Major European Markets definition

Major European Markets. (each a “Major European Market”) means France, Germany, Italy, Spain and the United Kingdom.

Major European Markets means [***].

Major European Markets means each of the United Kingdom, France, Germany and Italy.

Examples of Major European Markets in a sentence

• On a Program-by-Program basis, following receipt by Sarepta or its Affiliates or Sublicensees of Marketing Approval for a Licensed Product that is the subject of a given Program in the applicable country, Sarepta, either itself or through its Affiliates or Sublicensees, will use Commercially Reasonable Efforts to Commercialize at least one Licensed Product that is the subject of such Program in each of: (a) the United States, (b) any three Major European Markets, and (c) Japan.

More Definitions of Major European Markets

Major European Markets. France, Germany, Italy and Spain. “Marketing Authorisation” - any approval required from a Regulatory Authority to market and sell Product in any country in the Territory excluding, where necessary to market and sell Product in a specific country in the Territory, any form of pricing or reimbursement approval.

Major European Markets means [**].

Major European Markets means “Major European Markets” as such term is defined in the License Agreement.

Major European Markets means [***]. 1.68 “Manufacture” means, with respect to a Compound or Product, the receipt, handling and storage of active pharmaceutical ingredients and other materials, the manufacturing, processing, formulation, packaging and labeling (excluding the development of packaging and labeling components for Marketing Approval, which activities shall be considered Development activities), holding (including storage), quality assurance and quality control testing (including release and stability) of such Compound or Product (other than quality assurance and quality control related to development of the manufacturing process, which activities shall be considered Development activities) and shipping of such Compound or Product. “Manufacturing” shall have correlative meaning. 1.69 “Marketing Approval” means all approvals from the relevant Regulatory Authority necessary to initiate marketing and selling a product (including a Product) in any country, [***].

Major European Markets means the United Kingdom, France, Germany, Italy and Spain.

Major European Markets means each of the United Kingdom, France, Germany and Italy. “Manufacturing Cost” shall have the same meaning as in the Supply Agreement. “Merck Agreement” shall mean the Technology Transfer and License Agreement dated 26 July 1999 between Merck & Co. Inc. (“Merck”), Elan, Elan Pharmaceutical Research Corp. (now EDDI) and Elan Pharma International Limited. “MS” shall mean multiple sclerosis. 6 “MS Field” shall mean use as an oral prescription medicine for the treatment of MS in humans. “MS R & D” shall mean MS Research and Development Corporation, a Delaware corporation, having an office at 00 Xxxxxxx Xxxxx, Xxxxxxxxx, Xxx Xxxx 00000 XXX. “MS Term” shall mean shall mean the period beginning on 21 April 1998 and ending upon expiry or termination of this Agreement, howsoever arising. “NDA” shall mean the new drug application as defined in the Act and applicable regulations promulgated thereunder including any supplements or amendments thereto, which Acorda may file for the Product with the FDA. “NDA Approval” shall mean the final approval to market the Product by the FDA as defined under the Act. “NDA Equivalent” shall mean any new registration application or submission including any supplements or amendments thereto, such as a foreign counterpart to the NDA, which Acorda may file for the Product with any regulatory authority in any regulatory jurisdiction in the Territory other than the United States that is required to obtain Regulatory Approval in such jurisdiction. “NDA Timeline” shall mean the development and regulatory timeline attached hereto as Schedule 4. “Notional NSP” shall mean the estimated NSP of Product at the applicable time, which shall on a country-by-country basis be provided by Acorda to the Committee within ninety (90) days prior to commencement of each calendar year (or, for the Launch Year in any country, within ninety (90) days prior to the estimated date of First Commercial Sale in such country); provided, that:

Major European Markets means each of [**]. 1.157 “Manufacture” or “Manufacturing” means, with respect to a pharmaceutical product, activities directed to the sourcing and purchasing of materials, producing, manufacturing, processing, compounding, filling, finishing, packing, packaging, labeling, leafleting, assembly, quality assurance, quality control testing and release, shipping, storage, and sample retention of such product (or any components or process steps involving any such product). 1.158 “Manufacturing Costs” means [**]. 1.159 “Manufacturing Know-How” means, with respect to a Party, any and all Know- How which is Controlled by such Party or any of its Affiliates [**]. 1.160 “Manufacturing Technology Transfer” shall have the meaning set forth in Section 2.5(a). 1.161 “Manufacturing Technology Transfer Plan” shall have the meaning set forth in Section 2.5(a). 1.162 “Manufacturing Transition Date” means [**]. 1.163 “Materials” means any tangible compositions of matter, articles of manufacture, assays, chemical, biological or physical materials, and other similar materials. 1.164 “Material Regulatory Event” means a material regulatory issue relating to a Licensed Product in which a Regulatory Authority will not initiate review or refuses to accept filing of an NDA, MAA or other similar marketing application with respect to such Licensed Product on the basis of submission of a completed development program as agreed by the JSC, or if an accelerated or conditional approval with respect to such Licensed Product is ultimately unable to be converted to full approval. 1.165 “Material Safety Event” means a material safety event (whether as to the type of event or magnitude or severity of the safety issue) that arises prior to Completion of the Arvinas Clinical Trials Transfer and is reasonably likely to cause the continuation of the Arvinas Clinical Trial Activities to impose an unacceptable risk for patient safety.