Biosimilar Version means, with respect to a Licensed Product in a particular country, a therapeutic product that (a) [*], and (b) is [*].
Biosimilar Version means (a) in respect of a Product sold in the United States, a biological product approved under the Public Health Service Act section 351(k) that is highly similar to such Product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between such biological product and the Product in terms of the safety, purity and potency; (b) in respect of a Product sold in the European Union, a biological product approved under Article 10(4) of Directive 2001/83/EC and Section 4, Part II, Annex I to such Directive based on the demonstration of the similar nature of such biological product and the Product; and (c) in respect of a Product sold outside the United States and the European Union, a biological product approved under a similar pathway to (a) or (b) if such pathway exists and, if such pathway does not exist, a marketing approval granted by a regulatory authority to such Third Party with reference to such Product.
Biosimilar Version means, with respect to a Product that is being sold in a country or regulatory jurisdiction worldwide (the “Reference Product”), a biopharmaceutical product sold by a Third Party (other than a Third Party acting on behalf of or in concert with Purchaser or Dynavax or any Affiliate or sublicensee or assignee of Dynavax or Purchaser) in such country or regulatory jurisdiction worldwide that through reference to the regulatory approval of the Reference Product, is eligible for and has achieved regulatory approval in such country or regulatory jurisdiction pursuant to an abbreviated follow-on biological approval pathway established by the regulatory authority in such country or regulatory jurisdiction pursuant to the applicable law, or otherwise is approved for marketing and sale in such country or regulatory jurisdiction by an abridged procedure in reliance, in whole or in part, on the prior regulatory approval of the Reference Product or on the safety and efficacy data generated for the prior regulatory approval (in such country or regulatory jurisdiction) of the Reference Product, including any such biopharmaceutical product that (i) with respect to such biopharmaceutical product in the United States, has been approved as a biosimilar or interchangeable product by the FDA pursuant to 42 U.S.C. § 262 of the Public Health Service Act, (ii) with respect to such biopharmaceutical product subject to the regulatory jurisdiction of the EMA, has been approved as a similar biological medicine product by EMA as described in CHMP/437/04, issued 30 October 2005, as may be amended, or any subsequent or superseding law, statute or regulation or (iii) with respect to such biopharmaceutical product outside the United States and in a country which is not subject to the regulatory jurisdiction of the EMA, has otherwise obtained Regulatory Approval from a regulatory authority pursuant to similar statutory or regulatory requirement as that described in the foregoing subsections (i) and (ii) in such other country or regulatory jurisdiction.
Examples of Biosimilar Version in a sentence
After the entry of a Biosimilar Version of a Licensed Product in a country in the Territory, the royalties due under Section 9.5 for such Licensed Product in such country shall be reduced as follows: (i)by [*] in subsequent [*] if in [*]; and (ii)by [*] in subsequent [*] if in [*].
More Definitions of Biosimilar Version
Biosimilar Version means, with respect to a Product that is being sold in a country or regulatory jurisdiction in the Territory (the “Reference Product”), a biopharmaceutical product sold by a Third Party (other than a Third Party acting on behalf of or in concert with Pfizer or any Pfizer Affiliate or Sublicensee) in such country or regulatory jurisdiction in the Territory that through reference to the Regulatory Approval of the Reference Product, is eligible for and has achieved Regulatory Approval in such country or regulatory jurisdiction pursuant to an abbreviated follow-on biological approval pathway established by the Regulatory Authority in such country or regulatory jurisdiction pursuant to the applicable Law, or otherwise is approved for marketing and sale in such country or regulatory jurisdiction by an abridged procedure in reliance, in whole or in part, on the prior Regulatory Approval of the Reference Product or on the safety and efficacy data generated for the prior Regulatory Approval (in such country or regulatory jurisdiction) of the Reference Product, including any such biopharmaceutical product that (i) with respect to such biopharmaceutical product in the United States, has been approved as a biosimilar or interchangeable product by the FDA pursuant to 42 U.S.C. § 262 of the Public Health Service Act, (ii) with respect to such biopharmaceutical product subject to the regulatory jurisdiction of the EMA, has been approved as a similar biological medicine product by EMA as described in CHMP/437/04, issued 30 October 2005, as may be amended, or any subsequent or superseding law, statute or regulation or (iii) with respect to such biopharmaceutical product outside the United States and in a country which is not subject to the regulatory jurisdiction of the EMA, has otherwise obtained Regulatory Approval from a Regulatory Authority pursuant to similar statutory or regulatory requirement as that described in the foregoing subsections (i) and (ii) in such other country or regulatory jurisdiction in the Territory.
Biosimilar Version means, with respect to any Customer Product that is being sold in a country or regulatory jurisdiction (the “Reference Product”), any biopharmaceutical product sold by a third party (other than a third party acting on behalf of or in concert with Customer, any of its affiliates, any Licensee, or any sublicensee or assignee of any of the foregoing) in such country or jurisdiction, that through reference to the Regulatory Approval of the Reference Product, is eligible for and has achieved regulatory approval in such country or jurisdiction pursuant to an abbreviated follow-on biological approval pathway established by the Regulatory Authority in such country or jurisdiction pursuant to the Applicable Laws, or otherwise is approved for marketing and sale in such country or jurisdiction by an abridged procedure in reliance, in whole or in part, on the prior Regulatory Approval of the Reference Product or on the safety and efficacy data included in the prior Regulatory Approval (in such country or jurisdiction) of the Reference Product, including any such biopharmaceutical product that (i) with respect to such biopharmaceutical product in the United States, has been approved as a biosimilar or interchangeable product by the FDA pursuant to 42 U.S.C. § 262 of the Public Health Service Act, or (ii) with respect to such biopharmaceutical product in any country or regulatory jurisdiction, has otherwise obtained Regulatory Approval from a Regulatory Authority pursuant to similar statutory or regulatory requirement as that described in the foregoing clause (i) in such other country or jurisdiction.
Biosimilar Version means, with respect to a Product in a given country in the Territory, a Third Party pharmaceutical product (other than such Product hereunder) that: (i) contains injectable collagenases derived from Clostridium histolyticum as the sole active ingredient (and labeled for the same indications of treatment as such Product) and (ii) has been granted a marketing authorization by an abridged procedure that relies in whole or in part on safety and efficacy data generated for the marketing authorization for such Product as determined by the applicable Governmental Authority in such country and, in the case of those countries in the Territory that are a part of the EU, is authorized for the same indication as such Product in such country in accordance with Article 10 of Directive 2001/83/EC (as amended).
Biosimilar Version means, with respect to a Customer Product that is being sold in a country or regulatory jurisdiction (the “Reference Product”), a biopharmaceutical product sold by a third party (other than a third party acting on behalf of or in concert with Customer or any affiliate or sublicensee or assignee of Customer) in such country or jurisdiction, that through reference to the Regulatory Approval of the Reference Product, is eligible for and has achieved regulatory approval in such country or jurisdiction pursuant to an abbreviated follow-on biological approval pathway established by the Regulatory Authority in such country or jurisdiction pursuant to the Applicable Laws, or otherwise is approved for marketing and sale in such country or jurisdiction by an abridged procedure in reliance, in whole or in part, on the prior Regulatory Approval of the Reference Product or on the safety and efficacy data included in the prior Regulatory Approval (in such country or jurisdiction) of the Reference Product, including any such biopharmaceutical product that (i) with respect to such biopharmaceutical product in the United States, has been approved as a biosimilar or interchangeable product by the FDA pursuant to 42 U.S.C. § 262 of the Public Health Service Act, or (ii) with respect to such biopharmaceutical product in any country or regulatory jurisdiction, has otherwise obtained Regulatory Approval from a Regulatory Authority pursuant to similar statutory or regulatory requirement as that described in the foregoing clause (i) in such other country or jurisdiction.
Biosimilar Version means, with respect to Finished Product in a given country in the Territory, a Third Party pharmaceutical product (other than such Finished Product hereunder) that: (i) contains injectable collagenases derived from Clostridium histolyticum as the sole active ingredient (and labeled for the same indications of treatment as such Finished Product) and (ii) has been granted a marketing authorization by an abridged procedure that relies in whole or in part on safety and efficacy data generated for the marketing authorization for such Product as determined by the applicable Governmental Authority in such country.
Biosimilar Version means, with respect to a Product in the Territory, a Third Party pharmaceutical product (other than such Product hereunder) that: (i) contains injectable collagenases derived from Clostridium histolyticum as the sole active ingredient (and labeled for the same indications of treatment as such Product) and (ii) has been granted a marketing authorization by an abridged procedure that relies in whole or in part on safety and efficacy data generated for the marketing authorization for such Product as determined by the applicable Governmental Authority in the Territory.
Biosimilar Version of a Product means