Future Indication definition

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 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

  • 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).

  • 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.

  • 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.

  • 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.

  • XOMA will waive its right to Opt Back In under this Section 7.4(b) with respect to a particular Product in a particular Future Indication if it fails to timely provide the written notice of such intent or timely tender the fee for such Future Indication, each as provided herein.

  • 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.

  • The costs thereof (including any damages, costs or expenses resulting from any action) shall be shared 70 (Alexion)/30 (XOMA) between the Parties (unless such allegations relate only to a particular Product in a particular Future Indication as to which one Party has Opted Out and not Opted Back In, in which case all such costs shall be borne by the other Party).

  • Notwithstanding the foregoing, data generated by any clinical trials of Product shall be owned by Alexion; provided that XOMA shall be granted access rights to, and a license for such uses as may be reasonably necessary for the Development and Commercialization of any Product in a Future Indication as to which Alexion has Opted Out and not Opted Back In with respect to, such data, without any additional payment by XOMA.

  • Upon expiration of this Agreement pursuant to Section 13.1, provided that Alexion has at the time of expiration completed a Phase II Study for a Product in any Future Indication which XOMA has not Opted Back In to prior to such expiration, Alexion shall have an exclusive (even as to XOMA), sublicensable license under the XOMA Technology to use, develop, make, have made, sell, have sold, offer for sale, import and export Products only for such Future Indication(s) in the Territory.

  • Subject to Section 7.2, in the event the Development Committee or the JMC cannot reach consensus regarding a proposed Future Indication, the Party whose representatives oppose such proposal shall be deemed to have Opted Out of such Future Indication.


More Definitions of Future Indication

Future Indication means an Indication other than a Current Indication.
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Future Indication means any use of a Product for the treatment,
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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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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 use of a Product for the treatment of opioid addiction.

  • 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 biological and drug candidate, compound or other device or product being developed, labeled, manufactured, marketed, sold and/or distributed by the Company or a Company Subsidiary, or regarding which the Company or a Company has rights, and including any such biological and drug candidate, compound or product that has received Marketing Approval.

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

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

  • 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.

  • 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 an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

  • 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 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 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 [***].

  • 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 has the meaning set forth in Section 7.2.1.

  • 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 Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • 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.

Most Referenced Clauses

Most Referenced Definitions