Other Formulation definition

Other Formulation means any and all formulations of Collaboration Compound(s) other than the Initial Formulation.
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Other Formulation means (i) any formulation [ * ] other than the Current Product and the Current Pediatric Product, or (ii) any [ * ] is [ * ] to or [ * ] a [ * ] (which is the [ * ] that is [ * ] is administered in [ * ]. Other Formulations shall include without limitation [ * ] of the [ * ] formulation [ * ].
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Other Formulation means a formulation of a Licensed Product other than an Oral Formulation, Injectable Formulation, Inhaled Formulation or Topical Formulation.
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Examples of Other Formulation in a sentence

  • In the event that either Party proposes to Develop in the Shared Territory (a) a Collaboration Product for the Second Indication or Other Indication, within the Field (a “Label Expansion”) or (b) an Other Formulation for an indication within the Field, such Party shall make a written proposal to the JDC for the Development thereof, including a proposed work plan, budget and timeline (the “JDC Proposal Notice”).

  • Such Other Formulation and/or Other Indication shall not be included in the licenses granted to GSK in Section 7.1 or 7.3 or otherwise be available to GSK except to the extent provided in this Section 3.5.

  • Subject to the procedures set forth in this Section 3.5 to permit GSK to expand the licenses granted to it pursuant to Sections 7.1 and 7.3 to include Other Formulations and Other Indications, Gilead may at any time in its sole discretion (i) develop anywhere in the world, and Commercialize in the Gilead Territory, an Other Formulation for any indication, or (ii) develop anywhere in the world (subject to Section 3.8) and Commercialize in the Gilead Territory a Licensed Product for an Other Indication.

  • GSK shall not file any IND or Marketing Authorization Application for (i) any Other Formulation that is not a Licensed Product for any indication, or (ii) any Licensed Product for an indication that is not a Licensed Indication.

  • GSK shall not develop any Other Formulation or conduct any clinical trials of any Licensed Product for any Other Indication without the prior approval of the Joint Committee.

  • If Gilead [ * ] for (i) an Other Formulation for any indication, or (ii) a Licensed Product for an Other Indication, then Gilead shall so notify GSK.

  • Gilead shall notify GSK when it [ * ] of (i) an Other Formulation for any indication, or (ii) a Licensed Product for an Other Indication.

  • In accordance with Section 3.5(c), prior to any Other Formulation becoming a Licensed Product hereunder, the Parties shall execute a written agreement relating to its supply as further described in such Section.

  • If the Joint Committee is unable to reach consensus to approve GSK's development of any such Other Formulation as a Licensed Product or Other Indication as a Licensed Indication, then GSK shall not conduct such development; [ * ] .

  • Restrict Aerial Application to Liquid Formulations Only / Prohibit Aerial Application of All Other Formulation Types To address potential mixer/loader risks associated with DF/WDG and WSP formulations for aerial application to corn, sorghum, conservation reserve programs, winter weed control, guava, sod, fallow and sugarcane, the EPA is proposing to restrict aerial application to liquid formulations across all registered uses.


More Definitions of Other Formulation

Other Formulation means a formulation of a Licensed Product other than an Oral Formulation, Injectable Formulation, Inhaled Formulation or Topical Formulation. 1.46 “Person” means a natural person, a corporation, a partnership, a trust, a joint venture, a limited liability company, any governmental authority, or any other entity or organization. 1.47 “Phase 1 Clinical Trial” means the first lawful study in humans, conducted in accordance with 21 C.F.R. § 312.21(a) (or the equivalent laws and regulations in jurisdictions outside the United States), of the safety, metabolism and pharmacologic actions of a pharmaceutical or biologic product. 1.48 “Phase 3 Clinical Trial” means a clinical trial conducted in accordance with 21 C.F.R. § 312.21(b) (or the equivalent laws and regulations in jurisdictions outside the United States), of appropriate size and designed to evaluate the effectiveness of the product for a particular indication and to determine the common short-term side effects and risks associated with the product. 1.49 “PLA2” means any member of the phospholipase A2 family including the known forms of all species and any new forms of the enzyme that share the structural and enzymatic properties of this class.
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Related to Other 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;

  • 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.

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

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • 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.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

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

  • Licensed Compound means a TAK-385 Licensed Compound or a TAK-448 Licensed Compound.

  • 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;

  • Feed ingredient means each of the constituent materials making up a commercial feed.

  • Manufacturing Process means any process for—

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • 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;

  • Competing Products means any product or service in existence or under development that competes with any product or service of the Company Group about which the Participant obtained Confidential Information or for which the Participant provided advisory services or had sales, origination, marketing, production, distribution, research or development responsibilities in the last twenty-four (24) months of employment with the Company Group.

  • Products means information resources technologies that are, or are related to, EIR.

  • Competing Product means [***].

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • New Products means any product which is not an Enhanced Product or Existing Product but which is substantially similar to an of this Agreement, "New Product" or "New Products" shall mean any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • Nicotine product means the same as that term is defined in Section 76-10-101.

  • 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.