Reference Product definition

Reference Product means a biological Prescription Drug.

Reference Product means the single biological product licensed pursuant to 42 U.S.C. § 262(a) against which the interchangeable biological product was evaluated by the U.S. Food and Drug Administration pursuant to 42 U.S.C. § 262(k).

Reference Product means the single biological product licensed

Examples of Reference Product in a sentence

• Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.

• All these marketing authorisations are considered as belonging to the same global marketing authorisation, in particular for the purpose of the application of Article 10 of the directive, which lays down rules on data exclusivity and market protection and on the so-called European Reference Product.

• The Reference Product Sponsor must also identify which, if any, of these patents it would be prepared to license to the biosimilar applicant.

• Under 42 U.S.C. 351(k), patents that may be infringed by a sponsor of a biosimilar or interchangeable product must be in the “List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability” (referred to as the “Purple Book”).

• Pfenex has not out-licensed or otherwise granted rights to any Third Party under any Pfenex Technology with respect to Product or the Reference Product.

More Definitions of Reference Product

Reference Product means the single biological product licensed under section 351(a) of the PHS Act against which a biological product is evaluated in a 351(k) application (section 351(i)(4) of the PHS Act).

Reference Product has the meaning set forth in the definition of Generic Product.

Reference Product means a product as defined by the Federal Food and Drug Administration pursuant to 42 U.S.C. § 262.

Reference Product means (a) the injectable product containing botulinum neurotoxin serotype A as its sole active ingredient as marketed and manufactured by or on behalf of or under the authority of the Innovator as BOTOX® as of the Effective Date, together with any and all (b) modifications to the foregoing product described in (a) that do not change the function or therapeutic activity (including safety, purity and potency) or that do not require the conduct of a new full clinical program (Phase I through Phase III), (c) additional strengths and concentrations of any such product described in (a) or (b) that do not require the conduct of a new full clinical program (Phase I through Phase III), (d) devices for delivery of any such product described in (a), (b) or (c) by injection, and (e) such products described in (a), (b), (c) or (d) marketed under a different trademark or trade name, in each case ((b)-(e)): marketed and manufactured by or on behalf of or under the authority of the Innovator at any time during the Term. For clarity, the definition of Reference Product expressly excludes [*].

Reference Product means Forteo® (teriparatide), as branded and approved in the Territory.

Reference Product means Lucentis® (Ranibizumab), as approved in the applicable jurisdiction.

Reference Product means a single biological product