sBLA definition

sBLA means a supplemental BLA; and “NDA” means a New Drug Application and amendments thereto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 314 et seq., for FDA approval of a Licensed Product and “sNDA” means a supplemental NDA.
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sBLA means a Supplemental Biologic License Application, as defined in the FDCA and applicable regulations promulgated thereunder.
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sBLA means a biologics license application for the Product, any equivalent successor filing thereto with the FDA, and any supplements or amendments to any of the foregoing.
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More Definitions of sBLA

sBLA means a supplemental BLA.
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sBLA means a biologics license application for the Product, any
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sBLA means a supplemental BLA; and “NDA” means a New Drug Application and amendments thereto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 314 et seq., for FDA approval of a Therapy and “sNDA” means a supplemental NDA; Non-Publishing Party is defined in Clause 14.4.1; Opt-Out Candidate/ Therapy Is defined in Clause 17.2.1; Party or Parties is defined in the Preamble; Patent(s) means any and all patents and patent applications and any patents issuing therefrom or claiming priority therefrom, worldwide, together with any extensions (including patent term extensions and supplementary protection certificates) and renewals thereof, reissues, reexaminations, substitutions, confirmation patents, registration patents, invention certificates, patents of addition, renewals, divisionals, continuations, and continuations-in-part of any of the foregoing; Person means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization;
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sBLA means a supplemental BLA; and “NDA” means a New Drug Application and amendments thereto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 314 et seq., for FDA approval of a Product and “sNDA” means a supplemental NDA; [***] [***]; Net Sales of a Product, means the [***]. Net Sales will be calculated on a Product by Product and country by country basis. [***]. Sales of Products between the Licensee and the Licensee's Affiliates and/or Sublicensees shall be excluded from the computation of Net Sales. The supply of Products for use (a) in a Clinical Trial; (b) on a named patient basis; (c) for compassionate use; or (d) under Treatment IND shall be excluded from the computation of Net Sales. For Combination Products: In the event of a sale of a Combination Product and where such Combination Product is supplied for a single price, the following shall apply: (i) where the Basic Product and the other active agent is sold separately in the same country and to the extent the Average Sales Price of the Basic Product is known or can be calculated, the Average Sales Price of the Basic Product will be used for computation of Net Sales; and (ii) where the Average Sales price of the Basic Product is not known or cannot be calculated (for example because Basic Product and other active ingredient are not sold and priced separately), then the Average Sales Price invoiced for such Basic Product, to be used in the calculation of Net Sales in accordance with the above procedure, shall be a reasonable amount based on the relative value of the Basic Product and the other active ingredient(s) in the Combination Product, as mutually agreed by the Parties acting in good faith and taking into reasonable consideration the current average sale prices for products and/or active ingredient(s) similar to Z within the Combination Product. [***].
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sBLA is defined in Section 1.6.
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sBLA has the meaning set forth in Section 3.10.3(a).
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Related to sBLA

  • 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.

  • IND means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the equivalent agency in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

  • Drug abuse means the use of any controlled substance as defined in Section 893.03, Florida Statutes, as amended from time to time, not pursuant to a lawful prescription. The term drug abuse also includes the commission of any act prohibited by Chapter 893, Florida Statutes, as amended from time to time.

  • 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.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.