A contract facility that is engaged in significant manufacturing is not required to be separately licensed, as is the case in a Shared Manufacturing Arrangement.
DIAGAST purchases these IVSs from Merck-Millipore under a Shared Manufacturing Arrangement.
The In Vitro Substance (IVS) is purchased from (b) (4) under a Shared Manufacturing Arrangement.
Manufacturing Agreement has the meaning set forth in Section 4.3.
Collaborative pharmacy practice agreement means a written and signed
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 and Supply Agreement means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C.
Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:
Clinical Supply Agreement has the meaning set forth in Section 4.2.
Supply Agreement has the meaning set forth in Section 7.1.
Commercial Supply Agreement has the meaning set forth in Section 5.2.
Quality Agreement has the meaning set forth in Section 9.6.
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.
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.
Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:
Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):
Third Party Manufacturer means any person, firm or company which carries out the reproduction of Work and/or manufactures and/or prints the Licensed Publication on behalf of the Licensee;
Quality Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.3 of Exhibit B to the ITP.
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;
Supply Agreements has the meaning set forth in Section 7.1.
Manufacturing Process means any process for—
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.
Fully Burdened Manufacturing Cost means, with respect to any Licensed Product supplied by or on behalf of NVCR to Zai hereunder if such Licensed Product (or any precursor or intermediate thereof) is manufactured by a Third Party manufacturer [***].
Collaborative practice agreement means a written agreement
Technical Services Agreement means the Technical Services Agreement between Sabine Pass Liquefaction, LLC and Contractor, dated May 3, 2013 and any amendments thereto.
Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;
Supply contract means a contract under which a lessor buys or leases goods to be leased.
Collaborative pharmacy practice means a practice of pharmacy whereby one or
Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.