Common use of Manufacturing Requirements Clause in Contracts

Manufacturing Requirements. 5.5.1 SMI has and will manufacture the Modified Starch in accordance with the (i) Modified Starch Product Specifications, (ii) applicable Regulatory Laws including United States Regulatory Laws, and ISO 13485 requirements (including appropriate certification), MDD requirements, CMDCAS requirements, and (iii) other pertinent rules and regulations of Regulatory Authorities that have granted Regulatory Approval for the Modified Starch. In addition, during the Term, SMI will maintain, or cause to be maintained, the Modified Starch manufacturing facility’s (ies’) registrations as a certified medical device manufacturing facility with all applicable Regulatory Authorities and cause such facility to be maintained such that the facility would pass an audit for compliance with ISO 13485 (including appropriate certification), MDD, QSR and CMDCAS requirements. SMI shall maintain ongoing quality assurance and testing policies sufficient to satisfy its obligations under this Agreement, CryoLife’s standard requirements for approval as a vendor as described in CryoLife’s quality system review policy, and SMI’s standard quality assurance policies, copies of which have been provided to the other Party contemporaneously with the execution of this Agreement. 5.5.2 Once it obtains United States Regulatory Approval, CryoLife will Manufacture Products in accordance with the (i) Products Specifications, (ii) applicable Regulatory Laws, and ISO 13485 requirements (including appropriate certification), MDD requirements, QSR requirements, CMDCAS requirements, and (iii) other pertinent rules and regulations of Regulatory Authorities that have granted Regulatory Approval for the Products manufactured by CryoLife. Once it commences Commercial Manufacturing of the Products for a country in the Territory for which it can Manufacture pursuant to appropriate Regulatory Approval, CryoLife will maintain, or cause to be maintained, the Products manufacturing facility’s (ies’) registration as a certified medical device manufacturing facility with all applicable Regulatory Authorities and cause such facility to be maintained such that the facility would pass an audit for compliance with ISO 13485 (including appropriate certification), MDD, FDA GMP compliance, CMDCAS requirements, as applicable for such country. CryoLife shall maintain ongoing quality assurance and testing policies sufficient to satisfy its obligations under this Agreement. 5.5.3 Upon the request of either Party, the other Party shall provide the requesting Party with written evidence of compliance with the criteria set forth in this Section 5.5.

Manufacturing Requirements. 5.5.1 SMI has and (a) LICENSEE will manufacture the Modified Starch have manufactured on its behalf only by those manufacturers authorized by HONEYWELL pursuant to HONEYWELL’S Direct Ship Authority (“APPROVED MANUFACTURERS”) any LICENSED PRODUCTS in accordance with the (i) Modified Starch Product Specifications, (ii) applicable Regulatory Laws including United States Regulatory Laws, then-current guidelines of HONEYWELL’S Direct Ship Authority and ISO 13485 requirements (including appropriate certification), MDD requirements, CMDCAS requirements, and (iii) other pertinent laws, rules and regulations of Regulatory Authorities that have granted Regulatory Approval for the Modified Starchany REGULATORY AUTHORITIES in all applicable jurisdictions. In addition, during the Term, SMI will maintain, or cause event that LICENSEE fails to be maintained, the Modified Starch manufacturing facility’s (ies’) registrations as a certified medical device manufacturing facility with all applicable Regulatory Authorities and cause such facility to be maintained such that the facility would pass an audit for compliance with ISO 13485 (including appropriate certification), MDD, QSR and CMDCAS requirements. SMI shall maintain ongoing quality assurance and testing policies sufficient to satisfy its obligations under this Agreement, CryoLife’s standard requirements for approval as a vendor as described in CryoLife’s quality system review policy, and SMI’s standard quality assurance policies, copies of which have been provided to the other Party contemporaneously comply with the execution guidelines of this Agreement. 5.5.2 Once it obtains United States Regulatory Approval, CryoLife will Manufacture Products in accordance with the (i) Products Specifications, (ii) applicable Regulatory Laws, and ISO 13485 requirements (including appropriate certification), MDD requirements, QSR requirements, CMDCAS requirements, and (iii) other pertinent rules and regulations of Regulatory Authorities that have granted Regulatory Approval for the Products manufactured by CryoLife. Once it commences Commercial Manufacturing of the Products for a country in the Territory for which it can Manufacture pursuant to appropriate Regulatory Approval, CryoLife will maintain, or cause to be maintained, the Products manufacturing facility’s (ies’) registration as a certified medical device manufacturing facility with all applicable Regulatory Authorities and cause such facility to be maintained such that the facility would pass an audit for compliance with ISO 13485 (including appropriate certification), MDD, FDA GMP compliance, CMDCAS requirements, as applicable for such country. CryoLife shall maintain ongoing quality assurance and testing policies sufficient to satisfy its obligations under this Agreement. 5.5.3 Upon the request of either Party, the other Party shall provide the requesting Party with written evidence of compliance with the criteria HONEYWELL’S Direct Ship Authority set forth in this Section 5.5Article 13, HONEYWELL may, at its option, have manufactured, sell, have sold, import and distribute the LICENSED PRODUCTS through (a) one of the licensees to the PRE-EXISTING AGREEMENTS, or (b) a manufacturer of the LICENSED PRODUCTS to have manufactured and/or procure those LICENSED PRODUCTS in respect of which LICENSEE is failing to comply with HONEYWELL’S Direct Ship Authority, until HONEYWELL determines in its reasonable discretion that LICENSEE has cured such failure. The exercise of such right by HONEYWELL shall not be deemed to be a breach of LICENSEE’S exclusive rights under this AGREEMENT or the SUPPLY AGREEMENT, provided that HONEYWELL does not grant to any third party during such period, a license or sublicense to the TECHNOLOGY to have manufactured, sell, have sold, import or distribute the LICENSED PRODUCTS. In the event that LICENSEE fails to comply with the guidelines of HONEYWELL’S Direct Ship Authority, HONEYWELL shall, at LICENSEE’s request and expense, use reasonable efforts to assist LICENSEE in regaining compliance as soon as possible. (b) If LICENSEE desires to identify a new manufacturer for the LICENSED PRODUCTS, LICENSEE shall identify such manufacturer to HONEYWELL and request that such manufacturer become an APPROVED MANUFACTURER, and HONEYWELL shall analyze and consider the authorization of the proposed manufacturer as an APPROVED MANUFACTURER in respect of the LICENSED PRODUCTS, which authorization shall not be unreasonably withheld by HONEYWELL; provided that (a) LICENSEE will reimburse HONEYWELL for all out-of-pocket costs and expenses incurred by HONEYWELL in connection with its review and consideration of such authorization, and (b) the following shall be reasonable grounds for HONEYWELL to make its determination of whether or not to grant such authorizations: (1) whether or not the proposed supplier has an AS9100 quality system or other equivalent quality system reasonably satisfactory to HONEYWELL, (2) the extent to which technical resubstantiation and/or requalification of the products supplied by such manufacturer is required in order to meet HONEYWELL design specifications, and (3) whether or not such manufacturer has obtained a score of at least 3 on the HONEYWELL supplier common assessment scorecard.

Manufacturing Requirements. 5.5.1 SMI (a) Unless otherwise approved by Medifocus, JV shall have all Products manufactured by manufacturers who are currently manufacturing Products for Medifocus on such terms and conditions acceptable to both JV and Medifocus, including that (i) notwithstanding any prior inspection or payments, all Products shall be subject to final inspection and acceptance at JV’s designated destination point within sixty (60) days after delivery, (ii) without prejudice to any other right or remedy of JV, in case any item is defective in material or workmanship, or otherwise not in conformity with the Product Specifications, Product Approvals or the requirements of JV’s order, JV shall have the right to reject it, (iii) any item that has been rejected must be replaced by and will at the expense of manufacturer promptly after notice, (iv) JV shall not be required to pay for any rejected item, or its shipping costs or any other costs related thereto, and (v) that JV shall return all rejected Products to manufacturer at manufacturer’s expense. (b) JV shall be responsible for ensuring that all manufacturers utilized by JV shall manufacture the Modified Starch Products in accordance with (a) the (i) Modified Starch Product Specifications, (iib) applicable Regulatory regulations relating to Good Manufacturing Practices and similar protocols required by applicable Laws (“GMP”), quality system regulations of the FDA or CFDA (“QSR”), including United States Regulatory Lawsmaster device and lot history records, and ISO 13485 requirements (including appropriate certification), MDD 9001 and EN 46001 requirements, CMDCAS requirements, and (iiic) other pertinent rules and regulations of the FDA and any Foreign Regulatory Authorities that have granted Regulatory Approval for in other applicable jurisdictions and (d) JV’s quality assurance requirements. Upon the Modified Starchrequest of Medifocus, JV shall provide Medifocus with written evidence of compliance with the criteria set forth in the preceding sentence. In additionIf the manufacturer is someone other than Medifocus’ manufacturer of Products, during the Term, SMI will maintain, JV shall maintain or cause to be maintained, the Modified Starch manufacturing facility’s (ies’) registrations maintained registration of each facility in which any Product is manufactured as a certified medical device manufacturing facility and shall maintain such facility registration with all applicable Regulatory Authorities and or cause such facility to be maintained such that the facility would pass an audit for compliance comply with ISO 13485 (including appropriate certification), MDD, QSR GMP and CMDCAS requirements. SMI shall maintain ongoing quality assurance and testing policies sufficient to satisfy its obligations under this Agreement, CryoLife’s standard requirements for approval as a vendor as described in CryoLife’s quality system review policy, and SMI’s standard quality assurance policies, copies of which have been provided to the other Party contemporaneously with the execution of this AgreementQSR. 5.5.2 Once it obtains United States Regulatory Approval, CryoLife will Manufacture Products in accordance with the (i) Products Specifications, (ii) applicable Regulatory Laws, and ISO 13485 requirements (including appropriate certification), MDD requirements, QSR requirements, CMDCAS requirements, and (iii) other pertinent rules and regulations of Regulatory Authorities that have granted Regulatory Approval for the Products manufactured by CryoLife. Once it commences Commercial Manufacturing of the Products for a country in the Territory for which it can Manufacture pursuant to appropriate Regulatory Approval, CryoLife will maintain, or cause to be maintained, the Products manufacturing facility’s (ies’) registration as a certified medical device manufacturing facility with all applicable Regulatory Authorities and cause such facility to be maintained such that the facility would pass an audit for compliance with ISO 13485 (including appropriate certification), MDD, FDA GMP compliance, CMDCAS requirements, as applicable for such country. CryoLife shall maintain ongoing quality assurance and testing policies sufficient to satisfy its obligations under this Agreement. 5.5.3 Upon the request of either Party, the other Party shall provide the requesting Party with written evidence of compliance with the criteria set forth in this Section 5.5.

Manufacturing Requirements. 5.5.1 SMI has (a) INHALE shall establish, and will manufacture may amend from time to time in writing, the Modified Starch Manufacturing Requirements for the Devices, Base Units, Transjectors and Xxxxxxxx. Each CM shall implement the then current Manufacturing Requirements in accordance with their terms, and each CM shall periodically report to INHALE on its performance under such Manufacturing Requirements. Each CM shall agree to any changes in the Manufacturing Requirements so long as they (a) are required by the Regulatory Approvals or the Applicable Regulations or (b) are compatible with the scope [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. of such CM's overall business, and if not, the Parties shall discuss such changes to the Manufacturing Requirements in good faith. INHALE shall allow the CMs a commercially reasonable period of time to implement changes to the Manufacturing Requirements. The CMs agree to implement such changes in an expeditious and commercially prudent manner. [**] Any changes in the Manufacturing Requirements hereunder shall also be subject to the change control procedures set forth in Section 3.9. (b) INHALE acknowledges that the Manufacturing Requirements are determined by INHALE and transferred to each CM, [**] a Device, Base Unit, Transjector or Chamber that is not manufactured in accordance with the (i) Modified Starch Product SpecificationsManufacturing Requirements, (ii) applicable Regulatory Laws including United States Regulatory Laws, it shall promptly notify INHALE thereof and ISO 13485 requirements (including appropriate certification), MDD requirements, CMDCAS requirements, and (iii) other pertinent rules and regulations of Regulatory Authorities that have granted Regulatory Approval for the Modified Starch. In addition, during the Term, SMI will maintain, or cause CMs shall cooperate with INHALE in trying to be maintained, the Modified Starch manufacturing facility’s (ies’) registrations as a certified medical device manufacturing facility with all applicable Regulatory Authorities and cause resolve such facility to be maintained such that the facility would pass an audit for compliance with ISO 13485 (including appropriate certification), MDD, QSR and CMDCAS requirements. SMI shall maintain ongoing quality assurance and testing policies sufficient to satisfy its obligations under this Agreement, CryoLife’s standard requirements for approval as a vendor as described in CryoLife’s quality system review policy, and SMI’s standard quality assurance policies, copies of which have been provided to the other Party contemporaneously with the execution of this Agreementissue. 5.5.2 Once it obtains United States Regulatory Approval, CryoLife will Manufacture Products in accordance with the (i) Products Specifications, (ii) applicable Regulatory Laws, and ISO 13485 requirements (including appropriate certification), MDD requirements, QSR requirements, CMDCAS requirements, and (iii) other pertinent rules and regulations of Regulatory Authorities that have granted Regulatory Approval for the Products manufactured by CryoLife. Once it commences Commercial Manufacturing of the Products for a country in the Territory for which it can Manufacture pursuant to appropriate Regulatory Approval, CryoLife will maintain, or cause to be maintained, the Products manufacturing facility’s (ies’) registration as a certified medical device manufacturing facility with all applicable Regulatory Authorities and cause such facility to be maintained such that the facility would pass an audit for compliance with ISO 13485 (including appropriate certification), MDD, FDA GMP compliance, CMDCAS requirements, as applicable for such country. CryoLife shall maintain ongoing quality assurance and testing policies sufficient to satisfy its obligations under this Agreement. 5.5.3 Upon the request of either Party, the other Party shall provide the requesting Party with written evidence of compliance with the criteria set forth in this Section 5.5.