Common use of Supply Clause in Contracts

Supply. 2.1 During the Term, NPM shall allocate capacity to and shall manufacture and sell to CTI no less than the amounts of Product ordered by CTI with the issuance of a Binding Forecast PO pursuant to Section 2.16. All batches of Product shall be produced utilizing the Process and in accordance with the Specifications, cGMP, Government Approvals, and the terms of this Agreement. 2.2 Binding Forecast PO’s, as defined below, will be placed on CTI’s standard purchase orders then in effect with a minimum lead time of **. All terms and conditions of this Agreement shall govern the transactions between the Parties and any terms or conditions of said purchase order which conflict with this Agreement shall be null and void. NPM shall promptly manufacture and deliver all Firm Orders, as defined below, of Product in accordance with the related schedule and in compliance with the Specifications, cGMP and other applicable laws and regulations. ** 2.3 All Product supplied by NPM shall be delivered to CTI’s designated carrier per ** from NPM’s facility, as specified in the related Firm Order. ** 2.4 NPM shall ship the Product in accordance with applicable laws and regulations and in a commercially reasonable manner in accordance with the instructions set forth on Attachment D hereto. 2.5 CTI or its designee may, at CTI’s option, analyze each batch and samples from each batch of Product. ** 2.7 Subject to Sections 2.5 and 2.6, ** 2.8 NPM warrants that all applicable environmental and safety requirements are being and will be followed at its facilities. Additionally, the manufacture of the Product shall be in accordance with cGMP. For the purpose of quality assurance auditing and to evaluate compliance with applicable cGMPs, environmental and occupational health and safety laws and regulations, CTI shall have the right to audit and inspect per the Quality Agreement. ** 2.9 NPM shall notify CTI **of significant incidents relating to production of the Product **. 2.10 At CTI’s request, NPM shall, within five (5) business days, provide copies of all relevant environmental licenses and permits in their original language pertaining to its operation and shall notify CTI of any material change in status. ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.11 At CTI’s request, NPM will, within five (5) business days, provide the requirements set forth in Attachment F (the “Record Keeping and Accounting Schedule”). 2.12 At CTI’s request, NPM will, within five (5) business days, provide CTI with copies of all applicable insurance certificates in their original language. Insurance requirements of the Parties shall be listed in Attachment G (the “Insurance Requirements”). 2.13 During the Post-commercialization period **. 2.14 NPM agrees that it will conduct all necessary testing of the Product as required by the Specifications. All testing is to be performed during and at the completion of the manufacture of the Product. ** 2.15 NPM will ** provide to CTI copies of all correspondence, inspection reports and other reports issued by the FDA or other regulatory agencies with respect to those affecting the Product produced for CTI in NPM’ facilities. 2.16 During the Post-commercialization Period CTI shall submit to NPM ** a rolling commercial forecast, as follows: **. For clarification, these forecast and estimate requirements shall only be required to be provided for periods occurring during the actual Term of the Agreement. ** CTI agrees to purchase, and NPM agrees to produce, ** subject to Section 2.17 below. For clarity purposes, CTI shall be credited with the previous Binding Forecast PO’s in calculating the purchase requirement in this paragraph. 2.17 Each Binding Forecast PO shall identify and reference the quantity of Product ordered, the price to be paid for such Product, packaging requirements, delivery schedule, delivery locations, invoice information and other applicable instructions. If the amounts in the Binding Forecast PO are in compliance with Section 2.16, and Attachment B to this Agreement, the Binding Forecast PO shall be deemed accepted by NPM upon its receipt thereof and become a “Firm Order”. ** Use of e-mail is in this case is permitted, and e-mails shall be sent to the respective e-mail addresses indicated by the Parties. Subject to the cancellation and termination rights in this Agreement, Firm Orders shall be considered firm and non-cancelable, except as provided in Section 2.16 and 2.17 with respect to certain changes, if any, in any Binding Forecast PO. 2.18 During the Pre-commercialization Period CTI may submit NPM Binding Forecast PO with a minimum lead time of **. NPM shall then ** confirm to CTI its acceptance or non acceptance of the Binding Forecast PO, indicating the delivery date and the quantity of Product to be supplied. ** ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.19 In the event NPM fails to deliver any Product due under a Firm Order by the scheduled delivery date, the Price of such Product will be reduced as follows: 2.20 NPM shall not manufacture or sell the Product to any party other than CTI, or its designated affiliates or designated subsidiaries, without CTI’s prior written consent. 2.21 NPM shall not use any materials (including drug substance) provided by CTI hereunder for any purpose other than performing NPM’ obligations under this Agreement and/or the Quality Agreement.

Appears in 1 contract

Sources: Drug Product Manufacturing Supply Agreement (Cell Therapeutics Inc)

Supply. 2.1 During the Term, NPM shall allocate capacity Centaur undertakes to and shall manufacture and sell to CTI no less than supply Cutanix' ------ requirements of the amounts of Product ordered Compounds for use in connection with activities authorized by CTI with the issuance of a Binding Forecast PO pursuant to Section 2.16License Agreement. All batches of Product Centaur shall be produced utilizing Cutanix' exclusive supplier of the Process Compounds during the period beginning as of the date hereof and ending upon the earlier of: (i) Centaur's delivery of notice to Cutanix that it wishes to terminate the exclusivity for any reason, or (ii) Cutanix' delivery of notice to Centaur that it wishes to terminate Centaur's exclusivity due to Centaur's inability or unwillingness to fulfill its supply obligations under this Agreement, such period being referred to herein as the "Exclusive Period". For twelve (12) months following termination of the Exclusive Period, Centaur shall be obligated to supply Cutanix in accordance with the Specificationssame manner as during the Exclusive Period, cGMPsubject to Cutanix' delivery of forecasts and orders as provided below. Upon termination of the Exclusive Period, Government ApprovalsCentaur will provide (i) at no cost to Cutanix, all documents related to the manufacturing of Compounds that are reasonably required to enable another supplier to manufacture such Compounds, (ii) an unrestricted royalty-free license to any intellectual property or know- how used by Centaur in manufacturing the Compounds (without the right to grant sublicenses, except to a third party supplier for the limited purpose of manufacturing Compounds for Cutanix), and the terms of this Agreement. 2.2 Binding Forecast PO’s, as defined below, will be placed on CTI’s standard purchase orders then in effect with a minimum lead time of **. All terms and conditions of this Agreement shall govern the transactions between the Parties and any terms or conditions of said purchase order which conflict with this Agreement shall be null and void. NPM shall promptly manufacture and deliver all Firm Orders, as defined below, of Product in accordance with the related schedule and in (iii) subject to Cutanix' compliance with the Specificationscost reimbursement provisions of Section 3 hereof, cGMP technical and operating advice to facilitate the manufacturing of the Compounds by Cutanix or another supplier, subject in all cases to the agreement by any third party supplier not to use or disclose information provided by Centaur for any purpose, other applicable laws and regulations. ** 2.3 All Product supplied by NPM shall be delivered to CTI’s designated carrier per ** from NPM’s facility, as specified in the related Firm Order. ** 2.4 NPM shall ship the Product in accordance with applicable laws and regulations and in a commercially reasonable manner in accordance with the instructions set forth on Attachment D hereto. 2.5 CTI or its designee may, at CTI’s option, analyze each batch and samples from each batch of Product. ** 2.7 Subject to Sections 2.5 and 2.6, ** 2.8 NPM warrants that all applicable environmental and safety requirements are being and will be followed at its facilities. Additionally, than the manufacture of the Product shall be in accordance with cGMP. For the purpose of quality assurance auditing and to evaluate compliance with applicable cGMPs, environmental and occupational health and safety laws and regulations, CTI shall have the right to audit and inspect per the Quality Agreement. ** 2.9 NPM shall notify CTI **of significant incidents relating to production of the Product **Compounds for Cutanix. 2.10 At CTI’s request, NPM shall, within five (5) business days, provide copies of all relevant environmental licenses and permits in their original language pertaining to its operation and shall notify CTI of any material change in status. ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.11 At CTI’s request, NPM will, within five (5) business days, provide the requirements set forth in Attachment F (the “Record Keeping and Accounting Schedule”). 2.12 At CTI’s request, NPM will, within five (5) business days, provide CTI with copies of all applicable insurance certificates in their original language. Insurance requirements of the Parties shall be listed in Attachment G (the “Insurance Requirements”). 2.13 During the Post-commercialization period **. 2.14 NPM agrees that it will conduct all necessary testing of the Product as required by the Specifications. All testing is to be performed during and at the completion of the manufacture of the Product. ** 2.15 NPM will ** provide to CTI copies of all correspondence, inspection reports and other reports issued by the FDA or other regulatory agencies with respect to those affecting the Product produced for CTI in NPM’ facilities. 2.16 During the Post-commercialization Period CTI shall submit to NPM ** a rolling commercial forecast, as follows: **. For clarification, these forecast and estimate requirements shall only be required to be provided for periods occurring during the actual Term of the Agreement. ** CTI agrees to purchase, and NPM agrees to produce, ** subject to Section 2.17 below. For clarity purposes, CTI shall be credited with the previous Binding Forecast PO’s in calculating the purchase requirement in this paragraph. 2.17 Each Binding Forecast PO shall identify and reference the quantity of Product ordered, the price to be paid for such Product, packaging requirements, delivery schedule, delivery locations, invoice information and other applicable instructions. If the amounts in the Binding Forecast PO are in compliance with Section 2.16, and Attachment B to this Agreement, the Binding Forecast PO shall be deemed accepted by NPM upon its receipt thereof and become a “Firm Order”. ** Use of e-mail is in this case is permitted, and e-mails shall be sent to the respective e-mail addresses indicated by the Parties. Subject to the cancellation and termination rights in this Agreement, Firm Orders shall be considered firm and non-cancelable, except as provided in Section 2.16 and 2.17 with respect to certain changes, if any, in any Binding Forecast PO. 2.18 During the Pre-commercialization Period CTI may submit NPM Binding Forecast PO with a minimum lead time of **. NPM shall then ** confirm to CTI its acceptance or non acceptance of the Binding Forecast PO, indicating the delivery date and the quantity of Product to be supplied. ** ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.19 In the event NPM fails to deliver any Product due under a Firm Order by the scheduled delivery date, the Price of such Product will be reduced as follows: 2.20 NPM shall not manufacture or sell the Product to any party other than CTI, or its designated affiliates or designated subsidiaries, without CTI’s prior written consent. 2.21 NPM shall not use any materials (including drug substance) provided by CTI hereunder for any purpose other than performing NPM’ obligations under this Agreement and/or the Quality Agreement.

Appears in 1 contract

Sources: Services and Supply Agreement (Centaur Pharmaceuticals Inc)

Supply. 2.1 During 11.1.1 From time to time, the Term, NPM shall allocate capacity to and shall manufacture and sell to CTI no less than Company may screen the amounts of Product ordered by CTI with Pre-Made Plates that are in the issuance of a Binding Forecast PO Company’s possession pursuant to Section 2.16the Screening Services Agreement solely to the extent such screening is expressly permitted hereunder and subject to any restrictions, limitations or obligations set forth herein. All batches Notwithstanding the foregoing, in the event that the Company uses sixty percent (60%) of Product shall be produced utilizing the Process and volume of the solvent containing the Compounds in accordance with the Specifications▇▇▇▇▇ on any Pre-Made Plate, cGMP, Government Approvals, and the terms of this Agreement. 2.2 Binding Forecast PO’s, as defined below, will be placed on CTI’s standard purchase orders then in effect with a minimum lead time of **. All terms and conditions of this Agreement shall govern the transactions between the Parties and any terms or conditions of said purchase order which conflict with this Agreement shall be null and void. NPM Company shall promptly manufacture and deliver all Firm Orders, as defined below, of Product in accordance provide Pfizer with written notice thereof (the related schedule and in compliance with the Specifications, cGMP and other applicable laws and regulations“Exhaustion Notice”). ** 2.3 All Product supplied by NPM shall be delivered to CTI’s designated carrier per ** from NPM’s facility, as specified in the related Firm Order. ** 2.4 NPM shall ship the Product in accordance with applicable laws and regulations and in a commercially reasonable manner in accordance with the instructions set forth on Attachment D hereto. 2.5 CTI or its designee may, at CTI’s option, analyze each batch and samples from each batch of Product. ** 2.7 Subject to Sections 2.5 and 2.6, ** 2.8 NPM warrants that all applicable environmental and safety requirements are being and will be followed at its facilities. Additionally, the manufacture of the Product shall be in accordance with cGMP. For the purpose of quality assurance auditing and to evaluate compliance with applicable cGMPs, environmental and occupational health and safety laws and regulations, CTI Pfizer shall have the right to audit include the costs for replacing a Pre-Made Plate used by the Company in the Invoiced Costs after providing the Company with an Exhaustion Notice for such Pre-Made Plate (unless this Agreement is expiring or terminating, in which case, Pfizer may provide such an invoice as soon as reasonably practicable following the time of such expiration or termination). For clarity, any decision by Pfizer to not replace any such Compounds in a Pre-Made Plate shall not excuse the Company from reimbursing Pfizer for using such Pre-Made Plates as described in this Section. The Company shall pay Pfizer the costs of each screen that it conducts in connection with the Collaboration as set forth on Schedule 1.1(e) and inspect per the Quality Agreement. ** 2.9 NPM shall notify CTI **of significant incidents relating to production of the Product **specified in an invoice as an Invoiced Cost. 2.10 At CTI’s request11.1.2 From time to time, NPM shall, within five (5) business days, provide copies of all relevant environmental licenses the Company may submit to the Curator reasonable requests that Pfizer supply the Company with Compounds and permits Analogs to the extent the Company is permitted to perform Lead Seeking Activities or Candidate Designation Activities on such Compounds or Analogs in their original language pertaining to its operation and shall notify CTI of any material change in status. ** Indicates that certain information contained herein has been omitted and filed separately accordance with the Securities applicable notice granting Intent to Access or the AIP Notice. The Company may request such Compounds or Analogs as solid (i.e., neat) samples, in solution in ▇▇▇▇ tubes, or as part of custom-made plates or Pre-Made Plates to conduct research and Exchange Commission. Confidential treatment has been request with respect development solely to the omitted portions. **** Indicates that the amount of information omitted was a page or more in lengthextent expressly permitted hereunder, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect and, for clarity, subject to the omitted portionsany limitations set forth herein. 2.11 At CTI’s request, NPM will, within five 11.1.3 Pfizer may (5using good faith and in its sole discretion) business days, provide the requirements set forth in Attachment F (the “Record Keeping and Accounting Schedule”). 2.12 At CTI’s request, NPM will, within five (5) business days, provide CTI with copies of all applicable insurance certificates in their original language. Insurance requirements of the Parties shall be listed in Attachment G (the “Insurance Requirements”). 2.13 During the Post-commercialization period **. 2.14 NPM agrees that it will conduct all necessary testing of the Product as required grant or deny any such request made by the Specifications. All testing is Company pursuant to be performed during and at the completion of the manufacture of the Product. ** 2.15 NPM will ** provide to CTI copies of all correspondenceSection 11.1.2; provided that, inspection reports and other reports issued by the FDA or other regulatory agencies with respect to those affecting the Product produced for CTI in NPM’ facilities. 2.16 During the Post-commercialization Period CTI no event, shall submit to NPM ** a rolling commercial forecast, as follows: **. For clarification, these forecast and estimate requirements shall only Pfizer be required to be provided grant such a request (a) for periods occurring greater than or equal to fifty-percent (50%) of Pfizer’s and its Affiliates’ readily-available inventory of the applicable Compound or Analog, or (b) that would result in Pfizer’s and its Affiliates’ inventory of the applicable Compound or Analog being less than the quantities Pfizer reasonably believes (as determined by Pfizer in its sole discretion) are necessary for the research and development conducted by or on behalf of Pfizer and its Affiliates (including in connection with any Third Parties) during the actual Term six (6) month period after the Company’s request. Notwithstanding the foregoing, in no event will the Company in connection with any such request be treated more favorably than Pfizer’s or its Affiliates’ internal research units (or any successors thereof) would be treated if such research units had made such a request. Should Pfizer grant any Company request made pursuant to Section 11.1.2, the Company shall pay Pfizer the cost of replacing any Compound or Analog as an Invoiced Cost, it being understood that such Invoiced Cost will include only the cost of such Compound or Analog, and the Company shall be solely responsible for payment of any costs in respect of transfer (including shipping costs) of such Compound or Analog from Sigma-▇▇▇▇▇▇▇▇ or any other Third Party used to store such Compound or Analog, plus such pro rata portion of the Agreement. ** CTI agrees to purchase, and NPM agrees to produce, ** subject to Section 2.17 below. For clarity purposes, CTI shall be credited with the previous Binding Forecast PO’s in calculating the purchase requirement in this paragraphfacility fee from Sigma ▇▇▇▇▇▇▇▇ or such Third Party. 2.17 Each Binding Forecast PO shall identify and reference the quantity of Product ordered, the price to be paid for such Product, packaging requirements, delivery schedule, delivery locations, invoice information and other applicable instructions. If the amounts in the Binding Forecast PO are in compliance with Section 2.16, and Attachment B to this Agreement, the Binding Forecast PO shall be deemed accepted by NPM upon its receipt thereof and become a “Firm Order”. ** Use of e-mail is in this case is permitted, and e-mails shall be sent to the respective e-mail addresses indicated by the Parties. Subject to the cancellation and termination rights in this Agreement, Firm Orders shall be considered firm and non-cancelable, except as provided in Section 2.16 and 2.17 with respect to certain changes, if any, in any Binding Forecast PO. 2.18 During the Pre-commercialization Period CTI may submit NPM Binding Forecast PO with a minimum lead time of **. NPM shall then ** confirm to CTI its acceptance or non acceptance of the Binding Forecast PO, indicating the delivery date and the quantity of Product to be supplied. ** ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.19 In the event NPM fails to deliver any Product due under a Firm Order by the scheduled delivery date, the Price of such Product will be reduced as follows: 2.20 NPM shall not manufacture or sell the Product to any party other than CTI, or its designated affiliates or designated subsidiaries, without CTI’s prior written consent. 2.21 NPM shall not use any materials (including drug substance) provided by CTI hereunder for any purpose other than performing NPM’ obligations under this Agreement and/or the Quality Agreement.

Appears in 1 contract

Sources: Research and Development Collaboration and License Agreement (Zoetis Inc.)

Supply. 2.1 6.1 During the Termterm of this Agreement, NPM DOBFAR shall allocate capacity to manufacture, label and shall manufacture package, ship and sell to CTI no less than deliver the amounts Product for SAGENT on the terms and conditions specified in this Agreement and in compliance with all requirements of Product ordered by CTI with the issuance applicable laws, rules and regulations, and all other requirements of a Binding Forecast PO pursuant to Section 2.16any applicable cGMP and Specifications. All batches of The Product shall be produced utilizing manufactured by DOBFAR at the Process and applicable Manufacturing Facility in accordance with the Specifications, cGMP, Government Approvals, and the terms of this Agreement and the Quality Agreement. Except as set forth in Section 7.1, SAGENT shall not be required to order any fixed minimum quantity of Product or any quantity of Product for which it does not actually have a need, notwithstanding any forecast or prior course of dealing. 2.2 Binding Forecast PO’s, as defined below, will be placed on CTI’s standard purchase orders then in effect with a minimum lead time of **. All terms and conditions 6.2 During the term of this Agreement shall govern the transactions between the Parties and any terms or conditions of said purchase order which conflict with this Agreement Agreement, DOBFAR shall be null and void. NPM shall promptly solely responsible for arranging for an FDA-approved third party to manufacture and deliver all Firm Orders, as defined below, of Product in accordance with supply the related schedule and in compliance with the Specifications, cGMP and other applicable laws and regulations. ** 2.3 All Product supplied by NPM shall be delivered API necessary to CTI’s designated carrier per ** from NPM’s facility, as specified in the related Firm Order. ** 2.4 NPM shall ship manufacture the Product in accordance with all requirements of applicable laws laws, rules and regulations regulations, and all other requirements of any applicable cGMP and Specifications and in a commercially reasonable manner sufficient quantities to meet SAGENT’s forecasted needs for the Product; provided that DOBFAR shall give written notice to SAGENT in accordance advance of retaining any such third party API supplier. With respect to any third party API supplier that DOBFAR desires to use, DOBFAR shall ensure that such third party API supplier makes its facilities and records relating to the manufacture of the API available for inspection by SAGENT as SAGENT requests from time to time. In the event that during any such inspection, SAGENT identifies any instances of noncompliance with the instructions set forth on Attachment D hereto. 2.5 CTI requirements of applicable laws, rules and regulations, applicable cGMP or its designee maythe Specifications, then DOBFAR shall promptly provide a written plan for correcting such deficiencies (including a proposed timetable for implementing such corrections) and shall ensure that such deficiencies are corrected, at CTIDOBFAR’s optionor such third party API supplier’s sole expense, analyze each batch as soon as reasonably practicable. If not corrected to SAGENT’s satisfaction (or if the third party API supplier does not make its facility and samples from each batch of Productrecords available for inspection by SAGENT), then DOBFAR shall be required to secure a different third party API supplier, and to immediately cease using the noncompliant supplier. ** 2.7 Subject to Sections 2.5 Section 6.3, DOBFAR shall be solely responsible for ensuring that the API so supplied to it is of sufficient quality and 2.6, ** 2.8 NPM warrants that all applicable environmental and safety requirements are being and will meets other relevant standards in order for it to be followed at its facilities. Additionally, utilized by DOBFAR in the manufacture of the Product shall be in accordance with cGMP. For the purpose of quality assurance auditing and to evaluate compliance with applicable cGMPs, environmental and occupational health and safety laws and regulations, CTI shall have the right to audit and inspect per the Quality Agreement. ** 2.9 NPM shall notify CTI **of significant incidents relating to production of the Product **Section 6.1. 2.10 At CTI’s request, NPM shall, within five (5) business days, provide copies of all relevant environmental licenses and permits in their original language pertaining to its operation and shall notify CTI of any material change in status. ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.11 At CTI’s request, NPM will, within five (5) business days, provide the requirements set forth in Attachment F (the “Record Keeping and Accounting Schedule”). 2.12 At CTI’s request, NPM will, within five (5) business days, provide CTI with copies of all applicable insurance certificates in their original language. Insurance requirements of the Parties shall be listed in Attachment G (the “Insurance Requirements”). 2.13 During the Post-commercialization period **. 2.14 NPM agrees that it will conduct all necessary testing of the Product as required by the Specifications. All testing is to be performed during and at the completion of the manufacture of the Product. ** 2.15 NPM will ** provide to CTI copies of all correspondence, inspection reports and other reports issued by the FDA or other regulatory agencies with respect to those affecting the Product produced for CTI in NPM’ facilities. 2.16 During the Post-commercialization Period CTI shall submit to NPM ** a rolling commercial forecast, as follows: **. For clarification, these forecast and estimate requirements shall only be required to be provided for periods occurring during the actual Term of the Agreement. ** CTI agrees to purchase, and NPM agrees to produce, ** subject to Section 2.17 below. For clarity purposes, CTI shall be credited with the previous Binding Forecast PO’s in calculating the purchase requirement in this paragraph. 2.17 Each Binding Forecast PO shall identify and reference the quantity of Product ordered, the price to be paid for such Product, packaging requirements, delivery schedule, delivery locations, invoice information and other applicable instructions. If the amounts in the Binding Forecast PO are in compliance with Section 2.16, and Attachment B to this Agreement, the Binding Forecast PO shall be deemed accepted by NPM upon its receipt thereof and become a “Firm Order”. ** Use of e-mail is in this case is permitted, and e-mails shall be sent to the respective e-mail addresses indicated by the Parties. Subject to the cancellation and termination rights in this Agreement, Firm Orders shall be considered firm and non-cancelable, except as provided in Section 2.16 and 2.17 with respect to certain changes, if any, in any Binding Forecast PO. 2.18 During the Pre-commercialization Period CTI may submit NPM Binding Forecast PO with a minimum lead time of **. NPM shall then ** confirm to CTI its acceptance or non acceptance of the Binding Forecast PO, indicating the delivery date and the quantity of Product to be supplied. ** ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.19 In the event NPM fails to deliver any Product due under a Firm Order by the scheduled delivery date, the Price of such Product will be reduced as follows: 2.20 NPM shall not manufacture or sell the Product to any party other than CTI, or its designated affiliates or designated subsidiaries, without CTI’s prior written consent. 2.21 NPM shall not use any materials (including drug substance) provided by CTI hereunder for any purpose other than performing NPM’ obligations under this Agreement and/or the Quality Agreement.

Appears in 1 contract

Sources: Manufacturing Agreement

Supply. 2.1 During (i) Hospira shall Manufacture Product for Genzyme from Bulk that Genzyme shall supply to Hospira in quantities sufficient to satisfy Hospira’s gross manufacturing requirements of Product. Unless otherwise specified in the Termrelevant Project SOW, NPM Genzyme shall allocate capacity deliver all required quantities of Bulk for a particular Product no later than thirty (30) days prior to the date that Manufacturing of such Product is scheduled to commence. Hospira’s use of Bulk received from Genzyme shall be limited to those purposes contemplated by this Master Agreement and shall manufacture and sell to CTI no less than the amounts Manufacture of Product ordered by CTI with the issuance of a Binding Forecast PO for Genzyme. Genzyme shall deliver Bulk [**] Hospira’s Facility for all deliveries, pursuant to Section 2.16no-cost Purchase Orders that Hospira issues to Genzyme. All batches of Product Genzyme shall be produced utilizing responsible for all costs of transport and carriage insurance. In the Process and in accordance with event Genzyme fails more than once to deliver the Specifications, cGMP, Government Approvals, and the terms required quantities of this Agreement. 2.2 Binding Forecast PO’s, as defined below, will be placed on CTI’s standard purchase orders then in effect with Bulk for a minimum lead time of particular Product at least [**. All terms and conditions ] days prior to the date that Manufacturing of this Agreement shall govern the transactions between the Parties and any terms such Product is scheduled to commence, or conditions of said purchase order which conflict with this Agreement shall be null and void. NPM shall promptly manufacture and deliver all Firm Orders, as defined below, of Product in accordance with the related schedule and in compliance with the Specifications, cGMP and other applicable laws and regulations. ** 2.3 All Product supplied by NPM shall be delivered to CTI’s designated carrier per ** from NPM’s facility, as specified in the related Firm Orderrelevant Project SOW, the Alliance Team leaders shall meet to establish a remediation plan to address the failure. If Genzyme fails more than twice to deliver the required quantities of Bulk for a particular Product at least [** 2.4 NPM ] days prior to the date that [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Manufacturing of such Product is scheduled to commence, or as specified in the relevant Project SOW, then a member of the senior management team from each Party shall ship meet with one another to review the remediation plan established by the Alliance Team and determine whether Genzyme is capable of delivering Bulk within the specified delivery timeframe. The Parties will at that time determine whether Hospira will continue with the Manufacture the Product in accordance with applicable laws and regulations and question or, alternatively, decide in a commercially reasonable manner in accordance with the instructions set forth on Attachment D heretobest interests of the Parties that Hospira no longer manufacture such Product. 2.5 CTI (ii) With each delivery of Bulk, Genzyme will include a certificate of analysis, signed by an authorized individual from Genzyme’s Quality Group (or its designee mayhis/her designee) containing basic information regarding the Bulk, including: (A) the manufacturing date of the batch/lot delivered; (B) the batch/lot number; (C) the quantity of Bulk in such batch/lot as shipped to Hospira; (D) an indication of the expiry date of the batch/lot of Bulk by which Hospira must begin filling operations; and (E) the testing (if any) to which the batch/lot of Bulk has been subjected and the test results. (iii) Unless otherwise specified in the relevant Project SOW, within [**] calendar days of Hospira’s receipt of any Bulk supplied by Genzyme hereunder, Hospira shall: (A) perform an identification test on the Bulk and confirm the shipment quantity; and (B) notify Genzyme of any inaccuracies with respect to quantity or of any claim that any portion of the shipment fails the identification test. In the event Hospira notifies Genzyme of any deficiency in the quantity of Bulk received, Genzyme shall promptly investigate such deficiency and provide Hospira with instructions on how to handle the Bulk. Genzyme may ship to Hospira, at CTIGenzyme’s option, analyze each batch and samples from each batch of Product. ** 2.7 Subject to Sections 2.5 and 2.6, ** 2.8 NPM warrants that all applicable environmental and safety requirements are being and will be followed at its facilities. Additionallyexpense, the manufacture quantity of Bulk necessary to complete the Bulk shipment. In the event Hospira notifies Genzyme that the Bulk shipment does not conform to the Bulk Specifications, as evidenced by the results of the Product shall be in accordance with cGMP. For the purpose of quality assurance auditing and to evaluate compliance with applicable cGMPsrelevant identification test, environmental and occupational health and safety laws and regulations, CTI Genzyme shall have the right to audit and inspect per the Quality Agreement. ** 2.9 NPM shall notify CTI **of significant incidents relating to production of the Product **confirm such findings at Hospira’s Facility. 2.10 At CTI’s request(iv) If Genzyme determines that such shipment of Bulk did, NPM shallin fact, within five (5) business days, provide copies of all relevant environmental licenses and permits in their original language pertaining to its operation and shall notify CTI of any material change in status. ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect conform to the omitted portions. **** Indicates that the amount of information omitted was a page or more in lengthBulk Specifications, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.11 At CTI’s request, NPM will, within five (5) business days, provide the requirements set forth in Attachment F (the “Record Keeping and Accounting Schedule”). 2.12 At CTI’s request, NPM will, within five (5) business days, provide CTI with copies of all applicable insurance certificates in their original language. Insurance requirements of the Parties shall be listed in Attachment G (submit samples of such shipment to a mutually acceptable independent expert for testing. If such independent expert determines that the “Insurance Requirements”). 2.13 During shipment conformed to the Post-commercialization period **. 2.14 NPM agrees Bulk Specifications, Hospira shall bear all expenses of shipping and testing such shipment samples. If Genzyme or such independent expert confirms that it will conduct all necessary testing such shipment did not meet the Bulk Specifications, Genzyme shall use commercially reasonable efforts to replace, at no cost to Hospira, the portion of the Product as required by Bulk shipment which does not conform to the SpecificationsBulk Specifications and bear all expenses of shipping and testing the shipment samples. All testing is to be performed during and at Notwithstanding the completion of the manufacture of the Product. ** 2.15 NPM will ** provide to CTI copies of all correspondence, inspection reports and other reports issued by the FDA or other regulatory agencies with respect to those affecting the Product produced for CTI in NPM’ facilities. 2.16 During the Post-commercialization Period CTI shall submit to NPM ** a rolling commercial forecast, as follows: **. For clarification, these forecast and estimate requirements shall only be required to be provided for periods occurring during the actual Term of the Agreement. ** CTI agrees to purchase, and NPM agrees to produce, ** subject to Section 2.17 below. For clarity purposes, CTI shall be credited with the previous Binding Forecast PO’s in calculating the purchase requirement in this paragraph. 2.17 Each Binding Forecast PO shall identify and reference the quantity of Product orderedforegoing, the price to be paid for such Product, packaging requirements, delivery schedule, delivery locations, invoice information and other applicable instructions. If the amounts in the Binding Forecast PO are in compliance with Section 2.16, and Attachment B to this Agreement, the Binding Forecast PO shall be deemed accepted independent expert may also determine that additional sample testing by NPM upon its receipt thereof and become a “Firm Order”. ** Use of e-mail an independent laboratory is in this case is permitted, and e-mails shall be sent to the respective e-mail addresses indicated by the Parties. Subject to the cancellation and termination rights in this Agreement, Firm Orders shall be considered firm and non-cancelable, except as provided in Section 2.16 and 2.17 with respect to certain changes, if any, in any Binding Forecast POnecessary. 2.18 During the Pre-commercialization Period CTI may submit NPM Binding Forecast PO with a minimum lead time of **. NPM shall then ** confirm to CTI its acceptance or non acceptance of the Binding Forecast PO, indicating the delivery date and the quantity of Product to be supplied. ** ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.19 In the event NPM fails to deliver any Product due under a Firm Order by the scheduled delivery date, the Price of such Product will be reduced as follows: 2.20 NPM shall not manufacture or sell the Product to any party other than CTI, or its designated affiliates or designated subsidiaries, without CTI’s prior written consent. 2.21 NPM shall not use any materials (including drug substance) provided by CTI hereunder for any purpose other than performing NPM’ obligations under this Agreement and/or the Quality Agreement.

Appears in 1 contract

Sources: Master Supply Agreement (Genzyme Corp)

Supply. 2.1 During 6.1 Subject to Clause 7.6 below and Condition 14 (Force Majeure) of the TermTerms and Conditions, NPM Longport shall allocate capacity use all reasonable endeavors to and shall manufacture and sell supply the Scanner to CTI no less than the amounts of Product ordered by CTI with the issuance of a Binding Forecast PO pursuant to Section 2.16. All batches of Product shall be produced utilizing the Process and USMS in accordance with the Specifications, cGMP, Government Approvals, and the terms of this Agreementeach Order placed by USMS. 2.2 Binding Forecast PO’s6.2 Longport shall be entitled at any time or from time to time to make such modifications to the specification of the Scanner as it may in its sole discretion think fit. Whenever possible Longport will review any change in specification with USMS before they are implemented. 6.3 USMS shall in respect of each Order for the Scanner to be supplied hereunder be responsible for: (a) ensuring the accuracy of the Order; (b) providing Longport with any information which is reasonably necessary in order to enable Longport to fulfill the Order; 6.4 Upon receipt and confirmation of each Order Longport shall, as defined belowsoon as is reasonably practicable, will be placed on CTI’s standard purchase orders then in effect with a minimum lead inform USMS of Longport's estimated delivery date for the order. Longport shall use all reasonable endeavors to meet the delivery date, normally four months after receipt of order, but time of **delivery shall not be of the essence and accordingly Longport shall have no liability to USMS if, notwithstanding such endeavors, there is any delay in delivery. All terms and conditions Longport shall however advise USMS of this Agreement shall govern any expected delivery delays at the transactions between the Parties and any terms or conditions of said purchase order which conflict earliest practical opportunity. However, if Longport has been unable to deliver products ordered in accordance with this Agreement shall be null and void. NPM shall promptly manufacture and deliver all Firm Orders, as defined below, of Product in accordance with 120 days after the related schedule and in compliance with the Specifications, cGMP and other applicable laws and regulations. ** 2.3 All Product supplied by NPM shall be delivered to CTI’s designated carrier per ** from NPM’s facility, as specified in the related Firm Order. ** 2.4 NPM shall ship the Product in accordance with applicable laws and regulations and in a commercially reasonable manner in accordance with the instructions set forth on Attachment D hereto. 2.5 CTI or its designee may, at CTI’s option, analyze each batch and samples from each batch of Product. ** 2.7 Subject to Sections 2.5 and 2.6, ** 2.8 NPM warrants due date for that all applicable environmental and safety requirements are being and will be followed at its facilities. Additionally, the manufacture of the Product shall be in accordance with cGMP. For the purpose of quality assurance auditing and to evaluate compliance with applicable cGMPs, environmental and occupational health and safety laws and regulations, CTI order has passed then USMS shall have the right to audit have the Scanner manufactured by their own sources and inspect per the Quality Longport shall provide all necessary licenses required for this production. This manufacturing right shall only cover Scanners that USMS requires for their distribution needs as described in this Agreement. ** 2.9 NPM shall notify CTI **of significant incidents relating In circumstances where Longport is found to have defaulted as described in the above paragraph arbitration should be sought as described in Clause 10.3 to determine how the deposit outstanding, initially $500,000, is repaid and if this repayment should be made in cash or in components already in the production pipeline or some combination of the Product **two. 2.10 At CTI’s request, NPM shall, within five (5) business days, provide copies of all relevant environmental licenses and permits in their original language pertaining to its operation and shall notify CTI of any material change in status. ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.11 At CTI’s request, NPM will, within five (5) business days, provide the requirements set forth in Attachment F (the “Record Keeping and Accounting Schedule”). 2.12 At CTI’s request, NPM will, within five (5) business days, provide CTI with copies of all applicable insurance certificates in their original language. Insurance requirements of the Parties 6.5 Longport shall be listed in Attachment G (exclusively responsible for the “Insurance Requirements”). 2.13 During first 12 months of this Agreement for the Posttraining and support of end user customers contracted to USMS or any of USMS's sub-commercialization period **. 2.14 NPM agrees that it will conduct all necessary testing agents and USMS shall not seek such customer support from any other party. If after the first 12 months of this Agreement has concluded USMS or one of its sub-agents wishes to train and support their customers directly they shall be entitled so to do, provided they give 6 months notice to Longport. If USMS or any of your sub-agents wish to undertake the Product as required by the Specifications. All testing is to be performed during training and at the completion of the manufacture of the Product. ** 2.15 NPM will ** provide to CTI copies of all correspondence, inspection reports and other reports issued by the FDA or other regulatory agencies with respect to those affecting the Product produced for CTI in NPM’ facilities. 2.16 During the Post-commercialization Period CTI support responsibility they shall submit to NPM ** a rolling commercial forecastLongport for approval all training and support documentation and procedures. All such programs and documentation shall be subject to approval by Longport and Longport will on an on-going basis be exclusively responsibly for accrediting all Scanner related training and support programs and the personnel involved. Longport will have the right not to accredit any program or person, as follows: **and neither USMS nor its sub-agents shall use any non-accredited program or person in any training or support capacity with regard to the Scanner. For clarification, Fees will be charged for these forecast and estimate requirements shall only be required to be provided for periods occurring accreditation services by Longport. If during the actual Term first 18 months of the this Agreement any end-user customer of USMS requiring multiple Scanners, greater than 20, wishes to develop and use an in-house training program Longport and USMS shall work with that customer to develop an appropriate training program. Longport shall charge for its input into this program development. Details of Longport's standard end user support provision are presented in a Schedule 3 of this Agreement. ** CTI agrees to purchase, and NPM agrees to produce, ** subject to Section 2.17 below. For clarity purposes, CTI shall be credited with the previous Binding Forecast PO’s in calculating the purchase requirement in this paragraph. 2.17 Each Binding Forecast PO shall identify and reference the quantity 6.6 The terms of Product ordered, the price to be paid for such Product, packaging requirements, delivery schedule, delivery locations, invoice information and other applicable instructions. If the amounts in the Binding Forecast PO are in compliance with Section 2.16, and Attachment B to this Agreement, which includes the Binding Forecast PO Schedules attached hereto, shall be deemed accepted by NPM upon its receipt thereof and become a “Firm Order”. ** Use of e-mail is in this case is permitted, and e-mails shall be sent apply to the respective e-mail addresses indicated exclusion of any other terms and conditions including any implied by the Partiestrade, custom, practice or course of dealing. Subject Purported provisions to the cancellation and termination rights in this Agreement, Firm Orders shall be considered firm and non-cancelable, except as provided in Section 2.16 and 2.17 with respect to certain changes, if any, in any Binding Forecast POcontrary are excluded. 2.18 During the Pre-commercialization Period CTI may submit NPM Binding Forecast PO with a minimum lead time of **. NPM shall then ** confirm to CTI its acceptance or non acceptance of the Binding Forecast PO, indicating the delivery date and the quantity of Product to be supplied. ** ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.19 In the event NPM fails to deliver any Product due under a Firm Order by the scheduled delivery date, the Price of such Product will be reduced as follows: 2.20 NPM shall not manufacture or sell the Product to any party other than CTI, or its designated affiliates or designated subsidiaries, without CTI’s prior written consent. 2.21 NPM shall not use any materials (including drug substance) provided by CTI hereunder for any purpose other than performing NPM’ obligations under this Agreement and/or the Quality Agreement.

Appears in 1 contract

Sources: Confidentiality Agreement (Longport Inc)

Supply. 2.1 During the Term, NPM shall allocate capacity to and Hospira shall manufacture and sell the Products for OBI from the API that OBI shall supply to CTI Hospira at no less than the amounts of Product ordered by CTI with the issuance of a Binding Forecast PO pursuant cost. OBI shall supply API to Section 2.16. All batches of Product shall be produced utilizing the Process and Hospira in accordance with the Specifications, cGMP, Government Approvals, and the terms of this Agreement. 2.2 Binding Forecast PO’s, as defined below, will be placed on CTIquantities sufficient to satisfy Hospira’s standard purchase orders then in effect with a minimum lead time of **. All terms and conditions of this Agreement shall govern the transactions between the Parties and any terms or conditions of said purchase order which conflict with this Agreement shall be null and void. NPM shall promptly manufacture and deliver all Firm Orders, as defined below, of Product in accordance with the related schedule and in compliance with the Specifications, cGMP and other applicable laws and regulations. ** 2.3 All Product supplied by NPM shall be delivered to CTI’s designated carrier per ** from NPM’s facility, as specified in the related Firm Order. ** 2.4 NPM shall ship the Product in accordance with applicable laws and regulations and in a commercially reasonable manner in accordance with the instructions set forth on Attachment D hereto. 2.5 CTI or its designee may, at CTI’s option, analyze each batch and samples from each batch gross manufacturing requirements of Product. ** 2.7 Subject Hospira’s use of API received from OBI shall be limited to Sections 2.5 development contemplated by this Agreement and 2.6, ** 2.8 NPM warrants that all applicable environmental and safety requirements are being and will be followed at its facilities. Additionally, the manufacture of the Product for OBI . Hospira – Oxygen Biotherapeutics Agreement OBI shall ship all required quantities of API DDP (Incoterms 2000) to Hospira’s manufacturing plant in Clayton North Carolina, pursuant to no-cost purchase orders that Hospira issues to OBI. OBI shall be responsible for all costs of transport and carriage insurance. Within thirty (30) days of Hospira’s receipt of any API supplied by OBI hereunder, Hospira shall: (i) perform an identification test on the API and confirm the shipment quantity; and (ii) notify OBI of any inaccuracies with respect to quantity or of any claim that any portion of the shipment fails the identification test. In the event Hospira notifies OBI of any deficiency in accordance with cGMPthe quantity of API received, OBI shall promptly ship to Hospira, at OBI’s own expense, the quantity of API necessary to complete the API shipment. For In the purpose of quality assurance auditing and event Hospira notifies OBI that the API shipment does not conform to evaluate compliance with applicable cGMPsthe API Specifications, environmental and occupational health and safety laws and regulations, CTI OBI shall have the right to audit confirm such findings at Hospira’s manufacturing location. If OBI determines that such shipment of API conformed to the API Specifications, the parties shall submit samples of such shipment to a mutually acceptable independent laboratory for testing. If such independent laboratory determines that the shipment conformed to the API Specifications, Hospira shall bear all expenses of shipping and inspect per testing such shipment samples. If OBI or such independent laboratory confirms that such shipment did not meet the Quality Agreement. ** 2.9 NPM API Specifications, OBI shall notify CTI **of significant incidents relating replace, at no cost to production Hospira, the portion of the Product **. 2.10 At CTI’s request, NPM shall, within five (5) business days, provide copies of all relevant environmental licenses and permits in their original language pertaining to its operation and shall notify CTI of any material change in status. ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect API shipment which does not conform to the omitted portions. **** Indicates that API Specifications and bear all expenses of shipping and testing the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portionsshipment samples. 2.11 At CTI’s request, NPM will, within five (5) business days, provide the requirements set forth in Attachment F (the “Record Keeping and Accounting Schedule”). 2.12 At CTI’s request, NPM will, within five (5) business days, provide CTI with copies of all applicable insurance certificates in their original language. Insurance requirements of the Parties shall be listed in Attachment G (the “Insurance Requirements”). 2.13 During the Post-commercialization period **. 2.14 NPM agrees that it will conduct all necessary testing of the Product as required by the Specifications. All testing is to be performed during and at the completion of the manufacture of the Product. ** 2.15 NPM will ** provide to CTI copies of all correspondence, inspection reports and other reports issued by the FDA or other regulatory agencies with respect to those affecting the Product produced for CTI in NPM’ facilities. 2.16 During the Post-commercialization Period CTI shall submit to NPM ** a rolling commercial forecast, as follows: **. For clarification, these forecast and estimate requirements shall only be required to be provided for periods occurring during the actual Term of the Agreement. ** CTI agrees to purchase, and NPM agrees to produce, ** subject to Section 2.17 below. For clarity purposes, CTI shall be credited with the previous Binding Forecast PO’s in calculating the purchase requirement in this paragraph. 2.17 Each Binding Forecast PO shall identify and reference the quantity of Product ordered, the price to be paid for such Product, packaging requirements, delivery schedule, delivery locations, invoice information and other applicable instructions. If the amounts in the Binding Forecast PO are in compliance with Section 2.16, and Attachment B to this Agreement, the Binding Forecast PO shall be deemed accepted by NPM upon its receipt thereof and become a “Firm Order”. ** Use of e-mail is in this case is permitted, and e-mails shall be sent to the respective e-mail addresses indicated by the Parties. Subject to the cancellation and termination rights in this Agreement, Firm Orders shall be considered firm and non-cancelable, except as provided in Section 2.16 and 2.17 with respect to certain changes, if any, in any Binding Forecast PO. 2.18 During the Pre-commercialization Period CTI may submit NPM Binding Forecast PO with a minimum lead time of **. NPM shall then ** confirm to CTI its acceptance or non acceptance of the Binding Forecast PO, indicating the delivery date and the quantity of Product to be supplied. ** ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.19 In the event NPM fails to deliver any Product due under a Firm Order by the scheduled delivery date, the Price of such Product will be reduced as follows: 2.20 NPM shall not manufacture or sell the Product to any party other than CTI, or its designated affiliates or designated subsidiaries, without CTI’s prior written consent. 2.21 NPM shall not use any materials (including drug substance) provided by CTI hereunder for any purpose other than performing NPM’ obligations under this Agreement and/or the Quality Agreement.

Appears in 1 contract

Sources: Development and Supply Agreement (Oxygen Biotherapeutics, Inc.)

Supply. 2.1 6.1 During the Termterm of this Agreement, NPM DOBFAR shall allocate capacity to manufacture, label and shall manufacture package, ship and sell to CTI no less than deliver the amounts Product for SAGENT on the terms and conditions specified in this Agreement and in compliance with all requirements of Product ordered by CTI with the issuance applicable laws, rules and regulations, and all other requirements of a Binding Forecast PO pursuant to Section 2.16any applicable cGMP and Specifications. All batches of The Product shall be produced utilizing manufactured by DOBFAR at the Process and applicable Manufacturing Facility in accordance with the Specifications, cGMP, Government Approvals, and the terms of this Agreement and the Quality Agreement. Except as set forth in Section 7.1, SAGENT shall not be required to order any fixed minimum quantity of Product or any quantity of Product for which it does not actually have a need, notwithstanding any forecast or prior course of dealing. 2.2 Binding Forecast PO’s, as defined below, will be placed on CTI’s standard purchase orders then in effect with a minimum lead time of **. All terms and conditions 6.2 During the term of this Agreement shall govern the transactions between the Parties and any terms or conditions of said purchase order which conflict with this Agreement Agreement, DOBFAR shall be null and void. NPM shall promptly solely responsible for arranging for an FDA-approved third party to manufacture and deliver all Firm Orders, as defined below, of Product in accordance with supply the related schedule and in compliance with the Specifications, cGMP and other applicable laws and regulations. ** 2.3 All Product supplied by NPM shall be delivered API necessary to CTI’s designated carrier per ** from NPM’s facility, as specified in the related Firm Order. ** 2.4 NPM shall ship manufacture the Product in accordance with all requirements of applicable laws laws, rules and regulations regulations, and all other requirements of any applicable cGMP and Specifications and in a commercially reasonable manner sufficient quantities to meet SAGENT’s forecasted needs for the Product; provided that DOBFAR shall give written notice to SAGENT in accordance advance of retaining any such third party API supplier. With respect to any third party API supplier that DOBFAR desires to use, DOBFAR shall ensure that such third party API supplier makes its facilities and records relating to the manufacture of the API available for inspection by SAGENT as SAGENT requests from time to time. In the event that during any such inspection, SAGENT identifies any instances of noncompliance with the instructions set forth on Attachment D hereto. 2.5 CTI requirements of applicable laws, rules and regulations, applicable cGMP or its designee maythe Specifications, then DOBFAR shall promptly provide a written plan for correcting such deficiencies (including a proposed timetable for implementing such corrections) and shall ensure that such deficiencies are corrected, at CTIDOBFAR’s optionor such third party API supplier’s sole expense, analyze each batch as soon as reasonably practicable. If not corrected to SAGENT’s satisfaction (or if the third party API supplier does not make its facility and samples from each batch of Productrecords available for inspection by SAGENT), then DOBFAR shall be required to secure a different third party API supplier, and to immediately cease using the noncompliant supplier. ** 2.7 Subject to Sections 2.5 Section 6.3, DOBFAR shall be solely responsible for ensuring that the API so supplied to it is of sufficient quality and 2.6, ** 2.8 NPM warrants that all applicable environmental and safety requirements are being and will meets other relevant standards in order for it to be followed at its facilities. Additionally, utilized by DOBFAR in the manufacture of the Product shall be in accordance with cGMPSection 6.1. For the purpose of quality assurance auditing and to evaluate compliance with applicable cGMPs, environmental and occupational health and safety laws and regulations, CTI shall have the right to audit and inspect per the Quality Agreement. [** 2.9 NPM shall notify CTI **of significant incidents relating to production of the Product **. 2.10 At CTI’s request, NPM shall, within five (5) business days, provide copies of all relevant environmental licenses and permits in their original language pertaining to its operation and shall notify CTI of any material change in status. ** ] Indicates that certain information contained herein text has been omitted and which is the subject of a confidential treatment request. This text has been separately filed separately with the Securities and Exchange Commission 6.3 All Product manufactured, shipped and delivered by DOBFAR to SAGENT or SAGENT’s designees under this Agreement shall be packaged and labeled in accordance with this Agreement and the then-current packaging and labeling guidelines provided by SAGENT and in compliance with all requirements of applicable laws, rules and regulations, all other requirements of any applicable cGMP as well as the applicable Specifications and the Registration. Confidential treatment has been request SAGENT shall supply DOBFAR with respect SAGENT’s NDC number(s) for the Product and any trade dress that SAGENT wishes to have included in the labeling for the Product. DOBFAR shall print, either directly or through a third party, labels and other printed material to be included as part of the Product, and the cost of doing so shall be reflected in the price charged by DOBFAR for the Product pursuant to Article 9. From time to time, SAGENT may provide DOBFAR with modified trade dress or logos and upon receipt thereof, DOBFAR shall use its commercially reasonable efforts to incorporate such changes on the Products in accordance with SAGENT’s request. DOBFAR shall provide SAGENT with any modifications to the omitted portionslabeling for the Products as promptly as possible in order to ensure compliance with any and all applicable regulations. **** Indicates SAGENT shall reimburse DOBFAR for all reasonable costs incurred by DOBFAR in making modifications to labeling, branding, or imprinting packaging and/or manufacturing processes to accommodate SAGENT’s new labeling or to accommodate any other changes requested by SAGENT. Such reimbursement shall be made pursuant to invoices submitted by DOBFAR to SAGENT, undisputed amounts on such invoices shall be payable within thirty (30) days after SAGENT’s receipt thereof. SAGENT shall cooperate with DOBFAR to ensure that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.11 At CTI’s request, NPM will, within five (5) business days, provide the requirements set forth in Attachment F (the “Record Keeping and Accounting Schedule”). 2.12 At CTI’s request, NPM will, within five (5) business days, provide CTI with copies of all applicable insurance certificates in their original language. Insurance requirements of the Parties shall be listed in Attachment G (the “Insurance Requirements”). 2.13 During the Post-commercialization period **. 2.14 NPM agrees that it will conduct all necessary testing labeling of the Product as required by complies with the Specifications. All testing is to be performed during Registration for the Product. 6.4 DOBFAR shall schedule its manufacturing operations so that all Products delivered have the maximum shelf life possible and in any event no Product delivered hereunder shall have less than seventy-five (75%) of shelf life, based on the dating included on such Product’s packaging, remaining at the completion time of delivery; provided, however, that if SAGENT accepts delivery of Product prior to the Launch Date and such Product has less than 75% of shelf life, based on the dating included on such Product’s packaging, as of the manufacture Launch Date, then DOBFAR will, at no expense to SAGENT, replace such Product as soon as practicable with Product that has at least 75% of shelf life, based on the dating included on such Product’s packaging, as of the Product. ** 2.15 NPM will ** provide later of (i) the Launch Date or (ii) the date such replacement Product is actually delivered to CTI copies of all correspondence, inspection reports and other reports issued by the FDA or other regulatory agencies with respect to those affecting the Product produced for CTI in NPM’ facilitiesSAGENT. 2.16 During the Post-commercialization Period CTI shall submit to NPM ** a rolling commercial forecast, as follows: **. For clarification, these forecast and estimate requirements shall only be required to be provided for periods occurring during the actual Term of the Agreement. ** CTI agrees to purchase, and NPM agrees to produce, ** subject to Section 2.17 below. For clarity purposes, CTI shall be credited with the previous Binding Forecast PO’s in calculating the purchase requirement in this paragraph. 2.17 Each Binding Forecast PO shall identify and reference the quantity of Product ordered, the price to be paid for such Product, packaging requirements, delivery schedule, delivery locations, invoice information and other applicable instructions. If the amounts in the Binding Forecast PO are in compliance with Section 2.16, and Attachment B to this Agreement, the Binding Forecast PO shall be deemed accepted by NPM upon its receipt thereof and become a “Firm Order”. ** Use of e-mail is in this case is permitted, and e-mails shall be sent to the respective e-mail addresses indicated by the Parties. Subject to the cancellation and termination rights in this Agreement, Firm Orders shall be considered firm and non-cancelable, except as provided in Section 2.16 and 2.17 with respect to certain changes, if any, in any Binding Forecast PO. 2.18 During the Pre-commercialization Period CTI may submit NPM Binding Forecast PO with a minimum lead time of **. NPM shall then ** confirm to CTI its acceptance or non acceptance of the Binding Forecast PO, indicating the delivery date and the quantity of Product to be supplied. ** ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.19 In the event NPM fails to deliver any Product due under a Firm Order by the scheduled delivery date, the Price of such Product will be reduced as follows: 2.20 NPM shall not manufacture or sell the Product to any party other than CTI, or its designated affiliates or designated subsidiaries, without CTI’s prior written consent. 2.21 NPM shall not use any materials (including drug substance) provided by CTI hereunder for any purpose other than performing NPM’ obligations under this Agreement and/or the Quality Agreement.

Appears in 1 contract

Sources: Manufacture and Supply Agreement (Sagent Holding Co.)

Supply. 2.1 6.1 During the Termterm of this Agreement, NPM DOBFAR shall allocate capacity to manufacture, label and shall manufacture package, ship and sell to CTI no less than deliver the amounts Product for SAGENT on the terms and conditions specified in this Agreement and in compliance with all requirements of Product ordered by CTI with the issuance applicable laws, rules and regulations, and all other requirements of a Binding Forecast PO pursuant to Section 2.16any applicable cGMP and Specifications. All batches of The Product shall be produced utilizing manufactured by DOBFAR at the Process and applicable Manufacturing Facility in accordance with the Specifications, cGMP, Government Approvals, and the terms of this Agreement and the Quality Agreement. Except as set forth in Section 7.1, SAGENT shall not be required to order any fixed minimum quantity of Product or any quantity of Product for which it does not actually have a need, notwithstanding any forecast or prior course of dealing. 2.2 Binding Forecast PO’s, as defined below, will be placed on CTI’s standard purchase orders then in effect with a minimum lead time of **. All terms and conditions 6.2 During the term of this Agreement shall govern the transactions between the Parties and any terms or conditions of said purchase order which conflict with this Agreement Agreement, DOBFAR shall be null and void. NPM shall promptly solely responsible for arranging for an FDA-approved third party to manufacture and deliver all Firm Orders, as defined below, of Product in accordance with supply the related schedule and in compliance with the Specifications, cGMP and other applicable laws and regulations. ** 2.3 All Product supplied by NPM shall be delivered API necessary to CTI’s designated carrier per ** from NPM’s facility, as specified in the related Firm Order. ** 2.4 NPM shall ship manufacture the Product in accordance with all requirements of applicable laws laws, rules and regulations regulations, and all other requirements of any applicable cGMP and Specifications and in a commercially reasonable manner sufficient quantities to meet SAGENT’s forecasted needs for the Product; provided that DOBFAR shall give written notice to SAGENT in accordance advance of retaining any such third party API supplier. With respect to any third party API supplier that DOBFAR desires to use, DOBFAR shall ensure that such third party API supplier makes its facilities and records relating to the manufacture of the API available for inspection by SAGENT as SAGENT requests from time to time. In the event that during any such inspection, SAGENT identifies any instances of noncompliance with the instructions set forth on Attachment D hereto. 2.5 CTI requirements of applicable laws, rules and regulations, applicable cGMP or its designee maythe Specifications, then DOBFAR shall promptly provide a written plan for correcting such deficiencies (including a proposed timetable for implementing such corrections) and shall ensure that such deficiencies are corrected, at CTIDOBFAR’s optionor such third party API supplier’s sole expense, analyze each batch as soon as reasonably practicable. If not corrected to SAGENT’s satisfaction (or if the third party API supplier does not make its facility and samples from each batch of Productrecords available for inspection by SAGENT), then DOBFAR shall be required to secure a different third party API supplier, and to immediately cease using the noncompliant supplier. ** 2.7 Subject to Sections 2.5 Section 6.3, DOBFAR shall be solely responsible for ensuring that the API so supplied to it is of sufficient quality and 2.6, ** 2.8 NPM warrants that all applicable environmental and safety requirements are being and will meets other relevant standards in order for it to be followed at its facilities. Additionally, utilized by DOBFAR in the manufacture of the Product shall be in accordance with cGMPSection 6.1. For the purpose of quality assurance auditing and to evaluate compliance with applicable cGMPs, environmental and occupational health and safety laws and regulations, CTI shall have the right to audit and inspect per the Quality Agreement. [** 2.9 NPM shall notify CTI **of significant incidents relating to production of the Product **. 2.10 At CTI’s request, NPM shall, within five (5) business days, provide copies of all relevant environmental licenses and permits in their original language pertaining to its operation and shall notify CTI of any material change in status. ** ] Indicates that certain information contained herein text has been omitted and which is the subject of a confidential treatment request. This text has been separately filed separately with the Securities and Exchange Commission 6.3 All Product manufactured, shipped and delivered by DOBFAR to SAGENT or SAGENT’s designees under this Agreement shall be packaged and labeled in accordance with this Agreement and the then-current packaging and labeling guidelines provided by SAGENT and in compliance with all requirements of applicable laws, rules and regulations, all other requirements of any applicable cGMP as well as the applicable Specifications and the Registration. Confidential treatment has been request SAGENT shall supply DOBFAR with respect SAGENT’s NDC number(s) for the Product and any trade dress that SAGENT wishes to have included in the labeling for the Product. DOBFAR shall print, either directly or through a third party, labels and other printed material to be included as part of the Product, and the cost of doing so shall be reflected in the price charged by DOBFAR for the Product pursuant to Article 9. From time to time, SAGENT may provide DOBFAR with modified trade dress or logos and upon receipt thereof, DOBFAR shall use its commercially reasonable efforts to incorporate such changes on the Products in accordance with SAGENT’s request. DOBFAR shall provide SAGENT with any modifications to the omitted portionslabeling for the Products as promptly as possible in order to ensure compliance with any and all applicable regulations. SAGENT shall reimburse DOBFAR for all reasonable costs incurred by DOBFAR in making modifications to labeling, branding, or imprinting packaging and/or manufacturing processes to accommodate SAGENT’s new labeling or to accommodate any other changes requested by SAGENT. Such reimbursement shall be made pursuant to invoices submitted by DOBFAR to SAGENT, undisputed amounts on such invoices shall be payable within thirty (30) days after SAGENT’s receipt thereof. SAGENT shall cooperate with DOBFAR to ensure that the labeling of the Product complies with the Registration for the Product. 6.4 DOBFAR shall schedule its manufacturing operations so that all Products delivered have the maximum shelf life possible and in any event no Product delivered hereunder shall have less than [**** Indicates ] of shelf life, based on the dating included on such Product’s packaging, remaining at the time of delivery; provided, however, that if SAGENT accepts delivery of Product prior to the amount of information omitted was a page or more in length, Launch Date and such information was filed separately with the Securities and Exchange Commission. Confidential treatment Product has been request with respect to the omitted portions. 2.11 At CTI’s request, NPM will, within five (5) business days, provide the requirements set forth in Attachment F (the “Record Keeping and Accounting Schedule”). 2.12 At CTI’s request, NPM will, within five (5) business days, provide CTI with copies of all applicable insurance certificates in their original language. Insurance requirements of the Parties shall be listed in Attachment G (the “Insurance Requirements”). 2.13 During the Post-commercialization period **. 2.14 NPM agrees that it will conduct all necessary testing of the Product as required by the Specifications. All testing is to be performed during and at the completion of the manufacture of the Product. ** 2.15 NPM will ** provide to CTI copies of all correspondence, inspection reports and other reports issued by the FDA or other regulatory agencies with respect to those affecting the Product produced for CTI in NPM’ facilities. 2.16 During the Post-commercialization Period CTI shall submit to NPM ** a rolling commercial forecast, as follows: **. For clarification, these forecast and estimate requirements shall only be required to be provided for periods occurring during the actual Term of the Agreement. ** CTI agrees to purchase, and NPM agrees to produce, ** subject to Section 2.17 below. For clarity purposes, CTI shall be credited with the previous Binding Forecast PO’s in calculating the purchase requirement in this paragraph. 2.17 Each Binding Forecast PO shall identify and reference the quantity of Product ordered, the price to be paid for such Product, packaging requirements, delivery schedule, delivery locations, invoice information and other applicable instructions. If the amounts in the Binding Forecast PO are in compliance with Section 2.16, and Attachment B to this Agreement, the Binding Forecast PO shall be deemed accepted by NPM upon its receipt thereof and become a “Firm Order”. ** Use of e-mail is in this case is permitted, and e-mails shall be sent to the respective e-mail addresses indicated by the Parties. Subject to the cancellation and termination rights in this Agreement, Firm Orders shall be considered firm and non-cancelable, except as provided in Section 2.16 and 2.17 with respect to certain changes, if any, in any Binding Forecast PO. 2.18 During the Pre-commercialization Period CTI may submit NPM Binding Forecast PO with a minimum lead time of **. NPM shall then ** confirm to CTI its acceptance or non acceptance of the Binding Forecast PO, indicating the delivery date and the quantity of Product to be supplied. ** ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. less than [**** Indicates that ] of shelf life, based on the amount dating included on such Product’s packaging, as of information omitted was a page or more in lengththe Launch Date, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect then DOBFAR will, at no expense to the omitted portions. 2.19 In the event NPM fails to deliver any Product due under a Firm Order by the scheduled delivery dateSAGENT, the Price of replace such Product will be reduced as follows: 2.20 NPM shall not manufacture soon as practicable with Product that has at least 75% of shelf life, based on the dating included on such Product’s packaging, as of the later of (i) the Launch Date or sell (ii) the date such replacement Product is actually delivered to any party other than CTI, or its designated affiliates or designated subsidiaries, without CTI’s prior written consentSAGENT. 2.21 NPM shall not use any materials (including drug substance) provided by CTI hereunder for any purpose other than performing NPM’ obligations under this Agreement and/or the Quality Agreement.

Appears in 1 contract

Sources: Manufacture and Supply Agreement (Sagent Holding Co.)

Supply. 2.1 During 6.1 Subject to Clause 7.6 below and Condition 14 (Force Majeure) of the TermTerms and Conditions, NPM Longport shall allocate capacity use all reasonable endeavors to and shall manufacture and sell supply the Scanner to CTI no less than the amounts of Product ordered by CTI with the issuance of a Binding Forecast PO pursuant to Section 2.16. All batches of Product shall be produced utilizing the Process and USMS in accordance with the Specifications, cGMP, Government Approvals, and the terms of this Agreementeach Order placed by USMS. 2.2 Binding Forecast PO’s6.2 Longport shall be entitled at any time or from time to time to make such modifications to the specification of the Scanner as it may in its sole discretion think fit. Whenever possible Longport will review any change in specification with USMS before they are implemented. 6.3 USMS shall in respect of each Order for the Scanner to be supplied hereunder be responsible for : (a) ensuring the accuracy of the Order; (b) providing Longport with any information which is reasonably necessary in order to enable Longport to fulfill the Order; 6.4 Upon receipt and confirmation of each Order Longport shall, as defined belowsoon as is reasonably practicable, will be placed on CTI’s standard purchase orders then in effect with a minimum lead inform USMS of Longport's estimated delivery date for the order. Longport shall use all reasonable endeavors to meet the delivery date, normally four months after receipt of order, but time of **delivery shall not be of the essence and accordingly Longport shall have no liability to USMS if, notwithstanding such endeavors, there is any delay in delivery. All terms and conditions Longport shall however advise USMS of this Agreement shall govern any expected delivery delays at the transactions between the Parties and any terms or conditions of said purchase order which conflict earliest practical opportunity. However, if Longport has been unable to deliver products ordered in accordance with this Agreement shall be null and void. NPM shall promptly manufacture and deliver all Firm Orders, as defined below, of Product in accordance with 120 days after the related schedule and in compliance with the Specifications, cGMP and other applicable laws and regulations. ** 2.3 All Product supplied by NPM shall be delivered to CTI’s designated carrier per ** from NPM’s facility, as specified in the related Firm Order. ** 2.4 NPM shall ship the Product in accordance with applicable laws and regulations and in a commercially reasonable manner in accordance with the instructions set forth on Attachment D hereto. 2.5 CTI or its designee may, at CTI’s option, analyze each batch and samples from each batch of Product. ** 2.7 Subject to Sections 2.5 and 2.6, ** 2.8 NPM warrants due date for that all applicable environmental and safety requirements are being and will be followed at its facilities. Additionally, the manufacture of the Product shall be in accordance with cGMP. For the purpose of quality assurance auditing and to evaluate compliance with applicable cGMPs, environmental and occupational health and safety laws and regulations, CTI order has passed then USMS shall have the right to audit have the Scanner manufactured by their own sources and inspect per the Quality Longport shall provide all necessary licenses required for this production. This manufacturing right shall only cover Scanners that USMS requires for their distribution needs as described in this Agreement. ** 2.9 NPM shall notify CTI **of significant incidents relating In circumstances where Longport is found to have defaulted as described in the above paragraph arbitration should be sought as described in Clause 10.3 to determine how the deposit outstanding, initially $500,000, is repaid and if this repayment should be made in cash or in components already in the production pipeline or some combination of the Product **two. 2.10 At CTI’s request, NPM shall, within five (5) business days, provide copies of all relevant environmental licenses and permits in their original language pertaining to its operation and shall notify CTI of any material change in status. ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.11 At CTI’s request, NPM will, within five (5) business days, provide the requirements set forth in Attachment F (the “Record Keeping and Accounting Schedule”). 2.12 At CTI’s request, NPM will, within five (5) business days, provide CTI with copies of all applicable insurance certificates in their original language. Insurance requirements of the Parties 6.5 Longport shall be listed in Attachment G (exclusively responsible for the “Insurance Requirements”). 2.13 During first 12 months of this Agreement for the Posttraining and support of end user customers contracted to USMS or any of USMS's sub-commercialization period **. 2.14 NPM agrees that it will conduct all necessary testing agents and USMS shall not seek such customer support from any other party. If after the first 12 months of this Agreement has concluded USMS or one of its sub-agents wishes to train and support their customers directly they shall be entitled so to do, provided they give 6 months notice to Longport. If USMS or any of your sub-agents wish to undertake the Product as required by the Specifications. All testing is to be performed during training and at the completion of the manufacture of the Product. ** 2.15 NPM will ** provide to CTI copies of all correspondence, inspection reports and other reports issued by the FDA or other regulatory agencies with respect to those affecting the Product produced for CTI in NPM’ facilities. 2.16 During the Post-commercialization Period CTI support responsibility they shall submit to NPM ** a rolling commercial forecastLongport for approval all training and support documentation and procedures. All such programs and documentation shall be subject to approval by Longport and Longport will on an on-going basis be exclusively responsibly for accrediting all Scanner related training and support programs and the personnel involved. Longport will have the right not to accredit any program or person, as follows: **and neither USMS nor its sub-agents shall use any non-accredited program or person in any training or support capacity with regard to the Scanner. For clarification, Fees will be charged for these forecast and estimate requirements shall only be required to be provided for periods occurring accreditation services by Longport. If during the actual Term first 18 months of the Agreement. ** CTI agrees to purchase, and NPM agrees to produce, ** subject to Section 2.17 below. For clarity purposes, CTI shall be credited with the previous Binding Forecast PO’s in calculating the purchase requirement in this paragraph. 2.17 Each Binding Forecast PO shall identify and reference the quantity of Product ordered, the price to be paid for such Product, packaging requirements, delivery schedule, delivery locations, invoice information and other applicable instructions. If the amounts in the Binding Forecast PO are in compliance with Section 2.16, and Attachment B to this Agreement, the Binding Forecast PO shall be deemed accepted by NPM upon its receipt thereof and become a “Firm Order”. ** Use of e-mail is in this case is permitted, and e-mails shall be sent to the respective e-mail addresses indicated by the Parties. Subject to the cancellation and termination rights in this Agreement, Firm Orders shall be considered firm and non-cancelable, except as provided in Section 2.16 and 2.17 with respect to certain changes, if any, in any Binding Forecast PO. 2.18 During the Pre-commercialization Period CTI may submit NPM Binding Forecast PO with a minimum lead time of **. NPM shall then ** confirm to CTI its acceptance or non acceptance of the Binding Forecast PO, indicating the delivery date and the quantity of Product to be supplied. ** ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.19 In the event NPM fails to deliver any Product due under a Firm Order by the scheduled delivery date, the Price of such Product will be reduced as follows: 2.20 NPM shall not manufacture or sell the Product to any party other than CTI, or its designated affiliates or designated subsidiaries, without CTI’s prior written consent. 2.21 NPM shall not use any materials (including drug substance) provided by CTI hereunder for any purpose other than performing NPM’ obligations under this Agreement and/or the Quality Agreementany end-user customer of USMS requiring multiple Scanners, greater than 20, wishes to develop and use an in-house training program Longport and USMS shall work with that customer to develop an appropriate training program. Longport shall charge for its input into this program development.

Appears in 1 contract

Sources: Confidentiality Agreement (Us Medsys Corp)

Supply. 2.1 During (a) Ardelyx shall be responsible for supplying such quantities of Licensed Compound and Licensed Product for use in the Term, NPM Development and Commercialization of the Licensed Products under this Agreement as the Parties shall allocate capacity agree to and document in the MSA discussed below (the “API Supply”). Ardelyx shall manufacture also be responsible for supplying such quantities of Licensed Product and sell placebos for FOSUN’s Development activities hereunder as the Parties shall agree to CTI no less than and document in the amounts of Product ordered by CTI with MSA discussed below (the issuance of a Binding Forecast PO pursuant to Section 2.16“Development Supply”). All batches of Product API Supply and Development Supply delivered to FOSUN shall be produced utilizing paid for by FOSUN at the Process and Transfer Price. Ardelyx shall deliver such quantities of API Supply to FOSUN for Development as the Parties shall agree. (b) Ardelyx shall continue to supply sufficient Licensed Product to FOSUN for Commercialization, at the Transfer Price, until FOSUN notify Ardelyx in accordance with the Specificationsterms of the MSA to reduce or cease the supply due to the fact that (i) FOSUN is permitted under Applicable Law to Manufacture, cGMPor to have Manufactured, Government ApprovalsLicensed Product for Commercialization on its own, (ii) FOSUN has developed a commercial process for the Manufacture of the Licensed Product and has scaled up that process to Manufacture the Licensed Product in such volumes as reasonably take into account the anticipated demand for the Licensed Product throughout the Territory, and (iii) FOSUN has completed all the terms necessary regulatory procedures with CFDA to enable FOSUN to Manufacture commercial supplies of this Agreementthe Licensed Product. FOSUN shall use Commercially Reasonable Efforts to complete all activities set forth in (i) through (iii) above. 2.2 Binding Forecast PO’s, as defined below, will (c) The Parties agree and acknowledge that a separate manufacturing and supply agreement (“MSA”) is required to be placed on CTI’s standard purchase orders then in effect with a minimum lead time of **. All terms and conditions of this Agreement shall entered into between the Parties to further govern the transactions supply obligations undertaken by Ardelyx hereunder. The Parties shall also enter into a separate Quality Assurance Agreement (“QAA”) that shall define the manufacturing and supply quality responsibilities of the Parties for the Licensed Compound and the Licensed Product. The MSA and the QAA shall be negotiated in good faith between the Parties and any terms or conditions of said purchase order which conflict with this Agreement be executed as promptly as possible following the Effective Date. The Parties’ objective is that the MSA and the QAA shall be null entered into as soon as possible and void. NPM shall promptly manufacture and deliver all Firm Orders, as defined below, of Product in accordance with the related schedule and in compliance with the Specifications, cGMP and other applicable laws and regulations. ** 2.3 All Product supplied by NPM shall be delivered to CTI’s designated carrier per ** from NPM’s facility, as specified in the related Firm Order. ** 2.4 NPM shall ship the Product in accordance with applicable laws and regulations and in a commercially reasonable manner in accordance with the instructions set forth on Attachment D hereto. 2.5 CTI or its designee may, at CTI’s option, analyze each batch and samples from each batch of Product. ** 2.7 Subject to Sections 2.5 and 2.6, ** 2.8 NPM warrants that all applicable environmental and safety requirements are being and will be followed at its facilities. Additionally, the manufacture of the Product shall be in accordance with cGMP. For the purpose of quality assurance auditing and to evaluate compliance with applicable cGMPs, environmental and occupational health and safety laws and regulations, CTI shall have the right to audit and inspect per the Quality Agreement. ** 2.9 NPM shall notify CTI **of significant incidents relating to production of the Product **. 2.10 At CTI’s request, NPM shall, within five (5) business days, provide copies of all relevant environmental licenses and permits in their original language pertaining to its operation and shall notify CTI of any material change in status. ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. [**** Indicates that the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.11 At CTI’s request, NPM will, within five ] (5) business days, provide the requirements set forth in Attachment F (the “Record Keeping and Accounting Schedule”). 2.12 At CTI’s request, NPM will, within five (5) business days, provide CTI with copies of all applicable insurance certificates in their original language. Insurance requirements of the Parties shall be listed in Attachment G (the “Insurance Requirements”). 2.13 During the Post-commercialization period **. 2.14 NPM agrees that it will conduct all necessary testing of the Product as required by the Specifications. All testing is to be performed during and at the completion of the manufacture of the Product. ** 2.15 NPM will ** provide to CTI copies of all correspondence, inspection reports and other reports issued by the FDA or other regulatory agencies with respect to those affecting the Product produced for CTI in NPM’ facilities. 2.16 During the Post-commercialization Period CTI shall submit to NPM ** a rolling commercial forecast, as follows: **. For clarification, these forecast and estimate requirements shall only be required to be provided for periods occurring during the actual Term of the Agreement. ** CTI agrees to purchase, and NPM agrees to produce, ** subject to Section 2.17 below. For clarity purposes, CTI shall be credited with the previous Binding Forecast PO’s in calculating the purchase requirement in this paragraph. 2.17 Each Binding Forecast PO shall identify and reference the quantity of Product ordered, the price to be paid for such Product, packaging requirements, delivery schedule, delivery locations, invoice information and other applicable instructions. If the amounts in the Binding Forecast PO are in compliance with Section 2.16, and Attachment B to this Agreement, the Binding Forecast PO shall be deemed accepted by NPM upon its receipt thereof and become a “Firm Order”. ** Use of e-mail is in this case is permitted, and e-mails shall be sent to the respective e-mail addresses indicated by the Parties. Subject to the cancellation and termination rights in this Agreement, Firm Orders shall be considered firm and non-cancelable, except as provided in Section 2.16 and 2.17 with respect to certain changes, if any, in any Binding Forecast PO. 2.18 During the Pre-commercialization Period CTI may submit NPM Binding Forecast PO with a minimum lead time of **. NPM shall then ** confirm to CTI its acceptance or non acceptance of the Binding Forecast PO, indicating the delivery date and the quantity of Product to be supplied. ** ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. [**** Indicates that ]) days of the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portionsEffective Date. 2.19 In the event NPM fails to deliver any Product due under a Firm Order by the scheduled delivery date, the Price of such Product will be reduced as follows: 2.20 NPM shall not manufacture or sell the Product to any party other than CTI, or its designated affiliates or designated subsidiaries, without CTI’s prior written consent. 2.21 NPM shall not use any materials (including drug substance) provided by CTI hereunder for any purpose other than performing NPM’ obligations under this Agreement and/or the Quality Agreement.

Appears in 1 contract

Sources: License Agreement (Ardelyx, Inc.)

Supply. 2.1 During 5.1 Teva commits to buy its total demand of the Term, NPM shall allocate capacity Product for the Territory exclusively from Galena for the term of this Agreement. Galena agrees to exclusively sell and shall manufacture and sell to CTI no less than supply Teva with its total demand of the amounts of Product ordered by CTI with in the issuance of a Binding Forecast PO Territory under agreed conditions pursuant to Section 2.16. All batches of this Agreement. 5.2 Except as may be otherwise required by a specific Regulatory Authority, Galena will manufacture the Product shall be produced utilizing at the Process and manufacturing facility in [***] (“the Manufacturing Site”), strictly in accordance with the SpecificationsSpecifications and cGMP standards. Galena will enable the applicable Regulatory Authorities to inspect the Manufacturing Site without any delay, cGMP, Government Approvals, and the terms of this Agreement. 2.2 Binding Forecast PO’s, as defined below, will be placed on CTI’s standard purchase orders then in effect with a minimum lead time of **. All terms and conditions of this Agreement shall govern the transactions between the Parties and provided that any terms or conditions of said purchase order which conflict with this Agreement visit shall be null coordinated ahead of time with Galena, in order to enable the due registration and void. NPM shall promptly manufacture and deliver all Firm Orders, as defined below, commercialization of Product in accordance with the related schedule and in compliance with the Specifications, cGMP and other applicable laws and regulations. ** 2.3 All Product supplied by NPM shall be delivered to CTI’s designated carrier per ** from NPM’s facility, as specified in the related Firm Order. ** 2.4 NPM shall ship the Product in accordance with applicable laws and regulations and in a commercially reasonable manner in accordance the respective markets. Galena will utilize Reasonably Diligent Efforts to ensure that the Manufacturing Site will comply with the instructions set forth on Attachment D heretorequirements and requests of the Regulatory Authorities. 2.5 CTI or its designee may, at CTI’s option, analyze each batch and samples from each batch of Product. ** 2.7 Subject 5.3 Galena shall be entitled to Sections 2.5 and 2.6, ** 2.8 NPM warrants that all applicable environmental and safety requirements are being and will be followed at its facilities. Additionally, use contract manufacturers for the manufacture of the Product, subject to the following conditions: 5.3.1 Galena ensures that Teva is allowed to audit any contract manufacturer before manufacture of the Product by such contract manufacturer is commenced to enable Teva to confirm that the contract manufacturer is reasonably satisfactory to Teva, including without limitation the fact that it is cGMP compliant; 5.3.2 In the event it intends to replace a contract manufacturer, Galena shall procure Teva’s written consent thereto not less than six (6) months prior to such anticipated replacement; 5.3.3 Teva may refuse to accept the Product manufactured by a contract manufacturer appointed by Galena if Teva’s audit reveals that the contract manufacturer is not satisfactory to it, including without limitation due to the fact such contract manufacturer is not cGMP compliant or as a result of changes to the Product is no longer cGMP compliant. 5.4 Use of a contract manufacturer by Galena shall in no way limit Galena’ obligations under this Agreement and Galena shall be jointly and severally liable for actions and omissions of any contract manufacturers it employs. 5.5 Galena will supply the Product in accordance with cGMP. For the purpose of quality assurance auditing a Finished Form to Teva and to evaluate compliance with applicable cGMPs, environmental and occupational health and safety laws and regulations, CTI its Affiliates. 5.6 Teva shall have the right to audit inspect the Manufacturing Site used by Galena at reasonable times as agreed between the parties, which access Galena shall use Reasonably Diligent Efforts to procure, which requests will not result in an undue burden to Galena of the manufacturer. 5.7 Galena shall ensure that any Product supplied under this Agreement shall meet its quality Specifications as approved by the Regulatory Authorities in the Territory and inspect per contained in the Registration Dossier, including without limitation cGMP standards. Galena shall ensure that any changes made to such Specifications are not implemented without the prior written approval of the Regulatory Authorities in the Territory and/or Teva’s. 5.8 The supply of the Product by Galena to Teva shall also be subject to the terms and conditions of the Quality Agreement. **In the event of any inconsistencies between this Agreement and the Quality Agreement, the provisions of this Agreement shall prevail in all non-quality related matters. 2.9 NPM 5.9 Galena shall notify CTI **provide Teva with a Certificate of significant incidents relating Analysis (signed by a “Qualified Person” designated by Galena) for each batch delivered to production Teva in order to confirm that the applicable Product as delivered meets all its Specifications and cGMP standards. Galena shall provide Teva with any other document already in its possession or which can be reasonably obtained by Galena, and which could be required by the competent Regulatory Authority. 5.10 With the first lot of the Product **. 2.10 At CTI’s requestshipped to Teva, NPM Galena shall, within five (5) business daysat its own expense, send to Teva all necessary samples and standards, including, but not limited to, reference samples, impurities and stability samples, and reference and working standards necessary or requested by the Regulatory Authority for obtaining the Marketing Authorization or any other registration. In addition, Galena shall provide copies Teva with samples, free of all relevant environmental licenses charge, in quantities and permits in their original language pertaining timeline to its operation and be agreed between the parties for promotional purposes. If the parties mutually agree that additional samples are needed after the Marketing Authorization is granted, Galena shall notify CTI of any material change in statussupply Teva with such samples, at Teva’s expense. ** Indicates that certain information contained herein has been omitted and filed separately If samples are required due to changes initiated by Galena, Galena shall supply Teva with the Securities and Exchange Commissionsamples at no extra charge. Confidential treatment Galena shall ensure that each delivery of Product supplied to Teva has been request with respect a minimum shelf life remaining at the time of delivery equivalent to the omitted portions. at least: (a) [**** Indicates that the amount ]% of information omitted was a page its registered shelf-life; or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. 2.11 At CTI’s request, NPM will, within five (5b) business days, provide the requirements set forth in Attachment F (the “Record Keeping and Accounting Schedule”). 2.12 At CTI’s request, NPM will, within five (5) business days, provide CTI with copies of all applicable insurance certificates in their original language. Insurance requirements of the Parties shall be listed in Attachment G (the “Insurance Requirements”). 2.13 During the Post-commercialization period **. 2.14 NPM agrees that it will conduct all necessary testing of the Product as required by the Specifications. All testing is to be performed during and at the completion of the manufacture of the Product. ** 2.15 NPM will ** provide to CTI copies of all correspondence, inspection reports and other reports issued by the FDA or other regulatory agencies with respect to those affecting the Product produced for CTI in NPM’ facilities. 2.16 During the Post-commercialization Period CTI shall submit to NPM ** a rolling commercial forecast, as follows: **. For clarification, these forecast and estimate requirements shall only be required to be provided for periods occurring during the actual Term of the Agreement. ** CTI agrees to purchase, and NPM agrees to produce, ** subject to Section 2.17 below. For clarity purposes, CTI shall be credited with the previous Binding Forecast PO’s in calculating the purchase requirement in this paragraph. 2.17 Each Binding Forecast PO shall identify and reference the quantity of Product ordered, the price to be paid for such Product, packaging requirements, delivery schedule, delivery locations, invoice information and other applicable instructions. If the amounts in the Binding Forecast PO are in compliance with Section 2.16, and Attachment B to this Agreement, the Binding Forecast PO shall be deemed accepted by NPM upon its receipt thereof and become a “Firm Order”. ** Use of e-mail is in this case is permitted, and e-mails shall be sent to the respective e-mail addresses indicated by the Parties. Subject to the cancellation and termination rights in this Agreement, Firm Orders shall be considered firm and non-cancelable, except as provided in Section 2.16 and 2.17 with respect to certain changes, if any, in any Binding Forecast PO. 2.18 During the Pre-commercialization Period CTI may submit NPM Binding Forecast PO with a minimum lead time of **. NPM shall then ** confirm to CTI its acceptance or non acceptance of the Binding Forecast PO, indicating the delivery date and the quantity of Product to be supplied. ** ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect to the omitted portions. [**** Indicates that ] years, or as otherwise agreed in writing between the amount of information omitted was a page or more in length, and such information was filed separately with the Securities and Exchange Commission. Confidential treatment has been request with respect parties from time to the omitted portionstime. 2.19 5.11 In the event NPM fails that Galena is unable to deliver any supply Product due under for a Firm Order continuous period of six (6) months after the confirmed date of delivery, Teva shall be entitled to terminate this Agreement immediately by the scheduled delivery date, the Price of such Product will notice in writing to Galena. Such termination shall be reduced as follows: 2.20 NPM shall not manufacture or sell the Product without prejudice to any party other than CTI, or its designated affiliates or designated subsidiaries, without CTI’s prior written consentright available to Teva in case of termination under the governing law. 2.21 NPM shall not use any materials (including drug substance) provided by CTI hereunder for any purpose other than performing NPM’ obligations under this Agreement and/or the Quality Agreement.

Appears in 1 contract

Sources: License and Supply Agreement (Galena Biopharma, Inc.)