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 Fibroblast Program that relate to the Intrexon Materials. To the extent that Intrexon so elects, Intrexon may request that Fibrocell 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, bulk drug product or bulk quantities of other components of Fibrocell Products, then Intrexon shall provide to Fibrocell or a contract manufacturer selected by Fibrocell and approved by Intrexon all Information Controlled by Intrexon that is related to the manufacturing of such Intrexon Materials, bulk drug product or bulk qualities of other components of Fibrocell Products, for use in the Field and is reasonably necessary to enable Fibrocell or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials, bulk drug product or bulk quantities of other components of Fibrocell 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 Fibrocell or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any Fibrocell Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit Fibrocell 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 3 contracts

Samples: Exclusive Channel Collaboration Agreement (Castle Creek Biosciences, Inc.), Exclusive Channel Collaboration Agreement (Castle Creek Biosciences, Inc.), Exclusive Channel Collaboration Agreement (Fibrocell Science, 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 Fibroblast Program that relate to the Intrexon Materials. To the extent that Intrexon so elects, Intrexon may request that Fibrocell 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, bulk drug product or bulk quantities of other components of Fibrocell Products, then Intrexon shall provide to Fibrocell or a contract manufacturer selected by Fibrocell and approved by Intrexon all Information Controlled by Intrexon that is related to the manufacturing of such Intrexon Materials, bulk drug product or bulk qualities of other components of Fibrocell Products, for use in the Field and is reasonably necessary to enable Fibrocell or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials, bulk drug product or bulk quantities of other components of Fibrocell 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 Fibrocell or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any Fibrocell Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit Fibrocell 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 2 contracts

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

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 Fibroblast Program that relate to the Intrexon Materials. To the extent that Intrexon so elects, Intrexon may request that Fibrocell 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, bulk drug product or bulk quantities of other components of Fibrocell Collaboration Products, then Intrexon shall provide to Fibrocell or a contract manufacturer selected by Fibrocell and approved by Intrexon all Information Controlled by Intrexon that is related to the manufacturing of such Intrexon Materials, bulk drug product or bulk qualities of other components of Fibrocell Collaboration Products, for use in the Field and that is reasonably necessary to enable Fibrocell or such contract manufacturer (as appropriate) for the sole purpose of manufacturing solely to manufacture such Intrexon Materials, bulk drug product or bulk quantities of other components of Fibrocell Collaboration 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 Fibrocell or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, Party or any Fibrocell Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit Fibrocell 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: Channel Collaboration Agreement (Fibrocell Science, Inc.)

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 Fibroblast Probiotics 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 Fibrocell 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, bulk drug product or bulk quantities of other components of Fibrocell Oragenics Products, then Intrexon shall provide to Fibrocell Oragenics or a contract manufacturer selected by Fibrocell Oragenics and approved by Intrexon all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials, bulk drug product or bulk qualities of other components of Fibrocell Oragenics Products, for use in the Field and is (b) reasonably necessary to enable Fibrocell Oragenics or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials, bulk drug product or bulk quantities of other components of Fibrocell 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 IntrexonCONFIDENTIAL TREATMENT REQUESTED BY ORAGENICS, INC. Any manufacturing Information transferred hereunder to Fibrocell or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any Fibrocell Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit Fibrocell to switch manufacturers. EXECUTION COPY CONFIDENTIAL 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. Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to Oragenics or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any Oragenics Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit Oragenics to switch manufacturers.

Appears in 1 contract

Samples: Confidential Treatment (Oragenics Inc)

Manufacturing. Intrexon CPLB shall have use its commercially reasonable efforts to establish and maintain a manufacturing facility in India that complies with current good manufacturing standards in US, EMEA, India and any other territory in which CPLB intends to develop and commercialize any Product within the option and, time-frame set in the event it so electsBusiness Plan. The manufacturing facility shall be consistent with the applicable equipment, processes and procedures used by Novavax and Cadila in their manufacturing facilities, based in part on technology licensed to CPLB under the Restated Licenses. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Schedule I Assets. With respect to any Schedule I Assets, Cadila shall use Diligent Effortsits commercially reasonable efforts to transfer and/or assign any interest it owns or holds in the Schedule I Assets to CPLB as soon as reasonably practicable, but in no event shall such transfer conclude any later than 60 days after getting necessary regulatory approval for such transfer from the relevant regulatory authorities. In doing so, Cadila shall transfer regulatory approvals and licenses it owns with respect to perform any manufacturing activities in connection with the Fibroblast Program that relate Cadila Transferred Products to the Intrexon MaterialsCPLB. To the extent that Intrexon so elects, Intrexon may request that Fibrocell 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 4.1CPLB shall re-imburse to Cadila, 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, bulk drug product or bulk quantities of other components of Fibrocell Products, then Intrexon shall provide to Fibrocell or a contract manufacturer selected by Fibrocell and approved by Intrexon all Information Controlled by Intrexon that is related to the manufacturing of such Intrexon Materials, bulk drug product or bulk qualities of other components of Fibrocell Products, for use in the Field and is reasonably necessary to enable Fibrocell or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials, bulk drug product or bulk quantities of other components of Fibrocell Products, in each case as manufactured by Intrexon. The costs and expenses incurred by Intrexon in carrying out Cadila for development of Cadila Transferred Products from the date of First Restated JV Agreement till the date of such transfer transfer. Similarly, CPLB shall re-imburse to Cadila for any expenses incurred by Cadila for development of Novavax Products from the date of First Restated JV Agreement. All such expenses shall be borne mutually agreed by IntrexonCadila and Novavax in advance of reimbursement. Any manufacturing Information transferred hereunder Cadila has also acquired and / or owns and may further acquire several assets including machinery, equipment, etc. for CPLB’s business pertaining to Fibrocell or its contract manufacturer the Cadila Transferred Products. Cadila shall not transfer such assets at their respective cost. All such costs shall be further transferred to any Third Party, including any Product Sublicensee, or any Fibrocell Affiliate without the prior written consent mutually agreed by Cadila and Novavax in advance of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit Fibrocell 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 Commissionpayment.

Appears in 1 contract

Samples: Joint Venture Agreement (Novavax 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 Fibroblast SMA Therapeutics Program that relate to the Intrexon Materials, the manufacture of bulk drug product, the manufacturing of bulk quantities of other components of BioLife Products, or any earlier steps in the manufacturing process for BioLife Products. To the extent that Intrexon so elects, Intrexon may request that Fibrocell BioLife 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, bulk drug product or bulk quantities of other components of Fibrocell BioLife Products, then Intrexon shall provide to Fibrocell BioLife or a contract manufacturer selected by Fibrocell BioLife and approved by Intrexon all Information Controlled by Intrexon that is related to the manufacturing of such Intrexon Materials, bulk drug product or bulk qualities of other components of Fibrocell BioLife Products, for use in the Field and is reasonably necessary to enable Fibrocell BioLife or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials, bulk drug product or bulk quantities of other components of Fibrocell BioLife 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 Fibrocell BioLife or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any Fibrocell Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit Fibrocell 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. not be further transferred to any Third Party, including any Product Sublicensee, or any BioLife Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit BioLife to switch manufacturers.

Appears in 1 contract

Samples: Exclusive Research Collaboration Agreement (Intrexon Corp)

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 Fibroblast 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 Fibrocell Oragenics and Intrexon establish and execute a separate manufacturing and supply agreement, which CONFIDENTIAL TREATMENT REQUESTED BY ORAGENICS, INC. 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. 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, bulk drug product or bulk quantities of other components of Fibrocell Oragenics Products, then Intrexon shall provide to Fibrocell Oragenics or a contract manufacturer selected by Fibrocell Oragenics and approved by Intrexon all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials, bulk drug product or bulk qualities of other components of Fibrocell Oragenics Products, for use in the Field and is (b) reasonably necessary to enable Fibrocell Oragenics or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials, bulk drug product or bulk quantities of other components of Fibrocell 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 Fibrocell Oragenics or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any Fibrocell Oragenics Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit Fibrocell 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.

Appears in 1 contract

Samples: Exclusive Channel Collaboration Agreement (Oragenics Inc)

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 Fibroblast Probiotics 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 Fibrocell 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 CONFIDENTIAL TREATMENT REQUESTED BY INTREXON CORPORATION EXECUTION COPY CONFIDENTIAL 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. 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, bulk drug product or bulk quantities of other components of Fibrocell Oragenics Products, then Intrexon shall provide to Fibrocell Oragenics or a contract manufacturer selected by Fibrocell Oragenics and approved by Intrexon all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials, bulk drug product or bulk qualities of other components of Fibrocell Oragenics Products, for use in the Field and is (b) reasonably necessary to enable Fibrocell Oragenics or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials, bulk drug product or bulk quantities of other components of Fibrocell 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 Fibrocell Oragenics or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any Fibrocell Oragenics Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit Fibrocell 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.

Appears in 1 contract

Samples: Exclusive Channel Collaboration Agreement (Intrexon Corp)

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