Purchase Commitment. (a) During the Term and upon the terms and subject to the conditions of this Agreement, and as long as SAFC can demonstrate to Company’s reasonable satisfaction that SAFC: (i) provides conforming Product in accordance with the terms of this Agreement and (ii) can meet the Commercial Assurance (as defined below in Sec. 3.1) production levels, Company undertakes to purchase from SAFC not less than [***] of API (“Minimum Percentage Requirement”). The Parties acknowledge that Company placed and SAFC manufactured API for the Work Order dated October 17, 2017 under purchase order 80319 dated November 6, 2017 and Proposal dated March 7, 2018 under purchase order 80767 dated March 16, 2018. The Parties agree that the terms of this Agreement shall apply to the Manufacture of API pursuant only to Purchase Order 80767, however both Purchase Orders 80319 and 80767 shall apply towards the Minimum Percentage Requirement. [***]. Company agrees to cooperate in a prompt and timely manner with SAFC in any investigation and resolution of any quality issues with the API to enable SAFC to remedy any such issue. [***]. For clarity, API that is to be used for clinical purposes shall not be included when calculating Total Commercial Volume Requirements. (b) At any time and from time to time during the Term, if SAFC believes that Company is not purchasing the Minimum Percentage Requirement, it will provide Company with written notice requesting that Company provide sufficient documentation demonstrating such purchases. Company shall have [***] after such notice to provide this documentation. If Company does not provide such documentation within this [***] period or if such documentation does not demonstrate, to SAFC’s reasonable satisfaction, that Company purchased the Minimum Percentage Requirement based on Company’s demand forecast, the Parties will engage in good faith discussions for a period of an additional [***] in an effort to resolve the disagreement. If the Parties do not reach a mutually acceptable agreement within the foregoing [***] discussion period, then either Party may refer the matter to be resolved by binding arbitration. The arbitration shall be conducted in accordance with the Commercial Arbitration Rules of the American Arbitration Association in effect at the time of the arbitration to the extent that both Parties are domestic United States companies or in accordance with the International Arbitration Rules of the American Arbitration Association in effect at the time of the arbitration to the extent that one of the Parties is not a domestic United States company, except, in each instance, as such rules may be modified herein or by mutual agreement of the Parties. The seat of the arbitration shall be New York City, New York, USA, and it shall be conducted in the English language.
Appears in 2 contracts
Samples: Commercial Supply Agreement (Amag Pharmaceuticals Inc.), Commercial Supply Agreement (Amag Pharmaceuticals Inc.)
Purchase Commitment. (a) During Omnicare will meet and maintain the Term and upon the terms and subject to the conditions of this Agreement, and as long as SAFC can demonstrate to Company’s reasonable satisfaction that SAFC: (i) provides conforming Product in accordance with the terms of this Agreement and (ii) can meet the Commercial Assurance (as defined below in Sec. 3.1) production levels, Company undertakes to following purchase commitments:
2.2.1 purchase from SAFC Vendor not less than [***] of API its Net dollar volume of overall requirements for Branded Rx Products of Omnicare and the Omnicare Facilities, net of Permitted Purchases (“Minimum Brand Volume Net Purchase Percentage Requirement”). The Parties acknowledge that Company placed .
2.2.2 purchase from Vendor, through Vendor’s OneStop Program, not less than [***] of its Net dollar volume of overall requirements for Generic Products of Omnicare and SAFC manufactured API for the Work Order dated October 17Omnicare Facilities, 2017 under purchase order 80319 dated November 6, 2017 and Proposal dated March 7, 2018 under purchase order 80767 dated March 16, 2018. The Parties agree that the terms net of this Agreement shall apply to the Manufacture of API pursuant only to Permitted Purchases (“Generic Volume Net Purchase Order 80767, however both Purchase Orders 80319 and 80767 shall apply towards the Minimum Percentage Requirement”). [***].
2.2.3 Omnicare represents and warrants that its actual net generics spend for 2014 (annualized based upon the actual amounts from January 1, 2014 to November 30, 2014) shall have been an amount not less than [***] (the “2014 Generic Spend Target”). Company agrees If Omnicare does not achieve the Brand Volume Net Purchase Percentage Requirement, the Generic Volume Net Purchase Percentage Requirement or the 2014 Generic Spend Target, [***] by giving written notice to cooperate in a prompt and timely manner with SAFC in any investigation and resolution such effect to Omnicare. Following the giving of any quality issues such notice, the Parties shall negotiate in good faith with the API respect to enable SAFC to remedy any such issue. [***]. For clarity, API that is If the Parties come to be used for clinical purposes shall not be included when calculating Total Commercial Volume Requirements.
(b) At any time and from time to time during the Term, if SAFC believes that Company is not purchasing the Minimum Percentage Requirement, it will provide Company with written notice requesting that Company provide sufficient documentation demonstrating such purchases. Company shall have agreement [***] after such notice to provide this documentation]. If Company does not provide such documentation within this [***] period or if such documentation does not demonstrate, to SAFC’s reasonable satisfaction, that Company purchased To the Minimum Percentage Requirement based on Company’s demand forecast, extent the Parties will engage in good faith discussions for a period of an additional [***] in an effort to resolve the disagreement. If the Parties do cannot reach a mutually acceptable agreement within the foregoing [***] discussion periodagreement, then either Party may refer may, at its election and as its sole remedy, submit the matter dispute for binding mediation subject to be resolved by binding arbitration. The arbitration the provisions of Section 13.19 of the Agreement.
2.2.4 Omnicare shall be conducted not purchase Pharmaceutical Products from another vendor (including any wholesaler or manufacturer), except for (i) purchases that are Permitted Purchases, (ii) purchases in accordance with the Commercial Arbitration Rules operational transition plan contemplated by Schedule 2.2 (the “Transition Plan”) and (iii) purchases in amounts that would not cause Omnicare not to satisfy the requirement in this Section 2.2. For purposes of determining Omnicare’s compliance with the American Arbitration Association in effect at the time Brand Volume Net Purchase Percentage Requirement and Generic Volume Net Purchase Percentage Requirement, all purchases of the arbitration to the extent that both Parties are domestic United States companies or Pharmaceutical Products from other vendors (including wholesalers and manufacturers) in accordance with the International Arbitration Rules of the American Arbitration Association in effect at the time of the arbitration to the extent that one of the Parties is not a domestic United States company, except, in each instance, as such rules may be modified herein or by mutual agreement of the Parties. The seat of the arbitration Transition Plan shall be New York City, New York, USA, and it shall be conducted in the English languageincluded as if they were purchased from Vendor and/or Vendor’s One Stop Program (as applicable).
Appears in 1 contract
Samples: Pharmaceutical Prime Vendor Agreement (Omnicare Inc)
Purchase Commitment. (a) During the Term and upon Subject to the terms and subject to the conditions of this Agreement, Agreement and as long as SAFC can demonstrate to Company’s reasonable satisfaction that SAFC: SAFC (i) provides conforming and timely delivered Product in accordance with commercial Batches resulting from a production yield of not less than the terms minimum yield achieved in the prior [***] validation runs but in no case shall such production be less than a [***] yield of this Agreement and Product based on starting iron material (“Yield”); and, (ii) can meet the Commercial Assurance (as defined below in Sec. 3.1) production levels, Company undertakes agrees to purchase from SAFC not less than an annual minimum amount of Product equal to the greater of [***]Batches or [***] of API Product for use in the production and distribution of Finished Product for [***] (the “Minimum Percentage RequirementPurchase Commitment”) as measured [***], as the case may be, during the Term (the “Purchase Year”). The Parties acknowledge that Company placed and SAFC manufactured API for the Work Order dated October 17, 2017 under purchase order 80319 dated November 6, 2017 and Proposal dated March 7, 2018 under purchase order 80767 dated March 16, 2018. The Parties agree that the terms of this Agreement shall apply to the Manufacture of API pursuant only to Purchase Order 80767, however both Purchase Orders 80319 and 80767 shall apply towards In calculating the Minimum Percentage RequirementPurchase Commitment during each Purchase Year, Company shall be credited with all Product ordered, including amounts [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. used for samples and testing provided such amounts are authorized by applicable law for release and use by AMAG or its licensee [***]. Company In the event a Batch is produced with a Yield that is less than minimum criteria stated above, the Parties will negotiate in good faith to provide a price adjustment on such Batch. Further, SAFC agrees to cooperate notify Company promptly in a prompt and timely manner writing of when the percentage of manufacturing capacity consumed at the facility designated in Section 12.6 (c) with SAFC in any investigation and resolution the inclusion of any quality issues with the API to enable SAFC to remedy any such issue. amount of Product ordered by Company (“Capacity Notification”) equals or exceeds [***]] of such facility’s manufacturing capacity. For clarity, API that is to be used for clinical purposes shall not be included when calculating Total Commercial Volume Requirements.
(b) At any time and Company may at its discretion request Capacity Notification from SAFC from time to time during the Term, if SAFC believes term of this Agreement. To the extent that Company is the provisions in (i) or (ii) above are not purchasing maintained or the Minimum Percentage Requirement, it will provide Company with written notice requesting that Company provide sufficient documentation demonstrating such purchases. Company shall have Capacity Notification exceeds [***] after such notice of the applicable facility’s manufacturing capacity, Company shall have the right to provide this documentation. If Company does not provide such documentation within this reduce the Company’s Minimum Purchase Commitment hereunder by up to [***] period or if until such documentation does not demonstrate, time that that SAFC can demonstrate to SAFCCompany’s reasonable satisfaction, satisfaction that Company purchased SAFC can maintain the Minimum Percentage Requirement based on CompanyYield and Commercial Assurance production levels described in (i) and (ii) above and/or that the applicable facility’s demand forecast, the Parties will engage in good faith discussions for a period of an additional manufacturing capacity is less than [***] in an effort to resolve the disagreement. If the Parties do not reach a mutually acceptable agreement within the foregoing [***] discussion period, then either Party may refer the matter to be resolved by binding arbitration. The arbitration shall be conducted in accordance with the Commercial Arbitration Rules of the American Arbitration Association in effect at the time of the arbitration to the extent that both Parties are domestic United States companies or in accordance with the International Arbitration Rules of the American Arbitration Association in effect at the time of the arbitration to the extent that one of the Parties is not a domestic United States company, except, in each instance], as such rules the case may be modified herein or by mutual agreement of the Parties. The seat of the arbitration shall be New York City, New York, USA, and it shall be conducted in the English languagebe.
Appears in 1 contract
Samples: Commercial Supply Agreement (Amag Pharmaceuticals Inc.)