OncoMed Development Compound definition

OncoMed Development Compound means any Collaboration Compound and/or Product for which OncoMed has the exclusive (as between the Parties) right to conduct Development and/or Commercialization as described in Sections 3.1.2(d), 3.1.4(c), 3.4.1, 3.6.7, and 11.6.1.
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OncoMed Development Compound means any Collaboration Compound and/or Product for which OncoMed has the exclusive right to conduct Development and/or Commercialization, including without limitation any and all Collaboration Compounds or Products: (a) for which GSK does not exercise its GSK Program Option during the GSK Program Option Period as described in Sections 4.1.3(e)(iii) and/or 4.1.5; (b) that is terminated by GSK as described in Section 4.2.7; (c) that is terminated in accordance with Section 16.1.3(c); (d) that are within a Program that is terminated by GSK, as described in Section 14.6.2(b)(i); or (e) if the Agreement is terminated by GSK pursuant to Section 7.2.6 or 14.3.1, or by OncoMed pursuant to Section 14.2.1, 14.4, or 14.5.
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OncoMed Development Compound means any Collaboration Compound and/or Product for which OncoMed has the exclusive right to conduct Development and/or Commercialization, including without limitation any and all Collaboration Compounds or Products:
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Examples of OncoMed Development Compound in a sentence

  • For clarity, such licenses are granted only to the extent pertaining specifically to the OncoMed Development Compound.

  • Upon Completion of such Clinical Trial(s), when such GSK Development Compound becomes an OncoMed Development Compound, GSK will provide OncoMed with any material information, materials and data for such Program and will cooperate with OncoMed to provide a smooth transfer of such material information, materials and data as soon as reasonably practical.

  • In the event GSK decides not to file, prosecute or maintain certain Patents Controlled by GSK and covering any OncoMed Development Compound, OncoMed shall have the option to take up or progress any such filing, prosecution or maintenance of such Patents, at OncoMed’s own cost and expense, to the extent they claim or cover an OncoMed Development Compound.

  • Such reimbursement shall be paid in the form of an annual royalty of [***] of Net Sales of OncoMed Development Compound, provided that such payments due to BSP pursuant to this Section 3.1.4(d) shall not [***].

  • If a Late BSP Development Compound becomes an OncoMed Development Compound by virtue of a termination by BSP under Section 11.3 or OncoMed under Section 11.4, OncoMed shall reimburse BSP an amount equal to [***] (the sum of (x) and (y), the “Full Amount”).

  • BSP shall pay OncoMed an amount equal to [***] of the royalties and other license fees and costs owed and payable by OncoMed to a Third Party (other than pursuant to the Existing Agreements) pursuant to any Necessary License to which OncoMed is a party within [***] days after receiving an invoice therefor; excluding, for clarity, any amounts paid to such Third Party to the extent directly attributable to the exploitation solely of an OncoMed Development Compound.

  • For clarity, such license shall not extend to Research and Development activities for any OncoMed Development Compound.

  • Subject to the terms and conditions of this Agreement, including the conditions and limitations in Section 3.6.7, BSP grants to OncoMed a non-exclusive, royalty-free, non-transferable (except as provided in Section 13.4) license in the Territory, with the right to grant Sublicenses, under any [***], to Research, Develop, manufacture, use, import, offer for sale, sell, and Commercialize such OncoMed Development Compound in the Territory in the Field.

  • If a Late BSP Development Compound becomes an OncoMed Development Compound by virtue of a termination of a Biologic Collaboration Compound, a Biologic Collaboration Compound Class or this Agreement by OncoMed under Section 3.4.1 or Section 11.2 or 11.5, OncoMed shall reimburse BSP as provided in this Section 3.6.7(b)(iii) above except that the Full Amount shall be calculated by replacing “[***] in subsection (x), above, with [***] and replacing “[***] in subsection (y), above, with “[***].

  • Such reimbursement shall be in the form of the following payments: (A) a first payment of an amount equal to [***] of the Full Amount, which amount is due within [***], (B) a second payment in an amount equal to [***] of the Full Amount, which is due upon [***] such OncoMed Development Compound by OncoMed or any OncoMed Affiliate or Sublicensee, and (C) additional payments equal in the aggregate to [***] of the Full Amount, which shall be paid [***], until such time as the Full Amount has been fully paid.


More Definitions of OncoMed Development Compound

OncoMed Development Compound means any Collaboration Compound and/or Product for which OncoMed has the exclusive right to conduct Development and/or Commercialization, including without limitation any and all Collaboration Compounds or Products: [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (a) for which GSK does not exercise its GSK Program Option during the GSK Program Option Period as described in Sections 4.1.3(e)(iii) and/or 4.1.5; (b) that is terminated by GSK as described in Section 4.2.7; (c) that is terminated in accordance with Section 16.1.3(c); (d) that are within a Program that is terminated by GSK, as described in Section 14.6.2(b)(i); or (e) if the Agreement is terminated by GSK pursuant to Section 7.2.6 or 14.3.1, or by OncoMed pursuant to Section 14.2.1, 14.4, or 14.5.
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Related to OncoMed Development Compound

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Licensed Compound means [***].

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Exempt compound means the same as defined in Rule 2.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).