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.
Manufacturing operation means the designing,
Manufacturing Process means any and all processes, methods, procedures and activities (or any step in any process or activity) used or planned to be used by Manufacturer to Manufacture Product, as evidenced in the Batch Documentation or master Batch Documentation.
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.
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.
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;
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.
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.
Manufacturing means the production, preparation, propagation, conversion or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis, and includes any packaging or repackaging of the substances or labeling or relabeling of its container, and the promotion and marketing of such drugs and devices. Manufacturing also includes the preparation and promotion of commercially available products from bulk compounds for resale by pharmacists, practitioners, or other persons.
Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;
Manufacturing site means a location that produces, prepares, propagates, or compounds manufactured medical cannabis or medical cannabis products, directly or indirectly, by extraction methods, independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis, and is owned and operated by a licensee for these activities.
Analytical x-ray system means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.
Investigational Medicinal Product means the study drug or control material as defined in the Protocol.
Product Marketing Materials means all marketing materials used specifically in the marketing or sale of the specified Divestiture Product in the Geographic Territory as of the Closing Date, including, without limitation, all advertising materials, training materials, product data, mailing lists, sales materials (e.g., detailing reports, vendor lists, sales data), marketing information (e.g., competitor information, research data, market intelligence reports, statistical programs (if any) used for marketing and sales research), customer information (including customer net purchase information to be provided on the basis of either dollars and/or units for each month, quarter or year), sales forecasting models, educational materials, and advertising and display materials, speaker lists, promotional and marketing materials, Website content and advertising and display materials, artwork for the production of packaging components, television masters and other similar materials related to the specified Divestiture Product.
Automated drug dispensing system means a mechanical or electronic system that performs
Manufacturing Costs means costs for manufacturing a Compound or Product provided by one Party to the other Party which is (a) manufactured and supplied by a Third Party or (b) manufactured directly by the supplying Party or its Affiliate; in each case to the extent such costs are reasonably allocable to the Compound or Product supplied, and calculated in accordance with the supplying Party’s internal accounting policies and principles, so long as such Party’s calculations are in accordance with GAAP. For costs under clause (a) above, Manufacturing Costs means: (i) the amount paid by a Party or its Affiliates to such a Third Party in connection with the manufacture and supply of such Compound or Product (including expenses related to storage, QA and QC (including testing), shipping, handling, insurance, customs duties or excise taxes), plus (ii) a Party’s FTE costs (measured at the applicable FTE Rate) and other direct out-of-pocket costs recorded as an expense in accordance with its customary accounting practices (so long as the same are consistent with GAAP) in connection with such manufacture and supply, including supply chain management, payments owed to Third Parties on account of Third Party intellectual property licensed to a Party that is used in the course of such manufacture and supply, management of agreements with Third Party manufacturers for such Compound or Product and expenses related to storage, QA and QC (including testing), shipping, handling, insurance, customs duties or excise taxes. For costs under clause (b) above, Manufacturing Costs means the standard cost of goods sold. For purposes of this definition, “standard costs of goods sold” include materials (such as active ingredients, intermediates, semi-finished materials, excipients, primary and secondary packaging), and conversion costs (such as direct labor, equipment costs and quality testing), and an allocation of general site and manufacturing support costs (including an appropriate allocation of utilities, maintenance, engineering, safety, human resources, finance, plant management and other similar activities and including capital improvements in the form of depreciation, other equipment costs (where such costs are expensed by a Party in accordance with its customary practices)), customs duties or excise taxes, and sales taxes incurred on purchased Product; provided, however, that no allocation shall be made for unused plant capacity. All components of Manufacturing Costs shall be allocated on a basis consistent with its customary cost accounting practices applied by the Party to the other products it produces.
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;
Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:
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.
Clinical Development means the conduct of studies of the Product in humans in the Field to assess the dosing, safety and/or efficacy of the Product, including but not limited to Xxxxx 0 Clinical Trials, Phase 2 Clinical Trials and Phase 3 Clinical Trials, or as required by the applicable Regulatory Authority.
Commercialization means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Product, including activities related to marketing, promoting, distributing, and importing such Product, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization, and “Commercialized” has a corresponding meaning.
Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.
scientific research means any activities in the fields of natural or applied science for the extension of knowledge.
Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.
Manufacturing Cost means fully burdened internal and external costs of developing and manufacturing a Licensed Product, excluding the Active Pharmaceutical Ingredient in a Licensed Product (as this will be supplied by Novo Nordisk to Zosano free-of-charge), consisting of the following: [**] and shall exclude (i) costs and charges related to or occasioned by unused manufacturing capacity not otherwise committed to Licensed Product; (ii) the manufacture of other products at Zosano’s facilities; (iii) amortization of property, plant or equipment not specifically related to the development or manufacturing of Licensed Product, and (iv) allocation of general corporate overhead; and (b) with regard to external costs and charges these shall include the actual invoiced costs and charges of suppliers of goods and services directly related to the manufacture and shipment of Licensed Product. Manufacturing Cost shall be determined on an accrual basis in accordance with GAAP, applied on a basis consistent in the annual audited financial statements.