Common use of Commercial Supply Clause in Contracts

Commercial Supply. After the Option Termination Date: (a) if requested by Kolltan, the Parties shall undertake good faith negotiations regarding a commercial supply agreement pursuant to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune, quantities of the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and (b) if (i) for any reason the Parties have not entered into the Commercial Supply Agreement (including if Kolltan has not requested that the Parties undertake negotiations with respect to thereto pursuant to Section 3.6.4(a)) or (ii) the Commercial Supply Agreement is entered into by the Parties but expires or is terminated for any reason other than breach by Kolltan, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industry.

Appears in 3 contracts

Samples: License and Option Agreement (Celldex Therapeutics, Inc.), License and Option Agreement (Kolltan Pharmaceuticals Inc), License and Option Agreement (Kolltan Pharmaceuticals Inc)

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Commercial Supply. After i) Not later than ** before the Option Termination Date: (a) if requested by Kolltananticipated first commercial sale of the Licensed Product in the Licensed Territory, the Parties shall undertake commence good faith negotiations regarding of a commercial supply agreement pursuant that shall govern the supply of Commercial Product to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune, quantities of SymBio (the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and (b) if (i) for any reason the Parties have not entered , with a goal of entering into the Commercial Supply Agreement (including if Kolltan has not requested that no later than ** prior to the Parties undertake negotiations anticipated first commercial sale of the Licensed Product in the Licensed Territory. Pursuant to the Commercial Supply Agreement, Onconova shall be obligated, by itself or through its Third Party contract manufacturer, to supply to SymBio, and SymBio shall be required to purchase, all quantities of the Commercial Product required by SymBio to commercialize the Licensed Product in the Licensed Territory. Such Commercial Supply Agreement shall be consistent with respect to thereto pursuant to Section 3.6.4(a)) or (ii) the terms set forth in this Article 5, and shall include customary and reasonable terms and conditions commonly accepted in the pharmaceutical industry for supply of similar products at similar scale. Without limiting the foregoing, the Commercial Supply Agreement is entered into by shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties but expires or is terminated to enter into a quality agreement, backup rights for any reason other than breach by Kolltan, without limitation of any other rights that may be available SymBio to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and manufacture Licensed Products and rights for use SymBio to inspect facilities used to manufacture Commercial Product. ii) Pursuant to the Commercial Supply Agreement, Onconova shall supply SymBio with the Commercial Product meeting the relevant Specifications, at a price equal to the “Xxxx Up,” which shall be defined as Onconova’s Actual Unit Cost for the Commercial Product plus **, provided that (i) in Kolltan’s Commercialization activities hereunderno event shall the Xxxx Up exceed **, and further provided that in no event shall the sum of the price for supply of the Commercial Product to SymBio and the royalty payable pursuant to Section 15 with respect to the Commercial Product exceed **. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer calculations shall be based on the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media average Japan Net Selling Price and nutrient feeds used U.S. Net Selling Price calculated for all units of Commercial Product sold in the Manufacturing processcalendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. Kolltan acknowledges and agrees that With respect to any transfer supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or disclosure by Kolltan Japan Net Selling Price can be calculated, the Parties shall use an estimated U.S. Net Selling Price and/or Japan Net Selling Price, as applicable, for purposes of any MedImmune Manufacturing Know-How described in calculating the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industryXxxx Up.

Appears in 3 contracts

Samples: License Agreement (Onconova Therapeutics, Inc.), License Agreement (Onconova Therapeutics, Inc.), License Agreement (Onconova Therapeutics, Inc.)

Commercial Supply. After 8.01 Protox shall supply Kissei with, and Kissei shall purchase exclusively from Protox, all of the Option Termination Date: (a) if requested by Kolltanquantities of the Bulk Product that Kissei and its Affiliates and its Authorized Sublicensees require on a commercial basis for the repacking, marketing, distribution, promotion and sales of the Product in the Territory. The Bulk Product to be supplied shall have quality completely conformed with specifications in the current Registration. On delivery, the Parties Bulk Product shall undertake good faith negotiations regarding have at least [*…***…] percent ([…***…]%) of its shelf life. 8.02 The supply price of the Bulk Product for commercial use in the Territory to be delivered by Protox to Kissei as per paragraph 8.01 hereof shall be […***…] percent ([…***…]%) of […***…]. 8.03 The details of the supply, manner of payment of the supply price, allocations of risk and all other terms typically contained in a commercial supply agreement will be set out in a commercial supply agreement, which shall be entered into between the parties hereto. * ***Confidential Treatment Requested 8.04 Protox shall deliver the Bulk Product together with the certificate of analysis FOB (the airport to be agreed by the parties) and ICC Incoterms 2000 in accordance with the instructions indicated on the order form therefor submitted by Kissei to Protox as per paragraph 8.08 hereof. 8.05 Protox warrants that all of the Bulk Product to be supplied by Protox pursuant to which MedImmune would paragraph 8.01 hereof shall conform, upon delivery, with the specifications and quality as set out in the Registration in the Territory or as thereafter modified, taking into account the requirements by the relevant health authorities in the Territory with respect to the Bulk Product. 8.06 In the event that Protox is unable to supply Kissei with the quantity of Bulk Product requested by Kissei for a calendar quarter, in whole or part, as provided in this Agreement, for more than ninety (90) days, Kissei shall have the right to Kolltanmanufacture or engage a Third Party to manufacture such quantities of Bulk Product that Protox is unable to supply. To enable Kissei to manufacture or engage a Third Party to manufacture the Bulk Product, Protox, upon Kissei’s request, shall disclose the information required to manufacture and grant Kissei any and all licenses necessary for Kissei to manufacture the Bulk Product to Kissei, its Affiliate, its Authorized Sublicensee or any Third Party appointed by Kissei with any cost for such disclosure and licenses being borne by Protox, provided that any recipients of such information shall first agree to obligations of confidentiality in respect of such information. In the case that the Modified Protein or Bulk Product is manufactured by contract manufacturers, Protox shall give reasonable assistance to Kissei [*…***…]. For greater certainty, any failure by Protox to supply Bulk Product or Modified Protein under this Agreement shall not give Kissei the right to terminate this Agreement and Kissei shall not be obligated to pay Protox for any such undelivered Bulk Product. 8.07 In the event that any quantity of the Bulk Product supplied by Protox to Kissei hereunder does not comply with such specifications and quality referred to in paragraph 10.02(iii) hereof, Kissei shall have the right to request the replacement thereof by the quantity of the Modified Protein and the Bulk Product specified in the specifications and return to Protox such defective quantity of the Modified Protein and the Bulk Product in question at Protox’s expense. * ***Confidential Treatment Requested In the event that the quality control testing conducted by the parties of any supply of the Bulk Product leads to significant differences of results between Protox and Kissei as to quality, and Kolltan would purchase Kissei decides not to accept such lot of the Bulk Product supplied by Protox, the parties shall endeavor to settle such matter amicably and constructively between themselves. In the event that the parties fail to settle such dispute, the parties shall agree to refer such defective quantity of the Bulk Product to an independent laboratory as agreed upon between the parties for analysis. The results of the independent laboratory shall be final and binding upon the parties. All expenses incurred on such analysis will be borne by the party whose quality control results do not conform to the results of the independent laboratory. In the event that the independent laboratory upholds the results of Kissei relating to the quantity of the Bulk Product being defective, then Protox shall replace at its cost and expense the entire quantity of the Bulk Product as soon as possible. 8.08 At least one hundred and eighty (180) days prior to the beginning of each calendar quarter (January 1, April 1, July 1 and October 1), Kissei shall submit to Protox a written estimate of its requirements for Bulk Product for each of the consecutive four (4) calendar quarters commencing from MedImmunesuch calendar quarter. At least ninety (90) days prior to the beginning of each calendar quarter, Kissei shall provide Protox with a firm order for the quantity of Bulk Product that Kissei wishes Protox to ship to Kissei during such calendar quarter. In the event that the quantity of the Bulk Product ordered by Kissei in any calendar quarter exceeds [*…***…] percent ([…***…]%) of the quantity of the Bulk Product in the preceding estimate submitted by Kissei to Protox for such calendar quarter, Protox shall not be obliged, but shall use its commercially reasonable efforts, to supply Kissei with such quantities of the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale Bulk Product which exceed […***…] percent (“Commercial Supply Agreement”[…***…]%); and (b) if (i) for any reason the Parties have not entered into the Commercial Supply Agreement (including if Kolltan has not requested that the Parties undertake negotiations with respect to thereto pursuant to Section 3.6.4(a)) or (ii) the Commercial Supply Agreement is entered into by the Parties but expires or is terminated for any reason other than breach by Kolltan, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industry.

Appears in 3 contracts

Samples: Exclusive License Agreement (Sophiris Bio Inc.), Exclusive License Agreement (Sophiris Bio Inc.), Exclusive License Agreement (Sophiris Bio Inc.)

Commercial Supply. After Maruho shall have made the Option Termination Date: (a) if requested Product for Maruho’s sale and use in Japan, by Kolltan, a CMO that is either a CMO used by Upstream or a CMO that went through the Parties technology transfer process set out below. Upstream shall undertake good faith negotiations regarding a commercial supply agreement pursuant to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune, quantities of the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and (b) if either (i) for any reason make available to Maruho the Parties have not entered into the Commercial Supply Agreement (including if Kolltan right to purchase Bulk Licensed Compound and/or Product from one or more CMOs with whom Upstream has not requested that the Parties undertake negotiations with respect contracted to thereto pursuant to Section 3.6.4(a)) manufacture and supply Product, or (ii) the Commercial Supply Agreement is entered into by the Parties but expires or is terminated for any reason other than breach by Kolltan, without limitation of any other rights that may be make available to KolltanMaruho the right to purchase Bulk Licensed Compound and/or Product directly from Upstream. In either case of the above, upon KolltanUpstream shall enter into a quality agreement setting forth such quality control obligation with Maruho together with, if applicable, CMOs. Maruho and any such CMO, or Upstream in case of manufacturing by itself, shall negotiate and enter one or more supply agreements for the manufacture and supply of the Product directly from such CMO or Upstream to Maruho for Maruho’s written request sale and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Commercialization activities hereunderJapan. The foregoing sentence notwithstanding, except Upstream shall make commercially reasonable efforts to enable Maruho to procure Bulk Licensed Compound and/or Product from such CMO at the same price level as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer Upstream procure Bulk Licensed Compound and/or Product. In the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process. Kolltan acknowledges and agrees event that any transfer and/or disclosure such Bulk Licensed Compound or Product does not meet the Japanese industry standard and quality standards required by Kolltan of applicable law or regulation in Japan, Maruho may choose a new CMO in consultation with Upstream, subject any MedImmune Manufacturing Know-How described needed third party consents in accordance with the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, howeverLonza Agreement, if applicable. Maruho will be responsible for the technology transfer, at KolltanMaruho’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s sole expense, providedto the new third party CMO with the assistance of Upstream, howeverwhere Upstream shall transfer, that at Maruho’s sole expense, to the scope new CMO, all necessary know-how, any data and technology relating to the manufacture of such assistance will be the Compound and the Product, including, but not limited to, Master Cell Bank, information on manufacture, analysis and quality assurance, and pharmaceutical preparations and drug substances necessary to reasonable confirm the consistency of manufacturing quality before and customary assistance related to after technology transfer under similar circumstances in the biologics industrypursuant to this Section 5.3.2.

Appears in 2 contracts

Samples: License Agreement (Upstream Bio, Inc.), License Agreement (Upstream Bio, Inc.)

Commercial Supply. After the Option Termination Date: (a) if requested Ono shall have the right (but not the obligation) to Manufacture and/or package, or engage a Subcontractor to Manufacture, Ono’s requirements of particular Materials (e.g., Ono’s requirements of Drug Substance or Ono’s requirements of Drug Product of a particular Product) related to any Product for the Ono Territory. Promptly following Ono’s request, Array shall transfer, or cause to be transferred, to Ono or such Subcontractor all Array’s Know-How that is necessary, useful or actually used for such Manufacture, packaging and/ or testing and release of Materials (and the cost of such transfer of Array Know-How shall be borne by KolltanOno), and shall make personnel of Array reasonably available to assist Ono and/or its contractor in implementing the Array Know-How necessary to Manufacture and/or control and release such Materials. Upon completion of the technology transfer enabling Ono to Manufacture the Materials for the Ono Territory under the Marketing Approval, Array’s supply obligations under Sections 9.2 and 9.3(b) with respect to such Materials shall terminate and Ono shall assume all supply-related liability with respect to such Materials which it Manufactures or sources from Subcontractor. (b) Without limiting the foregoing, Ono shall have the right to obtain from Array Ono’s commercial requirements of Materials for the Ono Territory. Upon Ono’s request, the Parties shall undertake good faith negotiations regarding enter into a commercial supply agreement (a “Supply Agreement”) and commercial quality agreement (a “Quality Agreement”) on commercially reasonable terms documenting the arrangement pursuant to which: (i) Array shall supply Ono’s reasonable requirements for Materials for the Ono Territory, which MedImmune would supply to KolltanSupply Agreement shall contain forecasting and ordering procedures (including lead times), product specifications, delivery terms and other appropriate provisions mutually acceptable, and Kolltan would purchase from MedImmuneany customary terms, which terms shall in all cases be consistent with Array’s contractual arrangements with its Subcontractors, and taking into account the regulatory requirements imposed on Ono as the holder of the Marketing Approval. (ii) Array has made arrangements with Novartis to transfer and validate at no cost to Ono all technology reasonably necessary for the manufacturing and analytical testing of the Materials by [ * ] so that commercial quantities of Materials and can be supplied to Ono and released for the Licensed Antibody or Licensed Product, in any of its forms, for use Ono Territory; (iii) Materials supplied by Kolltan, Array to Ono for commercial sale of the Products shall be charged to Ono in an amount equal to (“Commercial Supply Agreement”); and (bA) if (i[ * ] of Array’s manufacturing cost to the extent that Array or its Affiliate(s) for any reason the Parties have not entered into the Commercial Supply Agreement (including if Kolltan has not requested that the Parties undertake negotiations with respect to thereto pursuant to Section 3.6.4(a)) Manufacture such Materials itself, or (ii) [ * ] of the Commercial Supply Agreement is entered into purchase price paid by Array for such Materials to the Parties but expires or is terminated for any reason other than breach extent that Array elects to have such Materials Manufactured by Kolltan, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industrySubcontractor.

Appears in 2 contracts

Samples: License, Development and Commercialization Agreement (Array Biopharma Inc), License, Development and Commercialization Agreement (Array Biopharma Inc)

Commercial Supply. After MTPC shall have the Option Termination Date: (a) if requested by Kolltanright to purchase from ADCT, and ADCT shall supply to MTPC, reasonable quantities of Products, [**], at [**] payable after receipt of the Parties shall undertake good faith negotiations regarding Products, pursuant to a commercial supply agreement pursuant to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune, quantities of (the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and (b) if (i) for any reason and a quality agreement therefor to be negotiated in good faith between the Parties have not entered into and executed reasonably in advance of a First Commercial Sale of a Product in the MTPC Territory, which terms and conditions will be consistent with the terms set forth in ADCT’s agreements with its contract manufacturers, and will include such other terms as are reasonable and customary in commercial supply agreements between collaborators. MTPC shall use ADCT, or its Affiliates or designees, as the sole source of Licensed Compounds and/or Products, until occurrence of the Transfer Completion pursuant to Section 8.5. 1.1.1 ADCT shall supply to MTPC reasonable quantities of Products necessary for sale in the MTPC Territory that MTPC orders under and in accordance with the Commercial Supply Agreement. 1.1.2 No later than ninety (90) days following execution of the Commercial Supply Agreement, and in any event, prior to the delivery of any Licensed Compounds and/or Products thereunder, the Parties shall in good faith negotiate and execute a related quality agreement (the “Commercial Quality Agreement”), which Commercial Quality Agreement will include such terms as are reasonable and customary. In the event that any Regulatory Authority in the MTPC Territory directs that a Third Party manufacturer be party to such Commercial Quality Agreement or a separate commercial quality agreement, the Parties will discuss and work in good faith to negotiate such agreement(s) with such Third Party manufacturer. If there is a change to the manufacturing specifications for the Licensed Compounds or Products, and Regulatory Approval for such change is required in the MTPC Territory in connection with the applicable manufacturing and marketing authorization in the MTPC Territory, then, until such Regulatory Approval is obtained, ADCT shall continue to supply MTPC, subject to the terms and conditions of the Commercial Supply Agreement (including if Kolltan has not requested that the Parties undertake negotiations then in effect, with respect to thereto pursuant to Section 3.6.4(a)) or (ii) the Commercial Supply Agreement is entered into by the Parties but expires or is terminated for any reason other than breach by Kolltan, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody Compounds or Products manufactured and Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation tested based on the manufacturing specifications existing prior to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope implementation of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industrychange.

Appears in 1 contract

Samples: License Agreement (ADC Therapeutics SA)

Commercial Supply. After Subject to the Option Termination Date: (a) other provisions of this Section 2.4.3, Celgene shall Manufacture and supply all Commercial Supplies. Within [* * *] after initiation of a Phase 3 Clinical Trial of a Sotatercept Licensed Product in the PH Field by Acceleron, its Affiliate or Sublicensee, if requested by KolltanCelgene elects to Manufacture Sotatercept Drug Product for Commercialization of Sotatercept Licensed Products in the PH Field, the Parties shall undertake negotiate in good faith negotiations regarding the terms of a commercial supply agreement pursuant to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune, quantities of (the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and ) for the supply by Celgene to Acceleron of Sotatercept Drug Product for Commercialization of Sotatercept Licensed Products in the PH Field. The Commercial Supply Agreement shall provide: (i) that Celgene shall use Commercially Reasonable Efforts to Manufacture and supply to Acceleron or its designee Sotatercept Drug Product for Commercialization of Sotatercept Licensed Products in the PH Field at a price equal to [* * *] of Celgene’s Fully Loaded Cost to Manufacture such Sotatercept Drug Product, and (ii) for such other terms and conditions as are reasonable and customary for similar commercial supply agreements in the pharmaceutical industry. In the event that, (a) despite having used good faith commercially reasonable efforts, the Parties are unable to reach agreement on the terms of a Commercial Supply Agreement within [* * *] following initiation of a Phase 3 Clinical Trial of a Sotatercept Licensed Product in the PH Field by Acceleron, its Affiliate or Sublicensee or (b) if (i) Celgene elects not to Manufacture Sotatercept Drug Product for any reason Commercialization of Licensed Products in the Parties PH Field, Acceleron shall have not entered into the right to Manufacture Commercial Supply Agreement (including if Kolltan has not requested that Supplies of Sotatercept Licensed Compounds and Sotatercept Licensed Products for Commercialization in the Parties undertake negotiations PH Field, in which case Celgene shall use good faith efforts to assist Acceleron in securing a source of supply for such Commercial Supplies and shall, and shall use Commercially Reasonable Efforts to cause those CMOs engaged by Celgene in the Manufacture of Sotatercept Licensed Compounds and Sotatercept Licensed Products to, provide a technology transfer in accordance with Applicable Laws and industry standards to Acceleron or its designee of manufacturing processes and Know-How to the extent necessary to Manufacture Sotatercept Licensed Compounds and Sotatercept Licensed Products for Commercialization in the PH Field; provided that, with respect to thereto pursuant any CMO, to Section 3.6.4(a)) the extent not permitted or (ii) the Commercial Supply Agreement is entered into by the Parties but expires or is terminated provided for any reason other than breach by Kolltan, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (Aagreement(s) MedImmune shall not unreasonably withhold with such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kindCMO, such transfer or disclosure shall be made at Kolltansubject to such CMO’s expenseconsent. The assistance described in clause (y) above cost of any technology transfer pursuant to this Section 2.4.3 shall be provided at MedImmune’s expense, provided, however, that borne equally by the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industryParties.

Appears in 1 contract

Samples: Collaboration, License and Option Agreement (Acceleron Pharma Inc)

Commercial Supply. 2.2.1 Subject to the terms and conditions of this Section 2.2, and except as otherwise provided in Section 3.4, TGC shall manufacture Bulk Licensed Product and supply such Bulk Licensed Product solely to Medeva, and Medeva agrees to purchase from TGC, Medeva's total requirements of Bulk Licensed Product for use in the manufacture of Licensed Products for marketing and commercialization in the Field. The price for Bulk Licensed Product to be paid by Medeva (the "Transfer Price") shall be determined as set forth in Schedule -------- 2. 2.2.2 At least nine (9) months prior to the first delivery to Medeva of Bulk Licensed Product for commercial sales is due to occur (the "First Commercial Quarter"), Medeva shall determine its requirements for Bulk Licensed Product and shall deliver to TGC a rolling twelve (12) month forecast (the "Commercial Forecast") of such requirements. The Commercial Forecast shall cover the four (4) succeeding calendar quarters commencing with and including the First Commercial Quarter. After delivery of the Option Termination initial Commercial Forecast, the Commercial Forecast shall be updated on a calendar quarterly basis by adding a calendar quarter to the previous Commercial Forecast. The quantities of Bulk Licensed Product for the first calendar quarter of each Commercial Forecast shall be firm. The quantities of Bulk Licensed Product for the remaining three (3) calendar quarters in each Commercial Forecast shall be non-binding estimates for planning purposes only. From time-to-time after the Effective Date: (a) if requested by Kolltan, the Parties shall undertake consider the timing of the delivery of Commercial Forecasts by Medeva to TGC and, if appropriate in light of market demand, manufacturing capacity, inventory levels, and other pertinent factors, negotiate in good faith negotiations regarding a commercial supply agreement pursuant revised time schedule for delivery of Commercial Forecasts. Medeva shall submit to which MedImmune would supply TGC a firm purchase order (a "Commercial Purchase Order") for the purchase of all Bulk Licensed Product at least ninety (90) days prior to Kolltanthe specified delivery date. Each Commercial Purchase Order shall specify the quantity or, and Kolltan would purchase from MedImmuneif more than one shipment is requested, quantities of Bulk Licensed Product ordered, and the requested delivery date or dates. Medeva shall not order, for any particular calendar quarter, less Bulk Licensed Antibody Product than the quantity of Bulk Licensed Product which was set forth in its firm Commercial Forecast for such calendar quarter. 2.2.3 TGC shall accept all Commercial Purchase Orders for a particular calendar quarter, provided the amount of Bulk Licensed Product ordered does not exceed the amount of the firm Commercial Forecast for such calendar quarter plus fifteen percent (15%). TGC shall use its Reasonable Commercial Efforts to fulfill the amount by which a Commercial Purchase Order exceeds a firm Commercial Forecast by more than 15% of such Commercial Forecast, but TGC shall have no obligation to do so beyond use of Reasonable Commercial Efforts. All Commercial Purchase Orders accepted by TGC shall not thereafter be cancelable by either Party. TGC shall use best efforts to meet the delivery date specified in the Commercial Purchase Order. TGC shall provide prompt written notice to Medeva in the event of any anticipated delays in the scheduled delivery date and shall cooperate with Medeva to reschedule delivery at the earliest possible date so as to minimize the impact on Medeva. 2.2.4 Delivery by TGC of Bulk Licensed Product to Medeva shall be made CIP (Incoterms 1990) at Medeva's facility in Rochester, New York, or such other Medeva facility in the U.S. selected by Medeva in the applicable Commercial Purchase Order. 2.2.5 TGC and Medeva each shall establish reasonable inventory levels of Bulk Licensed Product and Licensed Product, in any of its formsrespectively, including safety stock, to meet demand for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and (b) if (i) for any reason the Parties have not entered into the Commercial Supply Agreement (including if Kolltan has not requested that the Parties undertake negotiations with respect to thereto pursuant to Section 3.6.4(a)) or (ii) the Commercial Supply Agreement is entered into by the Parties but expires or is terminated for any reason other than breach by Kolltan, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media marketing and nutrient feeds used commercialization in the Manufacturing processField pursuant to this Supply Agreement and taking into account lead times for manufacture, price and procurement of material inputs, manufacturing capacity, product stability and expiration dating. Kolltan acknowledges and agrees Such inventory shall be utilized on a first-in-first-out (FIFO) basis. 2.2.6 It is understood that each Party may, for convenience, use its own standard preprinted forms of invoice, purchase order, acknowledgement or acceptance in the performance of its obligations hereunder; provided that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Knowterms, conditions or provisions in such pre-How described in printed forms which are inconsistent with or which modify or supplement this Supply Agreement or the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent LCA shall be made in good faith. The transfers null and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industryvoid.

Appears in 1 contract

Samples: Supply Agreement (Targeted Genetics Corp /Wa/)

Commercial Supply. After the Option Termination Date: (a) NEOPROBE agrees to either: (i) pay RELIABLE a capacity reservation fee of $[*] per year if requested no purchases of API are planned during a Commercial Contract Year covered by Kolltanthe Term of this Agreement, beginning in calendar year 2011; or (ii) continue to purchase [*]% of its commercial requirements of API for use in the Parties Finished Product in the Territory from RELIABLE (provided that RELIABLE is not in material breach of its obligations hereunder) during a Commercial Contract Year. In the event that NEOPROBE submits Commercial Orders (as defined in paragraph (c) below) for API with respect to any Commercial Contract Year for less than $[*], as set forth above, (and RELIABLE is not in material breach of its obligations hereunder), NEOPROBE will pay to RELIABLE the difference between: (a) the aggregate amounts actually paid by NEOPROBE to RELIABLE during such Commercial Contract Year; and (b) $[*]. Such payment will be made by NEOPROBE to RELIABLE within thirty (30) days after the end of such Commercial Contract Year. (b) After product launch, NEOPROBE shall undertake submit, in writing, to RELIABLE a good faith negotiations regarding a commercial supply agreement pursuant to which MedImmune would supply to Kolltanfaith, and Kolltan would purchase from MedImmune, initial forecast of the quantities of API estimated to be required on a Calendar Quarter basis during the Licensed Antibody or Licensed Productfollowing twelve (12) month period, in any of its forms, which forecast shall be for use by Kolltan, be for commercial sale (“Commercial Supply Agreement”)planning purposes only; and (bc) if thereafter, no later than fifteen (i15) days prior to the first day of each Calendar Quarter ("Q1"), NEOPROBE will provide RELIABLE with a good faith, rolling twelve (12) month forecast of its requirements for API in the Territory. The forecast for Q1 shall be binding on RELIABLE and NEOPROBE and shall constitute a firm purchase order ("Commercial Order") for any reason such quantities of API which NEOPROBE shall be committed to purchase during such Q1 period. The information for the remaining Calendar Quarters shall be for planning purposes only. Each Commercial Order shall be made pursuant to purchase orders which are in a form mutually acceptable to the Parties have not entered into in accordance with Section 3.2.4 and shall specify the Commercial Supply Agreement quantity of API ordered, the destination to which the API is to be delivered and the time and manner of delivery (including if Kolltan has not requested that the Parties undertake negotiations carrier to be used) in accordance with respect to thereto pursuant Section 4.3 and elsewhere in this Agreement. Subject to Section 3.6.4(a)) or (ii) the Commercial Supply Agreement is entered into by the Parties but expires or is terminated for any reason other than breach by Kolltan5.2, without limitation NEOPROBE shall purchase [*]% of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products its commercial requirements of API for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used Finished Product in the Manufacturing process. Kolltan acknowledges and agrees Territory from RELIABLE provided that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that RELIABLE is not reasonably standard in the biopharmaceutical industry for transfers or disclosures material breach of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industryits obligations hereunder.

Appears in 1 contract

Samples: Manufacture and Supply Agreement (Neoprobe Corp)

Commercial Supply. After Notwithstanding the Option Termination Dateterms of Section 6.1, Licensor has elected to terminate the production of new batches of commercial material of Compound. Licensor will facilitate and expedite the transfer of technology and know-how required to produce Compound through two independent companies (leading and secondary manufacturers) designated by Licensee. The transfer of technology and know-how means: (a) if requested by KolltanLicensor will furnish Licensee with the documents on technology and know-how required to produce Compound, the Parties shall undertake good faith negotiations regarding a commercial supply agreement pursuant to which MedImmune would supply to KolltanLicensor possesses. [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, and Kolltan would purchase from MedImmune, quantities of the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); andAS AMENDED (b) The technology and know-how is based on the pilot scale Compound manufacturing (7-15kg production per batch). (c) Licensee will dispatch the chemists to Japan to receive the lectures of the technology and know-how for the production of Compound at the expense of Licensee. (d) Licensor has no responsibility if (i) the Compound which Licensee or such two independent companies produce meets registration requirements within the Territory. Licensor and Licensee will bear respective costs for such technology transfer based on the discussion of the cost-sharing between the parties. Notwithstanding any reason technology transfer, Licensor shall retain the Parties have not entered into the Commercial Supply Agreement (including if Kolltan has not requested that the Parties undertake negotiations with respect right to thereto manufacture Compound pursuant to this Section 3.6.4(a)) or (ii) the Commercial Supply Agreement is entered into by the Parties but expires or is terminated for any reason other than breach by Kolltan, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used 6.2 in the Manufacturing processfuture. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan Licensor authorizes Licensee to maintain Licensor as producer of any MedImmune Manufacturing Know-How described record for Compound supply in the immediately preceding sentence current FDA clinical trials dossier and subsequent registration dossiers to a Third Party shall require be filed elsewhere (referring to the prior written consent current stock bulk batch and releasing test records of MedImmune; providedCompound GMP supply, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance which will be limited to reasonable used for Licensee's clinical trials and customary assistance related to technology transfer under similar circumstances in registration dossiers with the biologics industryFDA). Licensee will not maintain Licensor as an alternate source of commercial material.

Appears in 1 contract

Samples: License Agreement (Activbiotics Inc)

Commercial Supply. After As between the Option Termination Date:Parties, Eucure, itself or through its designees, will be solely responsible for Manufacturing Collaborative Product for all commercial uses in the Collaborative Territory. Eucure shall use Commercially Reasonable Efforts to supply, or cause to be supplied, to Tracon all amounts of Collaborative Product necessary for Tracon to Commercialize Collaborative Product in the Field in the Collaborative Territory, at Eucure’s COGS for such Collaborative 24. [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED Product plus a [***] percent ([***]%) markup. No later than [***] prior to the anticipated First Commercial Sale of the Collaborative Product in the Field in the Collaborative Territory, the Parties shall negotiate in good faith and enter into a written commercial supply and quality agreement, which will be consistent with the terms of this Agreement and include customary terms and conditions consistent with industry standard practices for such a commercial supply arrangement. (a) if requested by KolltanEucure shall enter into CMO Supply Agreements with one or more CMOs for the supply of Collaborative Product in quantities sufficient for the Commercialization of Collaborative Product in the Field in the Collaborative Territory, which arrangements shall be on terms reasonably acceptable to Tracon. Eucure shall be responsible for the shipment of Collaborative Product to a Tracon designated depot in the U.S.; The Parties will work together to manage importation of the Collaborative Product in accordance with importation laws of the U.S., China and other countries as applicable. For clarity, upon Eucure’s entry into a CMO Supply Agreement with a CMO for Collaborative Product, the Parties COGS for Collaborative Product shall undertake good faith negotiations regarding a commercial be the supply agreement pursuant price in such agreement; provided that such COGS amount shall not be greater than the price charged by same CMO to which MedImmune would Eucure or its partners in China for supply to Kolltan, and Kolltan would purchase from MedImmune, quantities of Collaborative Product that are manufactured in the Licensed Antibody or Licensed Product, same facility in any the same time period. Eucure shall annually provide Tracon with documentation providing the basis for establishment of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and (b) if (i) for any reason the Parties have not entered into the Commercial Supply Agreement (including if Kolltan has not requested that the Parties undertake negotiations COGS with respect to thereto pursuant commercial supply of Collaborative Product. Within [***] of commercial launch of Collaborative Product in the Field in the Collaborative Territory, Eucure shall use Commercially Reasonable Efforts to Section 3.6.4(a)) or (ii) the Commercial establish a second source of commercial supply of such Collaborative Product by entering into a second CMO Supply Agreement is entered into by with a CMO on terms that are reasonably acceptable to Tracon. In the Parties but expires or is terminated event that the CMO supplies Collaborative Product for any reason other than breach by Kolltanpurposes of Commercialization of Collaborative Product in both the Collaborative Territory and the Eucure Territory, without limitation of any other rights that may the requirements for Commercialization in the Collaborative Territory shall be available given equal treatment with respect to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products requirements for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer outside of the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used Field and/or in the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described Eucure Territory in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures event of a similar kind, such transfer shortage or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope interruption of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industrysupply.

Appears in 1 contract

Samples: Collaborative Development and Commercialization Agreement (Tracon Pharmaceuticals, Inc.)

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Commercial Supply. After the Option Termination Date: (a) if requested by Kolltan, the Parties DSP shall undertake good faith negotiations regarding a commercial supply agreement pursuant to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune, quantities Chelsea with all of Chelsea’s requirements of the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, Compound for commercial sale use on such terms and conditions as provided for in the Supply Agreement (the Commercial Supply Agreement”)) attached hereto as Exhibit F, which shall become effective upon the dosing of the first patient in Chelsea’s Phase III Clinical Trial using a Licensed Product. The Supply Agreement shall be an integral part of this Agreement, and in case of conflict between this Agreement and the Supply Agreement, this Agreement shall prevail. The Compound for commercial supply shall be sold to Chelsea at such price in Japanese Yen as agreed upon between the Parties pursuant to the Supply Agreement on the basis of FCA Kansai International Airport in Japan, as defined by INCOTERMS 2000 as amended. In the event such supply price for commercial supply exceeds an average price (excluding any special or time-limited discount prices) quoted by a Third Party to Chelsea for the Compound with substantially similar specifications (the “Market Price”) to the Compound supplied by DSP as determined by the Joint Committee, Chelsea and DSP shall discuss in good faith the possibility of reduction of the supply price to the level of the Market Price. In the event Chelsea and DSP do not agree to the reduction of the supply price within one hundred twenty (120) days of the commencement of negotiations as a result of a good faith dispute, then Chelsea may use the Compound manufactured by itself or its designee reasonably acceptable to DSP, which acceptance shall not be unreasonably withheld or delayed, and the royalty paid by Chelsea pursuant to Section 4.3 shall increase by one percent (1%) with respect to the Net Sales of Licensed Products containing the Compound not supplied by DSP. The Parties recognize that in the case Chelsea may use the Compound manufactured by itself or its designee, Chelsea will need substantial time and resources to prepare for such case and therefore, Chelsea may initiate its preparation for manufacture of the Compound, including but not limited to selection of candidates of its designated manufacturer, before Chelsea has the right to use the Compound manufactured by it or its designee hereunder, provided that DSP shall have no obligation to provide its Know-How on manufacturing of the Compound to Chelsea or Chelsea’s designee for the purpose of such Chelsea’s preparation. * Confidential treatment requested; and (b) if certain information omitted and filed separately with the SEC. Notwithstanding the foregoing, in the event (i) for any reason facility involved in the Parties have not entered into manufacture or storage of the Commercial Supply Compound hereunder is prohibited from, or materially adversely affected in its ability to, produce, store, or otherwise be involved in the provision of the Compound to Chelsea under this Agreement (including if Kolltan has not requested that by the Parties undertake negotiations with respect appropriate Regulatory Authorities or due to thereto pursuant such failure to Section 3.6.4(a)) comply; or (ii) the Commercial termination of the Supply Agreement is entered into by Chelsea pursuant to Section 11.3 or 11.4 of the Parties but expires Supply Agreement (each a “Back-up Trigger”), DSP shall provide to Chelsea the reasonable Know-How necessary to manufacture the Compound so that Chelsea may manufacture the Compound by itself or is terminated for any reason other than breach by Kolltanits designee reasonably acceptable to DSP and there shall be no such increase in royalty. In case of the occurrence of the Back-up Trigger described in (i) above, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request Chelsea and subject to MedImmune’s good faith consent as described below, MedImmune DSP shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated discuss in good faith by Kolltan such MedImmune Manufacturing Know-How and determine (i) the estimated period that DSP cannot supply the Compound and (yii) provide the quantity of the Compound which DSP cannot supply during the estimated period, and during such estimated period, Chelsea may manufacture the Compound by itself or its designee or procure the Compound from any third party. If, after such estimated period, DSP can demonstrate to Kolltan or Chelsea that it has cured the event giving rise to such Qualified Contract Manufacturer such technical assistanceBack-Up Trigger and is able to supply to Chelsea, on a long-term basis, the Compound in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture accordance with the Licensed Antibody and Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstandingSupply Agreement, except as set forth in Section 3.6.5 belowthen Chelsea shall, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer recommence the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in purchase of the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industryCompound from DSP.

Appears in 1 contract

Samples: Exclusive License Agreement (Chelsea Therapeutics International, Ltd.)

Commercial Supply. After In the Option Termination Date: (a) if requested by Kolltanevent that it is anticipated that Manufacturing Technology Transfer Completion will not be achieved sufficiently in advance of the launch of the first Licensed Product in the Territory, or at such earlier or later date as may be mutually agreed in writing, the Parties shall undertake will negotiate in good faith negotiations regarding a and enter into an agreement for commercial supply agreement pursuant by Epizyme to which MedImmune would supply to KolltanHutchmed of Drug Substance or Drug Product, as applicable, and Kolltan would purchase from MedImmunea related quality agreement, quantities of each on terms consistent with this Agreement and otherwise on commercially reasonable terms (collectively, the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and (b) if (i) for any reason . The Commercial Supply Agreement contain commercially reasonable terms including terms addressing forecasting, ordering, delivery, acceptance and rejection procedures, indemnification, limitations of liability, and quality assurance and control. From and after the Parties have not entered into execution of the Commercial Supply Agreement (including if Kolltan has and until Manufacturing Technology Transfer Completion under Section 7.2, and subject to the terms of such Commercial Supply Agreement and this Agreement and compliance with Applicable Law, Epizyme will, either itself or through Third Parties, Manufacture and supply Hutchmed with Drug Product in reasonably sufficient quantities for the Commercialization of Licensed Products in the Field in the Territory by the Hutchmed Entities in accordance with the Commercialization Plan and the terms of this Agreement. Hutchmed Entities shall not requested that use any quantity of Drug Product supplied by Epizyme for any purpose other than Commercialization in the Parties undertake negotiations Field and Territory in accordance with respect to thereto pursuant to Section 3.6.4(a)) or (ii) the Commercialization Plan and the terms of this Agreement, and Epizyme shall not be obligated under the Commercial Supply Agreement to supply quantities of Drug Product in excess of the forecasted quantity that Hutchmed notifies Epizyme, and Epizyme reasonably agrees, is entered into by needed to perform the Parties but expires or is terminated for any reason other than breach by Kolltan, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated Commercialization activities in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistancethe Territory. In addition, in each case ((x) and (y)) as reasonably required no event shall Epizyme supply to Hutchmed under the Commercial Supply Agreement any quantity of Drug Product co-formulated with an Other Combination Drug. For any quantity of Drug Product supplied by Epizyme to Hutchmed for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and purposes of Commercialization of Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described Field in the immediately preceding sentence Territory, Hutchmed shall pay to a Third Party shall require Epizyme the prior written consent Commercial Supply Price for such quantity, payable within [**] after receipt of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industryan invoice therefor.

Appears in 1 contract

Samples: License Agreement (Epizyme, Inc.)

Commercial Supply. After the Option Termination Date: The Parties will negotiate in good faith and enter into a supply agreement for commercial supply of Ivosidenib Materials and a related quality agreement (a) if requested by Kolltancollectively, the Parties shall undertake good faith negotiations regarding a commercial supply agreement pursuant to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune, quantities of the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and (b) if (i) for any reason the Parties have not entered into the Commercial Supply Agreement and the Clinical Supply Agreement each a “Supply Agreement”) at least [**] prior to the anticipated date of receipt of the first Regulatory Approval for the first Licensed Product in the Territory, or at such later date as may be mutually agreed in writing. The Commercial Supply Agreement will be consistent with the terms set forth in this Section 7.02 (including if Kolltan has not requested that Commercial Supply) and may include means of addressing disruptions in Manufacturing consistent with Section 7.07 (Supply Disruption), whether such disruptions in Manufacturing are of Licensee, Licensee’s CMO or a manufacturer of Agios. From and after the Parties undertake negotiations with respect to thereto pursuant to Section 3.6.4(a)) or (ii) execution of the Commercial Supply Agreement is entered into by the Parties but expires or is terminated for any reason other than breach by KolltanAgreement, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described belowthe terms of such Commercial Supply Agreement, MedImmune shall (x) transfer and/or disclose to Kolltan Agios will use Commercially Reasonable Efforts, either itself or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistancethrough Third Parties, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture and supply to Licensee Ivosidenib Materials in quantities that are reasonably sufficient for the Licensed Antibody and conduct of Commercialization of Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described Field in the immediately preceding sentence Territory by the Licensee Entities in accordance with the Launch Plan and the Commercial Plan. For any Ivosidenib Materials supplied by Agios to a Third Party Licensee pursuant to this Section 7.02 (Commercial Supply) for purposes of Commercialization of Licensed Products in the Field in the Territory, Licensee shall require pay to Agios the prior written consent Supply Price for such Ivosidenib Materials, payable within [**] after receipt of MedImmunean invoice therefor. Prior to the Manufacturing Technology Transfer, Licensee shall be responsible for the Manufacturing of Bulk Drug Product into Finished Drug Product for Commercialization in the Territory at its sole expense. After the Manufacturing Technology Transfer, Licensee shall be responsible for the Manufacturing of API Bulk Drug Substance into Finished Drug Product for Commercialization in the Territory at its sole expense; provided, however, that Licensee shall only be permitted to Manufacture API Bulk Drug Substance into Finished Drug Product (Aa) MedImmune shall not unreasonably withhold through a CMO approved by the JMC or (b) solely if Licensee is able to conduct such consent Manufacturing in compliance with cGMP and (B) MedImmune’s determination as all specifications provided by Agios from time to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; providedtime, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industryin-house.

Appears in 1 contract

Samples: License Agreement (Agios Pharmaceuticals Inc)

Commercial Supply. After the Option Termination Date: (a) if requested by KolltanThe initial Development Plan designates the initial commercial Supplier of the Combination Product, which Supplier shall be the source of Combination Product supply for purposes of the NDA filing and Launch in the United States. Within [ * ] after the Effective Date, the Parties JCC shall undertake good faith negotiations regarding a determine the most cost-efficient manner in which to source the commercial supply agreement pursuant to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune, quantities of the Licensed Antibody or Licensed Combination Product, including, without limitation, one or more alternate suppliers. Thereafter, during the term of this Agreement, the JCC shall review annually the appropriate source(s) of commercial supply of the Combination Product after Launch in the United States and agree upon appropriate changes. Each Member Party may propose interim changes with respect thereto from time to time between such reviews, which changes the JCC shall adopt if failure to do so would be likely to have a material adverse effect on the Combination Product business. If Gilead or BMS desires to be considered as a possible Supplier of the Combination Product, it shall submit a confidential written proposal to the JV for consideration by the JCC alongside written proposals submitted by recognized, reliable and sufficiently capitalized Third Parties and/or the supply terms pertaining to the initial Supplier. Any proposal submitted by a possible Supplier shall include an offer to perform any required tableting, blistering, packaging, labeling, analytical testing and storage activities with respect to commercial supplies of its formsthe Combination Product. The JCC shall select a Person to supply 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. JV with commercial supplies of the Combination Product on the basis of price, quality, reliability, GMP compliance, security of supply and other relevant commercial considerations. If a Third Party is selected as a Supplier, the JCC shall designate a Member Party to manage the relationship with that Supplier. Any supply contract between the JV and Gilead or BMS as Supplier shall be negotiated on an arm’s-length basis and shall contain such terms and conditions as are customary in the pharmaceutical industry, modified as appropriate for the Combination Product. The Parties anticipate that, following the Amended Effective Date, the JV and Gilead will negotiate an amendment to that certain Product Supply Services Agreement entered into by the JV and Gilead as of May 24, 2006, as well as the related Quality Agreement, for use by Kolltan, the purpose of establishing commercial supply arrangements with respect to the Combination Product for commercial sale (“Commercial Supply Agreement”); andCanada. (b) if (iThe JCC, directly or through a designated Member Party, and in coordination with the JDC, shall monitor Manufacturing capacity of, and forecasts and orders for, the Combination Product submitted to the relevant Supplier(s) for any reason to ensure that adequate commercial supplies of the Parties have not entered into the Commercial Supply Agreement (including if Kolltan has not requested that the Parties undertake negotiations with respect to thereto pursuant to Section 3.6.4(a)) or (ii) the Commercial Supply Agreement is entered into by the Parties but expires or is terminated for any reason other than breach by Kolltan, without limitation of any other rights that may Combination Product will be available to Kolltanmeet the demand therefor as projected by the JCC in commercial unit volume forecasts. The JCC shall prepare [ * ] rolling unit volume forecasts at least [ * ] before the commencement of each forecast period, upon Kolltan’s written request and subject shall update such unit volume forecasts on a [ * ] basis, or as the JCC deems necessary and appropriate. (c) In connection with the Manufacture by the Supplier of the commercial supply of the Combination Product for the JV, Gilead and BMS each shall supply to MedImmune’s good faith consent as described belowthe JV quantities of FTC and TDF, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How the case of Gilead, and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistanceEFV, in the case of BMS, and in each case ((x) in the form of bulk active pharmaceutical ingredient, pursuant to and (y)) as reasonably required for Kolltan or in accordance with their respective Supply Agreements. In consideration of such Qualified Contract Manufacturer supply, the JV shall pay to Manufacture Gilead and BMS, respectively, the Licensed Antibody Gilead Transfer Price and Licensed Products for use in Kolltan’s Commercialization activities hereunderthe BMS Transfer Price. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation JDC shall monitor orders under the respective Supply Agreements to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used assure consistency in the Manufacturing process. Kolltan acknowledges quantities of FTC, TDF and agrees that any transfer and/or disclosure EFV ordered by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industryJV thereunder.

Appears in 1 contract

Samples: Collaboration Agreement (Gilead Sciences Inc)

Commercial Supply. After (i) RemeGen shall be responsible, by itself or through one or more CMOs, to manufacture and supply to itself, its Affiliates and sublicensees the Option Termination RC48 Licensed Product for Commercialization in the Field in the RemeGen Territory. RemeGen shall be responsible, by itself or through one or more CMOs, for the commercial supply of the RC48 Licensed Product for Commercialization in the Field in the Seagen Territory; provided that at any time Seagen may notify RemeGen in writing that Seagen desires RemeGen to transfer the commercial manufacturing process for the RC48 Licensed Product to allow Seagen or its CMO to manufacture the RC48 Licensed Product for Commercialization in the Field in the Seagen Territory. Within [ * ] after the Effective Date: (a) if requested by Kolltan, the Parties shall undertake negotiate in good faith negotiations regarding and enter into a written supply agreement for such Commercial manufacture and supply by RemeGen of the RC48 Licensed Product to Seagen consistent with the terms set forth on Exhibit 6.1(b)(i) hereto and including that the supply price [ * ] (the “RC48 Commercial Supply Agreement”). (ii) If RemeGen receives Seagen’s written notice requesting that RemeGen transfer the commercial manufacturing process for the RC48 Licensed Product to allow Seagen or its CMO to manufacture the RC48 Licensed Product for Commercialization in the Field in the Seagen Territory, then in addition to the RemeGen technology transfer pursuant to Section 2.12(a), RemeGen will promptly prepare and submit to the JCMC, for its review, a plan (the “RC48 Manufacturing Technology Transfer Plan”) for the transfer to Seagen or its CMO of RemeGen RC48 Product Know-How with respect to the manufacture of the RC48 Licensed Product (such actions, “RC48 Manufacturing Technology Transfer”). The RC48 Manufacturing Technology Transfer will be complete when [ * ]. Following the review and approval by the [ * ] of the RC48 Manufacturing Technology Transfer Plan, RemeGen will perform the RC48 Manufacturing Technology Transfer in accordance with such RC48 Manufacturing Technology Transfer Plan to Seagen or its CMO, which shall be conducted at [ * ] sole cost and expense. Seagen or its CMO will notify RemeGen of any material deviations or non-conformities in the manufacture of the RC48 Licensed Product and permit the Parties to conduct joint for-cause audits of such facilities on an ongoing basis. All RC48 Licensed Product manufactured by or on behalf of Seagen shall be manufactured in compliance with all Applicable Laws and applicable [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. specifications for the RC48 Licensed Product. If Seagen is commercially manufacturing the RC48 Licensed Product, if requested by RemeGen, the Parties would negotiate in good faith to reach agreement on a commercial supply agreement pursuant to which MedImmune Seagen would supply RC48 Licensed Product to KolltanRemeGen for sale in the RemeGen Territory, on terms and Kolltan would purchase from MedImmune, quantities of the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and (b) if (i) for any reason the Parties have not entered into the Commercial Supply Agreement (including if Kolltan has not requested that the Parties undertake negotiations with respect conditions to thereto pursuant to Section 3.6.4(a)) or (ii) the Commercial Supply Agreement is entered into be agreed by the Parties but expires or is terminated for any reason other than breach by KolltanParties, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industryincluding [ * ].

Appears in 1 contract

Samples: License Agreement (Seagen Inc.)

Commercial Supply. After In the Option Termination Date: (a) if requested by Kolltanevent that it is anticipated that Manufacturing Technology Transfer Completion will not be achieved sufficiently in advance of the launch of the first Licensed Product in the Territory, or at such earlier or later date as may be mutually agreed in writing, the Parties shall undertake will negotiate in good faith negotiations regarding a and enter into an agreement for commercial supply agreement pursuant by Epizyme to which MedImmune would supply to KolltanHutchmed of Drug Substance or Drug Product, as applicable, and Kolltan would purchase from MedImmunea related quality agreement, quantities of each on terms consistent with this Agreement and otherwise on commercially reasonable terms (collectively, the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and (b) if (i) for any reason . The Commercial Supply Agreement contain commercially reasonable terms including terms addressing forecasting, ordering, delivery, acceptance and rejection procedures, indemnification, limitations of liability, and quality assurance and control. ​ From and after the Parties have not entered into execution of the Commercial Supply Agreement (including if Kolltan has and until Manufacturing Technology Transfer Completion under Section 7.2, and subject to the terms of such Commercial Supply Agreement and this Agreement and compliance with Applicable Law, Epizyme will, either itself or through Third Parties, Manufacture and supply Hutchmed with Drug Product in reasonably sufficient quantities for the Commercialization of Licensed Products in the Field in the Territory by the Hutchmed Entities in accordance with the Commercialization Plan and the terms of this Agreement. Hutchmed Entities shall not requested that use any quantity of Drug Product supplied by Epizyme for any purpose other than Commercialization in the Parties undertake negotiations Field and Territory in accordance with respect to thereto pursuant to Section 3.6.4(a)) or (ii) the Commercialization Plan and the terms of this Agreement, and Epizyme shall not be obligated under the Commercial Supply Agreement to supply quantities of Drug Product in excess of the forecasted quantity that Hutchmed notifies Epizyme, and Epizyme reasonably agrees, is entered into by needed to perform the Parties but expires or is terminated for any reason other than breach by Kolltan, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated Commercialization activities in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistancethe Territory. In addition, in each case ((x) and (y)) as reasonably required no event shall Epizyme supply to Hutchmed under the Commercial Supply Agreement any quantity of Drug Product co-formulated with an Other Combination Drug. For any quantity of Drug Product supplied by Epizyme to Hutchmed for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and purposes of Commercialization of Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described Field in the immediately preceding sentence Territory, Hutchmed shall pay to a Third Party shall require Epizyme the prior written consent Commercial Supply Price for such quantity, payable within [**] after receipt of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industryan invoice therefor.

Appears in 1 contract

Samples: License Agreement (HUTCHMED (China) LTD)

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