Extract to table

6 of the License Agreement, which requires the Parties to execute a pharmacovigilance agreement or safety data exchange agreement within thirty (30) days of the Effective Date of the License Agreement, governing the exchange of safety information between the Parties in connection with PPC-4187; NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows: ARTICLE 1 — DEFINITIONS Capitalized terms used in this Agreement and not otherwise defined herein shall have the meanings ascribed to them in the License Agreement

The following terms shall have the meanings set forth below for purposes of this Agreement: 1

For pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established, all noxious and unintended responses to a medicinal product related to any dose shall be considered adverse drug reactions

3 "Affiliate" shall have the meaning ascribed to such term in Section 1

15 "PBRER" means a Periodic Benefit-Risk Evaluation Report, prepared in accordance with ICH E2C(R2), which represents the current format and content recommended by ICH for periodic reporting of safety data and benefit-risk assessment, and which, for the purposes of this Agreement, shall be deemed to include PSURs to the extent that specific Regulatory Authorities continue to require PSURs by that designation

During the clinical development phase, the RSI shall be the safety information section of the current Investigator's Brochure for PPC-4187 maintained by Penterra