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 CONFIDENTIAL TREATMENT REQUESTED Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to omitted portions marked “***”. 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. 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. 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. 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. 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. Partner shall be permitted to terminate the Agreement for Safety Reasons upon [***] written notice to Atara, but only after consulting with Xxxxx at least [***] on Partner’s assessment with respect to such Safety Reasons. In this regard, “
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 Alexza if the Data and Safety Monitoring Board or any Regulatory Authority in the United States imposes a clinical hold on any clinical trial for a Product for [ * ] ([ * ]) consecutive months.
Termination for Safety Reasons. In the event that AstraZeneca determines in good faith in accordance with its internal procedures that there is a material safety issue associated with a Product, which safety issue was not disclosed to AstraZeneca prior to the Effective Date, then AstraZeneca shall discuss the matter with Ironwood as promptly as practicable. Provided that AstraZeneca does not modify its determination following such discussion, AstraZeneca may terminate this Agreement effective upon written notice thereof to Ironwood.
