Common use of Reporting etc Clause in Contracts

Reporting etc. Purchaser shall have the responsibility in the Territory for complying with all regulatory filings, reporting requirements and other matters which relate solely to Purchaser’s acting as a distributor of the Product in the Territory. In the event Purchaser determines that it is required to file this Agreement with the United States Securities and Exchange Commission, Purchaser shall provide Seller with reasonable prior notice of such requirement and shall request confidential treatment of the financial terms and other competitively sensitive or trade secret terms of this Agreement. All other regulatory reporting matters (including adverse event and product complaint reporting) shall be Seller’s responsibility. Purchaser represents and warrants that Purchaser has in place systems and resources for tracking and reporting any adverse events with respect to the Product, such systems and resources to be consistent with good commercial standards in the pharmaceutical industry. Purchaser shall notify Seller of receipt of any report(s) of adverse events or product complaints pursuant to a Pharmacovigilance Agreement. To the extent that any inconsistencies exist between the Pharmacovigilance Agreement and this Agreement, the stipulations and provisions in this Agreement shall prevail. Seller shall have the right to audit Purchaser’s systems with respect to handling adverse event reporting in connection with the Products, any such audit to be done during normal business hours on reasonable notice, and in a fashion to avoid unnecessary disruption to normal business operations. Any complaint or adverse event received by one party that relates to product manufacture or packaging must be reported to the other party within 3 business days. The Pharmacovigilence Agreement shall set forth additional details with respect to the handling of adverse event reporting. In order to ensure compliance with safety reporting requirements in the respective Territories the parties shall agree on a process and procedure for sharing adverse event information which shall be documented in a Pharmacovigilance Agreement (the “Pharmacovigilence Agreement”). Within thirty (30) days from the effective date of this Agreement each party shall assign a safety representative to begin discussions to ensure a Pharmacovigilence Agreement is executed no later than April 1, 2011. Pending execution of such agreement, the parties shall, as required, within thirty (30) days implement an interim procedure for exchange of any and all information concerning adverse events related to use of the Product regardless of source to ensure each party’s compliance with legal requirements in its respective territories.

Reporting etc. Purchaser shall have the responsibility in the Territory for complying with all regulatory filings, reporting requirements and other matters which relate solely to Purchaser’s acting as a distributor of the Product in the Territory. In the event Purchaser determines that it is required to file this Agreement with the United States Securities and Exchange Commission, Purchaser shall provide Seller with reasonable prior notice of such requirement and shall request confidential treatment of the financial terms and other competitively sensitive or trade secret terms of this Agreement. All other regulatory reporting matters (including adverse event and product complaint reporting) shall be Seller’s responsibility. Purchaser represents and warrants that Purchaser has in place systems and resources for tracking and reporting any adverse events with respect to the Product, such systems and resources to be Execution Copy consistent with good commercial standards in the pharmaceutical industry. Purchaser shall notify Seller of receipt of any report(s) of adverse events or product complaints pursuant to a Pharmacovigilance Agreement. To the extent that any inconsistencies exist between the Pharmacovigilance Agreement and this Agreement, the stipulations and provisions in this Agreement shall prevail. Seller shall have the right to audit Purchaser’s systems with respect to handling adverse event reporting in connection with the Products, any such audit to be done during normal business hours on reasonable notice, and in a fashion to avoid unnecessary disruption to normal business operations. Any complaint or adverse event received by one party that relates to product manufacture or packaging must be reported to the other party within 3 business days. The Pharmacovigilence Agreement shall set forth additional details with respect to the handling of adverse event reporting. In order to ensure compliance with safety reporting requirements in the respective Territories the parties shall agree on a process and procedure for sharing adverse event information which shall be documented in a Pharmacovigilance Agreement (the “Pharmacovigilence Agreement”). Within thirty (30) days from the effective date of this Agreement each party shall assign a safety representative to begin discussions to ensure a Pharmacovigilence Agreement is executed no later than April 1, 2011. Pending execution of such agreement, the parties shall, as required, within thirty (30) days implement an interim procedure for exchange of any and all information concerning adverse events related to use of the Product regardless of source to ensure each party’s compliance with legal requirements in its respective territories.