Collaboration Indication definition

Collaboration Indication means (a) any Indication that is or has been the subject of a Clinical Study referred to in the initial GDP attached to this Agreement as Exhibit B; (b) any Indication that is the subject of a Clinical Study that is added to the GDP after the Effective Date pursuant to Section 4.1.3; and (c) any Indication that is the subject of an Independent Study with respect to which an Opt-In Event has occurred pursuant to Section 4.3.5.
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Collaboration Indication means an Indication identified by either Party and designated by the JSC as a Collaboration Indication pursuant to Section 3.3.
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Collaboration Indication means any Indication that is or has been the subject of a Clinical Trial in the GDP for the Profit Share Product.
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Examples of Collaboration Indication in a sentence

  • The Parties agree to cooperate in good faith to identify one (1) Additional Collaboration Indication in the Territory for which the costs and expenses thereof shall be Allowable Development Expenses, subject to the provisions of Section 8.9 and the last sentence of this Section 4.1(b).

  • Subject to Section 8.9 and the last sentence of this Section 4.1(b), the Parties agree to Develop Product for the Additional Required Indication and one (1) Additional Collaboration Indication in the Territory and will enter into suitable Development Plans therefor by no later than [***] following the Effective Date.

  • Unless the Parties otherwise agree, Development of Product for each Additional Collaboration Indication shall be [***] such that enrollment of patients in a Clinical Trial for Product for [***], and enrollment of patients in a Clinical Trial for Product for any further Additional Collaboration Indications [***] for the [***].

  • A Party responsible for the first Pivotal Registration Study for a Collaboration Product in any Collaboration Indication shall establish, prior to the Initiation of the first Pivotal Registration Study for the applicable Collaboration Product, the global safety database for the Collaboration Products, and shall maintain such global safety database for so long as such Collaboration Product is under Development and/or Commercialization hereunder.

  • One of the halls will continue to be used by the only playgroup in the village, Dizzy Daisies, which operates 5 days per week during the school term.

  • Upon approval by the JSC, the additional Indication will become a Collaboration Indication (and included in an amended Exhibit D), and the Work Plan will be amended by the Parties to add appropriate Research Activities associated with the additional Indication.

  • No exercise by a Party of such opt-out right for any Collaboration Indication shall constitute a breach of this Agreement by such Party, but in the case of any such exercise, the Parties’ respective shares in Net Profits from all Collaboration Product for use in such Collaboration Indication shall be adjusted based on the applicable Profit Share Percentage.

  • If the Parties both wish to collaborate in the conduct of such Proposed Study(ies), the Proposing Party shall prepare an amendment to a Therapeutic Development Plan and Therapeutic Development Plan Budget for the Collaboration Indication for which such Collaboration Product is intended to be used, to include the Proposed Study(ies) for review by the JDC, and subsequent approval by the JSC.

  • The Parties shall be jointly responsible for the research and Development of each Collaboration Product Developed hereunder in accordance with the applicable Therapeutic Development Plan unless and until, where applicable, a Party exercises an Opt-Out Option as described below with respect to the Collaboration Indication for which such Collaboration Product is being Developed.

  • If each of the Parties is separately conducting Pivotal Registration Studies for the same Collaboration Product for the same Collaboration Indication, then Astellas shall hold the primary responsibility for establishing and maintaining the global safety database for such Collaboration Product and reporting quality complaints, adverse events and safety data; provided however, that the [*].

Related to Collaboration Indication

  • 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.

  • 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)).

  • 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.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • Position indicating device means a device on dental X-ray equipment used to indicate the beam position and to establish a definite source-surface (skin) distance. It may or may not incorporate or serve as a beam-limiting device.

  • 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.

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

  • 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.

  • Development Program means the implementation of the development plan.

  • Licensed Compound means [***].

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

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

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

  • Collaboration Patents means any and all Patents that claim or cover any of the Collaboration Know-How.

  • Collaboration Term has the meaning set forth in Section 2.1(h).

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

  • Collaboration IP means Collaboration Know-How and Collaboration Patents.

  • 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.

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

  • Collaboration Patent Rights means Patent Rights claiming Collaboration Know-How.

  • Collaboration has the meaning set forth in Section 2.1.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • 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.

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

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.