Ownership of Approvals and Registration Filings Sample Clauses

Ownership of Approvals and Registration Filings. 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 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. [*******************************]. (b) [*************]. (c) Regeneron in the United States and Aventis in all countries outside of the United States in the Territory 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.
Ownership of Approvals and Registration Filings. 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. (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.
Ownership of Approvals and Registration Filings. 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

  • 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 (a) Chartwell and Trenwick will make and cause their respective subsidiaries to make all necessary registrations and filings, as promptly as practicable, including those required under the HSR Act, the Securities Act, the Exchange Act, state securities laws and state insurance laws, in order to facilitate prompt consummation of the Merger, the Stock Option Agreement and the other transactions contemplated by this Agreement. In addition, Chartwell and Trenwick will each use their commercially reasonable efforts, and will cooperate fully with each other (i) to comply as promptly as practicable with all governmental requirements applicable to the Merger, the Stock Option Agreement and the other transactions contemplated by this Agreement, and (ii) to obtain as promptly as practicable all necessary permits, orders or other consents, approvals or authorizations from, or to avoid an action or proceeding by, any Governmental Entity and consents, approvals or waivers from all third parties (including Lloyd's) necessary in connection with the consummation of the Merger, the Stock Option Agreement and the other transactions contemplated by this Agreement. Each of Chartwell and Trenwick shall use its commercially reasonable efforts to provide such information and communications to Governmental Entities and Lloyd's as they may reasonably request. (b) Each of the parties shall provide to the other party copies of all applications or other communications in advance of filing or submission of such applications or communications to Governmental Entities or Lloyd's in connection with this Agreement. Trenwick shall give to Chartwell prompt written notice if it receives any notice or other communication from any Insurance Regulator or Lloyd's in connection with the transactions contemplated by this Agreement, and, in the case of any such notice or communication which is in writing, shall promptly furnish Chartwell with a copy thereof. Each of the parties shall give to the other party reasonable prior written notice of the time and place when any meetings may be held by it with Insurance Regulators or Lloyd's in connection with the transactions contemplated by this Agreement, and the party to whom such notice shall be given shall have the right to have a representative or representatives present at any such meeting. (c) Chartwell shall give prompt notice to Trenwick, and Trenwick shall give prompt notice to Chartwell, of (i) any representation or warranty made by it contained in this Agreement that is qualified as to materiality becoming untrue or inaccurate in any respect or any such representation or warranty that is not so qualified becoming untrue or inaccurate in any material respect or (ii) the failure by it to comply with or satisfy in any material respect any covenant, condition or agreement to be complied with or satisfied by it under this Agreement; provided, however, that no such notification shall affect the representations, warranties, covenants or agreements of the parties or the conditions to the obligations of the parties under this Agreement.

  • 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. (b) The Partnership and Royale shall use reasonable best efforts to give all notices to, and obtain all consents from, all third parties that are described in Section 4.03 and Section 5.03 of the Disclosure Schedules. (c) Without limiting the generality of the parties’ undertakings pursuant to subsections (a) and (b) above, each of the parties hereto shall use all reasonable best efforts to: (i) respond to any inquiries by any Governmental Authority regarding antitrust or other matters with respect to the transactions contemplated by this Agreement or any Ancillary Document; (ii) avoid the imposition of any order or the taking of any action that would restrain, alter or enjoin the transactions contemplated by this Agreement or any Ancillary Document; and (iii) in the event any Governmental Order adversely affecting the ability of the parties to consummate the transactions contemplated by this Agreement or any Ancillary Document has been issued, to have such Governmental Order vacated or lifted. (d) All analyses, appearances, meetings, discussions, presentations, memoranda, briefs, filings, arguments, and proposals made by or on behalf of either party before any Governmental Authority or the staff or regulators of any Governmental Authority, in connection with the transactions contemplated hereunder (but, for the avoidance of doubt, not including any interactions between Matrix or the Royale Parties and Governmental Authorities in the ordinary course of business, any disclosure which is not permitted by Law or any disclosure containing confidential information) shall be disclosed to the other party hereunder in advance of any filing, submission or attendance, it being the intent that the parties will consult and cooperate with one another, and consider in good faith the views of one another, in connection with any such analyses, appearances, meetings, discussions, presentations, memoranda, briefs, filings, arguments, and proposals. Each party shall give notice to the other party with respect to any meeting, discussion, appearance or contact with any Governmental Authority or the staff or regulators of any Governmental Authority, with such notice being sufficient to provide the other party with the opportunity to attend and participate in such meeting, discussion, appearance or contact. (e) Notwithstanding the foregoing, nothing in this Section 6.08 shall require, or be construed to require, the Partnership or Royale or any of their Affiliates to agree to (i) sell, hold, divest, discontinue or limit, before or after the Closing Date, any assets, businesses or interests of Royale, the Partnership or any of their respective Affiliates; (ii) any conditions relating to, or changes or restrictions in, the operations of any such assets, businesses or interests which, in either case, could reasonably be expected to result in a Partnership Material Adverse Effect or a Royale Material Adverse Effect, or which would materially and adversely impact the economic or business benefits to Parent, Royale, Matrix, the Partnership or their respective stockholders or partners, of the transactions contemplated by this Agreement; or (iii) any material modification or waiver of the terms and conditions of this Agreement.

  • 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.

  • Licenses and Approvals Contractor shall obtain and keep current all necessary licenses, approvals, permits and authorizations required by Applicable Laws to provide the Work. Contractor will be responsible for all fees and taxes associated with obtaining such licenses, approvals, permits and authorizations, and for any fines and penalties arising from its noncompliance with any Applicable Law.

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