Ownership of Approvals and Registration Filings Sample Clauses

Ownership of Approvals and Registration Filings. (a) Unless otherwise agreed to by the Parties, the Post-POC Principal Party shall be the Lead Regulatory Party and shall own (i) all Approvals with respect to Licensed Product in the Territory and (ii) the IND for Licensed Products during such time 44 as it is the Post-POC Principal Party and shall have the rights and obligations set forth in Sections 7.2 to 7.4 (inclusive) with respect thereto. ******************************.
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Ownership of Approvals and Registration Filings. (a) Regeneron shall own all Approvals and Registration Filings, with respect to the VEGF Products in the United States and shall have the rights and obligations set forth in Sections 7.2 to 7.4 (inclusive) with respect thereto. [*******************************].
Ownership of Approvals and Registration Filings. (a) Regeneron shall be the Lead Regulatory Party, and shall own all Approvals and Registration Filings, with respect to the Trap-1 Product in the U.S. and the Trap-2 Product in the U.S. and shall have the rights and obligations set forth in Sections 7.2 to 7.4 (inclusive) with respect thereto; provided, however, that Novartis shall perform the regulatory tasks set forth on SCHEDULE 11 with respect to the Trap-1 Product and the Trap-2 Product in the U.S., or as otherwise deemed appropriate by the JOC, provided such tasks are performed in accordance with this Agreement and applicable Law. (b) Novartis shall be the Lead Regulatory Party, and shall own all Approvals and Registration Filings, with respect to: (i) the Trap-1 Product in the Trap-1 Territory, other than in the U.S., with effect from the Effective Date; (ii) the Trap-2 Product in the Trap-2 Territory, other than in the U.S., with effect from the date of any proper exercise by Novartis of the Trap-2 Opt-In Rights; and (iii) the IL-1 Antibody Product, throughout the IL-1 Antibody Territory, and, in each case, shall have the rights and obligations set forth in Sections 7.2 to 7.4 (inclusive) with respect thereto. (c) The Lead Regulatory Party shall license, transfer, provide a letter of reference with respect to, or take other action necessary to make available the relevant Registration Filings and Approvals to and for the benefit of the other Party. 7.2
Ownership of Approvals and Registration Filings. (a) Regeneron shall be the Lead Regulatory Party, and shall own all Approvals and Registration Filings, (i) with respect to the Development of Regeneron Products in the Field in the Excluded Territory under the Global Development Plan and (ii) with respect to any site license for its manufacturing facilities anywhere in the world, and shall have the rights and obligations set forth in this Article 7 with respect thereto.
Ownership of Approvals and Registration Filings. (a) Regeneron shall be the Lead Regulatory Party, and shall own all Approvals and Registration Filings, with respect to the Trap-1 Product in the U.S. and the Trap-2 Product in the U.S. and shall have the rights and obligations set forth in Sections 7.2 to 7.4 (inclusive) with respect thereto; provided, however, that Novartis shall perform the regulatory tasks set forth on SCHEDULE 11 with respect to the Trap-1 Product and the Trap-2 Product in the U.S., or as otherwise deemed appropriate by the JOC, provided such tasks are performed in accordance with this Agreement and applicable Law.

Related to Ownership of Approvals and Registration Filings

  • Regulatory Filings and Approvals Copies of all necessary governmental and third party approvals, registrations, and filings in respect of the transactions contemplated by this Agreement;

  • Filings, Consents and Approvals The Company is not required to obtain any consent, waiver, authorization or order of, give any notice to, or make any filing or registration with, any court or other federal, state, local or other governmental authority or other Person in connection with the execution, delivery and performance by the Company of the Transaction Documents, other than: (i) the filings required pursuant to Section 4.4 of this Agreement, (ii) the filing with the Commission of the Prospectus Supplement, (iii) application(s) to each applicable Trading Market for the listing of the Shares and Warrant Shares for trading thereon in the time and manner required thereby and (iv) such filings as are required to be made under applicable state securities laws (collectively, the “Required Approvals”).

  • Licenses and Registrations It has all governmental, regulatory, self-regulatory, and exchange licenses, registrations, memberships, and approvals required to act as investment adviser to the Fund and it will obtain and maintain any such required licenses, registrations, memberships, and approvals.

  • Filings and Approvals Cooperate with the other in the preparation and filing, as soon as practicable, of (A) the Applications, (B) the Proxy Statement, (C) all other documents necessary to obtain any other approvals, consents, waivers and authorizations required to effect the completion of the Merger and the other transactions contemplated by this Agreement, and (D) all other documents contemplated by this Agreement;

  • Governmental Approvals and Filings Except for any notices required or permitted to be filed after the Closing Date with certain federal and state securities commissions, the Company shall have obtained all governmental approvals required in connection with the lawful sale and issuance of the Notes.

  • Approvals and Filings Other than the completion of the filing of the Series A Certificate of Designation, no authorization, approval or consent of any court, governmental body, regulatory agency, self-regulatory organization, stock exchange or market or the stockholders of the Company is required to be obtained by the Company for the entry into or the performance of this Agreement and the other Primary Documents.

  • Consents, Approvals and Filings The Company and Evergreen will make ------------------------------- and cause their respective subsidiaries and, to the extent necessary, their other affiliates to make all necessary filings, as soon as practicable, including, without limitation, those required under the HSR Act, the Securities Act, the Exchange Act, and the Communications Act (including filing an application with the FCC for the transfer of control of the Company FCC Licenses and the Evergreen FCC Licenses, which the parties shall file as soon as practicable (and in any event not more than 30 days) after the date of this Agreement), in order to facilitate prompt consummation of the Merger and the other transactions contemplated by this Agreement. In addition, the Company and Evergreen will each use its best efforts, and will cooperate fully and in good faith with each other, (i) to comply as promptly as practicable with all governmental requirements applicable to the Merger and the other transactions contemplated by this Agreement and the Viacom Transaction, and (ii) to obtain as promptly as practicable all necessary permits, orders or other consents of Governmental Entities and consents of all third parties necessary for the consummation of the Merger and the other transactions contemplated by this Agreement and the Viacom Transaction, including without limitation, the consent of the FCC to the transfer of control of the Company FCC Licenses and the Evergreen FCC Licenses, and the transfer of any FCC licenses in connection with the Viacom Transaction. Each of the Company and Evergreen shall use its best efforts to promptly provide such information and communications to Governmental Entities as such Governmental Entities may reasonably request. Each of the parties shall provide to the other party copies of all applications in advance of filing or submission of such applications to Governmental Entities in connection with this Agreement and shall make such revisions thereto as reasonably requested by such other party. Each party shall provide to the other party the opportunity to participate in all meetings and material conversations with Governmental Entities.

  • Governmental Approvals and Consents (a) Each party hereto shall, as promptly as possible, (i) make, or cause or be made, all filings and submissions required under any Law applicable to such party or any of its Affiliates; and (ii) use reasonable best efforts to obtain, or cause to be obtained, all consents, authorizations, orders and approvals from all Governmental Authorities that may be or become necessary for its execution and delivery of this Agreement and the performance of its obligations pursuant to this Agreement and the Ancillary Documents. Each party shall cooperate fully with the other party and its Affiliates in promptly seeking to obtain all such consents, authorizations, orders and approvals. The parties hereto shall not willfully take any action that will have the effect of delaying, impairing or impeding the receipt of any required consents, authorizations, orders and approvals.

  • Regulatory Consents and Approvals All consents, approvals and actions of, filings with and notices to any Governmental or Regulatory Authority necessary to permit Purchaser and Seller to perform their obligations under this Agreement and the Operative Agreements and to consummate the transactions contemplated hereby and thereby (a) shall have been duly obtained, made or given, (b) shall be in form and substance reasonably satisfactory to Purchaser, (c) shall not be subject to the satisfaction of any condition that has not been satisfied or waived and (d) shall be in full force and effect, and all terminations or expirations of waiting periods imposed by any Governmental or Regulatory Authority necessary for the consummation of the transactions contemplated by this Agreement and the Operative Agreements shall have occurred.

  • Consents, Licenses and Approvals The Administrative Agent shall have received, with a counterpart for each Lender, a certificate of a Responsible Officer of the Borrower (i) attaching copies of all consents, authorizations and filings referred to in Section 5.4, and (ii) stating that such consents, licenses and filings are in full force and effect, and each such consent, authorization and filing shall be in form and substance satisfactory to the Administrative Agent.

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