Biosimilar Product definition

Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

Biosimilar Product means [***].

Examples of Biosimilar Product in a sentence

• If a Biosimilar Product to a Product is sold in any country in the Territory during the Product Royalty Term for such Product and country, the Product Royalties payable with respect to such Product in such country will be reduced by [***] for the remainder of such Product Royalty Term.

• Under the Biosimilar Biological Product Authorization Performance Goal and Procedures, which sets forth FDA goals for fiscal years 2013-2017, the FDA is committed to reviewing and acting “on 70 percent of original biosimilar biological product application submissions within 10 months of receipt” for biosimilar biological product applications filed in 2014.2 Therefore, the FDA may complete its final review of the Hospira Epoetin Biosimilar Product before November, 2015.

• Unless otherwise agreed by the Parties, the unit volumes of each Biosimilar Product sold during a Calendar Quarter shall be as reported by IMS America Ltd.

• Without limiting the foregoing, Novartis agrees to take such actions with respect to Licensed Patent Rights as may required under the BPCIA and regulations thereunder, and any other Applicable Laws pertaining to the approval or sale of biosimilars or follow-on biologic products, as are permitted to persons having rights to a reference product in order to object to or prevent the sale of a Proposed Biosimilar Product.

• Unless otherwise agreed by the Parties, the unit sales of each such Biosimilar Product sold during a Reporting Period shall be as reported by [*****] or any other independent sales auditing firm reasonably agreed upon by the Parties.

More Definitions of Biosimilar Product

Biosimilar Product means, with respect to a particular Optioned Product and a particular country, a biologic therapeutic that (a) containing [***]; or (b) is otherwise determined by the FDA or other Regulatory Authority outside of the United States to be [***] with such Optioned Product, as set forth in 42 U.S.C. 262(k) or other analogous Applicable Law outside the United States. An Optioned Product licensed, marketed, sold, manufactured or produced by Takeda, its Affiliates or Sublicensees shall not constitute a Biosimilar Product.

Biosimilar Product means with respect to a Licensed Product, a therapeutic product that (i) contains as an active ingredient any [***], (ii) is Bioequivalent to such Licensed Product, and (iii) is [***].

Biosimilar Product means, with respect to a given Licensed Product, a biological product (a) that contains (i) an identical active ingredient(s) as the Licensed Antibody in such Licensed Product, or (ii) a “highly similar” active ingredient(s) to the Licensed Antibody in such Licensed Product, as the phrase “highly similar” is used in 42 U.S.C. § 262(i)(2), and subject to the factors set forth in FDA’s Guidance for Industry, “Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product,” (February 2012), at Section VI, or any successor FDA guidance thereto, (b) for which Regulatory Approval is obtained by referencing Regulatory Materials of such Licensed Product, (c) is approved for use in such country (or region) pursuant to a Regulatory Approval process governing approval of interchangeable or biosimilar biologics as described in 42 U.S.C. §§ 262, or a similar process for Regulatory Approval in any country (or region) outside the United States, or any other similar provision that comes into force, or is the subject of a notice with respect to such Licensed Product under 42 U.S.C. § 262(l)(2) or any other similar provision that comes into force in such country (or region), and (d) is sold in the same country as such Licensed Product by any Third Party that is not a Sublicensee of Celgene or its Affiliates with respect to the Prothena IP and did not purchase such product in a chain of distribution that included any of Celgene or any of its Affiliates or its Sublicensees.

Biosimilar Product means, with [***] a product that [***]

Biosimilar Product means in a particular country with respect to a Product that contains a Compound that is a protein or peptide, any pharmaceutical product that: (a) has received all necessary approvals by the applicable Regulatory Authorities in such country to market and sell such product as a pharmaceutical product; (b) is marketed or sold by a Third Party that has not obtained the rights to market or sell such product as a licensee, sublicensee or distributor of BMS or any of its Affiliates, licensees or sublicensees with respect to such product; and (c) is approved as a (i) “biosimilar” (in the United States) of such Product, (ii) as a “similar biological medicinal product” (in the EU) with respect to which such Product is the “reference medicinal product” or (iii) if not the US or EU, as the foreign equivalent of a “biosimilar” or “similar biological medicinal product” of such Product; in each case for use in such country pursuant to an expedited regulatory approval process governing approval of generic biologics based on the then-current standards for regulatory approval in such country (e.g., the Biologics Price Competition and Innovation Act of 2009 or an equivalent under foreign law) and where such regulatory approval was based in significant part upon clinical data generated by BMS (or its Affiliate or sublicensee) with respect to such Product.

Biosimilar Product means, with respect to a particular Product in a country, a pharmaceutical product that (a) contains an analytically comparable or identical active ingredient(s) as such Product, (b) is approved for use in such country pursuant to a regulatory approval process governing approval of generic, interchangeable or biosimilar biologics based on the then-applicable standards for regulatory approval in such country, whether or not such regulatory approval was based in whole or in part upon clinical data generated by the Parties pursuant to this Agreement or was obtained using some other type of abbreviated or expedited approval process and (c) is sold in the same country as such Product by any Third Party that is not a Sublicensee of BMS or its Affiliates and did not purchase such product in a chain of distribution that included any of BMS or any of its Affiliates or its Sublicensees.

Biosimilar Product means a pharmaceutical product that, with respect to a Product, (i) has been licensed as a biosimilar or interchangeable product by the FDA pursuant to Section 351(k) of the Public Health Service Act (42 U.S.C. 262(k)), as may be amended, or any subsequent or superseding law, statute, or regulation, (ii) has been licensed as a similar biological medical product by the EMA pursuant to Directive 2001/83/EC, as may be amended, or any subsequent or superseding law, statute, or regulation, or (iii) has otherwise achieved analogous Regulatory Approval from another applicable Regulatory Authority.