Common use of Commercial Supply Clause in Contracts

Commercial Supply. i) Not later than ** before the anticipated first commercial sale of the Licensed Product in the Licensed Territory, the Parties shall commence good faith negotiations of a commercial supply agreement that shall govern the supply of Commercial Product to SymBio (the “Commercial Supply Agreement”), with a goal of entering into the Commercial Supply Agreement no later than ** prior to the 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 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 shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for 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 no 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 calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or 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 calculating the Xxxx Up.

Appears in 3 contracts

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

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Commercial Supply. i) Not later than ** before the anticipated first commercial sale 8.01 Protox shall supply Kissei with, and Kissei shall purchase exclusively from Protox, all of the Licensed quantities 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 Licensed 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 commence good faith negotiations 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 that shall govern the will be set out in a commercial supply of Commercial Product to SymBio (the “Commercial Supply Agreement”), with a goal of entering into the Commercial Supply Agreement no later than ** prior to the 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 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 shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for 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 entered into between the Commercial Product plus parties hereto. * **, provided *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 (i) in no event shall the Xxxx Up exceed **, and further provided that in no event shall the sum all of the price for supply of the Commercial Bulk Product to SymBio and the royalty payable be supplied by Protox pursuant to Section 15 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 Commercial Bulk Product. 8.06 In the event that Protox is unable to supply Kissei with the quantity of Bulk Product exceed 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 manufacture 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 [*…***…]. The foregoing calculations 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 based on obligated to pay Protox for any such undelivered Bulk Product. 8.07 In the average Japan Net Selling Price event that any quantity of the Bulk Product supplied by Protox to Kissei hereunder does not comply with such specifications and U.S. Net Selling Price calculated for all units quality referred to in paragraph 10.02(iii) hereof, Kissei shall have the right to request the replacement thereof by the quantity of Commercial the Modified Protein and the Bulk Product sold specified in the calendar quarter preceding specifications and return to Protox such defective quantity of the calendar quarter Modified Protein and the Bulk Product in which Onconova invoices SymBio for Commercial Productquestion at Protox’s expense. With respect to * ***Confidential Treatment Requested In the event that the quality control testing conducted by the parties of any supply of Commercial the Bulk Product leads to significant differences of results between Protox and Kissei as to quality, and 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 period 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 such 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 which such calendar quarter. In the U.S. Net Selling Price and/or Japan Net Selling Price can 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 calculatedobliged, the Parties but shall use an estimated U.S. Net Selling Price and/or Japan Net Selling Priceits commercially reasonable efforts, as applicable, for purposes to supply Kissei with such quantities of calculating the Xxxx UpBulk Product which exceed […***…] percent ([…***…]%).

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. iAfter the Option Termination Date: (a) Not later than ** before the anticipated first commercial sale of the Licensed Product in the Licensed Territoryif requested by Kolltan, the Parties shall commence undertake good faith negotiations of regarding a commercial supply agreement that shall govern pursuant to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune, quantities of the supply Licensed Antibody or Licensed Product, in any of Commercial Product to SymBio its forms, for use by Kolltan, for commercial sale (the “Commercial Supply Agreement”), with a goal of entering ; and (b) if (i) for any reason the Parties have not entered into the Commercial Supply Agreement no later than ** prior (including if Kolltan has not requested that the Parties undertake negotiations with respect to the anticipated first commercial sale of the Licensed Product in the Licensed Territory. Pursuant thereto pursuant to the Commercial Supply Agreement, Onconova shall be obligated, by itself Section 3.6.4(a)) 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 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, (ii) the Commercial Supply Agreement shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for 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 enter into a quality agreementKolltan, backup rights 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 SymBio Kolltan or such Qualified Contract Manufacturer to manufacture Manufacture the Licensed Antibody and Licensed Products and rights for 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 Onconovause in Kolltan’s Actual Unit Cost for the Commercial Product plus **, provided that (i) in no 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 **Commercialization activities hereunder. The foregoing calculations 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 based on the average Japan Net Selling Price made in good faith. The transfers and U.S. Net Selling Price calculated for all units of Commercial Product sold 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 calendar quarter preceding 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 calendar quarter scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or 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 calculating the Xxxx Upbiologics 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)

Commercial Supply. i4.1 Ypsomed shall manufacture the Component Sets in accordance with the terms of this Agreement and the Specifications attached as Appendix 1. 4.2 Subject to the terms of this Agreement, AMAG shall purchase Component Sets from Ypsomed and Ypsomed shall supply AMAG with Component Sets. 4.3 In the event AMAG decides during the Term of this Agreement to develop (directly or indirectly) Not later than a new injection device for the administration of Bremelanotide, AMAG shall give Ypsomed notice thereof prior to issuing an invitation to tender or commencing negotiations with any third party in respect of developing such injection device. If, within [** before **] after AMAG gives such notice to Ypsomed, Ypsomed requests, in writing, an opportunity to submit a proposal with respect to the anticipated first commercial sale development, customization, manufacture and supply of such injection device, AMAG shall provide Ypsomed with the desired specifications on a confidential basis and negotiate in good faith with Ypsomed regarding any such proposal by Ypsomed. For the avoidance of doubt, AMAG shall be free to engage in parallel good faith negotiations, and to enter into a definitive agreement, with any third party with respect to the development, customization, manufacture and supply of the Licensed Product new injection device. 4.4 Ypsomed retains all rights to promotion, import, advertisement, distribution, offering for sale and sale in the Licensed TerritoryTerritory of the YpsoMate and/or customized variations thereof as well as other disposable injection systems, other than the Parties shall commence good faith negotiations of a Component Sets being supplied to AMAG pursuant to this agreement, to itself, its customers or distributors. 4.5 The commercial supply agreement that shall govern terms for the supply of Commercial Product Component Sets are set out in Appendix 3. 4.6 [***] at the Purchase Price set out in Appendix 3. The Purchase Price is firm until [***]. Thereafter, the Purchase Price is subject to SymBio (the “Commercial Supply Agreement”)adjustments, with a goal of entering into the Commercial Supply Agreement however no later more than on [** prior to the 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**] basis, to supply to SymBioreflect increases or decreases in raw material prices and other related cost influencing factors that are not under Ypsomed’s control; provided, and SymBio shall be required to purchasehowever, 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 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 that notwithstanding the foregoing, the Commercial Supply Agreement percentage increase or decrease in the Purchase Price shall contain rights for SymBio to audit not exceed the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for 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 lesser of (i) the percentage increase in no event shall the Xxxx Up exceed [***] since the then-current Purchase Price was established and (ii) [***]. In the event of a proposed adjustment to the Purchase Price under this Section 4.6, Ypsomed will in good faith submit a Price Change Order to AMAG to substantiate the adjustment, and further provided that such adjustment shall not take effect until the Price Change Order is signed by both Parties. 4.7 Throughout the Term, Ypsomed agrees to use its commercially reasonable efforts to identify and target all potential areas of cost improvement. [***]. In the event of a proposed adjustment to the Purchase Price under this Section 4.7, Ypsomed will in no event good faith submit a Price Change Order to AMAG to substantiate the adjustment, and such adjustment shall not take effect until the sum Price Change Order is signed by both Parties. 4.8 Beginning in [***], AMAG shall purchase at least the Minimum Annual Quantity of Component Sets in each remaining calendar year during the Initial Term as set out in Appendix 3. For the purpose of determining whether AMAG is in compliance with this Section 4.8, a Component Set is considered “purchased” as 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 calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold agreed Delivery Date in the respective Purchase Order, provided however that such ordered Component Sets will have been duly paid by AMAG (during such calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or Japan Net Selling Price can be calculated, the Parties shall use an estimated U.S. Net Selling Price and/or Japan Net Selling Priceyear or, as applicable, at a later stage in accordance with the terms of this Agreement). If AMAG does not purchase the Annual Minimum Quantity in a calendar year in accordance with this Section 4.8, AMAG shall pay Ypsomed at the end of such calendar year, upon receipt of an invoice and reasonable supporting documentation in accordance with Section 6, an amount equal to (a) the difference between (i) the Annual Minimum Quantity for purposes such calendar year and (ii) the aggregate number of calculating Component Sets purchased by AMAG (or its Affiliates or licensees) during such calendar year (such amount, the Xxxx Up“Shortfall”), multiplied by [***] of the Unit Price per Component Set as set forth in Appendix 3 (the “Shortfall Fee”). In the event that AMAG disputes the amount of the Shortfall Fee due under this Section 4.8, AMAG shall provide Ypsomed with written notice of such dispute within [***] of receipt of such invoice. If no written notice is provided by AMAG within [***] of receipt of such invoice AMAG shall be deemed to have given its approval to the Shortfall Fee. 4.9 The Parties - each for its obligations under this Agreement - shall comply with all Applicable Laws. The Parties acknowledge that AMAG has the right to market, sell and distribute the Bremelanotide Device in further countries than those enumerated in the definition of Applicable Laws and Authority in Section 1 subject to and in accordance with the terms of this Agreement. Accordingly, AMAG has the right to reasonably request Ypsomed to comply with any applicable laws other than the Applicable Laws as such laws are identified and deviate from the Applicable Laws and their requirements communicated in writing by AMAG to Ypsomed and to adjust the term Territory under Section 1 accordingly. In the event of any additional, successor or replacement applicable laws affecting Ypsomed's performance under this Agreement (including, without limitation, in respect of costs, timelines, facilities, equipment, processes, materials or systems), Ypsomed shall have the right to request and the Parties shall negotiate in good faith an amendment and/or modification pursuant to Section 3. For clarity, in the event that any additional, successor or replacement applicable laws that AMAG wishes Ypsomed to comply with, does not affect Ypsomed's performance under this Agreement, such additional applicable laws shall become automatically part of the Applicable Laws without any need for an amendment and/or modification pursuant to Section 3. 4.10 The Parties agree that the terms and conditions of this Agreement will govern the manufacture and supply of Component Sets pursuant to AMAG purchase order numbers 71635 and 71636, and such Component Sets are deemed to be Component Sets manufactured by Ypsomed and supplied to AMAG under this Agreement. In the event of a conflict between this Agreement and the Terms and Conditions, this Agreement shall control.

Appears in 2 contracts

Samples: Supply Agreement (Palatin Technologies Inc), Supply Agreement (Amag Pharmaceuticals, Inc.)

Commercial Supply. iIf Pulse Technologies desires to obtain supply of any Product (or any variant thereof or any version with different specifications) Not later than ** before for commercial use, then prior to negotiating the anticipated first commercial sale terms of the Licensed Product an agreement for such agreement, Pulse Technologies shall promptly notify Ikaria thereof in the Licensed Territorywriting. Ikaria shall, within 60 days after receipt of such notice, indicate to Pulse Technologies in writing whether Ikaria or any of its Affiliates wishes to enter into such an agreement and, if Ikaria indicates that Ikaria or any of its Affiliates do wish to enter into such agreement, the Parties shall commence negotiate in good faith negotiations of a commercial supply agreement that shall govern the supply of Commercial Product to SymBio (the “Commercial Supply Agreement”), with a goal of entering into the Commercial Supply Agreement no later than ** prior to the 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 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 shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality mutually agreeable terms pursuant to which Ikaria or any of its Affiliates would enter into agreement with Pulse Technologies. In such negotiations, Ikaria may elect to supply [**]% of Pulse Technologies requirements for the Product(s) in question, or such lesser quantity as Ikaria may elect in its sole discretion. If either (a) Ikaria indicates it does not wish to pursue such agreement, backup rights for SymBio (b) Ikaria fails to manufacture Licensed Products and rights for SymBio indicate its interest within such 30 day period or (c) Ikaria indicates it wishes to inspect facilities used enter into such agreement but the Parties fail to manufacture Commercial Product. ii) Pursuant reach agreement on the terms of such agreement or to execute a definitive agreement prior to 90 days after the Commercial Supply Agreementdate of Ikaria’s indication of interest, Onconova shall supply SymBio with the Commercial Product meeting the relevant Specifications, at a price equal to the “Xxxx Up,” which then Pulse Technologies shall be defined as Onconova’s Actual Unit Cost for free, without any further obligation to Ikaria under this Agreement with respect thereto, to enter into such an agreement with a Third Party; provided that, in the Commercial Product plus **event clause (c) of this sentence is applicable, provided if Pulse Technologies proposes to enter such agreement with a Third Party on terms that are materially less favorable to Pulse Technologies than the terms last offered in writing to Pulse Technologies by Ikaria, then (i) in no event shall the Xxxx Up exceed **Pulse Technologies shall, 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 calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to entering into such agreement with such Third Party, offer such terms to Ikaria, (ii) Ikaria shall have 15 days after the period during which the U.S. Net Selling Price and/or Japan Net Selling Price can be calculateddate of receipt of such offer from Pulse Technologies to notify Pulse Technologies in writing of its acceptance of such offer and (iii) (A) if Ikaria so accepts, the Parties shall use an estimated U.S. Net Selling Price and/or Japan Net Selling Pricepromptly enter into a definitive agreement for the commercial supply of such Product(s) on such terms, as applicableor (B) if Ikaria does not accept, then Pulse Technologies shall be free, without any further obligation to Ikaria under this Agreement with respect thereto, to enter into such commercial supply agreement with a Third Party; provided further that if Pulse Technologies does not enter into a definitive agreement for purposes such commercial supply with a Third Party within 180 days after the expiration of calculating the Xxxx UpIkaria’s under this Section 2.3, Ikaria’s rights under this Section 2.3 shall be reinstated.

Appears in 2 contracts

Samples: Drug Clinical Supply Agreement (Bellerophon Therapeutics LLC), Drug Clinical Supply Agreement (Bellerophon Therapeutics LLC)

Commercial Supply. i(a) Not later than ** before Ono shall have the anticipated first commercial sale right (but not the obligation) to Manufacture and/or package, or engage a Subcontractor to Manufacture, Ono’s requirements of the Licensed particular Materials (e.g., Ono’s requirements of Drug Substance or Ono’s requirements of Drug Product in the Licensed Territory, the Parties shall commence good faith negotiations of a commercial supply agreement that shall govern particular Product) related to any Product for the supply of Commercial Product to SymBio (the “Commercial Supply Agreement”), with a goal of entering into the Commercial Supply Agreement no later than ** prior to the anticipated first commercial sale of the Licensed Product in the Licensed Ono Territory. Pursuant 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 Commercial Supply Agreement, Onconova cost of such transfer of Array Know-How shall be obligated, borne 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 the terms set forth in this Article 5Ono), and shall include customary 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 reasonable terms 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 conditions commonly accepted in the pharmaceutical industry for supply of similar products at similar scale. 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 Commercial right to obtain from Array Ono’s commercial requirements of Materials for the Ono Territory. Upon Ono’s request, the Parties shall 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 Supply Agreement shall contain rights for SymBio forecasting and ordering procedures (including lead times), product specifications, delivery terms and other appropriate provisions mutually acceptable, and any 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 audit the Actual Unit Cost periodically, an obligation transfer and validate at no cost to Ono all technology reasonably necessary for the Parties manufacturing and analytical testing of the Materials by [ * ] so that commercial quantities of Materials and can be supplied to enter into a quality agreementOno and released for the Ono Territory; (iii) Materials supplied by Array to Ono for commercial sale of the Products shall be charged to Ono in an amount equal to (A) [ * ] of Array’s manufacturing cost to the extent that Array or its Affiliate(s) Manufacture such Materials itself, backup rights for SymBio to manufacture Licensed Products and rights for SymBio to inspect facilities used to manufacture Commercial Product. or (ii) Pursuant [ * ] of the purchase price paid by Array for such Materials to the Commercial Supply Agreement, Onconova shall supply SymBio with the Commercial Product meeting the relevant Specifications, at extent that Array elects to have such Materials Manufactured by 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 no 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 calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or 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 calculating the Xxxx UpSubcontractor.

Appears in 2 contracts

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

Commercial Supply. (i) Not later than ** before the anticipated first commercial sale of the Licensed Product in the Licensed Territory, the Parties shall commence good faith negotiations of a commercial supply agreement that shall govern the supply of Commercial Product to SymBio (the “Commercial Supply Agreement”), with a goal of entering into the Commercial Supply Agreement no later than ** prior to the anticipated first commercial sale of the Licensed Product in the Licensed Territory. Pursuant to the Commercial Supply Agreement, Onconova RemeGen shall be obligatedresponsible, by itself or through its Third Party contract manufacturerone or more CMOs, to manufacture and supply to SymBioitself, its Affiliates and SymBio sublicensees the RC48 Licensed Product for Commercialization in the Field in the RemeGen Territory. RemeGen shall be required to purchaseresponsible, all quantities by itself or through one or more CMOs, for the commercial supply of the Commercial Product required by SymBio to commercialize 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. Such Within [ * ] after the Effective Date, the Parties shall negotiate in good faith and enter into a written supply agreement for such Commercial Supply Agreement shall be manufacture and supply by RemeGen of the RC48 Licensed Product to Seagen consistent with the terms set forth in this Article 5, on Exhibit 6.1(b)(i) hereto and shall include customary and reasonable terms and conditions commonly accepted in including that the pharmaceutical industry for supply of similar products at similar scale. Without limiting price [ * ] (the foregoing, the Commercial Supply Agreement shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for SymBio to inspect facilities used to manufacture Commercial Product. ii) Pursuant to 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, Onconova shall supply SymBio with the Commercial Product meeting the relevant Specifications, at a price equal then in addition to the “Xxxx Up,” which shall be defined as Onconova’s Actual Unit Cost for the Commercial Product plus **, provided that (i) in no 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 RemeGen technology transfer pursuant to Section 15 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 Commercial manufacture of the RC48 Licensed Product exceed **(such actions, “RC48 Manufacturing Technology Transfer”). The foregoing calculations 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 based on the average Japan Net Selling Price conducted at [ * ] sole cost and U.S. Net Selling Price calculated for all units expense. Seagen or its CMO will notify RemeGen of Commercial Product sold any material deviations or non-conformities in the calendar quarter preceding manufacture of the calendar quarter 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 which Onconova invoices SymBio 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 Commercial the RC48 Licensed Product. With respect to any supply of Commercial Product prior to If Seagen is commercially manufacturing the period during which the U.S. Net Selling Price and/or Japan Net Selling Price can be calculatedRC48 Licensed Product, if requested by RemeGen, the Parties shall use an estimated U.S. Net Selling Price and/or Japan Net Selling Pricewould negotiate in good faith to reach agreement on a commercial supply agreement pursuant to which Seagen would supply RC48 Licensed Product to RemeGen for sale in the RemeGen Territory, as applicableon terms and conditions to be agreed by the Parties, for purposes of calculating the Xxxx Upincluding [ * ].

Appears in 1 contract

Samples: License Agreement (Seagen Inc.)

Commercial Supply. i) Not later than Cephalon agrees to use its Reasonable Business Efforts to supply Xxxxxxx Pharma and Xxxxxxx Pharma agrees to purchase from Cephalon sufficient quantities of commercial supplies of GMP quality finished dosage form Licensed Products in the Territory, to be packaged in bulk containers. Xxxxxxx Pharma acknowledges that Cephalon has engaged and may engage additional third party manufacturers to produce bulk drug substance and/or finished dosage form. Xxxxxxx Pharma shall pay Cephalon a transfer price for finished dosage form as described in Section 4.2. Such finished dosage form shall in all cases be ** before *Certain portions of this exhibit have been omitted based upon a request for confidential treatment that has been filed with the anticipated Commission. The omitted portions have been filed separately with the Commission. provided in a product format specified by Xxxxxxx Pharma to meet then current European regulatory requirements specified by the EMEA. Xxxxxxx Pharma shall purchase exclusively from Cephalon all of Xxxxxxx Pharma's requirements for the Licensed Products during the term of this Agreement. Xxxxxxx Pharma hereby grants to Cephalon a right of first commercial sale negotiation to obtain from Xxxxxxx Pharma the right to supply Xxxxxxx Pharma with Licensed Products after the expiration of the Licensed Product in term of this Agreement. In the Licensed Territory, the Parties shall commence good faith negotiations of a commercial supply agreement that shall govern the event Xxxxxxx Pharma requires supply of Commercial Product to SymBio (Licensed Products after the “Commercial Supply termination of this Agreement”), with a goal of entering into the Commercial Supply Agreement no later then not less than [** *] prior to the anticipated first commercial sale expiration or termination of this Agreement and prior to negotiating with any third party manufacturer, or manufacturing itself, Xxxxxxx Pharma shall notify Cephalon of its supply requirements. Cephalon shall have thirty (30) days thereafter to notify Xxxxxxx Pharma in writing that it is interested in supplying Xxxxxxx Pharma. If Cephalon so notifies Xxxxxxx Pharma then the parties shall proceed in good faith to negotiate a supply agreement for Licensed Products. If Cephalon notifies Xxxxxxx Pharma that it is not interested in such a supply arrangement, or fails to notify Xxxxxxx Pharma within such thirty-day period, or fails to reach agreement with Xxxxxxx Pharma on the terms of such supply arrangement within ninety (90) days after such notification, then Xxxxxxx Pharma shall be free to negotiate with any third party for supply. In the event that Cephalon determines to directly manufacture Licensed Products, or to contract with a new or additional third party manufacturer for supplies of Licensed Product at any time, then, if that Licensed Product is either currently under development or being commercialized by Xxxxxxx Pharma, Cephalon shall promptly notify Xxxxxxx Pharma and, upon the request of Xxxxxxx Pharma, the parties shall discuss the possibility of Cephalon granting manufacturing rights to Xxxxxxx Pharma to make Licensed Product for sale 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 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 shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for 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 no 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 calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or 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 calculating the Xxxx Up.

Appears in 1 contract

Samples: Development and License Agreement (Cephalon Inc)

Commercial Supply. iIf Pulse Technologies desires to obtain supply of any Product (or any variant thereof or any version with different specifications) Not later than ** before for commercial use, then prior to negotiating the anticipated first commercial sale terms of the Licensed Product an agreement for such agreement, Pulse Technologies shall promptly notify Ikaria thereof in the Licensed Territorywriting. Ikaria shall, within 60 days after receipt of such notice, indicate to Pulse Technologies in writing whether Ikaria or any of its Affiliates wishes to enter into such an agreement and, if Ikaria indicates that Ikaria or any of its Affiliates do wish to enter into such agreement, the Parties shall commence negotiate in good faith negotiations of a commercial supply agreement that shall govern the supply of Commercial Product to SymBio (the “Commercial Supply Agreement”), with a goal of entering into the Commercial Supply Agreement no later than ** prior to the 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 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 shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality mutually agreeable terms pursuant to which Ikaria or any of its Affiliates would enter into agreement with Pulse Technologies. In such negotiations, Ikaria may elect to supply [**]% of Pulse Technologies requirements for the Product(s) in question, or such lesser quantity as Ikaria may elect in its sole discretion. If either (a) Ikaria indicates it does not wish to pursue such agreement, backup rights for SymBio (b) Ikaria fails to manufacture Licensed Products and rights for SymBio indicate its interest within such 30 day period or (c) Ikaria indicates it wishes to inspect facilities used enter into such agreement but the Parties fail to manufacture Commercial Product. ii) Pursuant reach agreement on the terms of such agreement or to execute a definitive agreement prior to 90 days after the Commercial Supply Agreementdate of Xxxxxx’s indication of interest, Onconova shall supply SymBio with the Commercial Product meeting the relevant Specifications, at a price equal to the “Xxxx Up,” which then Pulse Technologies shall be defined as Onconova’s Actual Unit Cost for free, without any further obligation to Ikaria under this Agreement with respect thereto, to enter into such an agreement with a Third Party; provided that, in the Commercial Product plus **event clause (c) of this sentence is applicable, provided if Pulse Technologies proposes to enter such agreement with a Third Party on terms that are materially less favorable to Pulse Technologies than the terms last offered in writing to Pulse Technologies by Xxxxxx, then (i) in no event shall the Xxxx Up exceed **Pulse Technologies shall, 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 calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to entering into such agreement with such Third Party, offer such terms to Ikaria, (ii) Ikaria shall have 15 days after the period during which the U.S. Net Selling Price and/or Japan Net Selling Price can be calculateddate of receipt of such offer from Pulse Technologies to notify Pulse Technologies in writing of its acceptance of such offer and (iii) (A) if Ikaria so accepts, the Parties shall use an estimated U.S. Net Selling Price and/or Japan Net Selling Pricepromptly enter into a definitive agreement for the commercial supply of such Product(s) on such terms, as applicableor (B) if Ikaria does not accept, then Pulse Technologies shall be free, without any further obligation to Ikaria under this Agreement with respect thereto, to enter into such commercial supply agreement with a Third Party; provided further that if Pulse Technologies does not enter into a definitive agreement for purposes such commercial supply with a Third Party within 180 days after the expiration of calculating the Xxxx UpXxxxxx’s under this Section 2.3, Xxxxxx’s rights under this Section 2.3 shall be reinstated.

Appears in 1 contract

Samples: Supply Agreement

Commercial Supply. iMirati shall be solely responsible (itself or through its Affiliate or CMO) Not for the manufacture of the commercial supply of Licensed Product for Commercialization by Licensee and its Affiliates and Sublicensees in the Licensed Territory. Customary terms of forecasting and ordering procedures, product specifications, and other operational matters relating to the supply of the Licensed Product under this Section 8.2 shall be set forth in a commercial supply agreement to be negotiated in good faith and mutually agreed upon by the Parties no later than [** before the **] prior to Licensee’s anticipated date for first commercial sale launch of the a Licensed Product in the Licensed Territory, the Parties shall commence good faith negotiations of a commercial supply agreement that shall govern the supply of Commercial Product to SymBio Territory (the “Mirati Commercial Supply Agreement”) under which Mirati (or its CMO) will manufacture and supply to Licensee the quantities of Licensed Product required by Licensee (provided that, [***] shall not be obligated to [***] following its good faith determination that any event, incident or circumstance related to material safety issues, quality issues or regulatory concerns has occurred, to the extent such event, incident, or circumstance would reasonably require the suspension or cessation of [***] provided further, in such case, [***] shall promptly notify [***] of such determination and provide [***] with the basis for its determination (including supporting documentation), and the Parties shall discuss in good faith alternative arrangements to minimize[***] [***] with a goal of entering into mechanisms to address the Commercial Supply Agreement no later than foregoing being set forth in the [** prior **] ), whereby: (a) terms and conditions applicable to Mirati (or its Affiliates) pursuant to Third Party contracts relevant to the anticipated first Mirati supply chain, including production of drug substance, drug product and fill and finish services and the maximum capacities available thereunder, shall be taken into account; (b) a binding forecast will be made by Licensee, mirroring the binding forecast mechanisms and principles applicable to Mirati in its contracts with Third Party manufacturers; (c) commercial sale supply of the Licensed Product Products will be at [***] Mirati’s Manufacturing Cost and will be delivered [***]; and (d) [***] will obtain and maintain all required export or import licenses or authorizations, and shall serve as importer of record for all Licensed Products delivered in or into any Region in the Licensed Territory. Pursuant Territory pursuant to this Agreement and the [***]; all as to be further agreed in the Mirati 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 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 shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for 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 no 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 calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or 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 calculating the Xxxx Up.

Appears in 1 contract

Samples: Collaboration and License Agreement (Mirati Therapeutics, Inc.)

Commercial Supply. (i) Not No later than [** before **] (the anticipated first commercial sale of “Commercial Product”), HMI shall notify Supplier in writing that HMI intends to negotiate the Licensed Product in the Licensed Territory, the Parties shall commence good faith negotiations terms of a commercial supply agreement for such Commercial Product, and provide [***]. Supplier shall respond in writing within [***] after receiving such notice from HMI whether Supplier believes it can meet such capacity to produce commercial supplies of such Commercial Product, including any documentation reasonably substantiating Supplier’s capabilities and capacity to produce such commercial supplies, [***]. If Supplier’s written response states that Supplier does not believe it can provide such capacity or capabilities, then Section 2.3(b)(iii) shall govern apply. (ii) If Supplier’s written response states that Supplier believes it can provide such capacity and capabilities, then the Parties shall exclusively negotiate with each other in good faith for a period of no less than [***] (or such longer period as mutually agreed upon in writing by the Parties) to enter into a commercial supply of agreement for such Commercial Product to SymBio (the “Commercial Supply Agreement”). For avoidance of doubt, neither Party shall be obligated to enter into a Commercial Supply Agreement and subject to subsection (iii) below, HMI shall be free to negotiate and enter into with any Third Party a commercial supply agreement for such Commercial Product after the expiration of such exclusive negotiation period. [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential. (iii) If Supplier’s written response pursuant to Section 2.3(b)(i) states that Supplier does not believe it has the capacity or capability to Manufacture such Product for commercial use, HMI shall notify OXB in writing that HMI intends to negotiate the terms of a Commercial Supply Agreement for such Commercial Product, and that Supplier has stated it does not have the capacity or capabilities required for commercial supply of such Commercial Product. HMI will provide to OXB then-available information regarding the capacity HMI believes in good faith is required for such commercial supply of such Commercial Product, and any special capabilities that HMI believes are required for commercial supply of such Product. OXB shall respond in writing within [***] after receiving such notice from HMI whether OXB believes it can meet such capacity to produce commercial supplies of such Commercial Product, [***]. If OXB’s written response states that OXB believes it can provide such capacity or capabilities, then HMI shall negotiate exclusively in good faith with OXB for a period of no less than [***] (or such longer period as mutually agreed upon by the HMI and OXB) to enter into a Commercial Supply Agreement for such Commercial Product. If HMI and OXB do not agree on the terms of such Commercial Supply Agreement within such period, HMI shall be entitled to negotiate and enter into a Commercial Supply Agreement with any other Third Party for such Commercial Product without any further obligations owed under this Section 2.3(b). For clarity, this subsection (iii) shall not apply if the Parties commenced negotiations but did not enter into a Commercial Supply Agreement pursuant to subsection (ii). (iv) If for a given Product, HMI has complied with all of the provisions of subsection (i) and (ii) above and thereafter enters into a commercial supply arrangement with a goal Third Party or OXB for commercial supply of entering into such Product, Supplier shall, at HMI’s written request, promptly initiate Technology Transfer for such Product to such Third Party or OXB, as applicable. Such Technology Transfer shall be [***]. (v) The Parties agree that the Commercial Supply Agreement no later than ** prior to the anticipated first commercial sale of the Licensed Product may include provisions addressing contingencies 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 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 shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for 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 event that [**, provided that (i) in no 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 calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or 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 calculating the Xxxx Up].

Appears in 1 contract

Samples: Manufacturing and Supply Agreement (Homology Medicines, Inc.)

Commercial Supply. i) Not Subject to Section 7.2, the Parties shall use Commercially Reasonable Efforts to agree, not later than […** before **…] prior to the anticipated first commercial sale launch date of the Licensed Product in the Licensed Territory, on the Parties shall commence good faith negotiations principal terms of a commercial supply agreement that shall govern the supply of Commercial Product to SymBio (the “Commercial Supply Agreement”)) pursuant to which BeiGene shall purchase commercial supply of a Licensed Product (vialed drug product, with labeled or unlabeled) for the Territory from Zymeworks or directly from a goal of entering into mutually agreed CMO. The transfer price under the Commercial Supply Agreement no later than shall be […** prior to the anticipated first commercial sale **…]. The terms 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 the terms and conditions of this Agreement, the applicable terms and conditions of Clinical Supply Agreement, and the terms and conditions of any agreement between Zymeworks and its Third Party manufacturing partner(s), to the extent applicable to commercial supply of Licensed Product in the Field in the Territory. The Parties shall negotiate in good faith and endeavor to enter into such Commercial Supply Agreement at least […***…] prior to the earlier of (i) the estimated date of enrollment of the last patient in the ZW25 Multi-Regional Registrational Study and (ii) the estimated date of enrollment of the last patient in the first Phase 3 Clinical Trial of such Licensed Product in the Territory. Unless and until otherwise agreed by the Parties, and except as otherwise 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 Agreement, BeiGene shall contain rights purchase its commercial requirements for SymBio to audit Licensed Product in the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for SymBio to inspect facilities used to manufacture Commercial Product. ii) Pursuant Territory from Zymeworks pursuant to the Commercial Supply Agreement. Zymeworks shall invoice BeiGene for the Licensed Product upon delivery and BeiGene shall, Onconova shall supply SymBio with the Commercial Product meeting the relevant Specifications, at a price equal subject to the “Xxxx Up,” which shall be defined as Onconova’s Actual Unit Cost for the Commercial Product plus **, provided that (i) in no event shall the Xxxx Up exceed **, and further provided that in no event shall the sum of the price for supply terms of the Commercial Product to SymBio and Supply Agreement, pay the royalty payable pursuant to Section 15 with respect to the Commercial Product exceed undisputed invoiced amounts within […***…] after the date of such invoice.66 63 Competitive Information – Commercially Sensitive Terms. The foregoing calculations shall be based on the average Japan Net Selling Price 64 Competitive Information – Financial Provisions and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial ProductCommercially Sensitive Terms. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or 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 calculating the Xxxx Up65 Competitive Information – Commercially Sensitive Terms. 66 Competitive Information – Financial Provisions and Commercially Sensitive Terms.

Appears in 1 contract

Samples: License and Collaboration Agreement (Zymeworks Inc.)

Commercial Supply. iCommencing promptly after the Effective Date, the parties, primarily via the JMC, shall work together in good faith to negotiate commercial supply agreements (which shall include providing Mundipharma with reasonable advance notice of all scheduled meetings and scheduled calls with Cidara CMOs so that Mundipharma has an opportunity to physically attend such meetings and join such calls, and permitting Mundipharma to review and jointly prepare all drafts of term sheets and agreements, and to conduct quality audits and technical assessments) Not later than ** before the anticipated first commercial sale of the with Cidara’s selected Third Party CMOs (“Cidara CMO(s)”) for Compound (including Compound starting material) and Licensed Product for clinical use and commercial distribution in the Licensed Territoryparties’ respective Territories (the “CMO Supply Agreements”). As soon as is reasonably practicable following the Effective Date, the Parties parties shall commence negotiate in good faith negotiations of and enter into a separate written commercial supply agreement that shall govern agreement, pursuant to which, subject to Sections 0 and 4.18(d), Cidara will manufacture, or have manufactured, and supply, or have supplied, to Mundipharma, Licensed Product (including Pediatric Licensed Product) for commercial distribution in the supply of Commercial Product to SymBio Mundipharma Territory (the “Commercial Supply Agreement”), with a goal of entering into the . The Commercial Supply Agreement no later than ** prior to shall be negotiated in good faith by the anticipated first commercial sale parties and shall be on commercially reasonable terms consistent with the terms of this Agreement. In any event, but save as provided in the paragraph below, the provisions 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 the terms set forth in this Article 5with, and shall include customary and reasonable terms and conditions commonly accepted in be designed to permit Cidara to comply with its obligations under, the pharmaceutical industry for supply of similar products at similar scalecorresponding CMO Supply Agreements. Without limiting Subject to the foregoing, the Commercial Supply Agreement Agreement, and, to the extent applicable, the CMO Supply Agreements, shall contain rights for SymBio to audit be negotiated in line with the Actual Unit Cost periodicallyprinciples set forth in the Key Supply Terms attached hereto as Exhibit G. In addition, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for SymBio to inspect facilities used to manufacture Commercial Product. ii) Pursuant to the Commercial Supply Agreement, Onconova Agreement 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 […***…], and Cidara shall […***…], provided that (i) in no event shall the Xxxx Up exceed […***…]; provided, and further provided however, that in no event the foregoing provisions of this sentence shall the sum of the price for supply of the Commercial Product to SymBio and the royalty payable pursuant to Section 15 with respect not apply to the Commercial Product exceed extent […**. The foregoing calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or 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 calculating the Xxxx Up*…].

Appears in 1 contract

Samples: Collaboration and License Agreement (Cidara Therapeutics, Inc.)

Commercial Supply. iCIMAB or CIMAB's Contract Manufacturers shall supply to CIMYM and CIMYM shall supply to DAIICHI and/or its Affiliates, and DAIICHI and/or its Affiliates shall purchase from CIMYM one hundred percent (100%) Not later than of DAIICHI’s unit requirements of the Licensed Product in agreed form for the purpose of all commercial sales in accordance with the terms of this Agreement and the Supply Agreement. CIMYM shall be the exclusive supplier of the Licensed Product to DAIICHI or its Affiliates. CIMAB shall prepare one or more of CIMAB's Contract Manufacturer(s), at its cost and responsibility, as a back-up source for any quantity of the Licensed Product that is necessary for DAIICHI's requirements, including the Licensed Product for the Studies and PMS Studies under Clause 8.1, in the event of supply shortage by CIMAB as set forth in Clause 8.6. To prepare CIMAB's Contract Manufacturer(s), CIMAB shall ensure that CIMAB's Contract Manufacturer(s) implement tests including, but not limited to, the bioequivalence test and comparability lest, and DAIICHI shall have the right to audit CIMAB's Contract manufacturer for compliance with applicable regulatory laws in the Territory. The supply price (C.I.P by air) of the Licensed Product to DAIICHI for commercial sales in the Territory shall be as follows: (a) In the event that the National Health Insurance price ("XXX xxxxx") of the Licensed Product as of the first commercial sale in the Territory is JPY * or more per 200mg of TheraCIM h-R3, the supply price shall be * percent (*%) of the Net Sales Value of the Licensed Product in all dosage forms, during the term of the Re-examination Period for the Licensed Product in the Territory. After the Re-examination period, the supply price shall be reduced to * before percent (*%) until *th anniversary of the anticipated first commercial sale of the Licensed Product in the Territory. (b) In the event that the XXX xxxxx of the Licensed TerritoryProduct as of the first commercial sale in the Territory is JPY * or more but less than JPY * per 200mg of TheraCIM h-R3, the Parties supply price shall commence good faith negotiations be * percent (*%) of a commercial supply agreement that shall govern the Net Sales Value of the Licensed Product in all dosage forms, during the term of the Re-examination Period for the Licensed Product in the Territory. After the Re-examination period, the supply price shall be reduced to * percent (*%) until * anniversary of Commercial Product to SymBio (the “Commercial Supply Agreement”), with a goal of entering into the Commercial Supply Agreement no later than ** prior to the 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 . (c) The supply to SymBio, and SymBio shall be required to purchase, all quantities price after * anniversary of the Commercial Product required by SymBio to commercialize first commercial sale of the Licensed Product in the Licensed Territory. Such Commercial Supply Agreement Territory shall be consistent with the terms set forth separately negotiated 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 shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for good faith by the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for 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 no 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 calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which expiration of the U.S. Net Selling Price and/or Japan Net Selling Price can be calculatedinitial term of this Agreement. (d) In the event that the XXX xxxxx of the Licensed Product as of the first commercial sale in the Territory is less than JPY * per 200mg of TheraCIM h-R3, the Parties shall use an estimated U.S. Net Selling Price and/or Japan Net Selling Priceseparately negotiate in good faith on the supply price. (e) In the event that the XXX Xxxxx of the Licensed Product after launch is reduced severely, as applicablethe Parties shall separately negotiate in good faith on the supply price. (f) In the event that any Generic Drug of the Licensed Product is launched in the Territory, for purposes the Parties shall separately negotiate in good faith a reduction to the supply price. JPY * <= XXX xxxxx * % * % JPY * <= XXX xxxxx < JPY * * % * % separately discussed XXX xxxxx < JPY * separately discussed Payment shall be made by DAIICHI within sixty (60) days after the date of calculating receiving the Xxxx UpLicensed Product from CIMYM.

Appears in 1 contract

Samples: License Agreement (Ym Biosciences Inc)

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Commercial Supply. (a) NEOPROBE agrees to either: (i) Not later than pay RELIABLE a capacity reservation fee of $[** before ] per year if no purchases of API are planned during a Commercial Contract Year covered by the anticipated first Term of this Agreement, beginning in calendar year 2011; or (ii) continue to purchase [*]% of its commercial sale requirements of API for use in the Licensed Finished Product in the Licensed TerritoryTerritory 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 $[*], the Parties shall commence good faith negotiations as set forth above, (and RELIABLE is not in material breach of a commercial supply agreement that shall govern the supply of Commercial Product to SymBio (the “Commercial Supply Agreement”its obligations hereunder), with 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 submit, in writing, to RELIABLE a goal good faith, initial forecast of entering into the Commercial Supply Agreement quantities of API estimated to be required on a Calendar Quarter basis during the following twelve (12) month period, which forecast shall be for be for planning purposes only; and (c) thereafter, no later than ** fifteen (15) days prior to the anticipated 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 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 in accordance with Section 3.2.4 and shall specify the quantity of API ordered, the destination to which the API is to be delivered and the time and manner of delivery (including the carrier to be used) in accordance with Section 4.3 and elsewhere in this Agreement. Subject to Section 5.2, NEOPROBE shall purchase [*]% of its commercial sale requirements of API for use in the Licensed Finished 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 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 shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for 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 **, Territory from RELIABLE provided that (i) RELIABLE is not in no event shall the Xxxx Up exceed **, and further provided that in no event shall the sum material breach 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 calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or 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 calculating the Xxxx Upits obligations hereunder.

Appears in 1 contract

Samples: Manufacture and Supply Agreement (Neoprobe Corp)

Commercial Supply. i) Not later than With respect to each SYNGAP1 Co-Co Product, reasonably in advance of, but at least [** before **] prior to, the anticipated first First Commercial Sale thereof, the JCC shall determine a plan for the Manufacture and supply to each Party, its Affiliates and Sublicensees of such SYNGAP1 Co-Co Product for Commercialization in the Territory. If, pursuant to such plan, Acadia will conduct some or all commercial sale manufacturing of the Licensed SYNGAP1 Co-Co Product (including supplying Stoke, its Affiliates or Sublicensees), then the JCC will prepare a plan (each such plan a “SYNGAP1 Co-Co Technology Transfer Plan”) and Stoke shall transfer to Acadia or its CMO (subject to Section 2.2(b)(ii)) the Stoke SYNGAP1 Know-How (including, for example, Know-How from Stoke’s other research programs to the extent necessary or generally useful in the manufacture of ASOs) with respect to the manufacture of such SYNGAP1 Co-Co Product as set forth in the plan, the cost of which transfer shall be shared by the Parties equally (50:50) as an Other Expense. To the extent necessary while the commercial manufacturing process for the SYNGAP1 Co-Co Product is being transferred and validated, Stoke will, upon on a transitional basis (not to exceed [***] after first Regulatory Approval of such SYNGAP1 Co-Co Product in the Licensed Territory), provide commercial supplies of the SYNGAP1 Co-Co Product following the first Regulatory Approval thereof in the Territory, subject to the terms and conditions set forth in the relevant SYNGAP1 Co-Co Clinical Supply Agreement. As applicable, the Parties shall commence negotiate in good faith negotiations of and enter into an agreement pursuant to which a commercial Party would supply agreement that shall govern the supply of Commercial SYNGAP1 Co-Co Product to SymBio the other Party, its Affiliates and Sublicensees for use in performing Commercialization activities under the applicable SYNGAP1 Co-Commercialization Plan at a transfer price equal to such Party’s Manufacturing Cost (the each a SYNGAP1 Co-Co Commercial Supply Agreement”), with a goal of entering into the Commercial Supply Agreement no later than ** prior . With respect to the anticipated first commercial sale of the Licensed Product in the Licensed Territory. Pursuant to the each SYNGAP1 Co-Co 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 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 shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for 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 no 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 calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or Japan Net Selling Price can be calculated, the Parties shall use negotiate in good faith and enter into an estimated U.S. Net Selling Price and/or Japan Net Selling Price, as applicable, for purposes agreement governing the quality control of calculating the Xxxx Upproduct Manufactured pursuant to such agreement.

Appears in 1 contract

Samples: License and Collaboration Agreement (Stoke Therapeutics, Inc.)

Commercial Supply. i) Not later than ** before As between the anticipated first Parties, Eucure, itself or through its designees, will be solely responsible for Manufacturing Collaborative Product for all commercial sale uses in the Collaborative Territory. Eucure shall use Commercially Reasonable Efforts to supply, or cause to be supplied, to Tracon all amounts of the Licensed Collaborative Product necessary for Tracon to Commercialize Collaborative Product in the Licensed 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 commence negotiate in good faith negotiations of and enter into a written commercial supply agreement that shall govern the supply of Commercial Product to SymBio (the “Commercial Supply Agreement”)and quality agreement, with a goal of entering into the Commercial Supply Agreement no later than ** prior to the 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 which will be consistent with the terms set forth in of this Article 5, Agreement and shall include customary and reasonable terms and conditions commonly accepted consistent with industry standard practices for such a commercial supply arrangement. (a) Eucure 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 pharmaceutical industry 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 COGS for Collaborative Product shall be the supply price in such agreement; provided that such COGS amount shall not be greater than the price charged by same CMO to Eucure or its partners in China for supply of similar products at similar scaleCollaborative Product that are manufactured in the same facility in the same time period. Without limiting Eucure shall annually provide Tracon with documentation providing the foregoing, the Commercial Supply Agreement shall contain rights basis for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for 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 no event shall the Xxxx Up exceed **, and further provided that in no event shall the sum establishment of the price for supply of the Commercial Product to SymBio and the royalty payable pursuant to Section 15 COGS with respect to the Commercial Product exceed commercial supply of Collaborative Product. Within [**. The foregoing calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units *] of Commercial commercial launch of Collaborative Product sold in the calendar quarter preceding Field in the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect Collaborative Territory, Eucure shall use Commercially Reasonable Efforts to any establish a second source of commercial supply of Commercial such Collaborative Product prior by entering into a second CMO Supply Agreement with a CMO on terms that are reasonably acceptable to Tracon. In the period during which event that the U.S. Net Selling Price and/or 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, CMO supplies Collaborative Product for purposes of calculating Commercialization of Collaborative Product in both the Xxxx UpCollaborative Territory and the Eucure Territory, the requirements for Commercialization in the Collaborative Territory shall be given equal treatment with respect to requirements for use outside of the Field and/or in the Eucure Territory in the event of a shortage or interruption of supply.

Appears in 1 contract

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

Commercial Supply. iMirati shall be solely responsible (itself or through its Affiliate or CMO) Not for the manufacture of the commercial supply of Licensed Product for Commercialization by Licensee and its Affiliates and Sublicensees in the Licensed Territory. Customary terms of forecasting and ordering procedures, product specifications, and other operational matters relating to the supply of the Licensed Product under this Section 8.2 shall be set forth in a commercial supply agreement to be negotiated in good faith and mutually agreed upon by the Parties no later than [** before the **] prior to Licensee’s anticipated date for first commercial sale launch of the a Licensed Product in the Licensed Territory, the Parties shall commence good faith negotiations of a commercial supply agreement that shall govern the supply of Commercial Product to SymBio Territory (the “Mirati Commercial Supply Agreement”) under which Mirati (or its CMO) will manufacture and supply to Licensee the quantities of Licensed Product required by Licensee (provided that, [***] shall not be obligated to [***] following its good faith determination that any event, incident or circumstance related to material safety issues, quality issues or regulatory concerns has occurred, to the extent such event, incident, or circumstance would reasonably require the suspension or cessation of [***] provided further, in such case, [***] shall promptly notify [***] of such determination and provide [***] with the basis for its determination (including supporting documentation), and the Parties shall discuss in good faith alternative arrangements to minimize[***] [***] with a goal of entering into mechanisms to address the Commercial Supply Agreement no later than foregoing being set forth in the [** prior **] ), whereby: [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED (a) terms and conditions applicable to Mirati (or its Affiliates) pursuant to Third Party contracts relevant to the anticipated first Mirati supply chain, including production of drug substance, drug product and fill and finish services and the maximum capacities available thereunder, shall be taken into account; (b) a binding forecast will be made by Licensee, mirroring the binding forecast mechanisms and principles applicable to Mirati in its contracts with Third Party manufacturers; (c) commercial sale supply of the Licensed Product Products will be at [***] Mirati’s Manufacturing Cost and will be delivered [***]; and (d) [***] will obtain and maintain all required export or import licenses or authorizations, and shall serve as importer of record for all Licensed Products delivered in or into any Region in the Licensed Territory. Pursuant Territory pursuant to this Agreement and the [***]; all as to be further agreed in the Mirati 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 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 shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for 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 no 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 calculations shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or 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 calculating the Xxxx Up.

Appears in 1 contract

Samples: Collaboration and License Agreement (Zai Lab LTD)

Commercial Supply. i) Not later than At least ** before the anticipated first commercial sale of the Licensed Product in the Licensed Territory, the Parties shall commence good faith negotiations of a commercial supply agreement that shall govern the supply of Commercial Product to SymBio (the “Commercial Supply Agreement”), with a goal of entering into the Commercial Supply Agreement no later than ** prior to the anticipated first commercial sale date of Regulatory Approval of the Licensed Product in the Licensed Territory. Pursuant United States, (i) Serenity shall have executed Commercial supply agreements with manufacturers and/or suppliers of components of the Product, including without limitation the Compound and Device(s), provided that Serenity shall not enter into any such agreement without the prior written consent of Allergan, unless Allergan is notified of the identify of such manufacturer/supplier and the remaining terms of this Section 4.10(e) apply to such manufacturer/supplier, and (ii) the Parties shall negotiate in good faith, and enter into, the Commercial Supply Agreement, Onconova shall be obligated, by itself or through its Third Party contract manufacturer, to Agreement which will provide for the manufacture and 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 Field for Commercial Supply Agreement purposes on terms mutually acceptable to the Parties, with terms shall be consistent with the terms set forth contained in this Article 5such Commercial supply agreements with manufacturers and/or suppliers of components of the Product, 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, upon the Commercial Supply Agreement going into effect, the terms of this Agreement concerning Commercial supply of Product shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products be superseded and rights for SymBio to inspect facilities used to manufacture Commercial Product. ii) Pursuant to replaced by the Commercial Supply Agreement, Onconova . Serenity shall supply SymBio provide Allergan with the Commercial Product meeting the relevant Specifications, at a price equal to the “Xxxx Up,” which copy of each executed agreement with each subcontractor permitted hereunder. Any and all such subcontracts shall be defined as Onconova’s Actual Unit Cost for the Commercial Product plus **, provided that *. Such Commercial supply agreements shall contain: (i) terms consistent with provisions customarily found in no event shall agreements for the Xxxx Up exceed manufacture and supply of commercial quantities of products of a similar nature, including without limitation provisions relating to timing and size of production orders, shipping, certificates on delivery, risk of loss, inspection and acceptance, timing of invoices and payments, failure to supply, and remedies for breach of representations and warranties; ***Certain confidential information contained in this document, marked with 3 asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended. (ii) terms obligating such subcontractor to comply with Serenity’s obligations under the applicable terms of this Agreement, including without limitation ***, and further provided that in no event such subcontractor will comply with all applicable regulatory obligations. Serenity 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 require that ***. The foregoing calculations Any and all such agreements with manufacturers and/or suppliers of components of the Product shall be based on ***; (iii) the average Japan Net Selling Unit Transfer Price and U.S. Net Selling Price calculated for all units such Product; (iv) the representations and warranties set forth in Section 9.2(n) for the commercial supply of Commercial Product sold in the calendar quarter preceding Field (unless the calendar quarter Parties mutually agree to modify such provisions); and (v) the indemnification and disclaimers and limitations on liability no less stringent than the terms set forth in which Onconova invoices SymBio Articles 10 and 11 for Commercial Product. With respect to any the commercial supply of Commercial Product prior to in the period during which the U.S. Net Selling Price and/or Japan Net Selling Price can be calculated, Field (unless the Parties shall use an estimated U.S. Net Selling Price and/or Japan Net Selling Price, as applicable, for purposes of calculating the Xxxx Upmutually agree to modify such provisions).

Appears in 1 contract

Samples: License Agreement (Allergan Inc)

Commercial Supply. i) Not later than ** before the anticipated first commercial sale DSP shall supply Chelsea with all of Chelsea’s requirements of the Licensed Product Compound for commercial use on such terms and conditions as provided for in the Licensed Territory, the Parties shall commence good faith negotiations of a commercial supply agreement that shall govern the supply of Commercial Product to SymBio Supply Agreement (the “Commercial Supply Agreement”)) attached hereto as Exhibit F, with a goal of entering into which shall become effective upon the Commercial Supply Agreement no later than ** prior to the anticipated first commercial sale dosing of the first patient in Chelsea’s Phase III Clinical Trial using a Licensed Product in the Licensed TerritoryProduct. 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 The Supply Agreement shall be consistent with the terms set forth in an integral part of this Article 5Agreement, and shall include customary in case of conflict between this Agreement 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 shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for SymBio to inspect facilities used to manufacture Commercial Product. ii) Pursuant to the Commercial Supply Agreement, Onconova this Agreement shall prevail. The Compound for commercial supply SymBio with shall be sold to Chelsea at such price in Japanese Yen as agreed upon between the Commercial Product meeting the relevant Specifications, at a price equal Parties pursuant to the “Xxxx Up,” which shall be Supply Agreement on the basis of FCA Kansai International Airport in Japan, as defined by INCOTERMS 2000 as Onconova’s Actual Unit Cost 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 Commercial Product plus **Compound with substantially similar specifications (the “Market Price”) to the Compound supplied by DSP as determined by the Joint Committee, provided that (i) Chelsea and DSP shall discuss in no event shall good faith the Xxxx Up exceed **, and further provided that in no event shall the sum possibility of reduction of the supply price for supply to the level of the Commercial Product Market Price. In the event Chelsea and DSP do not agree to SymBio 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 payable paid by Chelsea pursuant to Section 15 4.3 shall increase by one percent (1%) with respect to the Commercial Product exceed **Net Sales of Licensed Products containing the Compound not supplied by DSP. The foregoing calculations 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; certain information omitted and filed separately with the SEC. Notwithstanding the foregoing, in the event (i) any facility involved in the manufacture or storage of the 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 by the appropriate Regulatory Authorities or due to such failure to comply; or (ii) the termination of the Supply Agreement by Chelsea pursuant to Section 11.3 or 11.4 of the 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 its designee reasonably acceptable to DSP and there shall be based no such increase in royalty. In case of the occurrence of the Back-up Trigger described in (i) above, Chelsea and DSP shall discuss in good faith and determine (i) the estimated period that DSP cannot supply the Compound and (ii) 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 Chelsea that it has cured the event giving rise to such Back-Up Trigger and is able to supply to Chelsea, on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or Japan Net Selling Price can be calculateda long-term basis, the Parties shall use an estimated U.S. Net Selling Price and/or Japan Net Selling PriceCompound in accordance with the Supply Agreement, as applicablethen Chelsea shall, for purposes recommence the purchase of calculating the Xxxx UpCompound from DSP.

Appears in 1 contract

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

Commercial Supply. i) Not Subject to Section 7.2, the Parties shall use Commercially Reasonable Efforts to agree, not later than […** before **…] prior to the anticipated first commercial sale launch date of the Licensed Product in the Licensed Territory, on the Parties shall commence good faith negotiations principal terms of a commercial supply agreement that shall govern the supply of Commercial Product to SymBio (the “Commercial Supply Agreement”)) pursuant to which BeiGene shall purchase commercial supply of a Licensed Product (vialed drug product, with labeled or unlabeled) for the Territory from Zymeworks or directly from a goal of entering into mutually agreed CMO. The transfer price under the Commercial Supply Agreement no later than shall be […** prior to the anticipated first commercial sale **…]. The terms 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 the terms and conditions of this Agreement, the applicable terms and conditions of Clinical Supply Agreement, and the terms and conditions of any agreement between Zymeworks and its Third Party manufacturing partner(s), to the extent applicable to commercial supply of Licensed Product in the Field in the Territory. The Parties shall negotiate in good faith and endeavor to enter into such Commercial Supply Agreement at least […***…] prior to the earlier of (i) the estimated date of enrollment of the last patient in the ZW49 Multi-Regional Registrational Study and (ii) the estimated date of enrollment of the last patient in the first Phase 3 Clinical Trial of such Licensed Product in the Territory. Unless and until otherwise agreed by the Parties, and except as otherwise 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 Agreement, BeiGene shall contain rights purchase its commercial requirements for SymBio to audit Licensed Product in the Actual Unit Cost periodically, an obligation for the Parties to enter into a quality agreement, backup rights for SymBio to manufacture Licensed Products and rights for SymBio to inspect facilities used to manufacture Commercial Product. ii) Pursuant Territory from Zymeworks pursuant to the Commercial Supply Agreement. Zymeworks shall invoice BeiGene for the Licensed Product upon delivery and BeiGene shall, Onconova shall supply SymBio with the Commercial Product meeting the relevant Specifications, at a price equal subject to the “Xxxx Up,” which shall be defined as Onconova’s Actual Unit Cost for the Commercial Product plus **, provided that (i) in no event shall the Xxxx Up exceed **, and further provided that in no event shall the sum of the price for supply terms of the Commercial Product to SymBio and Supply Agreement, pay the royalty payable pursuant to Section 15 with respect to the Commercial Product exceed undisputed invoiced amounts within […**. The foregoing calculations shall be based on *…] after the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units date of Commercial Product sold in the calendar quarter preceding the calendar quarter in which Onconova invoices SymBio for Commercial Product. With respect to any supply of Commercial Product prior to the period during which the U.S. Net Selling Price and/or 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 calculating the Xxxx Up.such invoice.66

Appears in 1 contract

Samples: License and Collaboration Agreement (Zymeworks Inc.)

Commercial Supply. iCommencing on LEVPHARMA’s Commercial Launch (defined as the date on which LEVPHARMA commences marketing the Product in any country in the Territory following its receipt of Regulatory Approval in the applicable country) Not later than ** before the anticipated first commercial sale of the Licensed Product and thereafter during the term of the Agreement (including all renewal terms of the Agreement), subject to the terms and conditions of this Article IV, SANQUIN shall supply LEVPHARMA with LEVPHARMA’s requirements for Product for commercial use pursuant to this Agreement in each country in the Licensed Territory, the Parties shall commence good faith negotiations of a commercial supply agreement that shall govern the supply of Commercial Product to SymBio Territory where LEVPHARMA has Regulatory Approval (the “Commercial Supply AgreementSupply”), with a goal of entering into the . Said Commercial Supply Agreement no later than ** prior of Product shall at all times be ordered and supplied according to the anticipated first commercial sale procedures outlined in Sections 4.2 and 4.3. [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] i. Scale Up and LEVPHARMA Funding SANQUIN has performed an analysis of the Licensed Product in feasibility of scaling up 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 production of the Commercial Product and provided the results of this analysis to LEVPHARMA. Commencing on the Effective Date of this Amendment, SANQUIN shall initiate a project to scale up the production of the Product (the “Scale Up”) at both the Brussels and Amsterdam Facilities in accordance with the following terms and conditions of the Scale Up process: a. In accordance with the project plan (the “Project Plan”) to be approved by the Parties, LEVPHARMA shall fund, up to a maximum required by SymBio to commercialize the Licensed Product in the Licensed Territory. Such Commercial Supply Agreement shall be consistent with total investment of 7.5 million euros, through a loan facility upon the terms set forth in this Article 5paragraph 4.1(c)(i)(e), * * * of the capital investments at the Brussels Facility, and shall include customary and reasonable terms and conditions commonly accepted in * * * of the pharmaceutical industry capital investments at the Amsterdam Facility, required to conduct the Scale Up for supply the purposes of similar products at similar scale. Without limiting the foregoing, LEVPHARMA’s obtaining from SANQUIN the Commercial Supply Agreement shall contain rights for SymBio to audit the Actual Unit Cost periodically, an obligation of its requirements for the Parties Product pursuant to enter into a quality agreement, backup rights paragraphs 4.1(c)ii(d) and (e) of this Agreement. The remaining * * * of funding required for SymBio to manufacture Licensed Products and rights for SymBio to inspect facilities used to manufacture Commercial Product. ii) Pursuant to the Commercial Supply Agreement, Onconova shall supply SymBio with Scale Up of the Commercial Product meeting the relevant Specifications, at a price equal to the “Xxxx Up,” which Amsterdam Facility shall be defined as Onconova’s Actual Unit Cost the obligation of SANQUIN. Further, the Project Plan and budget shall be premised on the basis that the total cost of the capital investments necessary for the Commercial Product plus **, provided that (i) in no event shall the Xxxx Up exceed **, and further provided that in no event shall the sum successful completion of the price for supply Scale Up will be such that the loan maximum of LEVPHARMA will be sufficient to fund completion of the Commercial Product to SymBio Scale Up. LEVPHARMA and the royalty payable pursuant to Section 15 with respect to the Commercial Product exceed **. The foregoing calculations SANQUIN shall be based on the average Japan Net Selling Price and U.S. Net Selling Price calculated for all units of Commercial Product sold cooperate in the calendar quarter preceding development of the calendar quarter in which Onconova invoices SymBio Project Plan for Commercial Product. With respect to any supply of Commercial Product the Scale Up and shall jointly agree on a final project budget for the Scale Up prior to commencement of the period during which the U.S. Net Selling Price and/or Japan Net Selling Price can be calculatedScale Up project. Other than as expressly set forth herein, the Parties shall use an estimated U.S. Net Selling Price and/or Japan Net Selling Pricehave no liability pursuant to this Section until they have provided their written approval of the final Project Plan and budget other than LEVPHARMA’s obligations to fund the engineering component of the Scale Up, which precedes the Project Plan, as applicableunder (c) hereunder. The Project Plan shall also provide that upon completion of the Scale Up, SANQUIN shall have the manufacturing capacity to satisfy the maximum output of Product contemplated by this Agreement. [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] b. LEVPHARMA’s loan obligation pursuant to the above paragraph a) includes, without limitation, the costs of all required engineering (as jointly determined by LEVPHARMA and SANQUIN, but subject to the ceiling set forth in paragraph (a)), and is based on the Parties’ assumptions as of the Effective Date of this Amendment. In the event that SANQUIN shall at any time anticipate or project a need for purposes any material increase in the amount of calculating funds required for the Xxxx Scale Up, SANQUIN will promptly notify LEVPHARMA of this fact in writing and the Parties shall confer in good faith to reach agreement as to whether, and to what extent, such increase will be funded by the respective Parties. A material increase shall mean an amount equal or greater to * * * of the initial budget agreed to by the Parties for the Scale Up. Increases that are below this threshold shall be funded by SANQUIN up to a cumulative maximum of * * * of the initial budget. c. The costs for the engineering component of the Scale Up are estimated to be * * * euros. This includes costs for hiring an additional engineer by SANQUIN as well as the costs for engineering services contracted out. As part of its funding obligation pursuant the above paragraphs a) and b), LEVPHARMA will reimburse SANQUIN for these engineering costs within 30 days of receiving SANQUIN’s invoices documenting its expenditure or payment of such costs. LEVPHARMA’s obligations for other costs and expenses related to the Scale Up, and the terms and conditions pursuant to which LEVPHARMA shall make any payments, shall be as set forth in the final Project Plan and budget approved by SANQUIN and LEVPHARMA. d. In addition, SANQUIN agrees to fund any necessary non-clinical studies required as a result of the Scale Up, including but not limited to conformance lot production and testing, comparability testing between product from the licensed facility/process and the scaled up facility/process, and any other non-clinical studies required by the Regulatory Authorities to obtain approval of the Scale Up. e. With respect to the loan provided by LEVPHARMA as contemplated by paragraph 4.1(c)(i)(a), SANQUIN hereby agrees that: (a) the loan shall be due and payable in full by the maturity date as defined in paragraph 4.1(c)(i)(f); (b) no interest shall accrue on the outstanding principal amount of the loan; (c) SANQUIN shall repay the outstanding principal by crediting LEVPHARMA a * * * discount on the Purchase price per Unit of Commercial Product delivered to LEVPHARMA upon execution of this Amendment and the amount of such discount shall be applied against the outstanding balance of the loan; and (

Appears in 1 contract

Samples: Distribution and Manufacturing Services Agreement (Lev Pharmaceuticals Inc)

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