Additional Indication Option definition

Additional Indication Option has the meaning set forth in Section 2.2(b).
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Additional Indication Option has the meaning set forth in Section 2.2(b). ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
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Additional Indication Option has the meaning assigned to such term in Section 4.4.2.
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Examples of Additional Indication Option in a sentence

  • 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.

  • 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”).

  • 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.

  • 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.

  • 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.

  • To exercise the Additional Indication Option for a particular Additional Disease Indication, Licensee may nominate in writing to Licensor an Additional Disease Indication for inclusion in the Commercial Field under this Agreement prior to the end of the Additional Indication Term.

  • 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.

  • 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.

  • 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.

  • 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.

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.

  • Second Extension Option shall have the meaning set forth in Section 2.2.1(b) hereof.

  • Extension Option shall have the meaning set forth in Section 2.5(c) hereof.

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

  • Development Milestone Payment 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.

  • Termination Option means the option of either party to terminate a transaction in the event that the other party fails to perform a Firm obligation to deliver Gas in the case of Seller or to receive Gas in the case of Buyer for a designated number of days during a period as specified on the applicable Transaction Confirmation.

  • First Extension Option shall have the meaning set forth in Section 2.6.1 hereof.

  • Sales Milestone Payment has the meaning set forth in Section 8.3.1.

  • Milestone Event has the meaning set forth in Section 8.4.

  • 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.

  • Renewal Option has the meaning set forth in §12.1.

  • 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.

  • Termination Option Event means an event of a kind defined as such in Section 4.1, 4.2 or 4.8.

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

  • 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.

  • 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: