Assignment of Regulatory Submissions Sample Clauses

Assignment of Regulatory Submissions. NVS will (a) [***] assign to HMI all of its rights, title, and interests in and to all Clinical Trial data, Regulatory Submissions, and Regulatory Approvals and Pricing Approvals (where applicable) solely related to any Terminated Targets, Terminated Candidates, and Terminated Products owned or Controlled by NVS or any of its Affiliates or its Sublicensees as of the effective date of termination, and (b) [***] transfer ownership of all such assigned Regulatory Submissions and Regulatory Approvals and Pricing Approvals (where applicable) to HMI, including submitting to each applicable Regulatory Authority a letter or other [***] documentation notifying such Regulatory Authority of the transfer of such ownership of such Regulatory Approval and Pricing Approval (where applicable).
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Assignment of Regulatory Submissions. NVS will (i) use Commercially Reasonable efforts to assign and transfer on an as-is, where-is basis to Pliant or its designee all of its rights, title, and interest in an to all Clinical Study data, Regulatory Materials (including drug master files), and Regulatory Approvals solely related to any Terminated Compounds and Terminated Products (A) owned or Controlled by NVS or any of its Affiliates or its Sublicensees as of the effective date of termination, (B) not already within Pliant's possession; and (C) to the extent permitted under Applicable Law; and (ii) take those steps reasonably necessary to transfer ownership of all such assigned Regulatory Materials and Regulatory Approvals to Pliant, including submitting to each applicable Regulatory Authority a letter or other necessary documentation notifying such Regulatory Authority of the transfer of such ownership of such Regulatory Approval. NVS shall reasonably cooperate, at no additional out-of-pocket cost to NVS, with reasonable requests by Pliant for reasonable assistance necessary to facilitate Pliant's assumption of regulatory responsibilities for such Terminated Compound or Terminated Product, if applicable, in the applicable countries in which direct transfer is not permitted.
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Assignment of Regulatory Submissions. Except with respect to any termination by Ionis under Section 14.2.2(a) (Ionis’ Right to Terminate), Ionis will, as promptly as practicable, transfer to Metagenomi possession and ownership of all Regulatory Approvals solely relating to the Exploitation of any Terminated Product in the Terminated Countries.
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Assignment of Regulatory Submissions. Ipsen will and hereby does, and will cause its Affiliates and Sublicensees to, (a) assign to Sutro all of its rights, title, and interests in and to all Clinical Trial data, submissions to any Regulatory Authority, Regulatory Approvals, and Pricing and Reimbursement Approvals (where applicable) related to the Licensed Compounds and Licensed Products owned or Controlled by Ipsen or any of its Affiliates or its or their Sublicensees as of the effective date of termination, and (b) take those steps reasonably necessary to transfer ownership of all such assigned regulatory submissions, Regulatory Approvals, and Pricing and Reimbursement Approvals (where applicable) to Sutro, including submitting to each applicable Regulatory Authority a letter or other necessary documentation notifying such Regulatory Authority of the transfer of such ownership of such regulatory submissions, Regulatory Approvals, and Pricing and Reimbursement Approvals (where applicable).
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Assignment of Regulatory Submissions. 5.2.1. Phase II Asset Clinical Trial Regulatory Submissions.
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Assignment of Regulatory Submissions. Licensee will and hereby does, and will cause its Affiliates and its Sublicensees to, (a) effective as of the effective date of termination, assign to Licensor all of its rights, title, and interests in and to all Clinical Trial data, Regulatory Submissions, and Regulatory Approvals applicable to any Licensed Compounds or Licensed Products and then owned or otherwise Controlled by Licensee or any of its Affiliates or its Sublicensees, and (b) to the extent assignment pursuant to clause (a) is delayed or is not permitted by the applicable Regulatory Authority, permit Licensor to cross-reference and rely upon any Clinical Trial data, Regulatory Submissions, and Regulatory Approvals filed by Licensee or its Affiliates or Sublicensees with respect to any Licensed Product. Licensee will take all reasonable steps necessary to transfer, or will cause its Affiliates and Sublicensees to transfer, ownership of all such assigned Regulatory Submissions and Regulatory Approvals to Licensor, including submitting to each applicable Regulatory Authority a letter or other necessary documentation (with a copy to Licensor) notifying such Regulatory Authority of the transfer of such ownership of each Regulatory Submission or Regulatory Approval.
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Assignment of Regulatory Submissions. With respect to the then-existing Licensed Compounds and Licensed Products in each Terminated Country or the Territory (as applicable), to the extent permitted by Applicable Law, Company will and hereby does, and will cause its Affiliates and Sublicensees (excluding those Sublicensees that enter into a direct license with HUTCHMED pursuant to Section 9.6.2 (Continuation of Sublicenses)) to (a) assign to HUTCHMED all of its rights, title, and interests in and to all Clinical Trial data, Regulatory Submissions and Regulatory Approvals related to such Licensed Compounds and Licensed Products owned or Controlled by Company or any of its Affiliates or its Sublicensees as of the effective date of termination, and (b) take those steps reasonably necessary to transfer ownership of all such assigned Regulatory Submissions and Regulatory Approvals to HUTCHMED, including submitting to each applicable Regulatory Authority a letter or other necessary documentation notifying such Regulatory Authority of the transfer of such ownership of such Regulatory Submissions and Regulatory Approvals.
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Related to Assignment of Regulatory Submissions

  • Regulatory Submissions From and after the Effective Date, NVS will[***] be responsible for (a) preparing, filing, and submitting, directly or through its Affiliates and permitted Sublicensees, all Regulatory Submissions for all Products in the Territory, and each material amendment or update thereto, in its name other than Jointly-Agreed Regulatory Submissions; and (b) interfacing, corresponding and meeting with Regulatory Authorities relating to Regulatory Submissions in the Territory for such Products; provided, that Regulatory Submissions and correspondence made to, and meetings held with, the FDA and EMA with respect to (i) [***] or (ii) [***] in each of (i) and (ii), will be prepared or conducted, as applicable, in collaboration with a representative from HMI’s regulatory team in accordance with this Article 7 (Regulatory Affairs); provided further that in all cases, such rights shall expressly exclude and not apply with Confidential Portions of this Exhibit marked as [***] have been omitted pursuant to a request for confidential treatment and have been filed separately with the Securities and Exchange Commission. Confidential Treatment Requested by Homology Medicines, Inc. respect to any data in Regulatory Submissions, correspondence, or meetings relating to any Other Components. Subject to Section 7.6 (Transfer of U.S. BLA for In-Vivo [***] Products), all Regulatory Approvals and Pricing Approvals for Products will be [***] owned by [***]. For all Products, NVS will timely inform HMI regarding the submission, receipt or denial of Regulatory Approval for such Product obtained or denied; provided, however, that NVS will inform HMI of such event prior to public disclosure of such event by NVS.

  • No Regulatory Approval By Buyer or Company, if either of their respective boards of directors so determines by a vote of a majority of the members of its entire board, in the event any Regulatory Approval required for consummation of the transactions contemplated by this Agreement shall have been denied by final, non-appealable action by such Governmental Authority or an application therefor shall have been permanently withdrawn at the request of a Governmental Authority.

  • Notice of Regulatory Action To the extent permitted by applicable Law, each Seller shall promptly notify the applicable Purchaser of any action, claim, inquiry, audit, investigation or examination taken or made by a Government Authority that may affect the conduct of a Serviced Appointment and shall consult with such Purchaser as to any changes in duties or other arrangements hereunder to be taken in connection therewith.

  • Regulatory Documentation Avidity and its Affiliates have generated, prepared, maintained and retained all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with, to the extent applicable, good laboratory and clinical practice and Applicable Law and all such information is true, complete and correct in all material respects and what it purports to be. “Regulatory Documentation” means all: (a) applications (including all INDs and applications for Regulatory Approval), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; (c) supplements or changes to any of the foregoing following Regulatory Approval; and (d) clinical and other data, including Clinical Trial data, contained or relied upon in any of the foregoing; in each case ((a), (b), (c) and (d)) relating to a Collaboration Target and Compounds Directed Against a Collaboration Target.

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