Study Budget. Institution represents that the Institution-provided study budget upon which the support is based reflects an informed estimate of all funds required to complete the Study.
Study Budget. A copy of the Study Budget is attached hereto as Schedule 2 and incorporated herein by reference. Payment as set forth in the Study Budget shall constitute full payment for the performance of the Study.
Study Budget. A copy of the Study Budget is attached hereto as Schedule 2 and incorporated herein by reference. Payment as set forth in the Study Budget shall constitute full payment for the performance of the Study. THIS SOW IS EXECUTED by the authorized representatives of SPONSOR and the Institution as of the date first written above. [NAME OF SPONSOR] [NAME OF INSTITUTION] Signature : Signature : Name : Name : Title : Date: …………………………………. Title : Date: …………………………………. PRINCIPAL INVESTIGATOR (READ AND ACKNOWLEDGED IF AN EMPLOYEE OF INSTITUTION) Signature : Name : Title : Date: ………………………………….
Study Budget. In consideration for conducting the Study, the Sponsor shall pay Institution for all services required under the Study pursuant to the attached agreed upon Budget.
Study Budget. 3.1 Sponsor agrees to pay MD Xxxxxxxx an amount equal to $75,000.00 inclusive of overhead and to support MD Anderson’s conduct of the Study as expressly set forth in Exhibit A (collectively, “Budget”). The schedule and procedure of payments under the Budget shall be made as set forth in Exhibit B, attached hereto. In the event of any conflict between Exhibit B and this Agreement, this Agreement shall control. Sponsor shall not be required to make any payment or perform any in-kind services in excess of the Budget without the prior written approval of a corporate officer of Sponsor.
Study Budget. 3.1 Sponsor agrees to pay MD Xxxxxxxx an amount equal to its expenditures and reasonable overhead in conducting the Study in the amount of US$1,507,352.33 (“Budget”). The schedule and procedure of payments under the Budget shall be made as set forth in Exhibit B, attached hereto. In the event of any conflict between Exhibit B and this Agreement, this Agreement shall control.
Study Budget. In consideration of the performance of the Services, CRO shall be paid the amounts set forth in the Study Budget, except as further specified in Attachment 4 of Exhibit B. The aggregate fees and expenses payable by BIOMARIN to CRO for the Services shall not exceed the fees and expenses specified in the Study Budget unless otherwise authorized in writing by BIOMARIN. In the event that the Study Budget provides that certain fees and expenses are estimates only, BIOMARIN’s obligations to pay amounts in excess of such estimates shall be expressly conditioned upon BIOMARIN receiving detailed advanced notice of CRO’s anticipated budget overages, and the reasons therefor, all of which must be satisfactory to BIOMARIN in its sole discretion. In addition, BIOMARIN shall only be obligated to pay the Pass Through Costs upon receipt of documentation of such expenses reasonably satisfactory to BIOMARIN.
Study Budget. Party B shall pay an amount of NTD (exclusive of VAT; and the same shall apply below) as the study budget required for the Study. Party B shall also make payments for any “Other Study-related Fees (Per Occurrence)” incurred during the conduct of the Study. The aforesaid study budget as required for the Study and “Other Study-related Fees (Per Occurrence)” shall collectively be referred to as “Study Budget”, their details and contents are as shown in the Appendix 2 (the “Budget Table”). Any taxes or transaction fees arising out of the Agreement shall be borne by Party B. The Study Budget shall be planned and utilized by Party A. After the commencement of the Study, Party B may no longer request for return of any non-refundable fees listed in the Budget Table.
Study Budget. (i) GTx acknowledges and agrees that upon receiving FDA’s comments on the Additional Phase III Protocol, it shall then finalize the Protocol and the associated clinical study budget for all third party external costs for the Additional Phase III Clinical Study (the “Study Budget”) and submit it to the CMO of Ipsen or any medical appointee designated by the CMO for review and approval, which Ipsen agrees to accomplish within [ * ] of its receipt of the Study Budget. The total amount set forth in the Study Budget shall be deemed to be the actual total third party external costs for the Additional Phase III Clinical Study.
(ii) GTx acknowledges and agrees that upon finalizing the Study Budget with Ipsen, it shall then have the obligation and responsibility to carry out the Additional Phase III Clinical Study of the 80mg toremifene Initial Product to allow GTX and Ipsen to obtain Regulatory Approvals of the product candidate for the ADT Indication from the FDA and the EMEA (and other Regulatory Agencies in the Ipsen territory) respectively.
(iii) In the event the total third party external costs in the Study Budget approved by GTx and Ipsen exceed the amount of €42 million (VAT excluded) by an amount up to, but not exceeding, [ * ]% of Xxxxx’x €42 million Additional Milestone Payment, GTx agrees that it will pay such excess costs. In the event the total third party external costs of the Study Budget approved by GTx and Ipsen are expected to exceed the [ * ]% threshold, GTx shall promptly notify Ipsen of such excess amount accompanied with all relevant supporting documents, copies of all correspondence and responses received by GTx from the relevant Regulatory Agency within sufficient time to allow Ipsen to review and consider the same. The Parties shall then agree to discuss as to whether to initiate the Additional Phase III Study and/or to renegotiate the terms of this First Amendment.
(iv) For the sake of clarity, once the Study Budget is finalized and approved by GTx and Ipsen and the Additional Phase III Study is initiated, and should the total actual third party external costs exceed the finalized Study Budget, any such excess amount shall be borne by GTx’s only and shall be upon GTx’s sole responsibility unless the Parties shall otherwise agree in writing. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the ...
Study Budget. A. PK 1. PK 00-001 $180,000 (-$162,000) 2. PK 99-001 $255,000 (-$ 50,780) 3. 97- M - 01 $ 80,000 4. Salamandra (Consultant) $125,000 (-$ 50,000)
B. CMC
1. Stability - Current $60,000 2. Post submission (12 mos., 18 mos., 24 mos.) 3 X $30,000 C. Clinical
1. 97- M - 02 CRO: Three (3) months remain @ $150,000/month
