Product License Approvals definition

Product License Approvals means those regulatory approvals required for the importation, promotion, marketing and sale of the Agreement Product and any Improved Agreement Product(s) in the Territory (including any reimbursement or pricing approvals).
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Product License Approvals means with respect to each country in the Territory, those regulatory approvals required for the promotion, marketing and sale of the Agreement Product in such country; provided, however, that, except as specifically provided to the contrary herein, Product License Approval shall not include any approvals with regard to pricing.
Sample 1

Examples of Product License Approvals in a sentence

  • All such labelling, packaging and promotional material shall be consistent with the relevant Product License Approvals and all labelling and packaging materials shall be reviewed by Biomatrix and shall be subject to its written approval prior to use, such approval not to be unreasonably withheld.

  • The Distributor shall use its best efforts to obtain and maintain at its cost any Product License Approvals and to conduct at its cost any clinical trials required for the marketing and sale of the Agreement Product and any Improved Agreement Product(s) in each country in the Territory, except for the European Territory, throughout the term of this Agreement.

  • All marketing and promotional material shall be consistent with the Product Guidelines and the relevant Product License Approvals, and deemed acceptable in such case.

  • All taxes (including income tax) arising from the grant or vesting of any Award under the TEHO PSP 2021 shall be borne by the respective Participant.

  • Biomatrix agrees that the regulatory authorities of the countries where the Agreement Product is marketed by Syntex or its designated Affiliates, or where applications have been made for Product License Approvals (hereinafter the "Regulatory Authorities") shall be able to inspect, during regular business hours, the facilities, documentation systems, operations and equipment as set forth in Section 9.3 above, as the same relate to the Agreement Product that is to be shipped to such countries.

  • Subject to Biomatrix's approval rights as set forth in Section 15.2(g), Syntex shall use its best efforts (as defined below) to obtain and maintain at its expense all regulatory approvals required for the marketing and sale by Syntex of the Agreement Product in each country in the Territory, including all Product License Approvals and pricing and reimbursement approvals where applicable.

  • All Product License Approvals held by Syntex or its designated Affiliate or nominee shall be maintained by Syntex at its cost throughout the term of this Agreement.

  • In addition, Biomatrix shall be entitled generally to oversee the strategy and content of all applications for Product License Approvals and the content of all such applications shall be subject to Biomatrix's prior written approval, such approval or disapproval to be given by Biomatrix within * of its receipt thereof, such approval not to be unreasonably withheld.

Related to Product License Approvals

  • Product Approvals means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

  • Development Approvals means all permits and other entitlements for use subject to approval or issuance by CITY in connection with development of the Property including, but not limited to: (a) general plan, general plan amendments, specific plans and specific plan amendments; (b) tentative and final subdivision and parcel maps; (c) conditional use permits and master plans; (d) zoning, zoning map amendments, and zoning text amendments; and, (e) grading and building permits.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Intellectual Property License Agreement means the intellectual property license agreement substantially in the form attached as Exhibit B to the Contribution and Distribution Agreement.

  • Third Party Licenses has the meaning set forth in Section 3.

  • Patent Licenses means all licenses, contracts or other agreements, whether written or oral, naming any Grantor as licensee or licensor and providing for the grant of any right to manufacture, use or sell any invention covered by any Patent (including, without limitation, all Patent Licenses set forth in Schedule II hereto).

  • Intellectual Property Licenses means (i) any grant by the Company to another Person of any right, permission, consent or non-assertion relating to or under any of the Purchased Intellectual Property and (ii) any grant by another Person to the Company of any right, permission, consent or non-assertion relating to or under any third Person’s Intellectual Property.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Company Licensed Intellectual Property means Intellectual Property Rights owned by any Person (other than a Group Company) that is licensed to any Group Company.

  • Company IP Licenses (other than “shrink wrap,” “click wrap,” and “off the shelf” software agreements and other agreements for Software commercially available on reasonable terms to the public generally with license, maintenance, support and other fees of less than $5,000 per year (collectively, “Off-the-Shelf Software Agreements”), which are not required to be listed, although such licenses are “Company IP Licenses” as that term is used herein), under which a Target Company is a licensee or otherwise is authorized to use or practice any Intellectual Property, and describes (A) the applicable Intellectual Property licensed, sublicensed or used and (B) any royalties, license fees or other compensation due from a Target Company, if any. Each Target Company owns, free and clear of all Liens (other than Permitted Liens), has valid and enforceable rights in, and has the unrestricted right to use, sell, license, transfer or assign, all Intellectual Property currently used, licensed or held for use by such Target Company, and previously used or licensed by such Target Company, except for the Intellectual Property that is the subject of the Company IP Licenses. For each Patent and Patent application in the Company Registered IP, the Target Companies have obtained valid assignments of inventions from each inventor. Except as set forth on Schedule 4.13(a)(iii), all Company Registered IP is owned exclusively by the applicable Target Company without obligation to pay royalties, licensing fees or other fees, or otherwise account to any third party with respect to such Company Registered IP.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Company License Agreements means any license agreements granting any right to use or practice any rights under any Intellectual Property (except for such agreements for off-the-shelf products that are generally available for less than $25,000), and any written settlements relating to any Intellectual Property, to which the Company is a party or otherwise bound; and the term “Software” means any and all computer programs, including any and all software implementations of algorithms, models and methodologies, whether in source code or object code.

  • Intellectual Property License means any license, permit, authorization, approval, contract or consent granted, issued by or with any Person relating to the use of Intellectual Property.

  • Licenses means all licenses, permits, certificates of authority, authorizations, approvals, registrations, franchises and similar consents granted or issued by any Governmental or Regulatory Authority.

  • Patent License means any written agreement granting any right with respect to any invention on which a Patent is in existence or a Patent application is pending, in which agreement Borrower now holds or hereafter acquires any interest.

  • Patent License Agreement means the Patent License Agreement substantially in the form of Exhibit C.

  • Government Approvals means all permits, licenses, authorisations, consents, clearances, decrees, waivers, privileges, approvals from and filing with government instrumentalities necessary for the development, construction and operation of the Work.

  • Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

  • CREFC® Intellectual Property Royalty License Fee With respect to each Mortgage Loan (including any REO Mortgage Loan) and for any Distribution Date, the amount accrued during the related Interest Accrual Period at the CREFC® Intellectual Property Royalty License Fee Rate on, in the case of the initial Distribution Date, the Cut-Off Date Balance of such Mortgage Loan and, in the case of any subsequent Distribution Date, the Stated Principal Balance of such Mortgage Loan as of the close of business on the Distribution Date in the related Interest Accrual Period; provided that such amounts shall be computed for the same period and on the same interest accrual basis respecting which any related interest payment due or deemed due on the related Mortgage Loan is computed and shall be prorated for partial periods. For the avoidance of doubt, the CREFC® Intellectual Property Royalty License Fee shall be payable from the Lower-Tier REMIC.

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority, including all INDs and NDAs.

  • Licensed Intellectual Property Rights means any Intellectual Property Rights owned by a third party that a Person has a right to use, exploit or practice by virtue of a license grant, immunity from Legal Action or otherwise.

  • FLEGT-licensed means production and process methods, also referred to as timber production standards, and in the context of social criteria, contract performance conditions (only), as defined by a bilateral Voluntary Partnership Agreement (VPA) between the European Union and a timber- producing country under the FLEGT scheme, where both Parties have agreed to establish a system under which timber that has been produced in accordance with the relevant laws of the producing country, and other criteria stipulated by the VPA, are licensed for export by the producing country government. This may also include any timber that has been independently verified as meeting all the producing country's requirements for a FLEGT licence, where a VPA has been signed but the FLEGT licensing system is not fully operational. Evidence from a country that has not signed up to a VPA which demonstrates that all of the requirements equivalent to FLEGT-licensed timber have been met will also be acceptable. CPET will produce further guidance on FLEGT-licensed or equivalent timber in due course.

  • Project Approvals means all approvals, consents, waivers, orders, agreements, authorizations, permits and licenses required under Applicable Laws or under the terms of any restriction, covenant, easement or agreement affecting all or any applicable Phase of the Project, or otherwise necessary or desirable for the ownership, acquisition, construction, development, equipping, use or operation of the Project.

  • Sub-Licensee means all person/ agency with whom Licensee has executed sub license agreement as per terms and conditions of license agreement executed between DMRC and the Licensee, for commercial utilization of the Bare Spaces.

  • Third Party License means licenses from third parties governing third party software embedded or used in the Trading Platform.