EX-10 7 filename7.htm EXECUTION COPY SUPPLY UMBRELLA AGREEMENT
Exhibit 10.7
EXECUTION COPY
This Supply Umbrella Agreement (this “Umbrella Agreement”), is made as of this 1st day of December 2004 (the “Effective Date”), by and between ALBA BIOSCIENCE (“Alba Bioscience”), a division of the SCOTTISH NATIONAL BLOOD TRANSFUSION SERVICE (hereinafter referred to as “SNBTS”) acting on behalf of THE COMMON SERVICES AGENCY constituted pursuant to the National Health Service (Scotland) Act 1978 (as amended) and having its principle place of business at Xxxx Xxxxxx, 0 Xxxxx Xxxx Xxxxxxxx, Xxxxxxxxx, XX00 0XX, and ORTHO-CLINICAL DIAGNOSTICS INC., a corporation of the State of New York, having a business office at 0000 XX Xxxxxxx 000 Xxxxx, Xxxxxxx, XX 00000 (hereinafter referred to as “OCD”).
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“Affiliates” of a party shall mean any entity that directly or indirectly controls, is controlled by or is under common control with such party. “Control” (and, with correlative meanings, the terms “controlled by” and “under common control with”) means, in the case of a corporation, the ownership of more than fifty percent (50%) of the outstanding voting securities thereof or, in the case of any other type of entity, an interest that results in the ability to direct or cause the direction of the management and policies of such party or the power to appoint more than fifty percent (50%) of the members of the governing body of the party, or if not meeting the preceding requirement, any company owned or controlled by or owning or controlling a party at the maximum control or ownership right permitted in the country where such party exists.
“Applicable Legal Requirements” shall mean any federal, state, local, municipal, foreign, international, multinational, or other administrative order, decree, constitution, law, ordinance, principle of common low, statute, or treaty applicable to any Product.
“Calendar Year” shall mean each twelve (12) month period commencing January 1 and ending with December 31.
“Certified Supplier” shall mean a supplier that has been assessed for quality, business, technical, environmental, health and safety considerations and subsequently approved by OCD.
“Confidential Information” shall mean (i) any proprietary or confidential information or other material in a tangible form that is marked as “confidential” at the time it is delivered to the receiving party or (ii) proprietary or confidential information disclosed orally that is identified as confidential or proprietary when disclosed and such disclosure of confidential information is confirmed in writing within thirty (30) days by the disclosing party.
“Delivered Duty Unpaid” or “DDU”, per Incoterms 2000, shall mean that the seller delivers the goods to the buyer, not cleared for import, and not unloaded from any arriving means of transport at the named place of destination. The seller must bear the costs and risks involved in bringing the goods thereto, other than, where applicable, any Duty for import in the country of destination. Such Duty must be borne by the buyer as well as any costs and risks caused by the buyer’s failure to clear the goods for import in time.
“Duty”, per Incoterms 2000, shall mean the responsibility for and the risks of the carrying out of customs formalities, and the payment of formalities, customs duties, taxes and other charges for import in the country of destination.
“FDA” shall mean the United States Food and Drug Administration or any successor entity (CDRH, CBER).
“First Commercial Sale” shall mean the first sale of a commercial lot of a Product in any country within the Territory, by OCD or any of its Affiliates to a Third Party.
“Incoterms 2000” shall mean the standard trade definitions most commonly used in international agreements, which were devised and published by the International Chamber of Commerce on January 1, 2000.
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“Know-How” shall mean any proprietary information, as may be modified from time to time, including, without limitation, any trade secret, that is useful in any aspect of the development, use, manufacture or sale of Products and is not publicly known, disclosed or published, including, without limitation, all pre-clinical, clinical, chemical, biochemical analytical, manufacturing, process, formulation and scientific information, whether or not capable of precise separate description but that alone or when accumulated give to the one acquiring it an ability to study, use, test, produce, formulate or distribute Products which one otherwise would not have known to study, use, test, produce, formulate or distribute in the same way.
“Patent” shall mean any claim in a patent or patent application or that is entitled to the priority of a patent or patent application.
“Products” shall mean those Products, collectively, which are manufactured by SNBTS pursuant to this Umbrella Agreement and each applicable Product Attachment.
“Product Attachment” shall mean, with respect to an individual Product, the exhibit that shall be completed and attached hereto by the mutual agreement of the parties.
“Product Requirements” shall mean written specifications for each Product as set forth in the Product Attachment including, but not limited to, the components, quality and performance specifications for such Products.
“Regulations” shall mean all current regulatory requirements such as ISO 9001, ISO 13485, EN 46001, EU Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices, and the current United States Food and Drug Administration Quality System Regulations, and any amendments thereof.
“Services” shall mean product development, contract manufacturing, Original Equipment Manufacturer (“OEM”), field trial and evaluation of the Products.
“Third Party” shall mean a party other than OCD, SNBTS or their Affiliates.
ARTICLE 2.0—SUPPLY OF PRODUCTS
Section 2.2. Exclusivity. As stated in the specific Product Attachment.
Section 2.3. Territory. As stated in the specific Product Attachment.
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Section 2.5. Labeling – SNBTS Trade Dress. For Products to be distributed or sold under SNBTS trade dress, unless otherwise stated in a specific Product Attachment, the label and package insert copy for each Product (if applicable) shall: (a) conform to SNBTS’ labeling specifications, and (b) comply with all Applicable Legal Requirements and Regulations.
ARTICLE 3.0—ADDITIONAL PRODUCT REQUEST
OCD may, in its sole discretion and from time to time, request SNBTS to supply a Product in accordance with the terms of this Umbrella Agreement. Following such request, the parties shall negotiate and agree upon the terms of a Product Attachment for such Product, which shall be attached hereto and made part of this Umbrella Agreement.
ARTICLE 4.0—RESPONSIBILITIES OF SNBTS
Section 4.1. Manufacturing. SNBTS agrees to maintain sufficient manufacturing capacity to meet the Product Forecasts as defined in Section 6.1 (Forecasts) provided by OCD and as may be defined in the specific Product Attachment. In addition, SNBTS will meet product performance and quality specifications set forth in any Product Attachment.
Section 4.2. Certificates of Analysis / Final Test Data. SNBTS agrees to provide OCD with a certificate of analysis and final test data for each shipment of Products, as required by OCD, in a format specified by OCD, and in accordance with the Quality System Agreement. In addition, if human-sourced material is used to produce any Product, SNBTS agrees to include a statement in the certificate of analysis of such Product indicating that the following analytes have been tested for and are not detected in the Products: syphilis, anti-HCV, anti-HIV-l/HIV-2, HIV antigen and HBsAg.
Section 4.3. Skill and Care. SNBTS shall use all reasonable skill and care in the provision of the Services consistent with the standards of practice within the industry.
Section 4.4. On-Going Stability Testing. SNBTS shall perform on-going stability testing for Products after First Commercial Sale using its approved procedures to ensure that the Products conform to their intended specifications. Testing will be performed at a frequency that is required by SNBTS’ quality standards and as specified in the Quality System Agreement. If any Product fails to meet the stability acceptance criteria at any given test point, SNBTS will follow its investigation procedures for no-test, invalids or failures. If the stability failure is confirmed prior to the expiration date of any Product, SNBTS will promptly inform OCD of such non-conformance and both Parties will agree on the course of action to follow.
Section 4.5. Technical Documentation. SNBTS shall use reasonable efforts to assist OCD in establishing technical documentation, as required, and in resolving any technical problems OCD may have with respect to the Products subject to agreement between the parties.
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ARTICLE 5.0—PRODUCT PRICING AND PAYMENT TERMS
If OCD fails to make any payment on the due date then, without limiting any other right or remedy available to SNBTS, then SNBTS may: i) suspend any further deliveries to OCD of the Product or Products that are the subject of such past due payment, and ii) charge OCD interest both before and after any judgment on the amount unpaid at the rate of one percent (1%) per month above the past-due invoice value from time to time, until payment in full is made (a part of the month being treated as a full month for the purpose of calculating interest). Notwithstanding the foregoing, SNBTS agrees to allow OCD a grace period of fifteen (15) business days before the late payment penalty is imposed. Such grace period shall begin on the first business day after the payment due date.
ARTICLE 6.0—FORECASTS AND ORDERING
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the quantity of each Product it intends to order for such year. Such Product Forecast shall be updated annually. The binding portion of the Product Forecast for each Product, if applicable, is defined in the specific Product Attachment. Both SNBTS and OCD will participate in a series of inventory and production planning meetings or conference calls scheduled at regular intervals over the course of this Umbrella Agreement. The purpose of these meetings is to discuss SIOP (Sales Inventory Operations Planning Process). This process will be used to align SNBTS’ production schedule with OCD’s delivery schedule. During these meetings, SNBTS will provide information regarding inventory, supply lead times, build lead times, capacity or any issues which may inhibit SNBTS from meeting delivery schedules, and OCD will convey the latest information on forecast and delivery schedule.
ARTICLE 7.0—DELIVERY OF PRODUCTS / PRODUCT ACCEPTANCE
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Section 7.5. Product Acceptance.
(A) Prior to the shipment of any Product for First Commercial Sale, members of OCD and SNBTS’ quality organizations will review OCD’s written criteria for incoming quality inspections and performance testing measures (“Incoming Testing”) that OCD shall use to accept or reject Product. Additionally, Product batches will be released for sale as specified in the Quality System Agreement between SNBTS and OCD.
(B) SNBTS shall test or cause to be tested each lot of Products pursuant to this Umbrella Agreement before delivery to OCD. Each lot must be accompanied by a certificate of analysis, as a minimum, as defined in the Quality System Agreement between SNBTS and OCD. Additional documentation requirements may be stated in a specific Product Attachment. Unless otherwise agreed upon between the parties, or as stated in a specific Product Attachment, SNBTS shall send such documentation to OCD along with delivery of Products. OCD is entitled to rely on such documentation for all purposes of this Umbrella Agreement. Nothing in this Umbrella Agreement shall be construed to require OCD to perform any Incoming Testing on any Products received from SNBTS.
(C) SNBTS will retain a representative sample (the “Library Sample”) of each lot of the Products sold to OCD for the duration of time specified in the Quality System Agreement. Each Product Attachment shall specify a time period for OCD to perform Incoming Testing on the Products to determine if they conform to the Product Requirements, are free from defects in material and workmanship, and otherwise comply with the warranties set forth in Article 19.0 (Representations and Warranties) and, on the basis of such inspection, accept or reject the shipment. OCD shall be deemed to have accepted the Products supplied by SNBTS as free from damage and defects and are in accordance with the terms of the relevant order in all respects unless OCD notifies SNBTS of any damage, defect, or discrepancy within the time period specified in the Product Attachment.
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ARTICLE 8.0—PRODUCTIVITY IMPROVEMENTS / GAIN SHARING
ARTICLE 9.0—FAILURE TO SUPPLY; FORCE MAJEURE
Section 9.1. Force Majeure Events.
(A) If either party is prevented from performing any of its obligations hereunder due to any cause which is beyond the non-performing party’s reasonable control,
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including fire, explosion, flood, or other acts of God; acts, regulations, or laws of any government; war or civil commotion; embargo, insurrection, strike, lock-out or labor disturbances; or failure of public utilities or common carriers (a “Force Majeure Event”), such non-performing party shall not be liable for breach of this Umbrella Agreement with respect to such non-performance to the extent such non-performance is due to a Force Majeure Event. Such non-performance will be excused for ninety (90) days or as long as such event shall be continuing (whichever period is shorter), provided that the non-performing party gives prompt written notice to the other party of the Force Majeure Event. Such non-performing party shall exercise commercially reasonable efforts to eliminate the Force Majeure Event and to resume performance of its affected obligations as soon as practicable. Notwithstanding the foregoing, nothing in this Section 9.1 shall excuse or suspend the obligation to make any payment due hereunder in the manner and at the time provided.
(B) In the event of a catastrophic failure affecting the manufacturing capabilities of either party, both OCD and SNBTS agree that, to the extent possible, the other party will make reasonable attempts to provide assistance in maintaining the supply of products to customers.
Section 9.2. Failure to Supply.
(A) Notwithstanding the provisions of Section 9.1 (Force Majeure Events), in the event that SNBTS shall be unable or unwilling or shall fail to supply any Product which conforms to the Product Requirements in such quantities as OCD shall request and in compliance with the delivery periods set forth in Article 6.0 (Forecasts and Ordering) (hereinafter referred to as a “Failure to Supply”), then the following provisions shall apply:
(1) during the initial ninety (90) days of any Failure to Supply, SNBTS shall use its best efforts to resume its supply obligations hereunder and, at its sole option, shall have the right to either: (A) designate a third-party manufacturer of the Products that is approved in writing by OCD (such approval not to be unreasonably withheld) and license to or otherwise make available to such approved third-party manufacturer all Know How and any other technical and proprietary materials, intellectual property, information and techniques necessary or helpful for such third-party manufacturer to procure required raw materials, including the documents held in escrow pursuant to Section 9.3 below; or (B) by written notice to OCD, activate the Licenses granted pursuant to Section 9.4 of this Umbrella Agreement and make available to OCD or an alternative supplier designated by OCD and approved in writing by SNBTS (such approval not to be unreasonably withheld) all Know How and any other technical and proprietary materials, intellectual property, information and techniques necessary or helpful for OCD or its designee to procure required raw materials or to produce Products, including the documents held in escrow pursuant to Section 9.3 below.
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(2) if SNBTS has not resumed its supply obligations within ninety (90) days after the commencement of a Failure to Supply and: (A) OCD has not received Products by such date from an approved third-party manufacturer designated by SNBTS or has not had its Licenses activated by SNBTS by such date and (B) after consultation between SNBTS and OCD, SNBTS has failed to demonstrate to OCD’s satisfaction likely prospects of success at either ending the Failure to Supply or securing an alternative supply of Products to OCD and OCD determines in its sole discretion that it can more quickly secure such alternative supplies by acting in accordance with clause (B) of the paragraph above, then upon written notice to SNBTS by OCD the Licenses shall be deemed activated and the provisions of clause (B) of the paragraph above shall apply.
(B) OCD shall have no obligation to purchase Products from SNBTS for the duration of any Failure to Supply and until any contractual obligations that OCD has assumed in connection with producing Products or obtaining them from a substitute source of supply shall have terminated. OCD shall have no obligation to affirmatively terminate any such contractual arrangement; provided, however, that OCD shall, to the extent that it is commercially reasonable, make a good faith effort to limit such contractual obligations to the anticipated duration and scope of such Failure to Supply.
(C) Notwithstanding anything to the contrary contained in this Umbrella Agreement, in the event that OCD shall make or have made the Products, pursuant to this Section 9.2, OCD shall be permitted to disclose to any third party any Confidential Information as is reasonably necessary in connection with such activities (subject to such third party agreeing in writing to be bound by the terms of Section 21.1 (Confidential Information) hereof).
(D) Notwithstanding the foregoing provisions of this Section 9.2, if such inability, unwillingness or failure to supply Products which conform with the applicable Product Requirements within the delivery period set forth herein occurs more than once in any calendar quarter such inability, unwillingness or failure shall be deemed a material breach of this Umbrella Agreement.
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obligations hereunder and any contractual obligations that OCD has assumed in order to produce or obtain a substitute source of Products shall have terminated (such period is hereinafter referred to as a “License Period”). OCD shall, to the extent that it is commercially reasonable, make a good faith effort to limit such contractual obligations to the anticipated duration and scope of such Failure to Supply. OCD shall not exercise its rights to manufacture or have manufactured by a Third Party the Products or to utilize such Patents and/or Know-How, in each case, pursuant to such license other than during such a License Period.
ARTICLE 10.0—TERM AND TERMINATION
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Section 10.7. Termination of Product Attachments—OCD. OCD may terminate a Product Attachment:
(1) with thirty (30) days prior written notice of upon reasonable determination of infringement of intellectual property rights of a Third Party;
(2) immediately upon written notice of OCD’s withdrawal from the market of the Product pertaining to such Product Attachment;
(3) with thirty (30) days prior written notice of SNBTS’ failure to supply in accordance with Section 9.2 of the Umbrella Agreement; and
(4) if OCD elects to withdraw the Product from its offering and builds the phase out of the Product into the forecast in accordance with Article 6.0 (Forecasts and Ordering).
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Section 11.3. Indemnity Claims.
(A) SNBTS or OCD (as the case may be, the “Indemnifying Party”) shall obtain the written consent of the SNBTS Indemnified Party or the OCD Indemnified Party (as the case may be, the “Indemnified Party”) prior to ceasing to defend, or settling or otherwise disposing of, any matter upon which a claim for indemnity hereunder is based, if as a result the Indemnified Party would become subject to injunctive or other equitable relief or the business of the Indemnified Party would be adversely affected in any manner.
(B) Each Indemnified Party agrees to give the Indemnifying Party prompt written notice of any matter upon which such Indemnified Party intends to base a claim for indemnification (an “Indemnity Claim”) under this Article 11.0. The Indemnifying Party shall have the right to participate jointly with the Indemnified Party in the Indemnified Party’s defense, settlement or other disposition of any Indemnity Claim. With respect to any Indemnity Claim relating solely to the payment of money damages and which could not result in the Indemnified Party’s becoming subject to injunctive or other equitable relief or otherwise adversely affect the business of the Indemnified Party in any manner, and as to which the Indemnifying Party shall have acknowledged in writing the obligation to indemnify the Indemnified Party hereunder, the Indemnifying Party shall have the sole right to defend, settle or otherwise dispose of such Indemnity Claim on such terms as the Indemnifying Party, in its sole discretion, shall deem appropriate; provided that the Indemnifying Party shall provide reasonable evidence of its ability to pay any damages claimed and, with respect to any such settlement, shall obtain the written release of the Indemnified Party from the Indemnity Claim. The Indemnifying Party shall obtain the written consent of the Indemnified Party prior to ceasing to defend, settling or otherwise disposing of any Indemnity Claim if as a result thereof the Indemnified Party would become subject to injunctive or other equitable relief or the business of the Indemnified Party would be adversely affected in any manner.
Section 12.1. SNBTS Insurance. SNBTS shall obtain and maintain, at all times, and at its own expense, during the term of this Umbrella Agreement and for a period of two (2) years after the termination of this Umbrella Agreement, valid and collectible general liability insurance in respect of the Products for death, illness, bodily injury and property damage in an amount not less than five million US Dollars ($5,000,000) per occurrence and ten million US Dollars ($10,000,000) in the aggregate on a yearly basis. Such insurance shall include worldwide coverage including coverage for USA jurisdiction claims and occurrences. Any exclusions or amendments to the policy form must be disclosed to OCD. Such policy shall name OCD as Insureds or Additional Named Insureds thereunder and SNBTS shall grant like coverage to OCD under a standard broad form vendor’s endorsement thereto. SNBTS shall, within ten (10) days of the Execution Date of this Umbrella Agreement, provide OCD with evidence of this coverage. OCD’s failure to demand such proof or forms shall not waive OCD’s rights to such coverage as
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specified herein. Such insurance policy shall provide that in the event such coverage should be materially adversely changed or terminated for any reason, the insurer thereunder will give SNBTS and OCD ten (10) days prior written notice of such change, termination or renewal.
ARTICLE 13.0—QUALITY CONTROL REQUIREMENTS
Section 13.1. Quality Control Requirements. In keeping with OCD Quality Assurance and Control Requirements and the provisions of ISO 13485, SNBTS shall comply with all of the provisions of the Quality System Agreement between SNBTS and OCD. In the event of a conflict in terms between this Umbrella Agreement and the Quality System Agreement, the Umbrella Agreement shall control.
Section 13.2. Customer Complaints.
(A) In the event that SNBTS or OCD receives any customer complaint regarding the Products, or any component thereof, manufactured by SNBTS and distributed by OCD, then that party shall promptly inform the other concerning the details of any such complaint or notice. The complaint or notice shall then be evaluated and investigated by OCD at OCD’s own cost. OCD may request SNBTS to conduct failure investigations using the process defined in the Quality System Agreement. SNBTS shall assist OCD in follow-up correction of Product complaints within the timeframe required by OCD’s procedures. If corrective actions are required, the cost of or part of the corrective action shall be borne by SNBTS up to the extent such complaint is attributable to a breach by SNBTS of any of its warranties, guarantees, representations, obligations or covenants contained herein, and shall be borne by OCD up to the extent such complaint is related to some cause or event attributable to OCD.
(B) Unless otherwise stated in a specific Product Attachment, OCD shall provide SNBTS with an updated listing of customer complaints, on a quarterly basis.
ARTICLE 14.0—REGULATORY OBLIGATIONS OF THE PARTIES
Section 14.1. Regulations. SNBTS shall prepare all necessary documents relating to its activities hereunder and needed for compliance with all current, applicable Regulations, At all times during this Umbrella Agreement, SNBTS shall provide sufficient evidence to OCD that SNBTS is in compliance with all current, applicable Regulations and shall inform OCD regarding any product quality/quality system issues such as non-conformities, significant process/document changes, serious Third Party audit observations or hold points.
Section 14.2. Regulatory Approvals.
(A) SNBTS agrees to cooperate with OCD in obtaining and maintaining all clearances and approvals from regulatory agencies required for the manufacture, sale and distribution of the Products under this Umbrella Agreement. SNBTS’ cooperation shall include, but shall not be limited to, providing to OCD, or appropriate agencies, bodies or authorities
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(1) certification that the Products were developed and/or manufactured in accordance with regulatory guidelines,
(2) other additional information including descriptions of associated quality assurance, quality control and engineering programs and procedures, and
(3) access to validation and testing reports. Because regulatory requirements vary throughout the world, the parties agree to cooperate with one another to obtain regulatory approvals where required.
(B) Where SNBTS is certified to EN ISO 13485: 2003, and/or ISO 9001, SNBTS shall conduct all activities necessary to maintain these certifications.
Section 14.3. Notification of Certain Events.
(A) If SNBTS becomes aware of information that reasonably suggests that the Products, or any component thereof, or products whose formulations are substantially similar thereto, has or may have caused or contributed to a death, serious injury, or has malfunctioned and that the Products, or any component thereof, or products whose formulations are substantially similar thereto, would be likely to cause or contribute to a death or serious injury if the malfunction were to recur, SNBTS shall notify OCD within one (1) business day of becoming aware of such information and shall provide OCD with any other facts or information that SNBTS has relating thereto. For the purposes of this Umbrella Agreement, a serious injury/serious illness (i) is an injury or illness that is life threatening, even if temporary in nature, (ii) results in permanent impairment of a body function or permanent damage to a body structure or (iii) necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
(B) SNBTS shall promptly provide OCD with copies of any inspection reports that it receives from any governmental entity of any notice of any claim or action relating to non-compliance with any laws, rules or regulations that are applicable to the Products or products substantially similar thereto.
(C) SNBTS shall notify OCD of any audit related to the manufacture of Products from any governmental entity/regulatory body of any of its facilities used for the manufacture of the Products or products substantially similar thereto, or any request for information from any governmental entity related to the manufacture of the Products or products substantially similar thereto, one (1) business day after SNBTS receives notice of such audit or such request and as specified in the Quality System Agreement.
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of any warranty by SNBTS hereunder. In the event that such recall or corrective action results from any cause or event attributable to OCD, including, without limitation, product registration, failure to register or storage of Products by OCD, OCD shall be responsible for all costs and expenses of such recall or corrective action. Should such recall or corrective action result from the fault of both parties, the parties shall share such costs and expenses proportionately. The parties agree to reasonably cooperate with each other in the resolution of any such recall or corrective action, regardless of fault, in accordance with the timeframe specified under OCD’s procedures for handling these matters.
ARTICLE 15.0—FACILITY INSPECTIONS
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ARTICLE 17.0—IMPROVEMENTS AND CHANGES TO PRODUCTS
Section 17.1. Product Changes and Improvements.
(A) From time to time during the term of this Umbrella Agreement, either party may submit to the other written proposals for the adoption, implementation or development of any change, improvement or modification to the Products. In no event, however, shall any such proposed change, improvement or modification (or any change or modification to the Product Requirements) be implemented or made without the prior written approval of OCD. If both parties mutually agree on any change, improvement or modification, the parties shall modify the Product Requirements to reflect same. The parties will mutually agree upon an implementation date. In the event that SNBTS is unable to supply Products that meet any reasonable changes to the Product Requirements proposed by OCD in good faith, then OCD shall be free to terminate the applicable Product Attachment under this Umbrella Agreement, upon thirty (30) days prior written notice to SNBTS, without payment of any penalty or other amount, except for those amounts due and owing to SNBTS at such time. SNBTS further agrees that no changes or modifications to the method or process of manufacture or production of the Products or the raw materials shall be made without prior written notification to and approval of OCD. In no event shall any change or modification be made to the method or process of manufacture or production of the Products or the raw materials, which change or modification shall have the effect of modifying or changing the Product Requirements, without the express written consent of OCD. Such notifications of changes or modifications must be made at least ninety (90) days prior to the implementation of same. Notwithstanding the foregoing, SNBTS reserves the right to make any changes to the Product Requirements of the Products:
(1) which are required to conform with any applicable statutory or EU requirements,
(2) where an essential change is required to correct impaired product performance, or
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(3) where the Products are to be supplied to SNBTS’ specification, which do not materially affect their quality or performance. SNBTS shall notify OCD of any such changes as soon as reasonably possible prior to the implementation of the change. In the event of any change, if applicable, OCD shall establish an appropriate qualification protocol, and OCD and SNBTS shall determine an appropriate inventory level for the pre-change Products in order to cover on-going requirements during the qualification process.
(B) SNBTS and OCD will follow the process for Product changes as defined in the Quality System Agreement between SNBTS and OCD.
ARTICLE 18.O—ADDITIONAL UNDERSTANDINGS OF THE PARTIES
Section 18.1. Most Favored Customer. In consideration of the arrangements provided in this Umbrella Agreement for OCD to purchase Products from SNBTS, SNBTS agrees that during the term of this Umbrella Agreement OCD shall be treated with “most favored nation” status in connection with pricing and allocation of similar quantities of Products, and SNBTS shall not provide any other customer with preferential or more favorable treatment with respect to pricing or allocation of similar quantities of any Products.
Section 18.2. Competing Products. The parties recognize and acknowledge that the other party and their Affiliates have been, and will continue to be, actively involved in the design, development and marketing of Competing Products in the field in which the Products are sold. The parties acknowledge that the other party and their Affiliates market, sell and distribute products which compete directly with the Products, and may continue to market, sell and distribute these and other Competing Products throughout the term of this Umbrella Agreement. Neither party will be obliged to release nor accept any confidential information relating to these developments.
ARTICLE 19.0—REPRESENTATIONS AND WARRANTIES
Section 19.1. SNBTS Product Representations and Warranties. SNBTS represents and warrants the following:
(A) All Products supplied in connection with this Umbrella Agreement shall be of merchantable quality and fit for the purpose intended by this Umbrella Agreement;
(B) All Products shall be free from defects in material and workmanship; and, SNBTS further warrants that it shall extend to OCD any broader warranties of any raw materials that may be provided by the manufacturer or supplier of such items;
(C) Each Product shall be manufactured and packaged in strict compliance with the terms of this Umbrella Agreement and the specific Product Attachment, will meet the subject Product Requirements, and will be in accordance and conformity with the Regulations and all Applicable Legal Requirements;
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(D) SNBTS shall comply with all present and future statutes, laws, ordinances and regulations relating to the manufacture and supply of Products being provided hereunder, including, without limitation, those enforced by the United States Food and Drug Administration (including compliance with good manufacturing practices) and International Standards Organization Rules 9000 et seq;
(E) No Products supplied to OCD in connection with this Umbrella Agreement will be adulterated or misbranded at the time of delivery within the meaning of the Federal Food, Drug and Cosmetic Act. SNBTS shall notify OCD promptly after receiving notice of any claim or action by the FDA or other governmental entity relating to non-compliance with this Section 19.1 (E) or any notice with respect to any violation of any applicable laws, rules or regulations which affect the manufacture of Products;
(F) SNBTS has the right to supply the Products to OCD for use in accordance with this Umbrella Agreement;
(G) SNBTS will manufacture the Products using a system of Good Manufacturing Practices. Each production lot will be manufactured using the same general methods as those used to manufacture samples of the Products supplied by SNBTS prior to the date hereof;
(H) Any process used by SNBTS to manufacture the Products or the incorporation into a Product of any component, part, reagent, antigen or element sourced from a Third Party by SNBTS shall not infringe or violate any patent, trademark, copyright or any other intellectual property or proprietary rights of any Third Party; and
(I) The above warranties are given by SNBTS subject to the following conditions:
(1) SNBTS shall be under no liability in respect of any defect arising from fair wear and tear, willful damage, negligence, abnormal working conditions, failure to follow SNBTS’ instructions (whether oral or in writing), mis-use or alteration or repair of Products without SNBTS’ approval, or failure to transport and store the Products correctly:
(2) SNBTS shall be under no liability in respect of any defect arising as a result of use by SNBTS of a specification or process provided by OCD.
Section 19.2. Mutual Representations and Warranties.
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(C) No Violation. OCD and SNBTS each represents to the other that the performance of its obligations under this Umbrella Agreement will not result in a violation or breach of, and will not conflict with or constitute a default under its charter documents or any agreement, contract, commitment or obligation to which such party or any of its Affiliates is a party or by which it is bound.
(D) Execution and Performance of Agreement. OCD and SNBTS each represents to the other that it has full right, power and authority to enter into and perform its obligations under this Umbrella Agreement. OCD and SNBTS each further represents and warrants to the other that the performance of its obligations under this Umbrella Agreement will not result in a violation or breach of, and will not conflict with or constitute a default under any agreement, contract, commitment or obligation to which such party or any of its Affiliates is a party or by which it is bound.
IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY MULTIPLIED, EXEMPLARY, PUNITIVE, SPECIAL, INCIDENTAL, INDIRECT OR CONSEQUENTIAL DAMAGES, WHETHER ARISING UNDER TORT, CONTRACT, STRICT LIABILITY OR ANY OTHER LEGAL THEORY (INCLUDING, WITHOUT LIMITATION, LOSS OF PROFIT OR REVENUE, INJURY TO BUSINESS OR REPUTATION, DOWNTIME COSTS, LOSS OF USE OF EQUIPMENT, COST OF ANY SUBSTITUTE EQUIPMENT, FACILITY OR SERVICE, OR INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY).
19.4 The liabilities of SNBTS for all claims made against it under this Article 19.0 shall be limited as set out in Section 11.1 (Indemnification by SNBTS).
ARTICLE 20.0—INTELLECTUAL PROPERTY
Section 20.1. Other than pursuant to Article 9.0 (Failure to Supply; Force Majeure) hereof and as otherwise specifically set forth herein, neither party hereto shall accrue any rights to Intellectual Property of the other party hereto. Neither party shall apply for registration of, or register any intellectual property rights in respect of, the Products or the intellectual property of the other party relating thereto and/or to the provision of the Services.
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ARTICLE 21.0—CONFIDENTIAL INFORMATION
Section 21.1. Confidentiality. All Confidential Information disclosed by one party to the other shall not be used by the receiving party except in connection with the activities contemplated by this Umbrella Agreement and shall be maintained in confidence by the receiving party. Except to the extent expressly authorized by this Umbrella Agreement or otherwise agreed to in writing, during the term of this Umbrella Agreement and for a period of ten (10) years following the termination of this Umbrella Agreement, neither party shall use or disclose to third parties any Confidential Information of the other (except to the extent reasonably necessary to exercise its rights or comply with its obligations under this Umbrella Agreement) and each party shall insure that its employees, officers and agents shall not use or disclose to third parties any Confidential Information of the other (except to the extent reasonably necessary to exercise its rights or comply with its obligations under this Umbrella Agreement); provided, however, that OCD may disclose Confidential Information of SNBTS to OCD’s Affiliates and consultants if such persons are informed of the confidential nature of such information and are under an obligation to keep such information confidential. For the avoidance of doubt, no disclosures of such Confidential Information shall be made by either party to subcontractors or agents without the prior written consent of the other party. Upon the termination or expiration of this Umbrella Agreement, each party shall return to the other, destroy, or delete all Confidential Information in written, electronic or other tangible form received from the other party hereunder. If the Confidential Information is destroyed or deleted, each party shall certify in writing to the other party that such destruction or deletion has been completed, Confidential Information shall not include information that is:
(A) known by or in possession of the receiving party at the time of its receipt as documented in written records;
(B) independently developed outside the scope of this Umbrella Agreement by employees of the receiving party having no access to or knowledge of the Confidential Information disclosed hereunder as documented in written records;
(C) in the public domain at the time of its receipt or thereafter becomes part of the public domain through no fault of the receiving party;
(D) received without an obligation of confidentiality from a Third Party having the right to disclose such information;
(E) required to be disclosed to governmental agencies in order to gain approval to sell Products, or disclosure is otherwise required by law, regulation or governmental or court order (so long as the receiving party provides notice of such disclosure, seeks to obtain protective orders or other available confidentiality treatment and, in the case of disclosures to the SEC, seeks confidential treatment to the extent reasonably requested by the disclosing party);
(F) released from the restrictions of this Section 21.1 by the express written consent of the disclosing party; or
(G) disclosed to agents, consultants, assignees, sublicensees or subcontractors of SNBTS or OCD or their Affiliates which have a need to know such information in connection with the performance of this Umbrella Agreement, provided that such persons are or agree in writing to be subject to the provisions of this Section 21.1 or substantially similar provisions.
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In the event either party must disclose the other party’s Confidential Information in order to comply with Applicable Legal Requirements, such party shall give reasonable advance notice to the other party of such proposed disclosure in order that the non-disclosing party may intercede and oppose such process, and shall use its reasonable commercial efforts to secure confidential treatment of such Confidential Information which is required to be disclosed.
The parties agree that a breach by either party of the covenants contained in Section 21.1 may result in substantial damages to the other party which would be difficult, if not impossible, to ascertain and therefore the parties agree that upon any such breach, OCD or SNBTS, their successors and assigns shall have the right, if such damages would be difficult to ascertain, to enforce the provision of this Section 21.1 by seeking a temporary or permanent injunction or by other proceeding in equity.
Section 22.1. SNBTS Trademark. OCD shall not be entitled to make use of SNBTS’ Trademark(s), as outlined in Exhibit 4 attached hereto, or name in any way either in respect of this Umbrella Agreement or any other agreement to which OCD is a party, without written consent from SNBTS.
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assigned to the purchaser of such assets or the surviving corporation of such merger or consolidation. Subject to the foregoing, this Umbrella Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and permitted assigns, and no other person shall have any right, benefit or obligation under this Umbrella Agreement as a third party beneficiary or otherwise. Any assignment in contravention of this Section 22.5 is void.
In the event that any assignment by OCD to an Affiliate is made pursuant to this Section 22.5 and the assignee ceases to be an Affiliate of OCD the assignee will, prior to ceasing to be an Affiliate of OCD, reassign to OCD or another of its Affiliates this agreement and/or any rights and obligations which have been assigned.
Notwithstanding the foregoing provisions of this Section 22.5, SNBTS shall be entitled without restriction to assign this agreement and its rights, interests or obligations under this agreement to a company which is incorporated for the purpose of acquiring the whole or any substantial part of the business and assets of Alba Bioscience.
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control. Notwithstanding the foregoing, to the extent that there is a conflict between the terms and conditions of the Umbrella Agreement and any Product Attachment, the terms and conditions of the Product Attachment shall control. For avoidance of doubt, this Umbrella Agreement does not supersede or otherwise effect the Supply Agreement dated November 3, 2003.
Section 22.13. Governing Law. This Umbrella Agreement shall be interpreted in all respects in accordance with the law of England and Wales.
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If to SNBTS: | Alba Bioscience Xxxxxx Xxxx Xx Xxxxxxxxx XX00 0XX, Xxxxxxxx Attention: Director | |||
If to OCD: | Executive Director, Business Development Ortho-Clinical Diagnostics 0000 XX Xxxxxxx 000 Xxxxxxx, XX 00000 XXX | |||
with a copy to: | Xxxxxxx & Xxxxxxx Office of General Counsel 0 Xxxxxxx & Xxxxxxx Xxxxx Xxx Xxxxxxxxx, XX 00000 XXX |
All such communications shall be deemed to be effective on the day on which personally served, or, if sent by registered mail, on the fourth (4th) day following the date presented to the postal authorities for delivery to the other party (the cancellation date stamped on the delivery or the envelope being evidence of the date of such delivery), or if by overnight delivery or facsimile, on the delivery or the facsimile date. Either party may give to the other written notice of change of address, in which event any communication shall thereafter be given to such party as above provided at such changed address.
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ARTICLE 23.0—APPROVALS
ORTHO-CLINICAL DIAGNOSTICS, INC. | ||||||||
By: | /s/ Xxxxxx Xxxxxxx | Date: 4/6/05 | ||||||
Name: Xxxxxx Xxxxxxx | ||||||||
Title: Vice President, Worldwide Operations | ||||||||
SCOTTISH NATIONAL BLOOD TRANSFUSION SERVICE A DIVISION OF THE COMMON SERVICES AGENCY | ||||||||
By: | /s/ Xxxxx Xxxxxxxx | Date: 5/12/05 | ||||||
Name: Xxxxx Xxxxxxxx | ||||||||
Title: National Director |
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LIST OF EXHIBITS
Exhibit 1 | Product Attachments | |
Exhibit 2 | Xxxxxxx & Xxxxxxx Policy on Employment of Young Persons | |
Exhibit 3 | Xxxxxxx & Xxxxxxx External Manufacturing Environmental Health and Safety Policy | |
Exhibit 4 | SNBTS Registered Trademarks |
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