Assignment of Regulatory Materials. At Angioblast’s request, Cephalon shall assign or cause to be assigned to Angioblast or its designee (or to the extent not so assignable, Cephalon shall take all reasonable actions to make available to Angioblast or its designee the benefits of) all Regulatory Materials for all Excluded Products in the Territory, including any such Regulatory Materials owned by Cephalon’s Affiliates and/or Marketing Partners. In addition, Cephalon shall promptly provide to Angioblast a copy of all Data and other Cephalon Know-How pertaining to all Excluded Products to the extent not previously provided to Angioblast and Angioblast shall have the right to use and disclose all Data and Cephalon Know How pertaining to such Excluded Products following termination of this Agreement with respect to such Excluded Product.
Assignment of Regulatory Materials. Licensee will and hereby does, and will cause its Affiliates and its Sublicensees to, (i) effective as of the effective date of termination, assign to Takeda all of its rights, title, and interests in and to all Regulatory Materials and Regulatory Approvals, to the extent allowed under Applicable Law, pertaining to the Terminated Compound or Terminated Products then Controlled by Licensee or any of its Affiliates or its Sublicensees (subject to the provisions of Section 3.3.2 (Sublicense Requirements)) and (ii) to the extent assignment pursuant to clause (i) is delayed or not permitted by the applicable Regulatory Authority, permit Takeda to cross-reference and rely upon any Regulatory Materials and Regulatory Approvals filed by Licensee with respect to any Terminated Product. As soon as practicable after such transfer, Licensee will take all steps necessary to transfer ownership of all such assigned Regulatory Materials and Regulatory Approvals to Licensee, including submitting to each applicable Regulatory Authority a letter or other necessary documentation (with a copy to Licensee) notifying such Regulatory Authority of the transfer of such ownership of each Regulatory Approval. Notwithstanding the foregoing, if such termination relates to a particular Terminated Field for the TAK-385 Licensed Compound, then the foregoing obligations shall apply with respect to the TAK-385 Licensed Compound and TAK-385 Licensed Products in the Terminated Field.
Assignment of Regulatory Materials. At Angioblast’s request, Cephalon shall assign or cause to be assigned to Angioblast or its designee (or to the extent not so assignable, Cephalon shall take all reasonable actions to make available to Angioblast or its designee the benefits of) all Regulatory Materials specific to the Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region, including any such Regulatory Materials owned by Cephalon’s Affiliates or Marketing Partners. In addition, Cephalon shall promptly provide to Angioblast a copy of all Data and other Cephalon Know-How pertaining to the Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region to the extent not previously provided to Angioblast and Angioblast shall have the right to use and disclose all Data and Cephalon Know How pertaining to such Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region following termination of this Agreement with respect to such Cardiovascular Products for use in the Cardiovascular Field in the Excluded Region.
Assignment of Regulatory Materials. At Angioblast’s request, Cephalon shall assign or cause to be assigned to Angioblast or its designee (or to the extent not so assignable, Cephalon shall take all reasonable actions to make available to Angioblast or its designee the benefits of) all Regulatory Materials for all Products in the Territory, including any such Regulatory Materials owned by Cephalon’s Affiliates and/or Marketing Partners. In addition, Cephalon shall promptly provide to Angioblast a copy of all Data and other Cephalon Know-How pertaining to all Products to the extent not previously provided to Angioblast and Angioblast shall have the right to use and disclose all Data and Cephalon Know How pertaining to such Products following termination of this Agreement.
Assignment of Regulatory Materials. To the extent permissible under applicable law, (a) Licensor will transfer and assign, or will cause the transfer or assignment, to EQRx or its designee, Licensor’s, or any of Licensor’s Affiliates’, entire right, title, and interest in and to all Regulatory Approvals and Regulatory Materials in the Territory with respect to the Licensed Antibodies and Licensed Products (other than those related to the Ongoing CS1001 ENKTL Trial or the Ongoing CS1003 HCC Trial) that are owned, controlled or possessed by Licensor or any of its Affiliates, and (b) the Parties will complete all other transition activities to enable EQRx to assume the regulatory responsibilities for the Licensed Antibodies and Licensed Products in the Territory (other than those related to the Ongoing CS1001 ENKTL Trial or the Ongoing CS1003 HCC Trial) within [***] of the Effective Date, provided that Licensor shall [***] to provide any relevant documents to EQRx [***] following the Effective Date. Licensor will continue to hold in its name, throughout the world, all Regulatory Approvals and Regulatory Materials related to the Ongoing CS1001 ENKTL Trial and the Ongoing CS1003 HCC Trial until the completion of such Ongoing CS1001 ENKTL Trial or Ongoing CS1003 HCC Trial, respectively, and Licensor will continue to be responsible for all regulatory responsibilities related to the Ongoing CS1001 ENKTL Trial and the Ongoing CS1003 HCC Trial until completion thereof. Promptly following the completion of the Ongoing CS1001 ENKTL Trial or the Ongoing CS1003 HCC Trial, Licensor will transfer and assign, or will cause the transfer or assignment, to EQRx or its designee, Licensor’s, or any of Licensor’s Affiliates’, entire right, title, and interest in and to all such Regulatory Approvals and Regulatory Materials with respect to the Ongoing CS1001 ENKTL Trial or the Ongoing CS1003 HCC Trial (as applicable) in the Territory that are owned, controlled or possessed by Licensor or any of its Affiliates and, following the completion of such transfer or assignment, EQRx will assume responsibility for all further regulatory activities for the Licensed Antibodies and Licensed Products throughout the Territory.
Assignment of Regulatory Materials. Within [***] following the date on which the Parties agree on the Technology Transfer Plan, (a) Hansoh will transfer and assign, or will cause the transfer or assignment, to EQRx or its designee Hansoh’s, or any of its Affiliates’, [***] and (b) the Parties will complete all other transition activities with respect to the Regulatory Materials [***] Hansoh will provide English translations of all of the foregoing Regulatory Materials and other regulatory documentation if available or, if not available, English translations will be made by or on behalf of Hansoh [***] option and cost, subject to [***] prior to such translation services being performed.
Assignment of Regulatory Materials. In the event of termination of this Agreement:
(i) where permitted by Applicable Law, Baylor shall promptly assign and transfer (or cause to be assigned and transferred) to Bellerophon or its designee (and, if in Baylor’s or its Affiliate’s possession or control, provide copies of) all Approvals and Regulatory Materials relating to Products, or to the extent not so transferrable, Baylor shall promptly take all reasonable actions to make available to Bellerophon or its designee, the benefits of such Regulatory Materials, including upon Bellerophon’s request, by providing a right of reference to any Regulatory Materials controlled by Baylor or Affiliate for Products, and providing Bellerophon with copies of all Clinical Data and all material correspondence between Baylor and its Affiliates and Regulatory Authorities relating to such Regulatory Materials; and
(ii) Baylor and Bellerophon will effectuate and coordinate an orderly transition of the relevant obligations and rights to Bellerophon as reasonably necessary for Bellerophon to Develop, Manufacture and Commercialize Products after termination of this Agreement in a manner consistent with Applicable Law and standards of ethical conduct of human Clinical Trials.
Assignment of Regulatory Materials. On a Licensed Target‑by‑Licensed Target basis, promptly following transition to Takeda of Regulatory Lead with respect to a Licensed Target and all Licensed Compounds, Licensed Products, and Companion Diagnostics directed to such Licensed Target (for clarity, including any HTT Compounds, HTT Products, and any Companion Diagnostics related thereto): (a) within sixty (60) days following the such transition to Takeda of Regulatory Lead Wave will send a letter to the each Regulatory Authority in the Territory to transfer and assign to Takeda Wave’s entire right, title, and interest in and to all Regulatory Approvals with respect to all such Licensed Compounds, Licensed Products, and Companion Diagnostics directed to such Licensed Target, and (b) within thirty (30) days following such transition to Takeda, (i) Wave will transfer and assign to Takeda Wave’s entire right, title, and interest in and to all INDs, NDAs, other Regulatory Materials, and other regulatory documentation in the Territory with respect to such all Licensed Compounds, Licensed Products, and Companion Diagnostics directed to such Licensed Target that is in the possession and control of Wave, excluding any drug master files maintained by Wave or a Third Party solely with respect thereto, and (ii) the Parties will complete all other transition activities within thirty (30) days of such transition to Takeda of Regulatory Lead.
Assignment of Regulatory Materials. Subject to the terms and conditions of this Agreement, AskAt hereby assigns to Arrys, on behalf of AskAt and its Affiliates, all Regulatory Materials in the Field and in the Territory.
Assignment of Regulatory Materials. Promptly following the Effective Date, (a) Xxxx will transfer and assign, or will cause the transfer or assignment, to EQRx or its designee Xxxx’x, or any of its Affiliates’, entire right, title, and interest in and to all INDs, NDAs, other Regulatory Materials, and other regulatory documentation, if any, in the EQRx Territory with respect to all Licensed Compounds and Licensed Products that are owned, in-licensed, controlled or possessed by Xxxx or any of its Affiliates, and (b) the Parties will complete all other transition activities within [***] of the Effective Date.
