Future Indication definition

Future Indication means an indication with respect to which no IND has previously been filed by either Party for a Product, and as to which a new IND will be required to be filed, to initiate human clinical trials of a Product therein.
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Future Indication means any use of a Product for the treatment, prophylaxis or diagnosis of any human or animal illness, sickness, interruption, cessation or disorder of a particular bodily function, system or organ except chemotherapy-induced thrombocytopenia; provided that for purposes of this definition, an individual “Future Indication” shall mean an indication with respect to which no IND has previously been filed by either Party for a Product, and as to which a new IND will be required to be filed, to initiate human clinical trials of a Product therein.
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Future Indication means an indication for a Product in the Licensed Field which has not obtained Regulatory Approval in a given country in the Territory as of the Effective Date. For the sake of clarity, and by way of example only, if a Product has obtained Regulatory Approval for a certain indication in Canada, but not in the United States, as of the Effective Date, then such indication is a Future Indication with respect to the United States.
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Examples of Future Indication in a sentence

  • The JMC shall review and evaluate such proposals and make a recommendation as to whether or not to pursue such Product in such Future Indication as proposed.

  • If Alexion does not commence any such action within ninety (90) days after notice of such infringement, then XOMA will (unless such Joint Patent Rights relate only to a particular Product in a particular Future Indication as to which XOMA has Opted Out and not Opted Back In) have the right to either initiate and prosecute such action or to control the defense of such declaratory judgment action.

  • Following completion of each successful Phase II Study for such Product in such Future Indication, XOMA shall provide Alexion with written notice of such completion and enclose a copy of a summary analysis performed in accordance with the pre-specified statistical analysis plan filed with the FDA.

  • In the alternative, Alexion may permit XOMA to conduct a Phase II Study for a proposed Future Indication at XOMA’s sole cost and risk but Alexion shall have the right, in its sole discretion, to exercise its Right of Prohibition after completion of each such Phase II Study.

  • With respect to any particular Product in a particular Future Indication, the Continuing Party will reimburse all of the Opted Out Party’s reasonable costs associated with compliance with this Section 7.8.

  • The costs and expenses of such recall or removal in each country, including expenses and other costs or obligations to Third Parties, the cost and expense of notifying customers and costs and expenses associated with shipment of the recalled Product from a customer to either Alexion or XOMA shall be included in Commercialization Expenses; except as to any Product in a Future Indication as to which one Party has Opted Out and not Opted Back In, in which case the other Party shall bear such costs.

  • If such infringement relates to the Joint Patent Rights, Alexion shall (unless such Joint Patent Rights relate only to a particular Product in a particular Future Indication as to which Alexion has Opted Out and not Opted Back In) have the first right, at its own cost and expense and in its sole discretion, to initiate, prosecute and control such legal action, or to control the defense of any declaratory judgment action for non-infringement relating thereto, including the right to settle any such action.

  • Appropriate provision shall be made so that the Continuing Party shall have the benefit of, but also all responsibility for (including without limitation with respect to the payment of royalties and other amounts due under), any third party licenses relating to such Product in such Future Indication.

  • Alexion will have final approval of all study objectives, primary study endpoints and success criteria for all studies relating to any Future Indication.

  • Alexion will (unless such allegations relate only to a particular Product in a particular Future Indication as to which Alexion has Opted Out and not Opted Back In) have the right to control any defense, using counsel selected by it with the consent of XOMA (which consent shall not be unreasonably withheld).


More Definitions of Future Indication

Future Indication means any use of a Product for the treatment, prophylaxis or diagnosis of any human or animal illness, sickness, interruption, cessation or disorder of a particular bodily function, system or organ except chemotherapy-induced thrombocytopenia; provided that for purposes of this definition, an individual "Future Indication" shall mean an indication with respect to which no IND has previously been filed by either Party for a Product, and as to which a new IND will be required to be filed, to initiate human clinical trials of a Product therein.
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Future Indication means an Indication other than a Current Indication.
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Future Indication means an Indication of the Product for the treatment of *** any other specific disease or condition in the Field to which the Parties mutually agree in writing. Confidential information omitted and filed with the Securities and Exchange Commission. Asterisks denote such omission.
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Future Indication means any use of a Product for the treatment,
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Related to Future Indication

  • First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.

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

  • Second Indication means [***].

  • Initial Indication means the treatment of Netherton Syndrome in humans in the Territory.

  • geographical indication , in relation to goods, means an indication which identifies such goods as agricultural goods, natural goods or manufactured goods as originating, or manufactured in the territory of a country, or a region or locality in that territory, where a given quality, reputation or other characteristic of such goods is essentially attributable to its geographical origin and in case where such goods are manufactured goods one of the activities of either the production or of processing or preparation of the goods concerned takes place in such territory, region or locality, as the case may be.

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • Indication means any disease or condition, or sign or symptom of a disease or condition.

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

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

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."

  • inherited metabolic disease means a disease caused by an inherited abnormality of body chemistry for which testing is mandated by law;

  • 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.

  • 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.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • Licensed Field means all fields of use.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Development Milestone Event shall have the meaning set forth in Section 9.2(a).

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

  • Phase III Trial means a human Clinical Trial of the Licensed Product, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use; (b) to define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) consistent with 21 CFR § 312.21(c).

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.