Development and Regulatory Sample Clauses

Development and Regulatory. 4.1 Technology Transfer; Transition Services; and Ad-hoc Services.

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. 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. 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 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. Development responsibilities 7.1 Save for those Development related matters which are the responsibility of Insite under this Agreement or pursuant to a Development Plan, Nicox shall be responsible, at its own cost, for: (a) Development of the Products in the Field in the Territory, including providing regulatory, clinical and pharmacovigilance expertise, managing pharmacovigilance activities and third party suppliers, and auditing key suppliers involved in Development for compliance with Regulatory Requirements in the Territory and their contractual obligations; (b) managing Chemistry, Manufacturing and Control for Product supply and clinical trial supplies in the Field in the Territory; (c) managing clinical and non-clinical development activities in the Territory; (d) subject to clause 7.3, obtaining and maintaining throughout the Term all necessary Regulatory Approvals for the Products in the Field in the Territory; (e) preparing all Regulatory Dossiers and, subject to clause 7.3, filing all Regulatory Submissions relating to the Products in the Field in the Territory, including conducting any and all clinical trials and research, collecting all necessary data and preparing all reports and other documentation required in connection with the obtaining and/or maintaining of any Regulatory Approval for the Products in the Field in the Territory; and (f) all communications and other dealings with Regulatory Authorities in the Territory relating to the Products in the Field, including filing all supplements and other documents with such Regulatory Authorities as are necessary to comply with Regulatory Requirements in the Territory. 7.2 The responsibilities in clause 7.1 shall be carried out in accordance with the terms of Development Plans and the decisions of the Collaboration and Development Committee. Every six (6) months following the Effective Date, Nicox shall provide to the Collaboration and Development Committee a written report summarizing the efforts and accomplishments of Nicox (including efforts and accomplishments through Authorized Resellers and other sub-licensees) during the preceding six (6)-month period in Developing Products in the Territory, and any data and information generated from or relating to such activities as described in clause 4.4. 7.3 All Regulatory Submissions and Regulatory Approvals for the Products in the Field in the Territory shall be made or held in the name either of Nicox or of any third party at Nicox’s election (on...

Development and Regulatory. 21 3.1 Initial Development Plan and Activities. 21 3.2 AbbVie Option. 24 3.3 [***]. 25

Development and Regulatory. Milestone Payment has the meaning set forth in clause 4.3.1.

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).