Voyager Territory definition

Voyager Territory means (a) the United States with respect to any Split Territory Agreement Program or Split Territory Agreement Product other than the HD Agreement Program and HD Agreement Product and (b) if Genzyme has exercised the Split Territory Program Option for the HD Agreement Program, the Voyager Territory will be the United States for the HD Licensed Program and any HD Licensed Product. For clarity, if Genzyme exercises the Co-Co Option for the HD Agreement Program, there will be no Voyager Territory with respect to the HD Agreement Program and HD Agreement Products.

Examples of Voyager Territory in a sentence

  • In addition, notwithstanding anything to the contrary in this Agreement, Genzyme shall not conduct any Clinical Study for a Split Territory Licensed Product in the Voyager Territory without Voyager’s prior written consent.

  • Other than Split Territory Global Development Activities, all Development activities to be undertaken with respect to each Split Territory Licensed Product by or on behalf of Voyager with respect to the Voyager Territory, including Secondary Indication Studies, shall be set forth in a written work plan and time table (each, a “Voyager Territory Development Plan”).

  • Voyager shall have sole responsibility for the Voyager Territory Development Plans, as described below.

  • Voyager will submit representative samples of its Voyager Territory Promotional Materials developed by it for use in the Voyager Territory to the PSC annually.

  • Voyager shall consider in good faith any timely comments Genzyme may have with respect to any such Voyager Territory Promotional Materials, but shall have final decision- making authority with respect to such Voyager Territory Promotional Materials.

  • Voyager will allow Genzyme a reasonable opportunity to review and comment on Voyager’s proposed response to any Material Communications with any Regulatory Authority in the Voyager Territory with respect to any Split Territory Licensed Product in advance of the transmission of such response, and Voyager will reasonably consider all comments timely provided by Genzyme in connection therewith.

  • In addition, upon request of either Party (on behalf of itself or a Sublicensee), the other Party shall obtain and provide to the requesting Party certificates or other formal or official attestations concerning the regulatory status of the Split Territory Licensed Products in the Genzyme Territory or the Voyager Territory, as applicable (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments).

  • Each Voyager Territory Development Plan shall subsequently be updated by Voyager from time-to-time at least once each Calendar Year not later than September 1 until such time as no further Development or Secondary Indication Studies are occurring or expected to occur with respect to the applicable Split Territory Licensed Product.

  • Voyager will be responsible for the creation, preparation, production, reproduction and filing with the applicable Regulatory Authorities, of relevant written sales, promotion and advertising materials relating to each Split Territory Licensed Product for use in the Voyager Territory (“Voyager Territory Promotional Materials”).

  • Within [***] after receipt of any Material Communication from a Regulatory Authority in the Voyager Territory with respect to any Split Territory Licensed Product, Voyager will provide Genzyme, through its Alliance Manager, with a brief written description of the principal issues raised in such Material Communication.

Related to Voyager Territory

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Licensed Territory means worldwide.

  • Territory means worldwide.

  • Relevant Territory means Hong Kong or such other territory as the Directors may from time to time decide if the issued ordinary share capital of the Company is listed on a stock exchange in such territory;

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Service Territory means the geographic area within which PG&E as a Utility Distribution Company is authorized and required to provide electric transmission and distribution service.

  • Union territory means the territory of—

  • Exclusive Territory means (1) the states of Illinois, Wisconsin, and Indiana; and

  • Traditional Territory means, subject to a Yukon First Nation Final Agreement, with respect to each Yukon First Nation and each Yukon Indian Person enrolled in that Yukon First Nation's Final Agreement, the geographic area within the Yukon identified as that Yukon First Nation's Traditional Territory on the map referred to in 2.9.0.

  • Licensed Field means all fields of use.

  • Sales territory means an area of exclusive sales responsibility for the brand or brands of beer sold by a supplier as designated by an agreement.

  • Competing Product means [***].

  • Competing Products means any product or service in existence or under development that competes with any product or service of the Company Group about which the Participant obtained Confidential Information or for which the Participant provided advisory services or had sales, origination, marketing, production, distribution, research or development responsibilities in the last twenty-four (24) months of employment with the Company Group.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Covered Products means Your Applications, Libraries, Passes, Safari Extensions, Safari Push Notifications, and/or FPS implementations developed under this Agreement.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound or the active pharmaceutical contained in a Unity Bcl-2 [***] Product, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

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

  • 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.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).