Common use of Rights to Regulatory Data Clause in Contracts

Rights to Regulatory Data. AquaBounty shall own and control all regulatory trial data and regulatory filings relating to Commercialization of AquaBounty Products (except to the extent such become Reverted Products). AquaBounty shall provide (or shall cause an applicable Product Sublicensee to provide) to Intrexon, upon its request, access to review all trial data and reports, regulatory filings, and communications from regulatory authorities that relate specifically and solely to AquaBounty Products. To the extent that there exist any trial data and reports, regulatory filings, and communications from regulatory authorities owned by AquaBounty (or a Product Sublicensee) that relate both to AquaBounty Products and other products produced by AquaBounty (or a Product Sublicensee) outside the Field or outside the Aquaculture Program, upon Intrexon’s request, AquaBounty shall provide (or shall cause an applicable Product Sublicensee to provide) to Intrexon access to review the portions of such data, reports, filings, and communications that relate to AquaBounty 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 these data, reports, filings, and communications relating to AquaBounty 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 Aquaculture Program, utilize knowingly any AquaBounty trial data or reports in support of obtaining regulatory approval for a product for use in the Field.

Rights to Regulatory Data. AquaBounty Genopaver shall own and control all regulatory trial data and regulatory filings relating to Commercialization of AquaBounty Genopaver Products (except to the extent such become Reverted Products). AquaBounty Genopaver shall provide (or shall cause an applicable Product Sublicensee to provide) to Intrexon at Intrexon, upon its request, access to review ’s written request full copies of all trial regulatory data and reports, regulatory filings, and communications from regulatory authorities that relate specifically and solely to AquaBounty Genopaver Products. To the extent that there exist any trial regulatory data and reports, regulatory filings, and communications from regulatory authorities owned by AquaBounty Genopaver (or a Product Sublicensee) that relate both to AquaBounty Genopaver Products and other products produced by AquaBounty Genopaver (or a Product Sublicensee) outside the Field or outside the Aquaculture ProgramField, upon Intrexon’s request, AquaBounty written request Genopaver shall provide (or shall cause an applicable Product Sublicensee to provide) to Intrexon access to review copies of the portions of such data, reports, filings, and communications that relate to AquaBounty Genopaver 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 these this data, reports, filings, and communications relating to AquaBounty Genopaver Products in regulatory filings made to obtain regulatory EXECUTION COPY 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. 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 Aquaculture Alkaloid Program, utilize knowingly any AquaBounty trial Genopaver data or reports in support of obtaining regulatory approval for a product for use in the Field.

Rights to Regulatory Data. AquaBounty JV shall own and control all regulatory trial data and regulatory filings relating to Commercialization of AquaBounty JV Products (except to the extent such become Reverted Products). AquaBounty JV shall provide (or shall cause an applicable Product Sublicensee to provide) to Intrexon at Intrexon, upon its request, access to review ’s reasonable request full copies of all trial data and reports, regulatory filings, and communications from regulatory authorities that relate specifically and solely to AquaBounty JV Products. To the extent that there exist any trial data and reports, regulatory filings, and communications from regulatory authorities owned by AquaBounty (or a Product Sublicensee) JV that relate both to AquaBounty JV Products and other products produced by AquaBounty (or a Product Sublicensee) JV outside the Field or outside the Aquaculture Ophthalmic Program, upon Intrexon’s request, AquaBounty reasonable request JV shall provide (or shall cause an applicable Product Sublicensee to provide) to Intrexon access to review copies of the portions of such data, reports, filings, and communications that relate to AquaBounty Productsa JV Product. 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 these this data, reports, filings, and communications relating to AquaBounty JV 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 Aquaculture Ophthalmic Program, utilize knowingly any AquaBounty JV trial data or reports in support of obtaining regulatory approval for a product for use in the Field. Intrexon shall keep the JSC apprised of any regulatory data that is shared with a Third Party or Affiliate pursuant to this Section 3.7. To the extent that Intrexon Controls, or has such contractual rights with Third Parties to use for such purposes, regulatory trial data or filings that relate to the use of JV Products in the Field, subject to its ongoing obligations of exclusivity under Section 3.5, JV shall be permitted to reference such data, reports, filings, and communications to obtain regulatory approval for JV Products 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. AquaBounty NewCo shall own and control all regulatory trial data and regulatory filings relating to Commercialization of AquaBounty Collaboration Products (except to the extent such become Reverted Products). AquaBounty NewCo shall provide (or shall cause an applicable Product Sublicensee to provide) to Intrexon at Intrexon, upon its request, access to review ’s written request full copies of all trial regulatory data and reports, regulatory filings, and communications from regulatory authorities that relate specifically and solely to AquaBounty Collaboration Products. To the extent that there exist any trial regulatory data and reports, regulatory filings, and communications from regulatory authorities owned by AquaBounty NewCo (or a Product Sublicensee) that relate both to AquaBounty Collaboration Products and other products produced by AquaBounty NewCo (or a Product Sublicensee) outside the Field or outside the Aquaculture ProgramField, upon Intrexon’s request, AquaBounty written request NewCo shall provide (or shall cause an applicable Product Sublicensee to provide) to Intrexon access to review copies of the portions of such data, reports, filings, and communications that 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. relate to AquaBounty Collaboration 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 these this data, reports, filings, and communications relating to AquaBounty Collaboration 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 Aquaculture Biofuels Program, utilize knowingly any AquaBounty trial NewCo data or reports in support of obtaining regulatory approval for a product for use in the Field.

Rights to Regulatory Data. AquaBounty (a) Histogenics shall own and control all regulatory trial data and regulatory filings relating to Commercialization of AquaBounty Products (except to the extent such become Reverted Products). AquaBounty shall provide (or shall cause an applicable Product Sublicensee to provide) to Intrexon, upon its request, access to review all trial data and reports, regulatory filings, and communications from regulatory authorities that relate specifically and solely to AquaBounty Collaboration Products. To the extent that there exist any trial data and reports, regulatory filings, and communications from regulatory authorities owned by AquaBounty (or a Product Sublicensee) that relate both to AquaBounty Products and other products produced by AquaBounty (or a Product Sublicensee) outside the Field or outside the Aquaculture Program, upon Intrexon’s request, AquaBounty Histogenics shall provide (or shall cause an applicable Product Sublicensee to provide) to Intrexon access following receipt of Intrexon’s written request full copies of all regulatory data and reports, regulatory filings, and communications from regulatory authorities to review the extent that they relate specifically to Intrexon Materials that are or express ingredients for Collaboration Products. To the extent that there exist any regulatory data and reports, regulatory filings, and communications from regulatory authorities owned by Histogenics (or a Product Sublicensee) that relate both to Collaboration Products and other products produced by Histogenics (or a Product Sublicensee) inside or outside the Field, following receipt of Intrexon’s written request Histogenics shall provide (or shall cause an applicable Product Sublicensee to provide) to Intrexon copies of the portions of such data, reports, filings, and communications that relate specifically to AquaBounty Intrexon Materials that are or express ingredients for Collaboration Products. Subject to its ongoing obligations of exclusivity under Section 3.53.5 and subject to Section 2.6, Intrexon shall be permitted, directly or in conjunction with or through partners or other channel collaborators, to reference these this data, reports, filings, and communications relating specifically to AquaBounty Intrexon Materials that are or express ingredients for Collaboration 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 3.73.8, Intrexon shall not, outside of the Aquaculture Program, utilize knowingly any AquaBounty trial data Histogenics data, reports, filings or reports communications in support of obtaining regulatory approval for a product indicated for use in the Field. To the extent that any Histogenics data, reports, filings or communications in this 3.8(a) contain Confidential Information such information shall be subject to the provisions of Article 7.