Common use of Pediatric Clinical Trials Clause in Contracts

Pediatric Clinical Trials. In the event that the Regulatory Authorities require a pediatric clinical trial to be conducted with respect to the Product, subject to the input by Distributor, Cipher shall he responsible for conducting such pediatric clinical trial, and submitting appropriate filings with the Regulatory Authorities. All Third Party out-of-pocket costs incurred by Cipher in the conduct of such pediatric clinical trial shall be [***] between the Parties (it being understood that Cipher shall pay such out-of-pocket costs and thereafter be reimbursed by Distributor for [***] thereof on a monthly basis within ten (10) business days of receiving an invoice and supporting details for such out-of-pocket costs. Notwithstanding the foregoing, if the requirement for a pediatric clinical trial can be achieved through alternative means approved by the Parties, including funding an existing Third Party tramadol ER pediatric study, all fees and costs paid to such Third Party by Cipher in connection therewith shall be [***] between the Parties (it being understood that Cipher shall pay such fees and costs and thereafter be reimbursed by Distributor for [***] thereof on a monthly basis with ten (10) business days after receiving an invoice with supporting details for such out-of-pocket costs.