Technical Development Matter definition

Technical Development Matter means any dispute concerning a Party's refusal to approve a clinical trial proposed pursuant to Section 2.6(b).

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Technical Development Matter means (i) any matter with respect to the Development of a VEGF Product involving the determination of any trial design issues, including without limitation protocols, endpoints and number of patients; provided that a decision on the matter would not have a material effect on the Development Costs and (ii) any dispute concerning the JDC’s refusal to approve Phase IIA Clinical Trials or Phase IIB Clinical Trials proposed by Regeneron pursuant to Section 2.4.

Technical Development Matter shall have the meaning set forth in Section 10.2.

Examples of Technical Development Matter in a sentence

For the purposes of this Agreement, the term "Technical Development Matter" shall mean any dispute concerning a Party's refusal to approve a clinical trial proposed pursuant to Section 2.6(b).
Disputes, controversies and claims related to matters intended to be decided within the governance provisions of this Agreement set forth in Article 3 shall be resolved pursuant to Article 3 and, to the extent such matters constitute a Technical Development Matter, Section 10.4, except in each case to the extent any such dispute, controversy or claim constitutes a Legal Dispute, in which event the provisions of Section 10.3 shall apply.
The Executive Officers shall diligently and in good faith, attempt to resolve the referred dispute within thirty (30) days of receiving such written notification, failing which, except for Legal Disputes, either Party may by written notice to the other Party require the specific issue in dispute to be submitted to a panel of experts in accordance with Section 10.4, if such dispute is with respect to a Technical Development Matter.
The Executive Officers shall diligently and in good faith, attempt to resolve the referred dispute within five (5) Business Days of receiving such written notification, failing which, except for Legal Disputes (unless as jointly agreed by the Parties), either Party may by written notice to the other Party require the specific issue in dispute to be submitted for resolution by an Expert Panel pursuant to Section 10.4, if such dispute is with respect to a Technical Development Matter.

More Definitions of Technical Development Matter

Technical Development Matter means (a) any dispute concerning a Party’s refusal to approve a clinical trial proposed pursuant to Section 2.6(b), (b) any dispute concerning standard distribution cost per unit of New Licensed Product applicable to a given Contract Year pursuant to clause (a)(i) of the definition of “Shared Commercial Expenses”, and/or (c) any dispute concerning whether an indication constitutes a “New Major Indication”.”

Technical Development Matter means (a) any matter involving the Development of a Licensed Product in the Field, including the determination of clinical trial design and any Development or regulatory dispute referred to the Executive Officers pursuant to Section 3.10(a)(iii) and (b) any dispute concerning a Party’s refusal to approve a clinical trial proposed pursuant to Section 2.6(b).