Product Work Plan definition

Product Work Plan means, with respect to a Product, the Product-specific plan, developed by the applicable Sub-Committee and approved by the JSC, outlining the Development, Manufacturing and Commercialization (including the pursuit of Regulatory Approval) of such Product in the Territory, including a Commercialization Plan developed by Mylan and reviewed (but not approved, except for the [***]) by the JSC and other information as provided in Section 2.1(b).
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Product Work Plan means, with respect to a Product, the Development Plan together with the Commercialization Plan.
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Examples of Product Work Plan in a sentence

  • All such Development Activities shall be conducted in accordance with this Agreement, the applicable Product Work Plan and Applicable Law.

  • Each Party shall promptly notify the other Party if the notifying Party reasonably determines that it is likely to otherwise exceed its allocated Development Expenses or Commercialization Expenses under an applicable Product Work Plan, and such excess expenses shall be treated as follows.

  • Momenta is authorized to perform the Development Activities (“Initial Development Activities”) and incur the Development Expenses associated therewith, in each case as set forth in Exhibit 2.1(a)(1) hereto, following the Effective Date and prior to the time the initial Product Work Plan is approved.

  • Each Party shall report the Shared Other Expenses and Development Expenses incurred by it in comparison to the Product Work Plan.

  • Each Party will report on Development Activities undertaken by it in performance of the Product Work Plan.

  • Each Party will report on Manufacturing Activities undertaken by or on behalf of it in performance of the Product Work Plan.

  • For clarity, the Product Work Plan for a Product will not include Commercialization Activities until the first Commercialization Plan for such Product is provided pursuant to Section 2.1(c) below.

  • All such Commercialization Activities shall be conducted in accordance with this Agreement, the applicable Product Work Plan and Applicable Law.

  • The Operational Management Team (OMT) will include one person from each partner (e.g. WP leader, Task leader, operational staff) to monitor and control the actual technical work of the work packages.

  • The Parties shall share all Commercialization Expenses for Commercialization Activities that are incurred by the Parties in accordance with each Product Work Plan, according to the Profit Share Percentage.

Related to Product Work Plan

  • Manufacturing Process means any process for—

  • Work Plan means a plan that describes each individual activity to be conducted to complete eligible activities and the associated costs of each individual activity.

  • Project Plan means the document to be developed by the Contractor and approved by WTL, based on the requirements of the Contract and the Preliminary Project Plan included in the Contractor’s bid. For the sake of clarity, the Agreed and Finalized Project Plan” refers to the version of the Project Plan submitted by the contractor after receiving the letter of Award and the same approved by WTL. The project plan may be changed/ modified during the course of the project. Should the Project Plan conflict with the provisions of the Contract in any way, the relevant provisions of the Contract, including any amendments, shall prevail.

  • Development Plan has the meaning set forth in Section 3.2.

  • 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.

  • Product Schedule means a product schedule documenting the specific terms and conditions applying to a Product as may be amended, updated or replaced from time to time (and includes any Electronic Platform Schedules);

  • Development Work means all work and services necessary or desirable in connection

  • 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.

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Research Plan shall have the meaning set forth in Section 2.1.

  • Work Order means an individually negotiated document that is executed by both Parties and which authorizes a Project, if any, in an indefinite quantity Contract.

  • Product Specification means the document referred to in:

  • Scope of Works means the sections of the RFQ detailing the technical requirements of the work to be carried out as existing at the Date of Acceptance of the Quotation and any modification of such Works thereafter directed or the use of which has been permitted by the Superintendent for the purposes of the Contract.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • The Work Order means the order placed by the Purchaser on the Supplier signed by the Purchaser including all attachments and appendices thereto and all documents incorporated by reference therein. The Work order shall be deemed as "Contract" appearing in the document.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Manufacturing Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • 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.

  • Scope of Work means the description of Services and Deliverables specified in the Contract and as may be amended.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • Development Program means the implementation of the development plan.