Independent Indication definition

Independent Indication means, with respect to a particular Collaboration Product, any Indication for which a Party has exercised its opt-out right pursuant to Section 4.1 and shall include all Opt Out Indications, provided that such Party has not exercised its opt-in right for such Indication pursuant to Section 4.4 (after which such Indication shall cease to be an Independent Indication). *Certain information on this page has been omitted and filed separately with the commission. Confidential treatment has been requested with respect to the omitted portions.
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Independent Indication means, with respect to a particular Collaboration Product, any Indication for which a Party has exercised its opt- out right pursuant to Section 4.1 and shall include all Opt Out Indications, provided that such Party has not exercised its opt-in right for such Indication pursuant to Section 4.4 (after which such Indication shall cease to be an Independent Indication).
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Independent Indication has the meaning set forth in Section 3.3.
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Examples of Independent Indication in a sentence

  • Upon exercise of an opt in right and payment of all amounts due under subsection (c) above, the Independent Indication shall cease being an Independent Indication and will automatically return to the scope of the Collaboration.

  • Subject to the terms of this Section 4.4, a Non-Developing Party will have the option to opt-in to the independent development of an Independent Indication on a one-time basis, exercisable by providing a notice in writing to the Independent Development Party within (i) the [****] (the “Opt In Trigger”) [****] or (ii) the [****].

  • If either Party is marketing a Product for an Independent Indication and cross field sales may be occurring with the same Product that is a Collaboration Product, the Parties shall meet and negotiate in good faith provisions similar to or designed to have the same economic effect as Section 6.8.

  • Commencing at the time of delivery of the Opt Out Notice, the Non-Developing Party promptly shall provide, at the sole cost of the Non-Developing Party, the Independent Development Party with copies of all data and information, and samples of all tangible items, comprising Know-how and other Technology of the Non-Developing Party relating to such Independent Product or Independent Indication, as the case may be.

  • During the period commencing with delivery of an Opt Out Notice and ending [****] following the effective date of such Opt Out Notice, the Non-Developing Party shall provide reasonable technical assistance as requested by the Independent Development Party to effectuate an orderly transition of the Development and Commercialization of such Independent Product or Independent Indication, as the case may be, to the Independent Development Party.

  • For each Independent Product and Independent Indication, the Independent Development Party will have the right, at its own option and expense, to plan and conduct the Development of and to Commercialize such Independent Product or Independent Indication, as the case may be, in accordance with the terms of Sections 4.2, 4.3 and 4.5. *Certain information on this page has been omitted and filed separately with the commission.

  • Within [****] of receipt of such written notice, the Independent Development Party shall provide to the Non-Developing Party a package of data and other information concerning the Independent Indication reasonably necessary to permit the Non-Developing Party to make an informed decision on its desire to opt in to Development and Commercialization in the manner set forth in this Agreement (the “Data Package”).

  • Unless and until the Non-Developing Party decides to Opt-in pursuant to the Opt In Trigger described herein, it shall have no further rights under the licenses provided to it under Article 11 with respect to such Independent Product or Independent Indication.

  • Prior to the date of the Opt-In Trigger, the Independent Development Party shall be obligated to Develop the Independent Indication, at its sole cost (subject to Section 4.2(b)), and shall use Diligent Efforts in such development.

  • If the Non-Developing Party owns the Product Trademarks (as defined in Section 12.13(a)) relating to the Independent Product (or Independent Indication, if there are Product Trademarks that relate specifically to such Indication), ownership of such Product Trademarks shall be transferred to the Independent Development Party in the Territories as to which the opt out occurs.

Related to Independent Indication

  • Independent study means a subject/program/activity that a person pursues autonomously that meets standards for approval criteria in the rules and includes a posttest.

  • Independent candidate means any candidate who claims not to be affiliated with a political party, and whose name has been certified on the office-type ballot at a general or special election through the filing of a statement of candidacy and nominating petition, as prescribed in section 3513.257 of the Revised Code.

  • Independent student means one whose parents have surrendered the right to his care, custody and

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

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

  • Independent testing laboratory means an independent organization, accepted by the Contracting Officer, engaged to perform specific inspections or tests of the work, either at the site or elsewhere, and report the results of these inspections or tests.

  • 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.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Second Indication means [***].

  • Initial Indication means the use of a Product for the treatment of opioid addiction.

  • Replacement Product means electric generating capacity, capacity-related benefits, environmental attributes, Energy or other electric products from a generation resource other than the Facility that are provided or delivered to replace or substitute for Contract Capacity or Storage Capacity (or any Capacity-Related Benefit, Environmental Attribute, Other Electric Product, Contract Energy, or Storage Energy associated therewith), in each case, in whole or in part, pursuant to Section 4.6.

  • POC means Point of Compliance. "POE" means Point of Exposure. "PSI" means pounds per square inch.

  • Replacement Candidate means any Candidate Introduced by the Agency to the Client to fill the Engagement following the Introduction of another Candidate whose Engagement either did not commence or was terminated during the first 12 weeks of the Engagement;

  • 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.

  • Independent physician means a physician who is chosen by the resident of the assisted living facility and who has no financial interest in the assisted living facility, directly or indirectly, as an owner, officer, or employee or as an independent contractor with the residence.

  • 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)).

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

  • 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.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Independent Third Party means any Person who, immediately prior to a contemplated transaction, does not own in excess of 5% of the Company’s Common Units on a fully-diluted basis (a “5% Owner”), who is not controlling, controlled by or under common control with any such 5% Owner and who is not the spouse or descendant (by birth or adoption) of any such 5% Owner or a trust for the benefit of such 5% Owner and/or such other Persons.

  • Commercialized shall have corresponding meanings.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • 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.

  • Indication means a generally acknowledged disease or condition, a significant manifestation of a disease or condition, or symptoms associated with a disease or condition or a risk for a disease or condition. For the avoidance of doubt, all variants of a single disease or condition (whether classified by severity or otherwise) shall be treated as the same Indication.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.