Exhibit 10.16
RESEARCH COLLABORATION AGREEMENT
This RESEARCH COLLABORATION AGREEMENT (the "Agreement"), effective as of October 18, 1996 (the "Effective Date"), is made by and between 3-Dimensional Pharmaceuticals, Inc. ("3DP"), a Delaware corporation, having a principal place of business at 665 Stockton Drive, Suite 104, Exton, Pennsylvania 19341, and BIOCRYST Pharmaceuticals, Inc. ("BIOCRYST"), a Delaware corporation, having a principal place of business at 2190 Parkway Lake Drive, Birmingham, Alabama 35244.
BACKGROUND
WHEREAS, 3DP has rights to certain compound libraries and to certain synthesis and screening technologies (including the DirectedDiversity technology and the ThermoFluor technology) which, when applied, may reduce the time and expense of identifying and developing potentially useful compounds for use in the prevention, treatment, diagnosis and monitoring of diseases, states and conditions in humans;
WHEREAS, BIOCRYST has identified certain compounds that are [**]
WHEREAS, subject to the terms and conditions of this Agreement, 3DP and BIOCRYST desire to have access to each other's technologies, discoveries and inventions and conduct a joint research program to attempt to identify and optimize compounds that act as [**]
NOW, THEREFORE, for and in consideration of the foregoing premises, and the covenants, conditions, and undertakings set forth herein, the receipt and sufficiency of which the parties hereby acknowledge, it is agreed by and between the parties as follows:
ARTICLE 1
DEFINITIONS
For purposes of this Agreement the following terms shall have the following meanings:
1.1 "3DP Compound" shall mean a compound contained in a 3DP Library
------------ and/or any other compound synthesized by 3DP independently of the Research Program for activity outside the Field excluding BIOCRYST Compounds and any compound contained in a Focused Library.
1.2 "3DP Library" shall mean any chemical compound library developed
----------- by or on behalf of 3DP independently of the Research Program for activity outside the Field using the 3DP Technology and excluding Focused Libraries.
1.3 "3DP Technology" shall mean the patented and proprietary
-------------- technology developed, licensed or acquired by 3DP prior to the Effective Date or developed, licensed or acquired by 3DP after the Effective Date either independently of the Research Program or by 3DP alone without any assistance or contribution from BIOCRYST as part of the Research Program, which is useful for the creation of custom combinatorial chemical libraries as well as
**Certain portions of this Exhibit have been omitted based upon a request for confidential treatment that has been filed with the Commission. The omitted portions have been filed separately with the Commission.
the chemical synthesis of compounds contained in such libraries, including without limitation the screening technologies known as DirectedDiversity and ThermoFluor.
1.4 "Affiliate" shall mean any corporation, firm, partnership or
--------- other entity which during the term of this Agreement controls, is directly or indirectly owned by or controlled by or is under common control with 3DP or BIOCRYST, respectively, but only for so long as such entity controls, is directly or indirectly owned by or controlled by, or is under common control with 3DP or BIOCRYST. For this purpose, control means the possession of the power to direct or cause the direction of the management and the policies of an entity whether through ownership, either directly or indirectly, of over fifty percent (50%) of the stock entitled to vote, or in the case of a non-corporate entity, the right to receive over fifty percent (50%) of either the profits or the assets upon dissolution or if not meeting the preceding requirements, any company owned or controlled by or owning or controlling 3DP or BIOCRYST at the maximum control or ownership right permitted in the country where such company exists.
1.5 "BIOCRYST Compounds" shall mean (i) the compounds and classes of
------------------ compounds specified on Exhibit A attached hereto, which have been identified by
--------- BIOCRYST prior to the Effective Date as having activity (or potential activity) [**] (ii) any derivatives of the compounds specified in Exhibit A that are
--------- "obvious" to scientists skilled in the art of compound structure or drug design. For purposes of this definition, "obvious" shall have the meaning ascribed to such term by the Federal Patent Laws of the United States of America.
1.6 "BIOCRYST Compound Derivative" shall mean a compound that (i)
---------------------------- has been synthesized in the course of the Research Program and demonstrates activity within the Field, (ii) is not a BIOCRYST Compound but (iii) is a non- obvious derivative of a BIOCRYST Compound. For purposes of this definition, "obvious" shall have the meaning ascribed to such term by the Federal Patent Laws of the United States of America.
1.7 "BIOCRYST Technology" shall mean BIOCRYST's structure based drug
------------------- design technologies developed, licensed or acquired by BIOCRYST prior to the Effective Date or developed, licensed or acquired by BIOCRYST after the Effective Date either independently of the Research Program or by BIOCRYST alone without any assistance or contribution from 3DP as part of the Research Program.
1.8 [**]
1.9 "Confidential Information" means all non-public, proprietary or
------------------------ otherwise confidential information, now owned, licensed or controlled or hereafter acquired, developed, owned, licensed or controlled by a disclosing party or any of its Affiliates during the Term of this Agreement. Confidential Information shall include, but not be limited to: (i) BIOCRYST Compounds and BIOCRYST Technology; (ii) the 3DP Libraries, the 3DP Compounds and the 3DP Technology; (iii) Focused Libraries and Research Results; (iv) Lead Compounds, BIOCRYST Compound Derivatives, Optimized Lead Compounds, and Development Candidates; and (v) Products prior to their first commercial sale.
**Certain portions of this Exhibit have been omitted based upon a request for confidential treatment that has been filed with the Commission. The omitted portions have been filed separately with the Commission.
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1.10 "Consultant" shall mean any Third Party that has been retained by
---------- either party to assist such party in performing any of its research obligations under this Agreement, and, in the case of BIOCRYST, includes, without limitation, the University of Alabama at Birmingham.
1.11 "Development Candidate" shall mean a Lead Compound, BIOCRYST
--------------------- Compound Derivative or an Optimized Lead Compound identified in the course of the Research Program that meets the criteria for full preclinical development of such compound into a drug for human use (i) as set forth in the Research Plan or (ii) as otherwise agreed by the parties.
1.12 "Field" shall mean inhibitors of [**], and all uses and
----- applications thereof; provided, however, that the Field may be broadened to
-------- ------- include [**] by mutual agreement of both parties in writing.
1.13 "Focused Assay" shall mean a test or trial developed specifically
------------- for screening against Focused Libraries in the course of the Research Program, to identify Lead Compounds, BIOCRYST Compound Derivatives or Optimized Lead Compounds that have activity in the Field, including, without limitation, ThermoFluor technology.
1.14 "Focused Library" shall mean any chemical compound library that
--------------- has been synthesized by or on behalf of 3DP specifically for use by or on behalf of 3DP or BIOCRYST in the course of the Research Program.
1.15 "Interest" shall mean a party's right, title and interest in any
-------- Jointly Owned Right.
1.16 "Invention" shall mean any invention or discovery, whether or not
--------- patented or patentable, including, but not limited to, discoveries, compositions, know-how, procedures, technical information, and any process, method, device, formula, protocol, technique, design, drawing, methodology, and biological or chemical material.
1.17 "Jointly Owned Rights" shall have the meaning ascribed to such
-------------------- term in Section 5.2 hereto.
1.18 "Lead Compound" shall mean a chemically defined compound that
------------- has been synthesized in the course of the Research Program, has activity in the Field and which meets the criteria set forth in the Research Plan to be fit for optimization, but excluding BIOCRYST Compounds and BIOCRYST Compound Derivatives.
1.19 "License Income" shall mean the gross amount actually received by
-------------- either party or its Affiliates for or on account of authorized licenses of rights to any Development Candidate or any Product containing such Development Candidate, including upfront license fees, milestone payments and royalties (the amount of the gross royalties being determined by the terms of the agreement with the authorized licensee, which may take into account factors such as combination sales) without deduction of any kind, but excluding the following:
**Certain portions of this Exhibit have been omitted based upon a request for confidential treatment that has been filed with the Commission. The omitted portions have been filed separately with the Commission.
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(a) Payments received by either party or its Affiliate solely
for performance of research and development, including but not limited
to milestone payments for achievement of objectives in research and
development, only to the extent that such payments cover the actual
cost of the research and development work.
(b) Investments made by a licensee in either party or its
Affiliates to the extent that such investments are made at current
market value, including but not limited to, any payments or other
consideration representing the current market value of shares in such
party or its Affiliates.
(c) Payments made to either party or its Affiliate solely to the
extent that they cover the actual costs of conducting clinical testing
and other activities in connection with obtaining regulatory approval
for a Product.
(d) Reimbursed expenses of either party or its Affiliates.
For purposes of Subparagraph (b) above, the "current market value" of the investment shall be determined as follows: (i) it shall be determined as at the earlier of (a) the date when the investment is made or (b) the day prior to the date when the investment is first publicly disclosed on the Dow Jones News
-------------- Wire (the "Determination Date"); (ii) if there is no public market for the ---- party's securities that are being purchased by the licensee, then the current market value shall be determined by that party's Board of Directors in good faith, and if the other party disputes such determination, the current market value shall be determined by an independent investment banker whose fees shall be shared by the parties; (iii) if there is a public market for such party's securities that are being purchased by the licensee, then the current market value shall be determined using the average of the closing price quoted on any exchange on which the securities are listed as published in The Wall Street
--------------- Journal for the ten (10) trading days prior to the Determination Date. ------- Notwithstanding the foregoing, in the event the licensee is purchasing a party's securities in connection with such party's initial public offering of such securities, the current market value shall be determined using the offering price of such securities to the public in such party's initial public offering.
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1.20 "Net Sales" shall mean the gross invoice price of a Product sold by
--------- 3DP, BIOCRYST or their Affiliates ("Selling Party") to Third Parties, less, to the extent included in such invoice price, the total of: (i) ordinary and customary trade discounts actually allowed; (ii) credits, rebates and returns; (iii) freight, postage, and duties paid for and separately identified on the invoice or other documentation maintained in the ordinary course of business; and (iv) excise taxes, sales taxes, value added taxes, and duties actually paid and separately identified on the invoice or other documentation maintained in the ordinary course of business. Net Sales shall also include the amount or fair market value of all other considerations received by the Selling Party from Third Parties in respect of a Product, whether such consideration is in cash, payment in kind, exchange, or another form. Sales between or among 3DP or BIOCRYST and their respective Affiliates or authorized licensees shall be excluded from the computation of Net Sales, except where such Affiliates or authorized licensees are end users of the Product, in which case such sales shall be deemed to have been made for cash at a price equal to the amount that would
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be charged to a Third Party at such time, in an arms-length transaction for a similar quantity of the Product. A "sale" of a Product is deemed to occur upon the earlier of invoicing, shipment or transfer of title in the Product to a Third Party, unless a party's Affiliate or licensee is an end user of the Product, in which case the sale shall occur upon the transfer of the Product to the Affiliate or licensee that is the end user. In the event that a Product is sold or distributed for use in combination with or as a component of other products, the calculation of "Net Sales" from such combination product shall be determined (i) by agreement of the parties acting reasonably in good faith or (ii) if agreement cannot be reached within six (6) months after commencement of negotiations, by arbitration in accordance with Article 10 hereof, in either case considering the relative importance and proprietary protection of the various products and components involved.
1.21 "Optimized Lead Compound" shall mean a Lead Compound or a
----------------------- BIOCRYST Compound Derivative which, through a process of optimization, demonstrates a specified level of activity in the Field (i) as set forth in the Research Plan or (ii) as otherwise agreed by the parties.
1.22 "Patent Rights" shall mean patent applications and issued
------------- patents, in the United States or any other country or jurisdiction, as well as any divisions, continuations, continuations-in-part, reissues, reexaminations, patents of addition, extensions or other governmental actions which extend any of the subject matter of such patent application or patent, and any substitutions, confirmations, registrations, or revalidation of any of the foregoing.
1.23 "Product" shall mean any product containing a Development
------- Candidate.
1.24 "Proprietary Rights" shall mean Patent Rights, copyrights, trade
------------------ secret rights, trademarks and similar rights.
1.25 "Research Committee" or "RC" shall mean the research organization
------------------ -- comprising representatives of 3DP and BIOCRYST as described in Article 3 hereof.
1.26 "Research Plan" shall mean the written overall plan prepared by
------------- the RC for the Research Program the parties will conduct in the Field during the Term.
1.27 "Research Program" shall mean the program of collaborative
---------------- research in the Field to be carried out by the parties in accordance with the Research Plan and the terms and conditions of this Agreement.
1.28 "Research Program Invention" shall mean an Invention first
-------------------------- conceived, identified, isolated, created or first reduced to practice by the parties, either independently or jointly, in the course of the Research Program excluding any improvement to 3DP's DirectedDiversity, BIOCRYST Technology and either party's assay technologies.
1.29 "Research Results" shall mean all data and information arising
---------------- from either party's performance of its obligations under the Research Plan in the course of the Research Program.
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1.30 "Term" shall mean the period commencing on the Effective Date and
---- terminating in accordance with Article II hereof.
1.31 "Third Party" shall mean any person, business or entity other
----------- than 3DP, BIOCRYST, and their respective Affiliates.
1.32 "Third Party Obligation" shall mean any contractual or other
---------------------- obligation of a party or any of its Affiliates to a Third Party, including, without limitation, an obligation to make payments to a Third Party for a license to technology or in respect of a Third Party's Proprietary Rights.
1.33 "Unresolved Dispute" shall mean a dispute or disagreement that
------------------ has arisen between the parties in connection with the validity, construction, meaning, enforceability, or performance of this Agreement or in connection with any aspect of the arrangements under this Agreement, that has been submitted for resolution to the RC, and to the senior officers of each party in accordance with Section 3.4 hereof, and remains unresolved after taking such steps.
ARTICLE 2
COLLABORATIVE RESEARCH PROGRAM
2.1 Preparation of Research Plan. Promptly after execution of this
----------------------------- Agreement, the parties' representatives on the RC shall commence preparation of a detailed research plan which shall set forth the parties' respective obligations and responsibilities in connection with the Research Program. Once the RC has prepared the proposed research plan, it shall submit the proposed research plan to the appropriate members of management of both parties for their review. Once the parties mutually agree that the proposed research plan is in an acceptable form, the proposed research plan shall become the Research Plan for purposes of this Agreement once it has been executed and delivered by a duly authorized representative of each party.
2.2 Research Program Activities. Once the Research Plan has been
---------------------------- completed and executed and delivered, subject to the terms and conditions set forth herein, the parties shall carry out the Research Program in accordance with the Research Plan with the goal of identifying Lead Compounds and Optimized Lead Compounds. The RC shall review the Research Plan on an ongoing basis and may revise the Research Plan periodically or as necessary by agreement of the RC in accordance with Article 3 hereto.
2.2.1 BIOCRYST's Responsibilities. BIOCRYST shall have the
--------------------------- following responsibilities, which shall be carried out in accordance with the Research Plan in the Field:
(a) providing results of its research, structural
knowledge of compounds and information regarding Research
Program Inventions, all within the Field;
(b) through its participation in the RC, designing
Lead Compounds based in part on the structural knowledge,
discoveries, Research Program Inventions, research results and
expertise described in Section 2.2.1(a) above;
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(c) conducting optimization of Lead Compounds or
BIOCRYST Compound Derivatives either independently or jointly
with 3DP;
(d) conducting preliminary preclinical
pharmacological analyses of Lead Compounds and Optimized Lead
Compounds to evaluate potency, efficacy and selectivity;
(e) presenting Lead Compounds, Optimized Lead
Compounds and the Research Results in relation thereto to the RC;
(f) providing adequate reagents for screening;
(g) screening assays as appropriate to validate and
confirm Focused Assay results; and
(h) performing such other responsibilities set forth
in this Agreement or that the parties may mutually agree upon
in writing.
2.2.2 3DP's Responsibilities. 3DP shall have the following
----------------------- responsibilities, which shall be carried out in accordance with the Research Plan in the Field:
(a) preparing Focused Libraries;
(b) preparing Focused Assays;
(c) screening the Focused Libraries using the Focused
Assays of its DirectedDiversity technology and ThermoFluor
technology, conducting chemical synthesis of the compounds in
the Focused Library which have activity in the Field discovered
by such screening, identifying Lead Compounds and providing
Research Results in relation thereto to the RC;
(d) conducting optimization of Lead Compounds or
BIOCRYST Compound Derivatives either independently or jointly
with BIOCRYST;
(e) presenting Lead Compounds, Optimized Lead
Compounds and Research Results in relation thereto to the RC; and
(f) performing such other responsibilities set forth
in this Agreement or that the parties may mutually agree upon in
writing.
2.2.3 Research Licenses. Subject to all the terms and
------------------ conditions of this Agreement, and only to the limited extent necessary for the purposes of this Agreement, each party (the "Licensor") hereby grants to the other party (the "Licensee") under its Proprietary Rights, a royalty free, non- transferable, non-sublicensable, license to conduct the Licensee's research responsibilities under the Research Plan for the Term of this Agreement.
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2.2.4 Disclosure of Research Results and Research Program
--------------------------------------------------- Inventions. Each party shall promptly disclose in writing to the chief ---------- scientific officer of the other party and to the RC, all Research Results and Research Program Inventions it develops, conceives or first reduces to practice in the course of the Research Program.
2.3 Access to Focused Libraries and Screening. BIOCRYST shall have direct
------------------------------------------ access to the Focused Libraries during the Research Program, as is necessary for purposes of the Research Program.
2.4 BIOCRYST Compounds and BIOCRYST Technology. 3DP acknowledges that (i)
-------------------------------------------- BIOCRYST has previously expended substantial financial and research resources in relation to its work in the Field and the BIOCRYST Technology that exists as of the Effective Date, (ii) has identified the BIOCRYST Compounds and (iii) has an on-going research, development and commercialization program in relation to the BIOCRYST Compounds in the Field which BIOCRYST shall be conducting independently of the arrangements under this Agreement. Notwithstanding any other provision of this Agreement to the contrary, the parties agree that BIOCRYST shall be free to (a) conduct its independent research, development and commercialization program in the Field in relation to BIOCRYST Compounds using the BIOCRYST Technology, (b) research, develop and commercialize BIOCRYST Compounds and any product or service based thereon in the Field, without restriction, reference or payment to 3DP, (c) conduct any independent research, development and commercialization program outside the Field in relation to BIOCRYST Compounds and BIOCRYST Technology and (d) research, develop and commercialize BIOCRYST Compounds, BIOCRYST Technology and any product or service based thereon outside the Field, without restriction, reference or payment to 3DP.
2.5 3DP Compounds, 3DP Libraries and 3DP Technology. BIOCRYST
------------------------------------------------- acknowledges that 3DP (i) has previously expended substantial financial and research resources in relation to the 3DP Compounds, the 3DP Libraries and the 3DP Technology that exist as of the Effective Date and (ii) has an on-going research, development and commercialization program in relation to the 3DP Compounds, the 3DP Libraries and the 3DP Technology outside the Field which 3DP shall be conducting independently of the arrangements under this Agreement. Notwithstanding any other provision of this Agreement to the contrary, the parties agree that 3DP shall be free to (a) conduct its independent research, development and commercialization program outside the Field in relation to the 3DP Compounds, the 3DP Libraries and the 3DP Technology, (b) research, develop and commercialize such 3DP Compounds, 3DP Libraries, the 3DP Technology and any product or service based thereon outside the Field, without restriction, reference or payment to BIOCRYST and (c) test within the Field any 3DP Compounds which have activity outside the Field solely to establish the potential for side-effects.
2.6 Records. 3DP, BIOCRYST and their Affiliates shall maintain records of
-------- their own activities and conduct in the course of the Research Program (or cause such records to be maintained) in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved in the performance of the Research Program (including, but not limited to, all data in the form required under any applicable governmental regulations and as
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directed by the RC). Each party shall allow the other party, at the other party's sole cost, to have reasonable access to all pertinent materials and data generated by or on behalf of such party in connection with the Research Program.
2.7 Expenditures.
-------------
2.7.1 BIOCRYST Expenditures. BIOCRYST shall bear all costs and
---------------------- expenses (other than 3DP's costs of participating in the RC and reviewing the Research Results from BIOCRYST's work) related to (i) performance of its obligations unde ...
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