Transition Activities. (i) The Parties wish to provide a mechanism to ensure that, assuming the Product is available to patients in the Terminated Countries in the Otsuka Territory as of the effective date of expiration or termination, patients who were being treated with Product(s) prior to such expiration or termination or who desire access to Product(s) can continue to have access to such Product(s) while the responsibilities for Product(s) in such Terminated Countries in the Otsuka Territory are transitioned from Otsuka to Aurinia or its designee. (ii) As such, Aurinia may request Otsuka to perform transition activities with respect to Product(s) in such Terminated Countries in the Otsuka Territory that are necessary or reasonably useful to (i) transition Commercialization activities (if any) to Aurinia, including transitioning distribution responsibilities to Aurinia or its designee, to avoid any shortage of Product(s) and minimize disruption to sales in such countries, (ii) provide patients with continued access to Product(s) (if applicable), (iii) enable Aurinia or its designee to assume and execute the responsibilities under all Regulatory Approvals and ongoing Clinical Trials for Product(s), and (iv) ensure long-term continuity of supply of Product(s) in such Terminated Country(ies); (collectively, the “Transition Activities”). (iii) If, within forty-five (45) days after the effective date of expiration or termination, Aurinia provides a written request to Otsuka to perform Transition Activities with respect to Product(s) and Terminated Country(ies) in the Otsuka Territory, then the Parties will mutually agree on a transition plan for Otsuka to perform such Transition Activities, including transition dates, and, to the extent permitted under Applicable Law, Otsuka or its Affiliate will conduct such Transition Activities in accordance with such plan, but in no event for longer than one year following the effective date of expiration or termination. In addition, the Parties will establish a transition committee consisting of at least each Party’s Alliance Managers, and up to two (2) additional representatives from each Party who are from other relevant functional groups to facilitate a smooth transition, and the Parties will mutually agree on talking points and a communication plan to customers, physicians, Regulatory Authorities, patient advocacy groups, and Clinical Trial investigators, in each case only if applicable at the time of expiration or termination, and Otsuka will make such communications to such applicable entities in accordance with the mutually agreed talking points. As part of the Transition Activities, Otsuka will cooperate with all reasonable requests of Aurinia relating to the transition of activities relating to the Product to Aurinia or its designee and, at Aurinia’s request, Otsuka shall provide Aurinia with reasonable assistance with any inquiries and correspondence with Regulatory Authorities regarding the Product. (iv) Aurinia shall pay Otsuka’s internal costs calculated using the same methodology as Otsuka used to calculate such expenses for Product in its most recently audited financial statements prior to the expiry or termination date and shall reimburse Otsuka for its out-of-pocket costs incurred in connection with performance of the Transition Activities within thirty (30) days of receipt of an invoice therefor from Otsuka. Except as set forth in Section 14.6(k) (with respect to Inventory Sell-Off), Aurinia will own all revenue derived from the Products after the effective date of termination and Otsuka will remit to Aurinia all such revenues received by Otsuka in the performance of the Transition Activities no later than the forty-fifth (45th) day following the end of the month in which such revenue was received.
Appears in 1 contract
Sources: Collaboration and License Agreement (Aurinia Pharmaceuticals Inc.)
Transition Activities. For a period of up to [***] following the effective date of termination:
(ia) The Parties wish to provide a mechanism to ensure that, assuming the Discontinued Product is available to patients in the Terminated Countries in the Otsuka Territory as of the effective date of expiration or terminationreversion date, patients who were being treated with Product(s) the Discontinued Product prior to such expiration or termination or who desire access to Product(s) the Discontinued Product can continue to have access to such Product(s) Discontinued Product while the regulatory and commercial responsibilities for Product(s) in such Terminated Countries in the Otsuka Territory Discontinued Product are transitioned from Otsuka Roche to Aurinia or its designee.
(ii) Ionis. As such, Aurinia Ionis may request Otsuka Roche to perform transition activities with respect to Product(s) in such Terminated Countries in the Otsuka Territory that are necessary or reasonably useful to (i1) transition Roche’s Commercialization activities (if any) to Aurinia, including transitioning distribution responsibilities Ionis to Aurinia or its designee, to avoid any shortage of Product(s) and minimize disruption to sales in such countriessales, (ii2) provide patients with continued access to Product(s) the applicable Discontinued Products (if applicable), (iii3) enable Aurinia Ionis (or its designee Ionis’ designee) to assume and execute the responsibilities under all Regulatory Approvals and ongoing Clinical Trials Studies for Product(s)the applicable Discontinued Product, and (iv4) ensure long-term continuity of supply of Product(s) in such Terminated Country(ies); for the Discontinued Product (collectively, the “Transition Activities”).
(iii) If, within forty-five (45) days after including, if applicable, the categories of services and deliverables listed on SCHEDULE 11.5.9, but no longer than [***] following the effective date of expiration or termination. If applicable, Aurinia provides a written request Roche will [***] SCHEDULE 11.5.9; provided Roche and ▇▇▇▇▇ may mutually agree in writing to Otsuka [***].
(b) Ionis may elect to have Roche perform the applicable Transition Activities with respect by providing written notice to Product(s) and Terminated Country(ies) in Roche no later than [***] following the Otsuka Territoryeffective date of the termination. If Ionis requests Transition Activities, then without limiting the provisions of Section 11.5 (Special Consequences of Termination of the Agreement), the Parties will mutually agree on upon a transition plan for Otsuka Roche to perform such the applicable Transition Activities, Activities including delivery and transition dates, and, to the extent permitted under Applicable Law, Otsuka or its Affiliate will conduct such Transition Activities in accordance with such plan, but in no event for longer than one year following the effective date of expiration or termination. In addition, the Parties will establish a transition committee consisting of at least each Party’s Alliance Managers, a representative from each Party’s chemistry, manufacturing and controls (“CMC”) group who was responsible for the Discontinued Product prior to the termination, and up to two (2) additional representatives from each Party who are from other relevant functional groups to facilitate a smooth transition. While Roche is providing applicable Transition Activities, Roche and the Parties Ionis will mutually agree on talking points and a communication plan [***].
(c) Ionis will [***] to customers, physicians, Regulatory Authorities, patient advocacy groups, and Clinical Trial investigators, in each case only if applicable at the time of expiration or termination, and Otsuka will make such communications to such applicable entities in accordance with the mutually agreed talking points. As part of perform the Transition Activities. In addition, Otsuka Ionis will cooperate with all reasonable requests of Aurinia relating [***] to the transition of activities relating to the Product to Aurinia or its designee and, at Aurinia’s request, Otsuka shall provide Aurinia with reasonable assistance with any inquiries and correspondence with Regulatory Authorities regarding the Product.
(iv) Aurinia shall pay Otsuka’s internal costs calculated using the same methodology as Otsuka used to calculate such expenses for Product in its most recently audited financial statements prior to the expiry or termination date and shall reimburse Otsuka for its out-of-pocket costs incurred in connection with performance of perform the Transition Activities within thirty (30) days of receipt of an invoice therefor from OtsukaActivities. Except as set forth in Section 14.6(k) (with respect to Inventory Sell-Off), Aurinia Ionis will own all revenue derived from the Products after the effective date of termination and Otsuka will remit to Aurinia all such revenues received by Otsuka in the performance of the Transition Activities no later than the forty-fifth (45th) day following the end of the month in which such revenue was received[***].
Appears in 1 contract
Sources: Research, Development, and License Agreement (Ionis Pharmaceuticals Inc)
Transition Activities. Upon termination of this Agreement under Section 13.2 except if this Agreement is terminated by Otsuka pursuant to Section 13.2.3 (ifor clarity, not if this Agreement expires pursuant to Section 13.1):
(a) The Parties wish to provide a mechanism to ensure that, assuming the any Product is available to patients in the Terminated Countries in the Otsuka Territory as of the effective date of expiration or termination, patients who were being treated with Product(s) Products prior to such expiration or termination or who desire access to Product(s) a Product can continue to have access to such Product(s) Products while the responsibilities for Product(s) in such Terminated Countries any Product in the Otsuka Territory are transitioned from Otsuka to Aurinia Perception or its designee.
(iib) As such, Aurinia Perception may request Otsuka to perform transition activities with respect to Product(s) in such Terminated Countries Products in the Otsuka Territory that are necessary or reasonably useful to (i) transition Commercialization activities (if any) to AuriniaPerception, including transitioning distribution responsibilities to Aurinia Perception or its designee, to avoid any shortage of Product(s) Products and minimize disruption to sales in such countriesthe Otsuka Territory, (ii) provide patients with continued access to Product(s) Products (if applicable), (iii) enable Aurinia Perception or its designee to assume and execute the responsibilities under all Regulatory Approvals and ongoing Clinical Trials Studies for Product(s)Products in the Otsuka Territory, and (iv) ensure long-term continuity of supply of Product(s) Products in such Terminated Country(ies); the Otsuka Territory (collectively, the “Transition Activities”).
(iiic) If, within forty-five (45) days [***] after the effective date of expiration or termination, Aurinia Perception provides a written request to Otsuka to perform Transition Activities with respect to Product(s) and Terminated Country(ies) in the Otsuka Territory, then the Parties will mutually agree on a transition plan for Otsuka to perform such Transition ActivitiesActivities (and neither Party shall unreasonably withhold its agreement to such transition plan), including transition dates, and, to the extent permitted under Applicable Law, Otsuka or its Affiliate will conduct such Transition Activities in accordance with such plan, but in no event for longer than one year [***] following the effective date of expiration or termination. In addition, the Parties will establish a transition committee consisting of at least each Party’s Alliance ManagersManager, and up to two (2) [***] additional representatives from each Party who are from other relevant functional groups to facilitate a smooth transition, and the Parties will mutually agree on talking points and a communication plan to customers, physicians, Regulatory Authorities, patient advocacy groups, and Clinical Trial Study investigators, in each case only if applicable at the time of expiration or termination, and Otsuka will make such communications to such applicable entities in accordance with the mutually agreed talking points. As part of the Transition Activities, Otsuka will cooperate with all reasonable requests of Aurinia Perception relating to the transition to Perception or its designee of activities relating to any Product in the Product to Aurinia or its designee Otsuka Territory and, at AuriniaPerception’s request, Otsuka shall provide Aurinia Perception with reasonable assistance with any inquiries and correspondence with Regulatory Authorities in the Otsuka Territory regarding the ProductProducts.
(ivd) Aurinia shall pay Otsuka’s internal costs calculated using the same methodology as Otsuka used to calculate such expenses for Product in its most recently audited financial statements prior to the expiry or termination date and shall reimburse Otsuka for its out-of-pocket costs incurred in connection with performance of the Transition Activities within thirty (30) days of receipt of an invoice therefor from Otsuka. Except as set forth in Section 14.6(k) (with respect to Inventory Sell-Off), Aurinia will own all revenue derived from the Products after the effective date of termination and Otsuka will remit to Aurinia all such revenues received by Otsuka in the performance of the Transition Activities no later than the forty-fifth (45th) day following the end of the month in which such revenue was received[***].
Appears in 1 contract
Sources: License and Collaboration Agreement (ATAI Life Sciences B.V.)
Transition Activities. (ia) The Parties wish to provide a mechanism to ensure that, assuming the Licensed Product is available to patients in the Terminated Countries in the Otsuka Territory as of the effective date of expiration or terminationreversion date, patients who were being treated with Product(s) the Licensed Product prior to such expiration or termination or who desire access to Product(s) the Licensed Product can continue to have access to such Product(s) Licensed Product while the regulatory and commercial responsibilities for Product(s) in such Terminated Countries in the Otsuka Territory Licensed Product are transitioned from Otsuka DSE to Aurinia or its designee.
(ii) Esperion. As such, Aurinia Esperion may request Otsuka DSE to perform transition activities with respect to Product(s) in such Terminated Countries in the Otsuka Territory that are necessary or reasonably useful to (i1) transition DSE’s Commercialization activities (if any) to Aurinia, including transitioning distribution responsibilities Esperion to Aurinia or its designee, to avoid any shortage of Product(s) and minimize disruption to sales in such countriessales, (ii2) provide patients with continued access to Product(s) the applicable Licensed Products (if applicable), (iii3) enable Aurinia Esperion (or its designee Esperion’s designee) to assume and execute the responsibilities under all Regulatory Approvals and ongoing Clinical Trials Studies for Product(s)the applicable Licensed Product, and (iv4) ensure long-term continuity of supply of Product(s) in such Terminated Country(ies); for the Licensed Product (collectively, the “Transition Activities”).
(iii) If, within forty-five (45) days after the effective date of expiration or termination, Aurinia provides a written request to Otsuka to perform Transition Activities with respect to Product(s) and Terminated Country(ies) in the Otsuka Territory, then the Parties will mutually agree on a transition plan for Otsuka to perform such Transition Activities, including transition dates, and, to the extent permitted under Applicable Law, Otsuka or its Affiliate will conduct such Transition Activities in accordance with such plan, but in no event for longer than one [***] year following the effective date of expiration or termination.
(b) Esperion may elect to have DSE perform the applicable Transition Activities by providing written notice to DSE no later than [***] days following the effective date of the termination. If Esperion requests Transition Activities, the Parties will mutually agree upon a transition plan for DSE to perform the applicable Transition Activities including delivery and transition dates. In addition, the Parties will establish a transition committee consisting of at least each Party’s Alliance Managers, and up to two (2) [***] additional representatives from each Party who are from other relevant functional groups to facilitate a smooth transition. While DSE is providing applicable Transition Activities, DSE and the Parties Esperion will mutually agree on talking points and a communication plan to customers, specialty pharmacies, physicians, Regulatory Authoritiesregulatory authorities, patient advocacy groups, and Clinical Trial clinical study investigators, in each case only if applicable at the time of expiration or terminationreversion, and Otsuka DSE will make all such communications to such applicable entities in accordance with the mutually agreed talking points. As part of the Transition Activities, Otsuka will cooperate with all reasonable requests of Aurinia relating to the transition of activities relating to the Product to Aurinia or its designee and, at Aurinia’s request, Otsuka shall provide Aurinia with reasonable assistance with any inquiries and correspondence with Regulatory Authorities regarding the Product.
(ivc) Aurinia shall pay Otsuka’s internal costs calculated using the same methodology as Otsuka used to calculate such expenses for Product in its most recently audited financial statements prior to the expiry or termination date and shall reimburse Otsuka for its out-of-pocket costs incurred in connection with performance of the Transition Activities within thirty (30) days of receipt of an invoice therefor from Otsuka. Except as set forth in Section 14.6(k) (with respect to Inventory Sell-Off), Aurinia [***] Esperion will own all revenue derived from the Products Licensed Product after the effective termination date of termination and Otsuka DSE will remit to Aurinia all such revenues received by Otsuka in the performance of the Transition Activities to Esperion no later than the forty-fifth (45th) [***] day following the end of the month in which such revenue was received.
Appears in 1 contract
Sources: License and Collaboration Agreement (Esperion Therapeutics, Inc.)