Common use of Data Certification Clause in Contracts

Data Certification. As promptly as practicable after the date of this Agreement, and in any event on or before August 15, 2013, the Sellers shall cause the Company to deliver to the Buyer the Company Data Package, which materials shall be certified as true and complete by the Company’s chief executive officer. During the Collaborative Data Exploration Period, the Company shall provide the Buyer with access to (a) the final database and the necessary analysis team to run additional data analyses, including analyses not specified in the formal statistical analysis plan, (b) electronic case report forms (eCRFs), patient narratives for serious adverse events and any additional raw data relating to (i) individual patients, (ii) subsets of patients, including from analysis groups pre-specified in the SAP, and (iii) from the data set as a whole and (c) data to enable a comparison to the two prior Company phase II studies of FibroCaps and to published third party studies of competitive products. In addition, during the Collaborative Data Exploration Period, the Company shall make its officers and employees available, and shall use its Reasonable Best Efforts to make its other representatives available, to the Buyer to facilitate a collaborative exploration of the data set included in the Company Data Package, including interactions as needed with the Company’s scientists, clinicians, regulatory, statistical and other internal experts. During the Collaborative Data Exploration Period, the Buyer shall be permitted to consult with (and provide the Company Data Package to) external experts engaged by the Buyer who are bound under conditions of confidentiality equivalent to those applicable to the Buyer. Any analyses which are requested by the Buyer outside the scope of pre-specified analyses will be undertaken with agreement from the Company, such agreement not to be unreasonably withheld, conditioned or delayed. The Buyer shall have the Collaborative Data Exploration Period to review the materials contained in the Company Date Package in conjunction with the Sellers and, upon the request of the Buyer from time to time but within the Collaborative Data Exploration Period, the Sellers shall cause the Company to meet (in person at the Buyer’s offices or by telephone) with representatives of the Buyer to discuss the contents thereof and any questions the Buyer may have with respect thereto.