Common use of Rights to Regulatory Data Clause in Contracts

Rights to Regulatory Data. Ampliphi shall own and control all regulatory trial data and regulatory filings relating to Commercialization of Ampliphi Products (except to the extent such become Reverted Products). Ampliphi shall provide to Intrexon at Intrexon’s request full copies of all trial data and reports, regulatory filings, and communications from regulatory authorities that relate specifically and solely to Ampliphi Products. To the extent that there exist any trial data and reports, regulatory filings, and communications from regulatory authorities owned by Ampliphi that relate both to Ampliphi Products and other products produced by Ampliphi outside the Field or outside the Bacteriophage Program, upon Intrexon’s request Ampliphi shall provide to Intrexon copies of the portions of such data, reports, filings, and communications that relate to Ampliphi Products, provided any such materials shall be Confidential Information of Ampliphi (except to the extent such become Reverted Products). Subject to its ongoing obligations of exclusivity under Section 3.5, Intrexon shall be permitted, directly or in conjunction with or through partners or other channel collaborators, to reference this data, reports, filings, and communications relating to Ampliphi Products in regulatory filings made to obtain regulatory approval for products for use in fields outside the Field. Intrexon shall have the right to use any such information in developing and Commercializing products outside the Field and to license any Third Parties to do so. Notwithstanding the provisions of this Section 3.7, Intrexon shall not, outside of the Bacteriophage Program, utilize any Ampliphi trial data or reports in support of obtaining regulatory approval for a product for use in the Field. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.

Rights to Regulatory Data. Ampliphi shall own and control all regulatory trial data and regulatory filings relating to Commercialization of Ampliphi Products (except to the extent such become Reverted Products). Ampliphi shall provide to Intrexon at Intrexon’s request full copies of all trial data and reports, regulatory filings, and communications from regulatory authorities that relate specifically and solely to Ampliphi Products. To the extent that there exist any trial data and reports, regulatory filings, and communications from regulatory authorities owned by Ampliphi that relate both to Ampliphi Products and other products produced by Ampliphi outside the Field or outside the Bacteriophage Program, upon Intrexon’s request Ampliphi shall provide to Intrexon copies of the portions of such data, reports, filings, and communications that relate to Ampliphi Products, provided any such materials shall be Confidential Information of Ampliphi (except to the extent such become Reverted Products). Subject to its ongoing obligations of exclusivity under Section 3.5, Intrexon shall be permitted, directly or in conjunction with or through partners or other channel collaborators, to reference this data, reports, filings, and communications relating to Ampliphi Products in regulatory filings made to obtain regulatory approval for products for use in fields outside the Field. Intrexon shall have the right to use any such information in developing and Commercializing products outside the Field and to license any Third Parties to do so. Notwithstanding the provisions of this Section 3.7, Intrexon shall not, outside of the Bacteriophage Program, utilize any Ampliphi trial data or reports in support of obtaining regulatory approval for a product for use in the Field. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.