Medical Affairs Materials definition

Medical Affairs Materials means the Medical Affairs Content, Regulatory Filings relating to Medical Affairs Content, training program and related materials contemplated by paragraph 5.4.4, and prepared scientific and medical information responses for use in responding to medical questions or inquiries from members of the medical profession contemplated by Section 5.14.
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Medical Affairs Materials is defined in Section 4.4.3.
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Medical Affairs Materials. Each Party may use any of the Medical Affairs Material in connection with the Medical Affairs Program activities under this Section 4, provided such use is in compliance with the terms of this Agreement and the Medical Affairs Program Plan or is otherwise approved by the Joint Clearance Committee. If Optimer elects to use any Medical Affairs Material created by Cubist under Section 4.4.2, Optimer shall reimburse Cubist for its reasonable, documented, out-of-pocket cost of producing or obtaining and providing such Medical Affairs Material for the Optimer Medical Affairs Force. Except as provided in Section 5.3.1, the Parties shall not use any materials in conducting Medical Affairs Program activities other than the Medical Affairs Materials approved by the Joint Clearance Committee.
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Examples of Medical Affairs Materials in a sentence

  • Without limiting the foregoing, Cubist shall have no right to include the Product Trademarks or the Optimer House Marks on business cards, stationery, trade show announcements and similar materials of Cubist and its Affiliates, and Cubist shall only be entitled to use approved Sales Program Materials and approved Medical Affairs Materials bearing the Product Trademarks (and, if approved by Optimer, the Optimer House Marks), without co-branding with any Cubist Trademarks, in connection with the Program.

  • Neither Party shall use any materials other than the Medical Affairs Materials that have undergone GSK’s internal review and approval process for use in connection with the conduct of Medical Affairs activities related to the Licensed Products under this Agreement; provided that, ITEOS will not be required to use any Medical Affairs Materials that ITEOS’s compliance team has not also approved.

  • GSK will be solely responsible for legal and regulatory review of such Medical Affairs Materials through its normal internal review process, and submission of Medical Affairs Content to applicable Regulatory Authorities for comments or approval as required.

  • GSK shall be responsible for providing and shipping to ITEOS all Medical Affairs Materials in quantities necessary for ITEOS to perform its activities under the Joint Commercialization Plan.

  • The Lead Party shall be responsible for providing and shipping to the other Party all Medical Affairs Materials in quantities necessary for such Party to perform its activities under the U.S. Commercialization Plan.

  • All such Medical Affairs Materials will be submitted to the MLR Working Group for review and approval, and such MLR Working Group will serve as the review and approval committee for all Medical Affairs Materials to be used by either Party in the U.S. following the GSK Medical Affairs procedural processes for approval of such materials.

  • GSK shall own all rights, title and interests in and to any and all such Medical Affairs Materials.

  • GSK shall prepare and produce all Medical Affairs Materials for the Licensed Products in the Territory in accordance with the Global Strategic Launch Plan and the Joint Commercialization Plan, which Medical Affairs Materials GSK will share with ITEOS for ITEOS’s review and comment, which comments GSK will consider in good faith.

  • Except as provided in Section 5.3.1, the Parties shall not use any materials in conducting Medical Affairs Program activities other than the Medical Affairs Materials approved by the Joint Clearance Committee.

  • The workbench provides a means of performing augmentation tasks in which a Micro-scene may be registered with the physical workbench and objects placed on the bench, while the room provides a container for an expansive virtual environment which may be many times larger than the physical expansion of the room.

Related to Medical Affairs Materials

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • 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.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • 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.

  • Development Activities means those activities which are normally undertaken for the development, construction, repair, renovation, rehabilitation or conversion of buildings for residential purposes, including the acquisition of property;

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • 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.

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • 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.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • 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.

  • Study Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study, but excluding the Institution’s ordinary patient records.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Development Activity means any activity defined as Development which will necessitate a Floodplain Development Permit. This includes buildings, structures, and non-structural items, including (but not limited to) fill, bulkheads, piers, pools, docks, landings, ramps, and erosion control/stabilization measures.

  • Medical cannabis pharmacy means the same as that term is defined in Section 26-61a-102.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Medical cannabis means the same as that term is defined in Section 26-61a-102.

  • 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.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Research Use shall have the meaning given in Section 2.2.2 of this Agreement.

  • 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.