Common use of Regulatory Approvals and Compliance Clause in Contracts

Regulatory Approvals and Compliance. LipoMatrix shall obtain and own all regulatory approvals, certificates, registrations, licenses, and permits related to the Products unless prohibited by local law. In the event that necessary approvals, certificates, registrations, licenses and permits required to sell and distribute the Products in the Territory are required by local law to be owned by, or held in the name of Distributor, Distributor agrees that upon termination of this Agreement for any reason, Distributor shall immediately take all steps necessary to promptly transfer the ownership, registration or entitlement of such registrations, certificates, licenses and permits to LipoMatrix or its designee. Distributor shall provide reasonable assistance to LipoMatrix in order to obtain any and all applicable regulatory approvals required by Governmental Agencies under the laws and/or regulations of any jurisdiction in order to market the Products within Territory, including but not necessarily limited to, meeting relevant standards and guidelines, preclinical, clinical and safety approvals required by Government Agencies. LipoMatrix shall reimburse Distributor for reasonable out-of-pocket expenses incurred by Distributor in connection with such assistance provided such expenses are approved in advance. LipoMatrix shall have the primary responsibility for manufacturing compliance and Distributor for any distribution compliance regarding any reporting or compliance matters in the Territory required of distributors by Government Agency rules and regulations, including but not limited to, recalls of the Products and reporting of adverse events involving the Products. The parties shall share information to allow each party to fulfill its compliance obligations hereunder. Each party shall promptly inform the other of any changes in regulatory or compliance status that might significantly affect the marketing of the Products in the Territory. Each party shall inform the other within two (2) working days of any actions taken by such party that could reasonably be expected to affect the regulatory or compliance status of LipoMatrix or the Products. Distributor shall make all reasonable efforts to comply with appropriate standards for review and approval of orders from its customers.

Regulatory Approvals and Compliance. LipoMatrix shall obtain and own all regulatory approvals, certificates, registrations, licenses, and permits related to the Products unless prohibited by local law. In the event that necessary approvals, certificates, registrations, licenses and permits required to sell and distribute the Products in the Territory are required by local law to be owned by, or held in the name of Distributor, Distributor agrees that upon termination of this Agreement for any reason, Distributor shall immediately take all steps necessary to promptly transfer the ownership, registration or entitlement of such registrations, certificates, licenses and permits to LipoMatrix or its designee. Distributor shall provide reasonable assistance to LipoMatrix in order to obtain any and all applicable regulatory approvals required by Governmental Agencies under the laws and/or regulations of any jurisdiction in order to market the Products within Territory, including but not necessarily limited to, meeting relevant standards and guidelines, preclinical, clinical and safety approvals required by Government Agencies. LipoMatrix shall reimburse Distributor for reasonable out-of-pocket expenses incurred by Distributor in connection with such assistance provided such expenses are approved in advance. LipoMatrix shall have the primary responsibility for manufacturing compliance and Distributor for any distribution compliance regarding any reporting or compliance matters in the Territory required of distributors by Government Agency rules and regulations, including but not limited to, recalls of the Products and reporting of adverse events involving the Products. The parties shall share information to allow each party to fulfill its compliance obligations hereunder. Each party shall promptly inform the other of any changes in regulatory or compliance status that might significantly affect the marketing of the Products in the Territory. Each party shall inform the other within two (2) working days of any actions taken by such party that could reasonably be expected to affect the regulatory or compliance status of LipoMatrix or the Products. Distributor shall make all reasonable efforts to comply with "Good Distribution Practices", as defined by EUCOMED, and with other appropriate standards for review and approval of orders from its customers.

Regulatory Approvals and Compliance. LipoMatrix shall obtain and own all regulatory approvals, certificates, registrations, licenses, and permits related to the Products unless prohibited by local law. In the event that necessary approvals, certificates, registrations, licenses and permits required to sell and distribute the Products in the Territory are required by local law to be owned by, or held in the name of Distributor, Distributor agrees that upon termination of this Agreement for any reason, Distributor shall immediately take all steps necessary to promptly transfer the ownership, registration or entitlement of such registrations, certificates, licenses and permits to LipoMatrix or its designee. Distributor shall provide reasonable assistance to LipoMatrix in order to obtain any and all applicable regulatory approvals required by Governmental Agencies under the laws and/or regulations of any jurisdiction in order to market the Products within Territory, including but not necessarily limited to, meeting relevant standards and guidelines, preclinical, clinical and safety approvals required by Government Agencies. LipoMatrix shall reimburse Distributor for reasonable reason able out-of-pocket expenses incurred by Distributor in connection with such assistance provided such expenses are approved in advance. LipoMatrix shall have the primary responsibility for manufacturing compliance and Distributor for any distribution compliance regarding any reporting or compliance matters in the Territory required of distributors by Government Agency rules and regulations, including but not limited to, recalls of the Products and reporting of adverse events involving the Products. The parties shall share information to allow each party to fulfill its compliance obligations hereunder. Each party shall promptly inform the other of any changes in regulatory or compliance status that might significantly affect the marketing of the Products in the Territory. Each party shall inform the other within two (2) working days of any actions taken by such party that could reasonably be expected to affect the regulatory or compliance status of LipoMatrix or the Products. Distributor shall make all reasonable efforts to comply with appropriate standards for review and approval of orders from its customers.