[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY

BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND

EXCHANGE COMMISSION.

 

Exhibit 10.29

 

TGS-004-90105

 

 

THIS INTERNATIONAL DISTRIBUTOR AGREEMENT (this “Agreement”) is effective as of the 21st of August 2017, (“Effective Date”), between ThermoGenesis Corp., a Delaware corporation with principal office 2711 Citrus Road, Rancho Cordova, CA 95742, USA and Boyalife W.S.N. a China corporation with its office at 88 Meiliang Road, Wuxi City, People’s Republic of China 214092 (“Distributor”).

 

R E C I T A L S

 

A.     ThermoGenesis’ business is to design, manufacture (directly or indirectly through manufacturing subcontractors) and sell medical devices and other products which utilize its proprietary thermodynamic and/or archiving technology for the processing of biological substances, including the concentration and cryopreservation of tissue and blood components.

 

B.     Distributor has facilities and experience in the distribution, sale and service of medical devices in the Territory (defined below), and desires to become the distributor and an authorized service provider for the Products (defined below), pursuant to the terms of this Agreement.

 

A G R E E M E N T

 

NOW, THEREFORE, in consideration of the foregoing, and for other good and valuable consideration, the receipt and sufficiency of which are acknowledged, the parties agree as follows:

 

1.        DEFINITIONS.

 

When used herein, capitalized terms shall have the following meanings:

 

“Affiliate” means, in respect of any specified Person, any other Person which, but only for so long as such other Person, directly or indirectly, controls, is controlled by, or is under common control with, such specified Person. The term “control” means the possession, directly or indirectly, of the power to direct or cause the direction of the management or policies of a Person, through the ownership of voting securities or other equity interests, and the terms “controlled” and “common control” have correlative meanings.

 

“Applicable ThermoGenesis Technology” has that meaning accorded to it in Section 9.1.3 of this Agreement.

 

“AXP Device” means the Auto Xpress™ System which automates the volume reduction process for cord blood and consists of a battery-operated device.

 

 

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“AXP Disposable” means the ThermoGenesis proprietary processing bag set that has integrated sampling segments.

 

“AXP System” means the combination of the AXP Device, the AXP Disposable and the XpressTRAK software.

 

“BioArchive Device” means ThermoGenesis’ computer-controlled, robotic liquid nitrogen cryopreservation and storage system that enables the freezing and managing of approximately 3,600 blood component samples.

 

“BioArchive Disposables” means Freezing Bag used for storage of 25 mL of fluid, Canisters which hold samples for storage in the BioArchive System, and Overwrap Bags that serve as a secondary barrier of protection to the stored cord blood sample.

 

“BioArchive System” means the combination of the BioArchive Device and the BioArchive Disposables and the Manual Bag Set.

 

“Change of Control” means (i) the direct or indirect sale or other disposition (in one or more related transactions to one or more parties) of all or substantially all of the assets of ThermoGenesis, or (ii) the direct or indirect transfer of 50% or more of the outstanding voting interest of ThermoGenesis, whether in a single transaction or series of related transactions.

 

“Customers” shall have the meaning accorded in Section 2.1 of this Agreement.

 

“Effective Date” means the date first written above.

 

“Field of Use” the Field of Use identified for each Product(s) on Exhibit A-1 attached hereto shall apply to the Territory for such Product(s), also listed on Exhibit A-1.

 

“Know-how” means any and all current and future know-how, technical information, technical knowledge, unpatentable inventions, manufacturing procedures, methods, trade secrets, processes, formulas, documentation and other tangible or intangible property or rights relating to ThermoGenesis’ products, whether or not capable of precise separate description but which alone, or when accumulated, gives to the Person acquiring it an ability to study, test, formulate, manufacture, produce or market something which it otherwise would not have known to study, test, formulate, manufacture, produce or market in the same or similar way.

 

“Manual Bag Set” means ThermoGenesis’ proprietary Transfer/Freezing Bag Set for use in manual volume reduction and storage of 25 mL cord blood samples.

 

 

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“Person” means any natural person or any corporation, partnership, limited liability company, business association, joint venture or other entity.

 

“Product(s)” means the devices, accessories and parts listed in Exhibit A attached hereto.

 

“Quota” means the annual minimum unit volumes of Products to be purchased by Distributor as identified for each Product(s) in Exhibit F.

 

“Term” means the time duration as stated in Section 2.1.1 of this Agreement.

 

“Territory” means the territory identified for each Product(s) on Exhibit A-1, as limited therein by the Field of Use for each designated Product(s).

 

“ThermoGenesis Marks” means any and all trademarks, trade names, service marks, service names, logos and similar proprietary rights whether now or in the future owned, controlled or licensed by ThermoGenesis and currently used or to be used in connection with the Product(s).

 

“ThermoGenesis’ Point of Shipment” as defined in the Uniform Commercial Code refers to ThermoGenesis’ manufacturing facilities and may be Rancho Cordova, Costa Rica, or a ThermoGenesis designated warehouse or supplier.

 

“XpressTRAK™” means ThermoGenesis’ proprietary GMP-compliant AXP operating software.

 

2.        DISTRIBUTION RIGHTS AND OBLIGATIONS.

 

2.1     Appointment as Distributor. Subject to existing distributors pending termination, if any, and the limitations as noted in Exhibit A-1, ThermoGenesis hereby appoints Distributor as ThermoGenesis’ distributor of the Product(s), and parts that are components thereof, to all existing and potential customers (“Customers”) within the Territory identified in Exhibit A-1. The rights and obligations as to the Product(s), and parts that are components thereof, shall be effective as of the Effective Date of Agreement. Additionally, Distributor shall service the Product(s) in the Territory under the terms set forth in this Agreement.

 

2.1.1     Term of Initial Appointment. Subject to earlier termination or renewal as provided in Section 10 below, Distributor’s initial appointment shall be for a term of three (3) years from the Effective Date of this Agreement (the “Term”).

 

2.2      No Appointment of Sub-Distributors. Distributor may not appoint any Persons to act as sub-distributors within any portion of the Territory, and any attempt to assign to any Person any or all of Distributor’s rights hereunder, and any attempt to delegate to any such Person any or all of Distributor’s obligations hereunder shall be null and void, and will not bind ThermoGenesis.

 

 

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2.3     Promotion of Product(s); Advertising.

 

2.3.1     Promotion. During the Term of this Agreement, Distributor shall use its good faith commercially reasonable efforts to develop a customer base and promote the sale of the Product(s) within the Territory. Distributor shall advertise and otherwise promote the Product(s) in a commercially reasonable manner and furnish appropriate Product(s) information (Instruction For Use and Operator Manuals) and promotional materials to its Customers.

 

2.3.2     Use of ThermoGenesis Marks. Distributor may refer to and advertise itself as an “Authorized Distributor” and “Authorized Service Provider” of the Product(s) within all or any portion of the Territory, and may indicate on its stationery, business cards or other printed materials that it is an “Authorized Distributor” and “Authorized Service Provider” of Product(s) and, subject to ThermoGenesis’ prior written approval, may have ThermoGenesis Marks imprinted thereon.

 

2.4     Forecasting of Product(s). Distributor shall provide to ThermoGenesis a rolling quarterly forecast of Distributor's requirements for the Product(s) for the twelve (12) month period commencing that quarter. The requirements for the first quarter period of each rolling quarterly forecast shall constitute a firm and binding Purchase Order for Product(s). The remaining rolling quarterly forecast shall constitute non-binding estimates of Product(s) and requirements for the period described, however the 2nd quarter in any forecast shall be varied by no more than +/- 20% in the subsequent binding forecast, unless mutually agreed by the parties. The 3rd and 4th quarter of each forecast are non-binding and may be modified by Distributor at any time in its sole discretion. Any aggregate increase in firm order quantities over forecasted quantities for a given quarter in excess of 20% shall be subject to mutual agreement and the capacity constraints of ThermoGenesis. Within three (3) months after the Effective Date of this Agreement, ThermoGenesis and Distributor will mutually determine the annual Quotas for each Product and list such Quotas in Exhibit F, hereto. Thereafter, ThermoGenesis retains the right to reevaluate the Quotas and, with Distributor, mutually determine and update the Quotas at least once per year or at such greater frequency as the parties may mutually agree in writing.

 

In the event annual Quota commitments have not been mutually established by the parties at the commencement of any calendar year during the term of this Agreement, ThermoGenesis shall have the right to unilaterally set yearly Quotas for such calendar year at any time during said calendar year. Such unilaterally established Quotas shall not exceed 10% growth over the previous year. Further, Distributor acknowledges and agrees that said revised Quotas shall be deemed “reasonable” absent a showing of lack of good faith by ThermoGenesis in establishing such Quotas.

 

2.5     Translation of Materials. Distributor shall bear the cost and responsibility of translating and/or preparing sales literature and other promotional materials for the Product(s) in the languages of the Territory, as needed, to effectively market the Products in the Territory. Distributor will be responsible for translations which may be required for any labeling or package insert associated with ThermoGenesis’ products.

 

 

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2.6      Trademark License. ThermoGenesis hereby grants to Distributor the non-exclusive, royalty-free right and license to use designated ThermoGenesis Marks associated with the Product(s) in connection with the marketing, distribution, sale and post-sale field service, technical assistance and support of the Product(s). Distributor agrees not to alter, obliterate, deface or remove any ThermoGenesis Marks displayed on any Product(s) or its packaging, or add any name, brand or trademark thereto without the prior written consent of ThermoGenesis. Notwithstanding the foregoing, Distributor’s trademarks may be displayed on Product(s) packaging, and the parties shall reasonably cooperate with one another to ensure that all Product(s) packaging and labeling prepared by ThermoGenesis complies with applicable law. Except as provided in this Agreement, nothing herein shall grant to Distributor any right, title or interest in the ThermoGenesis Marks, which right, title and interest shall remain fully and solely vested in ThermoGenesis. Distributor shall immediately notify ThermoGenesis if, during the term of this Agreement, Distributor becomes aware of any other Person who is using any trademark, trade name, service mark, service name or logo that is substantially or confusingly similar to those owned or used by Distributor pursuant to the authority granted by ThermoGenesis hereunder.

 

2.7      Reservation of Title. ThermoGenesis reserves to itself and retains all right, title and interest in and to the Applicable ThermoGenesis Technology and to any modifications, enhancements, improvements and upgrades thereto. Distributor may not duplicate, translate, decompile, reverse engineer or adapt the Product(s) without ThermoGenesis’ prior written consent.

 

2.8    No Other Rights. Except as expressly provided in this Agreement, no right, title, or interest is granted by ThermoGenesis to Distributor hereunder. ThermoGenesis may distribute products other than the Product(s) within the Territory, either directly or indirectly through distributors, and no right, title or interest is granted by ThermoGenesis to Distributor relating to such product and parts.

 

3.        APPOINTMENT AS SERVICE PROVIDER AND OBLIGATIONS.

 

3.1      Appointment as Authorized Service provider. ThermoGenesis hereby appoints Distributor as an exclusive service provider to repair and service the Product(s), and parts that are components thereof, including warranty service as applicable, to all Customers within the Territory.

 

3.1.1     Localized Depot Service Center Quality Requirement. In addition to the obligations as stated in Agreement, Distributor is authorized to provide repairs and preventative maintenance for ThermoGenesis products in localized Depot Service Centers and shall adhere to the quality requirements (as defined in Exhibit I).

 

 

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3.2      Clinical Application Support Specialist and Technical Service Personnel Qualifications, Training, and Availability. Subject to Section 3.1.1, Distributor shall have qualified application support specialist and technical service personnel that have appropriate experience in the troubleshooting, problem solving, customer training and repair and maintenance of medical products that are substantially similar to the Products. The number of application support specialist and technical service personnel shall be sufficient to provide application support and service to the ThermoGenesis customer base in their Territory and should be adjusted as needed to adequately support the installed base. Primary support and service personnel must be able to communicate in English in order to complete training as defined in Section 3.3 and for future communications with ThermoGenesis support engineers. Application support specialist and technical service personnel must be certified by ThermoGenesis before they are authorized to perform service on the Product(s). Technical service personnel must pass written examinations provided by ThermoGenesis before they receive their certification. There will be a ninety (90)-day probation period after certification to review the service program at each new distributor location. Special training qualification is required in order to perform installation and operator training of AXP and BioArchive Systems. Service personnel assigned to the support of ThermoGenesis Product(s) must be available to provide initial service contact to customers within twenty four (24) hours for customers with non-operational equipment. Once an initial assessment has been made, should a product require return to a manufacture site for repair, Distributor shall provide an AXP System device loaner, new or refurbished unit, to Customer within a reasonable time.

 

3.3     Clinical Application Support Specialist and Technical Service Personnel Training. ThermoGenesis shall provide application support and technical service training for Distributor’s field service personnel to enable Distributor to perform post-sale troubleshooting problem solving customer training and field service, technical assistance and support for its Customers, the frequency of such training shall be in the sole discretion of ThermoGenesis, provided, however, that at least one such training session shall be provided by ThermoGenesis within three (3) months of the date of this Agreement. Such training shall be conducted, at ThermoGenesis’ election, at ThermoGenesis’ Rancho Cordova, California facilities or at Distributor’s facilities in Territory. ThermoGenesis will provide such training without charge; provided, however, that Distributor shall bear all out-of-pocket costs incurred in connection with such training, including travel, airfare and lodging expenses, as well as the reimbursement of such out-of-pocket expenses reasonably incurred by ThermoGenesis to send a training representative to Distributor’s facilities in Territory. In addition, ThermoGenesis will provide Product(s) updates and service bulletins as they become available in English.

 

3.4     Facilities and Inventory; Repair and Replacement Parts Stock. Subject to Section 3.1.1, Distributor shall maintain sufficient spare parts, warehousing and distribution facilities and warranty service centers within the Territory to fulfill adequately the reasonable needs of its Customers for Product(s) and parts and to service the Product(s) during the life of the Product(s), including maintaining an adequate supply of loaner or refurbished units to be used in connection with service repairs in cases where a unit requires return to a manufacture site for repair.

 

 

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3.5     Other Information Reporting. Subject to Section 3.1.1, Distributor shall provide to ThermoGenesis, at Distributor’s expense and in English, each and every quality and/or service complaint within three (3) business days after receipt of such complaint by Customer. The complaint reporting form defined in Exhibit H should be used for reporting the information to ThermoGenesis. In addition, Distributor shall notify ThermoGenesis of any “incident” (as defined in Exhibit D) within twenty (24) hours as outlined in the vigilance procedure attached hereto as Exhibit D. Detailed information of service performed or actions taken to resolve the reported complaint shall be communicated to ThermoGenesis within three (3) business days after completion of the actions.

 

3.6     Post-Sale Clinical Application Support and Field Service, Technical Assistance, Support and Warranty Service. Distributor shall provide to its Customers post-sale clinical application support and field technical service, technical assistance and support for Product(s) sold by Distributor in the Territory. At the request of Customers, Distributor shall (a) install and service the Product(s), (b) perform all required inspections of installation and required service and preventative maintenance of the Product(s), as applicable, (c) timely respond to Customer calls and claims with respect to the Product(s), and (d) provide any applicable training for Customers. If, during the Term or any additional period agreed upon by both parties, Distributor performs any warranty service for its Customers during the warranty period for any Product(s), ThermoGenesis shall reimburse Distributor for the costs and expenses reasonably incurred, excluding labor and costs by Distributor in performing such service, which amount shall not exceed ThermoGenesis’ standard reimbursement schedule for such repair or have been pre-approved by ThermoGenesis. The cost of any field service or other support for any Product(s) performed by Distributor after the expiration of the applicable warranty period for such Product(s) shall be agreed upon between Distributor and the customers, unless such customer had previously agreed to the cost prior to the date hereof, and in such case the cost shall be the previously agreed price until Distributor and ThermoGenesis agree on subsequent new price. Distributor shall document all service visits and work performed (as defined in Exhibit G) and Distributor shall furnish to ThermoGenesis copies of any written reports prepared by Distributor with respect to repairs made by Distributor to the Product(s). Distributor shall contact ThermoGenesis regarding return of parts and shall return all required parts under warranty for analysis within thirty (30) days of repair to ThermoGenesis.

 

4.       TERMS OF PURCHASE OF PRODUCT.

 

4.1     Terms and Conditions. All purchases of Product(s) hereunder shall be subject to the provisions of this Agreement. Unless otherwise agreed in writing, nothing contained in any purchase order submitted pursuant to this Agreement shall in any way modify or add any provision to this Agreement. In the event of a conflict between the terms of any purchase order and the provisions of this Agreement, the provisions of this Agreement shall govern.

 

 

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4.2     Prices. All prices for Product(s) purchased by Distributor hereunder shall be Ex Works (EXW), ThermoGenesis’ Point of Shipment. The initial price to Distributor for each Product(s) is set forth opposite such Product(s) in Exhibit A, and such initial price will remain fixed through the end of ThermoGenesis’ fiscal year (ending June 30th). Thereafter, the purchase price to Distributor for such Product(s) may be increased or decreased by ThermoGenesis upon sixty (60) days’ prior written notice to Distributor.

 

4.3     Certain Taxes. The parties acknowledge that the purchase prices of Product(s) set forth in Exhibit A do not include any sales, excise, use, value added or other government taxes or duties that may be applicable to the export, import or purchase of the Product(s), including all income and income-based taxes imposed on ThermoGenesis under applicable laws in Territory, which taxes shall be the sole responsibility of and Distributor agrees that it will bear all such taxes and duties. When ThermoGenesis has the legal obligation to collect and/or pay such taxes or duties, the appropriate amount shall be added to Distributor’s invoice and paid by Distributor to ThermoGenesis, unless Distributor provides ThermoGenesis with a valid tax exemption certificate authorized by the appropriate governmental taxing authority, or provides proof of payment to such authority.

 

4.4    Order and Acceptance. All orders for Product(s) shall be by means of a signed written purchase order which shall be submitted to ThermoGenesis at ThermoGenesis’ address for notice purposes set forth in Section 12.4, and shall request a delivery date. Orders may be placed by telephone, facsimile transmission or, upon the parties’ agreement, on ThermoGenesis’ Web-Site or by e-mail. ThermoGenesis shall notify Distributor in writing within a reasonable period of time from submission of the purchase order of any rejected order. ThermoGenesis shall have no liability to Distributor with respect to purchase orders that are not accepted.

 

4.5     Invoicing; Payment. ThermoGenesis shall submit an invoice to Distributor with each shipment of Product(s) ordered by Distributor. Each invoice shall be due and payable in the manner agreed to by the parties set forth in Exhibit E. All invoices shall be sent to Distributor’s address for notice purposes set forth in Section 12.4, without regard to the actual shipping address for the Product(s). Each such invoice shall state Distributor’s aggregate and unit purchase price for Product(s) in the relevant shipment, plus any freight, taxes or other costs incident to the purchase or shipment initially paid by ThermoGenesis and to be borne by Distributor hereunder. Distributor shall make all payments to ThermoGenesis under this Agreement in United States dollars in immediately available funds to a bank account designated by ThermoGenesis in such invoice, or otherwise designated by ThermoGenesis in writing. Distributor shall not take any credits or offsets against amounts billed Distributor by ThermoGenesis without ThermoGenesis’ prior written consent.

 

 

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4.6     Shipping; Risk of Loss.

 

4.6.1     All Product(s) delivered by ThermoGenesis pursuant to this Agreement shall be suitably packed for surface or air shipment, in Distributor’s sole discretion, in ThermoGenesis’ standard shipping cartons, marked for shipment to such location or locations as Distributor may designate, and delivered to Distributor or its carrier, EXW, ThermoGenesis’ Point of Shipment. Risk of loss of Product(s) shall pass to Distributor upon delivery to the carrier at the EXW Point of Shipment.

 

4.6.2     ThermoGenesis shall ship all Product(s) in accordance with Distributor’s delivery instructions specified in Distributor’s purchase orders; provided, however, that if Distributor does not provide delivery instructions with respect to the carrier to be used, ThermoGenesis may use its customary carrier. Partial shipments are allowed. All freight, insurance and other shipping expenses, as well as any special packing expenses, shall be paid by Distributor. Distributor shall also bear all applicable taxes and duties that may be assessed against the Product(s) and parts after delivery to the carrier EXW, ThermoGenesis’ Point of Shipment.

 

4.6.3     ThermoGenesis shall use its good faith efforts to ship the Product(s) within a reasonable amount of time after receipt and acceptance of Distributor’s purchase order for the Product(s), consistent with ThermoGenesis’ shipping procedures in place from time to time. All shipments of Product(s) shall be deemed to conform to the relevant purchase order unless ThermoGenesis receives from Distributor, no later than fifteen (15) days after the receiving date of a given shipment, written notice specifying the shipment, the purchase order number and the exact nature of the discrepancy between the shipment and the order.

 

5.        WARRANTIES; REMEDIES FOR NON-CONFORMING PRODUCT.

 

5.1  Standard Warranty. ThermoGenesis’ standard warranty is attached hereto as Exhibit C.

 

5.2     Customer Warranty. Distributor shall have the right to pass on to their Customers the Product(s) warranties set forth in Section 5.1, except for the BioArchive System. For the BioArchive System, the Distributor shall have the right to pass on to their Customers the Product(s) warranties as set for in Section 5.1 for a period of three years from the date of purchase of the BioArchive System. After three years, prior to passing ThermoGenesis’ standard warranty to their Customer, the Distributor shall pay ThermoGenesis a fee of $6,000 USD and allow ThermoGenesis the right to inspect the BioArchive System prior to sale or installation to ensure it has been stored and handled correctly. The inspection will be at the sole discretion of ThermoGenesis and it will be the Distributors responsibility to repair or replace any damage discovered during the inspection. This cost will be in addition to the $6,000 USD inspection fee. A copy of the Product(s) warranty will be included in ThermoGenesis’ packaging of the Product(s) and parts.

 

 

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5.3     Return Materials Procedure. There are no rights of return for cash. Product(s) returns are allowed under ThermoGenesis’ warranty program. All Product(s) returns must be approved by ThermoGenesis and assigned a Return Material Authorization (“RMA”) number. To obtain an RMA number prior to return, the Distributor shall notify ThermoGenesis of the description of the Product(s), quantity, reason for return, serial number of device and date of purchase of Product(s) to be returned. All Product(s) returns from Distributor shall be sent directly to ThermoGenesis and be insured by Distributor. The RMA number shall be prominently displayed on the outside of the shipping box and the Product(s) shall be packaged to protect them from shipping damage. Repair for costs of damage due to improper packaging will be the responsibility of the Distributor.

 

6.         ADDITIONAL OBLIGATIONS OF DISTRIBUTOR.

 

6.1    Compliance with Laws. Distributor shall comply in all material respects with the laws and regulations (including, without limitation, health and safety regulations) applicable to the marketing, distribution, sale and service of Product(s) within the Territory. Distributor shall monitor the appropriate information sources in the Territory for material changes in such laws and regulations relating to the distribution of Product(s) within the Territory and notify ThermoGenesis in writing of all such material changes. The Distributor shall have a defined process for tracking customer shipments by lot and/or serial number to assist ThermoGenesis in event of a field corrective action.

 

6.2      Registrations, Licenses and Permits (other than CE Marks). If and as required from time to time under the laws of any province or state within the Territory, Distributor shall, at its expense, apply for and use its commercially reasonable efforts to obtain all registrations, licenses and permits that Distributor deems necessary to market, distribute, sell and service the Product(s) within such Territory, at no charge if ThermoGenesis makes a distribution partner change. Distributor shall furnish to ThermoGenesis copies of all applications, and all registrations, licenses and permits obtained therefrom, for the Product(s). Upon the expiration or earlier termination of this Agreement, such registrations, licenses and permits shall be transferred to ThermoGenesis or to a Person reasonably designated by ThermoGenesis, to the extent permitted by the terms of such registrations, licenses or permits and by applicable law, and ThermoGenesis shall reimburse Distributor for the expenses reasonably incurred to transfer the same.

 

 

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6.3     U.S. Export Controls. Distributor understands and acknowledges that ThermoGenesis is subject to regulation by agencies of the United States Government, including, without limitation, the United States Department of Commerce and the U.S. Food and Drug Administration, which prohibit export or diversion of certain products and technology to certain countries. Any and all obligations of ThermoGenesis to provide the Product(s), documentation, or any media in which any of the foregoing is contained, as well as any other technical assistance shall be subject in all respects to such United States laws and regulations as shall from time to time govern the license and delivery of technology and products abroad by Persons subject to the jurisdiction of the United States, including the Export Administration Act of 1979, as amended, any successor legislation, and the Export Administration Regulations issued by the Department of Commerce, Bureau of Export Administration. Distributor agrees to cooperate with ThermoGenesis, including, without limitation, providing required documentation, in order to obtain export licenses or exemptions therefrom.

 

6.4     Customer Notification. ThermoGenesis will be responsible for initiating product recalls. Distributor shall be responsible for notifying Customers of Product(s) and part recalls. Distributor shall submit a written report to ThermoGenesis of the recall status of the Product(s) or parts.

 

6.5    Customer Database Distributor shall provide to ThermoGenesis a customer database within three (3) months of execution of this contract and update the database at least once per year to include end user customer name, contact name, address, e-mail, phone number.

 

6.5.1     Quarterly Sales Analysis Report. Distributor shall provide a quarterly sales analysis containing relevant device and disposable product data, including part number, unit quantity, and selling price for all customers in the Territory. The sales analysis report will be sent to ThermoGenesis on or before thirty (30) days following the last day of ThermoGenesis’ fiscal year quarter. ThermoGenesis fiscal quarters are defined as January to March - 3^rd quarter, April to June - 4^th quarter, July to September - 1^st quarter and October to December - 2^nd quarter.

 

6.6     Development of the Cord Blood Processing, Cryopreservation and Storage Market Distributor will exert commercially reasonable best efforts to market, sell, distribute, and service the Product(s) in the Territory, consistent with the commercial efforts that Distributor would use to market and service its other products, and shall maintain a competent and adequate sales and technical service force trained in the marketing, sales, maintenance, and repair of the Product(s).

6.6.1     Distributor will utilize sufficient resources to develop and expand the installed base of Products in the assigned Territory and will hire, train and manage any necessary additional dedicated sales and technical service personnel to achieve the annual minimum sales unit Quota as defined in Exhibit F.

 

6.6.2     Distributor shall maintain a training program for sales and application support personnel in connection with demonstrations, use and sale of the Product(s), troubleshooting and problem resolution, and attend such scientific and clinical training programs, trade shows, exhibits and sales meetings in the Territory annually as may be agreed upon by Distributor and ThermoGenesis. In conjunction with ThermoGenesis, Distributor will establish, manage, and make a reasonable financial contribution to facilitate an annual BioArchive Users Group meeting in a different country each year of the Distribution Agreement. The purpose of the BioArchive Users Group will be to provide "real life" opportunities for sharing scientific and technical best practices learning from the shared experience of the members and shall provide other functions such as speakers at group meetings.

 

 

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6.7      No Conflicting Commitments. Distributor may not enter into any third party commitments or contracts with end-user customers for ThermoGenesis product sales or service and repair that supersedes or conflicts with the terms and conditions of Agreement.

 

7.         OBLIGATIONS OF THERMOGENESIS.

 

7.1       Compliance with Laws. ThermoGenesis shall comply in all material respects with all laws and regulations within the United States applicable to the manufacture, labeling, packaging and sale of the Product(s).

 

7.2     Support. ThermoGenesis shall provide consultation to Distributor concerning technical aspects and use of the Product(s) from time to time as reasonably requested by Distributor. Post warranty technical support and service assistance shall be provided to Distributor as described in Exhibit B, attached and incorporated herein.

 

7.3      Scientific and Technical Information. ThermoGenesis shall provide to Distributor scientific and technical information available to ThermoGenesis and required for Distributor to obtain any registrations, licenses and permits required for the sale and distribution of the Product(s) within the Territory, or to respond to inquiries from Customers, or governmental or regulatory authorities.

 

7.4      Product(s) Training. ThermoGenesis shall provide Product(s) training for Distributor’s product managers and clinical application support specialists on an as-needed basis to enable Distributor to promote the sale of Product(s) and parts and to perform post-sale field service, customer training, technical assistance and support for its Customers. Such Product(s) training shall be conducted, at ThermoGenesis’ election, at ThermoGenesis’ facilities or at Distributor’s facilities in Territory, and will be free of charge, provided, however, that Distributor shall be responsible for all out-of-pocket expenses incurred in connection with such Product(s) training, including travel, airfare and lodging expenses incurred by Distributor’s personnel while attending such training in California. In the case that ThermoGenesis provides training at Distributor’s facilities in Territory at Distributor’s request, Distributor will be responsible for all costs incurred in connection with such training (to be charged on a day-by-day basis), and including the reimbursement of out-of-pocket expenses reasonably incurred by ThermoGenesis in sending a training representative to the Distributor’s facilities in Territory. In addition, ThermoGenesis will provide Product(s) updates and service bulletins as they become available.

 

 

 

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7.5    Information Reporting. ThermoGenesis shall provide to Distributor, at ThermoGenesis’ expense, (i) information regarding any discovered defects in the Product(s), or any malfunction or deterioration in the performance of the Product(s), and (ii) any inadequacy in the labeling or the instructions for use. Distributor is responsible for disseminating the information to customers and service representatives as appropriate.

 

7.6      Responsible Person. Distributor shall notify the competent authorities in Territory that it has been designated as the person responsible for the marketing and distribution of the Product(s) within the Territory, and Distributor's address for notice purposes in Section 12.4 shall be the registered place of business for such purposes.

 

8.        JOINT OPERATING COMMITTEE

 

8.1     Upon the Effective Date, ThermoGenesis and Distributor shall establish a joint operating committee (“JOC”). The JOC shall be comprised of two (2) members appointed by ThermoGenesis and two (2) members appointed by Distributor. The JOC shall have the duties and responsibilities set forth in this Section.

 

8.2    The JOC shall discuss and work to reach consensus on the management and administration of the responsibilities and obligations of the Parties under the Agreement. If the JOC is unable to reach consensus on a matter, the issue shall be resolved by the senior most executives of the Parties responsible for the division administering the Agreement. If such senior executives cannot reach consensus and resolution, the Parties shall continue to comply with the express terms of the Agreement, and each Party shall have the right to decide how to proceed within each Party’s respective area of responsibility.

 

8.3    The JOC will meet no less than four (4) times a year, either in person or via video conferencing to review, among other things, sales performance, progress on sales metrics, the operating plan and budget, on hand inventory levels, customer usage information, and make such adjustments and changes as are agreed to by the Parties.

 

9.        REPRESENTATIONS AND WARRANTIES OF THE PARTIES.

 

9.1      ThermoGenesis. ThermoGenesis hereby represents and warrants to Distributor that:

 

9.1.1     ThermoGenesis is a corporation duly incorporated, validly existing and in good standing under the laws of the State of Delaware, and has all corporate power and authority to own, lease and operate its properties and to carry on its businesses as it is currently being conducted. ThermoGenesis has all necessary corporate power and authority to enter into this Agreement and to perform its obligations hereunder. This Agreement has been duly authorized, executed and delivered by ThermoGenesis.

 

 

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9.1.2     The execution, delivery and performance by ThermoGenesis of this Agreement and the consummation of the transactions contemplated hereby do not violate or conflict with the Certificate of Incorporation or Bylaws of ThermoGenesis, any material contract, agreement or instrument to which ThermoGenesis is a party or by which it or its properties are bound, or any judgment, decree, order or award of any court, governmental body or arbitrator by which ThermoGenesis is bound, or any law, rule or regulation applicable to ThermoGenesis.

 

9.1.3     ThermoGenesis is the sole, exclusive and lawful owner of all right, title and interest in and to the applicable ThermoGenesis technology incorporated in the Product(s) (“Applicable ThermoGenesis Technology”) and to the ThermoGenesis Marks, free and clear of all liens, claims, security interests or other restrictions or encumbrances. If this is an exclusive agreement, ThermoGenesis has not granted to any other Person any license, franchise or other rights to acquire, use or exploit the Applicable ThermoGenesis Technology within the Territory (or any portion thereof). ThermoGenesis has the right to grant the distribution and other rights to Distributor hereunder, without the consent of any other Person.

 

9.2      Distributor. Distributor hereby represents and warrants to ThermoGenesis that:

 

9.2.1     Distributor is a company duly organized and existing under the laws of Territory, and has all power and authority to own, lease and operate its properties and to carry on its businesses as currently conducted. Distributor has all necessary power and authority to enter into this Agreement and to perform its obligations hereunder. This Agreement has been duly authorized, executed and delivered by Distributor.

 

9.2.2    The execution, delivery and performance by Distributor of this Agreement and the consummation of the transactions contemplated hereby do not violate or conflict with the Certificate of Incorporation or Bylaws of Distributor, any material contract, agreement or instrument to which Distributor is a party or by which it or its properties are bound, or any judgment, decree, order or award of any court, governmental body or arbitrator by which Distributor is bound, or any law, rule or regulation applicable to Distributor.

 

9.2.3     Distributor and its Affiliates have the distribution facilities and personnel reasonably necessary to perform its functions and otherwise carry out its obligations under the terms of this Agreement.

 

9.2.4     Except as disclosed on Schedule 9.2.4, no owner of Distributor or its Affiliates are employed with, have any employment relationship or is independent contractor with ThermoGenesis.

 

 

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10.      TERM AND TERMINATION.

 

10.1   Term. The term of this Agreement shall commence on the Effective Date hereof and shall continue for three (3) years, unless earlier terminated pursuant to Section 10.2. This Agreement may be renewed for successive two (2) year periods by written notice from ThermoGenesis at least ninety (90) days prior to expiration of the then current term of this Agreement.

 

10.2    Termination of Agreement. This Agreement may be terminated as follows:

 

10.2.1     The parties may terminate this Agreement upon their mutual written agreement.

 

10.2.2     ThermoGenesis may immediately terminate this Agreement if Distributor breaches any of its material representations, warranties, covenants, annual growth minimums, payment terms or obligations under this Agreement.

 

10.2.3     Distributor may terminate this Agreement if ThermoGenesis breaches any of its material representations, warranties, covenants or obligations under this Agreement and such breach continues for a period of sixty (60) days following ThermoGenesis’ receipt of written notice from Distributor setting forth the nature of such breach; provided, however, that in the event such breach is not cured within such sixty (60) day period, Distributor may not terminate this Agreement if ThermoGenesis promptly commences to cure such breach within such sixty (60) day period and thereafter diligently pursues such cure to completion; provided further, however, that the cure period for any such breach shall not exceed ninety (90) days from the date of ThermoGenesis’ receipt of written notice from Distributor.

 

10.2.4     Either party may terminate immediately this Agreement by written notice upon the occurrence of any of the following events: (i) the other party is or becomes insolvent or unable to pay its debts as they become due within the meaning of the United States Bankruptcy Code (or any successor statute) or any analogous foreign statute; or (ii) the other party appoints or has appointed a receiver for all or substantially all of its assets, or makes an assignment for the benefit of its creditors; or (iii) the other party files a voluntary petition under the United States Bankruptcy Code (or any successor statute) or any analogous foreign statute; or (iv) the other party has filed against it an involuntary petition under the United States Bankruptcy Code (or any successor statute) or any analogous foreign statute, and such petition is not dismissed within ninety (90) days.

 

10.2.5     ThermoGenesis may terminate this agreement if Distributor fails to purchase Quota commitments on Exhibit F, and if this issue fails to be resolved in good faith discussions between ThermoGenesis and Distributor within a ninety (90)-day period following notice by ThermoGenesis to Distributor of such failure.

 

10.2.6     ThermoGenesis may terminate this agreement if Distributor fails to complete clinical application specialist support and technical service training within three (3) months from Effective date of Agreement.

 

 

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10.3    Effect of Termination.

 

10.3.1     The expiration or earlier termination of this Agreement shall not relieve any party of any of its rights or liabilities arising prior to or upon such expiration or earlier termination.

 

10.3.2     Within ten (10) business days following the effective date of the expiration or earlier termination of this Agreement, Distributor shall provide to ThermoGenesis a complete inventory of Product(s) and parts in Distributor’s possession, in transit between Distributor’s authorized locations or in transit to Distributor from ThermoGenesis or otherwise in Distributor’s control. ThermoGenesis may inspect Distributor’s Product(s) inventory and audit Distributor's records in the manner provided herein above.

 

10.3.3     Notwithstanding the expiration or earlier termination of this Agreement, Distributor may continue to market, distribute and sell Product(s) and parts within the Territory after the expiration or earlier termination of this Agreement until the earlier of (i) the date that Distributor has sold all of its Product(s) inventory existing as of the effective date of expiration or earlier termination and (ii) the six (6)-month anniversary of the effective date of expiration or earlier termination.

 

10.3.4      Notwithstanding Section 10.3.3, upon the expiration or earlier termination of this Agreement, Distributor may not enter into any new service contracts as an authorized service provider; provided, however, that Distributor may continue to provide service and repairs under existing service contracts through the then current terms of such contracts. Distributor may not renew such existing contracts, and upon the expiration of the then current term shall transfer each such contract to ThermoGenesis. Additionally, Distributor shall not be reimbursed for warranty work performed after the expiration or termination of this Agreement unless pre-approved by ThermoGenesis. ThermoGenesis and Distributor shall work together and perform further actions as needed to transition all aspects of Product(s) service to ThermoGenesis so that Customers’ service and warranty needs are met after the expiration or termination of this Agreement.

 

10.4     Return of Marketing Materials. Distributor shall return to ThermoGenesis all promotional materials for Product(s) previously furnished by ThermoGenesis and in Distributor’s possession at the time that Distributor is no longer entitled to distribute and sell any Product(s) hereunder and at this time Distributor shall no longer use the designations “Authorized Distributor” and “Authorized Service Provider” in connection with ThermoGenesis’ Product(s) on its business cards, stationery and other printed materials.

 

10.5    Force Majeure. Neither party shall be liable to the other party for non-performance of or delay in performing its obligations hereunder to the extent that performance is rendered impossible by strike, riot, war, acts of God, earthquake, fire, flood, governmental acts or orders or restrictions, failure of suppliers, or any other reason to the extent that the failure to perform is beyond the reasonable control of the non-performing party.

 

 

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11.      CONFIDENTIALITY.

 

11.1   Confidentiality. Each party acknowledges that, in the course of performing its duties and obligations under this Agreement, certain information that is confidential or proprietary to such party (“Confidential Information”) will be furnished by the other party or such other party’s representatives. Each party agrees that any Confidential Information furnished by the other party or such other party’s representatives will not be used by it or its representatives except in connection with, and for the purposes of, the promotion, marketing, distribution and sale of Product(s) and parts under this Agreement and, except as provided herein, will not be disclosed by it or its representatives without the prior written consent of the other party. Notwithstanding the foregoing, the parties agree that all Confidential Information shall be clearly marked “CONFIDENTIAL” or, if furnished in oral form, shall be stated to be confidential by the party disclosing such information at the time of such disclosure and reduced to a writing by the party disclosing such information which is furnished to the other party or such other party's representatives within forty-five (45) days after such disclosure.

 

11.2    Exceptions. The confidentiality obligations of each party under Section 11.1 do not extend to any Confidential Information furnished by the other party or such other party’s representatives that (i) is or becomes generally available to the public other than as a result of a disclosure by such party or its representatives, (ii) was available to such party or its representatives on a non-confidential basis prior to its disclosure thereto by the other party or such other party’s representatives, (iii) was independently developed without the use of the other party’s Confidential Information by representatives of such party who did not have access to the other party’s Confidential Information, as established by contemporaneous written records, or (iv) becomes available to such party or its representatives on an non-confidential basis from a source other than the other party or such other party’s representatives; provided, however, that such source is not bound by a confidentiality agreement with the other party or such other party's representatives.

 

11.3   Compelled Disclosure. In the event that either party or its representatives are requested or become legally compelled (by oral questions, interrogatories, requests for information or document subpoena, civil investigative demand or similar process) to disclose any Confidential Information furnished by the other party or such other party’s representatives or the fact that such Confidential Information has been made available to it, such party agrees that it or its representatives, as the case may be, will provide the other party with prompt written notice of such request(s) so that the other party may seek a protective order or other appropriate remedy and/or waive compliance with the provisions of this Agreement. In the event that such protective order or other remedy is not obtained, or that the other party waives compliance with the provisions of this Agreement, such party agrees that it will furnish only that portion of such Confidential Information that is legally required and will exercise its best efforts to obtain reliable assurance that confidential treatment will be accorded to that portion of such Confidential Information and other information being disclosed.

 

 

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11.4   Ownership of Confidential Information. The party disclosing or otherwise furnishing Confidential Information to the other party will retain the exclusive ownership of all right, title and interest in and to such Confidential Information.

 

11.5     Survival. The obligations of the parties under this Section 11 shall survive the expiration or earlier termination of this Agreement for a period of three (3) years.

 

12.       GENERAL PROVISIONS.

 

12.1    Independent Contractors. The relationship of ThermoGenesis and Distributor established by this Agreement is that of independent contractors, and nothing shall be deemed to create or imply any employer/employee, principal/agent, partner/partner or co-venturer relationship, or that the parties are participants in a common undertaking. Neither party may direct or control the activities of the other party or incur or assume any obligation on behalf of the other party or bind such other party to any obligation for any purpose whatsoever.

 

12.2     Governing Law. This Agreement and all acts and transactions pursuant hereto and the rights and obligations of the parties hereto shall be governed, construed and interpreted in accordance with the laws of the State of California, without reference to rules of conflicts or choice of laws. Any dispute or issue arising hereunder, including any alleged breach by Distributor, not resolved pursuant to Section 12.13 shall be heard, determined and resolved by an action commenced in the federal or state courts in Sacramento, California, which the parties hereby agree shall have the exclusive jurisdiction over the issues and the parties. Distributor hereby agrees to submit itself to the jurisdiction of the federal and state courts in Sacramento, California and waives the right to make any objections based on the exclusive jurisdiction or venue in such courts. The California courts shall have the right to grant all relief to which each party is or shall be entitled hereunder, including all equitable relief as the Court may deem appropriate. Distributor hereby consents to service of process by registered mail.

 

12.3     Entire Agreement. This Agreement, including the Exhibits, sets forth the entire agreement and understanding of the parties relating to the subject matter hereof and supersedes all prior oral and written, and all contemporary oral, negotiations, agreements and understandings with respect to the same.

 

 

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12.4     Notices. All notices, requests, claims, demands and other communications hereunder shall be in writing and shall be given (and shall be deemed to have been duly given upon receipt) by delivery in person, by email, by facsimile, or by registered or certified mail (postage prepaid, return receipt requested), to the other party at the following address (or at such other address for which such party gives notice hereunder):

 

If to Distributor:	____________________________
	____________________________
	____________________________
	Attn: _______________________ Title: ________________________
	Telephone:
	Facsimile:
If to ThermoGenesis	ThermoGenesis
	2711 Citrus Rd.
	Rancho Cordova, CA 95742
	Attn: Vivian Liu, COO
	Telephone: 1 (916) 858-5100
	Facsimile: (916) 858-5199

 

 

 

12.5     Assignment and Binding Effect. Except as otherwise provided in this Agreement, neither party may, directly or indirectly, assign its rights or delegate its duties under this Agreement without the prior written consent of the other party. No permitted assignment of rights or delegation of duties under this Agreement shall relieve the assigning or delegating party of its liabilities hereunder. For purposes of this Agreement, either party shall be deemed to have assigned this Agreement if any Person other than an Affiliate of such party purchases or otherwise acquires more than 50% of the outstanding voting securities of such party or more than 50% of the total assets of such party. This Agreement is binding upon, and inures to the benefit of, the parties and their respective successors and permitted assigns.

 

12.5.1     Change of Control. Notwithstanding the provisions of Section 12.5, an assignment by ThermoGenesis as a result of a Change of Control shall not require Distributor’s prior written consent. Distributor shall receive a written statement within ten (10) business days of the effective date of the Change of Control confirming if the new owner will take ownership of Agreement or if Agreement will be terminated.

 

 

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12.6     Partial Invalidity. If any provision of this Agreement is held to be invalid by a court of competent jurisdiction, then the remaining provisions shall remain, nevertheless, in full force and effect. The parties agree to renegotiate in good faith any term held invalid and to be bound by the mutually agreed substitute provision in order to give the most approximate effect intended by the parties.

 

12.7      No Waiver; Amendment. No waiver of any term or condition of this Agreement shall be valid or binding on any party unless agreed to in writing by the party to be charged. The failure of either party to enforce at any time any of the provisions of the Agreement, or the failure to require at any time performance by the other party of any of the provisions of this Agreement, shall in no way be construed to be a present or future waiver of such provisions, nor in any way affect the validity of either party to enforce each and every such provision thereafter. This Agreement may not be amended or modified except by the written agreement of the parties other than the amendment of Exhibit(s) A and F, which may be modified by ThermoGenesis on the intervals provided in this Agreement.

 

12.8     Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original and all of which, taken together, shall constitute one instrument.

 

12.9     Consent Not Unreasonably Withheld. No party given the right to approve or consent to any matter shall unreasonably withhold condition or delay its approval or consent. The failure to respond in writing within any specified time period shall be deemed unconditioned approval of or consent to the relevant matter, provided that the party requesting such approval or consent gives written notice requesting a response at least two (2) business days prior to the expiration of the specified time period, if any.

 

12.10   Construction; Interpretation. The headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. Any section, recital, exhibit, schedule and party references are to this Agreement unless otherwise stated. No party, nor its counsel, shall be deemed the drafter of this Agreement for purposes of construing the provisions of this Agreement, and all provisions of this Agreement shall be construed in accordance with their fair meaning, and not strictly for or against any party.

 

12.11   Further Assurances. Each party agrees to cooperate fully with the other and execute such instruments, documents and agreements and take such further actions to carry out the intents and purposes of this Agreement.

 

12.12   Press Releases and Announcements. Except as may be contemplated hereunder, neither party may issue any press release or make any public announcement concerning the transactions contemplated by this Agreement without the prior consent of the other party, except for any releases or announcements which may be required by or, in such party’s discretion, reasonably necessary under applicable law, in which case the party proposing to make such release or announcement will allow the other party a reasonable opportunity to review and comment on such release or announcement in advance of such issuance or making.

 

 

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12.13   Alternative Dispute Resolution.

 

12.13.1     In the event of any controversy, dispute or claim arising out of or in connection with this Agreement, the parties will endeavor to negotiate a mutually satisfactory solution. If a mutually satisfactory solution cannot be reached, the dispute shall, at either party’s written demand, be finally settled by arbitration in accordance with the Rules of Arbitration of the International Chamber of Commerce (“Rules”) by one arbitrator appointed in accordance with such Rules. The arbitration shall take place in Sacramento, California. The arbitration shall be held in the English language. The decision of the arbitrator shall be final and binding upon the parties and their respective personal representatives, heirs, devisees, successors and assigns.  Judgment may be entered on the arbitrator’s award in any court having proper jurisdiction.  The costs of arbitration, including attorneys’ fees, shall be awarded by the arbitrator to the prevailing party. 

 

12.13.2  Each party agrees that service of any process, summons, notice or document by U.S. registered mail to such party’s respective address set forth above shall be effective service of process for any action, suit or proceeding with respect to any matters for which it has submitted to jurisdiction pursuant to Section 12.2 [Governing Law]. Both Parties waive application of the procedures for service of process pursuant to the Hague Convention for Service Abroad of Judicial and Extrajudicial Documents.

 

12.13.3     The arbitrator shall be authorized to apportion its fees and expenses and the reasonable attorney’s fees and expenses of the parties as the arbitrator deems appropriate. In the absence of any such apportionment, the prevailing party in any arbitration or other proceeding shall be entitled, in addition to any other rights and remedies it may have, to reimbursement for its expenses, including court costs and reasonable fees of attorneys and other professionals.

 

12.13.4     The parties agree that this Section 12.13 has been included to resolve rapidly and inexpensively any claims or disputes between them with respect to this Agreement, and that this Section 12.13 shall be grounds for dismissal of any action commenced by any party in any court with respect to any controversy, dispute or claim arising out of or relating to this Agreement (or the breach hereof).

 

12.14   Governing Language. The English language version of this Agreement shall control in any dispute between the parties.

 

 

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12.15   Distribution of Competitive Products. Distributor agrees not to, directly or indirectly distribute competitive products of ThermoGenesis’ Products as defined in Exhibit A during the term of Agreement and two (2) years thereafter.

 

 

IN WITNESS WHEREOF, each of the undersigned has caused this Agreement to be duly executed.

 

 

ThermoGenesis:		ThermoGenesis
		/s/ Vivian Liu
		Vivian Liu COO
		Date:
DISTRIBUTOR:		Boyalife W.S.N.
		/s/ Lisa Li
		Name: Lisa Li
		Title:
		Date:

 

 

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SCHEDULE 9.2.4

DISCLOSURE OF EMPLOYMENT OR INDEPENDENT

CONTRACTOR RELATIONSHIPS

 

Name:
Relationship:
Phone Number:

 

 

Description:

 

 

 

If there is more than one employment disclosure, please provide the relative information below.

 

 

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EXHIBIT A

PRODUCT LINES & PRICING

 

BioArchive^® System

 

DESCRIPTION	PART NUMBER	LIST PRICE	DISTRIBUTOR DISCOUNT	DISTRIBUTOR PRICE US$
BioArchive System
BioArchive System-110V	8-4000-0	[*]	[*]	[*]
BioArchive System-220V	8-4000-1	[*]	[*]	[*]
Each BioArchive include:
1 BioArchive Unit
1 User Interface Computer w/Software, stand & Printer
2 Controlled Rate Freezer Units
1 Retrieval Cartridge Unit
1 Bar Code Label Printer w/ Morpher & Roll of Labels
1 Hand held Bar Code Scanner
1 Magnetic Retrieval Device
Accessories
Monitor, BioArchive Gui 17in. Flat Screen	1-00-164	[*]	[*]	[*]
Barcode scanner, hand held, USB	1-00-352	[*]	[*]	[*]
Printer, Inkjet, USB	1-00-353	[*]	[*]	[*]
Ribbon, Thermal Transfer, Eltron Printer Universal	2-00-001	[*]	[*]	[*]
Needle Positioning Jig	6-57-018	[*]	[*]	[*]
Canister Opening Tool, 100 per box	7-01-140	[*]	[*]	[*]
Fill/Seal Jig	7-63-051	[*]	[*]	[*]
Controlled Rate Freezing Module	7-65-009	[*]	[*]	[*]
Retrieval Cartridge	7-65-074	[*]	[*]	[*]
Manual Retrieval Device	7-80-001	[*]	[*]	[*]
Advanced Overwrap Sealing System (110V)	8-6200-0	[*]	[*]	[*]
Advanced Overwrap Sealing System (220V)	8-6200-1	[*]	[*]	[*]
Disposables
Bar Code Label Set (1000/roll)	6-01-036	[*]	[*]	[*]
Canister Sleeves (100 per box)	6-16-202	[*]	[*]	[*]
Overwrap Bags (100/box)	7-01-150	[*]	[*]	[*]
25ml Canisters (100 per box)	8-4360	[*]	[*]	[*]

 

 

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 BioArchive^® System (Continued) 

DESCRIPTION	PART NUMBER	LIST PRICE USD	DISTRIBUTOR DISCOUNT	DISTRIBUTOR PRICE USD
Spare Parts
Power Cord, IEC 60320 C13 to Type L, 2.5m (8ft)	50077	[*]	[*]	[*]
Power Cord, IEC 60320 C13 to Type D, 2.5m (8ft)	50078	[*]	[*]	[*]
Power Cord, IEC 60320 C13 to Type J, 2.5m (8ft)	50080	[*]	[*]	[*]
Power Cord, IEC 60320 C13 to Type H, 2.5m (8ft)	50081	[*]	[*]	[*]
Power Cord, IEC 60320 C13 to Type K, 2.5m (8ft), Hospital Grade	50149	[*]	[*]	[*]
Assembly, Thermistor Bundle/Guide Tube, Multivolt BioArchive	70052	[*]	[*]	[*]
Clamp Unit Assembly, Centron, Metal Gears	70101	[*]	[*]	[*]
Clamp Unit Assembly, Centron, Metal Gears, RFB	70101-RFB	[*]	[*]	[*]
Assy, UPS, OPTI, RoHS, Multivolt BA	70154	[*]	[*]	[*]
Spare, Periscope, BioArchive	710003	[*]	[*]	[*]
Non-RoHS Spare, Assy, Mounted E-stop CSD Board, BioArchive	710012	[*]	[*]	[*]
Assy, Pcb Bracket, Minor Lid	710013	[*]	[*]	[*]
Fuse 6.30A 5x20mm SB	1-00-120	[*]	[*]	[*]
USB to 2-Port PS/2, Splitter Cable Converter	1-00-360	[*]	[*]	[*]
Computer Accessory Galil 4-axis Control	1-03-015	[*]	[*]	[*]
Print Station, Barcode Labe, 100-240V, 60/60HZ	1-03-049	[*]	[*]	[*]
Fan, Whisper, 80 Cfm	1-15-022	[*]	[*]	[*]
Fan, Whisper, 80cfm, 230v 50/60 Hz	1-15-029	[*]	[*]	[*]
Opto, T Mount	1-19-004	[*]	[*]	[*]
Fuse 400mA 5x20mm SB	1-27-063	[*]	[*]	[*]
Fuse 3.15A 5x20mm SB	1-27-064	[*]	[*]	[*]
Fuse 200mA 5x20mm SB	1-27-065	[*]	[*]	[*]
Holder Fuse 5 X 20 Panel Mount	1-27-066	[*]	[*]	[*]
Power Transformer 115/230v, 50/60hz	1-33-020	[*]	[*]	[*]
Pwr Cord, Na, 10A, 3.05M, Hspt	1-54-052	[*]	[*]	[*]
Cord, Argentina, 250V	1-55-004	[*]	[*]	[*]
Core, Continental Europe, 230V	1-55-005	[*]	[*]	[*]
Cord Great Britain, 250V	1-55-007	[*]	[*]	[*]
Pins, Pin Tool, gage 0.023 OD	3-12-015	[*]	[*]	[*]
Pins, Pin Tool, gage 0.024 OD	3-12-016	[*]	[*]	[*]
Valve, Solenoid, Cryogenic	4-36-097	[*]	[*]	[*]
Valve, Relief, Cryogenic	4-36-098	[*]	[*]	[*]
Hose, Transfer Ln2, 1/2in Flare To 3/8in Npt, 6'	4-43-013	[*]	[*]	[*]
Thermistor Bundle, 48in, Teflon	6-00-031	[*]	[*]	[*]
Vent Tube Reservoir Heat Sink	6-00-140	[*]	[*]	[*]
Clamp Unit Assy, Centron, Altered, Refurbished	6-40-001-RFB	[*]	[*]	[*]
Gear Minor Lid Drive	6-55-113	[*]	[*]	[*]

 

 

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Cover, Gear, Major Lid	6-57-017	[*]	[*]	[*]
Kit, BioArchive Update SMS 4.0 & DOLN2 V2.0	7-00-001	[*]	[*]	[*]

 

  

  BioArchive^® System (Continued)

 

DESCRIPTION	PART NUMBER	LIST PRICE USD	DISTRIBUTOR DISCOUNT	DISTRIBUTOR PRICE USD
Periscope Evaporative Sponge Kit	7-00-195	[*]	[*]	[*]
Assy, Computer, BioArchive	7-00-202	[*]	[*]	[*]
Spare Embedded Controller Assy., BioArchive	710004	[*]	[*]	[*]
Embedded Controller Upgrade Kit	70096	[*]	[*]	[*]
Overwrap System, Kapton Kit	7-00-254	[*]	[*]	[*]
ASM, CSD Microcontroller	7-00-255	[*]	[*]	[*]
ASM, FC Microcontroller	7-00-256	[*]	[*]	[*]
ASM, LID Microcontroller	7-00-259	[*]	[*]	[*]
Assy, LN2 In-line Filter, 3/8 FPT (In) x 3/8 MPT (Out)	7-00-269	[*]	[*]	[*]
ASSY, UPS, 220-240VAC, 50/60HZ, OPTI	7-00-300	[*]	[*]	[*]
ASSY, UPS, 100-120V, 50/60HZ, OPTI	7-00-301	[*]	[*]	[*]
Harness, Crf Right	7-34-096	[*]	[*]	[*]
Harness, Crf Left	7-34-097	[*]	[*]	[*]
Harness, Periscope Signal	7-34-099	[*]	[*]	[*]
Harness, Lid Motor	7-34-100	[*]	[*]	[*]
Harness, Minor Signal	7-34-103	[*]	[*]	[*]
Cable, Heater Split	7-34-133	[*]	[*]	[*]
Motor Driver Harness	7-34-149	[*]	[*]	[*]
Motor Step Harness	7-34-150	[*]	[*]	[*]
Cable, Ln2 Fill Solenoid	7-34-151	[*]	[*]	[*]
Harness, Dewar Signal III	7-34-152	[*]	[*]	[*]
Assy, Crf Fan	7-35-065	[*]	[*]	[*]
Assy, Prot Motor	7-35-066	[*]	[*]	[*]
Assy, Plin Motor	7-35-067	[*]	[*]	[*]
Power Supply, Complete, Ln2	7-35-074	[*]	[*]	[*]
Assy, Motor Bracket, Minor Lid	7-35-077	[*]	[*]	[*]
Assy, Motor Bracket, Major Lid	7-35-078	[*]	[*]	[*]
Assy, Switch, Mushroom	7-35-084	[*]	[*]	[*]
Assy, Power Supply, 24v	7-35-085	[*]	[*]	[*]
Assy, CSD Board W/Fill control	7-35-126	[*]	[*]	[*]
Motor Drive (prot/major/mino)	7-35-146	[*]	[*]	[*]
Motor Drive (plin)	7-35-147	[*]	[*]	[*]
Control Board Assy, Centron, Modified	7-36-075	[*]	[*]	[*]
Plug Crf Slot	7-47-075	[*]	[*]	[*]
Assy, Vent Tube, Insulated	7-63-046	[*]	[*]	[*]

 

 

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Assy, Thermistor Bundle/Guide Tube	7-63-123	[*]	[*]	[*]
Refurbished Periscope Assy Ln2	7-65-001-RFB	[*]	[*]	[*]

 

 

  BioArchive^® System (Continued)

 

DESCRIPTION	PART NUMBER	LIST PRICE USD	DISTRIBUTOR DISCOUNT	DISTRIBUTOR PRICE USD
Hook Mech Assy Ln2	7-65-006	[*]	[*]	[*]
Refurbished, Assy, Controlled Rate Freezer	7-65-009-RFB	[*]	[*]	[*]
Assy, Linear Actuator, Plin	7-65-082	[*]	[*]	[*]
Thermistor Bundle, Micro-Pod	7-68-003	[*]	[*]	[*]
Tool, Plug, Crf	9-72-062	[*]	[*]	[*]
Assembly, Calibration Tool, Rack Height	9-72-147	[*]	[*]	[*]
Tool, Rotational Alignment, Assembly	9-72-342	[*]	[*]	[*]
Tool, Calibration, Height Switch Assembly	9-72-346	[*]	[*]	[*]
Tool, Canister Offset, Assy	9-72-347	[*]	[*]	[*]

 

 

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EXHIBIT A

PRODUCT LINES & PRICING

 

AXP^® AutoXpress™ System

DESCRIPTION	PART NUMBER	LIST PRICE USD	DISTRIBUTOR DISCOUNT	DISTRIBUTOR PRICE USD
AXP Cell Preparation Device	8-5102	[*]	[*]	[*]
Docking Station Main	8-5103	[*]	[*]	[*]
Counter Weight	8-5104	[*]	[*]	[*]
Weight Kit	8-5109	[*]	[*]	[*]
Device Stand	8-5108	[*]	[*]	[*]
Weight Compensation Cap	7-00-186	[*]	[*]	[*]
ABC Switch Box	8-5120	[*]	[*]	[*]
Adapter, 101-102 mm Round Bucket (Pack of 2)	8-5113	[*]	[*]	[*]
Adapter, Sorvall 11754/11297 Buckets (Pack of 2)	8-5114	[*]	[*]	[*]
Sorvall 11754 Bucket Pads (Pack of 2)	8-5155	[*]	[*]	[*]
Wireless Barcode Scanner	8-5106	[*]	[*]	[*]
AXP Operator Manual, English	37-00-101	[*]	[*]	[*]
Print Station Barcode Label	1-03-049	[*]	[*]	[*]
Battery Replacement Kit	710015	[*]	[*]	[*]
Battery Pack, 3 Cell, 3.6v	70149	[*]	[*]	[*]
Label Barcode LN2 Canister	8-5121	[*]	[*]	[*]
Freezing/Processing Bag Labels	8-5124	[*]	[*]	[*]
Startup Accessory Kit	8-5100	[*]	[*]	[*]
Component Retaining Clip Set	8-5148	[*]	[*]	[*]
Assy, Power Cable DB15	7-00-176	[*]	[*]	[*]
Assy, Serial Cable, Shielded	7-00-262	[*]	[*]	[*]
Pad, Bracket, Bottom	6-00-193	[*]	[*]	[*]
AXP Software License for 3 Years (up to 6 devices)	N/A	[*]	[*]	[*]
AXP Software License per year	N/A	[*]	[*]	[*]

 

Consumable Supplies
AXP Disposable Blood Processing Set.  Sold per case (24 bag sets)	8-5101	AXP Bagset Pricing Annual Volume <100,000 100,000 200,000 300,000 400,000	Pricing/Unit [*] [*] [*] [*] [*]

 

 

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		500,000	[*]
AXP QC Bag. Sold per case (10 units)	8-5110	[*] per unit

  

 

 

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EXHIBIT A-1

PRODUCTS

 

 

Product	Field of Use	Territory
AXP Platform	The practice of stem cell isolation and collection from umbilical cord blood.	Effective Immediately: Singapore Indonesia Philippines
BioArchive System	The practice of cryopreservation and archiving of stem cells for future transplant and treatment.
		Conditional Appointment: People’s Republic of China (excluding Hong Kong and Taiwan)   India

 

 

Note: Notwithstanding Section 2, and without limiting ThermoGenesis’ rights under Section 10.2, in the event that Distributor fails to meet the Quotas as outlined in Exhibit F, then Distributor’s rights under this agreement shall thereafter be non-exclusive.

 

 

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EXHIBIT B

Post Warranty Technical Support and Service Assistance

 

	1.	Technical Support via telephone, fax, or e-mail as per the following:

a)

Service Support Fee: US$ 10,000

1.

20 hours of support per year

2.

25% Discount on spare parts

3.

One Training for two (2) Engineers per year

b)

Non Contracted Service Support:

1.

4 hours of free support/yr. After that it will be chargeable at US$125.00 per hour

2.

10% discount on spare parts (usual)

3.

Engineer Training Fee: US$1,000.00

 

 

2. Service Assistance is available as follows:

 

Distributor’s service representative should attempt to resolve issue first and may request technical support via telephone, fax, or e-mail if necessary, subject to the rates listed above. If unsuccessful at resolving issue, Distributor may request an on-site visit by a ThermoGenesis Service Specialist. All expenses for this visit, including ThermoGenesis Field Service Engineer labor rates, will be the responsibility of the Distributor.

 

 

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EXHIBIT C

Limited Warranty

 

Warranty

ThermoGenesis warrants to the original purchaser that the unit will be free from defects in materials or workmanship for one year from the date of shipment, except for the BioArchive System. For the BioArchive System ThermoGenesis warrants to the original purchaser that the unit will be free from defects in material or workmanship for two years from the date of shipment or one year from the date of installation, whichever occurs first. ThermoGenesis also warrants that spare parts will be free from defects in material workmanship for a period of ninety (90) days, with the exception of the BioArchive periscope which has a one year warranty, or the maximum time required by applicable local law, from the date of shipment of the spare part. Equipment failure due to reasons other than manufacturing defects such as accident, misuse or failure to timely perform scheduled maintenance in accordance with the maintenance schedule included with the operating instructions for the unit is excluded from Warranty coverage. This Warranty covers the cost of parts needed to make Warranty repairs. ThermoGenesis reserves the right to replace any malfunctioning unit or part with a new or refurbished unit in lieu of repairing such unit. This Warranty and ThermoGenesis’ obligation to repair or replace defective parts is the sole and exclusive remedy of purchaser. Under no circumstances shall ThermoGenesis be liable for consequential or economic damages that might arise from a defective part.

 

ThermoGenesis warranties, as set forth herein, are exclusive and are in lieu of, and purchaser hereby waives, all other warranties, express or implied, including, without limitation, any implied warranties of merchantability of fitness for a particular purpose or warranty of non-infringement.

 

Procedure

If Warranty repairs are needed, contact the vendor or distributor from which you purchased your ThermoGenesis product(s), or if you purchased directly from ThermoGenesis or are unable to locate the appropriate vendor/distributor, contact ThermoGenesis directly at ThermoGenesis, 2711 Citrus Road, Rancho Cordova, CA 95742, Telephone: (916) 858-5100 or (800) 783-8357 in the U.S.; Fax: (916) 858-5199. For emergency repairs at night or on weekends or holidays, contact your ThermoGenesis Authorized Service Provider (“Service Provider”) directly and notify ThermoGenesis on the next business day. Failure to notify ThermoGenesis on the next business day after a request for emergency repairs may result in denial of coverage for that service call. When calling for service have available: (1) detailed information about the problem; (2) the serial number of the unit; (3) the service record for the unit; (4) the date and place of purchase of the unit.

 

Limitations. Equipment or spare part malfunctions other than those caused by defects in materials or workmanship, including malfunctions caused by misuse, accident or failure to perform scheduled maintenance, are excluded from coverage. Any alterations or modifications made to the unit (other than modifications or alterations made by ThermoGenesis) render the warranty null and void. ThermoGenesis will not be responsible for any consequential or incidental damages resulting from equipment malfunction or loss of use of the equipment. ThermoGenesis may authorize independent contractors to perform service. Service providers are independent contractors, not ThermoGenesis employees; consequently, ThermoGenesis is not responsible for the acts or omissions of the service providers, including without limitation, failure by a service provider to respond to calls for emergency service in a timely fashion.

 

 

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EXHIBIT D

Medical Devices Vigilance System

 

It is the Distributor’s responsibility to:

 

Establish procedures associated with product identification, traceability, handling, storage, packaging, preservation, and delivery. The distributor shall ensure that its employees are adequately trained on said procedures.

 

The distributor shall maintain shipment records for Company products that include consignee name and address, part numbers, lot numbers and serial numbers.

 

The distributor shall promptly report product complaints to the Company in accordance with timeliness requirements specified in the contract.

 

The distributor shall ensure that all local, regional, and national regulatory requirements are met in the countries to which the contract applies.

 

The above four responsibilities ensure that ThermoGenesis Therapeutics and the Distributor are in compliance with the MDD 93/42/ECC and with European Medical Device Reporting Regulations (MEDDEV 2.12/1, Rev 7).

 

ThermoGenesis Therapeutics will notify the Competent Authorities and the Notified Body of any adverse incidents that meet the criteria described in MDD Article 10. Systematic procedures for receiving and investigating customer complaints and for filing medical event (or near event) reports with appropriate Competent Authorities are in place. As necessary, based on review of such events and experience gained from device usage, appropriate corrective action is implemented.

 

If a Distributor becomes aware of a product complaint, notify ThermoGenesis and ThermoGenesis’ European Union Representative for Medical Device Reporting (EU Rep.) within twenty-four (24) hours.

 

Please complete and return a copy of the attached product complaint form within twenty-four (24) hours of learning of a product complaint, product malfunction, or patient injury to:

 

ThermoGenesis:

ThermoGenesis, 2711 Citrus Road, Rancho Cordova, CA 95742, USA, Telephone No. 916-858-5100 and Fax No, 916-858-5199; and

 

EU Rep.:

Medical Device Safety Service, Schiffgraben 41, 30175, Hanover, Germany Tel: +49-511-6262 8630, Fax: +49-511-6262 8633, e-mail: mdssgmbh@tonline.de, Internet: www.mdss.com; Contact: Ludgar Moller

 

 

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EXHIBIT E

PAYMENT TERM

 

 

Net seventy-five (75) days from date of invoice. Delinquent accounts shall incur a charge of the greater of one and one half percent (1 ½ %) of the outstanding balance per month or the maximum legal rate.

 

Furthermore, in the event of delinquency, ThermoGenesis reserves the right, at its sole discretion, to change the payment terms and may require full or partial prepayment for subsequent orders.

 

 

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EXHIBIT F

QUOTAS

 

 

 

Thermo 8-5101

AXP Disposable Processing Sets

50,000 bags

 

 

 

 

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EXHIBIT G

SERVICE REPORTING REQUIREMENTS

 

Date of Service:			Product Name:
Customer:			Model:
Contact Name:			Serial #:
Tel #:			Service Representative:

 

---

---

Description of Complaint/ Problems Found:

 

Service Performed/Actions Taken:

 

Resolution/Testing:

 

 

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Parts Used:

 

 

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EXHIBIT H

 

COMPLAINT REPORTING FORM

 

FIELD 1: CUSTOMER / PRODUCT INFORMATION

Date of Initial Contact:                         

Complainant Facility:                              

Name of Complainant:                         

Complainant Telephone Number:                          

Product Name:                                 Model:                            Serial Number:                                 

Lot Number (if applicable):                             

Assigned Investigator:                             

Severity Classification: ☐ Catastrophic    ☐Minor   ☐ Major    ☐ Critical

Complaint Communicated Via: ☐ E-Mail    ☐ Fax    ☐ Form

 

FIELD 2: COMPLAINT INFORMATION

Call Type:                                                                  Event Date:                                

Description of Complaint:                                                                                   

Location of failure:                                                                                                                

Step in process where failure occurred:                                            

Will the product be returned for evaluation?

☐ YES, RMA #                

☐ NO, provide reason:                

 

FIELD 3: SAFETY EVENT INFORMATION

3a. Was a Death or Injury sustained?

☐ YES - SAFETY COMPLAINT, complete section 3b*.

☐ NO - Is a death or injury possible? ☐ YES* ☐ NO

* Notify QS Management Representative or Designee

3b. Injury Information (if applicable):

Event Date:                                Time:                       ☐ a.m. ☐ p.m. ☐ Unknown

Type of Injury:      ☐ Death      ☐ Serious Injury      ☐ Other:                                  

Persons(s) Affected: Number:                                          

☐ User/Operator   ☐ Patient   ☐ Serviceperson   ☐ Bystander

Additional Information:                                                                                            

 

 

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FIELD 4: COMPLAINT ENTRY

Complaint Report Completed by:                                                               Date:                                             

Complaint Received and Entered into CHS by:                                       Date:                                             

Complaint File Number:                                                                              (Reference ThermoGenesis Control Number 340023 [A])

 

 

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EXHIBIT I

 

LOCALIZED DEPOT SERVICE CENTER QUALITY REQUIREMENTS

 

 

1.0           QUALITY SYSTEM REQUIREMENTS FOR DISTRIBUTORS

 

1.1

This Distributor agreement adds a quality set of requirements for the consistent supply of product(s) and/or service(s) through ThermoGenesis’ Distributor(s).

1.1.1

The Distributor must maintain active quality systems and conduct activities in compliance with applicable laws and regulations including, but not limited to instructions agreed to between the parties, applicable procedures, national, state and local laws/regulations/ ordinances/standards, and applicable regulatory requirements. These specifically include, but are not limited to:

 

●

Good Distribution and Storage Practice

●

Good Manufacturing Practice

●

ISO 9001 or ISO 13485.

●

Quality Management System to include:

- Quality Manual

- Critical Process Standard Operating Procedures

- Document controls

- Record controls

- Training procedures

- Process controls

- Identification and Traceability

- Facility controls

- Equipment – calibration and maintenance

- Compliant handling and reporting

- Labeling controls

 

1.1.2

The Distributor shall manage procedures relevant to ThermoGenesis’ projects/services to a documented Quality Management System (“QMS”) and ensure traceability of equipment, materials, personnel, products, processes, etc. Distributor shall keep records, the longer of, agreed to or required by regulations, and number of years.

1.1.3

Documentation and records pertaining to ThermoGenesis products, processes, or supporting activities must be made available to ThermoGenesis in a reasonable period of time when requested for review.

 

 

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1.1.4

These Quality requirements will be effective immediately and be effective for the remaining term of the distribution agreement.

 

2.	COMMUNICATION

2.1

Each Party will notify the other Party’s Primary Contact of any issues that impact the ability to conduct ThermoGenesis contracted activities. ThermoGenesis’ primary quality contact is the most senior manager in the Quality Assurance function.

 

 

 

3.	ADMINISTRATIVE INFORMATION

3.1

Organizational Structure: Distributor must maintain an adequate number of qualified personnel to perform and supervise ThermoGenesis activities and to meet quality and regulatory requirements.

3.1.1

Personnel must have the appropriate education, experience and be adequately trained on procedures applicable to their responsibilities. This training must be in a formal training program.

3.1.2

There must be mandatory regulatory compliance training for new employees and refresher training with sufficient frequency to ensure employees remain familiar with requirements.

3.1.3

This training must be documented and available for review.

 

 

 

4.	MANUFACTURING AND LOGISTICS

4.1

General:

4.1.1

ThermoGenesis will provide documents that pertain to the work that the Distributor will be performing. Distributor agrees to comply with mutually agreed requirements.

4.1.2

Equipment and facility qualification will be the responsibility of Distributor and may be reviewed by ThermoGenesis during audits.

4.1.3

Servicing, packaging and shipping will be performed according to procedures provided by ThermoGenesis or as mutually agreed.

4.2

Audits:

4.2.1

Distributor must allow ThermoGenesis employees or representative’s access to the facility to observe various operations and assist in problem solving to ThermoGenesis “issues.” Any such “in plant visits” will be coordinated in advance by both Parties

4.2.2

Distributor agrees to host audits by ThermoGenesis as required by ThermoGenesis policy. ThermoGenesis will provide Distributor sufficient notice of an audit.

 

 

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4.2.3

At the conclusion of the audit, an closing meeting will be held with representatives from ThermoGenesis and Distributor to discuss significant audit findings. A written audit report will be provided to Distributor. Distributor shall respond to audit findings within thirty days and detail the corrective action plans and timeframes for correction.

4.3

Facilities, Utilities, and Equipment:

4.3.1

Facilities, utilities and equipment must be qualified and validated for the work being performed.

4.3.2

Distributor must have a preventive maintenance (“PM”) program for all critical systems, utilities, manufacturing equipment and test instrumentation and equipment. Documentation must include a record of the type and frequency of testing.

4.3.3

Any utilities that could impact product/service quality are qualified and appropriately monitored.

4.3.4

Distributor must have a procedure for cleaning equipment.

4.3.5

Distributor must have a procedure for the operation and maintenance of computerized systems. The procedure must include periodic re-verification of system access privileges.

4.3.6

Distributor must have a written procedure for the issuance of parts and lot numbers that are used in regulatory documentation so that materials are uniquely identified and traceable.

4.3.7

Distributor must have a suitable storage facility that protects the product from possible deterioration, interference, theft, cross contamination, intermixing with other materials, or accidental use of unreleased material.

 

 

 

5.	QUALITY CONTROL (“QC”)

5.1

No additional testing or modification/deviation from procedures may occur without written approval by the ThermoGenesis Quality Management.

5.2

Distributor will test ThermoGenesis products using only calibrated and qualified equipment with approved analytical methods.

 

 

 

6.	QUALITY ASSURANCE

6.1

General Procedures: Distributor’s Quality Management is responsible for generating and maintaining all procedures and other documentation supporting regulatory operations within its facility.

6.2

Record Retention: At least thirty calendar days prior to record destruction, Distributor will alert the ThermoGenesis Quality Management contact. ThermoGenesis may request that the documentation or portions of the documentation be forwarded to ThermoGenesis for archiving.

 

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.   Boyalife W.S.N. Intl Distribution Contract Agreement # TGS-004-90105 Page 43 of 44

 

6.3

Change Management:

6.3.1

Distributor must have a written, approved and effective procedure(s) for managing and tracking changes to quality system and regulatory records.

6.3.2

Proposed changes to project/service documentation may only be accepted with the written approval of ThermoGenesis and may require validation before the change may be implemented.

6.4

Complaint Handling:

6.4.1

Distributor will comply with all reasonable requests in connection with the investigation of any product/service complaint.

6.4.2

Distributor will forward each complaint to ThermoGenesis in a timely manner (with 3 days).

6.4.3

Distributor will do the initial MDR reportable assessment. If a reportable event is probable, the distributor is required to notify ThermoGenesis immediately (within 4 hours of the decision).

 

 

 

7.	REGULATORY COMPLIANCE.

7.1

Regulatory Inspections and Correspondence:

7.1.1

Distributor must notify the ThermoGenesis Quality Contact immediately (within four hours) when any regulatory agency inspection is commencing involving ThermoGenesis.

7.1.2

Distributor will allow a ThermoGenesis representative to be present

7.1.3

A notice of any kind from any regulatory agency, the Distributor is required to make contract with ThermoGenesis immediately (within 1 business day).

7.1.4

ThermoGenesis will be solely responsible for all contacts and communications with any regulatory agencies with respect to all ThermoGenesis activities.

 

 

 

8.	RESOLUTION OF QUALITY-RELATED ISSUES

8.1

Quality-related issues will be discussed and resolved at the JOC.

 

 

[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.   Boyalife W.S.N. Intl Distribution Contract Agreement # TGS-004-90105 Page 44 of 44

 

9.	REMOVALS AND CORRECTIONS (RECALLS)

9.1

If either Party believes a removal, correction or other field action is warranted, that party will notify the other party in writing of the reasons an “action” is warranted.

9.2

Each Party shall within a reasonable time provide the other with a copy of any reports filed with the FDA or other regulatory agencies. Each party shall maintain records of all corrections or removals as required by law, and shall promptly provide the other party with a copy.

 

 

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