Development and Commercialization. Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).
Appears in 5 contracts
Samples: Exclusive Channel Collaboration Agreement (Castle Creek Biosciences, Inc.), Exclusive Channel Collaboration Agreement (Castle Creek Biosciences, Inc.), Exclusive Channel Collaboration Agreement (Intrexon Corp)
Development and Commercialization. Subject to Sections 4.6 and 4.7, Fibrocell Soligenix shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Soligenix Products. Fibrocell Soligenix shall be responsible for all costs incurred in connection with the Fibroblast Melioidosis Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Soligenix Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Soligenix Product (which research costs shall be reimbursed by FibrocellSoligenix); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection clause (a) above of the previous sentence shall include without limitation the scale-up of Intrexon Materials and for generating data for manufacturing-related active pharmaceutical ingredients for clinical trials regulatory approval submissions and Commercialization of Fibrocell Soligenix Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell Soligenix (with Intrexon’s consent).
Appears in 3 contracts
Samples: Exclusive Channel Collaboration Agreement (Intrexon Corp), Exclusive Channel Collaboration Agreement (Intrexon Corp), Collaboration Agreement (Soligenix, Inc.)
Development and Commercialization. Subject to Sections 4.6 4.5 and 4.74.6, Fibrocell AquaBounty shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved AquaBounty Products. Fibrocell AquaBounty shall be responsible for all costs incurred in connection with the Fibroblast Aquaculture Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 4.5 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell an AquaBounty Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvementsimprovements to Intrexon’s synthetic biology platforms) but, for clarity, excluding research described in Section 4.7 4.6 or research requested by the JSC AquaBounty for the development of a Fibrocell Product or an Improved AquaBounty Product (which research costs shall be reimbursed by FibrocellAquaBounty); (c) [*****]payments under Section 3.9(c)(i) in respect of Supplemental In-Licensed Third Party IP; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection clause (a) above of the previous sentence shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials generating data for regulatory approval submissions and Commercialization of Fibrocell AquaBounty Products undertaken pursuant to Section 4.64.5, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell AquaBounty (with Intrexon’s consent).
Appears in 3 contracts
Samples: Channel Collaboration Agreement, Exclusive Channel Collaboration Agreement (AquaBounty Technologies, Inc.), Exclusive Channel Collaboration Agreement (AquaBounty Technologies, Inc.)
Development and Commercialization. Subject to Sections 4.6 and 4.7, Fibrocell Ampliphi shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Ampliphi Products. Fibrocell Ampliphi shall be responsible for all costs incurred in connection with the Fibroblast Bacteriophage Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell an Ampliphi Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Ampliphi Product (which research costs shall be reimbursed by FibrocellAmpliphi); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection clause (a) above of the previous sentence shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials generating data for regulatory approval submissions and Commercialization of Fibrocell Ampliphi Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell Ampliphi (with Intrexon’s consent).
Appears in 3 contracts
Samples: Collaboration Agreement (AmpliPhi Biosciences Corp), Exclusive Channel Collaboration Agreement (Intrexon Corp), Exclusive Channel Collaboration Agreement (Intrexon Corp)
Development and Commercialization. Subject to Sections 4.6 and 4.7, Fibrocell Oragenics shall be solely responsible for the performance of the Lantibiotics Program and the development and Commercialization commercialization of Fibrocell Oragenics Products and Improved Productsin the Field. Fibrocell Oragenics shall be responsible for all costs incurred in connection with the Fibroblast Lantibiotics Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Oragenics Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Oragenics Product (which research costs shall be reimbursed by FibrocellOragenics); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization commercialization of Fibrocell Oragenics Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell Oragenics (with Intrexon’s consent).
Appears in 3 contracts
Samples: Exclusive Channel Collaboration Agreement (Intrexon Corp), Exclusive Channel Collaboration Agreement (Intrexon Corp), Channel Collaboration Agreement (Oragenics Inc)
Development and Commercialization. Subject to Sections 4.6 and 4.7, Fibrocell ZIOPHARM shall be solely responsible for the performance of the Cancer Program and the development and Commercialization commercialization of Fibrocell ZIOPHARM Products and Improved Productsin the Field. Fibrocell ZIOPHARM shall be responsible for all costs incurred in connection with the Fibroblast Cancer Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell ZIOPHARM Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic discovery-stage research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) (but, for clarity, excluding EXECUTION VERSION 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. research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell4.7); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients API for clinical trials and Commercialization commercialization of Fibrocell ZIOPHARM Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell ZIOPHARM (with Intrexon’s consent).
Appears in 2 contracts
Samples: Exclusive Channel Partner Agreement (Intrexon Corp), Exclusive Channel Partner Agreement (Intrexon Corp)
Development and Commercialization. Subject to Sections 4.6 and 4.7, Fibrocell Adeona shall be solely responsible for the performance of the PAH Program and the development and Commercialization commercialization of Fibrocell Adeona Products and Improved Productsin the Field. Fibrocell Adeona shall be responsible for all costs incurred in connection with the Fibroblast PAH Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Adeona Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Adeona Product (which research costs shall be reimbursed by FibrocellAdeona); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients API for clinical trials and Commercialization commercialization of Fibrocell Adeona Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell Adeona (with Intrexon’s consent).
Appears in 2 contracts
Samples: Exclusive Channel Collaboration Agreement (Adeona Pharmaceuticals, Inc.), Collaboration Agreement (Adeona Pharmaceuticals, Inc.)
Development and Commercialization. Subject to Sections 4.6 4.5 and 4.74.6, Fibrocell AquaBounty shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved AquaBounty Products. Fibrocell AquaBounty shall be responsible for all costs incurred in connection with the Fibroblast Aquaculture Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 4.5 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell an AquaBounty Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvementsimprovements to Intrexon’s synthetic biology platforms) but, for clarity, excluding research described in Section 4.7 4.6 or research requested by the JSC AquaBounty for the development of a Fibrocell Product or an Improved AquaBounty Product (which research costs shall be reimbursed by FibrocellAquaBounty); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection clause (a) above of the previous sentence shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials generating data for regulatory approval submissions and Commercialization of Fibrocell AquaBounty Products undertaken pursuant to Section 4.64.5, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell AquaBounty (with Intrexon’s consent).
Appears in 2 contracts
Samples: Exclusive Channel Collaboration Agreement (Intrexon Corp), Exclusive Channel Collaboration Agreement (Intrexon Corp)
Development and Commercialization. Subject to Sections 4.6 and 4.7, Fibrocell Oragenics shall be solely responsible for the development and Commercialization of Fibrocell Oragenics Products and Improved Productsin the Field. Fibrocell Oragenics shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell an Oragenics Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform 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. improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Oragenics Product (which research costs shall be reimbursed by FibrocellOragenics); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection clause (a) above of the previous sentence shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials generating data for regulatory approval submissions and Commercialization of Fibrocell Oragenics Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell Oragenics (with Intrexon’s consent).
Appears in 1 contract
Samples: Exclusive Channel Collaboration Agreement (Oragenics Inc)
Development and Commercialization. Subject to Sections 4.6 and 4.7, Fibrocell Oragenics shall be solely responsible for the development and Commercialization of Fibrocell Oragenics Products and Improved Productsin the Field. Fibrocell Oragenics shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell an Oragenics Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Oragenics Product (which research costs shall be reimbursed by FibrocellOragenics); (c) [*****]payments under Section 3.9(c)(i) in respect of Supplemental In-Licensed Third Party IP; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection clause (a) above of the previous sentence shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials generating data for regulatory approval submissions and Commercialization of Fibrocell Oragenics Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell Oragenics (with Intrexon’s consent).
Appears in 1 contract
Samples: Exclusive Channel Collaboration Agreement (Oragenics Inc)
Development and Commercialization. Subject to Sections 4.6 and 4.7, Fibrocell Oragenics shall be solely responsible for the development and Commercialization commercialization of Fibrocell Oragenics Products and Improved Productsin the Field. Fibrocell Oragenics shall be responsible for all costs incurred in connection with the Fibroblast Probiotics Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell an Oragenics Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research 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. requested by the JSC for the development of a Fibrocell Product or an Improved Oragenics Product (which research costs shall be reimbursed by FibrocellOragenics); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection clause (a) above of the previous sentence shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials generating data for regulatory approval submissions and Commercialization of Fibrocell Oragenics Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell Oragenics (with Intrexon’s consent).
Appears in 1 contract
Samples: Exclusive Channel Collaboration Agreement (Intrexon Corp)
Development and Commercialization. Subject to Sections 4.6 and 4.7, Fibrocell BioLife shall be solely responsible for the performance of the SMA Therapeutics Program and the development and and, upon successful execution by BioLife of its option under Section 5.1, Commercialization of Fibrocell BioLife Products and Improved Productsin the Field. Fibrocell BioLife shall be responsible for all costs incurred in connection with the Fibroblast SMA Therapeutics Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell BioLife Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved BioLife Product (which research costs shall be reimbursed by FibrocellBioLife); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization commercialization of Fibrocell BioLife Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell BioLife (with Intrexon’s consent).
Appears in 1 contract
Samples: Exclusive Research Collaboration Agreement (Intrexon Corp)
Development and Commercialization. Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Collaboration Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Collaboration Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Collaboration Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include include, if applicable, the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Collaboration Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).
Appears in 1 contract
Samples: Channel Collaboration Agreement (Fibrocell Science, Inc.)
Development and Commercialization. Subject to Sections 4.6 4.5 and 4.74.6, Fibrocell OvaScience shall be solely responsible for the development and Commercialization of Fibrocell Collaboration Products and Improved Products. Fibrocell OvaScience shall be responsible for all costs incurred in connection with the Fibroblast OPC Program to the extent included in a Work Plan approved by the JSC, except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 4.5 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Collaboration Product or Improved Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 4.6 or research requested by the JSC for the development of a Fibrocell Collaboration Product or an Improved Product (which research costs shall be reimbursed by FibrocellOvaScience); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection clause (a) above of the previous sentence shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials generating data for regulatory approval submissions and Commercialization of Fibrocell Collaboration Products undertaken pursuant to Section 4.64.5, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell OvaScience (with Intrexon’s consent).
Appears in 1 contract
Samples: Exclusive Channel Collaboration Agreement (OvaScience, Inc.)
Development and Commercialization. Subject to Sections 4.6 4.5 and 4.74.6, Fibrocell Histogenics shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Collaboration Products. Fibrocell Histogenics shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) if applicable, costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 4.5 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing the applicable portion of a Fibrocell Collaboration Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 4.6 or research requested by the JSC for the development of a Fibrocell Product or an Improved Collaboration Product (which research costs shall be reimbursed by FibrocellHistogenics); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents; and (e) any other costs mutually agreed upon by the Parties in writing as being Intrexon’s responsibility. The costs encompassed within subsection clause (a) above of the previous sentence shall include include, if applicable, the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials generating data for regulatory approval submissions and Commercialization of Fibrocell Collaboration Products undertaken pursuant to Section 4.64.5, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell Histogenics (with Intrexon’s consent).
Appears in 1 contract
Samples: Exclusive Channel Collaboration Agreement (Histogenics Corp)
Development and Commercialization. Subject to Sections 4.6 4.5 and 4.74.6, Fibrocell OvaXon shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Collaboration Products. Fibrocell OvaXon shall be responsible for all costs incurred in connection with the Fibroblast Collaborative Program to the extent included in a Work Plan approved by the JSC, except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 4.5 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Collaboration Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 4.6 or research requested by the JSC for the development of a Fibrocell Product or an Improved Collaboration Product (which research costs shall be reimbursed by FibrocellOvaXon); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection clause (a) above of the previous sentence shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials generating data for regulatory approval submissions and Commercialization of Fibrocell Collaboration Products undertaken pursuant to Section 4.64.5, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell OvaXon (with Intrexon’s consent).
Appears in 1 contract
Samples: Exclusive Channel Collaboration Agreement (OvaScience, Inc.)
Development and Commercialization. Subject to Sections 4.6 and 4.7, Fibrocell Oragenics shall be solely responsible for the performance of the Lantibiotics Program and the development and Commercialization commercialization of Fibrocell Oragenics Products and Improved Productsin the Field. Fibrocell Oragenics shall be responsible for all costs incurred in connection with the Fibroblast Lantibiotics Program except that Intrexon EGI shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with IntrexonEGI’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon EGI may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Oragenics Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon EGI Channel Technology and Intrexon EGI Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Oragenics Product (which research costs shall be reimbursed by FibrocellOragenics); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon EGI Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon EGI Materials and related active pharmaceutical ingredients for clinical trials and Commercialization commercialization of Fibrocell Oragenics Products undertaken pursuant to Section 4.6, which shall be at IntrexonEGI’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon EGI or Fibrocell Oragenics (with IntrexonEGI’s consent).
Appears in 1 contract
Samples: Exclusive Channel Collaboration Agreement (Oragenics Inc)
Development and Commercialization. Subject to Sections 4.6 and 4.7, Fibrocell ZIOPHARM shall be solely responsible for the performance of the GvHD Program and the [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. development and Commercialization commercialization of Fibrocell Products and Improved Productsin the Field. Fibrocell ZIOPHARM shall be responsible for all costs incurred in connection with the Fibroblast GvHD Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic discovery-stage research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) (but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell4.7); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients API for clinical trials and Commercialization commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell ZIOPHARM (with Intrexon’s consent).
Appears in 1 contract
Samples: Exclusive Channel Collaboration Agreement (Ziopharm Oncology Inc)
Development and Commercialization. Subject to Sections 4.6 and 4.7, Fibrocell Oragenics shall be solely responsible for the development and Commercialization commercialization of Fibrocell Oragenics Products and Improved Productsin the Field. Fibrocell Oragenics shall be responsible for all costs incurred in connection with the Fibroblast Probiotics Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell an Oragenics Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Oragenics Product (which research costs shall be reimbursed by FibrocellOragenics); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection clause (a) above of the previous sentence shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials generating data for regulatory approval submissions and Commercialization of Fibrocell Oragenics Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell Oragenics (with Intrexon’s consent). CONFIDENTIAL TREATMENT REQUESTED BY ORAGENICS, INC. 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.
Appears in 1 contract
Development and Commercialization. Subject to Sections 4.6 and 4.7, Fibrocell Ampliphi shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Ampliphi Products. Fibrocell Ampliphi shall be responsible for all costs incurred in connection with the Fibroblast Bacteriophage Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell an Ampliphi Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Ampliphi Product (which research costs shall be reimbursed by FibrocellAmpliphi); (c) [*****]payments under Section 3.9(c)(i) in respect of Supplemental In-Licensed Third Party IP; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection clause (a) above of the previous sentence shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials generating data for regulatory approval submissions and Commercialization of Fibrocell Ampliphi Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell Ampliphi (with Intrexon’s consent).
Appears in 1 contract
Samples: Channel Collaboration Agreement (AmpliPhi Biosciences Corp)