Regulatory and Recall. 7.1 Customer Regulatory Obligations. Customer is responsible for compiling the registration dossiers (with reasonable and necessary assistance from Encap), filing the marketing applications with the regulatory authorities in the Territory, and maintaining marketing authorizations for the Product and the costs associated with the same. Encap shall reasonably assist Customer in obtaining and maintaining marketing authorizations for the Product. Customer is responsible for (a) the formulation, use, packaging, labeling, distribution and disposal of Product, including compliance with all laws and regulations related to the same; (b) communicating with any governmental authority concerning the Product (for the avoidance of doubt, Encap may interact with governmental authorities for the purpose of fulfilling legal obligations); and (c) storing and handling Product in appropriate conditions following its delivery; and (d) determining that the Product is permitted for human use. Customer is responsible for developing all Product labeling, printing the labels, and for labeling content. PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT; [***] DENOTES OMISSIONS.
7.2 Ownership of Application. Customer will own and control all regulatory approvals in the Territory (including all associated contents and correspondences) and Applications therefore related to the Product, including the Application and any other marketing authorizations within the Territory, unless otherwise mutually agreed upon by the Parties. Encap shall permit Customer to include reference to Encap in the Application, and Encap agrees to such reference in the Application and to reasonably assist Customer as needed and required for the approval of the Application, such as pre approval inspection, DMF update or any other regulatory matter that needs Encap assistance.
Regulatory and Recall
