Safety Reasons. Either Party shall have the right to terminate this Agreement upon written notice to the other Party if the terminating Party reasonably determines, based upon additional information that becomes available or an analysis of the existing information at any time, that the medical risk/benefit of such Product is so unfavorable that it would be incompatible with the welfare of patients to Develop or Commercialize or to continue to Develop or Commercialize such Product. Prior to any such termination, the terminating Party shall comply with such internal review and management approval processes as it would normally follow in connection with the termination of the development and commercialization of its own products for safety reasons. The terminating Party shall document the decisions of such committees or members of management and the basis therefor and shall make such minutes and documentation available to the other Party promptly upon written request.
Safety Reasons. Either Party may terminate this Agreement at any time upon written notice to the other Party if (i) Acerus withdraws the Product from the market in the Territory for a safety reason, or (ii) (1) the FDA materially restricts the indications for the Product or (2) federal or state pricing controls are imposed that, in either case, would result in obvious and substantial loss of sales for the Product.
Safety Reasons. (a) SGI will have the right to terminate this Agreement upon ninety (90) days prior written notice to Unum with an explanation contained therein if, in the reasonable opinion of SGI’s senior management, the Research, Development or Commercialization of all Development Candidates and associated Products must be terminated for Safety Reasons attributable to ACTR T-cells. If SGI terminates this Agreement pursuant to this Section 16.5(a), then any obligation of SGI to continue to supply SGI Antibodies or of Unum to supply ACTR T-cells, or for either Party to otherwise facilitate the continued Development and Commercialization of Development Candidates and associated Products, under Section 16.6(a) will be of no force or effect. For clarity, Unum may challenge any such termination as an Arbitral Matter under Article 17; provided that the applicable Clinical Trial will be suspended pending the resolution of such challenge. [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED
Safety Reasons. Either Party shall have the right to terminate this Agreement upon written notice to the other Party if the terminating Party reasonably determines, based upon additional information that becomes available or an analysis of the existing information at any time, that the medical risk/benefit of such Product is so unfavorable that it would be incompatible with the welfare of patients to Develop or Commercialize or to continue to Develop or Commercialize such Product. Prior to any such termination, the terminating Party shall comply with such internal review and management approval processes as it would normally follow in connection with the termination of the development and commercialization of its own products for safety reasons. The terminating Party shall document the decisions of such [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. committees or members of management and the basis therefor and shall make such minutes and documentation available to the other Party promptly upon written request.
Safety Reasons. Either Party shall have the right to terminate this Agreement upon written notice to the other Party if the terminating Party reasonably determines, based upon additional information that becomes available or an analysis of the existing information at any time, that the medical risk/benefit of such Product is so unfavorable that it would be incompatible with the welfare of patients to Develop or Commercialize or to continue to Develop or Commercialize such Product. Prior to any such termination, the terminating Party shall comply with such internal review and management approval processes as it would normally follow in connection with the termination of the development and commercialization of its own products for safety reasons. The terminating Party shall document the decisions of such committees or members of management and the basis therefor and shall make such minutes and documentation available to the other Party promptly upon written request. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Safety Reasons. [ * ] shall have the right to terminate this Agreement upon written notice to [ * ] if [ * ], based upon additional information that becomes available or an analysis of the existing information at any time, that [ * ]. Prior to any such termination, [ * ] shall comply with such internal review and management approval processes as it would normally follow in connection with the termination of the development and commercialization of [ * ] for safety reasons. [ * ] shall document the decisions of such committees or members of management and the basis therefor and shall make such minutes and documentation available to [ * ] promptly upon written request.
Safety Reasons. NN may terminate this Agreement and the licenses granted hereunder upon six (6) months prior written notice to ZGEN with an explanation contained therein if, in the reasonable opinion of NN senior management, the development and/or commercialization of IL-21 Embodiments must be terminated for Safety Reasons. In such event, NN shall be obligated to pay to ZGEN all Milestone Fees outlined in Section 3.2 that have been achieved and accrued under this Agreement prior to termination. For purposes of this Section 10.3, “
Safety Reasons. AzurRx shall have the right to terminate this Agreement immediately upon written notice to FWB if AzurRx reasonably determines based upon additional information that become available or an analysis of the existing information at any time that the medical risk/benefit of the Product is so unfavorable that it would be incompatible with the welfare of patients to Develop or Commercialize or to continue to Develop or Commercialize the Product.
Safety Reasons. Either Party shall have the right to terminate or suspend its Development and/or Commercialization of the Product in its Territory upon written notice to the other Party if the terminating Party reasonably determines, based upon additional information that becomes available or an analysis of the existing information at any time, that the medical risk/benefit of the Product is so unfavorable that it would be incompatible with the welfare of patients to Develop or Commercialize or to continue to Develop or Commercialize such Product. Prior to any such termination, the terminating Party shall comply with such internal review and management approval processes as it would normally follow in connection with the termination of the development and commercialization of its own products for safety reasons. The terminating Party shall document the decisions of such committees or [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. members of management and the basis therefor and shall make such minutes and documentation available to the other Party promptly upon written request. In the event that Rigel terminates its Development or Commercialization of the Product according to this Section 14.2(d), and Kissei wishes to continue to Develop and/or Commercialize the Product in the Field in the Kissei Territory, Kissei shall notify Rigel in writing and any such continuation by Kissei shall occur only subject to an amendment to this Agreement to be negotiated between the Parties.
Safety Reasons. Exelixis shall have the right to terminate this Agreement on a Collaboration Target-by-Collaboration Target basis immediately upon written notice to Adagene if Exelixis reasonably determines, based upon additional information that becomes available or an analysis of the existing information at any time, that the medical risk/benefit of a Product directed to the applicable Collaboration Target is so unfavorable that it would be incompatible with the welfare of patients to Develop or Commercialize or to continue to Develop or Commercialize such Product.
