First Regulatory Approval means, in relation to each COVID Product, unless expressly stated otherwise in this Agreement, the earlier of (i) final marketing authorization for a COVID Product in any jurisdiction of the Territory, or (ii) the grant of any conditional authorization for a COVID Product in any jurisdiction of the Territory.
First Regulatory Approval means the first, of either CE marking certification or FDA approval, to be received by Oxford for the labelling, distribution and sale of the Product for use in the Field.
First Regulatory Approval means, [***].
Examples of First Regulatory Approval in a sentence
First Regulatory Approval in any one country US $*** in the Territory ____________________________ Created by Morningstar Document Research.
First Regulatory Approval of any Licensed Product in the United States or a Major EU Country (or by EMA through the centralized approval procedure) for any Indication and in any specific patient population.
History and physical examination: including vital signs, weight and anthropomorphic measurements.
First Regulatory Approval of the Product worldwide: (††) [***] [***] [***] 6.
Oxford will not be required to pay StemCell the Termination Fee in the event that Oxford terminates the Agreement due to its failure to receive First Regulatory Approval for whatever reason.
More Definitions of First Regulatory Approval
First Regulatory Approval means the first regulatory approval of a Licensed Product by a regulatory authority in [*].
First Regulatory Approval means the first Regulatory Approval of an HTG Assay by a Regulatory Authority. For the sake of clarity, the First Regulatory Approval does not include a subsequent approval in a different country of the same HTG Assay.
First Regulatory Approval means authorisation for marketing a Product by the United States Food and Drug Administration or by the governing health authority in any other country or region.
First Regulatory Approval means Regulatory Approval granted by the FDA or a Regulatory Approval granted by an appropriate Regulatory Authority in a foreign country, whichever is earlier.
First Regulatory Approval means the first Regulatory Approval of the Product in any jurisdiction in the Territory. 1.49 “FTE” means the equivalent of the work of one (1) employee full time for one (1) Year consisting of a total of (a) [*] hours per Year for employees of a Party or its Affiliate [*] and (b) [*] hours per Year for employees of a Party or its Affiliate [*] (or, in each case ((a) and (b)), such other number as may be agreed to by the Parties by mutual Party Written Consent, or by the JSC) directly related to the Commercialization of the Product, or any other activities contemplated under this Agreement. Any such employee who devotes less than [*] hours or [*] hours, as applicable, per Year (or such other number as may be agreed by the Parties by Party Written Consent or by the JSC) shall be treated as an FTE on a pro-rata basis upon the actual number of hours worked divided by [*] or [*] (or such other number as may be agreed by the Parties by mutual Party Written Consent, or by the JSC). 1.50 “FTE Costs” means, with respect to FTEs for Development, Manufacturing, Commercialization and other activities conducted under this Agreement for the Product, the cost of an FTE based on a blended global rate of [*] for all activities conducted under this Agreement for the Product. Commencing January 1, 2021 and upon January 1 of each Year thereafter, such rate will be adjusted in accordance with the [*]. 1.51 “Genmab Major Market” means [*]. 1.52 “Global Plan” means the Global Development Plan (including the Global Regulatory Plan incorporated therein) and the Global Manufacturing Plan, individually or collectively, as the context requires. 1.53 “Good Clinical Practice” or “GCP” shall mean any and all laws, rules, regulations, guidelines and generally accepted standards and requirements regarding the ethical conduct of clinical trials, including the U.S. Code of Federal Regulations (“CFR”) Title 21, ICH GCP Guidelines E6(R1), current step 4 version, dated 10 June 1996, national legislation implementing European Community Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, European Community Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards to investigational medicinal products for human use, in each ca...
First Regulatory Approval means the first to occur of the HNC Regulatory Approval and the Melanoma Regulatory Approval.
First Regulatory Approval means with respect to a Joint Product, on an indication-by-indication basis, the date on which the Lead Party has obtained all Regulatory Approvals in the United States and the European Union for such Product for such indication.