Specified Indication definition

Specified Indication shall have the meaning set forth in Section 3.1(b).
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Specified Indication means (i) the distinct disease identified in a Specification Notice for which an initial BLA for a Specified Product is filed and (ii) the distinct disease identified in a Specification Notice for which a separate Efficacy Supplement would be required following filing of an initial BLA for a Specified Product.
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Specified Indication means any of the following Indications: any Primary Indication, Multiple Sclerosis, Huntington’s Disease, Epilepsy, Duchenne Muscular Dystrophy, Alzheimer’s Disease, Xxxxxxxxx’x Disease and Stroke.
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Examples of Specified Indication in a sentence

  • If the Proposed Field is not a Ciba Field and if the Drug proposed to be delivered pursuant to the Dermion Proposed System is not a Ciba Proprietary Drug for treatment of the Specified Indication, Dermion may freely develop the Dermion Proposed System for a third party (which development may be pursuant to an agreement under which Dermion grants exclusive licenses to such third party).

  • If during the term of this Agreement Ciba makes the determination to engage a third party (other than Dermion) to develop a System for a Drug owned, licensed or manufactured by Ciba (other than a Ciba Proprietary Drug for treatment of the Specified Indication, which shall be covered by Section 3.5(a) above) (a "Ciba Proposed System"), prior to initiating discussions with such third party, Ciba shall notify Dermion in writing.

  • If the Dermion Proposed System relates to the delivery of a Ciba Proprietary Drug for treatment of the Specified Indication, Ciba shall have the right during the term of this Agreement to elect to have Dermion develop a Product for such Ciba Proprietary Drug for treatment of the Specified Indication for it pursuant to the Program instead of the Proposed Dermion System.

  • Schedule 3.1(b) attached hereto sets forth as of the date hereof certain Drugs with respect ******************** *****************************************, and which Ciba believes are potentially therapeutic if delivered pursuant to a System in the treatment of the indication (the "Specified Indication") set forth in Schedule 3.1(b) with respect to such Drug.

  • On a Specified Indication-by-Specified Indication basis, Genzyme will pay to Voyager a one-time, non-refundable, non-creditable payment of twenty million dollars ($20,000,000) (the “Sales Milestone Payment”) when aggregate Net Sales for all Licensed Products in such Specified Indication in the Territory during the Royalty Term reaches [**] dollars ($[**]) (the “Sales Milestone Event”).

  • The development of any such Product for a Novartis Proprietary Drug for treatment of the Specified Indication pursuant to the Program shall be pursuant to this Agreement or an amendment to this Agreement (provided, that, other than providing for incremental costs to be paid by Novartis and incremental personnel, facilities and resources to be provided by Dermion, such amendment shall be on the same terms and conditions as this Agreement).

  • No later than at the time of the delivery of the First Report, Voyager will determine in its sole discretion if DM1 will be permitted to be the second Specified Indication and provide Genzyme with written notice of its determination.

  • If Dermion so elects, it shall give notice thereof to the Committee within fifteen (15) Business Days of receipt by the Committee of such notice, in which case Ciba shall be prohibited during the term of this Agreement from developing the Ciba Proposed Proprietary System for treatment of the Specified Indication outside the scope of the Program, subject to the last sentence of this Section 3.5(a).

  • If Voyager does not provide Genzyme written notice that DM1 will not be permitted to be the second Specified Indication by the time of delivery of the First Report, Genzyme may, in its sole discretion, select one (1) of DM1 or FSHD as the second Specified Indication and shall notify Voyager of its selection within [**] following delivery of the First Report by Voyager.

  • Notwithstanding the foregoing, if Licensee selects as a Specified Indication any (i) [***] or (ii) [***], then, in each case ((i)and (ii) ), it shall be obligated to pay the amounts set forth below in column (A) of Table 1 for the each of the [***] such [***] (as applicable) selected as Specified Indications (i.e., for each of the [***], and for each of the [***]), but thereafter shall not be obligated to pay any Milestones for any subsequent [***], as applicable, selected as Specified Indications.


More Definitions of Specified Indication

Specified Indication means (a) Pompe Disease or (b) the indication designated pursuant to Section 2.2 (Identification of Second Specified Indication), in each case ((a) or (b)) as designated by Genzyme pursuant to Section 2.4 (Option Exercise). For the avoidance of doubt, upon designation pursuant to Section 2.2 (Identification of Second Specified Indication), there shall be two (2) potential Specified Indications, and the second such Specified Indication shall be one of DM1 or FSHD.
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Specified Indication has the meaning set forth in Article 2.8.
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Related to Specified Indication

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

  • 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 [***].

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

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

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

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

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

  • 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.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • 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.

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

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

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

  • Phase I Trial means a clinical trial of a Licensed Product in human patients designated as a Phase I Trial and conducted primarily for the purpose of determining the safety of and/or the metabolism and pharmacologic actions of the Licensed Product in humans, as described under 21 CFR § 312.21(a) (as hereafter modified or amended) and any of its foreign equivalents. For purposes of this definition, Phase I Trial shall specifically exclude trials in healthy volunteers.

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.