocrine [***] during the term of the
Research Program, provided however, that the first payment
will be due on [***] business day following the date the
Parties shall have both signed this Agreement.
(b) Reporting and Reconciliation. Within thirty (30) days after
the end of each calendar quarter during the term of the
Research Program, Neurocrine will provide to Wyeth-Ayerst a
report setting forth the number of Neurocrine Researcher FTEs
devoted to the Research Program in such calendar quarter along
with their names and titles. In the event that Neurocrine
shall, in any calendar quarter, devote to the conduct of the
Research Program fewer than the number of Neurocrine
Researcher FTEs funded by Wyeth-Ayerst for the such calendar
quarter as required under Section 5.4 hereof, Neurocrine shall
in good faith endeavor to devote, at its own expense,
additional Neurocrine Researcher FTEs to the conduct of the
Research Program in subsequent calendar quarters to make up
for the shortfall. If, despite Neurocrine's good faith efforts
to make up any shortfall in number of Neurocrine Researcher
FTEs devoted to the Research Program versus the funded number
of Neurocrine Researcher FTEs set forth in Section 5.5, it is
determined at the end of the term of the Research Program that
Neurocrine has, over the life of the Research Program,
utilized less than the number of Neurocrine Researcher FTEs
funded by Wyeth-Ayerst hereunder, Neurocrine shall within
thirty (30) days after such determination refund to
Wyeth-Ayerst the excess Research Program funding provided to
Neurocrine under Section 5.5(a) above, which refund shall be
equal to [***] multiplied by the difference between (x) the
number (in the aggregate) of Neurocrine Researcher FTEs that
were funded by Wyeth-Ayerst [***] Research Program in
accordance with Section 5.5 and (y) the actual number of
Neurocrine Researcher FTEs, in the aggregate, that were
devoted to the Research Program [***] Research Program. For
example, if the number of Neurocrine Researcher FTEs funded by
Wyeth-Ayerst [***] of the Research Program was [***] and
Neurocrine, in fact, only utilized [***] Neurocrine Researcher
FTEs [***] of the Research Program, Neurocrine would refund
[***] to Wyeth-Ayerst.
(c) Records and Audits. During the term of the Research Program
and for a period of three (3) years thereafter, Neurocrine
shall keep and maintain accurate and complete records showing
the time devoted and activities performed by each Neurocrine
Researcher in performing Neurocrine's obligations under the
Research Program in sufficient detail such that the number of
Neurocrine Researcher FTEs applied to the Research Program
during each calendar quarter thereof can be accurately
determined. Upon fifteen (15) days prior written notice from
Wyeth-Ayerst, Neurocrine shall permit an independent certified
public accounting firm of nationally recognized standing
selected by Wyeth-Ayerst and reasonably acceptable to
Neurocrine, to examine the relevant books and records of
Neurocrine and its Affiliates as may be reasonably necessary
to verify the accuracy of the reports submitted to
Wyeth-Ayerst under Section 5.5(b) hereof and the number of
Neurocrine Researcher FTEs applied to the performance of
Neurocrine's obligations under the Research Program. An
examination under this Section 5.5(c) shall not occur more
than once in any calendar year and no such examination may be
conducted more than eighteen (18) months after the expiration
or earlier termination of the Research Program. The accounting
firm shall provide both Neurocrine and Wyeth-Ayerst a written
report disclosing whether the reports submitted by Neurocrine
are correct or incorrect and the specific details concerning
any discrepancies. No other information shall be provided to
Wyeth-Ayerst.
5.6 Invention Assignment Agreements. Each Neurocrine Researcher and each
scientist of Wyeth-Ayerst conducting the Research Program will have
executed Neurocrine's or Wyeth-Ayerst's, as the case may be, standard
non-disclosure and invention assignment agreement.
5.7 Reporting and Disclosure.
(a) Reports. Prior to each quarterly meeting of the Steering
Committee, Neurocrine and Wyeth-Ayerst will each provide the
other with written copies of all materials they intend to
present at the Steering Committee meeting plus, to the extent
not set forth in the Steering Committee materials, a written
report summarizing any other material data and information
arising out of the conduct of the Research Program. In the
event that after receipt of any such report, either Party
shall request additional data or information relating to
Research Program data or Collaboration Technology licensed
hereunder, the Party to whom such request is made shall
promptly provide to the other Party such data or information
that such Party reasonably believes is necessary for the
continued conduct of the Research Program.
(b) Quarterly Meetings. At the quarterly meetings of the Steering
Committee, Wyeth-Ayerst and Neurocrine will review in
reasonable detail (i) all data and information generated in
the conduct of the Research Program by each Party, and (ii)
all Collaboration Technology licensed hereunder developed by
the Parties.
(c) Disclosure. During the term of the Research Program, the
Parties will promptly disclose to one another all data,
information, inventions, techniques and discoveries (whether
patentable or not) arising out of the conduct of the Research
Program and all inventions, techniques and discoveries
(whether patentable or not) included in Collaboration
Technology licensed hereunder.
5.8 Data.
(a) Neurocrine Data. All data and information arising out of the
Research Program which relates specifically to Compounds from
the Neurocrine Proprietary Chemical Library will be owned by
Neurocrine, will be Neurocrine Confidential Information and,
subject to the licenses granted to Wyeth-Ayerst, if any, as
set forth herein, may be used by Neurocrine for any purpose.
(b) Wyeth-Ayerst Data. All data and information arising out of the
Research Program which relates specifically to Compounds from
the Wyeth-Ayerst Proprietary Chemical Library will be owned by
Wyeth-Ayerst, will be Wyeth-Ayerst Confidential Information
and, subject to the licenses granted to Neurocrine, if any, as
set forth herein, may be used by Wyeth-Ayerst for any purpose.
(c) Other Research Program Data. All data and information arising
out of the Research Program which is not Neurocrine Data or
Wyeth-Ayerst Data as set forth in (a) and (b) above, will be
jointly owned by the Parties and will be Joint Confidential
Information and, subject to the licenses granted or to be
granted by one Party to the other, if any, as set forth
herein, may be used by the Parties for any purpose.
(d) Wyeth-Ayerst Research, Clinical Development and
Commercialization Data. All data and information arising out
of Wyeth-Ayerst's research and preclinical development of Lead
Compounds and/or Collaboration Products after the term of the
Research Program and all data and information arising out of
the clinical development and commercialization of
Collaboration Products by Wyeth-Ayerst will belong to
Wyeth-Ayerst and shall be Wyeth-Ayerst Confidential
Information.
5.9 Materials.
(a) Research Program Materials. During the term of this Agreement,
upon request by either Party, the Party to whom the request is
made will promptly provide to the other Party such quantities
of Research Program Materials as shall be reasonably available
in excess of its own needs for such other Party to carry out
its respective responsibilities under this Agreement. Subject
to the licenses set forth in Article Three, each Party may use
the Research Program Materials created or developed by such
Party for any purpose.
(b) Neurocrine Materials. During the term of this Agreement,
Neurocrine will supply to Wyeth-Ayerst Neurocrine Materials
reasonably (both in quantity and identity) requested by
Wyeth-Ayerst provided (i) such Neurocrine Materials are
reasonably and readily available to Neurocrine in excess of
Neurocrine's own requirements, and (ii) supply of such
Neurocrine Materials will not, in Neurocrine's sole judgment,
(A) conflict with Neurocrine's internal or collaborative
research programs, (B) conflict with Neurocrine's internal
policies regarding such materials or (C) violate any agreement
to which Neurocrine is a party. Any Neurocrine Materials
provided to Wyeth-Ayerst hereunder together with materials
derived therefrom thereof (i) may only be used by Wyeth-Ayerst
and Wyeth-Ayerst's permitted sublicensees in the conduct of
the Research Program and/or in the discovery and/or
development of Lead Compounds and/or Collaboration Products,
(ii) may not be supplied to Third Parties, other than Third
Parties that, with the approval of the Steering Committee, are
under contract with one of the Parties to perform services in
support of the Research Program, without Neurocrine's prior
written consent which can be withheld for any reason in
Neurocrine's sole discretion and (iii) will, at Neurocrine's
option and at Neurocrine's request be returned to Neurocrine
or destroyed. The provision of Neurocrine Materials hereunder
will not constitute any grant, option or license under any
Neurocrine Patent Rights, except as expressly set forth
herein.
(c) Wyeth-Ayerst Materials. During the term of the Research
Program, Wyeth-Ayerst will supply to Neurocrine Wyeth-Ayerst
Materials reasonably (both in quantity and identity) requested
by Neurocrine, provided that (i) such Wyeth-Ayerst Materials
are reasonably and readily available in excess of
Wyeth-Ayerst's own requirement and (ii) supply of such
Wyeth-Ayerst owned Materials will not, in Wyeth-Ayerst's sole
judgment, (A) conflict with Wyeth-Ayerst's internal or
collaborative research programs, (B) conflict with
Wyeth-Ayerst's internal policies regarding such materials or
(C) violate any agreement to which Wyeth-Ayerst is a party.
Any Wyeth-Ayerst Materials provided to Neurocrine hereunder
together with any materials derived therefrom (i) may only be
used by Neurocrine in the conduct of the Research Program,
(ii) may not be supplied to Third Parties without
Wyeth-Ayerst's prior written consent which can be withheld for
any reason in Wyeth-Ayerst's sole discretion and (iii) will,
at Wyeth-Ayerst's option and at Wyeth-Ayerst's request, be
returned to Wyeth-Ayerst or destroyed. The provision of
Wyeth-Ayerst Materials hereunder will not constitute any
grant, option or license under any Wyeth-Ayerst Patent Rights,
except as expressly set forth herein.
ARTICLE SIX
SELECTION OF LEAD COMPOUNDS
AND COLLABORATION PRODUCTS
6.1 Selection of Lead Compounds During Term of Research Program. Lead
Compounds may be selected by the Steering Committee during the term of
the Research Program from Hits in the Neurocrine Proprietary Chemical
Library, Wyeth-Ayerst Proprietary Chemical Library or any other library
the Parties shall agree to screen in connection with the Research
Program. Additionally, if any Compound in the Neurocrine Proprietary
Chemical Library is identified as a Hit during the term of the Research
Program, Wyeth-Ayerst may, upon written notice to Neurocrine, select
such Compound as a Lead Compound at any time during [***].
6.2 Selection of Lead Compounds After Term of Research Program. Lead
Compounds may be selected by Wyeth-Ayerst after the term of the
Research Program from Compounds in the Wyeth-Ayerst Proprietary
Chemical Library or any other library Wyeth-Ayerst shall elect to
screen in connection with the development of Lead Compounds and
Collaboration Products using the Collaboration Technology.
Notwithstanding the foregoing, except as expressly provided in Section
6.1 above, in no event will Wyeth-Ayerst be entitled after the term of
the Research Program to select Compounds from Compounds in the
Neurocrine Proprietary Chemical Library as Lead Compounds or
Collaboration Products.
6.3 Selection of Collaboration Products. Lead Compounds will become
Collaboration Products upon Wyeth-Ayerst's decision that the Lead
Compound is a suitable clinical candidate or Wyeth-Ayerst shall elect
to file an IND with respect to such Lead Compound. Wyeth-Ayerst's
determination that a Lead Compound is a suitable clinical candidate
will be based on its preclinical profile and competitive and other
commercial considerations.
6.4 Designation of Lead Compounds and Collaboration Products. It is the
Parties' intention that the licenses set forth in Articles Three and
Twelve and all rights granted by either Party hereunder be limited to
Lead Compounds and Collaboration Products and neither Party grants to
the other any right or license in or to Patent Rights or any other
rights a Party may have in its Proprietary Chemical Library or any
Compounds included therein that are not Lead Compounds or Collaboration
Products. The Parties agree that during the term of the Research
Program (a) a compound may only be designated a Lead Compound upon the
determination of the Steering Committee, as recorded in the minutes of
a Steering Committee meeting or by written consent of the Steering
Committee, that such compound meets the criteria set forth herein for a
Lead Compound and (b) a Lead Compound may only be designated a
Collaboration Product upon Wyeth-Ayerst's written notice to the
Steering Committee that Wyeth-Ayerst has elected to initiate clinical
development with respect to the Lead Compound. After the term of the
Research Program, a compound will only be designated a Lead Compound or
a Collaboration Product hereunder upon timely written notice (within
sixty (60) days after the determination or election set forth below)
from Wyeth-Ayerst to Neurocrine describing the compound and setting
forth Wyeth-Ayerst's determination that such compound meets the
criteria set forth herein for a Lead Compound or Wyeth-Ayerst's
election to initiate clinical development of a Lead Compound elevating
the Lead Compound to Collaboration Product status hereunder.
ARTICLE SEVEN
DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION
7.1 Wyeth-Ayerst Development. Wyeth-Ayerst will, directly and/or through
Third Parties, use Commercially Reasonable Efforts to complete the
preclinical development, conduct, fund and make all decisions regarding
the clinical development of Collaboration Products. Wyeth-Ayerst will
have complete control, authority and responsibility for the regulatory
strategies adopted for the clinical development of all Collaboration
Products and will own all Regulatory Filings and Regulatory Approvals
relating to any Lead Compound or Collaboration Product.
7.2 Progress Reports. After the end of the Research Program, Wyeth-Ayerst,
within sixty (60) days after each June 30 and December 31, will provide
Neurocrine with a report summarizing the status of Wyeth-Ayerst's
clinical development activities during the six (6) month period ending
on such June 30 or December 31, as applicable, for Collaboration
Products then in active development by Wyeth-Ayerst and summarize the
development plans for Collaboration Products for the following six (6)
month period, provided, however, that Wyeth-Ayerst's failure to achieve
any of the goals or plans set forth in any such summary shall not, in
and of itself, constitute a failure by Wyeth-Ayerst to use Commercially
Reasonable Efforts to develop Collaboration Products hereunder.
7.3 Manufacturing. Wyeth-Ayerst shall use Commercially Reasonable Efforts
to manufacture Collaboration Products, directly and/or through
contracted Third Parties for sale in those countries of the Territory
where such Collaboration Products have received Regulatory Approval.
7.4 Commercialization of Collaboration Products. Wyeth-Ayerst in its sole
discretion will make all decisions regarding the commercialization and
sales and marketing of Collaboration Products and will use Commercially
Reasonable Efforts to commercialize Collaboration Products in those
countries of the world where such Collaboration Products have received
Regulatory Approval. The use of Commercially Reasonable Efforts by any
Affiliate or sublicensee of Wyeth-Ayerst to commercialize Collaboration
Products in a country shall satisfy Wyeth-Ayerst's obligation to use
Commercially Reasonable Efforts to commercialize such Collaboration
Product in such country.
7.5 Co-Promotion. On a Collaboration Product by Collaboration Product basis
at the time of NDA filing, if Neurocrine can demonstrate to
Wyeth-Ayerst's reasonable satisfaction that Neurocrine has commercial
presence in a United States or Canadian market segment not covered by
Wyeth-Ayerst or, in Wyeth-Ayerst's view, not sufficiently covered and
capability to promote such Collaboration Product in such market
segment, Wyeth-Ayerst and Neurocrine will discuss[***] co-promote such
Collaboration Product in the United States and Canada. If the Parties
agree that it would be in the commercial best interests of the Parties
for Wyeth-Ayerst and Neurocrine to so co-promote such Collaboration
Product, the Parties will, [***], use good faith efforts to negotiate a
co-promotion agreement setting forth the rights and obligations of each
Party, including, without limitation, payments to be made by either
Party to the other Party and responsibility for marketing and
promotional expenses. If, (i) [***], Neurocrine either fails to notify
Wyeth-Ayerst of its desire to co-promote such Collaboration Product or
fails to demonstrate to Wyeth-Ayerst's reasonable satisfaction that
Neurocrine has the required commercial presence and capability to
promote such Collaboration Product, or (ii) the Parties fail to enter
into a co-promotion agreement by the end of the [***] period described
above in this Section 7.5, Wyeth-Ayerst shall thereafter be free, at
its sole election, to enter into a co-promotion agreement with any
Third Party with respect to such Collaboration Product.
ARTICLE EIGHT
LICENSE FEES
8.1 License Fees. Each of the following License Fees will be payable to
Neurocrine one-time only within thirty (30) days following confirmation
by the Steering Committee that the specified event has occurred.
Event Payment
Validation of [***] model of Neurodegeneration [***] (such model [***]
and criteria for validation to be selected and agreed upon by the
Steering Committee as soon as practicable after the first Steering
Committee meeting)
Completion of screening of [***] compounds selected by the Steering [***]
Committee from the Neurocrine Proprietary Chemical Library,
Wyeth-Ayerst Proprietary Chemical Library and/or some other
library(ies) selected by the Steering Committee for the first to
complete of [***] using Neurocrine's novel High Throughput
Screening ("HTS") technology, provided, however, that the [***]
compounds selected by the Steering Committee must all be readily
available to Neurocrine in 96 well plates suitable for screening
and within a timeframe that will not materially or unreasonably
delay Neurocrine's screening efforts
The later to occur of (i) completion of screening of [***] [***]
compounds selected by the Steering Committee from the Neurocrine
Proprietary Chemical Library, Wyeth-Ayerst Proprietary Chemical
Library and/or some other library(ies) selected by the Steering
Committee for the second to complete of [***] using Neurocrine's
HTS technology and (ii) the [***] anniversary of the Effective Date
[***] target validation of [***] in a model [***] (such mode and [***]
criteria for validation to be selected and agreed upon by the
Steering Committee as soon as practicable after the first Steering
Committee meeting)
[***] validation of [***] in a model (such model and criteria for [***]
validation to be selected and agreed upon by the Steering Committee
as soon as practicable after the first Steering Committee meeting)
[***] target validation of [***] in an appropriate model for [***] [***]
(such model and criteria for validation to be selected and agreed
upon by the Steering Committee as soon as practicable after the
first Steering Committee meeting)
[***] validation of the [***] in an appropriate model for [***], [***]
(such model and criteria for validation and disease category to be
selected and agreed upon by the Steering Committee as soon as
practicable after the first Steering Committee meeting)
For the purposes of the foregoing, Neurocrine's HTS for activity
against [***] will be deemed `complete' when [***]compounds selected by
the Steering Committee have been screened for activity against [***]
and Neurocrine has prepared and delivered to Wyeth-Ayerst a final
report setting forth the results. Upon the achievement of a Licensee
Fee triggering event for [***], any License Fees relating to prior
triggering events for [***] which have not been paid, shall be deemed
payable.
8.2 Additional License Fees. The following additional License Fees will be
payable to Neurocrine [***] only regardless of the number of
Collaboration Products and the number of indications for each
Collaboration Product developed and commercialized.
Additional
Event License Fee
Filing, by Wyeth-Ayerst, of an IND in the United States [***]
permitting the clinical study of [***]
Filing, by Wyeth-Ayerst, of an IND in the United States [***]
permitting the clinical study of [***]
Filing, by Wyeth-Ayerst, of an IND in the United States [***]
permitting the clinical study of [***]
Filing, by Wyeth-Ayerst, of an IND in the United States [***]
permitting the clinical study of [***]
Achievement, by Wyeth-Ayerst, of ICE for the [***] [***]
Achievement, by Wyeth-Ayerst, of ICE for the [***] [***]
Achievement, by Wyeth-Ayerst, of ICE for the [***] [***]
Achievement, by Wyeth-Ayerst, of ICE for the [***] [***]
Initiation, by Wyeth-Ayerst, of a Pivotal Trial to study [***]
the [***]
Initiation, by Wyeth-Ayerst, of a Pivotal Trial to study [***]
the [***]
Initiation, by Wyeth-Ayerst, of a Pivotal Trial to study [***]
the [***]
Initiation, by Wyeth-Ayerst, of a Pivotal Trial to study [***]
the [***]
Filing, by Wyeth-Ayerst, of an NDA in the United States, [***]
and acceptance, by the FDA, of such NDA for filing
seeking Regulatory Approval in the United States of the
[***]
Filing, by Wyeth-Ayerst, of an NDA in the United States, [***]
and acceptance, by the FDA, of such NDA for filing,
seeking Regulatory Approval in the United States of the
[***]
Filing, by Wyeth-Ayerst, of an NDA in the United States, [***]
and acceptance, by the FDA, of such NDA for filing,
seeking Regulatory Approval in the United States of the
[***]
Filing, by Wyeth-Ayerst, of an NDA in the United States [***]
and acceptance, by the FDA, of such NDA for filing,
seeking Regulatory Approval in the United States of the
[***]
Filing, by Wyeth-Ayerst, of an NDA in Europe (either a [***]
centralized filing or filing in at least one (1) of the
European Major Market Countries), and acceptance, by the
applicable European Regulatory Authorities, of such NDA
for filing, seeking Regulatory Approval in Europe (or
such European country) of the [***]
Filing, by Wyeth-Ayerst, of an NDA in Europe (either a [***]
centralized filing or filing in at least one (1) of the
European Major Market Countries), and acceptance, by the
appropriate European Regulatory Authorities, of such NDA
for filing seeking Regulatory Approval in Europe (or such
European country) of the [***]
Filing, by Wyeth-Ayerst, of an NDA in Europe (either a [***]
centralized filing or filing in at least one (1) of the
European Major Market Countries), and acceptance, by the
applicable European Regulatory Authorities, of such NDA
for filing seeking Regulatory Approval in Europe (or such
European country) of the [***]
Filing, by Wyeth-Ayerst, of an NDA in Europe (either a [***]
centralized filing or filing in at least one (1) of the
European Major Market Countries), and acceptance, by the
applicable European Regulatory Authorities, of such NDA
for filing seeking Regulatory Approval in Europe (or such
European country) of the [***]
United States Regulatory Approval granted to Wyeth-Ayerst [***]
for the [***]
United States Regulatory Approval granted to Wyeth-Ayerst [***]
for the [***]
United States Regulatory Approval granted to Wyeth-Ayerst [***]
for the [***]
United States Regulatory Approval granted to Wyeth-Ayerst [***]
for the [***]
European (either centralized or in at least one (1) [***]
European Major Market Country) Regulatory Approval
granted to Wyeth-Ayerst for the [***]
European (either centralized or in at least one (1) [***]
European Major Market Country) Regulatory Approval
granted to Wyeth-Ayerst for the [***]
European (either centralized or in at least one (1) [***]
European Major Market Country) Regulatory Approval
granted to Wyeth-Ayerst for the [***]
European (either centralized or in at least one (1) [***]
European Major Market Country) Regulatory Approval
granted to Wyeth-Ayerst for the [***]
Any additional License Fees paid for a Collaboration Product which does
not achieve Regulatory Approval shall be fully creditable against
Additional License Fees that may be payable for Collaboration Products
subsequently developed [***]. No additional License Fee shall be
payable for the third or any subsequent Collaboration Product to
achieve the specified event.
ARTICLE NINE
ROYALTIES
9.1 Royalty Rates. Wyeth-Ayerst will pay to Neurocrine, Royalties, on a
Collaboration Product by Collaboration Product basis, which Royalties
shall be calculated using the following formula:
[***]
where,
A equals [***] of Wyeth-Ayerst's worldwide Net Sales
of such Collaboration Product, which, during the
calendar year in question, are [***]
B equals [***] of Wyeth-Ayerst's worldwide Net Sales
of such Collaboration Product, which, during the
calendar year in question, [***]; and
C equals [***] of Wyeth-Ayerst's worldwide Net Sales
of such Collaboration Product, which, during the
calendar year in question, are [***].
By way of example only, if, during a given year, Wyeth-Ayerst, its
Affiliates and sublicensees [***] the royalty payable by Wyeth-Ayerst
to Neurocrine during such year would be calculated as follows:
[***]
Neurocrine acknowledges and agrees that nothing in this Agreement shall
be construed as representing an estimate or projection of either (i)
the number of Collaboration Products that will or may be successfully
developed and/or commercialized estimate or (ii) anticipated sales or
the actual value of the Neurocrine Technology, any Lead Compound or any
Collaboration Product and that the figures set forth in this Section
9.1 or elsewhere in this Agreement or that have otherwise been
discussed by the Parties are merely intended to define Wyeth-Ayerst's
royalty obligations to Neurocrine in the event such sales performance
is achieved. WYETH-AYERST MAKES NO REPRESENTATION OR WARRANTY, EITHER
EXPRESS OR IMPLIED, THAT IT WILL BE ABLE TO SUCCESSFULLY DEVELOP AND/OR
COMMERCIALIZE ANY COLLABORATION PRODUCTS OR, IF COMMERCIALIZED, THAT IT
WILL ACHIEVE ANY PARTICULAR SALES LEVEL OF SUCH COLLABORATION
PRODUCT(S).
9.2 Royalty Adjustments. Royalties on a Collaboration Product are subject
to reductions and adjustments as a result of certain events as set
forth below; provided, however, in no event will Royalties on a
Collaboration Product in any country be [***] by reason of the
adjustments set forth below.
(a) Royalty Adjustment for Unpatented Products. If, during a given
calendar quarter, a Collaboration Product is an Unpatented
Product in one or more countries, the Royalties will be
payable to Neurocrine for the Net Sales of such Collaboration
Product in such country(ies) during such calendar quarter at
[***] of the royalty rate(s) set forth in Section 9.1 above.
To calculate the Unpatented Product Royalties, [***]. The fact
that a Collaboration Product is an Unpatented Product in one
country during any calendar quarter shall not result in a
reduction of the royalty rate used to calculate the Royalty
payable for sales of Collaboration Products in any other
country during such calendar quarter.
(b) Competition. If Competition exists, during a given calendar
quarter with respect to a Collaboration Product in a country,
the royalty rate(s) used to calculate the Royalties payable to
Neurocrine for the sale of such Collaboration Product in such
country during such calendar quarter will [***] of the royalty
rate(s) set forth in Section 9.1 above. To calculate the
Royalties when Competition exists in one or more countries,
[***]. The existence of Competition in one country during any
calendar quarter shall not result in a reduction of the
royalty rate used to calculate the Royalty payable for sales
of Collaboration Products in any other country during such
calendar quarter. If at the time of determining any
Competition adjustments, applicable IMS International data (or
such other data as may be mutually agreed by the Parties) for
such time period is unavailable, Wyeth-Ayerst may make a
reasonable estimate thereof based on prior available IMS
International data (or such other data as may be mutually
agreed by the Parties) and calculate the applicable Royalty
based on such estimate, and any difference in Royalty payments
made by Wyeth-Ayerst based on such estimate and Royalty
payments based on actual data, once available, will be
accounted for by an adjustment payment by Wyeth-Ayerst at the
time the next quarter Royalty payment is made or an adjustment
credit against Wyeth-Ayerst's future Royalty obligations, as
the case may be.
9.3 Term of Royalty. Royalties will be payable on a country by country and
Collaboration Product by Collaboration Product basis until the later of
(i) the last to expire, in such country, of the Patent Rights included
within the Collaboration Technology, [***] or (ii) with respect to the
sale of such Collaboration Product in countries of the European Union,
[***] from First Commercial Sale of such Collaboration Product in the
European Union and, with respect to the sale of such Collaboration
Product in any country outside of the European Union, [***] from First
Commercial Sale of such Collaboration Product in such country. Upon the
expiration of Wyeth-Ayerst's obligation to pay Royalties to Neurocrine
hereunder with respect to a Collaboration Product, Wyeth-Ayerst shall
have a fully paid, irrevocable, exclusive and unrestricted license
under the Collaboration Technology to make, have made, use, sell, offer
to sell and import such Collaboration Product.
9.4 Reports and Payments.
(a) Cumulative Royalties. The obligation to pay Royalties under
this Article Nine shall be imposed only once (i) with respect
to any sale of the same unit of Collaboration Product and (ii)
with respect to a single unit of Collaboration Product
regardless of how many Valid Claims of Patent Rights included
in the Collaboration Technology would, but for this Agreement,
be infringed by the making, using or selling of such
Collaboration Product.
(b) Statements and Payments. Wyeth-Ayerst shall deliver to
Neurocrine within sixty (60) days after the end of each
calendar quarter, a report certified by Wyeth-Ayerst as
accurate to the best of its ability based on information then
available to Wyeth-Ayerst, setting forth for such calendar
quarter the following information on a country-by-country and
Collaboration Product by Collaboration Product basis: (i) Net
Sales of such Collaboration Product in such country, (ii) the
basis for any adjustments to the Royalty payable for the sale
of such Collaboration Product in such country and (iii) the
Royalty due hereunder for the sale of such Collaboration
Product in such country. The total Royalty due for the sale of
Collaboration Products during such calendar quarter shall be
remitted at the time such report is made.
(c) Taxes and Withholding. All payments under this Agreement will
be made without any deduction or withholding for or on account
of any tax unless such deduction or withholding is required by
applicable law or regulations. If the paying Party is so
required to deduct or withhold such Party will (i) promptly
notify the other Party of such requirement, (ii) pay to the
relevant authorities the full amount required to be deducted
or withheld promptly upon the earlier of determining that such
deduction or withholding is required or receiving notice that
such amount has been assessed against the other Party, (iii)
promptly forward to the other Party an official receipt (or
certified copy) or other documentation reasonably acceptable
to the other Party evidencing such payment to the authorities.
In case the other Party can not take a full credit against its
tax liability for the withholding tax deducted or withheld by
the paying Party, then such other Party may propose a change
to the then current arrangement with respect to the flow of
moneys under this Agreement in order to reduce or eliminate
the extra cost for any Party and the Parties, with no
obligation as to outcome, shall discuss such proposal in good
faith.
(d) Currency. All amounts payable and calculations hereunder shall
be in United States dollars. As applicable, Net Sales shall be
translated into United States dollars in accordance with
Wyeth-Ayerst's customary and usual translation procedures,
consistently applied.
(e) Maintenance of Records; Audit. For a period of three (3)
years, Wyeth-Ayerst shall maintain and shall cause its
Affiliates and sublicensees to maintain complete and accurate
books and records in connection with the sale of Collaboration
Products hereunder, as necessary to allow the accurate
calculation of Royalties due hereunder including any records
required to calculate any Royalty adjustments hereunder. Once
per calendar year Neurocrine shall have the right to engage an
independent accounting firm acceptable to Wyeth-Ayerst, at
Neurocrine's expense, which shall have the right to examine in
confidence the relevant Wyeth-Ayerst records as may be
reasonably necessary to determine and/or verify the amount of
Royalty payments due hereunder. Such examination shall be
conducted during Wyeth-Ayerst's normal business hours, after
at least fifteen (15) days prior written notice to
Wyeth-Ayerst and shall take place at the Wyeth-Ayerst
facility(ies) where such records are maintained. Each such
examination shall be limited to pertinent books and records
for any year ending not more than thirty-six (36) months prior
to the date of request. Before permitting such independent
accounting firm to have access to such books and records,
Wyeth-Ayerst may require such independent accounting firm and
its personnel involved in such audit, to sign a
confidentiality agreement (in form and substance reasonably
acceptable to Wyeth-Ayerst) as to any of Wyeth-Ayerst's, its
Affiliates or sublicensees' confidential information which is
to be provided to such accounting firm or to which such
accounting firm will have access, while conducting the audit
under this Section 9.5 (e). The Neurocrine independent
accounting firm will prepare and provide to both Neurocrine
and Wyeth-Ayerst a written report disclosing only whether the
Royalty reports submitted and Royalties paid by Wyeth-Ayerst
are correct or incorrect and the specific details concerning
any discrepancies. No other information shall be provided to
Neurocrine. In the event there was an under-payment by
Wyeth-Ayerst hereunder, Wyeth-Ayerst shall promptly (but in no
event later than thirty (30) days after Wyeth-Ayerst's receipt
of the independent auditor's report so correctly concluding)
make payment to Neurocrine of any short-fall. In the event
that there was an over-payment by Wyeth-Ayerst hereunder,
Neurocrine shall promptly (but in no event later than thirty
(30) days after Neurocrine's receipt of the independent
auditor's report so correctly concluding) refund to
Wyeth-Ayerst the excess amount. In the event any payment by
Wyeth-Ayerst shall prove to have been incorrect by more than
seven and one-half percent (7.5%) to Neurocrine's detriment,
Wyeth-Ayerst will pay the reasonable fees and costs of
Neurocrine's independent auditor for conducting such audit.
9.5 Third Party Payments.
(a) OHSU Agreement. The Parties have agreed to share equally the
royalty payments to OHSU required under paragraph 6.02 of the
OHSU Agreement (the "Shared Obligation"). All other payments
under the OHSU Agreement shall be the responsibility of
Neurocrine. Neurocrine shall be responsible for making all
payments due under the OHSU License Agreement and, within ten
(10) days of making any payment required under paragraph 6.02
of the OHSU Agreement, Neurocrine shall provide to
Wyeth-Ayerst documentary evidence that such payment has been
made. Within thirty (30) days after Wyeth-Ayerst receives from
Neurocrine such documentary evidence, Wyeth-Ayerst shall pay
to Neurocrine an amount equal to [***] of the payments due to
the Oregon Health Sciences University pursuant to [***] for
Licensed Patent Rights (as defined in the OHSU Agreement)
included in the Neurocrine Technology licensed to Wyeth-Ayerst
hereunder, provided, however, that any credits that may accrue
to Neurocrine by reason of payments by Neurocrine to OHSU
pursuant to [***] will be considered a credit against
Neurocrine's portion of Shared Obligation, and any credits
that may accrue pursuant to [***] or Wyeth-Ayerst, as the case
may be, will be considered a credit against Neurocrine's or
Wyeth-Ayerst's, respectively, portion of the Shared
Obligation.
(b) Neurocrine Technology. [***] from any Third Party owning or
Controlling Patent Rights which would be infringed by [***]
under this Agreement, a license under such Patent Rights,
which license would permit [***] will be solely responsible
for paying [***] of the license fees and royalties that may be
payable to any such Third Party for such license(s). In the
event [***] fails or in unable to negotiate an agreement with
such Third Party within [***] may negotiate such license on
terms reasonably agreed to by [***] and in the event [***] in
obtaining such license on terms agreed to by [***] in its good
faith business judgment [***] amounts payable thereunder. If
[***] is unable to agree as to whether it is necessary to
obtain such a license from a Third Party, the issue shall be
referred to [***].
(c) Collaboration Products. Except as set forth in (a) and (b)
above, [***] determining whether to negotiate an agreement
with any Third Party that owns or Controls a Patent Right
claiming the manufacture or use of any Collaboration Product.
[***] from any Third Party owning or Controlling Patent Rights
which would be infringed by the development and sale of Lead
Compounds and Collaboration Products, a license under such
Patent Rights, and in the event [***] obtains such a license,
[***] shall pay [***] that may be payable to such Third Party
for such license(s).
(d) Third Party Licenses. Any rights to Third Party Patent Rights
licensed by Neurocrine or Wyeth-Ayerst, as the case may be,
under paragraphs (b) and (c) above, shall be considered
Neurocrine Technology or Wyeth-Ayerst Technology,
respectively. In each case, Wyeth-Ayerst and Neurocrine shall
use their Commercially Reasonable Efforts to ensure that such
licenses provide for the right to sublicense of the Third
Party Patent Rights in connection with the license of the
Neurocrine Technology and Wyeth-Ayerst Technology upon
termination of this Agreement pursuant to Article Twelve. Any
sublicenses of Third Party Patent Rights pursuant to Article
Twelve shall be subject to the assumption by the Party to whom
the rights are sublicensed of all payment and performance
obligations in connection with the exercise of the sublicensed
rights by such Party.
ARTICLE TEN
CONFIDENTIALITY, PUBLICATION AND
PUBLIC ANNOUNCEMENTS
10.1 Confidentiality. Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing, the Parties agree that, for
the term of this Agreement and for [***], each Party (the "Receiving
Party"), receiving hereunder any information designated hereunder as
Confidential Information of the other Party or information of the other
Party marked "Confidential" (in either case, the "Disclosing Party"),
shall keep such information confidential and shall not publish or
otherwise disclose or use for any purpose other than as provided for in
this Agreement except, to the extent that it can be established:
(a) by the Receiving Party that the Confidential Information was
already known to the Receiving Party (other than under an
obligation of confidentiality), at the time of disclosure by
the Disclosing Party and such Receiving Party has documentary
evidence to that effect;
(b) by the Receiving Party that the Confidential Information was
generally available to the public or otherwise part of the
public domain at the time of its disclosure to the Receiving
Party;
(c) by the Receiving Party that the Confidential Information
became generally available to the public or otherwise part of
the public domain after its disclosure or development, as the
case may be, and other than through any act or omission of a
party in breach of this confidentiality obligation;
(d) by the Receiving Party that the Confidential Information was
disclosed to that Party, other than under an obligation of
confidentiality, by a Third Party who had no obligation to the
Disclosing Party not to disclose such information to others;
(e) by the Receiving Party that the Confidential Information was
independently discovered or developed by the Receiving Party
without the use of the Confidential Information belonging to
the other Party and the Receiving Party has documentary
evidence to that effect
10.2 Authorized Disclosure.
(a) Each Party. Each Party may disclose Confidential Information
belonging to the other Party to the extent such disclosure is
reasonably necessary to:
(i) file or prosecute patent applications
claiming inventions included within the
Collaboration Technology,
(ii) prosecute or defend litigation,
(iii) exercise rights hereunder provided such
disclosure is covered by terms of
confidentiality similar to those set forth
herein, and
(iv) comply with applicable governmental laws and
regulations.
In the event a Party shall deem it necessary to disclose
pursuant to this Section 10.2 (a), Confidential Information
belonging to the other Party, the Disclosing Party shall to
the extent possible give reasonable advance notice of such
disclosure to the other Party and take reasonable measures to
ensure confidential treatment of such information.
(b) Use. Wyeth-Ayerst shall have the right to use Neurocrine
Confidential Information in the conduct of the Research
Program and in developing and commercializing Lead Compounds
and Collaboration Products. Neurocrine shall have the right to
use Wyeth-Ayerst Confidential Information in the conduct of
the Research Program and, in the event this Agreement shall be
terminated in accordance with Sections 12.3, 12.4, 12.5(a) or
12.6, in the development and commercialization of Lead
Compounds and Collaboration Products and Compounds [***].
Neurocrine shall also have the right to use that portion of
the Wyeth-Ayerst Confidential Information that relates [***].
Subject to the license granted in Article Three hereof and the
terms of this Article Ten, each Party shall have the right to
use the Joint Confidential Information for any purpose.
10.3 SEC Filings. The Parties will consult with one another on the terms of
this Agreement to be redacted in SEC filings.
10.4 Publications. During the term of the Research Program, each Party will
submit to the other Party for review and approval all proposed
academic, scientific and medical publications relating to the Research
Program, Lead Compounds, Collaboration Products and/or Collaboration
Technology for review in connection with preservation of exclusive
Patent Rights and/or to determine whether Confidential Information
should be modified or deleted. The nonpublishing Party shall have no
less than thirty (30) days to review each proposed publication. The
review period may be extended for an additional thirty (30) days in the
event the nonpublishing Party can demonstrate a reasonable need for
such extension including, but not limited to, the preparation and
filing of patent applications. By mutual agreement, this period may be
further extended. Wyeth-Ayerst and Neurocrine will each comply with
standard academic practice regarding authorship of scientific
publications and recognition of contribution of other parties in any
publications relating to Research Program, Lead Compounds,
Collaboration Products and/or Collaboration Technology.
10.5 Public Announcements.
(a) Coordination. The Parties agree on the importance of
coordinating their public announcements respecting this
Agreement and the subject matter thereof (other than academic,
scientific or medical publications that are subject to the
publication provision set forth above). Neurocrine and
Wyeth-Ayerst will, from time to time, and at the request of
the other Party discuss and agree on the general information
content relating to this Agreement, the Research Program, Lead
Compounds, Collaboration Products and/or Collaboration
Technology which may be publicly disclosed.
(b) Announcements. Neither Party will make any public announcement
(whether required by law or otherwise) regarding this
Agreement, the Research Program, Lead Compounds, Collaboration
Products and/or Collaboration Technology (other than academic,
scientific or medical publications which are subject to the
publication provision set forth above) without giving the
other Party the opportunity to review and comment prior to
release.
ARTICLE ELEVEN
INDEMNIFICATION
11.1 Indemnification by Wyeth-Ayerst. Wyeth-Ayerst will indemnify, defend
and hold harmless Neurocrine, its Affiliates, and each of its and their
respective employees, officers, directors and agents (each, a
"Neurocrine Indemnified Party") from and against any and all liability,
loss, damage, expense (including reasonable attorneys' fees and
expenses) and cost (collectively, a "Liability") which the Neurocrine
Indemnified Party may be required to pay to one or more Third Parties
resulting from or arising out of (i) any claims of any nature (other
than claims by Third Parties relating to patent infringement) arising
out (y) the conduct of the Research Program or use of Collaboration
Technology of by, on behalf of or under authority of, Wyeth-Ayerst
(other than by Neurocrine) or (z) research, development and/or
commercialization of Lead Compounds and/or Collaboration Products by,
on behalf of or under authority of, Wyeth-Ayerst (other than by
Neurocrine) and/or (ii) any Wyeth-Ayerst representation or warranty set
forth herein being untrue in any material respect when made, except in
each case, to the extent caused by the negligence or willful misconduct
of Neurocrine or any Neurocrine Indemnified Party. Notwithstanding the
foregoing, Wyeth-Ayerst shall have no obligation to defend, indemnify
or hold harmless any Neurocrine Indemnified Party from and against any
Liability arising out of or resulting from the infringement of a Third
Party Patent Right.
11.2 Indemnification by Neurocrine. Neurocrine will indemnify, defend and
hold harmless Wyeth-Ayerst, its Affiliates, and each of its and their
respective employees, officers, directors and agents (each, a
"Wyeth-Ayerst Indemnified Party") from and against and all Liability
which the Wyeth-Ayerst Indemnified Party may be required to pay to one
or more Third Parties arising out of (i) any claims of any nature
(other than claims by Third Parties relating to patent infringement)
arising out of the conduct of the Research Program by, on behalf of, or
under the authority of Neurocrine (other than by Wyeth-Ayerst) and/or
(ii) any Neurocrine representation or warranty set forth herein having
been untrue in any material respect when made, except in each case, to
the extent caused by the negligence or willful misconduct of
Wyeth-Ayerst or any Wyeth-Ayerst Indemnified Party. Notwithstanding the
foregoing, Neurocrine shall have no obligation to defend, indemnify or
hold harmless any Wyeth-Ayerst Indemnified Party from and against any
Liability arising out of or resulting from the infringement of a Third
Party Patent Right.
11.3 Procedure. Each Party will notify the other in the event it becomes
aware of a claim for which indemnification may be sought hereunder. In
case any proceeding (including any governmental investigation) shall be
instituted involving any Party in respect of which indemnity may be
sought pursuant to this Article Eleven, such Party (the "Indemnified
Party") shall promptly notify the other Party (the "Indemnifying
Party") in writing and the Indemnifying Party and Indemnified Party
shall meet to discuss how to respond to any claims that are the subject
matter of such proceeding. The Indemnifying Party, upon request of the
Indemnified Party, shall retain counsel reasonably satisfactory to the
Indemnified Party to represent the Indemnified Party and shall pay the
fees and expenses of such counsel related to such proceeding. In any
such proceeding, the Indemnified Party shall have the right to retain
its own counsel, but the fees and expenses of such counsel shall be at
the expense of the Indemnified Party unless (i) the Indemnifying Party
and the Indemnified Party shall have mutually agreed to the retention
of such counsel or (ii) the named parties to any such proceeding
(including any impleaded parties) include both the Indemnifying Party
and the Indemnified Party and representation of both parties by the
same counsel would be inappropriate due to actual or potential
differing interests between them. All such fees and expenses shall be
reimbursed as they are incurred. The Indemnifying Party shall not be
liable for any settlement of any proceeding effected without its
written consent, but if settled with such consent or if there be a
final judgment for the plaintiff, the Indemnifying Party agrees to
indemnify the Indemnified Party from and against any loss or liability
by reason of such settlement or judgment. The Indemnifying Party shall
not, without the written consent of the Indemnified Party, effect any
settlement of any pending or threatened proceeding in respect of which
the Indemnified Party is, or arising out of the same set of facts could
have been, a party and indemnity could have been sought hereunder by
the Indemnified Party, unless such settlement includes an unconditional
release of the Indemnified Party from all liability on claims that are
the subject matter of such proceeding.
11.4 Insurance. Each Party further agrees to use its Commercially Reasonable
Efforts to obtain and maintain, during the term of this Agreement,
Commercial General Liability Insurance, including Products Liability
Insurance, with reputable and financially secure insurance carriers to
cover its indemnification obligations under Sections 11.1 or 11.2, as
applicable, or self-insurance, with limits of not less than [***] per
occurrence and in the aggregate.
ARTICLE TWELVE
TERM AND TERMINATION
12.1 Government Approvals.
(a) Government Approvals. Each of Neurocrine and Wyeth-Ayerst
shall use its good faith efforts to eliminate any concern on
the part of any court or government authority regarding the
legality of the proposed transaction, including, if required
by federal or state antitrust authorities, promptly taking all
steps to secure government antitrust clearance, including,
without limitation, cooperating in good faith with any
government investigation including the prompt production of
documents and information demanded by a second request for
documents and of witnesses if requested.
(b) Co-operation. Neurocrine and Wyeth-Ayerst will cooperate and
use respectively all reasonable efforts to make all other
registrations, filings and applications, to give all notices
and to obtain as soon as practicable all governmental or other
consents, transfers, approvals, orders, qualifications
authorizations, permits and waivers, if any, and to do all
other things necessary or desirable for the consummation of
the transactions as contemplated hereby. Neither Party shall
be required, however, to divest products or assets or
materially change its business if doing so is a condition of
the transactions contemplated by this Agreement.
12.2 Term. Unless earlier terminated by mutual agreement of the Parties or
pursuant to the provisions of this Article Twelve, this Agreement will
continue in full force and effect on a country-by country and
Collaboration Product by Collaboration Product basis until the
obligation to pay Royalties with respect to the sale of such
Collaboration Product in such country expires as provided in Section
9.3 hereof.
12.3 Early Termination for [***]. In the event that at any time after the
[***] anniversary of the Effective Date, the Steering Committee shall
determine that [***] as set forth in Exhibit B Parts 1(a), 1(b), 2(a)
and 2(b), has been demonstrated for [***] (or, if this Agreement has
already been terminated with respect to [***] pursuant to Section 12.4,
the [***] subject to this Agreement), Wyeth-Ayerst may elect to
terminate this Agreement upon [***] months prior written notice to
Neurocrine. Upon such termination, Wyeth-Ayerst will have no further
funding obligation for the Research Program. In the event this
Agreement shall be terminated pursuant to this Section 12.3, all
licenses granted by Neurocrine to Wyeth-Ayerst hereunder will revert to
Neurocrine and:
(i) Wyeth-Ayerst will disclose to Neurocrine all material
Research Program research and pre-clinical data on
Hits generated prior to the date of termination
provided such data are reasonably available to
Wyeth-Ayerst and Neurocrine shall have the right to
use such data, at its own risk and expense, in its
development of Compounds (other than Wyeth-Ayerst
Compounds) which [***]
(ii) Wyeth-Ayerst will grant to Neurocrine a perpetual,
irrevocable, exclusive, royalty-free, fully-paid,
worldwide license under the Wyeth-Ayerst Technology
and Wyeth-Ayerst's interest in the Joint Technology
to make, have made, use, import, market, offer for
sale and sell in the Field of Use, Compounds (other
than Wyeth-Ayerst Compounds) which [***]
(iii) Wyeth-Ayerst shall remain free to develop and
commercialize any Wyeth-Ayerst Compound, provided,
however, that such Compound is not developed for any
indication in [***] and the continued identification,
development and commercialization of such Compound
does not utilize Neurocrine Technology.
12.4 Termination of Collaboration Product Development and Commercialization.
Subject to satisfaction of Wyeth-Ayerst's minimum Research Program
Funding commitment (i.e., [***] of Research Program Funding), in the
event that Wyeth-Ayerst shall elect at any time to discontinue all
activities relating to the development and commercialization of all
Collaboration Products which [***] or shall elect to discontinue use of
Commercially Reasonable Efforts in the development and
commercialization of all Collaboration Products which [***]
Wyeth-Ayerst shall provide written notice to Neurocrine setting forth
Wyeth-Ayerst's election to terminate this Agreement with respect to
[***] and upon Neurocrine's receipt of such notice this Agreement with
respect to [***], will terminate. In the event this Agreement shall be
terminated with respect to a Neurocrine Transporter pursuant to this
Section 12.4:
(i) Wyeth-Ayerst will disclose to Neurocrine all material
Research Program research, pre-clinical and clinical
data generated prior to the date of termination on
Hits, Lead Compounds and Collaboration Products
relating to the terminated Neurocrine Transporter(s),
provided such data are reasonably available to
Wyeth-Ayerst and Neurocrine shall have the right to
use such data, at its own risk and expense, in its
development of Compounds [***] which [***]
(ii) Wyeth-Ayerst will assign (or, if the filing [***]
grant a right of cross reference) to Neurocrine all
Regulatory Filings relating to Compounds designated
as Lead Compounds and/or Collaboration Products prior
to the date of termination of this Agreement (other
than Lead Compounds and/or Collaboration Products
which are [***] in so far as such Regulatory Filings
relate to [***];
(iii) Wyeth-Ayerst will grant to Neurocrine a perpetual,
irrevocable, exclusive, royalty-free, fully-paid,
worldwide license under the [***] to make, have made,
use, sell and import in the Field of Use, Compounds
including Compounds designated as Lead Compounds and
Collaboration Products prior to the date of
termination of this Agreement (but excluding [***]
only [***] in which [***]
(iv) Wyeth-Ayerst will enter into good faith negotiations
with Neurocrine regarding the grant to Neurocrine of
the licenses as set forth in (A), (B) and (C) below,
to allow Neurocrine to continue to develop and
commercialize, [***] designated as Lead Compounds or
Collaboration Products prior to the date of
termination of this Agreement:
(A) an exclusive, worldwide license under the
[***] to make, have made, use, import,
offer for sale and sell in the Field of Use
[***] which are [***], such license to be
on commercially reasonable terms and
conditions mutually agreed by the Parties
including, without limitation, provision of
payments intended to reflect both Parties'
investment and opportunity in such
Compounds and royalties on net sales of
such [***] the Royalties payable by
Wyeth-Ayerst to Neurocrine hereunder and
other terms and conditions which
Wyeth-Ayerst believes are reasonable
necessary or desirable to protect
Wyeth-Ayerst's research, development and
commercialization activities for [***];
(B) an exclusive, worldwide license under the
[***] to make, have made, use, import,
offer for sale and sell in the Field of Use
only [***] in which [***], such licenses to
be on commercially reasonable terms and
conditions mutually agreed by the Parties
including, without limitation, provision of
payments intended to reflect both Parties'
investment and opportunity in such
Compounds and royalties on net sales of
such [***] the Royalties payable by
Wyeth-Ayerst to Neurocrine hereunder and
other terms and conditions which
Wyeth-Ayerst believes are reasonable
necessary or desirable to protect
Wyeth-Ayerst's research, development and
commercialization activities for [***];
(C) an exclusive, worldwide license under the
[***] to make, have made, use, import,
offer for sale and sell in the Field of Use
only [***] in which [***], such licenses to
be on commercially reasonable terms and
conditions mutually agreed by the Parties
including, without limitation, provision of
payments intended to reflect both Parties'
investment and opportunity in such
Compounds and royalties on net sales of
such [***] Royalties payable by
Wyeth-Ayerst to Neurocrine hereunder and
other terms and conditions which
Wyeth-Ayerst believes are reasonable
necessary or desirable to protect
Wyeth-Ayerst's research, development and
commercialization activities [***]
(D) upon the grant of the licenses set forth in
(A), (B) and/or (C) above, Wyeth-Ayerst will
assign (or, if the filing [***] grant a
right of cross reference) to Neurocrine all
Regulatory Filings on [***] that are the
subject of the license in so far as such
Regulatory Filings relate [***] which [***]
and
(v) Wyeth-Ayerst shall remain free to develop and/or
sublicense any [***] to Third Parties, provided,
however, in no event will Wyeth-Ayerst commercialize
or sublicense Third Parties to commercialize [***]
designated as Lead Compounds or Collaboration
Products prior to the date of termination of this
Agreement (a) for [***] and (b) if the identification
or continued development and commercialization of
such Compound utilizes Neurocrine Technology.
Notwithstanding the foregoing, Wyeth-Ayerst shall have no obligation to
negotiate or grant any of the licenses set forth in (iv) (A), (B), or
(C) above with respect to [***].
12.5 Default.
(a) Wyeth-Ayerst. Upon the Default by Wyeth-Ayerst under this
Agreement, Neurocrine may notify Wyeth-Ayerst of such Default
and require that Wyeth-Ayerst cure such Default within [***],
provided, however, that if such Default is not susceptible of
cure within [***] period and Wyeth-Ayerst uses its
Commercially Reasonable Efforts to cure such default, such
[***] period shall be extended to [***]. In the event
Wyeth-Ayerst shall not have cured the Default at the end of
the period specified in the preceding sentence, Neurocrine may
upon written notice to Wyeth-Ayerst terminate this Agreement
and upon such termination:
(i) all licenses granted by Neurocrine to Wyeth-
Ayerst herein will revert to Neurocrine:
(ii) Wyeth-Ayerst will satisfy its minimum
Research Funding commitment hereunder [***]
to the extent not previously satisfied;
(iii) Wyeth-Ayerst will disclose to Neurocrine all
material Research Program research,
pre-clinical and clinical data on Hits, Lead
Compounds and Collaboration Products
generated prior to the date of termination
of this Agreement, provided such data are
reasonably available to Wyeth-Ayerst and
Neurocrine thereafter shall have the right
to use such data, at its own risk and
expense, to develop Compounds [***] which
[***];
(iv) Wyeth-Ayerst will assign (or, if the filing
[***] grant a right of cross reference) to
Neurocrine all Regulatory Filings relating
to Compounds designated as Lead Compounds
and/or Collaboration Products prior to the
date of termination of the Agreement (other
than Lead Compounds and/or Collaboration
Products that are [***] in so far as such
Regulatory Filings relate [***] in which
[***];
(v) Wyeth-Ayerst will grant to Neurocrine a
perpetual, irrevocable, exclusive,
royalty-free, fully-paid, worldwide license
under [***] to make, have made, use, import,
market, offer for sale and sell in the Field
of Use, Compounds including Compounds
designated as Lead Compounds and/or
Collaboration Products prior to the date of
termination of this Agreement [***] only
[***] in which [***];
(vi) Wyeth-Ayerst will grant to Neurocrine an
exclusive, worldwide license under [***] to
make, have made, use, import, market, offer
for sale and sell in the Field of Use only
[***] in which [***] which have been
designated as Lead Compounds and/or
Collaboration Products prior to the date of
termination of this Agreement, such license
to be on commercially reasonable terms and
conditions to be mutually agreed by the
Parties including provision of payments
intended to reflect both Parties'
investment and opportunity in such
Compounds and royalties on net sales of
[***] Royalties payable by Wyeth-Ayerst to
Neurocrine hereunder provided, however,
that Wyeth-Ayerst shall have no obligation
to negotiate or grant any license with
respect to any [***]
(vii) upon the grant of the licenses set forth in
(vi) above, Wyeth-Ayerst will assign (or, if
the filing is not [***] in which [***] grant
a right of cross reference) to Neurocrine
all Regulatory Filings on the Wyeth-Ayerst
Compounds that are the subject of the
license in so far as such Regulatory Filings
relates [***] in which [***]; and
(viii) Wyeth-Ayerst shall remain free to develop
and/or sublicense [***] provided, however,
in no event will Wyeth-Ayerst commercialize
or sublicense Third Parties to commercialize
any [***] designated as Lead Compounds or
Collaboration Products prior to the date of
termination of this Agreement (a) for [***]
in which [***] and (b) if the
identification, continued development and
commercialization of such Compound utilizes
Neurocrine Technology.
(b) Neurocrine. Upon the Default by Neurocrine under this
Agreement, Wyeth-Ayerst may notify Neurocrine of such Default
and require that Neurocrine cure such Default within [***],
provided, however, that if such Default is not susceptible of
cure within such [***] period and Neurocrine uses its
Commercially Reasonable Efforts to cure such default, such
[***] period shall be extended to [***]. In the event
Neurocrine shall not have cured the Default within the period
specified in the preceding sentence, Wyeth-Ayerst may upon
written notice to Neurocrine elect to terminate this Agreement
and upon such termination:
(i) Neurocrine will grant to Wyeth-Ayerst a
perpetual, irrevocable, non-exclusive,
royalty-free, fully paid, worldwide license
under the Neurocrine Transporter Technology
to make, have made, use, import, market,
offer for sale and sell in the Field of Use,
Compounds (other than Neurocrine Compounds)
which [***]
(ii) Neurocrine will grant to Wyeth-Ayerst a
perpetual, irrevocable, exclusive,
royalty-free, fully paid, worldwide license
under the Neurocrine Technology and
Neurocrine's interest in the Joint
Technology to make, have made, use, import,
market, offer for sale and sell in the Field
of Use, Compounds (other than Neurocrine
Compounds), only [***] in which [***]
(iii) Neurocrine will grant to Wyeth-Ayerst an
exclusive, royalty-free, worldwide license
under the Neurocrine Technology and
Neurocrine's interest in the Joint
Technology to develop, make, have made, use,
import, market, offer for sale and sell in
the Field of Use, Neurocrine Compounds which
have been designated as Lead Compounds
and/or Collaboration Products prior to the
date of termination of this Agreement only
[***].
12.6 Bankruptcy. Each party may, in addition to any other remedies available
to it by law or in equity, exercise the rights set forth below by
written notice to the other Party (the "Insolvent Party"), in the event
the Insolvent Party shall have become insolvent or bankrupt, or shall
have made an assignment for the benefit of its creditors, or there
shall have been appointed a trustee or receiver of the Insolvent Party
or for all or a substantial part of its property, or any case or
proceeding shall have been commenced or other action taken by or
against the Insolvent Party in bankruptcy or seeking reorganization,
liquidation, dissolution, winding-up arrangement, composition or
readjustment of its debts or any other relief under any bankruptcy,
insolvency, reorganization or other similar act or law of any
jurisdiction now or hereafter in effect, or there shall have been
issued a warrant of attachment, execution, distraint or similar process
against any substantial part of the property of the Insolvent Party,
and any such event shall have continued for sixty (60) days
undismissed, unbonded and undischarged. All rights and licenses granted
under or pursuant to this Agreement by Neurocrine and Wyeth-Ayerst are,
and shall otherwise be deemed to be, for purposes of Section 365 (n) of
the U.S. Bankruptcy Code, licenses of rights to "intellectual property"
as defined under Section 101 of the U.S. Bankruptcy Code. The Parties
agree that the Parties as licensees of such rights under this
Agreement, shall retain and may fully exercise all of their rights and
elections under the U.S. Bankruptcy Code. The Parties further agree
that, in the event of the commencement of a bankruptcy proceeding by or
against either Party under the U.S. Bankruptcy Code, the other Party
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 same, if not already in the their
possession, shall be promptly delivered to them (i) upon any such
commencement of a bankruptcy proceeding upon its written request
therefor, unless the Party subject to such proceeding elects to
continue to perform all of their obligations under this Agreement or
(ii) if not delivered under (i) above, upon the rejection of this
Agreement by or on behalf of the Party subject to such proceeding upon
written request therefor by the other Party.
(a) Neurocrine. In the event Neurocrine shall be an Insolvent
Party, Wyeth-Ayerst:
(i) may terminate the Research Program; and/or
(ii) keep this Agreement in full force and effect and
retain all licenses granted by Neurocrine to
Wyeth-Ayerst herein to make, have made, use, import,
market, offer for sale and sell Lead Compounds and
Collaboration Products in the Field of Use, subject
to the payment to Neurocrine of the License Fees and
Royalties set forth above.
(b) Wyeth-Ayerst. In the event Wyeth-Ayerst shall be an Insolvent
Party, Neurocrine may, to the extent permitted by applicable
law, terminate this Agreement and all licenses granted by
Neurocrine to Wyeth-Ayerst herein will revert to Neurocrine
and:
(i) Wyeth-Ayerst will disclose to Neurocrine all material
Research Program research, pre-clinical and clinical
data on Hits, Lead Compounds and Collaboration
Products generated prior to the date of termination
provided such data are reasonably available to
Wyeth-Ayerst and Neurocrine thereafter shall have the
right to use such data, at its own risk and expense,
to develop Compounds [***] which [***]
(ii) Wyeth-Ayerst will assign (or, if the filing is not
[***] in which [***] grant a right of cross
reference) to Neurocrine all Regulatory Filings
relating to Lead Compounds and/or Collaboration
Products (other than Lead Compounds and/or
Collaboration Products [***]) in so far as such
Regulatory Filings relate [***] in which [***];
(iii) Wyeth-Ayerst will grant to Neurocrine a perpetual,
irrevocable, exclusive, royalty-free, fully-paid,
worldwide license [***] to make, have made, use,
import, market, offer for sale and sell in the Field
of Use, Compounds ([***]) which [***];
(iv) Wyeth-Ayerst will grant to Neurocrine, a perpetual,
irrevocable, exclusive, royalty free, fully-paid,
worldwide license [***] to make, have made, use,
import, market, offer for sale and sell in the Field
of Use, Neurocrine Compounds designated as Lead
Compounds and/or Collaboration Products prior to the
date of termination of this Agreement for [***] in
which [***];
(v) Wyeth-Ayerst will grant to Neurocrine an exclusive,
worldwide license under [***] to make, have made,
use, import, market, offer for sale and sell in the
Field of Use, [***] which have been designated as
Lead Compounds and/or Collaboration Products prior to
the date of termination of this Agreement for [***]
in which [***], such license to be on commercially
reasonable terms and conditions mutually agreed by
the Parties including provision of payments intended
to reflect both Parties' investment and opportunity
in such Compounds and royalties on net sales of such
[***] Royalties and License Fees payable by
Wyeth-Ayerst to Neurocrine hereunder and upon the
grant of such license, Wyeth-Ayerst will assign to
Neurocrine all Regulatory Filings on [***] which have
been designated as Lead Compounds and/or
Collaboration Products prior to the date of
termination of this Agreement.
12.7 Acquisition. Upon the Acquisition of Neurocrine by a Third Party (a)
such that Neurocrine [***], (b) such that Neurocrine [***], or (c) who
is [***], Wyeth-Ayerst shall have the right at any time on or before
[***] following such the completion of such Acquisition to elect one or
more of the following:
(a) terminate the Research Program;
(b) terminate this Agreement; or
(c) keep this Agreement in full force and effect and
retain all licenses granted by Neurocrine to
Wyeth-Ayerst herein to make, have made, use, sell and
import Lead Compounds and Collaboration Products, in
the Field of Use, subject to the payment to
Neurocrine of the License Fees and Royalties set
forth above.
12.8 Liabilities. Termination of this Agreement shall not release either
Party from any obligation or liability which shall have accrued at the
time of termination, or preclude either Party from pursuing all rights
at law and in equity with respect to any Default under this Agreement.
Notwithstanding the foregoing, neither Party will be liable for
punitive, exemplary or consequential damages incurred by the other
Party arising out of any Default under this Agreement.
12.9 Disclaimer. WITH RESPECT TO ANY DATA, INFORMATION OR INTELLECTUAL
PROPERTY THAT EITHER PARTY BECOMES OBLIGATED TO TRANSFER TO THE OTHER
UNDER THIS ARTICLE TWELVE, THE TRANSFERING PARTY MAKES NO
REPRESENTATIONS AND EXPRESSLY DISCLAIMS AND MAKES NO WARRANTIES OF ANY
KIND, WRITTEN OR ORAL, EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, OR THAT ANY SUCH INFORMATION, DATA OR INTELLECTUAL
PROPERTY IS ACCURATE OR COMPLETE OR CAN BE USED BY THE RECEIVING PARTY
WITHOUT INFRINGING THE INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.
ARTICLE THIRTEEN
INTELLECTUAL PROPERTY
13.1 Inventions. Each Party shall own Patent Rights claiming inventions made
by its employees or agents in the performance of such Party's
obligations under this Agreement (respectively, "Neurocrine Inventions"
and "Wyeth-Ayerst Inventions") and both Parties shall jointly own
inventions made jointly by employees or agents of both Parties in the
performance of their obligations hereunder ("Joint Inventions").
Inventorship shall be determined in accordance with United States laws
of inventorship.
13.2 Patent Prosecution.
(a) Wyeth-Ayerst Inventions and Collaboration Products.
Wyeth-Ayerst, at its expense, shall use Commercially
Reasonable Efforts to prepare, file, prosecute, and maintain
worldwide (i) Patent Rights relating to Wyeth-Ayerst
Inventions and (ii) Patent Rights claiming Lead Compounds
and/or Collaboration Products exclusively licensed to
Wyeth-Ayerst hereunder.
(b) OHSU Licensed Patent Rights. Consistent with the terms and
conditions of the OHSU Agreement, OHSU shall be responsible
for preparation, filing, prosecution and maintenance of Patent
Rights relating to the Licensed Patent Rights (as defined in
the OSHU Agreement) included in the Collaboration Technology.
Wyeth-Ayerst and Neurocrine will [***] after the Effective
Date in connection with the preparation, filing, prosecution
and maintenance of such Patent Rights. Wyeth-Ayerst shall pay
to Neurocrine its share of such expenses within thirty (30)
days after Wyeth-Ayerst's receipt from Neurocrine of an
invoice therefor, which invoice shall be accompanied by
supporting documentation showing, in reasonable detail, the
expenses so incurred.
(c) Neurocrine Inventions. Neurocrine, [***], will use
Commercially Reasonable Efforts to prepare, file, prosecute,
and maintain worldwide Patent Rights relating to Neurocrine
Inventions.
(d) Joint Inventions. Wyeth-Ayerst, [***], shall use Commercially
Reasonable Efforts to prepare, file, prosecute, and maintain
worldwide Patent Rights relating to Joint Inventions.
13.3 Enforcement of Patent Rights.
(a) Wyeth-Ayerst Inventions. Wyeth-Ayerst shall have the sole
right but not the obligation, in its own name and at its own
expense, to enforce Patent Rights relating to Wyeth-Ayerst
Inventions or Wyeth-Ayerst Technology against any Third Party
suspected of infringing a claim of such a Patent Right.
(b) Neurocrine Inventions and Joint Inventions. Wyeth-Ayerst shall
have the first right, but not the obligation, in its own name,
to enforce Patent Rights relating to Neurocrine Inventions and
Joint Inventions, against any Third Party suspected of
infringing a claim of such a Patent Right. In the event
Wyeth-Ayerst shall not elect to enforce any Patent Right
relating to a Neurocrine Invention or Joint Invention,
Neurocrine shall have the right to do so. The Party electing
to enforce such Patent Rights (the "Enforcing Party") shall
have exclusive control over the conduct of any such
proceedings, including the right to settle or compromise such
proceedings consistent with Wyeth-Ayerst's licenses hereunder,
provided, however, that the Enforcing Party may not settle or
compromise any such action in a manner which diminishes the
Patent Rights relating to any Neurocrine Inventions without
Neurocrine's consent or Joint Inventions without the consent
of both Parties or which would impose any financial obligation
on the other Party without such other Party's consent. The
expenses of any proceeding the Enforcing Party initiates,
including lawyers' fees and costs, shall be borne by the
Enforcing Party, provided, however, that the other Party (the
"Non-enforcing Party") may elect to pay [***] of all such
expenses. The Non-enforcing Party will cooperate fully with
the Enforcing Party in such action upon request by the
Enforcing Party. In the event the Non-enforcing Party has not
elected [***], any award or recovery paid to the Enforcing
Party by a Third Party as a result of such patent infringement
proceedings (whether by way of settlement or otherwise) shall
first be applied toward reimbursement of legal fees, costs and
expenses incurred by the Enforcing Party, and from the
remainder, if any, Wyeth-Ayerst in the event Wyeth-Ayerst
shall be the Enforcing Party shall pay to Neurocrine (or
Neurocrine shall retain in the event Neurocrine shall be the
Enforcing Party) an amount equal to the applicable Royalty
rate set forth in Article Nine as applied to the remainder as
though such remainder were added to Net Sales in the year in
which the recovery is made. In the event the Non-enforcing
Party [***], such award or recovery paid to the Enforcing
Party shall first be applied toward reimbursement of legal
fees, costs and expenses incurred by the Parties (in
proportion to expenses incurred), and the remainder, if any,
shall be divided equally between the Parties.
(c) OHSU Licensed Patent Rights. Wyeth-Ayerst, as Neurocrine's
exclusive sublicensee of certain Patent Rights included in the
OHSU Licensed Patent Rights (as defined in the OHSU
Agreement), shall have with respect to patent enforcement of
Patent Rights exclusively licensed to Wyeth-Ayerst hereunder,
the rights of an exclusive sublicensee under Article Eleven of
the OHSU Agreement.
(d) Neurocrine Technology. Neurocrine shall have the sole right
but not the obligation, in its own name and at its own
expense, to enforce Patent Rights relating to Neurocrine
Technology (other than Neurocrine Inventions and OHSU Licensed
Patent Rights (as defined in the OHSU Agreement)) against any
Third Party suspected of infringing a claim of such a Patent
Right.
13.4 Infringement Defense.
(a) Wyeth-Ayerst. Wyeth-Ayerst shall have the right, but not the
obligation, to defend and control any suit against any of
Wyeth-Ayerst, Wyeth-Ayerst's Affiliates or sublicensees,
alleging infringement of any patent or other intellectual
property right of a Third Party arising out of the
manufacture, use, sale, offer to sell or importation of a
Collaboration Product by Wyeth-Ayerst, Wyeth-Ayerst's
Affiliates or sublicensees. Wyeth-Ayerst shall be responsible
for the costs and expenses, including lawyer's fees and costs,
associated with any suit or action, Wyeth-Ayerst and
Neurocrine will consult with one another and cooperate in the
defense of any such action. If Wyeth-Ayerst finds it necessary
or desirable to join Neurocrine as a party to any such action,
Neurocrine will execute all papers and perform such acts as
shall be reasonably required, at Wyeth-Ayerst expense. In the
event the patent claim of any Third Party is held in a final
and unappealable order of a court to be valid and infringed,
or if Wyeth-Ayerst enters into a settlement of such
proceedings, Wyeth-Ayerst shall pay the full amount of any
damages and/or settlement amounts due to such Third Party,
provided, however, [***].
(b) OHSU Licensed Patent Rights. Wyeth-Ayerst, as Neurocrine's
exclusive sublicensee of certain Patent Rights included in the
OHSU Licensed Patent Rights (as defined in the OHSU
Agreement), shall have with respect to infringement defense
relating to Licensed Patent Rights (as defined in the OHSU
Agreement) exclusively licensed to Wyeth-Ayerst hereunder, the
rights of an exclusive sublicensee under Article Eleven of the
OHSU Agreement.
13.5 Cooperation Between the Parties. The Parties recognize that the
designation of a Compound as a Lead Compound or Collaboration Product
may impact the designation of the Party responsible for such invention
under this Article Thirteen. The Parties anticipate that patent
applications may be filed on Compounds prior to designation of the
Compound as Lead Compound or Collaboration Product, and agree to
co-operate in deciding how to allocate responsibilities and expenses in
the event designation of a Compound as a Lead Compound or Collaboration
Product impacts responsibilities under this Article Thirteen. In
addition, the Parties agree to cooperate with each other in the
preparation, filing, prosecuting, maintenance, defense and enforcement
of Patent Rights included in Collaboration Technology licensed
hereunder. In any action taken in the prosecution of, or in the defense
of an action by a Third Party related to patent invalidity or
non-patentability of any patent application or patent claiming
Collaboration Technology licensed hereunder, neither Party shall admit
the invalidity or non-patentability of any Patent Right or take any
other action that may diminish Patent Rights within Collaboration
Technology licensed hereunder without the other Party's prior written
consent. Wyeth-Ayerst agrees to provide Neurocrine with sufficient time
to review, comment and consult on all patent applications and patents
and all correspondence to and from the various patent offices,
including, but not limited to, proposed responses, interferences and
oppositions, claiming Neurocrine Inventions, Joint Inventions and
Wyeth-Ayerst Inventions. The Parties agree to cooperate with each other
and to use best efforts to ensure the cooperation of any of their
respective personnel and licensee(s) or licensor(s) as might reasonably
be requested in any such matters, and shall sign any necessary legal
papers and provide the prosecuting party with data or other information
in support thereof. The Parties will confer on what action to take with
respect to the defense of infringement proceedings naming both
Wyeth-Ayerst and Neurocrine or in proceedings to enforce patents
claiming Collaboration Technology licensed hereunder against a Third
Party. If the Parties cannot agree on the course of action to be taken
in the filing, prosecution, maintenance, or enforcement of any Joint
Invention or Wyeth-Ayerst Invention, Wyeth-Ayerst's decisions shall
control. If the Parties cannot agree on the course of action to be
taken in the filing, prosecution, maintenance, or enforcement of
Neurocrine Invention, Neurocrine's decisions shall control.
ARTICLE FOURTEEN
MISCELLANEOUS
14.1 Disputes. If the Parties are unable to resolve a dispute among them
informally, Wyeth-Ayerst and Neurocrine, by written notice to the
other, may have such dispute referred to their respective executive
officers designated for attempted resolution by good faith
negotiations:
For Wyeth-Ayerst: President of Wyeth-Ayerst
Research for development issues
President Wyeth-Ayerst Global Pharmaceuticals
for commercialization issues
For Neurocrine: President and Chief Executive Officer
Any such dispute shall be submitted to the above-designated executive
officers no later than thirty (30) days following such request by
either Wyeth-Ayerst or Neurocrine. In the event the designated
executive officers are not able to resolve any such dispute within
[***] after submission of the dispute to such executive officers,
Wyeth-Ayerst or Neurocrine, as the case may be, may pursue what ever
measures are legally available to them to resolve such dispute. All
negotiations pursuant to this Section 14.1 shall be treated as
compromise and settlement negotiations. Nothing said or disclosed, nor
any document produced, in the course of such negotiations which is not
otherwise independently discoverable shall be offered or received as
evidence or used for impeachment or for any other purpose in any
current or future arbitration or litigation.
14.2 Assignment. Neither this Agreement nor any interest hereunder shall be
assignable by either Party without the prior written consent of the
other Party, except for assignment by operation of law in connection
with a merger of a Party with or into another Person. This Agreement
shall be binding upon the successors and permitted assigns of the
Parties and the name of a Party appearing herein shall be deemed to
include the names of such Party's successors and permitted assigns to
the extent necessary to carry out the intent of this Agreement. Any
assignment not in accordance with this Section 14.2 shall be void.
14.3 Further Actions. Each Party agrees to execute, acknowledge and deliver
such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent
of the Agreement.
14.4 Force Majeure. No Party shall be liable to the other Party for loss or
damages or shall have any right to terminate this Agreement for any
default or delay attributable to any Force Majeure, if the Party
affected shall give prompt notice of any such cause to the other Party.
The Party giving such notice shall thereupon be excused from such of
its obligations hereunder as it is thereby disabled from performing for
so long as it is so disabled, provided, however, that such affected
Party commences and continues to use its Commercially Reasonable
Efforts to cure such cause.
14.5 Correspondence and Notices.
(a) Ordinary Notices. Correspondence, reports, documentation, and
any other communication in writing between the Parties in the
course of ordinary implementation of this Agreement shall be
delivered by hand, sent by facsimile transmission (receipt
verified), or by airmail to the employee or representative of
the other Party who is designated by such other Party to
receive such written communication.
(b) Extraordinary Notices. Extraordinary notices and other
communications hereunder (including, without limitation, any
notice of force majeure, breach, termination, change of
address, exercise of rights to negotiate additional
agreements, etc.) shall be in writing and shall be deemed
given if delivered personally or by facsimile transmission
(receipt verified), mailed by registered or certified mail
(return receipt requested), postage prepaid, or sent by
nationally recognized express courier service, to the Parties
at the following addresses (or at such other address for a
Party as shall be specified by like notice, provided, however,
that notices of a change of address shall be effective only
upon receipt thereof):
All correspondence to Wyeth-Ayerst shall be addressed as
follows:
Wyeth-Ayerst Laboratories
▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇. ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: Senior Vice President, Global Business Development
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
with a copy to:
American Home Products Corporation
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▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
Attn: Senior Vice President and General Counsel
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
All correspondence to Neurocrine shall be addressed as
follows:
Neurocrine Biosciences, Inc.
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▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇-▇▇▇▇
Attn: Director Product Licensing
Fax: ▇▇▇-▇▇▇-▇▇▇▇
with a copy to:
Neurocrine Biosciences, Inc.
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▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇-▇▇▇▇
Attn: Corporate Secretary
Fax: ▇▇▇-▇▇▇-▇▇▇▇
14.6 Amendment. No amendment, modification or supplement of any provision of
this Agreement shall be valid or effective unless made in writing and
signed by a duly authorized officer of each Party.
14.7 Waiver. No provision of the Agreement shall be waived by any act,
omission or knowledge of a Party or its agents or employees except by
an instrument in writing expressly waiving such provision and signed by
a duly authorized officer of the waiving Party.
14.8 Counterparts. This Agreement may be executed in any number of
counterparts, each of which need not contain the signature of more than
one Party but all such counterparts taken together shall constitute one
and the same agreement.
14.9 Descriptive Headings. The descriptive headings of this Agreement are
for convenience only, and shall be of no force or effect in construing
or interpreting any of the provisions of this Agreement.
14.10 Governing Law. This Agreement shall be governed by and interpreted in
accordance with the substantive laws of the State of Delaware (without
regard to conflict of law principles) and the Parties hereby submit to
the exclusive jurisdiction of the federal courts of the state of
California.
14.11 Severability. In the event that any clause or portion thereof in this
Agreement is for any reason held to be invalid, illegal or
unenforceable, the same shall not affect any other portion of this
Agreement, as it is the intent of the Parties that this Agreement shall
be construed in such fashion as to maintain its existence, validity and
enforceability to the greatest extent possible. In any such event, this
Agreement shall be construed as if such clause of portion thereof had
never been contained in this Agreement, and there shall be deemed
substituted therefor such provision as will most nearly carry out the
intent of the Parties as expressed in this Agreement to the fullest
extent permitted by applicable law unless doing so would have the
effect of materially altering the right and obligations of the Parties
in which event this Agreement shall terminate and all the rights and
obligations granted to the Parties hereunder shall cease and be of no
further force and effect.
14.12 Entire Agreement of the Parties. This Agreement constitutes and
contains the complete, final and exclusive understanding and agreement
of the Parties and cancels and supersedes any and all prior
negotiations, correspondence, understandings and agreements including,
without limitation, the Prior Agreement, whether oral or written, among
the Parties respecting the subject matter hereof and thereof.
14.13 Independent Contractors. The relationship between Wyeth-Ayerst and
Neurocrine created by this Agreement is one of independent contractors
and neither Party shall have the power or authority to bind or obligate
the other except as expressly set forth in this Agreement.
14.14 No Trademark Rights. Expect as otherwise provided herein, no right,
express or implied, is granted by this Agreement to use in any manner
the name "Neurocrine Biosciences" "Wyeth-Ayerst," or any other trade
name or trademark of the other Party or its Affiliates in connection
with the performance of this Agreement.
14.15 Accrued Rights; Surviving Obligations. Unless explicitly provided
otherwise in this Agreement, termination, relinquishment or expiration
of the Agreement for any reason shall be without prejudice to any
rights which shall have accrued to the benefit to any Party prior to
such termination, relinquishment or expiration, including damages
arising from any breach hereunder. Such termination, relinquishment or
expiration shall not relieve any Party from obligations which are
expressly indicated to survive termination or expiration of the
Agreement, including, without limitation, those obligations set forth
in Articles Ten, Eleven and Twelve and Sections 5.8, 5.9, 9.4, 14.1 and
14.5 hereof.
14.16 Export. Notwithstanding anything to the contrary set forth herein, all
obligations of Neurocrine and Wyeth-Ayerst are subject to prior
compliance with United States and foreign export regulations and such
other United States and foreign laws and regulations as may be
applicable and to obtaining all necessary approvals required by
applicable agencies of the governments of the United States and foreign
jurisdictions. Neurocrine and Wyeth-Ayerst will co-operate with one
another and provide assistance to one another as reasonably necessary
to obtain any required approvals.
IN WITNESS WHEREOF, duly authorized representatives of the Parties have
duly executed this Agreement to be effective as of the Effective Date.
AMERICAN HOME PRODUCTS CORPORATION, NEUROCRINE BIOSCIENCES, INC.
acting through its
WYETH-AYERST LABORATORIES DIVISION
By /s/ ▇▇▇▇ ▇▇▇▇ By: /s/ ▇▇▇▇ ▇▇▇▇▇
Name: ▇▇▇▇ ▇▇▇▇ Name: ▇▇▇▇ ▇▇▇▇▇
Title: Vice President & Title: President &
Associate General Counsel Chief Executive Officer
Date: 03/02/98 Date: 03/02/98
EXHIBIT A
TRANSPORTERS
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EXHIBIT B
LEAD COMPOUND
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EXHIBIT C
PATENT RIGHTS
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EXHIBIT D
OHSU AGREEMENT
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EXHIBIT E
THIRD PARTY PATENTS
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EXHIBIT F
OTHER NEUROCRINE OBLIGATIONS
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