Funding of Development Program. MDCO shall reimburse Eagle up to [*] (the “Development Cap”) for Eagle’s internal and out-of-pocket costs for conducting the Development Program for the Next Products after the Effective Date; provided, however, that if such post-Effective Date costs incurred on or before the receipt of Regulatory Approval by the FDA for the Next Products are less than the Development Cap, then MDCO shall reimburse Eagle for internal and out-of-pocket costs incurred by Eagle in developing the Next Products prior to the Effective Date, up to the Development Cap for such pre-Effective Date and post-Effective Date costs, in the aggregate. Eagle shall provide MDCO with a budget and other documentation reasonably requested by MDCO in connection with such payments, which budget shall be made a part of the Development Plan and shall be included within Exhibit B. MDCO shall make the payments described in this Section 3.6 within thirty (30) days after MDCO’s [*] = 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 406 of the Securities Act of 1933, as amended. receipt of an invoice therefor, which invoice shall not be issued by Eagle more frequently than monthly.
Funding of Development Program. P&U shall be responsible for conducting, and for all expenses related to, preclinical development and clinical trials for all Products containing Candidate Drugs, including, without limitation, toxicology studies, pharmacology studies, formulation, clinical trials, and regulatory filings. If Geron co-promotes a particular Product in the U.S. pursuant to Article 11 below, P&U shall be entitled to the Clinical Expense Credit * Certain portions of this Exhibit have been omitted for which confidential treatment has been requested and filed separately with the Securities and Exchange Commission. against royalties due Geron for that Product; provided however, that in no event shall any Clinical Expense Credit or any portion thereof be applied more than once.
Funding of Development Program. (a) RESPONSIBILITY FOR DEVELOPMENT COSTS. UNITED STATES. Development Costs for Development of Products in the U.S. (i.e., the costs of those Development activities required to be undertaken to obtain Marketing Approval in the U.S.) shall be shared by the Parties in the same proportion as the Parties shall share Operating Profits or Losses in the U.S. pursuant to Section 4.5. Each Party shall be responsible for expenses incurred by it in excess of the Development Budget pertaining thereto, unless otherwise approved by Steering Committee.
Funding of Development Program. Pursuant to the Financial Appendix, each of the Parties shall pay the Development Costs as follows:
Funding of Development Program. (a) RESPONSIBILITY FOR DEVELOPMENT COSTS.
Funding of Development Program. 20 5.1. FUNDING ................................................ 20 5.2. DEVELOPMENT RATE ....................................... 20 5.3. OTHER APPROVED DEVELOPMENT COSTS ....................... 21 5.4. PAYMENT ................................................ 21 5.5. EXCESS COSTS ........................................... 21 5.6. RECONCILIATION ......................................... 22
Funding of Development Program. Merck shall fund all clinical development activities for all Products for all Indications, all GLP toxicology studies for a Compound, and all other pre-clinical development activities that are conducted after the identification of a Development Candidate, including all related product development and manufacturing activities, which are (a) required by the applicable Regulatory Authority for a particular clinical study, (b) reasonably necessary or appropriate to conduct additional clinical studies, or (c) reasonably necessary or useful to support the filing of an NDA or comparable application for Marketing Authorization for the Product which is the subject of the clinical development activity, except that GTx shall be fully responsible for funding all clinical development activities for the Cancer Trial, with no reimbursement from Merck. In the event that GTx engages in activities in support of the Development Program as requested by the PDC, GTx shall submit a budget of the expenses that it expects to incur as a result of such activities to the PDC, and such expenses shall be reviewed and agreed upon by the PDC prior to GTx engaging in any such activities. Upon completion of such activities and submission of an invoice by GTx, Merck shall reimburse GTx for such previously approved expenses. Reimbursement of such previously approved expenses shall occur within thirty (30) days after receipt by Merck of such invoice.
Funding of Development Program. (a) LILLY will pay to ISIS US$20,000,000 for the conduct and conclusion of preclinical and clinical studies relating to Product and conducted by ISIS, including the pivotal, on-going Phase III study. Such payment will be made within [*] days after the Effective Date, and LILLY will use its best efforts to make such payment no later than September 30, 2001.
Funding of Development Program. Elanco shall pay seventy five percent (75%) and Licensor shall pay twenty five percent (25%) of Development Fees and Expenses incurred up to and through [***]. Notwithstanding the foregoing, in no event shall Licensor’s portion of the Development Fees and Expenses during such period exceed $7,000,000 (seven million U.S. Dollars) (the “Development Funding Cap”), which the Parties will review and adjusted by mutual written agreement in the event that an update of the Development Operating Plan results in a significant change of the Development Fees and Expenses. Notwithstanding the foregoing, each Party shall be solely responsible for all costs and expenses such Party incurs in connection with the conduct of its activities under the Development Program.
Funding of Development Program. (a) Pursuant to the Financial Appendix, each of the Parties shall pay those Development Costs listed below its name in the following table: -------------------------------------------------------------------------------------------------------- Field Inspire Genentech -------------------------------------------------------------------------------------------------------- Field A Development Costs for INS365 through Development Costs for INS365 beginning with the the completion of Phase IIa clinical Phase IIb clinical trials for such Product, plus trials for such Product, as provided any Phase IIa development costs in excess of in Section 5.7(b). [CONFIDENTIAL TREATMENT REQUESTED] pursuant to Section 5.7(b). -------------------------------------------------------------------------------------------------------- Field B Development Costs through the Development Costs for all Products beginning with completion of Phase II clinical the Phase III clinical trials for the first trials for the first Product. If Product; provided, however, that if Inspire Inspire exercises its Co-Development exercises its Co-Development Option, Genentech Option, Inspire shall also pay shall pay[CONFIDENTIAL TREATMENT REQUESTED] for [CONFIDENTIAL TREATMENT REQUESTED] the first Product beginning with Phase III for the first Product beginning with clinical trials for that Product and [CONFIDENTIAL Phase III clinical trials for that TREATMENT REQUESTED] for each subsequent Product; Product and [CONFIDENTIAL TREATMENT and, provided further, Genentech shall pay REQUESTED]for each subsequent Product. [CONFIDENTIAL TREATMENT REQUESTED] for all Products. -------------------------------------------------------------------------------------------------------- Field C None. All. -------------------------------------------------------------------------------------------------------- -18- -------------------------------------------------------------------------------------------------------- Field D Development Costs for one Product Development Costs for all Products after the through the filing of the first IND filing of the first IND for the first such Product. for the first such Product. -------------------------------------------------------------------------------------------------------- Field E None. All. --------------------------------------------------------------------------------------------------------
