Termination for Safety Reasons. Either Party shall have the right to terminate this Agreement with respect to any Product in the Territory, without liability for any compensation or other payment obligation to the other Party due to such termination except as expressly specified in this Agreement, by providing the other Party with at least [***] ([***]) days prior written notice of termination, if, at any time, (a) [***] such Product, caused or is likely to cause a fatal, life-threatening or other serious adverse safety event that is reasonably expected, based upon then available data, to preclude obtaining Regulatory Approval for such Product, or, if Regulatory Approval of such Product has already been obtained, to preclude continued marketing of such Product, or (b) [***]. Notwithstanding anything to the contrary in the foregoing, neither Party shall have the right to terminate this Agreement pursuant to this Section 12.3 based on a safety concern [***].
Termination for Safety Reasons. Brii Bio may terminate this Agreement at any time during the Term immediately upon providing written notice to VBI if a Data and Safety Monitoring Board or any Regulatory Authority in the Licensed Territory imposes a clinical hold on any Clinical Trial for a Licensed Product for six (6) consecutive months.
Termination for Safety Reasons. If AZ terminates this Agreement with respect to a Collaboration Antigen in its entirety pursuant to Section 16.6, then (a) all licenses and other rights granted by each Party to the other Party with respect to such Collaboration Antigen shall terminate, (b) the exclusivity restrictions with respect to each Party in Article 17 shall terminate with respect to such Collaboration Antigen, and (c) each Party shall return all Confidential Information of the other Party (and all tangible embodiments thereof) relating to such Collaboration Antigen; provided, however, that each Party shall have the right to retain one (1) copy for its legal files for the sole purpose of determining its obligations hereunder.
Termination for Safety Reasons. Each Party shall have the right to terminate this Agreement on a Compound-by- Compound and Product-by-Product basis with respect to such Party’s field and territory at any time upon providing ninety (90) days prior written notice to the other Party (i) if senior executives responsible for the terminating Party’s pharmacovigilance and clinical science functions determine in good faith that the risk/benefit profile of the Compound or Product is such that the Compound or Product cannot continue to be Developed or administered to patients safely; or (b) upon the occurrence of serious adverse events related to the use of the Compound or Product that cause the terminating Party to conclude that the continued use of the Compound or Product by patients will result in patients being exposed to a product in which the risks outweigh the benefits.
Termination for Safety Reasons. Notwithstanding Section 14.2, Servier shall be permitted to terminate the Agreement on thirty (30) days’ notice or within a shorter period if required under Applicable Law, on a country-by-country basis, promptly, for Safety Reasons.
Termination for Safety Reasons. BLS may terminate this Agreement in its entirety or on a Product-by-Product or country-by-country basis at any time during the Term immediately upon providing written notice to ACADIA if the Data and Safety Monitoring Board or any Regulatory Authority in the United States or Canada imposes a clinical hold on any clinical trial for a Product for six (6) consecutive months.
Termination for Safety Reasons. Subject to the rest of this Section 13.4, either Party may terminate this Agreement upon written notice to the other Party based on Safety Reasons. Upon receiving such written notice, each Party shall immediately cease all the Development and/or Commercialization activities that give rise to such Safety Reasons. If either Party disputes the existence of such Safety Reasons, such dispute shall be referred to JDC prior to resorting to the procedures under Article 14 and the applicable Party’s right to terminate this Agreement shall be stayed during the pendency of such dispute resolution process, provided that neither Party may engage in any Development and/or Commercialization activities that give rise to such Safety Reasons until such dispute is finally resolved in favor of the Party disputing such Safety Reasons. Upon such termination for Safety Reasons, each Party shall be responsible at its expense for the wind-down of any Development (including without limitation any clinical trials for the Licensed Product being conducted by or on behalf of each Party) and any Commercialization activities for the Licensed Product(s).
Termination for Safety Reasons. Notwithstanding the foregoing, Celgene shall have the right to terminate this Agreement immediately on a Licensed Compound-by-Licensed Compound or Licensed Product-by-Licensed Product basis upon written notice to Forma Inc. based on Safety Reasons. Upon such termination for Safety Reasons, Celgene shall be responsible, at its expense, for the wind-down, if any, of any development of the applicable Licensed Compound or Licensed Product (including any Clinical Trials for the applicable Licensed Compound or Licensed Product being conducted by or on behalf of Celgene, in consultation with the applicable Regulatory Authority) and any commercialization activities for the applicable Licensed Compound or Licensed Product. Such termination shall become effective upon the date that Celgene notifies Forma Inc. in writing that such wind-down is complete. Upon such termination for Safety Reasons, all licenses granted by one Party to the other Party under this Agreement shall terminate solely with respect to the applicable Licensed Compound or Licensed Product. Upon mutual agreement of the Parties, Celgene shall transfer and assign to Forma Inc. any Regulatory Filings and Regulatory Approvals that have been filed by Celgene for the applicable Licensed Compound or Licensed Product and all data (including Regulatory Data) made, collected or otherwise generated under this Agreement by Celgene in connection with its activities for the applicable Licensed Compound or Licensed Product, and Forma Inc. shall be permitted to use such data for any purpose.
Termination for Safety Reasons. (a) Each Party shall have the right to terminate this Agreement on a Compound-by- Compound and Product-by-Product basis with respect to such Party’s field and territory at any time upon providing ninety (90) days prior written notice to the other Party (i) if senior executives responsible for the terminating Party’s pharmacovigilance and clinical science functions determine in good faith that the risk/benefit profile of the Compound or Product is such that the Compound or Product cannot continue to be Developed or administered to patients safely; or (b) upon the occurrence of serious adverse events related to the use of the Compound or Product that cause the terminating Party to conclude that the continued use of the Compound or Product by patients will result in patients being exposed to a product in which the risks outweigh the benefits.
(b) Notwithstanding the foregoing, following the execution of an Option Product License Agreement or Exercised Product License Agreement, the terms of such license agreement shall govern the handling of termination for safety reasons with respect to the activities that are the subject of such license agreement (which shall be on the basis of this Section 15.3) and any termination of this Agreement shall not affect the existence of such Option Product License Agreement or Exercised Product License Agreement.
Termination for Safety Reasons. If AZ determines, in good faith, that it is not feasible for AZ or its sublicensees to pursue the research, development, launch or sale of a Licensed Product that binds to and is directed against a Collaboration Antigen in one or more Major Markets due to safety concerns, including adverse events of such Licensed Product, then AZ shall promptly notify ABX in writing of such determination and provide ABX with the pertinent information with respect thereto. If ABX determines that it can solve AZ’s concerns by making the Licensed Product more safe (e.g., by using a different dose or route of administration) and ABX wishes to convert such Antigen into a Discontinued Antigen, then ABX shall notify AZ in writing thereof, which notice shall include any information supporting its determination. Promptly following the receipt of such notice from ABX, the Parties shall discuss the situation in good faith. If AZ determines that it is safe for AZ or its sublicensees to pursue the research, development, launch or sale of such Licensed Product in such Major Market(s), then AZ shall have the right to elect not to terminate this Agreement with respect to such Collaboration Antigen and instead continue to Exploit such Licensed Product pursuant to this Agreement. If following such good faith discussion and review of such information provided by ABX, AZ still believes in good faith that it is not feasible to pursue the research, development, launch or sale of such Licensed Product due to safety concerns, AZ may, in its sole discretion, terminate this Agreement with respect to such Collaboration Antigen in its entirety or with respect to such Major Market(s) [Confidential treatment requested] prior written notice to ABX.
