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 Products 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 Products 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 Excluded Region following termination of this Agreement with respect to such Excluded Region.
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. [***] = Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406.
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. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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 THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 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. To the extent permissible under applicable law and as specified within the Transition Plan, (a) Junshi will transfer and assign, or will cause the transfer or assignment, to Coherus or its regulatory agent, Junshi’s, or any of Junshi’s Affiliates’, entire rights, title, and interests in and to all Regulatory Approvals and Regulatory Materials in the Coherus Territory with respect to the Licensed Antibodies and Licensed Products (other than those related to any Junshi Clinical Trial) that are owned, Controlled, or possessed by Junshi or any of its Affiliates, and (b) the Parties will complete all other transition activities to enable Coherus to assume the regulatory responsibilities for the Licensed Antibodies and Licensed Products in the Coherus Territory (other than those related to the Junshi Clinical Trials) by such time as agreed by the JDC (i) after the Effective Date with respect to JS001 and (ii) after each Option Exercise Date with respect to all Option Molecules and Option Products that are the subject of the Option Program for which Coherus exercises the License Option. In any event, Junshi will use reasonable efforts to provide any relevant documents to Coherus as soon as practical following the Effective Date or the Option Exercise Date, as applicable. Except as otherwise specified in the Transition Plan, Junshi will continue to hold in its name, throughout the world, all Regulatory Approvals and Regulatory Materials related to the Ongoing JS001 Clinical Trials until the completion thereof, and Junshi will continue to be responsible for all regulatory responsibilities related to the Ongoing JS001 Clinical Trials in the Coherus Territory until completion thereof and receipt of Regulatory Approval in the Coherus Territory for the Licensed Antibody and Licensed Product that is the subject of a trial. Promptly following receipt of any such Regulatory Approval, Junshi will transfer and assign, or will cause the transfer or assignment, to Coherus or its regulatory agent, Junshi’s, or any of Junshi’s Affiliates’, entire rights, title, and interests in and to all such Regulatory Approvals and Regulatory Materials with respect to such Ongoing JS001 Trial in the Coherus Territory that are Controlled by Junshi or any of its Affiliates, and following the completion of such transfer and assignment, unless otherwise agreed by the JDC, Coherus will assume responsibility for all further regulatory activities for the Licensed Antibodies and Licensed Products th...
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. 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 ** Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. 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. ORIC will and hereby does, and will cause its Affiliates to, effective as of the effective date of termination, assign to Mirati all of its rights, title, and interests in and to all Regulatory Materials, filings for Pricing and Reimbursement Approval, Regulatory Approvals, Clinical Data and other material documentation, in each case, (A) as in existence as of such date, (B) to the extent allowed under applicable Law, and (C) to the extent pertaining to a Licensed Compound or Licensed Product, as such Licensed Compound or Licensed Product exists at such time (“Subject Regulatory Materials”). To the extent assignment pursuant to the preceding sentence is delayed or is not permitted by the applicable Regulatory Authority, ORIC will and hereby does, and will cause its Affiliates to, effective as of the effective date of termination, grant to Mirati an exclusive and irrevocable right of access and right of reference to such Subject Regulatory Materials. ORIC will, and will cause its Affiliates to, take all reasonable steps necessary to transfer ownership of all such Subject Regulatory Materials to Mirati, including submitting to each applicable Regulatory Authority a letter or other necessary documentation (with a copy to Mirati) notifying such Regulatory Authority of the transfer of such ownership of each Regulatory Approval within the Subject Regulatory Materials, and will reasonably cooperate with Mirati to make the benefits of such Subject Regulatory Materials available to Mirati or its designee(s).
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.
