Pharmos' Development Obligations. If mutually agreed to by the parties, Pharmos shall use good faith, scientifically reasonable efforts to execute each R&D Plan substantially in accordance with its terms and in consultation with BLP. In connection therewith, Pharmos shall be responsible for the preparation and conduct of all Phase I, II and III studies and other clinical trials as may be included in the subject R&D Plan, the preparation, submission and maintenance of any NDA's in connection therewith in the name of Pharmos, the provision to BLP of Drug Substance necessary for use in the generation of suitable materials for the conduct of related clinical trials, and generally otherwise do all such things with respect to a Development Product as previously done by Pharmos in connection with the Initial Drug Product. Except as specifically set forth in this Agreement or as otherwise agreed in writing by Pharmos and BLP, all actions taken by Pharmos in connection with its obligations under this Section shall be at the sole cost and expense of Pharmos.
Pharmos' Development Obligations. If mutually agreed to by the -------------------------------- parties, Pharmos shall use good faith, scientifically reasonable efforts to execute each R&D Plan substantially in accordance with its terms and in consultation with BLP. In connection therewith, Pharmos shall be responsible for the preparation and conduct of all Phase I, II and III studies and other clinical trials as may be included in the subject R&D Plan, the preparation, submission and maintenance of any NDA's in connection therewith in the name of Pharmos, the provision to BLP of Drug Substance necessary for use in the generation of suitable materials for the conduct of related clinical trials, and generally otherwise do all such things with respect to a Development Product as previously done by Pharmos in connection with the Initial Drug Product. Except as specifically set forth in this Agreement or as otherwise agreed in writing by Pharmos and BLP, all actions taken by Pharmos in connection with its obligations under this Section shall be at the sole cost and expense of Pharmos. If BLP believes in good faith that an R&D Plan is not being substantially performed in accordance with such Plan, the parties shall at the request of BLP meet to mutually determine in good faith any corrective actions, and associated costs, which may be necessary to perform such R&D Plan. If the parties are unable to agree, in good faith, on any corrective actions and associated costs, or if agreement on the foregoing is reached but Pharmos subsequently breaches such agreement, BLP may, following written notice to Pharmos, assume responsibility for performing Pharmos's obligations with respect to such aspect of the particular R&D Plan which Pharmos failed to be performed on a commercially reasonable, cost- effective basis, and offset the out-of-pocket costs associated therewith against any payment obligations owed to Pharmos hereunder in an equitable manner which does not cause Pharmos to breach any of its other obligations hereunder. Notwithstanding anything contained in this Section 4.4 to the contrary, BLP's obligation to agree in good faith on any corrective actions and associated costs will not be deemed to impose on BLP any obligation to assume responsibility for any costs which are not expressly assumed by BLP hereunder.
