Clinical Development Program Clause Samples
Clinical Development Program. Licensee shall pay, within thirty (30) days from the receipt of valid invoices from Licensor, ***** of all costs for Licensor's current Phase II clinical trial up to a maximum of *****, and shall at its expense, use commercially reasonable best efforts (a) to conduct a clinical development program directed to obtaining FDA approval of at least one Product for at least one Indication to be selected by Licensee (the "Development Program"), and (b) if, in the opinion of Licensee, the results of the Development Program so justify, to diligently seek FDA approval for such Product for such Indication. For purposes of this Section, "commercially reasonable best efforts" shall mean efforts consistent with those used by Licensee in its own priority development projects with its own products deemed to have high commercial potential.
Clinical Development Program. MERCK may, at its sole discretion, undertake, and shall solely own the results of, the Clinical Development Program. MERCK shall have the sole responsibility to make any and all regulatory filings for Compound and Product in the Territory as MERCK, in its sole discretion, deems appropriate, and MERCK shall be the sole owner of all regulatory submissions and government approvals therefor. Similarly, MERCK shall have and conduct any and all communications and interactions with regulatory agencies with respect to the Compound and Product, including without limitation Regulatory Authorities, and other government authorities. ISIS shall cooperate with MERCK in all of these activities whenever and to the extent requested by MERCK, and shall supply MERCK with any and all information necessary or useful to MERCK in preparing and filing regulatory and other government submissions, and in obtaining regulatory and other governmental approvals.
Clinical Development Program. Licensee shall use commercially reasonable best efforts (a) to conduct a clinical development program directed to obtaining FDA approval of at least one Product for at least one Indication to be selected by Licensee (the "Development Program"), and (b) if, in the opinion of Licensee, the results of the Development Program so justify, to diligently seek FDA approval for such Product for such Indication. For purposes of this Section, "commercially reasonable best efforts" shall mean efforts consistent with those used by Licensee in its own priority development projects with its own products deemed to have high commercial potential.
Clinical Development Program