Acquired Regulatory Approvals definition

Acquired Regulatory Approvals means all Regulatory Approvals held by any of the Sellers or their respective Affiliates exclusively with respect to any Product, including the Regulatory Approvals listed on Schedule 1.1(f) of the Seller Disclosure Letter.
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Acquired Regulatory Approvals means (a) NDA number [***] (the “Product NDA”), (b) IND number [***], (c) IND number [***], and (d) all other Regulatory Approvals and Regulatory Approval Applications owned or controlled by any Seller Group Member relating to the Product, and all amendments and supplements with respect to any of the foregoing filed with the applicable Regulatory Authority by any Seller Group Member. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***] HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.
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Acquired Regulatory Approvals means the US NDA number 212157, Investigational New Drug (IND) Application 125585 and Investigational New Drug (IND) Application 138593, and all amendments and supplements thereto filed with the FDA as of the Closing.
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Examples of Acquired Regulatory Approvals in a sentence

  • The transfer of ownership of the Acquired Regulatory Approvals shall be effective on the date on which Purchaser provides notice of exercise of the Option and is referred to herein as the “Option Closing Date.” Within [***]of the Option Closing Date, Seller shall provide an executed Seller FDA Letter to Purchaser, notifying the FDA that the Acquired Regulatory Approvals have been transferred to Purchaser as of the Option Closing Date.

  • On the terms and subject to the conditions set forth in this Agreement, upon the Closing, the Seller Group Members shall grant to Purchaser, and Purchaser shall accept from the Seller Group Members, an exclusive option to transfer ownership of the Acquired Regulatory Approvals for no additional consideration (“Option”), exercisable by Purchaser upon written notice to Seller during the Option Exercise Period.

  • For clarity, as of the Closing, there will be no Liens upon any of the Acquired Assets, Acquired Regulatory Approvals or Licensed Intellectual Property and Seller has not taken any action or committed any omission that would adversely affect or in any way impair, interfere with or prevent Purchaser’s right to receive the benefit of the assignments, transfers and licenses granted under this Agreement.

  • The Seller may retain an archival copy of any Acquired Regulatory Approvals including supplements and records that are required to be kept under 21 C.F.R. §314.81.

  • Upon the occurrence of the Fifth Amendment Effective Date, any security interest or other Liens granted to or held by the Agent under any Loan Document in respect of the Acquired Assets and Acquired Regulatory Approvals (as such terms are defined in the Asset Transfer Agreement) shall immediately be automatically, permanently and irrevocably released and discharged (such released assets, the “Released Assets”) (collectively, the “Release”).

  • Subject to the Transition Services Agreement, each of the Sellers and Purchaser shall use reasonable best efforts to take any actions required by any Governmental Entity necessary to effect the transfer of the Acquired Regulatory Approvals from one or more of the Sellers and/or their respective Affiliates, as applicable, to Purchaser, and shall cooperate with each other in order to effectuate the foregoing transfer of the Acquired Regulatory Approvals.

  • There are no Proceedings pending by a Seller Group Member, or that a Seller Group Member intends to initiate, against any other Person relating to or affecting the assignment of the Acquired Assets or Acquired Regulatory Approvals or license to the Licensed Intellectual Property.

  • Except as set forth on Schedule 3.4 of the Disclosure Schedules, Seller has good and marketable title to, or a valid right to use, all of the tangible and intangible Acquired Assets and Acquired Regulatory Approvals, free and clear of any and all Liens and has obtained from the remainder of the Seller Group Members any other rights necessary to execute, deliver and perform its obligations under this Agreement.

  • The Sellers and Purchaser shall establish a mutually acceptable and prompt communication and interaction process to ensure the orderly transfer of the Acquired Regulatory Approvals at the Closing, including the transfer of the Regulatory Documentation comprising or referenced in the Acquired Regulatory Approvals in formats acceptable to Purchaser.

  • Except as set forth on Schedule 3.8 of the Disclosure Schedules, there are no Liabilities existing or Proceedings or Orders pending against a Seller Group Member or, to the Knowledge of Seller, threatened against a Seller Group Member, relating to or affecting the assignment of Acquired Assets or Acquired Regulatory Approvals or license to the Licensed Intellectual Property.


More Definitions of Acquired Regulatory Approvals

Acquired Regulatory Approvals means (i) the new drug application number 208223 and Investigational New Drug (IND) Application 118668 for Zembrace SymTouch (DFN-11) and all amendments and supplements thereto filed with the FDA as of the Closing Date, (ii) the new drug application number 210884 and Investigational New Drug (IND) Application 108088 for (Tosymra) (DFN-02) and all amendments and supplements thereto filed with the FDA as of the Closing Date and (iii) all files, records and correspondence relating to the foregoing (i) and (ii).
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Acquired Regulatory Approvals means the BLAs and other Regulatory Approvals filed or acquired by a Seller or any Affiliate of a Seller with respect to the Product, as listed on Schedule 1.1(c) of the Seller Disclosure Letter.
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Acquired Regulatory Approvals means the Regulatory Approvals held by Seller or any of its Affiliates primarily with respect to the Exploitation of the Product, including the Regulatory Approvals listed on Schedule 1.1(c) of the Seller Disclosure Letter, but excluding the Excluded Assets.
Sample 1
Acquired Regulatory Approvals means (a) NDA number [***] (the “Product NDA”), (b) IND number [***], (c) IND number [***], and (d) all other Regulatory Approvals and Regulatory Approval Applications owned or controlled by any Seller Group Member relating to the Product, and all amendments and supplements with respect to any of the foregoing filed with the applicable Regulatory Authority by any Seller Group Member. “Affiliate” means, with respect to any Person, any other Person that directly or indirectly controls, is controlled by or is under common control with such Person. As used herein, the term “control” means: (a) the power to vote [***] of the voting power of a Person, or (b) the possession, directly or indirectly, of any other power to direct or cause the direction of the management and policies of such a Person, whether through ownership of voting securities, by contract or otherwise.
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Acquired Regulatory Approvals means all Regulatory Approvals regarding the Acquired Products.
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Related to Acquired Regulatory Approvals

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Product Approvals means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • FDA Approval means the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.

  • Pricing Approval means such governmental approval, agreement, determination or decision establishing prices for a Licensed Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • Project Approvals means all approvals, consents, waivers, orders, agreements, authorizations, permits and licenses required under Applicable Laws or under the terms of any restriction, covenant, easement or agreement affecting all or any applicable Phase of the Project, or otherwise necessary or desirable for the ownership, acquisition, construction, development, equipping, use or operation of the Project.

  • Development Approvals means all permits and other entitlements for use subject to approval or issuance by CITY in connection with development of the Property including, but not limited to: (a) general plan, general plan amendments, specific plans and specific plan amendments; (b) tentative and final subdivision and parcel maps; (c) conditional use permits and master plans; (d) zoning, zoning map amendments, and zoning text amendments; and, (e) grading and building permits.

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • Gaming Approvals means with respect to any action by a particular Person, any consent, finding of suitability, license, approval or other authorization required for such action by such Person from a Gaming Authority or under Gaming Laws.

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority, including all INDs and NDAs.

  • ANDA means Abbreviated New Drug Application.

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Export Approvals has the meaning specified in Section 4.26(a).

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.