OncoMed Development Compound definition

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:
Sample 1Sample 2Sample 3
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.
Sample 1Sample 2

Examples of OncoMed Development Compound in a sentence

  • 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.

  • For clarity, such licenses are granted only to the extent pertaining specifically to the 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 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 “[***].

  • 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”).

  • With respect to actions relating to any Patents Controlled by GSK and covering an OncoMed Development Compound or a Product containing an OncoMed Development Compound where such Patents are licensed to OncoMed under Section 5.5, GSK will have the first right, but not an obligation, to bring any action or proceeding anywhere in the Territory, at its own expense, in its own name and entirely under its own direction and control.

  • 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.

  • OncoMed shall exercise such right by written notice to BSP within [***] after such BSP Development Compound becomes an OncoMed Development Compound.

  • 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 - 71 - Development Compound.

  • Coordination of benefits is a provision that is intended to help insurance companies avoid duplication of claims and delays in payments.

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 (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • 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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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 In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • 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 each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • Phase III Clinical Trial means a large, controlled or uncontrolled Clinical Study that would satisfy the requirements of 21 CFR 312.21(c), intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

  • 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.

  • 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 Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to 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).

  • Pivotal Clinical Trial means a pivotal human clinical trial of a Licensed Product with a defined dose or a set of defined doses of such Licensed Product designed to ascertain efficacy and safety of such Licensed Product for the purpose of enabling the preparation and submission of an MAA to the competent Regulatory Authorities in a country of the Territory, as further defined in 21 C.F.R. § 312.21(c) for the U.S., as amended from time to time, or the corresponding foreign regulations.