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 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 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 Ampliphi Products, then Intrexon shall provide to Ampliphi or a contract manufacturer selected by Ampliphi and approved by Intrexon all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of Ampliphi Products for use in the Field and (b) reasonably necessary to enable Ampliphi or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of 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 Ampliphi or its contract manufacturer shall not be further transferred to any Third Party, including any sublicensee of Ampliphi, or any Ampliphi Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit Ampliphi to switch manufacturers.

Appears in 3 contracts

Samples: Exclusive Channel Collaboration Agreement (Intrexon Corp), Exclusive Channel Collaboration Agreement (Intrexon Corp), Channel Collaboration Agreement (AmpliPhi Biosciences Corp)

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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 Bacteriophage 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 Ampliphi 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 Ampliphi Soligenix Products, then Intrexon shall provide to Ampliphi Soligenix or a contract manufacturer selected by Ampliphi Soligenix and approved by Intrexon all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities quantities of other components of Ampliphi Soligenix Products for use in the Field and (b) reasonably necessary to enable Ampliphi Soligenix or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of Ampliphi 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 Ampliphi Soligenix or its contract manufacturer shall not be further transferred to any Third Party, including any sublicensee of AmpliphiSoligenix, or any Ampliphi Soligenix Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit Ampliphi Soligenix to switch manufacturers.

Appears in 3 contracts

Samples: Exclusive Channel Collaboration Agreement (Intrexon Corp), Exclusive Channel Collaboration Agreement (Intrexon Corp), Collaboration Agreement (Soligenix, Inc.)

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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 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 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 Ampliphi Products, then Intrexon shall provide to Ampliphi or a contract manufacturer selected by Ampliphi and approved by Intrexon all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of Ampliphi Products for use in the Field and (b) reasonably necessary to enable Ampliphi or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of 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 Ampliphi or its contract manufacturer shall not be further transferred to any Third Party, including any sublicensee of Ampliphi, or any Ampliphi Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit 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.

Appears in 1 contract

Samples: Collaboration Agreement (AmpliPhi Biosciences Corp)

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