Supply Agreement
Category: Supply
ARTICLE 2
MANUFACTURING AND SUPPLY OBLIGATIONS
Section 2.1 Supply of Product
Subject to the terms and conditions of this Agreement, S&N hereby appoints Westaim as S&N’s exclusive supplier of Products in the Territory and Westaim agrees to supply Products in the Territory exclusively to S&N, and Westaim undertakes and agrees to sell to S&N, and S&N agrees to purchase from Westaim, such quantities of Products as are ordered by S&N from time to time. S&N shall order all of its requirements for Products exclusively from Westaim. Westaim shall not sell Products to any Person other than S&N or an Affiliate of S&N without the express written consent of S&N.
Section 2.2 Forecasting; Purchase Orders; QA and QC
Unless otherwise agreed to in writing by Westaim and S&N, the supply by Westaim to S&N of a particular Product shall be on the following terms and conditions:
| 2.2.1 | Westaim agrees to supply to S&N and S&N agrees to purchase exclusively from Westaim such quantities of such Product as S&N shall request monthly by written purchase order, all in accordance with the terms of this Agreement. S&N shall, on a monthly basis during the Term (except during any period in which S&N is exercising its rights under the Manufacturing License in accordance with Article 4), provide Westaim with a twelve (12) month non-binding rolling forecast of S&N’s estimated requirements for the Product. Such twelve (12) month non-binding rolling forecast shall be provided to Westaim no later than five (5) Business Days preceding the beginning of each calendar month and shall cover the twelve (12) month period commencing with the calendar month next following such calendar month (e.g., on or before September 21, 2001, S&N is required to provide Westaim with an updated twelve (12) month rolling non-binding forecast for the period November 1, 2001 to October 31, 2002). S&N shall on a monthly basis request a supply of the Product from Westaim by way of written purchase order. The purchase order for a particular month shall be delivered to Westaim no later than five (5) Business Days preceding the beginning of the particular month. The minimum amount of the Product ordered by S&N for any particular month shall be [***] of the requirements last estimated for such month in the applicable twelve (12) month non-binding rolling forecast. Each purchase order shall be binding on S& N and Westaim, and Westaim shall fill each purchase order of S&N within [***] days from receipt of such purchase order, provided, however, that, with respect to a particular month, in the event S&N’s purchase order exceeds [***] of the requirements last estimated for such month in the applicable twelve (12) month non-binding rolling forecast, Westaim shall not be obligated to fill the amount of such purchase order in excess of [***] but shall only be required to use reasonable commercial efforts to fill the amount of such purchase order in excess of the requirements last |
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| estimated for such month in the applicable twelve (12) month non-binding rolling forecast. Further, notwithstanding the above, but subject to Westaim complying with Section 11.11, under no circumstances shall Westaim be obligated to supply a quantity of Products over any period that exceeds the quantity of Products that can be produced by the Equipment during such period using the S&N Production Capacity; | |||
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| 2.4.1 | Westaim represents and warrants to S&N that each Product will be produced in compliance with all applicable laws, the non-compliance with which would have a material adverse effect on Westaim’s ability to meet its obligations under this Agreement in relation to such Product. Westaim shall at all times relevant throughout the Term own, hold or possess all material licenses, franchises, permits, privileges, immunities, registrations, approvals (including, without limitation, regulatory approvals), authorizations and qualifications (“Government Permits”) necessary to allow it to manufacture and produce the Products. All such Government Permits shall in all material respects be valid, subsisting and in good standing at all relevant times throughout the Term. | ||
Section 2.5 Inspection by S&N
No more frequently than once per calendar year, Westaim shall allow S&N, upon reasonable written notice to Westaim and in any event within fifteen (15) days of such notice being given,
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during normal business hours and with a representative of Westaim present, if Westaim makes a representative available, to visit Westaim’s manufacturing facility and to review the quality control procedures and manufacturing records of Westaim, in order to assure satisfaction of the requirements of this Agreement. Westaim shall respond to all reasonable comments or requests provided by S&N to Westaim with respect to the foregoing.
Section 2.6 Import/Export Licenses
S&N shall be responsible for obtaining, at its expense, any import/export licenses required by any governmental authority with respect to Products from and after its delivery to S&N pursuant to this Agreement.
Section 2.7 Label Content
S&N shall be responsible for ensuring that the label and product insert for any Product sold in any country in the Territory comply with all legal, governmental and regulatory requirements of such country, and, to the extent required for Westaim to fully and effectively meet all of its obligations under this Agreement. S&N shall be responsible for advising Westaim in writing and in a timely manner of all such country specific requirements in connection with the packaging of Products including without limitation label, package insert, language and other such requirements, and Westaim shall be responsible for following all reasonable instructions and advice provided by S&N to Westaim in this regard.
Section 2.8 Validation
All facilities, processes, equipment and analytical methods used for control of critical process steps employed by Westaim in the manufacture and production of Products shall be validated in accordance with the rules, regulations and guidance documents of the Regulatory Authorities and shall otherwise be in material compliance with all applicable laws, rules and regulations.
Section 2.9 Regulatory Matters
Westaim agrees that it will allow all inspections of its facilities required by any Regulatory Authority and will appropriately respond, forthwith upon receipt and in consultation with S&N, to all requests of any Regulatory Authority and shall provide copies of all such responses to S&N forthwith upon receipt.
Section 2.10 Production Records
The manufacture of Product shall be recorded in batch production record format that is in compliance with the requirements of the Regulatory Authorities. With respect to a particular manufacturing run, Westaim will, upon the written request of S&N, provide S&N reasonable access to Westaim’s batch production records with respect to such manufacturing run during normal business hours. Product and plant master files shall also be maintained by Westaim in accordance with the requirements of the Regulatory Authorities and such files shall be available upon reasonable written notice during normal business hours to the Regulatory Authorities or S&N.
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