Product Queries. DISTRIBUTOR shall perform the medical information services for the Product by using up-to-date, and SUPPLIER approved, resources; Summary of Product Characteristics or local equivalent; and the English Product Questions & Answers (Q&A) document(s). DISTRIBUTOR shall translate into English (and certify the accuracy of such translation) at its risk and expense all (i) Product medical queries outside the scope of the Summary of Product Characteristics (or local equivalent) and the English Product Q&A document(s); and (ii) Product stability queries it receives and forward them in an anonymous form to SUPPLIER’s Address for Medical Information Purposes (ANNEX I) [***] = 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. within [***] of receipt. The answer will be compiled in English by SUPPLIER’s respective department and will be sent within [***] of receipt to DISTRIBUTOR, unless the complexity of the queries received requires a longer response time, in which case SUPPLIER will respond as soon as practicable (and in any event not later than within [***]) inform DISTRIBUTOR of the expected delay. DISTRIBUTOR shall be responsible for translation to the local language(s) at its risk and expense, for ensuring that answers are compliant with local laws and regulations e.g. by adding specific required information and for contacting and liaising with its customer.
Product Queries. DISTRIBUTOR shall perform the medical information services for the Product by using up-to-date and SUPPLIER approved resources: Summary of Product Characteristics or local equivalent and the English Product Questions & Answers (Q&A) document(s). [***] = 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. DISTRIBUTOR shall forward all Product medical queries outside the scope of the Summary of Product Characteristics (or local equivalent) and the English Product Q&A document(s) it receives in an anonymous form to SUPPLIER’s Address for Medical Information Purposes (ANNEX I) as soon as practicable after receipt but no longer than [***]. The answer will be compiled by SUPPLIER’s respective department and will be sent as soon as practicable, but no longer than [***], to DISTRIBUTOR, who shall be responsible for ensuring that answers are compliant with local laws and regulations e.g. by adding specific required information and for contacting and liaising with its customer.
Product Queries. DISTRIBUTOR shall perform the medical information services for the Product by using up-to-date and SUPPLIER approved resources (i) Summary of Product Characteristics or local equivalent (ii) English Product Questions & Answers (Q&A) document(s) and (iii) Standard Response Documents (SRDs) approved by the SUPPLIER. DISTRIBUTOR shall translate into English at its risk and expense all (i) Product medical queries outside the scope of the Summary of Product Characteristics (or local equivalent), English Product Q&A and English SRDs it receives and forward them in an anonymous form to SUPPLIER’s Address for Medical Information Purposes (ANNEX J) within [***] Business Days of receipt. The answer will be compiled in English by XXXXXXXX’s respective department or med info service provider and will be sent as soon as practicable to DISTRIBUTOR, who shall be responsible for translation to the local language(s) at its risk and expense, for ensuring that answers are compliant with local laws and regulations e.g. by adding specific required information and for contacting and liaising with its customer.
