Product Information has the meaning specified in Section 10.12(a).
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.
Product means any deliverable under the Contract, which may include commodities, services, technology or software.
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.
Diagnostic Product means an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.
Proprietary product means a manufactured component or other product that is produced by a private person. It may be protected by patent, trademark or copyright.
Licensed Information means any information concerning the Licensed Program, which is owned by the Licensor and is licensed to the Licensee together with the Licensed Program. Licensed Information includes such information as input form, user manual, interface format and input/output format and is delivered to and used by the Licensee as confidential information or proprietary property of the Licensor.
Technical Information means technical data or computer software, as those terms are defined in the clause at DFARS 252.227-7013, Rights in Technical Data-Non Commercial Items, regardless of whether or not the clause is incorporated in this solicitation or contract. Examples of technical information include research and engineering data, engineering drawings, and associated lists, specifications, standards, process sheets, manuals, technical reports, technical orders, catalog-item identifications, data sets, studies and analyses and related information, and computer software executable code and source code.
Controlled technical information means technical information with military or space application that is subject to controls on the access, use, reproduction, modification, performance, display, release, disclosure, or dissemination. Controlled technical information would meet the criteria, if disseminated, for distribution statements B through F using the criteria set forth in DoD Instruction 5230.24, Distribution Statements on Technical Documents. The term does not include information that is lawfully publicly available without restrictions.
Reference biological product means the single biological product licensed pursuant to 42 U.S.C.
Regulatory Materials means any regulatory application, submission, notification, communication, correspondence, registration and other filings made to, received from or otherwise conducted with a Regulatory Authority in connection with the Development, manufacture, marketing, sale or other Commercialization of a Product in the Field in a particular country or jurisdiction. “Regulatory Materials” includes any IND, Marketing Approval Application and Regulatory Approval.
Commercialized shall have corresponding meanings.
complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.
Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.
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.
Biological Materials means certain tangible biological materials that are necessary for the effective exercise of the Patent Rights, which materials are described on Exhibit A, as well as tangible materials that are routinely produced through use of the original materials, including, for example, any progeny derived from a cell line, monoclonal antibodies produced by hybridoma cells, DNA or RNA replicated from isolated DNA or RNA, recombinant proteins produced through use of isolated DNA or RNA, and substances routinely purified from a source material included in the original materials (such as recombinant proteins isolated from a cell extract or supernatant by non-proprietary affinity purification methods). These Biological Materials shall be listed on Exhibit A, which will be periodically amended to include any additional Biological Materials that Medical School may furnish to Company.
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.
Manufactured end product means any end product in product and service codes (PSCs) 1000-9999, except—
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:
Licensed Know-How means all Know-How that (a) is Controlled by Pfizer or any of its Affiliates as of the effective date of the Pfizer-MPP Agreement, (b) directly relates to the use of the Compound, Product or Licensed Product in the Field, and (c) is not in the public domain or otherwise generally known. For the avoidance of doubt, (i) Licensed Know-How shall not include any Know-How to the extent solely and directly related to any other Pfizer compound or to the extent related to the use of the Compound, Product or Licensed Product outside the Field and (ii) Licensed Know-How includes only that Know-How, designated by Pfizer in its sole discretion, necessary for the manufacture, registration and commercialization of the Compound and/or Licensed Product for use in the Field. For the avoidance of doubt, Licensed Know-How excludes any Know-How related to ritonavir that has been (either as of the Effective Date or at any time during the term of this Agreement) in-licensed by Pfizer from any Third Party.
Biological Material means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system;
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;
Medical information means any information about a consumer's medical or mental health treatment or diagnosis by a health care professional.