Development and Regulatory. 3.1 Pre Exercise Development Plan and Budget and Activities.
Development and Regulatory. 21 3.1 Initial Development Plan and Activities. 21 3.2 AbbVie Option. 24 3.3 [***]. 25
Development and Regulatory. Spectrum (itself and through its Affiliates and Sublicensees, as applicable) shall use Commercially Reasonable Efforts to develop and obtain Marketing Approvals of the Products for an indication in the Field in the Major Markets in the Spectrum Territory.
Development and Regulatory. (a) From and after the Amendment No. 2 Effective Date, Buyer shall, in its sole discretion, be solely responsible to Develop the Products in the Territory and for making all Regulatory Filings and seeking Regulatory Approval for the Products in the applicable jurisdiction) and be responsible for conducting all meetings with Regulatory Authorities in connection therewith.
(b) To the extent required, each Party shall grant or cause to be granted to the other and its Affiliates or sublicensees cross-reference rights to any relevant drug master files and other filings submitted by such Party or its Affiliates with any Regulatory Authority relevant to the Products. In countries where cross-reference rights are deemed insufficient, each Party shall assist the other in preparing and providing the relevant Regulatory Authorities with equivalent Regulatory Filings in order to enable such other Party to comply with its regulatory obligations and obtain the relevant Regulatory Approvals.
Development and Regulatory. 1Antibody Sequence Delivery. For each Accepted Target, AbbVie will use Commercially Reasonable Efforts to deliver to Licensor the sequence of an Antibody Controlled by AbbVie that specifically binds to such Accepted Target and that AbbVie believes meets the Antibody Criteria (the “Discovery Antibody”), together with related materials and data as set forth in the Discovery Research Plan. Following such delivery, Licensor will promptly evaluate whether such Discovery Antibody meets the Antibody Criteria in accordance with the Discovery Research Plan and the timeline set forth therein. If the JRC determines that a Discovery Antibody does not meet the Antibody Criteria, the JRC will promptly provide AbbVie with written notice identifying the deficiencies and AbbVie may, in its sole discretion and upon written notice to Licensor, elect to either (a) select a new Discovery Antibody for the existing Accepted Target or (b) select a Substitute Target pursuant to Section 2.2. Following AbbVie’s selection, this Section 4.1 will apply with respect to the new Discovery Antibody.
Development and Regulatory. 3.1 [ * ] Transfer. As soon as possible and, in any event, no later than [ * ], Licensor shall, at AGT’s expense, deliver to AGT, at an address specified by AGT, at least [ * ] of [ * ] in accordance with this Agreement (the “Transferred Materials”). The Transferred Materials shall be Manufactured by Licensor or its Affiliates (or its’ or its Affiliates’ designated manufacturer) according to the applicable current good manufacturing practices pursuant to Applicable Law and shipped under appropriate conditions (including temperature control if needed).
Development and Regulatory. 4.1 Technology Transfer; Transition Services; and Ad-hoc Services.
Development and Regulatory. 3.1 Current Status of Development of Lead Product and MDX-1379
3.2 Global Development Plans and Budgets and Annual Development Plans and Budgets
Development and Regulatory. Current Status of Development of Lead Product and the Lead Agents. As of the Effective Date, (a) Medarex is conducting the Melanoma Trial and (b) the Parties plan to initiate the Clinical Trials for other Indications as set forth in the Global Development Plan and Budget as Previously Disclosed for the Lead Product and the Lead Agents.
Development and Regulatory
