Common use of Manufacturing Facility Clause in Contracts

Manufacturing Facility. (a) Subject to the parties pre-existing commitments, each party shall dedicate as much of their facility's capacity as is necessary to carry out this Agreement. Cheminor and Schein shall notify the other in writing of any pending * redacted pursuant to confidential treatment request. inspection, reports and/or legal action by the FDA or other Regulatory Authority and each party shall have the right, if practicable, to have representatives present for such inspection of the other party. Each party shall provide the other with a copy of each FDA or other Regulatory Authority inspection report (and/or associated notices, correspondence and telephone contact reports) (redacted as to information as to products not covered by the other party's distribution rights) within three (3) business days of receipt and a copy of their reply prior to submittal to the FDA or other Regulatory Authority for the other party's review and comment thereon. (b) Cheminor shall establish departments, systems, procedures and practices supported by adequate, qualified and trained personnel at the Facility to cover all aspects of developing and manufacturing pharmaceutical products in compliance with Applicable Law so as to enable it to perform its obligations hereunder, which shall include without limitation the following: (i) current good manufacturing practice, safety and environmental compliance; (ii) product development; (iii) preparation of applications for Regulatory Approval of Products; (iv) quality control and assurance; (v) regulatory affairs and compliance; (vi) qualifying and validating all systems, processes and equipment; (vii) preparing training manuals, standard operating procedures, standard practice instructions and policies; (viii) responding to all Regulatory Notices and taking all steps necessary to correct the deficiencies cited therein; (ix) manufacturing; (x) clinical work and bio-equivalency; and (xi) preparation, submission and maintenance of applications for Regulatory Approval (including ANDAs and non-U.S. equivalents). (c) Schein shall establish departments, systems, procedures and practices supported by adequate, qualified and trained personnel at its facilities to cover all aspects of developing and manufacturing pharmaceutical products in compliance with Applicable Law so as to enable it to perform its obligations hereunder, which shall include without limitation the following: (i) current good manufacturing practice, safety and environmental compliance; (ii) product development; (iii) preparation of applications for Regulatory Approval of Products; (iv) quality control and assurance; (v) regulatory affairs and compliance; (vi) qualifying and validating all systems, processes and equipment; (vii) preparing training manuals, standard operating procedures, standard practice instructions and policies; (viii) responding to all Regulatory Notices and taking all steps necessary to correct the deficiencies cited therein; (ix) manufacturing; (x) clinical work and bio-equivalency; and (xi) preparation, submission and maintenance of applications for Regulatory Approval (including ANDA's and non-US equivalents).

Manufacturing Facility. (a) Subject Based on Principia's commitment to purchase Wafers and to pay the Non-Recurring Engineering and Facility Payment and the Monthly Facility Availability Payments, both as defined hereinbelow, as well as other promises contained herein, Bandwidth shall construct, own, operate, and make available, as provided hereinbelow, the Manufacturing Facility on the terms and conditions as set forth herein. b) Principia hereby agrees and acknowledges, that as a material precondition to Bandwidth's ability to complete the Manufacturing Facility, it shall license the Principia Background IP to Bandwidth for use on Principia's behalf, subject to the parties pre-existing commitmentsterms and conditions of Section 6, hereinbelow, and shall provide reasonable consulting services to integrate Principia's technology by Principia's employees or contractors, at Principia's sole expense. c) Bandwidth shall determine, in its sole discretion, the materials, facilities, and support necessary for the manufacture of the Wafers, and shall construct, install, qualify, and provide the same. At the time that the Manufacturing Facility is fully qualified and ready to commence the manufacture of the Wafers (the "Substantial Completion"), it shall include some or all of the following: i) (the "*** Reactors"), each party with the capacity of producing approximately *** Wafers per run; ii) Support Facilities, to include gas cabinets, gas exhaust and scrubbers, and related components; iii) Production Support Equipment, to include blue/green PL system wafer inspection system, gas detection equipment, and related components; iv) Facility Engineering for gas distribution, gas detection, cleanroom controls, electrical system design and UPS installation; *** Represents text omitted pursuant to a request for confidential treatment. The omitted material has been filed separately with the Securities and Exchange Commission. v) Facility Engineering, Start-up and Technical Support for: A) Reactor specification, facility design. B) Installation and start-up. C) Qualification of material and definitization of the Manufacturing Specification and Protocols, which shall dedicate be agreed and reduced to writing by the Parties, in good faith and within a reasonable time after the installation of the *** Reactors (but no more than one hundred twenty (120) days thereafter, and which shall contain the specifications and protocols indicated in EXHIBIT A, attached hereto. Principia shall further assist as much necessary and reasonable, upon Bandwidth's request, with defining the required process specifications and qualifying the equipment as provided in Paragraph 2(b), hereinabove; and vi) Start-up Materials, to include required gas sources and wafers to commission and qualify the Manufacturing Facility. d) The anticipated time frame (the "Construction Timeline") to Substantial Completion of their facilitythe Manufacturing Facility is twelve (12) months, which shall include, but not be limited to, the order process for the *** Reactors, the delivery of the *** Reactors, and the installation and qualification of the *** Reactors with the assistance of Principia. Principia hereby agrees and acknowledges that the Construction Timeline represents Bandwidth's capacity best estimate and that the actual time frame is subject to, and contingent on, timely inputs from various parties beyond Bandwidth's control, including, but not limited to, Principia. Bandwidth makes no representation or warranty as is necessary to carry out the outcome or timing of the Substantial Completion of the Manufacturing Facility except that it will use commercially reasonable efforts to meet the Construction Timeline. Principia agrees and acknowledges that no delay in the Substantial Completion of the facility shall be grounds for suspension of the Facility Availability Payments as provided at Paragraph 4(b), hereinbelow, provided that Bandwidth uses commercially reasonable efforts. e) Title to and ownership of the Manufacturing Facility shall vest solely in Bandwidth. Bandwidth alone shall be responsible for its operation, maintenance, and upkeep so as to meet the obligations set forth herein. Production of Wafers, in the quantity required by Principia and subject to the ordering forecast protocols set forth hereinbelow, shall have priority over other uses of the Manufacturing Facility. Bandwidth shall, in its sole discretion, use the Manufacturing Facility for such other purposes that do not interfere with the requirements of this Agreement. Cheminor and Schein Principia shall notify not place, nor be entitled, in equity or under operation of law, to place, any lien or encumbrance on the other in writing Manufacturing Facility or any of its contents including, but not limited to, pursuant to the Uniform Commercial Code or as pledged collateral for any debt of any pending * redacted kind, nor shall it allow any party to do so on its behalf or on the behalf of any third party. f) In the event that Principia seeks to make any improvement in the design of the Device, or structure of the Wafer that requires changes in the production parameters, or any other change or improvement to the Principia Background IP, Principia shall promptly convey the same to Bandwidth, pursuant to the provisions of Paragraph *** Represents text omitted pursuant to a request for confidential treatment requesttreatment. inspectionThe omitted material has been filed separately with the Securities and Exchange Commission. 6(a), reports and/or legal action by and shall cooperate to re-qualify the FDA or other Regulatory Authority Manufacturing Facility equipment, with the expense thereof to be considered an increase in Bandwidth's cost of manufacture pursuant to Paragraph 4(d), hereinbelow. The Parties agree that such changes will result in the revised product being characterized as "Wafers" subject to this Agreement and each party shall have that the right, if practicable, to have representatives present for such inspection of the other party. Each party shall provide the other with a copy obligations of each FDA Party to this Agreement are not diminished or other Regulatory Authority inspection report (and/or associated notices, correspondence and telephone contact reports) (redacted as to information as to products not covered voided should such changes be instituted by the other party's distribution rights) within three (3) business days of receipt and a copy of their reply prior to submittal to the FDA or other Regulatory Authority for the other party's review and comment thereonPrincipia. (b) Cheminor shall establish departments, systems, procedures and practices supported by adequate, qualified and trained personnel at the Facility to cover all aspects of developing and manufacturing pharmaceutical products in compliance with Applicable Law so as to enable it to perform its obligations hereunder, which shall include without limitation the following: (i) current good manufacturing practice, safety and environmental compliance; (ii) product development; (iii) preparation of applications for Regulatory Approval of Products; (iv) quality control and assurance; (v) regulatory affairs and compliance; (vi) qualifying and validating all systems, processes and equipment; (vii) preparing training manuals, standard operating procedures, standard practice instructions and policies; (viii) responding to all Regulatory Notices and taking all steps necessary to correct the deficiencies cited therein; (ix) manufacturing; (x) clinical work and bio-equivalency; and (xi) preparation, submission and maintenance of applications for Regulatory Approval (including ANDAs and non-U.S. equivalents). (c) Schein shall establish departments, systems, procedures and practices supported by adequate, qualified and trained personnel at its facilities to cover all aspects of developing and manufacturing pharmaceutical products in compliance with Applicable Law so as to enable it to perform its obligations hereunder, which shall include without limitation the following: (i) current good manufacturing practice, safety and environmental compliance; (ii) product development; (iii) preparation of applications for Regulatory Approval of Products; (iv) quality control and assurance; (v) regulatory affairs and compliance; (vi) qualifying and validating all systems, processes and equipment; (vii) preparing training manuals, standard operating procedures, standard practice instructions and policies; (viii) responding to all Regulatory Notices and taking all steps necessary to correct the deficiencies cited therein; (ix) manufacturing; (x) clinical work and bio-equivalency; and (xi) preparation, submission and maintenance of applications for Regulatory Approval (including ANDA's and non-US equivalents).

Manufacturing Facility. (a) Cheminor has designed, constructed and will timely, but no later than December 31, 1998, validate a commercial manufacturing facility in accordance with Applicable Law (excluding the **** ******* production plant) in Hyderabad, India, (the "Facility") to develop and manufacture products in compliance with Applicable Law. Subject to the parties pre-existing commitments, each party shall dedicate as much of their facility's capacity as is necessary to carry out this Agreement. Cheminor and Schein shall notify the other in writing of any pending * redacted pursuant to confidential treatment request. inspection, reports and/or legal action by the FDA or other Regulatory Authority and each party shall have the right, if practicable, to have representatives present for such inspection of the other party. Each party shall provide the other with a copy of each FDA or other Regulatory Authority inspection report (and/or associated notices, correspondence and telephone contact reports) (redacted as to information as to products not covered by the other party's distribution rights) within three (3) business days of receipt and a copy of their reply prior to submittal to the FDA or other Regulatory Authority for the other party's review and comment thereon. (b) Cheminor shall establish departments, systems, procedures and practices supported by adequate, qualified and trained personnel at the Facility to cover all aspects of developing and manufacturing pharmaceutical products in compliance with Applicable Law so as to enable it to perform its obligations hereunder, which shall include without limitation the following: (i) current good manufacturing practice, safety and environmental compliance; (ii) product development; (iii) preparation of applications for Regulatory Approval of Products; (iv) quality control and assurance; (v) regulatory affairs and compliance; (vi) qualifying and validating all systems, processes and equipment; (vii) preparing training manuals, standard operating procedures, standard practice instructions and policies; (viii) responding to all Regulatory Notices and taking all steps necessary to correct the deficiencies cited therein; (ix) manufacturing; (x) clinical work and bio-equivalency; and (xi) preparation, submission and maintenance of applications for Regulatory Approval (including ANDAs and non-U.S. equivalents). (c) Schein shall establish departments, systems, procedures and practices supported by adequate, qualified and trained personnel at its facilities to cover all aspects of developing and manufacturing pharmaceutical products in compliance with Applicable Law so as to enable it to perform its obligations hereunder, which shall include without limitation the following: (i) current good manufacturing practice, safety and environmental compliance; (ii) product development; (iii) preparation of applications for Regulatory Approval of Products; (iv) quality control and assurance; (v) regulatory affairs and compliance; (vi) qualifying and validating all systems, processes and equipment; (vii) preparing training manuals, standard operating procedures, standard practice instructions and policies; (viii) responding to all Regulatory Notices and taking all steps necessary to correct the deficiencies cited therein; (ix) manufacturing; (x) clinical work and bio-equivalency; and (xi) preparation, submission and maintenance of applications for Regulatory Approval (including ANDA's and non-US equivalents).