Genentech Protocol definition

Genentech Protocol means the clinical trial protocol for the Phase Ib/II study to evaluate the efficacy and safety of the Corvus Compound and the Genentech Compound used in the Combination in patients with non-small cell lung cancer, as agreed in writing by the Parties.
Sample 1

Examples of Genentech Protocol in a sentence

  • The total enrollment shall not exceed the maximum number of Subjects specified in the Genentech Protocol, unless such number is increased by an amendment to the Genentech Protocol.

  • Genentech shall obtain IRB review and approval of the Genentech Protocol and the informed consent form to be used in the Study in accordance with Applicable Law.

  • For purposes of Section 8.3, a “Disclosure” means a press release or other public disclosure concerning this Agreement or the subject matter hereof, including the terms and conditions of this Agreement and the Genentech Protocol.

  • Genentech shall perform all regulatory obligations imposed on the Sponsor (including preparing and submitting Regulatory Documentation for the Study, in accordance with the Genentech Protocol and Applicable Law).

  • Any proposed amendments to the Genentech Protocol necessary to protect the safety of Subjects shall be promptly reported to Corvus in writing.

  • Notwithstanding anything to the contrary in this Agreement, the prior written consent of Corvus is required for amendments to the Genentech Protocol that are (a) material amendments ([***]), [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.

  • Genentech shall conduct, and use commercially reasonable efforts to cause all Project Participants to conduct and complete, the Study in accordance with this Agreement, the Genentech Protocol and Applicable Law.

  • The Joint Development Committee shall determine, consistent with the Genentech Protocol, the time points during the Study at which the Study Data and Control Arm Data will be available to the Parties.

Related to Genentech Protocol

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Kyoto Protocol means the protocol to the UNFCCC adopted at the Third Conference of the Parties to the UNFCCC in Kyoto, Japan on 11 December 1997 as may be amended;

  • Research Program has the meaning set forth in Section 2.1.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • Collaboration Know-How means all Know-How and Materials discovered, created, conceived, developed or reduced to practice in the course of performing activities under the Collaboration Program (whether solely by one Party or jointly by the Parties, in each case with their Affiliates or any Third Parties or any employees, consultants or agents of any of the foregoing which perform activities under the Collaboration Program).

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Development Plan has the meaning set forth in Section 3.2.

  • BMS means the Company, all related companies, affiliates, subsidiaries, parents, successors, assigns and all organizations acquired by the foregoing.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • 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)).

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • Development Program means the implementation of the development plan.

  • Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Research Use shall have the meaning given in Section 2.2.2 of this Agreement.

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

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Development Activities means those activities which are normally undertaken for the development, construction, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Research Project means a discrete scientific endeavor to answer a research question or a set of research questions related to medical marijuana and is required for a medical marijuana research license.

  • 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.