Amended and Restated 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 Nucryst as S&N’s exclusive supplier of Products in the Territory and Nucryst agrees to supply Products in the Territory exclusively to S&N, and Nucryst undertakes and agrees to sell to S&N, and S&N agrees to purchase from Nucryst, 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 Nucryst. Nucryst 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 Nucryst and S&N, the supply by Nucryst to S&N (and any S&N Affiliate) of a particular Product shall be on the following terms and conditions:
| 2.2.1 | Nucryst agrees to supply to S&N and S&N agrees to purchase exclusively from Nucryst such quantities of such Product as S&N shall request monthly by |
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| 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 Nucryst with a twelve (12) month rolling non-binding forecast of S&N’s estimated requirements (per calendar month during such twelve (12) month period) for Products (the “Rolling Forecast”). Such Rolling Forecast shall be provided to Nucryst 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 Nucryst with an updated twelve (12) month Rolling Forecast for the period November 1, 2001 to October 31, 2002). S&N shall on a monthly basis request a supply of Products from Nucryst by way of written purchase orders. The purchase order for a particular month shall be delivered to Nucryst no later than [***] days preceding the beginning of a 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 Rolling Forecast. Each purchase order shall be binding on S&N and Nucryst, provided, however, that, with respect to a particular month, in the event S&N’s purchase order exceeds [***] of the quantities of each Product last estimated for such month in the applicable Rolling Forecast, Nucryst shall not be obligated to fill the amount of such purchase order in excess of [***] (“Maximum Quantity”) but shall only be required to use reasonable commercial efforts to fill the amount of such purchase order in excess of the requirements last estimated for such month in the applicable Rolling Forecast. Further, notwithstanding the above, under no circumstances shall Nucryst 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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| Rejection Date, as soon as is practicable following S&N becoming aware of the non-conformance of the Product, if such Product did not conform to the requirements of Section 2.2.3 at the time it was delivered to S&N and the nonconformance resulted from a latent defect not capable of being detected by S&N during a reasonable inspection of the Product at the time of delivery to S&N. If Nucryst disagrees with the alleged non-conformity of such Product, and after the Parties have endeavoured to settle such disagreement between themselves, then an independent laboratory, mutually agreed upon in writing by the Parties (acting reasonably), shall analyze samples of the alleged nonconforming Product to determine compliance. Nucryst and S&N shall be bound by the laboratory analysis of such alleged non-conformity of such Product with the requirements of Section 2.2.3. The cost incurred in connection with retaining the independent laboratory shall be borne by S&N if the Product in question is found to conform to the requirements of Section 2.2.3 and by Nucryst if the Product in question is found to not conform to the requirements of Section 2.2.3. To the extent it is determined that any Product supplied by Nucryst to S&N under this Agreement does not conform to the requirements of Section 2.2.3 and subject to Section 5.1 and any third party claim pursuant to Section 9.1(i), Nucryst’s sole obligation and S&N’s sole remedy shall be to have Nucryst replace such non-conforming Product at no additional cost to S&N. | |||
Section 2.3 Delivery; Title; Risk of Loss
Nucryst shall deliver Products to S&N [***], or such other facilities as Nucryst and S&N, by mutual agreement in writing, may from time to time designate.
Each delivery of the Products shall be accompanied by:
| 2.3.1 | a packing list which includes a purchase order reference number, part/lot number and quantities of each Product delivered; |
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| 2.3.2 | for deliveries to the US/Canada, Nucryst shall provide to the Largo QA department an electronic version of the certificate of analysis incorporating a statement of sterility; | ||
Section 2.4 Representations
| 2.4.1 | Nucryst 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 Nucryst’s ability to meet its obligations under this Agreement in relation to such Product. Nucryst 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 (“Governmental Permits”) necessary to allow it to manufacture and deliver 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. | ||
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