Target Sanction Data Package definition

Target Sanction Data Package means, with respect to a Strategy directed to a Neurology Target, the data package Ionis presented to Ionis’ RMC to obtain approval to justify expending resources to identify a human Development Candidate, all in accordance with Ionis’ standard processes; provided such package contains the same level of detail as the data packages Ionis currently presents to Ionis’ RMC to approve Ionis’ own internal gene targets and is consistent with and contains the results from all the activities under the applicable Target Sanction Plan.
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Target Sanction Data Package means, with respect to a Neurology Target, the data package Isis presented to its RMC to obtain approval to justify expending resources to identify a human Development Candidate, all in accordance with Isis’ standard processes; provided such package contains the same level of detail as the data packages Isis currently presents to its Research Management Committee to approve Isis’ own internal gene targets.
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Target Sanction Data Package means, with respect to a High Interest Target, [***].
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Examples of Target Sanction Data Package in a sentence

  • For clarity, in requesting additional supporting information in connection with a Target Sanction Data Package, Biogen may not request Ionis to perform any additional experiments or studies, or generate any additional data beyond that which is set forth in the applicable Target Sanction Plan.

  • For clarity, in requesting additional supporting information in connection with a Target Sanction Data Package, Biogen may not request Ionis to perform any additional experiments or studies, or generate any additional data.

  • Each time Ionis delivers to the Neurology JRC a Target Sanction Data Package for a Strategy under this Section 1.4, if requested by Biogen, Ionis will promptly provide any additional supporting data in Ionis’ possession that is reasonably necessary for Biogen to make a decision as to whether to designate such Strategy as a Collaboration Program.

  • As soon as reasonably practicable after the Parties complete the activities in the agreed upon Target Sanction Plan for a particular Strategy directed to a High Interest Target or Collaboration Target, Ionis will deliver a Target Sanction Data Package to the Neurology JRC for review.

  • Within [***] days after the date Isis delivered the applicable Target Sanction Data Package to the Neurology JRC, by written notice to Isis, Biogen Idec will either designate such Isis Neurology Target as a Collaboration Target (in which case Section 1.6 will apply), or, to the extent permitted below, a Biogen Idec Alternate Modality Target (in which case Section 1.7 will apply).

  • Subject to Section 1.2.3(f), if, during the Research Term in the course of conducting work outside of the Collaboration with respect to any Ionis Neurology Target, Ionis achieves Target Sanction with respect to any Strategy directed to such Ionis Neurology Target, then Ionis will deliver a Target Sanction Data Package for such Strategy directed to such Ionis Neurology Target to the Neurology JRC for review as soon as reasonably practicable.

  • After the Parties complete the activities to achieve Target Sanction for a particular High Interest Target that is not an ALS Target, Isis will deliver a Target Sanction Data Package for such High Interest Target to the Neurology JRC for review as soon as reasonably practicable.

  • If, during the Research Term in the course of conducting work outside of the Collaboration with respect to any Isis Neurology Target, Isis achieves Target Sanction with respect to such Isis Neurology Target, then Isis will deliver a Target Sanction Data Package for such Isis Neurology Target to the Neurology JRC for review as soon as reasonably practicable.

  • Each time Isis delivers the Neurology JRC a Target Sanction Data Package for a High Interest Target under this Section 1.3 the Parties will schedule a meeting of the Neurology JRC within [***] days following delivery of such Target Sanction Data Package.

  • Upon completion of the activities in the Disease Research Plan to support Target Sanction for a particular High Interest Target, Isis will deliver a Target Sanction Data Package for such High Interest Target to the JSC for review as soon as reasonably practicable for the JSC to determine whether or not such High Interest Target has achieved Target Sanction and thus is eligible to become a Collaboration Target.

Related to Target Sanction Data Package

  • Data Package has the meaning set forth in Section 2.9(a).

  • Third-party filer means an entity that submits a Product filing to the Commission on behalf of an Insurer.

  • Target Population means persons with low incomes who have one or more disabilities, including mental illness, HIV or AIDS, substance abuse, or other chronic health condition, or individuals eligible for services provided pursuant to the Lanterman Developmental Disabilities Services Act (Division 4.5 (commencing with Section 4500) of the Welfare and Institutions Code) and may include, among other populations, adults, emancipated minors, families with children, elderly persons, young adults aging out of the foster care system, individuals exiting from institutional settings, veterans, and homeless people.

  • 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).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Soft Target means a target that will suffer minimum damage and cause minimum damage to the subject vehicle in the event of a collision.

  • Phase III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • 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.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • DNA profile means a letter or number code which represents a set of identification characteristics of the non-coding part of an analysed human DNA sample, i.e. the particular molecular structure at the various DNA locations (loci);

  • 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.

  • Expiry Date (Data di Scadenza) means the Expiry Date as specified in § 1 of the Product and Underlying Data.

  • Non-Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who does not have a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • 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:

  • Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Participating Certified Clinical Nurse Specialist means a Certified Clinical Nurse Specialist who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • 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.

  • DRS/Profile means the system for the uncertificated registration of ownership of securities pursuant to which ownership of ADSs is maintained on the books of the Depositary without the issuance of a physical certificate and transfer instructions may be given to allow for the automated transfer of ownership between the books of DTC and the Depositary. Ownership of ADSs held in DRS/Profile is evidenced by periodic statements issued by the Depositary to the Holders entitled thereto.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • KPI Target means the acceptable performance level for a KPI as set out in each KPI;

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.