Biosimilar Notice definition

Biosimilar Notice means a copy of any application submitted by a Third Party to the FDA under 42 U.S.C. § 262(k) of the PHS Act (or, in the case of a country of the Territory outside the United States, any similar law) for Regulatory Approval of a biological product, which application identifies a Licensed Product as the reference product with respect to such product, and other information that describes the process or processes used to manufacture the biological product.
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Biosimilar Notice means a copy of any application submitted by a Third Party to the FDA under 42 U.S.C. § 262(k) of the PHS Act (or, in the case of a country of the Territory outside the United States, any similar law) for Regulatory Approval of a biological product, which application identifies a Licensed Product as the reference product with respect to such product, and other information that describes the process or processes used to manufacture the biological product.* **Certain information contained herein has been omitted pursuant to Regulation S-K 601(b)(10). Confidential treatment has been granted with r espect to the omitted portions.
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Biosimilar Notice means a copy of any application submitted by a Third Party to the FDA under 42 U.S.C. § 262(k) of the PHS Act (or, in the case of a country of the Territory outside the United States, any similar law) for Regulatory Approval of a biological product, which application identifies a Licensed Product as the reference product with respect to such product, and other information that describes the process or processes used to manufacture the biological product. ***Certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
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Examples of Biosimilar Notice in a sentence

  • Within [***] days following Novartis’ receipt of the Biosimilar Notice, Novartis shall provide the Applicant with a copy of the Proposed Patent List and the Other Required Information; provided, however, that the Proposed Patent List provided to Applicant shall include any patent within the Licensed Patent Rights specified in writing by ImmunoGen for inclusion, absent manifest error.

  • Celgene shall give written notice to Acceleron of receipt of a Biosimilar Notice received by Celgene with respect to a Licensed Product, and Celgene shall consult with Acceleron with respect to the selection of the Patent Rights to be submitted pursuant to 42 U.S.C. § 262(1) (or any similar law in any country of the Territory outside the United States); provided that [* * *].

  • Pfizer shall give written notice to CytomX of receipt of a Biosimilar Notice received by Pfizer with respect to a Licensed Product, and Pfizer shall consult with CytomX with respect to the selection of the Patent Rights to be submitted pursuant to 42 U.S.C. § 262(l) (or any similar law in any country of the Territory outside the United States); provided that Pfizer shall have final say on such selection of Patent Rights.

  • Pfizer will give written notice to BioNTech of receipt of a Biosimilar Notice received by Pfizer with respect to a Product, and Pfizer will consult with BioNTech with respect to the selection of any BioNTech Patent Rights to be submitted pursuant to 42 U.S.C. § 262(l) (or any similar law in any country of the Territory outside the United States); provided that Pfizer will have final say on such selection of BioNTech Patent Rights.

  • Within [***] following Novartis’ receipt of the Biosimilar Notice, Novartis shall provide the Applicant with a copy of the Proposed Patent List and the Other Required Information; provided, however, that the Proposed Patent List provided to Applicant shall include any patent within the Licensed Patent Rights specified in writing by ImmunoGen for inclusion, absent manifest error.

  • The MA Holder will give written notice to the other Party of receipt of a Biosimilar Notice received by MA Holder with respect to a Product, and MA Holder will consult with the other Party with respect to the selection of any Patent Rights to be submitted pursuant to 42 U.S.C. § 262(l) (or any similar law in any country of the Territory outside the United States); provided that the MA Holder will have final say on such selection of Patent Rights.

  • Allogene will give written notice to Cellectis of receipt of a Biosimilar Notice received by Allogene with respect to an Allogene Licensed Product, and Allogene will consult with Cellectis with respect to the selection of the Patent Rights to be submitted pursuant to 42 U.S.C. § 262(l) (or any similar law in any country of the Territory outside the United States); provided that Allogene will have final say on such selection of Patent Rights.

  • The MA Holder will give written notice to the other Party of receipt of a Biosimilar Notice received by MA Holder with respect to a Product, and MA Holder will consult with the other Party 55 with respect to the selection of any Patent Rights to be submitted pursuant to 42 U.S.C. § 262(l) (or any similar law in any country of the Territory outside the United States); provided that the MA Holder will have final say on such selection of Patent Rights.

  • Pfizer will give written notice to Valneva of receipt of a Biosimilar Notice received by Pfizer with respect to a Product, and Pfizer will consult with Valneva with respect to the selection of any Valneva Patent Rights to be submitted pursuant to 42 U.S.C. § 262(1) (or any similar law in any country of the Territory outside the United States); provided that Pfizer will have final say on such selection of Valneva Patent Rights.

  • Allogene will give written notice to Cellectis of receipt of a Biosimilar Notice received by Allogene with respect to an Confidential Allogene Licensed Product, and Allogene will consult with Cellectis with respect to the selection of the Patent Rights to be submitted pursuant to 42 U.S.C. § 262(l) (or any similar law in any country of the Territory outside the United States); provided that Allogene will have final say on such selection of Patent Rights.


More Definitions of Biosimilar Notice

Biosimilar Notice means a copy of any application submitted by a Third Party to the FDA under 42 U.S.C. § 262(k) of the Public Health Service Act (or, in the case of a country of the Territory outside the United States, any similar law) for Regulatory Approval of a biopharmaceutical product, which application identifies a Product as the Reference Product with respect to such product, and other information that describes the process or processes used to manufacture the biopharmaceutical product. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Biosimilar Notice means a copy of any application submitted by a Third Party to the FDA under 42 U.S.C. § 262(k) of the United States Public Health Service Act, as amended, and the rules and regulations promulgated thereunder (or, in the case of a country of the Territory outside the United States, any similar law) for Regulatory Approval of a biological product, which application identifies a Licensed Product as the reference product with respect to such product, and other information that describes the process or processes used to manufacture the biological product. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Biosimilar Notice means a copy of any application submitted by a Third Party to the FDA under 42 U.S.C. § 262(k) of the Public Health Service Act (or, in the case of a country of the Territory outside the United States, any similar law) for Regulatory Approval of a biopharmaceutical product, which application identifies a Product as the Reference Product with respect to such product, and other information that describes the process or processes used to manufacture the biopharmaceutical product.3 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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Biosimilar Notice means a copy of any application submitted by a Third Party to the FDA under 42 U.S.C. § 262(k) of the United States Public Health Service Act, as amended, and the rules and regulations promulgated thereunder (or, in the case of a country of the Territory outside the United States, any similar law) for Regulatory Approval of a biological product, which application identifies a Licensed Product as the reference product with respect to [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. such product, and other information that describes the process or processes used to manufacture the biological product.
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Related to Biosimilar Notice

  • 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 means a biological product that is highly similar to a specific reference biological

  • FOIA Notice means a decision notice, enforcement notice and/or an information notice;

  • Alternative nicotine product means any vaping product, whether or not it includes nicotine, including electronic smoking devices, that can be ingested into the body by chewing, smoking, absorbing, dissolving, inhaling, or by any other means. ‘Alternative nicotine product’ does not include:

  • Licensed Compound means [***].

  • Valid write-in candidate means a candidate who has qualified as a write-in

  • Denial notice means a board notification denying an application for the issuance or renewal of a license as required by the Act.

  • Xxxxx Notice means the Notice of Grant of Stock Option accompanying the Agreement, pursuant to which Optionee has been informed of the basic terms of the option evidenced hereby.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Exempt compound means the same as defined in Rule 2.

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • Indication means any human disease or condition, or sign or symptom of a human disease or condition.

  • OJEU Notice means the contract notice published in the Official Journal of the European Union.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Pre-Notice shall have the meaning ascribed to such term in Section 4.13.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • The Material/ Product means all the materials along with the accessories which the contractor is required to supply to the Bank under the Contract.

  • infringement notice has the meaning set forth in Section 7.4.1;

  • Opt-Out Notice has the meaning specified therefor in Section 2.02(a) of this Agreement.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Replacement Candidate means any Candidate Introduced by the Agency to the Client to fill the Engagement following the Introduction of another Candidate whose Engagement either did not commence or was terminated during the first 12 weeks of the Engagement;

  • Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.

  • Term SOFR Notice means a notification by the Administrative Agent to the Lenders and the Borrower of the occurrence of a Term SOFR Transition Event.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.