First to File Exclusivity definition

First to File Exclusivity means, to the extent applicable, up to six (6) months of marketing exclusivity in the U.S. from the FDA under and pursuant to 21 U.S.C. Section 355(j)(5)(B)(iv) of the Federal Food, Drug and Cosmetic Act, as amended.
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First to File Exclusivity means, to the extent applicable, up to 180 days of marketing exclusivity in the United States from the FDA under and pursuant to 21 U.S.C. Section 355(j)(5)(B)(iv) of the Federal Food, Drug and Cosmetic Act, as amended.
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First to File Exclusivity means the period of up to one hundred and eighty (180) days of Marketing exclusivity in the United States granted for each of the Products (under approved ANDAs) by the FDA under and pursuant to 21 U.S.C. Section 355(j)(5)(B)(iv) of the Federal Food, Drug and Cosmetic Act, as amended.
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Examples of First to File Exclusivity in a sentence

  • One means by which generics compete is by seeking Sole First to File Exclusivity.

  • Although Teva and other generics also filed ANDAs for generic atorvastatin calcium, it was generally believed in the industry that Ranbaxy was eligible to receive Sole First to File Exclusivity, and thus, a 180 day period during which it could sell its generic atorvastatin free from competition by other generic versions of the drug (except the authorized generic version that Pfizer had licensed to Watson).15.

  • Notwithstanding the foregoing, this Section 6.10.6 shall not apply to Ranbaxy solely with respect to Product in the event that and to the extent that Ranbaxy challenges an FDA final determination that Ranbaxy should not be awarded First to File Exclusivity for the Ranbaxy Product as specified in Section 2.8.2(i).

  • Ranbaxy’s Sole First to File Exclusivity for atorvastatin ended on May 29, 2012.

  • Each of the Parties agrees that it will not enter into any agreement(s) with another generic company containing a provision not to challenge or otherwise take any adverse action against another generic company’s Sole First to File Exclusivity for a drug that is intended or likely to be sold in New York State, unless reasonably ancillary to a procompetitive agreement.

  • In the event that there are any claims, actions, demands or suits by a third party, attempting to invalidate ALO's entitlement to First to File Exclusivity, Teva shall, upon the reasonable request and at the expense of ALO, assist ALO in defending such action, and provided ALO is not in breach of any of its material obligations hereunder, Teva shall not take any action that would invalidate ALO's entitlement to First to File Exclusivity.

  • From the documents on record and the sequence of events, it was quite clear that BP USA did not have any right to legally compel Ranbaxy to relinquish/selectively waive its First to File Exclusivity (“FFE”) rights in favour of BP USA by issuing a valid Ready Date Notice (which was issued on 23.11.2011) as the tentative approval was received by BP USA only on 1 December 2011.

  • It also did not contain any information from the VIGOR study, the most recent study of cardiovascular safety in rheumatoid arthritis patients.66 Instead, the card presented pooled data from clinical trials conducted prior to the drug’s approval in osteoarthritis patients.

  • It was acknowledged that Ranbaxy had filed ANDA No. 76477 and was eligible for First to File Exclusivity (FFE) rights for the product.

  • Neither ALO nor any of its Affiliates shall directly or indirectly, assign, transfer or otherwise encumber in any respect its First to File Exclusivity rights relating to any Product to any Person other than Teva (or a Teva Affiliate); provided, however, that the foregoing shall not apply to ALO Tablet Products if Teva exercises its option under Section 2.1(b)(iii) hereof.


More Definitions of First to File Exclusivity

First to File Exclusivity means the period of one hundred eighty (180) days of marketing exclusivity in the Territory granted by FDA under and pursuant to 21 U.S.C. section 355(j)(5)(B)(iv).
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Related to First to File Exclusivity

  • Regulatory Exclusivity means any exclusive marketing rights or data exclusivity rights conferred by any Regulatory Authority with respect to a pharmaceutical product other than Patents, including orphan drug exclusivity, new chemical entity exclusivity, data exclusivity, or pediatric exclusivity.

  • Regulatory Exclusivity Period means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country which confers an exclusive Commercialization period during which AbbVie or its Affiliates or Sublicensees have the exclusive right to market and sell a Licensed Compound or Licensed Product in such country through a regulatory exclusivity right.

  • Exclusivity means the specificity of the test method for validating microbial testing methods. It evaluates the ability of the method to distinguish the target organisms from similar but genetically distinct non-target organisms.

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • 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.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • 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.

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

  • Exclusivity Period means the period beginning on the date hereof and ending on the first to occur of (a) the date six (6) months after the date hereof and (b) the mutually agreed termination of this Agreement pursuant to Section 6.01(b).

  • Regulatory Approval means, with respect to the Licensed Product in any country or jurisdiction, all approvals (including, where required, pricing and reimbursement approvals), registrations, licenses or authorizations from the relevant regulatory authority in a country or jurisdiction that is specific to the Licensed Product and necessary to market and sell such Licensed Product in such country or jurisdiction.

  • Biologics License Application or “BLA” means, with respect to a country or extra-national territory, a request for permission to introduce, distribute, sell or market a biologic product in such country or some or all of such extra-national territory, including pursuant to 21 CFR 601.2 in the U.S.

  • ANDA means an abbreviated new drug application filed with the FDA, pursuant to its rules and regulations (or any equivalent or replacement mechanism).

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

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

  • License Period means the period beginning from the Commencement Date and ending on the Termination Date.

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

  • 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.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Licensed Product as a drug in a regulatory jurisdiction.

  • Patent Cooperation Treaty means the Patent Cooperation Treaty done at Washington on June 19, 1970;

  • Royalty Term has the meaning set forth in Section 8.4(b).

  • Patent Applications means all published and unpublished nonprovisional and provisional patent applications, reexamination proceedings, invention disclosures and records of invention, applications for certificates of invention and priority rights, in any country and regardless of formal name, including without limitation, substitutions, continuations, continuations-in-part, divisions, renewals, revivals, reissues, re-examinations and extensions thereof.

  • 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.

  • Patent Application means an application for patent protection for an Invention with any domestic or foreign patent-issuing authority.

  • 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.