Common use of Responsibility for Development Clause in Contracts

Responsibility for Development. ILDONG shall have the sole right and responsibility for, and shall have full control and authority over, at its sole cost and expense (including without limitation all costs attributable to the supply of Product for the conduct of Clinical Trials), the Development of Products in the Territory, including conducting all Development activities (including bridging study(ies), if such study(ies) are necessary due to regulatory gaps) beyond the Development activities being conducted by the SUBLICENSOR outside of the Territory (which should be supportive of obtaining Marketing Authorization by the FDA and/or EMA, but may or may not be sufficient to support the obtaining of Marketing Authorization in the Territory) and establishing the methods and means by which it performs such activities under this Agreement. Should ILDONG, for any regulatory filing, desire to utilize data from any clinical trials or studies conducted in indications outside *, *, *, and *, which have been fully funded by the SUBLICENSOR, ILDONG shall pay to the SUBLICENSOR *% of the full cost of the trial which produced such data. ILDONG shall have the right to engage Third Party contractors to perform any of its Development activities in the Territory, provided such Third Party contractors are approved by SUBLICENSOR, such approval not to be unreasonably withheld, and subject to the execution by each such Third Party contractor of an agreement containing provisions that are consistent with and comparable in scope to, Articles 7 and 8 of this Agreement.

Responsibility for Development. ILDONG shall have the sole right and responsibility for, and shall have full control and authority over, at its sole cost and expense (including without limitation all costs attributable to the supply of Product for the conduct of Clinical Trials), the Development of Products in the Territory, including conducting all Development activities (including bridging study(ies), if such study(ies) are necessary due to regulatory gaps) beyond the Development activities being conducted by the SUBLICENSOR outside of the Territory (which should be supportive of obtaining Marketing Authorization by the FDA and/or EMA, but may or may not be sufficient to support the obtaining of Marketing Authorization in the Territory) and establishing the methods and means by which it performs such activities under this Agreement. Should ILDONG, for any regulatory filing, desire to utilize data from any clinical trials or studies conducted in indications outside *, *, *, and *, which have been fully funded by the SUBLICENSOR, ILDONG shall pay to the SUBLICENSOR *% of the full cost of the trial which produced such data. ILDONG shall have the right to engage Third Party contractors to perform any of its Development activities in the Territory, provided such Third Party contractors are approved by SUBLICENSOR, such approval not to be unreasonably withheld, and subject to the execution by each such Third Party contractor of an agreement containing provisions that are consistent with and comparable in scope to, Articles 7 and 8 of this Agreement. * Confidential material redacted and filed separately with the Commission.