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AMENDED AND RESTATED RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

Research and Development Agreement

AMENDED AND RESTATED RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT | Document Parties: Chiron Corporation | Novartis Vaccines and Diagnostics, Inc | XOMA (US) LLC You are currently viewing:
This Research and Development Agreement involves

Chiron Corporation | Novartis Vaccines and Diagnostics, Inc | XOMA (US) LLC

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Title: AMENDED AND RESTATED RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
Date: 3/11/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

AMENDED AND RESTATED RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT, Parties: chiron corporation , novartis vaccines and diagnostics  inc , xoma (us) llc
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Exhibit 10.24C

AMENDED AND RESTATED

RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

This Amended and Restated Research, Development and Collaboration Agreement (this “ Agreement ”) is effective as of July 1, 2008 (the “ Effective Date ”) by and between Novartis Vaccines and Diagnostics, Inc. (f/k/a Chiron Corporation), a Delaware corporation with offices at 4650 Horton Street, Emeryville, California 94608 (together with its Affiliates, “ NVDI ”), and XOMA (US) LLC, a Delaware limited liability company with offices at 2910 Seventh Street, Berkeley, California 94710 (together with its Affiliates, “ XOMA ”). NVDI and XOMA are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties .” When used in this Agreement, capitalized terms shall have the meanings set forth in Article 1.

RECITALS

1. The Parties established a collaborative relationship to research, develop and commercialize antibody products in the field of oncology pursuant to that certain agreement executed on February 27, 2004 by and between the Parties (the “Initial Agreement” ).

2. The Parties entered into that certain Research, Development and Commercialization Agreement dated as of May 26, 2005 (the “Original Agreement” ) to replace the Initial Agreement to set forth in further detail the terms of the collaborative relationship between the Parties.

3. The Parties now wish to amend and restate the Original Agreement on the terms set forth below.

IN CONSIDERATION of the mutual covenants and agreements contained in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

ARTICLE 1

DEFINITIONS

The following terms shall have the following meanings as used in this Agreement:

1.1 “Accounting Standards” means (a) with respect to NVDI, International Financial Reporting Standards, and (b) with respect to XOMA, United States generally accepted accounting principles, in each case consistently applied and as in effect from time to time.

1.2 “Affiliate” means any entity that is controlled by, controls or is under common control with NVDI or XOMA, as applicable. For such purpose, the term “ control ” means (a) direct or indirect ownership of more than fifty percent (50%) of the voting interest in the entity in question, or more than fifty percent (50%) interest in the income of the entity in question; or (b) possession, directly or indirectly, of the power to direct or cause the direction of management or policies of the entity in question (whether through ownership of securities or other ownership interests, by contract or otherwise).


1.3 “Agreement Product” means any of the Collaboration Products, Resumed Products, Reactivated Products and Ongoing Products.

1.4 “Agreement Target” means each of the Targets in the Original Collaboration immediately prior to the Effective Date as set forth on Schedule 1.4 .

1.5 “Antibody” means any immunoglobulin molecule whether in monospecific or any other form and shall include, without limitation, immunoglobulin fragments, such as Fv, Fab, F(ab’) and single-chain antibodies.

1.6 “Antibody Product” means any composition of matter or article of manufacture consisting essentially of an Antibody alone or integrally associated with a composition of matter or article of manufacture (including without limitation conjugates bound to a toxin, label or other moiety) providing therapeutic, half-life, safety or other advantages to the Antibody. For the avoidance of doubt, Antibody Product does not include gene therapy products, Fc fusion proteins lacking antibody variable domains or viral conjugates.

1.7 “BLA” means a biologics license application with the FDA as more fully described at 21 CFR § 601.2, or successor equivalent.

1.8 “Collaboration Inventions” means any and all Inventions Controlled by a Party and made, conceived, reduced to practice or otherwise acquired or licensed, either alone or jointly with another, on or after the Effective Date of the Initial Agreement and before the Effective Date and arising out of the activities of the Parties under the Original Collaboration and pursuant to research and development plans and budgets approved under the Initial Agreement or the Original Agreement, excluding, however, any and all Inventions encompassed within the Expression and Engineering Technologies. For the avoidance of doubt, (a) any and all such Inventions which constitute an improvement to either NVDI Background IP or XOMA Background IP made, conceived, reduced to practice or otherwise acquired or licensed on or after the Effective Date of the Initial Agreement and before the Effective Date and in the course of the Original Collaboration shall be deemed to be Collaboration Inventions, and (b) any and all Inventions made, conceived, reduced to practice or otherwise acquired or licensed on or after the Effective Date shall not be Collaboration Inventions. Notwithstanding the foregoing, the Parties acknowledge that, to the extent any Collaboration Invention is covered by a license or other agreement with a Third Party, such Collaboration Invention shall, for all purposes of this Agreement, be subject to the financial and other obligations, limitations and restrictions contained in such Third Party license or agreement.

1.9 “Collaboration IP” means any and all Collaboration Know-How and any and all Collaboration Patent Rights.

1.10 “Collaboration Know-How” means any and all Know-How Controlled by a Party and made, conceived, reduced to practice or otherwise acquired or licensed, either alone or jointly with others, on or after the Effective Date of the Initial Agreement and before the Effective Date and arising out of the activities of the Parties under the Original Collaboration and


pursuant to research and development plans and budgets approved under the Initial Agreement or the Original Agreement that is necessary or useful in the research, development, manufacture or commercialization of a Collaboration Product, excluding, however, any and all Know-How encompassed within the Expression and Engineering Technologies. For the avoidance of doubt, (a) any and all such Know-How which constitutes an improvement to either NVDI Background IP or XOMA Background IP made, conceived, reduced to practice or otherwise acquired or licensed on or after the Effective Date of the Initial Agreement and before the Effective Date and in the course of the Original Collaboration shall be deemed to be Collaboration Know-How, and (b) any and all Know-How made, conceived, reduced to practice or otherwise acquired or licensed on or after the Effective Date shall not be Collaboration Know-How. Notwithstanding the foregoing, the Parties acknowledge that, to the extent any Collaboration Know-How is covered by a license or other agreement with a Third Party, such Collaboration Know-How shall, for all purposes of this Agreement, be subject to the financial and other obligations, limitations and restrictions contained in such Third Party license or agreement.

1.11 “Collaboration Patent Rights” means Patent Rights claiming Collaboration Inventions.

1.12 “Collaboration Product” means any Antibody Product that: (a) binds to CD40 or [*] and (b) is identified, generated or otherwise created, or acquired from a Third Party, by either Party before or after the Effective Date, provided, however, that such Antibody Product shall cease to be a Collaboration Product when the Target it binds to becomes a Pending Target pursuant to Section 2.1(d)(i), and provided, further that, if such Target again becomes a Collaboration Target pursuant to Section 2.1(d)(ii), such Antibody Product, as well as any other Antibody Product that binds to the same Target and that has been, or is later, identified, generated or otherwise created, or acquired from a Third Party by either Party at any time, shall again become a Collaboration Product.

1.13 “Collaboration Target” means each of CD40 and [*] unless or until either or both of such Targets become Pending Targets pursuant to Section 2.1(d)(i), but subject to either or both of such Targets again becoming Collaboration Targets pursuant to Section 2.1(d)(ii).

1.14 “Commercially Reasonable and Diligent Efforts” means, with respect to the efforts to be expended by a Party hereunder, efforts and resources comparable to those used by the Top 10 Pharmaceutical Companies (with respect to NVDI), or an appropriately funded biotechnology company of comparable market capitalization (with respect to XOMA) as would reasonably be expected to be exerted or employed for a product proprietary to that company, which product is of similar market potential (taking into account the relevant patent and proprietary position) at a similar stage in its development or product life to the applicable Target, Antibody or Antibody Product (or another comparable product if no such Antibody Product exists), utilizing sound and reasonable scientific, business, (where relevant) pre-clinical and clinical practice and judgment in order to develop and commercialize such product in a timely manner. A Party’s obligation to devote Commercially Reasonable Efforts may be satisfied by that Party’s or its Affiliate’s efforts.) Notwithstanding the foregoing, to the extent that the performance of a Party’s responsibilities hereunder is adversely affected by the other Party’s failure to perform its responsibilities hereunder, such Party shall not be deemed to have failed to use Commercially Reasonable and Diligent Efforts in performing such responsibilities.


1.15 [*]

1.16 “Confidential Information” means all know-how, inventions, technical, marketing, financial or other similar information, including without limitation proprietary information and biological and other tangible materials (whether or not patentable). Materials, know-how or other information that is orally, electronically or visually disclosed by a Party, or is disclosed in writing without an appropriate letter, stamp or legend, shall constitute Confidential Information if such information is of the type that should reasonably have been considered confidential by the receiving Party at the time of disclosure, given the circumstances surrounding the disclosure of such materials, know-how or other information.

1.17 “Control” or “Controlled” means, with respect to any Know-How or Patent Rights, possession of the ability (whether arising by ownership or license) to grant rights, ownership, access, a license or a sublicense (as applicable) to such intellectual property as provided for herein without violating the terms of any written agreement with a Third Party entered into prior to the time such Party would be first required hereunder to grant the other Party such access, license or sublicense.

1.18 “Controlling Party” means (a) with respect to Collaboration Inventions and Post-Effective Date Inventions made, conceived or reduced to practice in the course of a Collaboration Project or in the course of developing or commercializing a Collaboration Product, and all Collaboration Patent Rights and Post-Effective Date Patent Rights covering or claiming any such Invention(s), NVDI, (b) with respect to Collaboration Inventions and Post-Effective Date Inventions made, conceived or reduced to practice in the course of a Resumed Project or in the course of developing or commercializing a Resumed Product, and all Collaboration Patent Rights and Post-Effective Date Patent Rights covering or claiming any such Invention(s), XOMA, (c) with respect to Collaboration Inventions and Post-Effective Date Inventions made, conceived or reduced to practice in the course of a Reactivated Project or an Ongoing Project, and all Collaboration Patent Rights and Post-Effective Date Patent Rights covering or claiming any such Invention(s), the Party progressing such Reactivated Project or Ongoing Project, and (d) with respect to Collaboration Inventions and Post-Effective Date Inventions made, conceived or reduced to practice in the course of Preliminary Research with respect to a particular Inactive Project, and all Collaboration Patent Rights and Post-Effective Date Patent Rights covering or claiming any such Invention(s), the Party conducting such Preliminary Research.

1.19 “Effective Date of the Initial Agreement” means February 27, 2004.

1.20 “Expression and Engineering Technologies” means (a) the bacterial cell expression technology Controlled by XOMA Ireland Limited and subsequently licensed to XOMA (with the right to sublicense hereunder) and any improvements thereto which are made, conceived, reduced to practice or otherwise acquired or licensed on or after the Effective Date of the Initial Agreement and before the Effective Date and in the course of the Original Collaboration, and (b) the Human Engineering™ Technology.

1.21 “FDA” means the United States Food and Drug Administration and any successor agency.


1.22 “Human Engineering Technology” means the Human Engineering™ technology Controlled by XOMA Ireland Limited and subsequently licensed to XOMA (with the right to sublicense hereunder) and any improvements thereto which are made, conceived, reduced to practice or otherwise acquired or licensed on or after the Effective Date of the Initial Agreement and before the Effective Date and in the course of the Original Collaboration.

1.23 “Inactive Product” means: (a) in the case where CD40 or [*] is the Inactive Target, an Antibody Product that is deemed an Inactive Product pursuant to Section 2.1(d)(iv); (b) in the case where an Inactive Target becomes a Reactivated Target and later becomes an Inactive Target again pursuant to Section 2.2(d), an Antibody Product that is deemed an Inactive Product pursuant to Section 2.2(d); and (c) in the case of any other Inactive Target, (i) an Antibody Product that binds to such Inactive Target and that was initially identified, generated or otherwise created, or acquired from a Third Party, by either Party in the course of the Original Collaboration, or (ii) any other Antibody Product that also binds to such Inactive Target and that is derived from, or derived from the use of, an Antibody Product referred to in clause (i) of this sentence.

1.24 “Inactive Target” means any Agreement Target that is not subject to a Project. The Inactive Targets existing as of the Effective Date are set forth on Schedule 1.24 .

1.25 “IND” means an investigational new drug application with the FDA as more fully described at 21 CFR § 312.20, or successor equivalent, or a comparable filing with a Regulatory Authority outside the United States.

1.26 “Inventions” means any and all inventions, discoveries or ideas, and improvements thereto (whether or not patentable).

1.27 “Know-How” means any and all know-how, trade secrets, data, processes, techniques, procedures, compositions, materials, devices, methods, formulas, protocols, pre-clinical and clinical data and information, including any and all chemical, biochemical, toxicological, and scientific research information, whether in written, electronic, graphic or video form or any other form or format.

1.28 “Net Sales” means the gross invoice price of Products sold by or on behalf of NVDI (or its Affiliates or sublicensees) for sale of Collaboration Products, NVDI Ongoing Products and NVDI Reactivated Products, or XOMA (or its Affiliates or sublicensees) for sale of Resumed Products, XOMA Ongoing Products and XOMA Reactivated Products, as the case may be (each, a “ Selling Entity ”), in each case to Third Parties, in bona fide, arms-length transactions after deduction of all of the following (reasonably documented):

(a) [*]

all as determined in accordance with the Selling Entity’s usual and customary Accounting Standards as consistently applied by the Selling Entity.


Amounts invoiced between a Selling Entity and its Affiliates for quantities of Product for use in clinical trials or for resale, or by a Selling Entity or its Affiliates to permitted sublicensees of the license(s) granted hereunder for resale shall not be included in the calculation of Net Sales.

Any of the items set forth above that would otherwise be deducted from the invoice price in the calculation of Net Sales but which are separately charged to Third Parties shall not be deducted from the invoice price in the calculation of Net Sales.

Net Sales of any Product sold by or on behalf of a Selling Entity or its Affiliates as part of a product that in addition to Product contains one or more other active ingredients (a “Combination Product”), shall be calculated as follows:

 

 

(1)

The Net Sales for the purpose of determining royalty-style payments on sales of the Combination Product shall be calculated by [*].

 

 

(2)

[*]

1.29 “NVDI Background IP” means any and all Know-How and Patent Rights (including, for example, intellectual property relating to Agreement Targets) Controlled by NVDI as of the Effective Date of the Initial Agreement (or, in the case of intellectual property relating to Agreement Targets accepted for inclusion in the Original Collaboration pursuant to Section 3.3(d) of the Original Agreement after the Effective Date of the Initial Agreement, as of the date on which each such Agreement Target was so accepted) that are [*] for (a) research relating to Agreement Target(s) or (b) research, development, manufacture or commercialization of Resumed Products, XOMA Ongoing Products or XOMA Reactivated Products. NVDI Background IP also includes any and all Know-How and Patent Rights that are necessary for either of the purposes set forth in clauses (a) and (b) of the immediately preceding sentence and that came to be Controlled by NVDI after the Effective Date of the Initial Agreement and either (x) before the Effective Date but not in the course of the Original Collaboration or (y) on or after the Effective Date, except (i) to the extent the inclusion of such Know-How and Patent Rights in NVDI Background IP would constitute a breach or violation of or a default under, or would otherwise be inconsistent with, the terms and provisions of any license or other agreement giving rise to or governing such Know-How or Patent Rights, and (ii) that, in the event the inclusion of such Know-How or Patent Rights in NVDI Background IP would subject either or both of the Parties to additional financial or other adverse obligations to a Third Party, such Know-How or Patent Rights shall not be so included in NVDI Background IP unless the Parties so agree (which agreement shall not be unreasonably withheld or delayed). For the avoidance of doubt, the Parties acknowledge that, to the extent any NVDI Background IP is covered by a license or other agreement with a Third Party, such NVDI Background IP shall, for all purposes of this Agreement, be subject to the financial and other obligations, limitations and restrictions contained in such Third Party license or agreement. NVDI Background IP shall include, without limitation, those licenses, patents and patent applications set forth on Schedule 1.29 .

1.30 “Original Collaboration” means the collaborative relationship between the Parties as governed by the Initial Agreement and the Original Agreement during the period from the Effective Date of the Initial Agreement through the Effective Date.


1.31 “Patent Rights” means (a) unexpired letters patent (including inventor’s certificates) which have not been held invalid or unenforceable by a court of competent jurisdiction from which no appeal can be taken or has been taken within the required time period (and which have not been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, or been abandoned), including without limitation any substitution, extension, registration, confirmation, reissue, re-examination, supplementary protection certificates, confirmation patents, patent of additions, renewal or any like filing thereof and (b) pending applications for letters patent which have not been canceled, withdrawn from consideration, finally determined to be unallowable by the applicable governmental authority for whatever reason (and from which no appeal is or can be taken), and/or abandoned, including without limitation any continuation, division or continuation-in-part thereof and any provisional applications.

1.32 “Phase I Clinical Trial” means that portion of the process seeking Regulatory Approval which provides for human trials for the purposes of determining toxicity, metabolism, absorption, elimination and other pharmacological action, as more fully described at 21 CFR § 312.21(a).

1.33 “Phase II Clinical Trial” means that portion of the process seeking Regulatory Approval which provides for human trials for the purposes of determining dose and evaluating safety and efficacy in the proposed therapeutic indication, as more fully described at 21 CFR § 312.21(b).

1.34 “Phase III Clinical Trial” means that portion of the process seeking Regulatory Approval which provides for human trials on sufficient numbers of patients intended for the purposes of (a) establishing safety and efficacy for an intended use; and (b) defining warnings, precautions and adverse reactions in the dosage to be prescribed, as more fully described at 21 CFR § 312.21(c).

1.35 “Post-Effective Date Inventions” means any and all Inventions Controlled by a Party and made, conceived, reduced to practice or otherwise acquired or licensed, either alone or jointly with another, on or after the Effective Date and arising out of the activities of such Party in connection with the development or commercialization of Collaboration Products, NVDI Ongoing Products, Resumed Products, XOMA Ongoing Products or Reactivated Products. For the avoidance of doubt, any and all Inventions comprising the Expression and Engineering Technologies as such technologies exist on or after the Effective Date shall not be Post-Effective Date Inventions. Notwithstanding the foregoing, the Parties acknowledge that, to the extent any Post-Effective Date Invention is covered by a license or other agreement with a Third Party, such Post-Effective Date Invention shall, for all purposes of this Agreement, be subject to the financial and other obligations, limitations and restrictions contained in such Third Party license or agreement.

1.36 “Post-Effective Date Patent Rights” means Patent Rights claiming or covering Post-Effective Date Inventions.

1.37 “Project” means any of the Collaboration Projects, Pending Projects, Resumed Projects, Reactivated Projects or Ongoing Projects. For clarity, each Project shall consist of research and development activities relating to a particular Agreement Target and the Agreement Products corresponding to such Agreement Target.


1.38 “R&D Plans and Budgets” means research and development plans and budgets relating to Agreement Targets and Agreement Products approved in accordance with the terms of the Original Agreement, as in effect immediately prior to the Effective Date.

1.39 “Regulatory Approval” means any approvals (including pricing and reimbursement approvals), licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity necessary for the manufacture and sale of any Agreement Product in a regulatory jurisdiction.

1.40 “Regulatory Authority” means any national (e.g., the FDA), supranational (e.g., the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in any jurisdiction of the world involved in the granting of Regulatory Approvals for pharmaceutical products.

1.41 “Royalty-Style Payment Period” means with respect to any Collaboration Product, Resumed product, NVDI Ongoing Product, XOMA Ongoing Product or Reactivated Product, the longer of (i) the period during which such Product is covered by a Valid Claim of Related XOMA Patent Rights or Related NVDI Patent Rights as the case may be or (ii) twenty (20) years from the launch of such Product on a country-by-country basis.

1.42 [*]

1.43 “Target” means any biological molecule that is believed to be accessible to an Antibody.

1.44 “Third Party” means any person or entity other than NVDI or XOMA or their respective Affiliates.

1.45 “Top 10 Pharmaceutical Companies” means [still to be provided by NVDI] .

1.46 “United States” or “ U.S. ” means the United States of America, including its territories and possessions, the District of Columbia and Puerto Rico.

1.47 “Valid Claim” means a claim of an issued Patent Right that has not expired or been revoked, held invalid or unenforceable by a patent office, court or other governmental agency of competent jurisdiction in a final and non-appealable judgment (or a judgment from which no appeal was taken within the allowable time period).

1.48 “XOMA Background IP” means any and all Know-How and Patent Rights (including, for example, intellectual property relating to Agreement Targets) Controlled by XOMA as of the Effective Date of the Initial Agreement (or, in the case of intellectual property relating to Agreement Targets accepted for inclusion in the Original Collaboration pursuant to Section 3.3(d) of the Original Agreement after the Effective Date of the Initial Agreement, as of the date on which each such Agreement Target was so accepted) that are [*] for (a) research


relating to Agreement Target(s) or (b) research, development, manufacture (including expression vectors and other technology for expression of proteins in mammalian and other non-bacterial cells) or commercialization of Collaboration Product(s), NVDI Ongoing Product(s) or NVDI Reactivated Product(s). XOMA Background IP shall also include any and all Know-How and Patent Rights that are necessary for either of the purposes set forth in clauses (a) and (b) of the immediately preceding sentence and that came to be Controlled by XOMA on or after the Effective Date of the Initial Agreement and either (x) before the Effective Date but not in the course of the Original Collaboration or (y) on or after the Effective Date, except (i) to the extent the inclusion of such Know-How and Patent Rights in XOMA Background IP would constitute a breach or violation of or a default under, or would otherwise be inconsistent with, the terms and provisions of any license or other agreement giving rise to or governing such Know-How or Patent Rights, and (ii) that, in the event the inclusion of such Know-How or Patent Rights in XOMA Background IP would subject either or both of the Parties to additional financial or other adverse obligations to a Third Party, such Know-How or Patent Rights shall not be so included in XOMA Background IP unless the Parties so agree (which agreement shall not be unreasonably withheld or delayed). For the avoidance of doubt, the Parties acknowledge that, to the extent any XOMA Background IP is covered by a license or other agreement with a Third Party, such XOMA Background IP shall, for all purposes of this Agreement, be subject to the financial and other obligations, limitations and restrictions contained in such Third Party license or agreement. XOMA Background IP shall include, without limitation, those licenses, patents and patent applications set forth on Schedule 1.48 . Notwithstanding any provision of this Agreement to the contrary, XOMA Background IP shall not include the Expression and Engineering Technologies.

In addition, the following terms have the meanings given them in the corresponding Sections of this Agreement:

 

Term

  

Section

Agreement

  

Introduction

Article 10 Disputes

  

10.1

Assignment Date

  

11.1(b)

Claims

  

4.1

Collaboration Projects

  

2.1(a)

Coordination Committee

  

2.3(b)

Effective Date

  

Introduction

Exclusivity Period

  

2.1(d)(iv)

Inactive Project

  

2.1(d)(iv)

Initial Agreement

  

Recitals

Interest Period

  

3.12

Interest Rate

  

3.12

Losses

  

8.5(a)

Match Period

  

2.2(c)(ii)

Match Right Period

  

2.2(c)(ii)

NVDI

  

Introduction

NVDI Ongoing Product

  

2.2(c)(i)(B)

NVDI Ongoing Project

  

2.2(c)(i)(B)


NVDI Reactivated Product

  

2.2(b)

NVDI Reactivated Project

  

2.2(b)

NVDI Releasees

  

4.1

NVDI Releasors

  

4.2

Ongoing Product

  

2.2(c)(i)(B)

Ongoing Project

  

2.2(c)(i)(B)

Original Agreement

  

Recitals

Party/Parties

  

Introduction

Pending Product

  

2.1(d)(i)

Pending Project

  

2.1(d)(i)

Pending Target

  

2.1(d)(i)

Phase III Decision Point

  

2.2(c)(ii)

Preliminary Research

  

2.2(a)

Proof-of-Concept Data

  

2.2(b)

Reactivated Product

  

2.2(b)

Reactivated Project

  

2.2(b)

Reactivated Target

  

2.2(b)

Related NVDI Patent Rights

  

7.2(b)

Related XOMA Patent Rights

  

7.2(c)

Requesting Party

  

2.4

Resumed Product

  

2.1(d)(ii)

Resumed Project

  

2.1(d)(ii)

Resumed Target

  

2.1(d)(ii)

Responding Party

  

2.4

Secured Note Agreement

  

3.1

Security Agreement

  

3.2

Term

  

9.1

Third Party Background IP Agreements

  

3.6(f)

Third Party Transaction

  

2.2(c)(ii)

Transition Period

  

2.1(b)

Trigger Date

  

2.1(d)(ii)

XOMA

  

Introduction

XOMA Ongoing Product

  

2.2(c)(i)(B)

XOMA Ongoing Project

  

2.2(c)(i)(B)

XOMA Reactivated Product

  

2.2(b)

XOMA Reactivated Project

  

2.2(b)

XOMA Releasees

  

4.2

XOMA Releasors

  

4.1


ARTICLE 2

RESEARCH AND DEVELOPMENT

2.1 Collaboration Targets; Resumed Targets.

(a) NVDI Control. XOMA and NVDI have been conducting research and development activities relating to Collaboration Targets and Collaboration Products in accordance with existing R&D Plans and Budgets (the “ Collaboration Projects ”). Commencing upon the Effective Date, NVDI will assume complete control over the conduct of the Collaboration Projects, but in any event consistent with existing protocols and applicable legal requirements. NVDI shall have the sole decision-making authority and responsibility, to be exercised at its sole discretion (subject to its obligations under Section 2.1(c)), without consultation with XOMA or any other entity, regarding all development, research, manufacturing, regulatory, safety, marketing and commercialization activities related to such Collaboration Products anywhere in the world, including rights and decision-making authority regarding involvement by Third Parties. Notwithstanding the foregoing or any other provision hereof to the contrary, NVDI will inform XOMA in a timely manner of any correspondence or other communication with any Regulatory Authority regarding the regulatory status of, or that otherwise relates to the regulatory process concerning, the cell line provided by XOMA to NVDI for use in connection with the Agreement Target known as [*].

(b) Transition Period. For a period of [*] days following the Effective Date (or until such period is earlier terminated by agreement of the Parties) (the “ Transition Period ”), (i) XOMA shall use Commercially Reasonable and Diligent Efforts, as specifically requested by NVDI and at NVDI’s expense, to assist in the orderly and timely transfer of responsibilities and necessary materials to the control of NVDI in order to give effect to Section 2.1(a), and (ii) from time to time at NVDI’s sole discretion, NVDI may (but has no obligation to) propose to XOMA that XOMA assist in research and/or development activities related to, or provide other services in connection with, one or more Collaboration Projects. XOMA will consider such proposal, but has no obligation to undertake any such activities or to provide any such services. If NVDI and XOMA agree to have XOMA assist in such activities or provide such services, then the Parties shall negotiate in good faith with respect to terms under which XOMA would do so. Within [*] after the Effective Date, XOMA shall provide to NVDI all reasonably useful data and information in its possession, which shall include without limitation production cell lines, cell banks, production batch records, clinical trial materials, research and assay reagents, test methods and regulatory submissions, relating to Collaboration Projects. From time to time at NVDI’s sole discretion, NVDI may (but shall have no obligation to) propose to XOMA that XOMA assist in providing information and expertise to NVDI to assist NVDI in preparing regulatory filings and responding to Regulatory Authority inquiries regarding INDs and/or BLAs relating to one or more Collaboration Products [*]. XOMA will consider any such proposal in good faith, but shall have no obligation to undertake any such activities or to provide any such services. If NVDI and XOMA agree to have XOMA assist in such activities or provide such services, then the Parties shall negotiate in good faith with respect to terms under which XOMA would do so. Following the Transition Period, XOMA shall have no obligation whatsoever under this Agreement to assist or provide any services to, and following such [*] XOMA shall have no obligation whatsoever under this Agreement to provide any materials to, NVDI in connection with the Collaboration Projects.


(c) Diligence. NVDI shall use Commercially Reasonable and Diligent Efforts in the development and commercialization of the Collaboration Products.

(i) Without limiting the generality of the foregoing, NVDI shall use Commercially Reasonable and Diligent Efforts to achieve each of the following diligence events:

(ii) [*]

(iii) [*]

(d) XOMA’s Right to Resumed Products.

(i) In the event NVDI decides not to proceed with all Collaboration Projects related to the development and/or commercialization of a particular Collaboration Product, NVDI shall promptly notify XOMA in writing of such decision, upon which notification such Collaboration Project(s) shall cease to be Collaboration Project(s) and shall be deemed “ Pending Project(s) ”, such Collaboration Product shall cease to be a Collaboration Product and shall be deemed a “ Pending Product ”, and the Target that is the subject of such Project shall cease to be a Collaboration Target and shall be deemed a “ Pending Target .” In addition, if NVDI fails to use Commercially Reasonable and Diligent Efforts to develop and/or commercialize any Collaboration Product(s) with respect to a particular Collaboration Target, XOMA may notify NVDI in writing of such failure and NVDI shall have [*] after receiving such notification to remedy such failure. If NVDI fails to do so within such [*] (or, if such notice is disputed by NVDI, following resolution of such dispute in XOMA’s favor), the Collaboration Project(s) related thereto shall also cease to be Collaboration Project(s) and shall be deemed “ Pending Project(s) ”, each Collaboration Product related thereto shall also cease to be a Collaboration Product and shall be deemed a “ Pending Product ”, and the Target that is the subject of such Project shall cease to be a Collaboration Target and shall be deemed a “ Pending Target .”

(ii) Within [*] after a Project becomes a Pending Project (the “ Trigger Date ”), NVDI shall provide to XOMA all reasonably useful data and information in its possession, which shall include without limitation production cell lines, cell banks, production batch records, clinical trial materials, research and assay reagents, test methods and regulatory submissions relating to such Pending Project. For a period of [*] after the Trigger Date, XOMA shall have the exclusive option to provide NVDI with written notice to assume complete control over such Pending Project. If XOMA does not exercise such option during such [*] period then from the expiration of such period until the end of the Exclusivity Period (as defined in Section 2.1(d)(iv) below), either Party shall have the option to provide the other Party with written notice to assume complete control over such Pending Project. Any such notification by XOMA shall not be construed as XOMA’s waiving any claims against NVDI. If NVDI resumes control over such Pending Project, then such Pending Project shall cease to be a Pending Project and shall again become a Collaboration Project, each Antibody Product related thereto shall cease to be a Pending Product and shall again be deemed a Collaboration Product, the Target that is the subject of such Project shall cease to be a Pending Target and shall again be deemed a Collaboration


Target, and the terms and conditions under this Agreement with respect to a Collaboration Project, Collaboration Product or Collaboration Target shall again apply thereto. If XOMA assumes control over such Pending Project, then such Pending Project shall cease to be a Pending Project and shall be deemed a “ Resumed Project ”, each Antibody Product related thereto, including any other Antibody Product that binds to the same Target and that has been, or is later, identified, generated or otherwise created, or acquired from a Third Party by either Party at any time, shall cease to be a Pending Product and shall be deemed a “ Resumed Product ”, and the Target that is the subject of such Project shall cease to be a Pending Target and shall be deemed a “ Resumed Target ”). XOMA shall thereupon have the sole decision-making authority and responsibility, to be exercised at its sole discretion, without consultation with NVDI or any other entity, regarding all research, development, manufacturing, regulatory, safety, marketing and commercialization activities related to such Resumed Project and all Resumed Product(s) anywhere in the world, including rights and decision-making authority regarding involvement by Third Parties, without any further obligation to NVDI, except under Section 3.6(b).

(iii) If XOMA assumes control over any Project pursuant to Section 2.1(d)(ii) above, for a period of at least [*] following receipt of such notice, NVDI shall use Commercially Reasonable and Diligent Efforts, as specifically requested by XOMA and at XOMA’s expense, to assist in the orderly and timely transfer of responsibilities and necessary materials to the control of XOMA in order to give effect to the last sentence of Section 2.1(d)(ii), which materials shall include without limitation production cell lines, cell banks, production batch records, clinical trial materials, research and assay reagents, test methods and regulatory submissions relating to such Resumed Projects. From time to time at XOMA’s sole discretion, XOMA may (but shall have no obligation to) propose to NVDI that NVDI assist in research and/or development activities related to, or provide other services in connection with, the development and/or commercialization of one or more Resumed Products. NVDI will consider such proposal in good faith, but shall have no obligation to undertake any such activities or to provide any such services. If NVDI and XOMA agree to have NVDI assist in such activities or provide such services, then the Parties shall negotiate in good faith with respect to terms under which NVDI would do so. Following the transition of such Resumed Products to XOMA, NVDI shall have no obligation whatsoever under this Agreement to assist, or provide any services or materials to, XOMA in connection with the development or commercialization of such Resumed Products.

(iv) Subject to Section 11.1(b), for the Exclusivity Period (as defined below) with respect to a particular Pending Project, neither Party shall have the right to develop and/or commercialize any Antibody Product binding to the applicable Pending Target, without first assuming control over such Pending Project pursuant to Section 2.1(d)(ii) above, in which case such Party shall develop and commercialize such Antibody Product as a Collaboration Product under such Collaboration Project, or a Resumed Product under such Resumed Project, as the case may be. “ Exclusivity Period ” shall mean the period commencing upon the first Trigger Date with respect to a particular Pending Project and continuing until the [*] provided that, (A) if NVDI assumes control over any Pending Project under Section 2.1(d)(ii) above as a Collaboration Project and later terminates all development efforts related thereto, so that such Project again becomes a Pending Project, then the Exclusivity Period shall commence upon the Trigger Date on which such Project became a Pending Project for the first time and shall expire upon [*]


or (B) if XOMA assumes control over any Pending Project under Section 2.1(d)(ii) above as a Resumed Project and later terminates all development efforts thereto, so that such Project again becomes a Pending Project, then [*]. At the end of the Exclusivity Period for a particular Pending Project, if neither Party is pursuing such Project as a Collaboration Project or Resumed Project, then such Pending Project shall cease to be a Pending Project and shall be deemed an “ Inactive Project ,” the Target that is the subject of such Project shall cease to be a Pending Target and shall be deemed an Inactive Target, and (C) each Antibody Product that had then been identified, generated or otherwise created, or acquired from a Third Party, by either Party that binds to the relevant Target, and (D) any other Antibody Product that also binds to the same Agreement Target and that is derived from, or derived from the use of, an Antibody Product referred to in clause (C) above, shall cease to be a Pending Product and be deemed an Inactive Product.

(v) For clarity, subject to Section 11.1(b), XOMA shall not have the right to, either by itself or in collaboration with a Third Party, develop, commercialize and/or provide related services with respect to any Antibody Product that binds to any Collaboration Target, and NVDI shall not have the right to, either by itself or in collaboration with a Third Party, develop, commercialize and/or provide related services with respect to any Antibody Product that binds to any Resumed Target. Otherwise, either Party shall be free, by itself or in collaboration with a Third Party, to develop, commercialize and/or provide related services with respect to products that bind to any of the Agreement Targets, subject to the limitations with respect to Pending Projects under this Section 2.1(d) and with respect to Inactive Projects under Section 2.2 below.

2.2 Inactive Targets.

(a) Activities with Respect to Inactive Targets .

(i) At any time(s), each Party shall have the right, at its sole discretion and expense, to perform preclinical research with respect to any Inactive Target and any Antibody Product related thereto, until such Party obtains Proof-of-Concept Data with respect to such Inactive Target (such preclinical research, the “ Preliminary Research ”). Upon the reasonable, written request of a Party intending to perform Preliminary Research with respect to an Inactive Target, the other Party will provide, at the requesting Party’s expense, any useful materials in its control relating directly and solely to such Inactive Target and created during the period from the Effective Date of the Initial Agreement through the Effective Date and as part of the Original Collaboration, which materials may include without limitation production cell lines, cell banks, production batch records, clinical trial materials, research and assay reagents, test methods and regulatory submissions relating to such Inactive Target but shall exclude any materials that the requesting Party could readily obtain from another source without undue expense or undue delay to such preclinical research.

(ii) To the extent a Party has generated during Preliminary Research, or at any time(s) plans to generate, any new Antibody Product that binds to any Inactive Target that is not an Inactive Product, it shall have the right to do so, free and clear of any obligations to the other Party under this Agreement, regardless of whether the other Party is pursuing the same Agreement Target through developing and/or commercializing any Antibody Product under this Section 2.2 as a Reactivated Product or an Ongoing Product.


(iii) To the extent a Party elects to further develop or optimize any Inactive Product, it shall do so pursuant to this Agreement and in particular the provisions of this Section 2.2.

(b) Right to Inactive Projects. In the event that a Party has obtained data from an animal proof-of-principle or animal proof-of-concept study with respect to any Inactive Product (the “ Proof-of-Concept Data ”), and intends to pursue human clinical trials of such Inactive Product, that Party shall notify the other Party in writing, and provide the other Party a written description of its Proof-of-Concept Data. Within [*] after such other Party receives such written notice, subject to the rest of this Section 2.2(b), such Inactive Product and any other Inactive Product related to the same Inactive Target shall cease to be an Inactive Product and shall be deemed a “ Reactivated Product ”, the development and/or commercialization activities with respect to such Inactive Target and each Reactivated Product related to such Inactive Target shall be deemed a “ Reactivated Project ”, and such Agreement Target shall be deemed a “ Reactivated Target .” The Party which has first obtained the Proof-of-Concept Data shall have the exclusive right, as between the Parties, to further progress such Reactivated Project and to develop and commercialize each Reactivated Product related thereto, provided that the other Party shall maintain the right to develop and/or commercialize products (including Antibody Products) related to the same Inactive Target provided that such products do not comprise a Reactivated Product. A Reactivated Project under development or commercialization by NVDI shall be deemed an “ NVDI Reactivated Project ” and the Reactivated Product(s) thereunder, “ NVDI Reactivated Product(s) .” A Reactivated Project under development or commercialization by XOMA shall be deemed a “ XOMA Reactivated Project ” and the Reactivated Product(s) thereunder, “ XOMA Reactivated Product(s) .” If, upon receiving the notification from the first Party that it has obtained the Proof-of-Concept Data with respect to a particular Inactive Product, the other Party claims that it has also obtained Proof-of Concept Data for an Inactive Product related to the same Inactive Target, then such other Party shall notify the first Party in writing within [*] after receiving the notification from the first Party of such other Party’s claim. In such event, the Parties shall discuss in good faith to resolve such claim, and either Party may initiate the dispute resolution procedures set forth in Article 10 hereof to resolve such claim. The Party which has been determined by such resolution to have first obtained such Proof-of-Concept Data with respect to an Inactive Product related to such Inactive Target shall have the exclusive right, as between the Parties, to further progress such Project as a Reactivated Project and to develop and commercialize each Inactive Product related thereto as a Reactivated Product, pursuant to the terms and conditions of this Agreement. The Party not progressing any particular Reactivated Project shall have the match right pursuant to Section 2.2(c)(ii) below with respect to such Reactivated Project, and the potential opt-in rights under Sections 2.2(c)(i) and (iii) below. For clarity, any such opt-in right, if exercised with respect to any particular Reactivated Project, shall have the effect only of providing for the Party which made the opt-in payment to obtain an increased royalty-style payment on the Net Sales of the Agreement Products related thereto, and shall not allow such Party to actively participate in the progressing of such Project or the development and commercialization of such Agreement Products related thereto.


(c) Opt-In Right and Match Right .

(i) IND Filing Opt-In Rights.

(A) If, as a result of any research and development activities conducted with respect to a Reactivated Project, the Party advances the development of a Reactivated Product related thereto such that it has filed an IND for such Reactivated Product, then such Party shall have the right, but not the obligation, to offer the other Party the right to opt-in on such Reactivated Project pursuant to this Section 2.2(c). If such Party elects to offer the other Party such opt-in right, it shall provide written notice thereof, together with all reasonably useful data and information in its possession relating to such Reactivated Project, including the documentation for the filing of the IND. The Party receiving the opt-in offer shall have a period of [*] from the date it receives such notice, data and information to evaluate such data and information and to exercise its opt-in rights.

(B) If the Party exercises its opt-in right, the Party opting-in shall pay the Party who progressed the Reactivated Project a one-time option fee of [*]. Upon payment of such amount to the Party offering such opt-in right, the Reactivated Project shall cease to be a Reactivated Project and shall be deemed an “ Ongoing Project ” and each Reactivated Product related thereto shall cease to be a Reactivated Product and shall be deemed an “ Ongoing Product .” Specifically, if NVDI has progressed such Reactivated Product, such Ongoing Project shall be deemed an “ NVDI Ongoing Project ” and each Reactivated Product related thereto, an “ NVDI Ongoing Product ”, and if XOMA has progressed such Reactivated Project, such Ongoing Project shall be deemed a “ XOMA Ongoing Project ” and each Reactivated Product related thereto, a “ XOMA Ongoing Product .” In each case, such Ongoing Project and Ongoing Product shall be subject to the terms and conditions set forth in this Agreement applicable to such Ongoing Project and Ongoing Product including without limitation the terms and conditions under Sections 2.2(d) and (e), and Article 3.

(C) In the event that the Party receiving the opt-in offer of this Section 2.2(c) does not exercise its rights to opt in, the other Party shall be permitted to progress such Reactivated Project and to research, develop and commercialize all Reactivated Products related to such Reactivated Target, either alone or with a Third Party, free of any further obligation to the other Party under this Section 2.2.

(ii) Match Right. With respect to any Reactivated Project under development by a Party and for which such Party did not offer the opt-in right to the other Party pursuant to Section 2.2(c)(i) above, the other Party shall have a Match Right for such Reactivated Project at any time before the Phase III Decision Point (the “ Match Right Period ”). “ Phase III Decision Point ” means the time when the Party developing such Reactivated Project makes a decision, after a post-Phase II Clinical Trial meeting with the FDA or equivalent regulatory authority with respect to a Reactivated Product related thereto, to conduct a Phase III Clinical Trial with respect to such Reactivated Product. At any time during the Match Right Period with respect to such Reactivated Project, if the Party conducting the development of such Reactivated Project proposes to license or otherwise grant any development and commercialization rights to a Third Party with respect to such Reactivated Project or any Reactivated Product related thereto (a “ Third Party Transaction ”), then, prior to entering into a binding agreement with respect to the essential terms of such Third Party Transaction, such Party shall provide the other Party with written notice of such terms, together with all reasonably useful information, including all material information provided to the Third Party, to the extent such information was


not previously provided to the receiving Party. The receiving Party shall have the right, in its sole discretion, to enter into an agreement with the offering Party on substantially the same terms as those contained in such notice by providing written notice of such election within thirty (30) days of receipt of such notice (the “ Match Period ”), provided that to the extent any of the material terms of the Third Party Transaction are specific to the Third Party, its products or business, XOMA and NVDI shall negotiate in good faith substitute terms which shall provide equivalent value therefor. In the event that the receiving Party does not exercise such right within the Match Period, the offering Party will be free to enter into the Third Party Transaction with the Third Party on the terms proposed (or on other terms no more favorable to the Third Party than those offered to the receiving Party). In the event the offering Party enters into such Third Party Transaction, such Party shall have no further obligation to the other Party with respect to such Reactivated Project except as set forth in Article 3.

(iii) Phase III Decision Point Opt-In Rights. In the event that the Party conducting the development of a Reactivated Project: (A) did not offer the opt-in right to the other Party pursuant to Section 2.2(c)(i) above; (B) did not enter into any Third Party Transaction with respect to such Reactivated Project and/or any Reactivated Product related thereto within the Match Right Period in compliance with Section 2.2(c)(ii); and (C) has advanced such Reactivated Project to a Phase III Decision Point, then:

(W) As soon as practicable following the occurrence of a Phase III Decision Point in respect of a Reactivated Product related to such Reactivated Project, the Party progressing such Reactivated Project shall have the obligation to offer the other Party the right to opt-in on such Reactivated Project and shall provide written notice thereof, together with all reasonably useful data and information in its possession relating to such Reactivated Project, including the memorandum contemplated by the clause (Z) below, to the other Party.

(X) The Party receiving such notice shall have a period of [*] from the date it receives such notice, data, information and memorandum, to evaluate such data, information and memorandum and to inform the other Party as to whether it will opt-in on such Reactivated Project. If the Party exercises its opt-in right, the Party opting-in shall pay the Party who progressed the Reactivated Project a one-time option fee of [*]. Upon payment of such amount to the Party offering such opt-in right, the Reactivated Project shall cease to be a Reactivated Project and shall be deemed an Ongoing Project, and each Reactivated Product related thereto shall cease to be a Reactivated Product and shall be deemed an Ongoing Product, in the same manner as set forth in Section 2.2(c)(i)(B) above.

(Y) In the event that the Party receiving opt-in offer of this Section 2.2(c)(iii) does not exercise its rights to opt in, the other Party shall be permitted to progress such Reactivated Project and to research, develop and commercialize all Reactivated Products related to such Reactivated Target, either alone or with a Third Party, free of any further obligation to the other Party under this Section 2.2.

(Z) Such Phase III Decision Point shall be evidenced by a memorandum to be delivered to the receiving Party together with a notice delivered pursuant to this Section 2.2(c)(iii), and such memorandum shall set forth (1) the rationale for the decision to conduct a Phase III Clinical Trial with respect to the particular Reactivated Product related to such


Reactivated Project, (2) the indication(s) to be pursued in connection with such Phase III, and (3) the estimated date of the first dosing of the first patient in such Phase III. In no event shall there occur the first dosing of the first patient in Phase III prior to delivery of such memorandum and the expiration of the opt-in rights contemplated by this Section 2.2(c)(iii)(Z).

(d) Termination of Development Activities . In the event a Party terminates the development activities with respect to a Reactivated Project or an Ongoing Project for which such Party has sole control and responsibility under Section 2.3 below, such Party shall notify the other Party in writing, and thereupon such Project shall again become an Inactive Project, the Target that is the subject of such Project shall again be deemed an Inactive Target, and each Inactive Product related thereto shall again be deemed an Inactive Product.

(e) Reactivation of Certain Inactive Projects . Notwithstanding Section 2.2(b), with respect to each Inactive Project that was deemed an Inactive Project under Section 2.1(d)(iv) or Section 2.2(d), either Party may progress such Inactive Project and conduct further development and commercialization with respect to the Inactive Products related thereto by providing the other Party with written notice, upon which notice such Project shall again become a Reactivated Project and each such Inactive Product related thereto shall again become a Reactivated Product, in each case subject again to the applicable terms under this Agreement and in particular the provisions under Sections 2.2 and 2.3.

2.3 Parties’ Responsibilities.

(a) NVDI shall have sole control and responsibility with respect to the research and development of the Agreement Targets that are the subjects of the Collaboration Projects, NVDI Reactivated Projects and NVDI Ongoing Projects, and the research, development, commercialization, regulatory affairs and manufacture (including clinical and commercial supply) of all Collaboration Products, NVDI Ongoing Products and NVDI Reactivated Products under this Agreement, in each case in compliance with all applicable laws and regulations. XOMA shall have sole control and responsibility with respect to the research and development of the Agreement Targets that are the subjects of the Resumed Projects, XOMA Reactivated Projects and XOMA Ongoing Projects, and the research, development, commercialization, regulatory affairs and manufacture (including clinical and commercial supply) of all Resumed Products, XOMA Ongoing Products and XOMA Reactivated Products under this Agreement, in each case in compliance with all applicable laws and regulations.

(b) Without limiting the foregoing, a coordination committee (the “ Coordination Committee ”) will be maintained to facilitate the sharing of information and ideas as reasonably necessary to enable the Parties to meaningfully preserve and exercise their rights and satisfy their obligations under this Agreement. The Coordination Committee will be comprised of three (3) representatives of each Party and will meet (which meetings may be in person, by videoconference or by teleconference) periodically at such times as the members of the Coordination Committee shall agree. Each Party will use Commercially Reasonable and Diligent Efforts to keep the other Party infor


 
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