Common use of Manufacturing Clause in Contracts

Manufacturing. Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.

Manufacturing. Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Melioidosis Program that relate to of the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon either Party may request that AquaBounty Soligenix and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Soligenix Products, then Intrexon shall provide to AquaBounty Soligenix or a contract manufacturer selected by AquaBounty Soligenix and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities quantities of other components of AquaBounty Soligenix Products for use in the Field and (b) reasonably necessary to enable AquaBounty Soligenix or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Soligenix Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty Soligenix or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicenseesublicensee of Soligenix, or any AquaBounty Soligenix Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty Soligenix to switch manufacturers.

Manufacturing. Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Bacteriophage Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty Ampliphi and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Ampliphi Products, then Intrexon shall provide to AquaBounty Ampliphi or a contract manufacturer selected by AquaBounty Ampliphi and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Ampliphi Products for use in the Field and (b) reasonably necessary to enable AquaBounty Ampliphi or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Ampliphi Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty Ampliphi or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicenseesublicensee of Ampliphi, or any AquaBounty Ampliphi Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty Ampliphi to switch manufacturers.

Manufacturing. Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture PAH Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materialsbulk drug product, the manufacturing of bulk quantities of other components of Adeona Products, or any earlier steps in the manufacturing process for Adeona Products. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials Materials, bulk drug product or bulk quantities of other components of AquaBounty Adeona Products, then Intrexon shall provide to AquaBounty Adeona or a contract manufacturer selected by AquaBounty Adeona and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials Materials, bulk drug product or bulk qualities of other components of AquaBounty Products Adeona Products, for use in the Field and (b) is reasonably necessary to enable AquaBounty Adeona or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials Materials, bulk drug product or bulk quantities of other components of AquaBounty Adeona Products, in each case as manufactured by Intrexon. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty Adeona or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, Party or any AquaBounty Adeona Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty Adeona to switch manufacturers.

Manufacturing. Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Lantibiotics Program that relate to the Intrexon Materials, including through the use manufacture of a suitable Third Party contract manufacturerbulk drug product, the manufacturing of bulk quantities of other components of Oragenics Products, or any earlier steps in the manufacturing process for Oragenics Products. To the extent that Intrexon so elects, Intrexon may request that AquaBounty Oragenics and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials Materials, bulk drug product or bulk quantities of other components of AquaBounty Oragenics Products, then Intrexon shall provide to AquaBounty Oragenics or a contract manufacturer selected by AquaBounty Oragenics and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials Materials, bulk drug product or bulk qualities of other components of AquaBounty Products Oragenics Products, for use in the Field and (b) is reasonably necessary to enable AquaBounty Oragenics or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials Materials, bulk drug product or bulk quantities of other components of AquaBounty Oragenics Products, in each case as manufactured by Intrexon. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty Oragenics or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, Party or any AquaBounty Oragenics Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty Oragenics to switch manufacturers. 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.

Manufacturing. Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Ophthalmic Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty JV and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty JV Products, then Intrexon shall provide to AquaBounty JV or a contract manufacturer selected by AquaBounty JV and approved by Intrexon (such approval not to be deemed to have been given if Intrexon holds at least 50% of the equity of JV and in no event to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty JV Products for use in the Field and (b) reasonably necessary to enable AquaBounty JV or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty JV Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty JV or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, sublicensee of JV or any AquaBounty Affiliate JV Affiliate, without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty JV to switch manufacturers.

Manufacturing. Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Bacteriophage Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty Ampliphi and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Ampliphi Products, then Intrexon shall provide to AquaBounty Ampliphi or a contract manufacturer selected by AquaBounty Ampliphi and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Ampliphi Products for use in the Field and (b) reasonably necessary to enable AquaBounty Ampliphi or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Ampliphi Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty Ampliphi or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicenseesublicensee of Ampliphi, or any AquaBounty Ampliphi Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty Ampliphi to switch manufacturers. 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.

Manufacturing. Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty Oragenics and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials Materials, bulk drug product or bulk quantities of other components of AquaBounty Oragenics Products, then Intrexon shall provide to AquaBounty Oragenics or a contract manufacturer selected by AquaBounty Oragenics and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials Materials, bulk drug product or bulk qualities of other components of AquaBounty Products Oragenics Products, for use in the Field and (b) reasonably necessary to enable AquaBounty Oragenics or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials Materials, bulk drug product or bulk quantities of other components of AquaBounty Oragenics Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty Oragenics or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Oragenics Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty Oragenics to switch manufacturers.

Manufacturing. Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, Efforts to perform any manufacturing activities in connection with the Aquaculture GvHD Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materialsbulk drug product, the manufacturing of bulk quantities of other components of Products, or any earlier steps in the manufacturing process for Products. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials Materials, bulk drug product or bulk quantities qualities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty ZIOPHARM or a contract manufacturer selected by AquaBounty ZIOPHARM and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials Materials, bulk drug product or bulk qualities of other components of AquaBounty Products Products, for use in the Field and (b) is reasonably necessary to enable AquaBounty ZIOPHARM or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials Materials, bulk drug product or bulk quantities of other components of AquaBounty Products, in each case as manufactured by Intrexon. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty ZIOPHARM or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, Party or any AquaBounty ZIOPHARM Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty ZIOPHARM to switch manufacturers.