Exhibit 10.7E
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
COMBINATION PRODUCT DEVELOPMENT AND COMMERCIALIZATION
AGREEMENT
BETWEEN GENENTECH, INC.
AND
TERCICA, INC.
TABLE OF CONTENTS Page Article 1 Definitions 1 1.1 " Affiliate" 1 1.2 " AGHD Indication" 2 1.3 " Agreement" 2 1.4 " ALS" 2 1.5 " Annual Budget" 2 1.6 " Best Efforts in in the Commercialization of Combination Products in Short Stature Indications and the AGHD Indication" 2 1.7 " Booking Party" 2 1.8 " BP3" 2 1.9 " CFR" 3 1.10 " Combination Product" 3 1.11 " Commercial Deciding Vote Election" 3 1.12 " Commercialization" 3 1.13 " Commercialization Plan" 3 1.14 " Commercial Manufacturing and Supply Agreement" 3 1.15 " Confidential Information" 3 1.16 " Control" 4 1.17 " Covers" 4 1.18 " Decidng Vote" 4 1.19 " Development" 4 1.20 " Development Costs" 4 1.21 " Development Plan" 4 1.22 " Diligent Efforts" 4 1.23 " Distribution Costs" 4 1.24 " Effective Date" 5 1.25 " Execution Date" 5 1.26 " Excluded Indications" 5 1.27 " Expiration of Genentech' s Options" 5 1.28 " FBMC" or " Fully Burdened Manufacturing Costs" 5 1.29 " FDA" 5 1.30 " FFDCA" 5 1.31 " Field" 5 1.32 " Financial Appendix" 5 1.33 " Financial Schema" 5 1.34 " First Commercial Sale" 5 1.35 " First Opt-In" 5 1.36 " First Option" 5 1.37 " First Option Event-AGHD/Other" 5 1.38 " First Option Event-Short Stature" 5 1.39 " First Option Notice Date-AGHD/Other" 5 1.40 " First Option Notice Date-Short Stature" 5
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 1.41 " First Option Notice Period" 5 1.42 " G&A Costs" or " General and Administrative Costs" 5 1.43 " GAAP" 5 1.44 " Genentech" 6 1.45 " Genentech Know-How" 6 1.46 " Genentech Manufacturing Opt-In" 6 1.47 " Genentech Opt-In" 6 1.48 " Genentech Opt-In Date" 6 1.49 " Genentech Opt-Out" 6 1.50 " Genentech Patents" 6 1.51 " GH" or " Growth Hormone" 6 1.52 " Gross Sales" 7 1.53 " HSR Act" 7 1.54 " HSR Conditions" 7 1.55 " HSR Filing" 7 1.56 " IGF-1" 7 1.57 " IGF-1 Agreements" 7 1.58 " IGF-1 Formulated Bulk" 7 1.59 " IND" 7 1.60 " Indication" 7 1.61 " Initial Development Plan" 7 1.62 " Initial Equity Investment" 8 1.63 " Initial Indications" 8 1.64 " Initial Short Stature Indication" 8 1.65 " Initial Short Stature Patient Population" 8 1.66 " Initiates Development" 8 1.67 " Interest Rate" 8 1.68 " International IGF-1 Agreement" 8 1.69 " Joint Know-How" 8 1.70 " Joint Patent" 8 1.71 " Joint Trademarks" 8 1.72 " JSC" or " Joint Steering Committee" 9 1.73 " Know-How" 9 1.74 " Lead Commercial Party" 9 1.75 " Lead Development Party" 9 1.76 " Liability" 9 1.77 " Manufacture" 9 1.78 " NDA" 9 1.79 " Net Sales" 9 1.80 " Non-Short Stature Product" 9 1.81 " Operating Profits & Losses" 9 1.82 " Opt-In Information" 10 1.83 " Opt-Out Effective Date" 10 1.84 " Opt-Out Notice" 10 1.85 " Opt-Out Response Date" 10 1.86 " Other Indication" 10
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 1.87 " Other Indication NDA Submission Notice" 10 1.88 " Other Operating Income/Expense" 10 1.89 " Patent" 10 1.90 " Patent Office" 10 1.91 " Phase I Clinical Trial" 10 1.92 " Phase II Clinical Trial" 11 1.93 " Phase II/III or Phase III Clinical Trial" 11 1.94 " Pivotal Study-Enabling Phase II Clinical Trial" 11 1.95 " Pre-Mixed Formulation" 11 1.96 " Promotional Activities" 11 1.97 " Regulatory Approval" 11 1.98 " Regulatory Authority" 11 1.99 " Regulatory Authority Documentation" 12 1.100 " Sales Returns and Allowances" 12 1.101 " Second Opt-In" 12 1.102 " Second Option" 12 1.103 " Second Option Equity Investment" 12 1.104 " Second Option Event-AGHD/Other" 12 1.105 " Second Option Event-Short Stature" 12 1.106 " Second Option Notice Date-AGHD/Other" 12 1.107 " Second Option Notice Date-Short Stature" 12 1.108 " Second Option Notice Period" 12 1.109 " Short Stature Indications" 12 1.110 " Short Stature Product" 12 1.111 " Sublicensee" 12 1.112 " TerGen" 12 1.113 " Tercica Know-How" 12 1.114 " Tercica Opt-Out" 13 1.115 " Tercica Patents" 13 1.116 " Terminated Product Group" 13 1.117 " Termination Date" 13 1.118 " Territory" 13 1.119 " Third Party" 13 1.120 " Third Party Claims" 13 1.121 " Third Party Royalties" 13 1.122 " Trademark" 13 1.123 " U.S. IGF-1 Agreement" 13 1.124 " Valid Claim" 13 Article 2 Overview; Opt-Ins and Opt-Outs 13 2.1 Overview. 13 2.2 Genentech' s First Option. 14 2.3 Genentech' s Second Option. 15 2.4 Genentech' s Commercial Deciding Vote Election. 16 2.5 Reimbursement of Development Costs Prior to Genentech Opt-In. 17 2.6 Sharing of Operating Profits & Losses After Genentech Opt-In. 17
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 2.7 Expiration of Genentech' s Options. 17 2.8 Genentech Opt-Out. 18 2.9 Tercica Opt-Out. 18 2.10 Opt-Out Process. 19 Article 3 Joint Management 20 3.1 Existing Joint Steering Committee. 20 3.2 Composition of the Joint Steering Committee. 21 3.3 Duration, Scope of Authority and Responsibilities of the Joint Steering Committee. 21 3.4 Meetings of the Joint Steering Committee. 21 3.5 Decisions of the Joint Steering Committee; Deciding Votes. 22 3.6 Subcommittees; Designated Representatives. 23 3.7 Financial Representatives. 24 3.8 Alliance Managers. 24 Article 4 Development 24 4.1 Development Responsibilities. 24 4.2 Preparation of Development Plans and Annual Budgets. 25 4.3 Access to Technology and Documentation. 26 4.4 Regulatory Affairs. 27 4.5 Development Costs. 28 4.6 Development Efforts. 28 Article 5 Commercialization Activities 28 5.1 Commercialization Responsibilities. 28 5.2 Preparation of Commercialization Plans and Annual Budgets. 30 5.3 Co-Promotion. 31 5.4 Commercialization Costs. 31 5.5 Commercialization Efforts. 31 Article 6 Licenses and Restrictive Covenants 31 6.1 Licenses to Tercica. 31 6.2 Licenses to Genentech. 32 6.3 Sublicenses; Exercise of Licensed Rights by Third Parties. 33 6.4 Revocation of Covenants Regarding Other Combination Products. 35 6.5 No Implied Licenses; Covenant Regarding Exercise of Rights. 35 6.6 Covenant Regarding Challenges to Licensed Patents. 35 Article 7 Payments 36 Article 8 Manufacture and Supply 36 8.1 Development and Commercial Supply. 36 8.2 Provision of Know-How; Coordination of Manufacturing and Supply. 38 8.3 Commercial Manufacturing and Supply Agreement. 39 8.4 Form of GH Supplied by Genentech. 39
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Article 9 Confidentiality and Publicity 39 9.1 Non-Use and Non-Disclosure of Confidential Information. 39 9.2 Limitation on Disclosures. 40 9.3 Other Permitted Disclosure. 40 9.4 Publications. 40 9.5 Term. 41 9.6 Termination of Mutual Confidentiality Agreements. 41 9.7 Publicity and Other Public Disclosures. 41 9.8 Use of Names. 42 Article 10 Ownership of Intellectual Property; Joint Trademarks; Patent Rights 42 10.1 Ownership of Intellectual Property. 42 10.2 Selection, Registration and Protection of Joint Trademarks. 42 10.3 Patent Filings and Prosecution. 43 10.4 Patent and Trademark Costs. 44 10.5 Patent Enforcement Rights. 44 10.6 Infringement of Third Party Rights. 46 Article 11 Representations, Warranties and Covenants 46 11.1 Representations, Warranties and Covenants of Each Party. 46 11.2 Additional Warranties by Tercica. 47 11.3 Additional Warranties by Genentech. 47 11.4 Disclaimer of Warranty of Non-Infringement. 47 Article 12 Safety Reporting; Quality Agreement 48 12.1 Safety Reporting. 48 12.2 Quality Agreements. 49 Article 13 Term and Termination 49 13.1 Term. 49 13.2 Termination for Material Breach. 49 13.3 Termination of Entire Agreement. 49 13.4 Termination Related to a Product Group. 49 13.5 Surviving Rights. 52 13.6 Accrued Rights. 52 Article 14 Product Liability, Indemnification and Insurance 53 14.1 Combination Products for Indications with Shared Operating Profits & Losses. 53 14.2 Indemnification by Genentech. 53 14.3 Indemnification by Tercica. 53 14.4 Indemnification Procedures. 53 14.5 Limitation on Damages. 55 14.6 Insurance. 55 Article 15 Dispute Resolution 55
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 15.1 Disputes Generally. 55 15.2 Internal Resolution. 55 15.3 Arbitration. 56 15.4 Subject Matter Exclusions. 56 15.5 Injunctive Relief. 57 Article 16 Miscellaneous 57 16.1 Exports. 57 16.2 Section 365(n) of the Bankruptcy Code. 57 16.3 Assignment. 57 16.4 Force Majeure. 57 16.5 Independent Contractors. 58 16.6 Further Assurances. 58 16.7 Notices. 58 16.8 Waiver. 59 16.9 Severability. 59 16.10 Entire Agreement; Modifications. 59 16.11 Governing Law. 59 16.12 Captions and Construction. 59 16.13 Consultation with Counsel. 59 16.14 Counterparts; Facsimiles. 60 16.15 HSR Act. 60 Exhibits Exhibit A Excluded Indications Exhibit B Genentech Patents Exhibit C Initial Development Plan Exhibit D Financial Appendix Exhibit E Press Release Exhibit F Intentionally OmittedExhibit G Payments, Equity Issuances and Royalties
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
COMBINATION PRODUCT DEVELOPMENT AND COMMERCIALIZATION AGREEMENT THIS COMBINATION PRODUCT DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (" Agreement" ), dated as of July 6, 2007 (" Execution Date" ), by and between Genentech, Inc., a
Delaware corporation having an office located at 1 DNA Way, South San Francisco, California 94080 (" Genentech" ) and Tercica, Inc. a Delaware corporation having an office located at 2000 Sierra Point Parkway, Suite 400, Brisbane, California 94005 (" Tercica" ). Genentech and Tercica are sometimes referred to herein individually as a " Party" and collectively as the " Parties."
RECITALS
A. Tercica and Genentech have entered into that certain License and Collaboration Agreement, effective as of April 15, 2002, as amended (" U.S. IGF-1 Agreement" ) and that certain International License and Collaboration Agreement, effective as of July 25, 2003, as amended (" International IGF-1 Agreement" ), pursuant to which Tercica licensed from Genentech certain rights to develop and commercialize IGF-1 in the United States and in all foreign countries, respectively, (such agreements, collectively, the " IGF-1 Agreements" ).
B. The IGF-1 Agreements contain restrictions on each Party' s ability to develop a combination product containing both human growth hormone and IGF-1.
C. The Parties now desire to enter into this Agreement pursuant to which the Parties will collaborate in the development and commercialization of product(s) containing both human growth hormone and IGF-1.
AGREEMENT
NOW, THEREFORE , for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows.
Article 1 Definitions
The following terms, whether used in the singular or plural, shall have the meanings set forth below, unless otherwise specifically indicated:
1.1 " Affiliate" of a Party means any corporation or other business entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with such Party. For purposes of this definition, the term " control" (including, the correlative meanings, " controlled by" and " under common control with" ) means (a) the direct or indirect ownership of fifty percent (50%) or more of the stock having the right to vote for directors thereof (or general partnership interests) or (b) the ability to otherwise control the decisions of the board of directors or equivalent governing body thereof. In the case of
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Genentech, for purposes of this Agreement, the term " Affiliate" shall not include Roche Holding Ltd (for purposes of this definition, " Roche" ) and its successors, or any entity that controls, is controlled by or is under common control with Roche, in each case, that is not controlled by Genentech. 1.2 " AGHD Indication" means the Indication in which an adult patient has growth hormone deficiency as measured by a generally accepted growth hormone stimulation test, where such adult patient either (a) has growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy or trauma; or (b) was growth hormone deficient during childhood as a result of congenital, genetic, acquired or idiopathic causes.
1.3 " Agreement" is defined in the preamble of this agreement.
1.4 " ALS" means an acid-labile subunit of the insulin-like growth factor binding protein complex that in its native form is found in human plasma, as described in U.S. Patent No. 5324820 assigned to Central Sydney Area Health Service, and mammalian equivalents of human ALS.
1.5 " Annual Budget" means, with respect to a given Development Plan or Commercialization Plan, the associated calendar year budget for such Development Plan or Commercialization Plan, which shall be prepared in accordance with Section D.3.1 of the Financial Appendix. Each Annual Budget associated with a Development Plan shall include Development Costs and associated G&A Costs. Each Annual Budget associated with a Commercialization Plan shall include all of the other categories (i.e., other than Development Costs) in the Financial Schema and associated G&A Costs.
1.6 " Best Efforts in the Commercialization of Combination Products in Short Stature Indications and the AGHD Indication" means, with respect to a given Party, that such Party' s Commercialization efforts, allocation of resources and/or funding in support of the Commercialization of any and all Combination Product(s) for any and all Short Stature Indication(s) and the AGHD Indication shall (a) be no less than the highest level applied by such Party to any of such Party' s competing products commercialized in such Short Stature Indication(s) or the AGHD Indication and (b) not place any Combination Product(s) at a significant disadvantage to any of such Party' s competing products commercialized in such Short Stature Indication(s) or the AGHD Indication. 1.7 " Booking Party" means, with respect to a given Combination Product, the Party that books sales of such Combination Product, in accordance with Section D.2.3 of the Financial Appendix.
1.8 " BP3" means native-sequence insulin-like growth factor binding protein-3, as described in WO 89/09268 published Oct. 5, 1989 as BP3, that binds IGF-1, including human BP3 and allelic variants thereof and animal equivalents thereto, for example, the bovine, ovine, porcine and equine species, and may be from any source, whether natural, synthetic or recombinant, provided that it will bind to the appropriate binding domain of IGF-1.
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
1.9 " CFR" means the Code of Federal Regulations. 1.10 " Combination Product" means a pharmaceutical formulation or product for use in the Field that contains GH and IGF-1 (including, without limitation, formulations and products containing GH and (a) IGF-1 combined with BP3, (b) IGF-1 combined with ALS or (c) IGF-1 combined with BP3 and ALS) and that, in all cases (except for the purposes of the definitions of Phase I Clinical Trial and Phase II Clinical Trial), is administered either as a (i) Pre-Mixed Formulation or (ii) single injection from a pre-filled, dual-chamber container-closure system (e.g., a syringe or vial). Combination Products include Short Stature Products and Non-Short Stature Products.
1.11 " Commercial Deciding Vote Election" is defined in Section 2.4.
1.12 " Commercialization" and, with correlative meaning, " Commercialize," " Commercializing" or the like, means all activities directed to marketing, sales and distribution of a Combination Product including, without limitation, strategic marketing (including trademarks), pre-launch and launch activities, sales effort, promotion, pricing and reimbursement and customer support.
1.13 " Commercialization Plan" means, with respect to a given Combination Product for all Indications for which a particular Party is designated as the Lead Commercial Party, a comprehensive plan for the Commercialization of such Combination Product for such Indications in the Territory. A Commercialization Plan shall define the Commercialization activities to be performed (including, without limitation, messaging, product positioning, product distribution, sales force sizing and deployment) and shall identify the respective responsibilities of the Parties, subject to the provisions of the Agreement including, without limitation, the co-promotion provisions under Section 5.3. 1.14 " Commercial Manufacturing and Supply Agreement" is defined in Section 8.3. 1.15 " Confidential Information" means all materials, Know-How or other information, including, without limitation, proprietary materials, Know-How and other information, whether or not patentable, regarding a Party' s technology, products, business information or objectives, which is designated as confidential in writing by the disclosing Party, whether by letter or by use of an appropriate stamp or legend, prior to or at the time any such material, Know-How or other information is disclosed by the disclosing Party to the other Party. Notwithstanding the foregoing, 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 of a Party if (a) the disclosing Party, within thirty (30) days after such disclosure, delivers to the other Party a written document or documents describing the materials, Know-How or other information and referencing the place and date of such oral, electronic, visual or written disclosure and the names of the persons to whom such disclosure was made or (b) such information is of the type that is customarily considered to be confidential information by persons engaged in activities that are substantially similar to the activities being engaged in by the Parties pursuant to this Agreement.
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
1.16 " Control" with the correlative meaning " Controlled by" means, with respect to intellectual property, possession of the right to grant a license or sublicense as provided for herein without violating (a) any law or governmental regulation applicable to such license or sublicense or (b) the terms of any agreement or other arrangement with any Third Party that exists as of the Effective Date, or if such right is acquired after the Effective Date, as of the date a Party first gained possession of such right. 1.17 " Covers" means that the Manufacture, use, sale, offer for sale or import of a specified product would infringe a Valid Claim in the referenced Patent.
1.18 " Deciding Vote" means that where expressly provided in the Agreement (including, without limitation, under Section 3.5) that a given Party has the " Deciding Vote" with respect to a particular dispute, such Party' s JSC co-chair has the right to make the final decision regarding such dispute (subject to any express limitations on such right) as provided under Section 3.5(c), and such dispute shall not be subject to dispute resolution under Article 15.
1.19 " Development" and, with correlative meaning, " Develop," " Developing" or the like, means all activities directed to research or development of a Combination Product in connection with obtaining, maintaining and/or expanding Regulatory Approval of such Combination Product including, without limitation, (a) preclinical testing, toxicological, pharmacokinetic, metabolic or clinical aspects of such Combination Product (including any Phase IV studies); (b) process development, stability studies, formulation development, Manufacturing scale-up, production of clinical batches, validation studies, development of quality assurance/quality control testing for such Combination Product; and (c) regulatory affairs (including, without limitation, label negotiations) related to such Combination Product.
1.20 " Development Costs" is defined in Section D.1 of the Financial Appendix.
1.21 " Development Plan" means, with respect to a given Combination Product for all Indications for which a particular Party is designated as the Lead Development Party, a comprehensive plan for the Development of such Combination Product for such Indications, designed to generate the preclinical, clinical and regulatory information required for filing NDAs and obtaining Regulatory Approvals for such Combination Product for such Indications in the Territory. A Development Plan shall define the Development activities to be performed and shall identify the respective responsibilities of the Parties for such activities. Unless expressly provided in the Agreement, or otherwise agreed by the Parties, the Lead Development Party for a given Development Plan shall be responsible for performing all activities in such Development Plan.
1.22 " Diligent Efforts" means the efforts consistent with the exercise of prudent scientific and business judgment, consistent with the effort applied to other pharmaceutical products of similar potential and market size by the Party in question (or, if the Party in question has no other pharmaceutical product of similar potential and market size, by other similarly sized pharmaceutical companies that do). 1.23 " Distribution Costs" is defined in Section D.1 of the Financial Appendix.
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
1.24 " Effective Date" is defined in Section 16.15(b). 1.25 " Execution Date" is defined in the preamble of this Agreement. 1.26 " Excluded Indications" means any human disease, disorder or condition of the central nervous system (" CNS" ) including, without limitation, CNS diseases and conditions arising out of the causes set forth in Exhibit A.
1.27 " Expiration of Genentech' s Options" is defined in Section 2.7.
1.28 " FBMC" or " Fully Burdened Manufacturing Costs" is defined in Section D.1 of the Financial Appendix.
1.29 " FDA" means the United States Food and Drug Administration and any successor agency or authority thereto.
1.30 " FFDCA" means the United States Federal Food, Drug and Cosmetic Act.
1.31 " Field" means all prophylactic, diagnostic and therapeutic uses in humans for any Indication. For clarity, " Field" does not include the Excluded Indications.
1.32 " Financial Appendix" means the financial appendix set forth in Exhibit D.
1.33 " Financial Schema" is defined in Section D.1 of the Financial Appendix.
1.34 " First Commercial Sale" means, with respect to a given Combination Product, the first sale for use of such Combination Product in the Field in any country in the Territory after Regulatory Approval has been obtained.
1.35 " First Opt-In" is defined in Section 2.2(b).
1.36 " First Option" is defined in Section 2.2(b). 1.37 " First Option Event-AGHD/Other" is defined in Section 2.2(a). 1.38 " First Option Event-Short Stature" is defined in Section 2.2(a). 1.39 " First Option Notice Date-AGHD/Other" is defined in Section 2.2(a). 1.40 " First Option Notice Date-Short Stature" is defined in Section 2.2(a). 1.41 " First Option Notice Period" is defined in Section 2.2(b). 1.42 " G&A Costs" or " General and Administrative Costs" is defined in Section D.1 of the Financial Appendix.
1.43 " GAAP" is defined in Section D.1 of the Financial Appendix.
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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
1.44 " Genentech" is defined in the preamble of this Agreement. 1.45 " Genentech Know-How" means Know-How (or, with reference to tangible substances, samples of Know-How) Controlled by Genentech during the term of this Agreement ( excluding Genentech' s interest in any Joint Know-How) that is necessary or used by Genentech for the Development, Manufacture or Commercialization of any Combination Product in the Field. For clarity, the term " Genentech Know-How" does not include any Know-How licensed to Genentech from Tercica under this Agreement or the IGF-1 Agreements.
1.46 " Genentech Manufacturing Opt-In" is defined in Section 8.1(d).
1.47 " Genentech Opt-In" and, with correlative meaning, " Genentech Opted-In," " Genentech Opts-In" or the like, means the exercise by Genentech of its First Option or its Second Option. 1.48 " Genentech Opt-In Date" means the date on which Tercica received the notice that Genentech exercised its First Option or its Second Option, as the case may be.
1.49 " Genentech Opt-Out" and, with correlative meaning " Genentech Opted-Out," " Genentech Opts-Out" or the like, is defined in Section 2.8.
1.50 " Genentech Patents" means any Patent Controlled by Genentech during the term of this Agreement ( excluding Genentech' s interest in any Joint Patents) that Covers Combination Product(s) in the Field (including, without limitation, the Patents that are set forth in Exhibit B) that contain as additional component(s) only pharmaceutically acceptable carriers, excipients, stabilizers, buffers, antioxidants, osmolytes, preservatives, low-molecular-weight polypeptides, proteins, amino acids, carbohydrates, sugars, salt-forming counter-ions, bacteriostatic water for injection, sterile water and/or surfactants.
Notwithstanding the foregoing, " Genentech Patents" do not include a given Pate ...