Common use of CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION Clause in Contracts

CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. Spectrum shall retain control over management of the chemical, pharmaceutical and other process development related to the manufacturing of the Product (including API and Bulk Product), including stability testing; provided, that Spectrum shall keep Topotarget informed of proposed process development or other changes related to the manufacturing of the Product (including API and Bulk Product) and shall obtain Topotarget’s prior written approval for any Material Change, not to be unreasonably withheld or delayed. In addition, Spectrum shall have the sole right and obligation to prepare and submit the drug master file (as such term is defined in the 21 C.F.R., Section 314.420) to the FDA for the manufacture of the API, and Topotarget shall reasonably cooperate with Spectrum in connection therewith, including by providing to Spectrum any information and records in Topotarget’s possession that is required for the preparation and filing of such drug master file. Spectrum shall share a copy of the drug master file with Topotarget before submission to the FDA (and any subsequent versions of the drug master file) and shall in good faith consider to incorporate any feedback provided by Topotarget. Spectrum shall not make any material changes in the drug master file without the prior approval of Topotarget, which shall not be unreasonably withheld or delayed. For avoidance of doubt, the foregoing drug master file is included in the right of reference granted by Spectrum to Topotarget pursuant to Section 4.6. Spectrum agrees to supply API, Bulk Product and NPP Product to Topotarget (or its designees) for use, distribution and sale in the Topotarget Territory, which supply shall be governed by the terms of this Section 5.6. The price for such supplies of API, Bulk Product and NPP Product (or components thereof) will not exceed the Cost of Goods (with “Spectrum” substituted for “Topotarget” in Sections 1.28 and 1.110) plus [***] percent ([***]%). In light of the foregoing, and upon Topotarget’s request, Spectrum agrees to reasonably cooperate with Topotarget in obtaining, and Spectrum will use Commercially Reasonable Efforts to obtain, from the FDA or other Regulatory Authority a Certificate of Pharmaceutical Product (CPP) with respect to Product manufactured by any Third Party manufacturers engaged by Spectrum to produce commercial supplies of API and/or Product. If necessary, Spectrum will serve as the point of contact with the FDA or other Regulatory Authority with respect to the CPP. Topotarget is responsible for preparation and submission of regulatory and commercial filings for the Product in the Topotarget Territory.

Appears in 2 contracts

Samples: License and Collaboration Agreement (Spectrum Pharmaceuticals Inc), License and Collaboration Agreement (Spectrum Pharmaceuticals Inc)

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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. Spectrum shall retain control over management will promptly (but in no case more than [***] ([***]) Business Days after its receipt of a purchase order placed pursuant to this section), acknowledge in writing its receipt of such API purchase order. Spectrum will promptly notify Topotarget within [***] ([***]) Business Days of Spectrum’s Third Party manufacturer accepting Spectrum’s purchase order that includes the chemical, pharmaceutical amounts ordered by Topotarget and other process development related will include in such notice any adjustments made by such Third Party manufacturer to the manufacturing of quantity ordered by Topotarget or the Product (including API and Bulk Product), including stability testing; provided, that delivery date therefor. Spectrum shall keep Topotarget informed of proposed process development or other changes related will not permit such Third Party manufacturer to make any adjustments to the manufacturing of quantity ordered by Topotarget or the Product (including API and Bulk Product) and shall obtain Topotarget’s prior written approval for any Material Change, not to be unreasonably withheld or delayed. In addition, Spectrum shall have the sole right and obligation to prepare and submit the drug master file (as such term is defined in the 21 C.F.R., Section 314.420) to the FDA delivery date specified by Topotarget for the manufacture of the API, and Topotarget shall reasonably cooperate API if such quantity ordered or delivery date specified comply with Spectrum in connection therewith, including by providing to Spectrum any information and records in Topotarget’s possession that is required for the preparation and filing of such drug master file. Spectrum shall share a copy of the drug master file with Topotarget before submission to the FDA (and any subsequent versions of the drug master file) and shall in good faith consider to incorporate any feedback provided by Topotarget. Spectrum shall not make any material changes in the drug master file without the prior approval of Topotarget, which shall not be unreasonably withheld or delayed. For avoidance of doubt, the foregoing drug master file is included in the right of reference granted by Spectrum to Topotarget pursuant to Section 4.6. Spectrum agrees to supply API, Bulk Product and NPP Product to Topotarget (or its designees) for use, distribution and sale in the Topotarget Territory, which supply shall be governed by the terms of this Section 5.6. The price for Upon sending such supplies notice, such purchase order, as modified pursuant to such notice, shall become a Firm Order, unless such notice modifies such purchase order such that the amount of API, Bulk Product and NPP Product (or components thereof) will not exceed the Cost of Goods (with “Spectrum” substituted for “Topotarget” in Sections 1.28 and 1.110) plus API ordered by Topotarget is increased by more than [***] percent ([***]%)) or the delivery date of the ordered API is delayed by more than [***] ([***]) days, in which case such purchase order, as modified, will not be a Firm Order unless accepted in writing by Topotarget. In light If no such notice is received by Topotarget within [***] ([***]) Business Days after Spectrum’ receipt of such purchase order, then Spectrum shall have been deemed to accept such purchase order and such purchase order will be deemed a Firm Order. Any purchase orders for API submitted by Topotarget shall reference this Agreement and shall be governed exclusively by the terms contained herein. If there is any inconsistency or conflict between the terms and conditions of this Agreement and any provisions in any API purchase order, invoice or similar document furnished by Topotarget or Spectrum to the other Party, the terms and conditions of this Agreement shall control except for matters of quality, in which case the Technical Agreement shall control. Notwithstanding the foregoing, and upon Topotarget’s requestif Spectrum wishes to combine its orders for API with those of Topotarget for maximum cost efficiency/full lot quantities, Spectrum Topotarget agrees to discuss in good faith such proposed combination of orders with Spectrum and to reasonably cooperate with Topotarget in obtaining, and Spectrum will use Commercially Reasonable Efforts to obtain, from the FDA or other Regulatory Authority a Certificate of Pharmaceutical Product (CPP) with respect to Product manufactured by consider any Third Party manufacturers engaged by Spectrum to produce commercial supplies of API and/or Product. If necessary, Spectrum will serve as the point of contact with the FDA or other Regulatory Authority with respect to the CPP. Topotarget is responsible for preparation and submission of regulatory and commercial filings for the Product resulting adjustments in the Topotarget Territorytiming of the ordering process set forth above.

Appears in 2 contracts

Samples: License and Collaboration Agreement (Spectrum Pharmaceuticals Inc), License and Collaboration Agreement (Spectrum Pharmaceuticals Inc)

CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. Spectrum shall retain control over management will promptly (but in no case more than [***] ([***]) Business Days after its receipt of a purchase order placed pursuant to this section) acknowledge in writing its receipt of such Bulk Product and/or NPP Product purchase order. In the chemicalevent Spectrum is manufacturing a new lot of product to meet Topotarget’s requirements, pharmaceutical Spectrum will notify Topotarget within [***] ([***]) Business Days of Spectrum’s Third Party manufacturer accepting Spectrum’s purchase order that includes the amounts ordered by Topotarget and other process development related will include in such notice any adjustments made by such Third Party manufacturer to the manufacturing of quantity ordered by Topotarget or the Product (including API and Bulk Product), including stability testing; provided, that delivery date therefor. Spectrum shall keep Topotarget informed of proposed process development or other changes related will not permit such Third Party manufacturer to make any adjustments to the manufacturing of quantity ordered by Topotarget or the Product (including API and Bulk Product) and shall obtain Topotarget’s prior written approval for any Material Change, not to be unreasonably withheld or delayed. In addition, Spectrum shall have the sole right and obligation to prepare and submit the drug master file (as such term is defined in the 21 C.F.R., Section 314.420) to the FDA delivery date specified by Topotarget for the manufacture of the API, and Topotarget shall reasonably cooperate with Spectrum in connection therewith, including by providing to Spectrum any information and records in Topotarget’s possession that is required for the preparation and filing of such drug master file. Spectrum shall share a copy of the drug master file with Topotarget before submission to the FDA (and any subsequent versions of the drug master file) and shall in good faith consider to incorporate any feedback provided by Topotarget. Spectrum shall not make any material changes in the drug master file without the prior approval of Topotarget, which shall not be unreasonably withheld or delayed. For avoidance of doubt, the foregoing drug master file is included in the right of reference granted by Spectrum to Topotarget pursuant to Section 4.6. Spectrum agrees to supply API, Bulk Product and NPP Product to Topotarget (if such quantity ordered or its designees) for use, distribution and sale in the Topotarget Territory, which supply shall be governed by delivery date specified comply with the terms of this Section 5.6. The price for Upon sending such supplies notice, such purchase order, as modified pursuant to such notice, shall become a “Firm Order”, unless such notice modifies such purchase order such that the amount of API, Bulk Product and and/or NPP Product (or components thereof) will not exceed the Cost of Goods (with “Spectrum” substituted for “Topotarget” in Sections 1.28 and 1.110) plus ordered by Topotarget is increased by more than [***] percent ([***]%)) or the delivery date of the ordered Bulk Product and/or NPP Product is delayed by more than [***] ([***]) days, in which case such purchase order, as modified, will not be a Firm Order unless accepted in writing by Topotarget. In light If no such notice is received by Topotarget within [***] ([***]) Business Days after Spectrum’s receipt of such purchase order, then Spectrum shall have been deemed to accept such purchase order and such purchase order will be deemed a Firm Order. Any purchase orders for Bulk Product and/or NPP Product submitted by Topotarget shall reference this Agreement and shall be governed exclusively by the terms contained herein. If there is any inconsistency or conflict between the terms and conditions of this Agreement and any provisions in any Bulk Product and/or NPP Product purchase order, invoice or similar document furnished by Topotarget or Spectrum to the other Party, the terms and conditions of this Agreement shall control except for matters of quality, in which case the Quality Agreement shall control. Notwithstanding the foregoing, if Spectrum wishes to combine its orders for Bulk Product and upon Topotarget’s requestNPP Product with those of Topotarget for maximum cost efficiency/full lot quantities, Spectrum Topotarget agrees to discuss in good faith such proposed combination of orders with Spectrum and to reasonably cooperate with Topotarget in obtaining, and Spectrum will use Commercially Reasonable Efforts to obtain, from the FDA or other Regulatory Authority a Certificate of Pharmaceutical Product (CPP) with respect to Product manufactured by consider any Third Party manufacturers engaged by Spectrum to produce commercial supplies of API and/or Product. If necessary, Spectrum will serve as the point of contact with the FDA or other Regulatory Authority with respect to the CPP. Topotarget is responsible for preparation and submission of regulatory and commercial filings for the Product resulting adjustments in the Topotarget Territorytiming of the ordering process set forth above.

Appears in 2 contracts

Samples: License and Collaboration Agreement (Spectrum Pharmaceuticals Inc), License and Collaboration Agreement (Spectrum Pharmaceuticals Inc)

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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION. As of the date hereof, Spectrum hereby assumes liability and project management from BIIB of all responsibilities and obligations accruing on or after the date hereof under that certain Amended and Restated Commercial Supply Agreement, dated January 25, 2008, by and between BIIB and Xxxxxx Pharmaceutical Solutions LLC (“Baxter”), as amended by (i) that certain letter, dated October 12, 2009, from Baxter to BIIB and (ii) that certain letter, dated December 9, 2010, from Baxter to BIIB (signed by BIIB on December 28, 2010). Biogen Idec shall use commercially reasonable efforts from the date hereof through October 31, 2012 to obtain Xxxxxx’x written consent to the assignment of such agreement by BIIB to RIT (it being understood that Biogen Idec shall not be required to make any payment or provide any guarantee in order to obtain such consent) and, thereupon, Biogen Idec shall cause BIIB to assign such agreement to RIT. Spectrum shall retain control over management of assist BIIB in such efforts. To the chemicalextent such consent has not been obtained by October 31, pharmaceutical and other process development related to the manufacturing of the Product (including API and Bulk Product), including stability testing; provided, that Spectrum shall keep Topotarget informed of proposed process development or other changes related to the manufacturing of the Product (including API and Bulk Product) and shall obtain Topotarget’s prior written approval for any Material Change, not to be unreasonably withheld or delayed. In addition2012, Spectrum shall use commercially reasonable efforts to have Baxter and RIT enter into a replacement agreement for such agreement (which, among other things, terminates such agreement and any further liability of BIIB thereunder). In the sole right event that neither an assignment of nor replacement for such agreement is achieved within a reasonable period of time, Biogen Idec shall use commercially reasonable efforts to provide the benefits of such contract to Spectrum (by reserving “fill slots” with Baxter) during 2012 so long as Spectrum bears all costs, expenses and obligation to prepare and submit the drug master file (as such term is defined in the 21 C.F.R., Section 314.420) to the FDA for the manufacture of the API, and Topotarget shall reasonably cooperate with Spectrum other liabilities in connection therewith. Upon Spectrum’s written request, including by providing Biogen Idec shall sell to Spectrum any information Spectrum, and records in Topotarget’s possession that is required for the preparation and filing of such drug master file. Spectrum shall share a copy of the drug master file with Topotarget before submission to the FDA (and any subsequent versions of the drug master file) and shall in good faith consider to incorporate any feedback provided by Topotarget. Spectrum shall not make any material changes in the drug master file without the prior approval of Topotarget, which shall not be unreasonably withheld or delayed. For avoidance of doubtpurchase from Biogen Idec, the foregoing drug master file is included equipment related to Zevalin owned by Biogen Idec but held by Baxter at Xxxxxx’x facility in the right connection with such agreement on an “as is” basis without any representation or warranty of reference granted by Spectrum to Topotarget pursuant to Section 4.6. Spectrum agrees to supply APIany kind, Bulk Product and NPP Product to Topotarget express or implied (including, without limitation, any warranties of quality, performance, merchantability or its designees) fitness for use, distribution and sale in the Topotarget Territory, which supply shall be governed by the terms of this Section 5.6a particular use or purpose). The price for of such supplies of API, Bulk Product and NPP Product (or components thereof) will not exceed the Cost of Goods (with “Spectrum” substituted for “Topotarget” in Sections 1.28 and 1.110) plus equipment shall be US $[***] percent ([***]%). In light of the foregoing, and upon Topotarget’s request, Spectrum agrees to reasonably cooperate with Topotarget in obtaining, and Spectrum will use Commercially Reasonable Efforts to obtainshall be responsible in all manners for removing such equipment from Xxxxxx’x facility (including, from the FDA or other Regulatory Authority a Certificate without limitation, coordinating with Baxter and arranging for shipment of Pharmaceutical Product (CPP) such equipment, as well as paying for all costs and expenses with respect to Product manufactured by any Third Party manufacturers engaged by Spectrum to produce commercial supplies of API and/or Product. If necessary, Spectrum will serve as the point of contact with the FDA or other Regulatory Authority with respect to the CPP. Topotarget is responsible for preparation and submission of regulatory and commercial filings for the Product in the Topotarget Territorythereto).

Appears in 1 contract

Samples: Omnibus Amendment to Zevalin Supply Arrangements (Spectrum Pharmaceuticals Inc)

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