FSD Study definition
Examples of FSD Study in a sentence
Subject to the terms of the Development Plan for the FSD Study and this Section 5.2, [***].
In consideration of Endoceutics’ conduct of the FSD Study, AMAG shall pay to Endoceutics an amount corresponding to [***] of the direct costs (the “FSD Study Consideration”) with AMAG paying up to a maximum of twenty million dollars ($20,000,000).
Endoceutics shall invoice the FSD Study Consideration to AMAG on a monthly basis within thirty (30) days following the end of each calendar month, and each such invoice shall be accompanied by reasonable supporting documentation evidencing the amounts reflected in such invoice.
The Parties shall consult with each other, and keep the other Party regularly and fully informed of, the preparation, Regulatory Authority review, and approval of submissions and communications with Regulatory Authorities with respect to the FSD Study.
The Development Plan will be updated by the Parties in accordance with Section 4.2(a) to reflect any updates to the FSD Study and a description of any AMAG Studies to be conducted.
With respect to the FSD Study, Endoceutics shall promptly provide AMAG with copies of all Data with respect to the conduct of the FSD Study.
The Development Plan will include clinical studies and related budgets for (i) the FSD Study, as such studies have been discussed by Endoceutics with the FDA as of the Execution Date, and (ii) any AMAG Studies.
Endoceutics shall consult with AMAG with respect to the FSD Study and shall consider AMAG’s comments in good faith; provided that [***] shall have final-decision making authority with respect to the FSD Study, including the portion of the Development Plan related thereto; provided that Endoceutics will not undertake any action that AMAG in good faith reasonably demonstrates [***].
AMAG may cause an independent, certified public accountant reasonably acceptable to Endoceutics to audit such records to confirm such FSD Study Costs related to the FSD Study and/or spend under the Commercialization Plan covering not more than [***] following the Calendar Quarter to which they pertain.
Subject to obtaining Endoceutics’ prior written consent, such consent not to be unreasonably withheld, conditioned, or delayed, AMAG may, alone, or through an Affiliate or Sublicensee, conduct one or more additional clinical studies of the Product in the Field anywhere in the world for the purpose of obtaining or maintaining Regulatory Approval of the Product in the Field in the Territory or for Commercializing the Product in the Field in the Territory that are not the FSD Study (each, an “AMAG Study”).