Medical Inquiries for the Product. Following the Effective Date, Licensee, as the intended beneficiary under this Agreement of the privileges of ownership of the Product Approvals in the Field in the Territory, shall be responsible for handling all medical questions or inquiries in the Territory, including all Product Complaints, with regard to any Product sold by or on behalf of Licensee (or any of its Affiliates), in each case in accordance CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. with Applicable Laws and this Agreement. Amarin shall provide a copy of any standardized responses to medical inquiries to Licensee for Licensee’s use with respect to the Product in the Field in the Territory. Amarin shall immediately forward any and all medical questions or inquiries which it receives with respect to any Product sold by or on behalf of Licensee (or any of its Affiliates) in the Territory to Licensee in accordance with all Applicable Laws and Licensee shall immediately forward to Amarin any and all medical questions or inquiries that it receives with respect to Product (i) not sold by or on behalf of Licensee (or any of its Affiliates) in the Territory or (ii) outside of the Territory, in each case in accordance with all Applicable Laws. Notwithstanding the foregoing, Amarin shall be responsible for handling all Product Complaints other than those related to the Development and Commercialization of the Product in the Field in the Territory, and Licensee shall refer all such Product Complaints to Amarin. Licensee shall be responsible for handling all Product Complaints related to the Development and Commercialization of the Product in the Field in the Territory, and Amarin shall refer all such Product Complaints to Licensee.
Appears in 1 contract
Samples: Development, Commercialization and Supply Agreement (Amarin Corp Plc\uk)
Medical Inquiries for the Product. Following the Effective Date, LicenseeAKP, as the intended beneficiary under this Agreement of the privileges of ownership of the Product Approvals in the Field in the Territory, shall be responsible for handling all medical questions or inquiries relating to the Field in the Territory, including all Product Complaints, with regard to any Product sold by or on behalf of Licensee AKP (or any of its Affiliates), in each case in accordance CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. with Applicable Laws and this Agreement. Amarin shall provide a copy of any standardized responses to medical inquiries to Licensee for Licensee’s use with respect to the Product in the Field in the Territory. Amarin VectivBio shall immediately forward to AKP any and all medical questions or inquiries which it receives with respect to any Product sold by or on behalf of Licensee AKP (or any of its Affiliates) in the Field in the Territory to Licensee AKP in accordance with all Applicable Laws Laws, and Licensee AKP shall immediately forward to Amarin VectivBio any and all medical questions or inquiries that it receives with respect to Product (i) not Products sold by or on behalf of Licensee VectivBio (or any of its Affiliates) in the Territory or (ii) Field outside of the Territory, in each case Territory in accordance with all Applicable Laws. Notwithstanding the foregoing, Amarin VectivBio shall be responsible for handling all Product Complaints that are related to the Global Trial SBS Adult in the Territory and all other Product Complaints other than those related to the Development and Commercialization of the Product in the Field in the Territory, and Licensee AKP shall immediately (i) refer all such Product Complaints to Amarin. Licensee shall be responsible for handling VectivBio and (ii) notify VectivBio of all other Product Complaints related that it receives with respect to the Development and Commercialization of the Product in the Field in the Territory and which could reasonably be expected to be material to the Development or Commercialization of the Product outside of the Territory; provided, however, that VectivBio shall not issue any public statement regarding any such Product Complaint without notifying the JSC unless required by Applicable Law. AKP shall be responsible for handling all Product Complaints (i) that are related to the Development of the Product in the Field in the Territory (excluding any Product Complaints related to the Global Trial SBS Adult in the Territory) and (ii) that are related to Commercialization of the Product in the Field in the Territory, and Amarin VectivBio shall immediately refer all such Product Complaints to LicenseeAKP; provided, however, that AKP shall not issue any public statement regarding any such Product Complaint without notifying the JSC unless required by Applicable Law.
Appears in 1 contract
Samples: Development and Commercialization Agreement (VectivBio Holding AG)
Medical Inquiries for the Product. Following the Effective Date, Licensee, as the intended beneficiary under this Agreement of the privileges of ownership of the Product Regulatory Approvals in the Field in the Territory, shall be responsible for handling all medical questions or inquiries in the Territory, including all Product Complaints, with regard to any Product sold by or on behalf of Licensee (or any of its Affiliates), in each case in accordance CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. with Applicable Laws and this Agreement. Amarin VBL shall provide a copy of any standardized responses to medical inquiries to Licensee for Licensee’s use with respect to the Product in the Field in the Territory. Amarin VBL shall immediately forward any and all medical questions or inquiries which it receives with respect to any Product sold by or on behalf of Licensee (or any of its Affiliates) in the Territory to Licensee in accordance with all Applicable Laws and Licensee shall immediately forward to Amarin VBL any and all medical questions or inquiries that it receives with respect to Product (i) not sold by or on behalf of Licensee (or any of its Affiliates) in the Territory or (ii) outside of the Territory, in each case in accordance with all Applicable Laws. Notwithstanding the foregoing, Amarin VBL shall be responsible for handling all Product Complaints other than those related to the Development and Commercialization of the Product in the Field in the Territory, and Licensee shall refer all such Product Complaints to AmarinVBL. Licensee shall be responsible for handling all Product Complaints related to the Development and Commercialization of the Product in the Field in the Territory, and Amarin VBL shall refer all such Product Complaints to Licensee.
Appears in 1 contract
Samples: Development, Commercialization and Supply Agreement (Vascular Biogenics Ltd.)
Medical Inquiries for the Product. Following the Effective Date, Licensee, as the intended beneficiary under this Agreement of the privileges of ownership of the Product Approvals in the Field in Territory for the TerritoryField, (or its designee) shall be responsible for handling all medical questions or inquiries in the Territory, including all Product Complaints, with regard to any Product sold by or on behalf of Licensee (or any of its Affiliates), in each case in accordance CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. with Applicable Laws and this Agreement. Amarin shall provide a copy of any standardized responses to medical inquiries inquiries, and such other information as Licensee may reasonably request, to Licensee for Licensee’s use with respect to the Product in the Field in Territory for the TerritoryField. Amarin shall immediately [***] forward to Licensee any and all medical questions or inquiries which it receives with respect to any the Product sold by or on behalf of Licensee (or any of its Affiliates) in the Territory to Licensee in accordance with all Applicable Laws Laws, and Licensee shall immediately [***] forward to Amarin any and all medical questions or inquiries that it receives with respect to the Product (ia) not sold by or on behalf of Licensee (or any of its Affiliates) in the Territory or (iib) outside of the Territory, in each case in accordance with all Applicable Laws. Notwithstanding the foregoing, Amarin shall be responsible for handling managing all Product Complaints other than those related to the Development and or Commercialization of the Product in the Field in or outside the Territory, and Licensee shall refer all such Product Complaints to Amarin. , and Licensee shall be responsible reasonably cooperate with the management and resolution of such Product Complaints. The Parties shall specify in the pharmacovigilance agreement detailed processes (including timing) for handling all the periodic reconciliation of Product Complaints related to between the Development and Commercialization of the Product in the Field in the Territory, and Amarin shall refer all such Product Complaints to LicenseeParties.
Appears in 1 contract
Samples: Development, Commercialization and Supply Agreement (Amarin Corp Plc\uk)