Common use of Transition Activities Clause in Contracts

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 (for clarity, not if this Agreement expires pursuant to Section 13.1): (a) The Parties wish to provide a mechanism to ensure that, assuming any Product is available to patients in the Otsuka Territory as of the effective date of termination, patients who were being treated with Products prior to such termination or who desire access to a Product can continue to have access to such Products while the responsibilities for any Product in the Otsuka Territory are transitioned from Otsuka to Perception or its designee. (b) As such, Perception may request Otsuka to perform transition activities with respect to Products in the Otsuka Territory that are necessary or reasonably useful to (i) transition Commercialization activities (if any) to Perception, including transitioning distribution responsibilities to Perception or its designee, to avoid any shortage of Products and minimize disruption to sales in the Otsuka Territory, (ii) provide patients with continued access to Products (if applicable), (iii) enable Perception or its designee to assume and execute the responsibilities under all Regulatory Approvals and ongoing Clinical Studies for Products in the Otsuka Territory, and (iv) ensure long-term continuity of supply of Products in the Otsuka Territory (collectively, the “Transition Activities”). (c) If, within [***] after the effective date of termination, Perception provides a written request to Otsuka to perform Transition Activities in the Otsuka Territory, then the Parties will mutually agree on a transition plan for Otsuka to perform such Transition Activities (and neither Party shall unreasonably withhold its agreement to such transition plan), including transition dates, and, to the extent permitted under Applicable Law, Otsuka will conduct such Transition Activities in accordance with such plan, but in no event for longer than [***] following the effective date of termination. In addition, the Parties will establish a transition committee consisting of at least each Party’s Alliance Manager, and up to [***] 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 Study investigators, in each case only if applicable at the time of 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 Perception relating to the transition to Perception or its designee of activities relating to any Product in the Otsuka Territory and, at Perception’s request, Otsuka shall provide Perception with reasonable assistance with any inquiries and correspondence with Regulatory Authorities in the Otsuka Territory regarding the Products. (d) [***].

Transition Activities. Upon termination In connection with the transition of this Agreement under Section 13.2 except if this Agreement is terminated by Otsuka pursuant each Program to Section 13.2.3 (for clarityNeurocrine, not if this Agreement expires pursuant to Section 13.1): (a) The Parties wish to provide a mechanism to ensure that, assuming any Product is available to patients and as further detailed in the Otsuka Territory as of Transition Plan, Voyager shall conduct the effective date of termination, patients who were being treated with Products prior to such termination or who desire access to a Product can continue to have access to such Products while the responsibilities following activities for any Product in the Otsuka Territory are transitioned from Otsuka to Perception no additional consideration: 4.4.1 Voyager shall provide all assistance reasonably necessary for Neurocrine or its designee.designees to continue the Manufacture and Development of all Collaboration Products in such Program; 4.4.2 Upon Neurocrine’s request, Voyager shall assign to Neurocrine any agreements (b) As such, Perception may request Otsuka to perform transition activities including any agreement with any Third Party manufacturer with respect to Products in a Collaboration Candidate or Collaboration Product) solely relating to the Otsuka Territory Development or Manufacture of any Collaboration Candidate or Collaboration Product to which Voyager or any of its Affiliates is a party; provided that if any such agreement is not assignable to Neurocrine (because consent is required or because it relates to products that are necessary not Collaboration Products), Voyager shall take all actions reasonably requested by Neurocrine so that Neurocrine may receive the benefits of such agreement applicable to Collaboration Candidates and Collaboration Products, which may include assigning a statement of work or reasonably useful work order to (i) transition Commercialization activities (if any) Neurocrine and facilitating a discussion of the terms of a services agreement between Neurocrine and the applicable counterparty; 4.4.3 Voyager shall transfer to PerceptionNeurocrine copies of all data, reports, records, materials and other information arising out of the applicable Program, including transitioning distribution responsibilities all non-clinical and clinical data relating to Perception any Collaboration Candidate or its designee, to avoid any shortage of Products and minimize disruption to sales in the Otsuka Territory, (ii) provide patients with continued access to Products (if applicable), (iii) enable Perception or its designee to assume and execute the responsibilities under all Regulatory Approvals and ongoing Clinical Studies for Products in the Otsuka TerritoryCollaboration Product, and all adverse event or other safety data resulting from such Program, as well as any chemistry, manufacturing and controls (ivCMC) ensure long-term continuity of supply of Products or other Manufacturing data generated in the Otsuka Territory (collectively, the “Transition Activities”).connection with such Program; and (c) If, within [***] after the effective date of termination, Perception provides 4.4.4 Voyager shall provide Neurocrine with a written request to Otsuka to perform Transition Activities in the Otsuka Territory, then the Parties will mutually agree on a transition plan for Otsuka to perform such Transition Activities (summary of its inventory of Collaboration Candidates and neither Party shall unreasonably withhold its agreement to such transition plan), including transition dates, and, to the extent permitted under Applicable Law, Otsuka will conduct such Transition Activities in accordance with such plan, but in no event for longer than [***] following the effective date of termination. In addition, the Parties will establish a transition committee consisting of at least each Party’s Alliance ManagerCollaboration Products, and up Voyager shall, at Neurocrine’s election, promptly destroy such inventory or deliver such inventory to [***] additional representatives from each Party who are from other relevant functional groups to facilitate a smooth transitionNeurocrine. Voyager represents and warrants that, and the Parties will mutually agree on talking points and a communication plan to customers, physicians, Regulatory Authorities, patient advocacy groups, and Clinical Study investigators, in each case only if applicable at the time of terminationdelivery, all clinical supply of Collaboration Candidates and Otsuka Collaboration Products (a) will make such communications to such applicable entities have been Manufactured in accordance with applicable Law, including cGMP, (b) will not be adulterated or misbranded under the mutually agreed talking points. As part of the Transition Activities, Otsuka will cooperate with all reasonable requests of Perception relating Act and may be introduced into interstate commerce pursuant to the transition to Perception or its designee of activities relating to any Product in Act, (c) will comply with the Otsuka Territory andspecifications therefor, at Perception’s request, Otsuka shall provide Perception with reasonable assistance with any inquiries and correspondence with Regulatory Authorities in the Otsuka Territory regarding the Products. (d) [***]will comply with the quality agreement to be entered into between the Parties. In the event that Voyager cannot make such representations with respect to any such inventory, Voyager shall destroy such inventory and certify such destruction to Neurocrine, unless requested otherwise by Neurocrine; provided that if any such non-compliance results from either (i) Voyager’s gross negligence or willful misconduct in the Manufacture of such inventory or (ii) Voyager’s negligence or willful misconduct in the oversight of any Third Party’s Manufacture of such inventory, Voyager shall reimburse the amounts paid by Neurocrine under the Development Plan for the Manufacture of such inventory.

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 (for clarity, not if this Agreement expires pursuant to Section 13.1): (a) The Parties wish Between the Execution Date and the Closing Date, Seller shall promptly furnish Buyer with such reasonable sample quantities of any Promotional Materials that Seller may have utilized in connection with Products during the three (3) month period prior to provide a mechanism the Execution Date, for use by Buyer in preparing its own Promotional Materials and; provided, however, that Buyer shall not distribute such Promotional Materials prior to ensure the Effective Time or prior to making any modifications or revisions necessary to clarify that, assuming from and after the Effective Time, Seller is no longer selling the Products. All costs and expenses incurred by Buyer with respect to creating any Product is available to patients in the Otsuka Territory as of the effective date of termination, patients who were being treated with Products prior to such termination or who desire access to a Product can continue to have access to such Products while the responsibilities for any Product in the Otsuka Territory are transitioned from Otsuka to Perception or its designeePromotional Materials shall be borne by Buyer. (b) As such, Perception may request Otsuka The Parties agree to perform transition activities with respect to Products negotiate in good faith and at the Otsuka Territory that are necessary or reasonably useful to (i) transition Commercialization activities (if any) to Perception, including transitioning distribution responsibilities to Perception or its designeeClosing enter into a Transition Services Agreement, to avoid any shortage of Products be effective immediately after the Effective Time, incorporating the terms set forth on Exhibit 6.7(b) and minimize disruption to sales in such other terms as are mutually agreed by the Otsuka Territory, (ii) provide patients with continued access to Products (if applicable), (iii) enable Perception or its designee to assume and execute the responsibilities under all Regulatory Approvals and ongoing Clinical Studies for Products in the Otsuka Territoryparties, and providing for the services specified therein, pursuant to which Seller and Buyer shall perform certain transitional services for the other Party in accordance with the terms and conditions thereof (iv) ensure long-term continuity of supply of Products in the Otsuka Territory (collectively, the “Transition ActivitiesServices Agreement”). (c) IfThe parties agree to negotiate in good faith and at the Closing enter into a Contract Manufacturing Agreement, within [***] to be effective immediately after the effective date of terminationEffective Time, Perception provides a written request to Otsuka to perform Transition Activities in incorporating the Otsuka Territory, then terms set forth on Exhibit 6.7(c) and such other terms as are mutually agreed by the Parties will mutually agree on a transition plan for Otsuka to perform such Transition Activities (and neither Party shall unreasonably withhold its agreement to such transition plan), including transition dates, and, to the extent permitted under Applicable Law, Otsuka will conduct such Transition Activities in accordance with such plan, but in no event for longer than [***] following the effective date of termination. In addition, the Parties will establish a transition committee consisting of at least each Party’s Alliance Managerparties, and up providing for the services specified therein, pursuant to [***] 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 Study investigators, in each case only if applicable at the time of termination, and Otsuka will make such communications to such applicable entities which Buyer shall manufacture certain Excluded Products for Seller after Closing in accordance with the mutually agreed talking points. As part of terms and conditions thereof (the Transition Activities, Otsuka will cooperate with all reasonable requests of Perception relating to the transition to Perception or its designee of activities relating to any Product in the Otsuka Territory and, at Perception’s request, Otsuka shall provide Perception with reasonable assistance with any inquiries and correspondence with Regulatory Authorities in the Otsuka Territory regarding the Products“Contract Manufacturing Agreement”). (di) [***]Each of Buyer and Seller acknowledge that the Seller Shared Use Assets (which constitute Excluded Assets except to the extent segregated or split pursuant to this Section), the Buyer Shared Use Assets (which constitute Purchased Assets except to the extent segregated or split pursuant to this Section) (such Assets, the “Shared Use Assets”) are currently used in or necessary to both the Biologics SBU and that portion of Seller’s business comprised of Excluded Assets (such business of Seller, the “Excluded Business”). (ii) The Parties agree to cooperate and use commercially reasonable efforts between the Effective Time and the Closing Date to split or segregate such Shared Use Assets to allow: (A) Seller to retain, from and after the Effective Time, that portion of any such Buyer Shared Use Asset that is necessary for the operation of the Excluded Business after the Effective Time and that is not necessary for the operation of the Biologics SBU after the Effective Time, as agreed prior to the Closing, or as otherwise agreed, by the Parties; and (B) Buyer to acquire, from and after the Effective Time, that portion of any such Seller Shared Use Asset that is (x) necessary for the operation of the Biologics SBU after the Effective Time, (y) a Corporate Shared Services Asset necessary for or used in the provision of corporate shared services at the Boca Raton Facility and (z) that is not necessary for the operation of the Excluded Business after the Effective Time, as agreed prior to the Closing by the Parties. (iii) To the extent that a Buyer Seller Shared Use Asset is split or segregated pursuant to this Section, the split or segregated portion agreed by the Parties to be owned or held by Seller after the Effective Time shall constitute, without further action required by the Parties, an Excluded Asset. To the extent that a Seller Shared Use Asset is split or segregated pursuant to this Section, the split or segregated portion agreed by the Parties to be owned or held by Buyer after the Effective Time shall constitute, without further action required by the Parties, a Purchased Asset.

Transition Activities. Upon termination In connection with the transition of this Agreement under Section 13.2 except if this Agreement is terminated by Otsuka pursuant each Program to Section 13.2.3 (for clarityNeurocrine, not if this Agreement expires pursuant to Section 13.1): (a) The Parties wish to provide a mechanism to ensure that, assuming any Product is available to patients and as further detailed in the Otsuka Territory as of Transition Plan, Voyager shall conduct the effective date of termination, patients who were being treated with Products prior to such termination or who desire access to a Product can continue to have access to such Products while the responsibilities following activities for any Product in the Otsuka Territory are transitioned from Otsuka to Perception no additional consideration: 4. 4.1 Voyager shall provide all assistance reasonably necessary for Neurocrine or its designeedesignees to continue the Manufacture and Development of all Collaboration Products in such Program; 4. 4.2 Upon Neurocrine’s request, Voyager shall assign to Neurocrine any agreements (b) As such, Perception may request Otsuka to perform transition activities including any agreement with any Third Party manufacturer with respect to Products in a Collaboration Candidate or Collaboration Product) solely relating to the Otsuka Territory Development or Manufacture of any Collaboration Candidate or Collaboration Product to which Voyager or any of its Affiliates is a party; provided that if any such agreement is not assignable to Neurocrine (because consent is required or because it relates to products that are necessary not Collaboration Products), Voyager shall take all actions reasonably requested by Neurocrine so that Neurocrine may receive the benefits of such agreement applicable to Collaboration Candidates and Collaboration Products, which may include assigning a statement of work or reasonably useful work order to (i) transition Commercialization activities (if any) Neurocrine and facilitating a discussion of the terms of a services agreement between Neurocrine and the applicable counterparty; 4. 4.3 Voyager shall transfer to PerceptionNeurocrine copies of all data, reports, records, materials and other information arising out of the applicable Program, including transitioning distribution responsibilities all non-clinical and clinical data relating to Perception any Collaboration Candidate or its designee, to avoid any shortage of Products and minimize disruption to sales in the Otsuka Territory, (ii) provide patients with continued access to Products (if applicable), (iii) enable Perception or its designee to assume and execute the responsibilities under all Regulatory Approvals and ongoing Clinical Studies for Products in the Otsuka TerritoryCollaboration Product, and all adverse event or other safety data resulting from such Program, as well as any chemistry, manufacturing and controls (ivCMC) ensure long-term continuity of supply of Products or other Manufacturing data generated in the Otsuka Territory (collectively, the “Transition Activities”)connection with such Program; and 4. (c) If, within [***] after the effective date of termination, Perception provides 4.4 Voyager shall provide Neurocrine with a written request to Otsuka to perform Transition Activities in the Otsuka Territory, then the Parties will mutually agree on a transition plan for Otsuka to perform such Transition Activities (summary of its inventory of Collaboration Candidates and neither Party shall unreasonably withhold its agreement to such transition plan), including transition dates, and, to the extent permitted under Applicable Law, Otsuka will conduct such Transition Activities in accordance with such plan, but in no event for longer than [***] following the effective date of termination. In addition, the Parties will establish a transition committee consisting of at least each Party’s Alliance ManagerCollaboration Products, and up Voyager shall, at Neurocrine’s election, promptly destroy such inventory or deliver such inventory to [***] additional representatives from each Party who are from other relevant functional groups to facilitate a smooth transitionNeurocrine. Voyager represents and warrants that, and the Parties will mutually agree on talking points and a communication plan to customers, physicians, Regulatory Authorities, patient advocacy groups, and Clinical Study investigators, in each case only if applicable at the time of terminationdelivery, all clinical supply of Collaboration Candidates and Otsuka Collaboration Products (a) will make such communications to such applicable entities have been Manufactured in accordance with applicable Law, including cGMP, (b) will not be adulterated or misbranded under the mutually agreed talking points. As part of the Transition Activities, Otsuka will cooperate with all reasonable requests of Perception relating Act and may be introduced into interstate commerce pursuant to the transition to Perception or its designee of activities relating to any Product in Act, (c) will comply with the Otsuka Territory andspecifications therefor, at Perception’s request, Otsuka shall provide Perception with reasonable assistance with any inquiries and correspondence with Regulatory Authorities in the Otsuka Territory regarding the Products. (d) [***]will comply with the quality agreement to be entered into between the Parties. In the event that Voyager cannot make such representations with respect to any such inventory, Voyager shall destroy such inventory and certify such destruction to Neurocrine, unless requested otherwise by Neurocrine; provided that if any such non-compliance results from either (i) Voyager’s gross negligence or willful misconduct in the Manufacture of such inventory or (ii) Voyager’s negligence or willful misconduct in the oversight of any Third Party’s Manufacture of such inventory, Voyager shall reimburse the amounts paid by ▇▇▇▇▇▇▇▇▇▇ under the Development Plan for the Manufacture of such inventory.