SUPPLY AGREEMENT AMENDED AND RESTATED BETWEEN ASH STEVENS INC. AND CERUS CORPORATION
Exhibit 10.6
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [ * ], HAS BEEN OMITTED BECAUSE CERUS CORPORATION HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CERUS CORPORATION IF PUBLICLY DISCLOSED.
AMENDED AND RESTATED
BETWEEN
ASH ▇▇▇▇▇▇▇ INC.
AND
CERUS CORPORATION
TABLE OF CONTENTS
SEC. PAGE
1. PURCHASES AND DELIVERY 2
2. PRODUCT FORECAST; RAW MATERIALS; INVENTORY; MAINTENANCE FEES 3
3. STABILITY STUDIES; REFERENCE STANDARDS; OTHER SERVICES 4
4. TRANSFER OF OWNERSHIP; SHIPMENT OF PRODUCTS 4
5. TERMINATION 5
6. GUARANTEE 5
7. WARRANTIES AND INDEMNIFICATIONS 5
8. CONFIDENTIAL INFORMATION 7
9. INTELLECTUAL PROPERTY 8
10. COMPLIANCE WITH LAW 8
11. OTHER PROVISIONS 9
TABLE OF EXHIBITS
CROSS
REFERENCE EXHIBIT PAGE
SUMMARY A QUALITY AGREEMENT A-1
SUMMARY B SPECIFICATIONS B-1
SUMMARY C PRICING C-1
AMENDED AND RESTATED SUPPLY AGREEMENT
This Amended and Restated Supply Agreement (the “Supply Agreement”) is effective on the date of the last signature hereto (“Effective Date”), by and between ▇▇▇ ▇▇▇▇▇▇▇ INC., a Michigan corporation with its principal place of business at ▇▇▇▇ ▇▇▇▇ ▇. ▇▇▇▇▇ ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇ (“▇▇▇ ▇▇▇▇▇▇▇”); and CERUS CORPORATION, a Delaware corporation with its principal place of business at ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ (“Cerus”). ▇▇▇ ▇▇▇▇▇▇▇ and ▇▇▇▇▇ are each individually referred to in this Supply Agreement as a “Party” and, collectively, as the “Parties”.
This Supply Agreement amends and restates the Supply Agreement entered into between ▇▇▇ ▇▇▇▇▇▇▇ and ▇▇▇▇▇, effective November 14, 2002.
▇▇▇ ▇▇▇▇▇▇▇ agrees to manufacture Cerus proprietary S-59 compound (also known as Amotosalen and referred to in this Supply Agreement as “Product” or “Products”) in accordance with the terms and conditions of the Quality Agreement entered concurrently with this Supply Agreement and incorporated by reference herein in the attached Exhibit A (the “Quality Agreement”), and Product specifications set forth in Exhibit B attached hereto (the “Specifications”). Products will be manufactured and stored at Ash ▇▇▇▇▇▇▇ facilities located at, ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇. Cerus desires to purchase Products for use or for inclusion in systems for resale by Cerus and/or its affiliates, distributors and licensees (the “Systems”).
▇▇▇ ▇▇▇▇▇▇▇ acknowledges that all intellectual property relating to the Products is the property of ▇▇▇▇▇.
Prices of the Products are:
See EXHIBIT C.
Payment with respect to such Product shall be due [ * ] after receipt by ▇▇▇▇▇ of the invoice with respect thereto; provided that if Cerus rejects such Product pursuant to Section 7, then payment shall be due within [ * ] after receipt by ▇▇▇▇▇ of both the replacement Product and Certificate of Analysis therefor (assumes pre-delivery approval of Product sample). Cerus will provide information on shipping address at the time of purchase. The “bill to” address shall be Cerus Corporation, ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇., ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, unless otherwise noted at the time of issuance of an Order (as further defined below in Section 1 of this Supply Agreement).
This Supply Agreement will have an initial term (the “Initial Term”) which will run from the Effective Date until December 31st, 2015, unless earlier terminated by either Party pursuant to the provisions of this Supply Agreement.
Either Party may terminate this Supply Agreement without cause at the end of the Initial Term by providing written notice of termination at least one (1) year in advance of the effective termination date for a notice given to ▇▇▇ ▇▇▇▇▇▇▇, and two (2) years in advance of the effective termination date for a notice given to Cerus (each a “Notice of Termination”). The Initial Term of the Supply Agreement shall be automatically extended for successive extension periods of two (2) years each (the “Automatic Extension Period(s)”), unless either Party provides the above-described Notice of Termination before the termination date of the Initial Term or the then-effective Automatic Extension Period, or unless the Supply Agreement is otherwise terminated pursuant to the provisions of this Supply Agreement. The Initial Term and Automatic Extension Periods are collectively referred to herein as the “Term.”
Upon termination of this Supply Agreement, the provisions of Sections 6-10 of the Terms and Conditions shall remain in effect in accordance with their terms.
TERMS AND CONDITIONS
1. PURCHASES AND DELIVERY
(a) Subject to paragraph (b), ▇▇▇ ▇▇▇▇▇▇▇ shall sell Products to Cerus, and Cerus shall purchase from Ash ▇▇▇▇▇▇▇ Products for use or resale at Cerus’ discretion anywhere in the world (also referred to hereinafter as “Territory”). Cerus will order Products from ▇▇▇ ▇▇▇▇▇▇▇ by placing purchase orders during the Term of this
Supply Agreement (“Orders”). ▇▇▇ ▇▇▇▇▇▇▇ shall acknowledge promptly each Cerus Order in writing and confirm delivery dates to destinations specified by Cerus. As time is of the essence in meeting Cerus’ requirements for Product, ▇▇▇ ▇▇▇▇▇▇▇ shall ship Product in time to comply with ▇▇▇▇▇’ required delivery dates as specified in the Purchase Order, provided that the earliest such date provides a lead-time of at least [ * ] to produce the Products after receipt of starting materials by ▇▇▇ ▇▇▇▇▇▇▇. ▇▇▇ ▇▇▇▇▇▇▇ is required to maintain a supply of starting materials, as provided in Section 2, below. All sales of Products shall be subject to the terms and conditions of this Supply Agreement and, to the extent they specify quantities, destinations and delivery dates, to Cerus Orders. This Supply Agreement shall not be subject to the terms, conditions or provisions of any confirmation or business form of ▇▇▇ ▇▇▇▇▇▇▇ or, except as provided in the immediately preceding sentence, Cerus Orders. ▇▇▇ ▇▇▇▇▇▇▇ shall not be liable for failure or delay in filling Cerus Orders because of any cause such as strikes, wars and Acts of God beyond the control of and occurring without the fault of ▇▇▇ ▇▇▇▇▇▇▇; provided, however, that ▇▇▇ ▇▇▇▇▇▇▇ shall notify Cerus promptly of anticipated delays and shall use all reasonable efforts to fill such Orders as soon as possible. Without limiting its other available remedies, Cerus may cancel any Order, in whole or in part, which is delayed more than [ * ].
(b) Nothing in this Supply Agreement will obligate Cerus to commence manufacture of Systems incorporating Products or continue manufacture once production has commenced. If Cerus discontinues manufacture of Systems incorporating the Products, it shall be required to purchase and pay ▇▇▇ ▇▇▇▇▇▇▇ for orders that have been placed and for the fulfillment of which ▇▇▇ ▇▇▇▇▇▇▇ has made substantial preparations at the agreed pricing, prorated to the extent of completion of such orders at the time of discontinuation.
2. PRODUCT FORECAST; RAW MATERIALS; INVENTORY; MAINTENANCE FEES
(a) Forecast. By [ * ] of each calendar year, Cerus shall provide ▇▇▇ ▇▇▇▇▇▇▇ with an annual delivery forecast estimating the quantity of Compound Cerus anticipates that it will purchase from ▇▇▇ ▇▇▇▇▇▇▇ for such calendar year (the “Annual Forecast”). At such time Products are being ordered on [ * ] basis or more than [ * ] are being produced per year, Cerus shall provide ▇▇▇ ▇▇▇▇▇▇▇ with a [ * ] rolling, delivery forecast estimating the quantity of Compound Cerus anticipates that it will purchase from ▇▇▇ ▇▇▇▇▇▇▇ in the periods specified (the “Rolling Forecast”). Cerus shall update the Rolling Forecast every [ * ]; and inform ▇▇▇ ▇▇▇▇▇▇▇ as soon as possible if Cerus reasonably expects that Orders for Compound would vary significantly (more than [ * ]) from the Rolling Forecast. In any event, however, Cerus shall place firm orders for the quantities shown in the most recent [ * ] Rolling Forecast.
(b) Changes. Cerus will place purchase orders to ▇▇▇ ▇▇▇▇▇▇▇ for the manufacture of Product. If ▇▇▇▇▇ subsequently cancels or modifies a purchase order for any reason, Cerus shall be required to pay ▇▇▇ ▇▇▇▇▇▇▇ a pro-rated amount based on the extent of completion of the order at the time of the cancellation or modification. Upon receipt of such notification by ▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇▇ shall promptly provide Cerus with an invoice outlining the expenses incurred up to that date for the manufacture of Product. Payment terms and lead times are respectively described in the Preamble and paragraph (a) of Section 1 of this Supply Agreement.
(c) Starting Materials. ▇▇▇ ▇▇▇▇▇▇▇ will use its best efforts at all times to maintain [ * ] supply of starting materials for the Product. ▇▇▇ ▇▇▇▇▇▇▇ will provide Cerus with an itemization of the quantity of such materials maintained upon request and will promptly notify Cerus in the event of any difficulty, or anticipated difficulty, in obtaining any starting material. In the event of any termination of this Supply Agreement by ▇▇▇▇▇, other than for breach by ▇▇▇ ▇▇▇▇▇▇▇, Cerus will be required to purchase at [ * ] cost any unexpired starting materials that are dedicated to the Products up to a maximum of [ * ]. Cerus shall also have the right to purchase any starting materials at [ * ] cost in the event of termination of this Supply Agreement for any reason other than breach by Cerus of this Supply Agreement.
(d) Storage. ▇▇▇ ▇▇▇▇▇▇▇ will store up to [ * ] of finished Product inventory without any storage charge or carrying charge to Cerus. Upon request, ▇▇▇ ▇▇▇▇▇▇▇ will provide Cerus with an update of the quantity of such inventory maintained. If Cerus requires storage of greater quantities, ▇▇▇ ▇▇▇▇▇▇▇ may charge Cerus a reasonable storage charge. Such inventory will be stored at Ash ▇▇▇▇▇▇▇’ Riverview Michigan GMP warehouse; this facility must be suited for storage of the Product and shall be subject to Cerus’ inspection and approval. ▇▇▇ ▇▇▇▇▇▇▇ must notify Cerus of any changes in storage location or storage conditions for the Product. ▇▇▇ ▇▇▇▇▇▇▇ will provide to Cerus upon the Effective Date of this Supply Agreement, and each anniversary date thereof, a certificate of all-risk
insurance in the amount of at least [ * ], naming Cerus as an additional insured as its interests may appear. ▇▇▇ ▇▇▇▇▇▇▇ shall maintain an inventory of Product primary reference standard and provide same to Cerus’ contractors upon request.
(e) Security Interest. ▇▇▇ ▇▇▇▇▇▇▇ hereby grants ▇▇▇▇▇ a security interest in all finished Product inventory and work-in-process and in all starting materials and other property used in the production of Products to secure the performance of ▇▇▇ ▇▇▇▇▇▇▇’ obligations under this Supply Agreement. ▇▇▇ ▇▇▇▇▇▇▇ agrees to execute appropriate UCC financing statements and other documents necessary or appropriate to evidence or perfect this security interest.
(f) Samples At Cerus’ request, ▇▇▇ ▇▇▇▇▇▇▇ will pre-ship a sample of Product from each lot to Cerus (or at Cerus’ direction, to Cerus’ designee) upon completion of that lot. Each sample will be accompanied by a Certificate of Analysis for the sample.
(g) Maintenance Fee. If ▇▇▇▇▇ has ordered, by December 31 of any calendar year, less than [ * ] of product for such calendar year, Cerus will pay ▇▇▇ ▇▇▇▇▇▇▇, a maintenance fee, as follows:
If the Amount Ordered is: Maintenance Fee
Less than [ * ] but more than [ * ] [ * ]
Less than [ * ] but more than [ * ] [ * ]
Less than [ * ] but more than [ * ] [ * ]
Less than [ * ] but more than [ * ] [ * ]
Less than [ * ] [ * ]
The maintenance fee is in consideration of ▇▇▇ ▇▇▇▇▇▇▇’ continuous support for the Product.
3. STABILITY STUDIES; REFERENCE STANDARDS; OTHER SERVICES
▇▇▇ ▇▇▇▇▇▇▇ agrees to conduct stability studies on finished Products, [ * ] in accordance with a protocol approved by ▇▇▇▇▇. ▇▇▇ ▇▇▇▇▇▇▇ agrees to qualify and maintain an inventory of Product primary reference standard and to provide same to ▇▇▇▇▇’ contractors upon request. From time to time, ▇▇▇▇▇ may make requests for other services that are beyond the scope of routine manufacture, including, but not limited to, Product change (as further detailed in the Quality Agreement). For each of the above, the scope of work, pricing, and terms, will be outlined in an amendment to this contract or in a work order, each deemed to be incorporated into this Supply Agreement and governed by its terms and conditions. For avoidance of doubt, a “work order” shall mean a written, signed order for the performance by ▇▇▇ ▇▇▇▇▇▇▇ of mutually-agreed services.
4. TRANSFER OF OWNERSHIP; SHIPMENT OF PRODUCTS
Title and ownership to Products shall pass to Cerus at the time of their release as finished Products by ▇▇▇ ▇▇▇▇▇▇▇, whether or not such Products are being immediately shipped to Cerus or further stored as inventory by ▇▇▇ ▇▇▇▇▇▇▇, pursuant to paragraphs (c) and/or (d) of Section 2 of this Supply Agreement. ▇▇▇ ▇▇▇▇▇▇▇ shall ship the Products to destinations specified by Cerus by mutually agreed upon carriers. Unless otherwise agreed to in writing, ▇▇▇▇▇ shall pay all normal freight charges. ▇▇▇ ▇▇▇▇▇▇▇ shall include a packing list in each shipment of the Products providing the following information: (i) Cerus Purchase Order No.; (ii) Cerus Product Code; (iii) Quantity; (iv) ▇▇▇ ▇▇▇▇▇▇▇ Lot Number and (v) Certificate of Analysis. ▇▇▇ ▇▇▇▇▇▇▇ shall also fax a copy of each packing list to the destination and to Cerus (to the address specified by Cerus, which may be different from the destination) for each shipment at the time of shipment. ▇▇▇ ▇▇▇▇▇▇▇ will also include a material safety data sheet (MSDS) in each shipment. Detailed requirements and procedures relating to packaging and shipment of Product should be included in the Master Batch Records (as further defined in the Quality Agreement) collected and maintained by ▇▇▇ ▇▇▇▇▇▇▇ with respect to the Product.
5. TERMINATION
Either Cerus or ▇▇▇ ▇▇▇▇▇▇▇ may terminate this Supply Agreement for any material breach by the other Party [ * ] after written notice containing details of the breach if the breach remains uncured at the end of the notice period. Either Party may terminate this Supply Agreement effective immediately with written notice if the other Party shall
file for bankruptcy, shall be adjudicated bankrupt, shall take advantage of applicable insolvency laws, shall make an assignment for the benefit of creditors, shall be dissolved or shall have a receiver appointed for its property. Cerus shall have the right to terminate this Supply Agreement immediately if Ash ▇▇▇▇▇▇▇ breaches its warranties contained in Section 7 or its guarantee contained in Section 6 under this Supply Agreement. If this Supply Agreement is terminated due to breach by ▇▇▇ ▇▇▇▇▇▇▇, such termination will not relieve ▇▇▇ ▇▇▇▇▇▇▇ of its obligation to deliver Products ordered by Cerus prior to receipt of written notice of such termination, except to the extent Cerus cancels such Orders.
6. GUARANTEE
All Products sold to Cerus are hereby guaranteed by ▇▇▇ ▇▇▇▇▇▇▇, as of the date of their receipt by Cerus or its designee , to meet the Specifications and requirements specified by Cerus under this Supply Agreement, and, to be, on such date, not adulterated or misbranded within the meaning of the United States Federal Food, Drug and Cosmetic Act (the “Act”), or amendments thereto, and any similar federal, state or local laws or regulations, and not an article which may not, under the provisions of the Act, be introduced into interstate commerce.
7. WARRANTIES AND INDEMNIFICATIONS
(a) ▇▇▇ ▇▇▇▇▇▇▇ WARRANTS THAT IT POSSESSES GOOD AND MARKETABLE TITLE TO THE PRODUCTS SOLD TO CERUS UNDER THIS SUPPLY AGREEMENT AND THAT SUCH PRODUCTS ARE FREE FROM DEFECTS IN MANUFACTURE, WORKMANSHIP AND MATERIALS, AND ARE IN COMPLIANCE WITH THE SPECIFICATIONS REFERENCED IN EXHIBIT B. ALL IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY ARE EXPRESSLY DISCLAIMED. ▇▇▇ ▇▇▇▇▇▇▇ MAKES NO REPRESENTATION OR WARRANTY WITH REGARD TO THE SAFETY OR EFFICACY OF THE PRODUCT OR QUALIFICATION OF THE PRODUCT AS A PHARMACEUTICAL COMPOUND OR OF NON-INFRINGEMENT.
(b) ▇▇▇▇▇ will indemnify and hold harmless ▇▇▇ ▇▇▇▇▇▇▇ and ▇▇▇ ▇▇▇▇▇▇▇’ suppliers against any and all claims, actions, causes of action, liabilities, losses, costs, damages or expenses (including reasonable attorneys’ fees) to the extent arising out of or in consequence of (1) Cerus’ negligence (including that of its suppliers) and/or misconduct or (2) [ * ], provided that Cerus shall not be obligated to indemnify ▇▇▇ ▇▇▇▇▇▇▇ from any liability to the extent caused by ▇▇▇ ▇▇▇▇▇▇▇ or its suppliers’ negligence or misconduct.
(c) ▇▇▇ ▇▇▇▇▇▇▇ will indemnify and hold harmless Cerus against any and all claims, actions, causes of action, liabilities, losses, costs, damages or expenses (including reasonable attorneys’ fees) to the extent arising out of or in consequence of (1) ▇▇▇ ▇▇▇▇▇▇▇’ negligence (including that of its suppliers) and/or misconduct or (2) [ * ], provided that ▇▇▇ ▇▇▇▇▇▇▇ shall not be obligated to indemnify Cerus from any liability to the extent caused by Cerus’ negligence or misconduct.
(d) Each Party agrees to give the others prompt written notice of any claims made, including any claims asserted or made by any governmental authority, for which the other might be liable under the foregoing indemnification, together with the opportunity to defend, negotiate and settle such claims. Each Party will cooperate fully with the others in defending or otherwise resolving any such action, and each indemnified Party in any such action may at its option and expense be represented in such action. Neither Cerus nor ▇▇▇ ▇▇▇▇▇▇▇ shall be responsible or bound by any compromise made by the other Party without their prior written consent, which shall not be unreasonably withheld.
EXCEPT AS OTHERWISE SET FORTH IN THIS SECTION 7 OF THIS SUPPLY AGREEMENT, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE OR PERFORMANCE OF THE PRODUCTS.
(e) ▇▇▇ ▇▇▇▇▇▇▇ shall obtain and keep in force during the Term of this Supply Agreement comprehensive liability insurance covering each occurrence of bodily injury (including death) and property damage in an amount of not less than [ * ], including:
(i) Blanket Contractual Liability; and
(ii) Blanket Broad Form Property Damage
The insurance policy shall be endorsed to name ▇▇▇▇▇ as additional insured and to provide for written notification to Cerus by the insurer not less than [ * ] prior to cancellation, expiration or modification. A certificate of insurance evidencing compliance with this Section and referencing this Supply Agreement shall be furnished to Cerus by ▇▇▇ ▇▇▇▇▇▇▇ within [ * ] of this Supply Agreement’s Effective Date and on each anniversary date thereof.
8. CONFIDENTIAL INFORMATION
8.1. General. Each Party shall maintain in confidence all Confidential Information of the other Party, as defined in Section 8.2, and shall not use, disclose or grant use of such Confidential Information, except as expressly authorized by this Supply Agreement. A Party may disclose Confidential Information of the other Party to employees requiring access thereto for the purposes of this Supply Agreement, provided, however, that prior to making any such disclosures, each such employee shall be apprised of the duty and obligation to maintain such Confidential Information in confidence and not to use such information for any purpose other than in accordance with the terms and conditions of this Supply Agreement. Each Party agrees to take all steps necessary to ensure that the Confidential Information received shall be maintained in confidence including such steps as it takes to prevent the disclosure of its own proprietary and confidential information of like character. Both Parties agree that this Supply Agreement shall be binding upon its affiliates, and upon the employees of such Party and its affiliates. Each Party shall take all steps necessary to ensure that its affiliates and employees will comply with the terms and conditions of this Supply Agreement.
8.2 Definitions. As used in this Supply Agreement, the term “Confidential Information” shall mean any information disclosed by either Party to the other Party in the performance of this Supply Agreement, whether in oral, written, graphic or electronic form. For the purposes of this Supply Agreement, “▇▇▇ ▇▇▇▇▇▇▇ Confidential Information” shall mean any and all standard operating procedures relating to the business of ▇▇▇ ▇▇▇▇▇▇▇. “Cerus Confidential Information” shall mean any and all data and information relating to, contained or embodied in, the INTERCEPT Blood System; S-59 (amotosalen); information regarding plans for research development, present and future products, marketing and selling, business plans, budgets and unpublished financial statements, licenses, prices and costs, suppliers and customers.
8.3 Exclusions. The term “Confidential Information” shall not be deemed to include information which: (i) is now, or hereafter becomes, through no act or failure to act on the part of the recipient Party, generally known or available; (ii) is known by the recipient Party at the time of receiving such information as evidenced by its records; (iii) is hereafter furnished to the recipient Party by a third party, as a matter of right and without restriction or disclosure; or (iv) is the subject or a written permission to disclose provided by the other Party.
8.4 Authorized Disclosures. Notwithstanding any other provision of this Supply Agreement, disclosure of Confidential Information shall not be precluded if such disclosure:
(a) is in response to a valid order of a court or other governmental body of the United States or any political subdivision thereof; provided, however, that the Party shall first have given notice to the other Party and shall have made a reasonable effort to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued;
(b) is otherwise required by law or regulation; provided that the disclosing Party shall first have given notice to the other and shall have made a reasonable effort to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the law or regulation required; or
(c) is otherwise necessary to establish rights or enforce obligations under this Supply Agreement, but only to the extent that any such disclosure is necessary.
9. INTELLECTUAL PROPERTY
(a) ▇▇▇ ▇▇▇▇▇▇▇ shall make prompt written disclosure to Cerus and hereby assigns to Cerus all right, title and interest in and to any inventions, methods, processes, developments, improvements, know-how or trade secrets which ▇▇▇ ▇▇▇▇▇▇▇, its employees or agents may solely or jointly conceive or reduce to practice in the course of or as a result of any development or change control relating to the commercialization of the Product (collectively the
“Intellectual Property”). Without limiting the generality of the preceding sentence, it is understood and agreed by the Parties that any and all standard operating procedures relating to the business of ▇▇▇ ▇▇▇▇▇▇▇ that are not specific to the INTERCEPT Blood System or Cerus shall be owned by ▇▇▇ ▇▇▇▇▇▇▇; and, that any and all data and information, relating to, contained or embodied in, the INTERCEPT Blood System and S-59 (amotosalen) shall be owned by ▇▇▇▇▇.
(b) ▇▇▇ ▇▇▇▇▇▇▇ will assist ▇▇▇▇▇ in obtaining and enforcing United States and foreign proprietary rights relating to any and all Intellectual Property. To that end ▇▇▇ ▇▇▇▇▇▇▇ will execute, verify and deliver such documents and perform such other acts (including appearing as a witness) as ▇▇▇▇▇ may reasonably request for use in applying for, obtaining, perfecting, evidencing, sustaining and enforcing such proprietary rights and the assignment thereof. In addition, ▇▇▇ ▇▇▇▇▇▇▇ will execute, verify and deliver assignments of such proprietary rights to ▇▇▇▇▇. Cerus shall compensate ▇▇▇ ▇▇▇▇▇▇▇ at a reasonable rate for the time actually spent by ▇▇▇ ▇▇▇▇▇▇▇ at ▇▇▇▇▇’ request on such assistance.
(c) In the event ▇▇▇▇▇ is unable for any reason, after reasonable effort, to secure ▇▇▇ ▇▇▇▇▇▇▇’ signature on any document needed in connection with the actions specified in Section 9(b), ▇▇▇ ▇▇▇▇▇▇▇ hereby irrevocably designates and appoints ▇▇▇▇▇ and its duly authorized officers and agents as its agent and attorney-in-fact, to act for and in its behalf to execute, verify and file any such documents and to do all other lawfully permitted acts to further the purposes of Section 9(b) with the same legal force and effect as if executed by Ash ▇▇▇▇▇▇▇.
(d) ▇▇▇ ▇▇▇▇▇▇▇ agrees and acknowledges that it shall acquire no rights of any kind whatsoever with respect to any patents, copyrights, trademarks, trade secrets or other proprietary rights of ▇▇▇▇▇ as a result of ▇▇▇ ▇▇▇▇▇▇▇’ performance under this Supply Agreement or otherwise.
10. COMPLIANCE WITH LAW
The Parties represent that they are and will remain in compliance with all applicable laws, regulations and orders relating to the manufacture of the Products.
11. OTHER PROVISIONS
(a) This Supply Agreement, Addendums, amendments and work orders thereto, together with the provisions of the Quality Agreement that are incorporated by reference herein, contain the entire agreement between the Parties relating to the subject matter of this Supply Agreement and any other understandings between the Parties relating to the subject matter of this Supply Agreement are superseded by this Supply Agreement. None of the terms of this Supply Agreement shall be deemed to be waived or amended by either Party unless such a waiver or amendment specifically references this Supply Agreement and is in writing signed by the Party to be bound.
(b) All notices and demands required or permitted to be given or made pursuant to this Supply Agreement shall be in writing and effective when personally given or when placed in an envelope and deposited in the United States mail postage prepaid, addressed as follows:
If to Cerus: If to ▇▇▇ ▇▇▇▇▇▇▇:
Cerus Corporation Ash ▇▇▇▇▇▇▇ Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ 861 ▇▇▇▇ ▇. Lodge Freeway
Concord, CA 94520 Detroit, MI 48202-3398
Attention: Vice President, Legal Affairs Attention: President
or to such other address as to which either Party may notify the other.
(c) This Supply Agreement shall be binding upon and inure to the benefit of the Parties, their successors and assigns. This Supply Agreement shall be assignable: (i) by ▇▇▇▇▇, in whole or in part, without the consent of ▇▇▇ ▇▇▇▇▇▇▇ to any Affiliate of Cerus; (ii) by either Party with the written consent of the other; or (iii) by either Party without the consent of the other to the purchaser of substantially all the assets of its business to which this Supply Agreement relates. Any attempted assignment that does not comply with the terms of this Section shall be void.
(d) This Supply Agreement is deemed to have been executed in and shall be governed by and construed according to the laws of the State of Michigan, applicable to contracts made and to be performed in that State. If particular portions of this Supply Agreement are ruled unenforceable, such portions shall be deleted and all other terms and conditions of this Supply Agreement shall remain in full force and effect.
(e) Unless expressly approved in advance and in writing by ▇▇▇▇▇, respectively, ▇▇▇ ▇▇▇▇▇▇▇ shall make no reference to Cerus or to the subject matter of this Supply Agreement in any publicity, advertising or other public statements or documents either during or after the Term of this Supply Agreement. This shall not apply to such reference or disclosure required by law or governmental agency. Notwithstanding the foregoing, ▇▇▇ ▇▇▇▇▇▇▇ shall be authorized to publicly disclose that it is a contract manufacturer to Cerus for the synthesis of the Product.
(f) The relationship of the Parties under this Supply Agreement shall be and at all times remains one of independent contractors. No Party is an employee, agent or legal representative of the other Party or shall have any authority to assume or create obligations on the other Party’s behalf.
(g) Cerus or ▇▇▇▇▇’ designee (with ▇▇▇▇▇’ authorization) may audit upon reasonable notice ▇▇▇ ▇▇▇▇▇▇▇ manufacturing (excluding confidential cost information) and quality books and records once per calendar year for the purpose of confirming compliance with the terms of this Supply Agreement.
(h) ▇▇▇ ▇▇▇▇▇▇▇ shall manufacture and supply Products exclusively for Cerus and Cerus’ designees pursuant to this Supply Agreement. ▇▇▇ ▇▇▇▇▇▇▇ shall not during the Term and for a period of [ * ] following the expiration of the Term or termination pursuant to an uncured material breach by ▇▇▇ ▇▇▇▇▇▇▇ of this Supply Agreement, manufacture or supply Products or substantially equivalent products to any other person or entity anywhere in the world without Cerus’ express written permission.
IN WITNESS WHEREOF, authorized representatives of the parties have executed this Supply Agreement.
ASH ▇▇▇▇▇▇▇ INC. CERUS CORPORATION
By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇ By: /s/ ▇▇▇▇▇ ▇▇▇▇▇
Name: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇ Name: ▇▇▇▇▇ ▇▇▇▇▇
Title: President and CEO Title: VP, Finance and Chief Accounting Officer
Date: 23 August 2011 Date: 1 September 2011
EXHIBITS A-C ATTACHED HERETO ARE PART OF THIS SUPPLY AGREEMENT
EXHIBIT A
QUALITY AGREEMENT
{10 pages omitted}
EXHIBIT B
PRODUCT SPECIFICATIONS
[ * ]
{5 pages omitted}
EXHIBIT C
PRODUCT PRICING OF S-59 (AS OF 2011)
[ * ]
{1 page omitted}