Common use of Compliance and Approval Clause in Contracts

Compliance and Approval. DISTRIBUTOR shall ensure Promotional Materials comply with the Marketing Authorization, all Applicable Laws and all other applicable rules and regulations in the Territory. DISTRIBUTOR shall submit Promotional Materials to SUPPLIER for review and approval, in sufficient advance to allow SUPPLIER to verify if such Promotional Materials comply with SUPPLIER’s global branding strategies and the relevant Marketing Authorization. DISTRIBUTOR shall, at its own risk, cost and expense, translate Promotional Materials into the English language or certify in writing that any Promotional Material in a local language is a correct translation of the Promotional Material provided by SUPPLIER and that the translation was made by a certified translator. SUPPLIER shall provide comments or approval within fifteen (15) Business Days from receipt of a complete submission. If SUPPLIER does not give approval or comments within that fifteen (15) Business Day period, such Promotional Material shall be deemed approved. 5 AUTHORIZATIONS, PHARMACOVIGILANCE, COMPLAINTS, RECALLS AND ESCALATIONS 5.1 Regulatory and Pricing Approval

Compliance and Approval. DISTRIBUTOR shall submit DISTRIBUTOR Promotional Materials, which DISTRIBUTOR shall ensure Promotional Materials comply with the Marketing Authorization, all Applicable Laws and and/or all other applicable rules and regulations in the Territory. DISTRIBUTOR shall submit Promotional Materials to SUPPLIER , for review and approval, in sufficient advance approval by SUPPLIER on a timely basis to allow SUPPLIER to verify if such Promotional Materials comply are in line with SUPPLIER’s global branding strategies and the relevant Marketing Authorization. In the event that such Promotional Materials are not in line with global branding strategies and relevant Marketing Authorization, SUPPLIER will notify DISTRIBUTOR of any discrepancies and request DISTRIBUTOR to cure such discrepancies. Upon reasonable request by SUPPLIER, and provided SUPPLIER has no internal resources to read and understand [***] text, DISTRIBUTOR shall, at its own risk, cost and expense, translate Promotional Materials into the English language or certify in writing that any Promotional Material in a local language is a correct translation of the Promotional Material provided by SUPPLIER and that the translation was made by a certified translator. SUPPLIER shall provide comments or approval within fifteen (15) Business Days [***] from receipt of a complete submission. If SUPPLIER does not give approval or comments within that fifteen (15) Business Day [***] period, such Promotional Material shall be deemed approved. 5 AUTHORIZATIONS, PHARMACOVIGILANCE, COMPLAINTS, RECALLS AND ESCALATIONS 5.1 Regulatory and Pricing Approval.

Compliance and Approval. DISTRIBUTOR shall ensure that all Promotional Materials comply with the relevant Marketing Authorization, all Applicable Laws and and/or all other applicable rules and regulations in the Territory. DISTRIBUTOR shall submit to SUPPLIER drafts or prototypes of all Promotional Materials to SUPPLIER in the English language for review and approval, in sufficient advance approval by SUPPLIER at least [***] prior to allow the release of such Promotional Materials. SUPPLIER to shall verify if such Promotional Materials comply are in line with SUPPLIER’s global branding strategies and relevant Marketing Authorization. In the event that such Promotional Materials are not in line with global branding strategies and/or the relevant Marketing Authorization, SUPPLIER will notify DISTRIBUTOR of any discrepancies and request DISTRIBUTOR to cure such discrepancies. Upon reasonable request by SUPPLIER DISTRIBUTOR shall, at its own risk, cost and expense, translate [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) CUSTOMARILY AND ACTUALLY TREATED BY THE REGISTRANT AS PRIVATE OR CONFIDENTIAL. Promotional Materials into the English language or certify in writing that any Promotional Material in a local language is a correct translation of the Promotional Material provided by SUPPLIER and that the translation was made by a certified translatorin accordance with ISO 17100:2015. SUPPLIER shall use its Reasonable Commercial Efforts to provide comments or approval within fifteen (15) Business Days [***], however in any case not later than [***], from receipt of a complete submission. If SUPPLIER does not give approval or comments within that fifteen (15) Business Day period, such Promotional Material shall be deemed approved. 5 AUTHORIZATIONS, PHARMACOVIGILANCE, COMPLAINTS, RECALLS AND ESCALATIONS 5.1 Regulatory and Pricing Approval.

Compliance and Approval. DISTRIBUTOR shall ensure that all Promotional Materials comply with the relevant Marketing Authorization, all Applicable Laws and and/or all other applicable rules and regulations in the Territory. DISTRIBUTOR shall submit to SUPPLIER drafts or prototypes of all Promotional Materials to SUPPLIER in the English language for review and approval, in sufficient advance approval by SUPPLIER at least [***] prior to allow the release of such Promotional Materials. SUPPLIER to shall verify if such Promotional Materials comply are in line with SUPPLIER’s global branding strategies and relevant Marketing Authorization. In the event that such Promotional Materials are not in line with global branding strategies and/or the relevant Marketing Authorization, SUPPLIER will notify DISTRIBUTOR of any discrepancies and request DISTRIBUTOR to cure such discrepancies. Upon reasonable request by SUPPLIER DISTRIBUTOR shall, at its own risk, cost and expense, translate Promotional Materials into the English language or certify in writing that any Promotional Material in a local language is a correct translation of the Promotional Material provided by SUPPLIER and that the translation was made by a certified translatorin accordance with ISO 17100:2015. SUPPLIER shall use its Reasonable Commercial Efforts to provide comments or approval within fifteen (15) Business Days [***], however in any case not later [***], from receipt of a complete submission. If SUPPLIER does not give approval or comments within that fifteen (15) Business Day period, such Promotional Material shall be deemed approved. 5 AUTHORIZATIONS, PHARMACOVIGILANCE, COMPLAINTS, RECALLS AND ESCALATIONS 5.1 Regulatory and Pricing Approval.