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.
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 Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;
Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:
Finished Product means a cannabis product in its final form to be sold at a retail premises.
Designated Products means products provided by Motorola to Licensee with which or for which the Software and Documentation is licensed for use.
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.
Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities.
Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:
Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.
Bulk drug substance means any substance that is represented for use, and that, when used in the
Manufacturing Process means any process for—
Drug Product means a specific drug in dosage form from a known source of manufacture, whether
Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.
Hemp products means all products made from industrial hemp,
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.
API means the American Petroleum Institute.
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.
Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):
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;
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.
Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.
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;
Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.
Manufacturing Cost means ***
Manufacturing Costs means, with respect to a given AquaBounty Product, the full-time equivalent costs (under a reasonable accounting mechanism to be agreed upon by the Parties) and out-of-pocket costs that AquaBounty or any of its Affiliates incurred in manufacturing such products, including costs and expenses incurred in connection with (a) the development or validation of any manufacturing process, formulations or delivery systems, or improvements to the foregoing; (b) manufacturing scale-up; (c) in-process testing, stability testing and release testing; (d) quality assurance/quality control development; (e) internal and Third Party costs and expenses incurred in connection with qualification and validation of Third Party contract manufacturers, including scale up, process and equipment validation, and initial manufacturing licenses, approvals and inspections; (f) packaging development and final packaging and labeling; (g) shipping configurations and shipping studies; and (h) overseeing the conduct of any of the foregoing. “Manufacturing Costs” shall further include: (i) to the extent that any such AquaBounty Product is manufactured by a Third Party manufacturer, the out-of-pocket costs incurred by AquaBounty or any of its Affiliates to the Third Party for the manufacture and supply (including packaging and labeling) thereof, and any reasonable out-of-pocket costs and direct labor costs incurred by AquaBounty or any of its Affiliates in managing or overseeing the Third Party relationship determined in accordance with the books and records of such Party or its Affiliates maintained in accordance with US GAAP; and (ii) to the extent that any such AquaBounty Product is manufactured by AquaBounty or any of its Affiliates, direct material and direct labor costs attributable to such product, as well as reasonably allocable overhead expenses, determined in accordance with the books and records of AquaBounty or its Affiliates maintained in accordance with US GAAP.