Current Formulation definition

Current Formulation means the [***] and any other formulation of a Licensed Product used for any clinical or non-clinical study set forth on Schedule 1.44.
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Current Formulation means the approved formulations of Cimzia® (including the formulations for lyophilized vials, pre-filled syringes and the autoinjector) existing as of the Effective Date, each as described in the relevant approved BLAs existing as of the Effective Date.
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Current Formulation means Valrubicin at a concentration of 40 mg/ml in 50% Cremophor(R) EL (polyoxyethyleneglycol triricinoleate)/ 50% dehydrated alcohol or other formulations that are accepted by the FDA without the regulatory requirement for a formal clinical study to be submitted in support of such change in formulation.
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Examples of Current Formulation in a sentence

  • Plaintiff alleges that the Current Formulation infringes on Plaintiff’s patent, United States Patent No. 5,665,152.Plaintiff sues SMN and Mars for patent infringement and misappropriation of trade secrets.

  • Otsuka will have the right to elect whether Perception (through its CMO(s)) Manufactures and supplies API or Clinical Samples and whether any such Clinical Samples will be supplied in the form of bulk vials of Product in the Current Formulation (without labeling) or finished Product in the Current Formulation.

  • The Parties will use good faith efforts to implement any such assignments requested by Otsuka in accordance with such schedule in order for Otsuka to procure Clinical Samples in the Current Formulation directly from such CMO(s).

  • See also: “Access to medicines and IPR: UNITAID moving towards a Patent Pool?” UNITAID Second Consultative Forum (Dakar, Senegal, 6 December 2008) Jorge Bermudez Executive-Secretary, UNITAID: http://www.unitaid.eu/images/test/2e_cf_unitaid_unitaid%20jb_patent%20pool_61208.pdf.50 Current formulation of criteria – (A/HRC/8/WG..2/TF/2, 31 January 2008, Annex 2) Table 1: Application of Current Formulation of Right to Development Criteria to TDR and TGF Structural/Institutional Framework Outcome/Obligations 80.

  • LEVINE C./KOHLBERG L./HEWER A., The Current Formulation of Kohlberg’s Theory and a Response to Critics, vol.

  • This Can Be Considered the Current Formulation of the Laws of Software Evolution.

  • The initial Development Plan for the Current Formulation shall be submitted by Otsuka to the JCC for approval in accordance with Section 3.1.7 within [***] after the Effective Date.

  • See also: “Access to medicines and IPR: UNITAID moving towards a Patent Pool?” UNITAID Second Consultative Forum (Dakar, Senegal, 6 December 2008) Jorge Bermudez Executive-Secretary, UNITAID: http://www.unitaid.eu/images/test/2e_cf_unitaid_unitaid%20jb_patent%20pool_61208.pdf.48 Current formulation of criteria – (A/HRC/8/WG..2/TF/2, 31 January 2008, Annex 2)Table 1: Application of Current Formulation of Right to Development Criteria to TDR and TGF Structural/Institutional Framework Outcome/Obligations 80.


More Definitions of Current Formulation

Current Formulation means the formulation of nimodipine microspheres, including the drug substance, biodegradable polymer as described further in the table below: Quantities Based upon Batch Sizes of: Weight Ingredient [**] [**] (%) [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**]
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Current Formulation means any intravenous formulation of a Product for infusion existing as of the Effective Date.
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Current Formulation means REDACTED (y) "CTA" means Clinical Trial Application in Canada. (z) "Development" means, in respect of each country in the Territory, work conducted under the Development Plan and as set out in Section 2.3 for the Indication up to the issuance of an Approval Letter in each such country for a Product in the Field. (aa) "Development Costs" means REDACTED (bb) "Development Plan" means the detailed plan(s) related to the research and the development (including work to obtain Governmental Approvals, including Marketing Authorizations), for RSD1235 in its Current Formulation for the Indication in the Field in the Territory, including the Phase III Studies and all supporting pre-clinical work, chemistry and manufacturing necessary to conduct the Phase III Studies, the technical transfer and manufacturing scale up and approval of a commercial manufacturing process, and to secure NDA Approval and the budget therefor as amended from time to time by the JDMC pursuant to which the Parties shall conduct the Development under the terms of this Agreement. The Development Plan for the United States and Canada is attached hereto as Exhibit 1.1(bb). (cc) "Effective Date" means the date whereupon all the requirements of Sections 15.1(a), 15.1(b), 15.1(c) and 15.1(d) have been met, provided that neither Party has terminated this Agreement prior to such requirements being met pursuant to Section 15.3. (dd) "Executive Summary" shall mean a report containing the information related to a Phase III Study that is described in Exhibit 1.1(dd). (ee) "FDA" means the United States Food and Drug Administration in the United States and any other comparable, applicable administrative agency in any other country in the Territory, or any successor entity thereto. (ff) "FHI Know How" means REDACTED
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Current Formulation means [REDACTED: formulation of Product as of October, 2003]
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Related to Current Formulation

  • Formulation means the combination of various ingredients designed to render the product useful and effective for the purpose claimed, or the form of pesticide as purchased by users;

  • 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.

  • Certified components means components of X-ray systems which are subject to regulations promulgated under Public Law 90-602, the “Radiation Control for Health and Safety Act of 1968,” the Food and Drug Administration.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Combination Products means COBI Combination Products, EVG Combination Products, TDF Combination Products, TAF Combination Products and Quad Product.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Blood component means that part of blood separated by physical or mechanical means.

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Manufacturing Process means any process for—

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Dose is a generic term that means absorbed dose, dose equivalent, effective dose equivalent, committed dose equivalent, committed effective dose equivalent, total organ dose equivalent, or total effective dose equivalent. For purposes of these regulations, "radiation dose" is an equivalent term.

  • 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;

  • ingredient means any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form;

  • Interchangeable biological product means a biological product that the federal Food and Drug Administration has:

  • 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.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.

  • 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.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.

  • API means the American Petroleum Institute.

  • 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.

  • Development Plan has the meaning set forth in Section 3.2.

  • Semi-annual (2/Year) sampling frequency means the sampling shall be done during the months of June and December, unless specifically identified otherwise.