Additional Indication Option definition

Additional Indication Option has the meaning set forth in Section 2.2(b).
Sample 1Sample 2Sample 3
Additional Indication Option has the meaning assigned to such term in Section 2.4.
Sample 1

Examples of Additional Indication Option in a sentence

  • Auxilium may exercise the Additional Indication Option at any time during the Exercise Period by delivering to BTC a written notice of exercise with regard to such Additional Indication (each, an “Exercised Indication”) that sets forth the effective date of the exercise (the “Exercised Indication Date”).

  • The period during which Auxilium may exercise an Additional Indication Option (the “Exercise Period”) shall commence on the date on which BTC submits a Phase II Clinical Trial report to Auxilium for the Product for such Additional Indication and ends one hundred and twenty (120) days thereafter.

  • Furthermore, if Licensee exercises the Substitution Indication Option and/or Additional Indication Option granted to Licensee under Sections 2.2 and 2.3, respectively, Licensee will use commercially reasonable efforts to develop, commercialize, market, promote, and sell Licensed Products for the Disease Indication(s) subject to such option in the Commercial Field.

  • For each exercise by Licensee of an Additional Indication Option granted to Licensee under Section 2.3, Licensee shall pay Licensor a fee of five hundred thousand U.S. Dollars ($500,000) for the exercise of such option.

  • The Parties acknowledge that there may be different Grant Dates for each Additional Disease Indication, depending on when and if Licensee exercises the Additional Indication Option for a particular Additional Disease Indication.

  • This Agreement shall commence on the Effective Date and, unless terminated earlier as provided in this Article 12, shall continue until the later of (i) the expiration of the Additional Indication Option Exercise Period, or (ii) the expiration of the Royalty Term if an Option is exercised (the “Term”).

  • As set forth above, Licensee, at its sole discretion, may exercise the Additional Indication Option with respect to any or all of the Additional Disease Indications.

  • The period during which Endo may exercise an Additional Indication Option (the “Exercise Period”) shall commence on the date on which BTC submits a Phase II Clinical Trial report to Endo for the Product for such Additional Indication and ends one hundred and twenty (120) days thereafter.

  • For the avoidance of doubt, the foregoing license granted pursuant to Section 2.3.3 will be deemed granted on the Grant Date on an Additional Disease Indication-by-Additional Disease Indication basis, solely with respect to the Commercial Field associated with the Additional Disease Indication for which the Additional Indication Option was exercised under this Section 2.3 and solely with respect to Licensed Products for the particular Additional Disease Indication.

  • In the event Endo desires to exercise its Additional Indication Option at any stage of development activity prior to the submission of a Phase II Clinical Trials report (each, an “Early Exercised Indication”), Endo shall deliver to BTC a written notice of Early Exercised Indication with regard to such Additional Indication.

Related to Additional Indication Option

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

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

  • Development Milestone Event has the meaning set forth in Section 7.2.1.

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

  • Development Milestone is defined in Section 5.3.

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

  • 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:

  • Sales Milestone Payment shall have the meaning set forth in Section 8.4.

  • 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.

  • Milestone Event has the meaning set forth in Section 8.2.1.

  • Second Indication means [***].

  • 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.

  • License Period means the period beginning from the Commencement Date and ending on the Termination Date.

  • 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.

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

  • 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)).

  • Milestone means an event or task described in the Implementation Plan which must be completed by the corresponding date set out in such plan;

  • Major Market Country means each of the United States, Japan, France, Germany, Italy, Spain and the United Kingdom.

  • Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • 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.

  • 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:

  • Development Schedule shall have the meaning set forth in Section 1.1.

  • Major Market Countries means the United States, Japan, England, Germany, France, Italy and Spain.

  • 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.

  • Milestone Payment has the meaning set forth in Section 4.2.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.