Product Transition definition

Product Transition means Sanquin’s cessation of the sale and marketing of the Cetor and Cebitor products and initiation of the sale and marketing, directly or through distributors, as applicable, of the ViroPharma Product, on and around the Transition Trigger Date, with the cooperation of ViroPharma and all in accordance with Applicable Law and the provisions of this Agreement.

Examples of Product Transition in a sentence

  • For example, the System Engineering Technical Processes (as defined by NPR 7123.1 Systems Engineering Processes and Requirements and the SP-2007-6105 Systems Engineering Handbook), list:• Requirements Design• Technical Solution Definition• Technical Planning• Technical Control• Technical Assessment• Technical Decision Analysis• Product Transition • Evaluation• Design Realization Some of these engineering phases are programmatic in nature and may provide (relatively) more information than data.

  • At the reasonable written request of Myovant for any Additional Transition Services for the transfer of documentation, information and other materials reasonably available and necessary for the Manufacture of Drug Product, further, the Parties shall negotiate in good-faith, and may (as for Takeda, in any event, shall not be obligated to) enter into a subsequent transition plan therefor (the “Drug Product Transition Plan”).

  • The Drug Product Transition Plan so entered shall set forth the timelines, obligations, deliverables and other duties of each Party with respect to the transfer of Takeda Materials reasonably available and necessary for the Manufacture of Drug Product.

  • These factors are divided into 3 main groups, namely: Product Transition, Product Revision and Product Operation.

  • Amgen shall transition the regulatory activities related to the Products pursuant to the Initial Product Transition Services Schedule or a transition plan and timeline agreed at the JAC within thirty (30) days following the Effective Date, as applicable.

  • In any event, Supplier shall use all its reasonable efforts to make available in response to requests for support and advice for Product Transition the current Supplier employee who has particular knowledge of the Product or process.

  • Amgen shall (i) transition the mutually agreed upon Development activities with respect to each Product pursuant to the Initial Product Transition Services Schedule or a transition plan and timeline agreed upon by the JAC within thirty (30) days following the Effective Date, as applicable, and (ii) no later than thirty (30) days following the Effective Date, provide to the JSC an initial Global Development Plan and Global Development Budget for each of the Products.

  • For the avoidance of doubt, [*] from Amgen to BeiGene pursuant to Section 3.1.1 (Transition and Development of Products) and Section 5.1.2(b) (Initial In-Line Product Transition).

  • Within thirty (30) days of successfully achieving the following milestones for a Licensed Product, Transition will make the following non-refundable payments to Lilly.

  • Pursuant to Section 3.3, if a Product Transition occurs, then this Section 7.1 shall be replaced in total and for the remainder of the Delivery Term by the alternate Section 7.1 provided in Appendix IX.

Related to Product Transition

  • Product Candidate means each biological and drug candidate, compound or other device or product being developed, labeled, manufactured, marketed, sold and/or distributed by the Company or a Company Subsidiary, or regarding which the Company or a Company has rights, and including any such biological and drug candidate, compound or product that has received Marketing Approval.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • 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.

  • 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.

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • Product Trademark means (a) any trademark or trade name, whether or not registered, or any trademark application, renewal, extension or modification thereto, in the Territory, or any trade dress and packaging, that is applied to or used with Products by Xxxxxx and (b) all goodwill associated therewith, and any promotional materials relating thereto.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Development Activities means those Development activities undertaken by or on behalf of a Party or its Affiliates with respect to the Product in the Field.

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Development Program means the implementation of the development plan.

  • Commercialization Costs means the out-of-pocket costs and expenses incurred by Adapt or its Affiliates directly attributable to, or reasonably allocable to, the Commercialization of a Product. Commercialization Costs for a Product shall include, preparation of promotional, advertising, communication, medical, and educational materials relating to the Product and other Product literature and selling materials, activities directed to marketing of the Product, including purchase of market data, development and conduct of market research, advertising, public relations, public affairs and other communications with Third Parties regarding the Product; development and conduct of sales force training (including materials, programs and travel to and attendance at training programs) for medical representatives responsible for promoting the Product; and development and maintenance of sales bulletins, call reporting and other monitoring/tracking, sales force targeting, validation and alignment programs and documentation.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • Product Trademarks means the Trademark(s) to be used by AbbVie or its Affiliates or its or their respective Sublicensees for the Development or Commercialization of Licensed Products in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (excluding, in any event, any trademarks, service marks, names or logos that include any corporate name or logo of the Parties or their Affiliates).

  • licensed activities means things authorised to be done by the licence

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Development Milestone is defined in Section 5.3.

  • Competing Product means [***].

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Product Terms means the document that provides information about Products available under this Agreement. The Product Terms document is published on the Licensing Site and is updated from time to time.