Combination Study definition

Combination Study means a clinical or preclinical study testing IFN Lambda with one or more Combination Molecules.
View Source
Combination Study has the meaning as defined in Section 3.1.5.
View Source
Combination Study means a Clinical Trial to evaluate a Combination Therapy.
View Source

Examples of Combination Study in a sentence

  • Among other things, the Pharmacovigilance Agreement shall require MacroGenics and any Collaborators to submit safety data concerning any adverse experiences and any other safety information arising from or related to the use of the Licensed Compound as a single agent or as a component of any Combination Regimen in any MacroGenics Combination Study or Collaborator Combination Study, as applicable, as necessary for Incyte to maintain the Global Safety Database.

  • Further, MacroGenics shall supply all quantities of Licensed Compound Bulk Drug Substance that are required for any particular Incyte Monotherapy Study or Incyte Combination Study from the same MacroGenics Manufacturing Facility, provided that such supply requirements do not exceed the reasonably available then-current planned capacity of the applicable Manufacturing Facility.

  • The Party performing such Permitted Combination Study shall provide the JDC with summary updates not less than […***…] with respect to the conduct of any such Permitted Combination Study that includes one or more proprietary pipeline products of such Party.

  • For clarity, an Incyte Combination Study shall only be performed by Incyte, its Affiliates or its sublicensees.

  • For all units of Licensed Compound Bulk Drug Substance and Licensed Compound Drug Product that MacroGenics Manufactures for its own use or use by its Development Partners in connection with a MacroGenics Combination Study, MacroGenics shall submit to Incyte in advance of such supply a confirmatory “Order” indicating the information set forth in (A) through (D) with respect to the quantities that it will supply.

  • Unless the other Party […***…], the Party proposing to conduct such Permitted Combination Study (itself, or with or through any Third Party) may thereafter conduct such Permitted Combination Study at its sole cost and expense.

  • Combination Sponsor shall sponsor its respective Combination Study under its existing IND for its Pipeline Asset or a separate IND for the Combination Regimen, with a Right of Reference to the IND of the Licensed Compound or Licensed Product solely if required by a Regulatory Authority and only as it relates specifically to the Licensed Compound or Licensed Product.

  • For the avoidance of doubt, a decision by Ono not to seek a new or expanded Marketing Approval for a Product in the Ono Territory based on a Declined Clinical Study or a Combination Study shall not constitute a breach by Ono of its diligence under this Section 8.1(a).

  • BeiGene shall have five (5) business days (or a shorter time period if required by a regulatory authority from the date on which Immix provides the applicable Protocol amendment (or, if applicable, Combination Study amendment) to BeiGene to approve and/or provide any comments to Immix concerning the proposed amendment.

  • This Agreement begins on the Effective Date and, subject to early termination as provided in Section 4(b), shall continue in force until the earlier of (i) the one-year anniversary of the date that Immix provides BeiGene with the Combination Study’s final clinical study report or (ii) the date of termination of the Combination Study (the “Term”).

Related to Combination Study

  • Pivotal Trial means (a) a Phase 2 Clinical Trial, or a combination Phase 2 Clinical Trial and Phase 3 Clinical Trial, that (taken together with any other trials completed prior to or concurrently with such trial) is intended to support Marketing Approval for a Product by the relevant Regulatory Authority in the indication under study, or (b) a Phase 3 Clinical Trial.

  • 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)).

  • 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 III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.