Comparative Clinical Study definition

Comparative Clinical Study means the controlled study of Product by the administration of Product to human beings where the principal purpose of such studies is to provide confirmatory/comparative safety, efficacy and immunogenicity data necessary to support the filing for Regulatory Approval for Product, all as described in more detail in that certain memorandum exchanged between the Parties on the Signature Date and referencing this Agreement.
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Examples of Comparative Clinical Study in a sentence

  • Hospira shall provide Pfenex, through the Executive Steering Committee, a reasonable opportunity to review and comment upon the draft protocol for the Comparative Clinical Study (and all amendments thereto); all such comments shall be made by Pfenex as soon as practical, but in any event within fifteen (15) days from the date Pfenex receives a copy of the draft protocol or any amendment.

  • Commencing on the date hereof and continuing until Comparative Clinical Study Costs exceed an aggregate amount equal to Forty Million Dollars ($40,000,000), Hospira shall [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.

  • Hospira, at its expense, shall be responsible for and control the manufacturing of Product and shall control the procurement, manufacture, and qualification of the Components required for the manufacture of Product and all costs thereof, including with respect to Product for use in the Comparative Clinical Study.

  • The Technical Transfer Plan shall also include a target completion date prior to the initiation of the Comparative Clinical Study upon which target completion date Pfenex’s activities and obligations under the Technical Transfer Plan shall end.

  • Following Successful Completion of the Comparative Clinical Study with respect to Product, Hospira shall use Commercially Reasonable Efforts to obtain and maintain, solely in its own name (or the name of one of its Affiliates) and, subject to Section 3.5(b) at its own cost, all Regulatory Approvals for Product in each Major Market, including using Commercially Reasonable Efforts to perform those activities assigned to Hospira under the Development Plan in accordance with the timelines therefor.

  • If this Agreement expires at the end of the Term, then Pfenex shall pay Hospira for any unpaid or unreimbursed Comparative Clinical Study Costs, Regulatory Approval Costs and/or Commitment Costs (in each case only to the extent of the portion that Pfenex owes to Hospira pursuant to the terms of Article III) within thirty (30) days following such expiration.

  • It is understood that the Comparative Clinical Study Costs shall not include any employee related expenses of Hospira or its Affiliates, which, as between Hospira and Pfenex, shall be the sole responsibility of Hospira.

  • The Executive Steering Committee shall have the right to determine and finalize the protocol for the Comparative Clinical Study; provided, that the Executive Steering Committee (and Hospira in its exercise of its ability to finally resolve matters related to clinical trial protocols for Product pursuant to Section 7.4(b)) shall consider in good faith Pfenex’s comments with respect thereto.

  • Pfenex shall reimburse Hospira for fifty percent (50%) of documented amounts actually paid by Hospira to a Third Party for the conduct of the Comparative Clinical Study with respect to Product in accordance with the Development Plan (the total amount so paid by Hospira the “Comparative Clinical Study Costs”); provided, that the aggregate reimbursement amount to which Hospira shall be entitled with respect to the Comparative Clinical Study Costs shall not exceed Twenty Million Dollars ($20,000,000).

  • Mylan Inc., has ICON with the management of the “A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects with Diabetic Macular Edema” study (hereinafter referred to as the “Study”) SPONSOR’s business partner for the Study (as defined below) is Momenta Pharmaceuticals, Inc.