Additional Formulation definition

Additional Formulation means any formulation of the Wakix Product other than its initial formulation under the LCA, [***], which the Parties may agree from time to Develop under this Agreement.
Additional Formulation means any formulation (other than a Product) directed to the treatment of PH1 using the LNP Technology and the Dicerna Materials necessary or useful to support Dicerna’s preclinical studies and clinical trials that is Manufactured by Protiva.
Additional Formulation means [***]

Examples of Additional Formulation in a sentence

  • COMPOSITION / INFORMATION ON INGREDIENTSChemical Composition Information*for reformulated gasoline Additional Formulation InformationA complex blend of petroleum-derived normal and branched-chain alkane, cycloalkane, alkene, and aromatic hydrocarbons.

  • In the event the Parties cannot agree upon the Clinical Supply Price and the Commercial Supply Price for the Additional Formulation, SAG may use a qualified Back-Up Supplier for the manufacture of the Additional Formulation in accordance with Article 2.14.

  • Notwithstanding Article 2.2, SAG may elect to qualify a back-up supplier ("Back-Up Supplier") reasonably acceptable to RTU for any Authorized Generic, Additional Formulation or the supply of Drug Substance and Drug Product which acceptance shall not be unreasonably withheld, conditioned or delayed in the event that RTU is unable, or determines that it will be unable, to produce Drug Substance or Drug Product in accordance with SAG's Orders or Specifications, Authorized Generic or Additional Formulation.

  • For such purpose, RTU shall grant to such Back-Up Supplier a non-exclusive, royalty-free, license under the patent rights and know-how owned by RTU to manufacture Drug Substance and Drug Product, Authorized Generic or Additional Formulation solely as the Back-Up Supplier pursuant to the terms of this Agreement.

  • Plan and Annual Development Plan and Budget to include such Additional Indication or Additional Formulation.

  • If (i) the Parties are unable to reach agreement on definitive documentation of the license to the new Formulation during such *** period or (ii) the Formulation Exercise Period expires without exercise, the Developing Party shall be under no further obligation to license the Additional Formulation to the Negotiating Party.

  • In such event, the Parties shall (by mutual Party Written Consent or Joint Committee Consent) cause the Long‑Term Development Plan and Annual Development Plan and Budget to be updated to include binding plans with respect to such Additional Indication or Additional Formulation, as applicable.

  • If the JSC agrees to the initiation of a Development program for such an Additional Formulation it shall forthwith constitute a “Product”.

  • Article 1.1. "Additional Formulation" means any and all formulations other than the Initial Formulation.

  • At any time during the Term Ono may submit a written request to Progenics requesting the right to engage in research activities in the Territory with respect to any Additional Formulation.


More Definitions of Additional Formulation

Additional Formulation means any and all formulations other than the Initial Formulation.
Additional Formulation shall have the meaning set forth in Section 2.11(b).

Related to Additional Formulation

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

  • 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;

  • Additional Products means products, services and applications that are not part of the Services but that may be accessible, via the Admin Console or otherwise, for use with the Services.

  • 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.

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

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

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

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • Reagent means any product other than fuel that is stored on-board the vehicle and is provided to the exhaust after-treatment system upon request of the emission control system.

  • 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.

  • Assay means a laboratory analysis of Crude Petroleum to include the following: A.P.I. Gravity, Reid vapor pressure, composition, pour point, water and sediment content, sulfur content, viscosity, distillation, hydrogen sulfide, flash/boiling point and other characteristics as may be required by Carrier.

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

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

  • Manufacturing Process means any process for—

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

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Additional Indication means any indication other than the Initial Indication.

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

  • 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;

  • New Products means 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.

  • Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities.

  • 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.

  • 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.

  • Biological agent shall mean any pathogenic (disease producing) micro-organism(s) and/or biologically produced toxin(s) (including genetically modified organisms and chemically synthesized toxins) which cause illness and/or death in humans, animals or plants.

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

  • Field means all fields of use.