UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): November 22, 2019

 

THERMOGENESIS HOLDINGS, INC.

(Exact Name of Registrant as Specified in Charter)

 

 

 

 

 

   

Delaware

 

333-82900

 

94-3018487

(State or Other Jurisdiction

 

(Commission

 

(IRS Employer

of Incorporation)

 

File Number)

 

Identification No.)

 

 

 

   

2711 Citrus Road, Rancho Cordova, California

 

95742

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code (916) 858-5100

 

N/A
(Former Name or Former Address, if Changed Since Last Report)

 


 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

      ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

      ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

      ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

      ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Exchange Act:

 

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $.001 par value

 THMO

Nasdaq Capital Market 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

          Emerging growth company      ☐              

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.           ☐


 

 

 

 

Item 1.01.

Entry into a Material Definitive Agreement.

 

As previously disclosed in a Form 8-K filed on October 22, 2019, ThermoGenesis Holdings, Inc. f/k/a Cesca Therapeutics Inc. (the "Company”) on October 21, 2019 entered into a Joint Venture Agreement (the “JV Agreement”) with Healthbanks Biotech (USA) Inc., a stem cell bank network ("Healthbanks”), under which the Company and Healthbanks agreed to form a new company named ImmuneCyte Life Sciences Inc. ("ImmuneCyte”), which will develop, own and operate an immune cell banking business.  On November 22, 2019, the Company and Healthbanks closed the transaction contemplated by the JV Agreement, and in connection with the closing, the Company, Healthbanks, and ImmuneCyte entered into the following additional agreements on November 22, 2019:

 

 

Contribution Agreement:  The Company and ImmuneCyte entered into a Contribution Agreement (the “Contribution Agreement”) under which the Company contributed to ImmuneCyte the patents and trademarks relating to the Company’s clinical development assets as a result of the Company’s decision to discontinue its clinical development program, as well as the patents and trademarks relating to the Company’s inactive Res-Q product line. 

 

 

Supply Agreement:  The Company and ImmuneCyte entered into a Supply Agreement (the “Supply Agreement”) under which ImmuneCyte will have the exclusive worldwide right to purchase the Company’s proprietary cell processing equipment in the immune cell banking business and a non-exclusive right to purchase it for other cell-based contract development and manufacturing (CMO/CDMO) services. Under the Supply Agreement, the Company will supply to ImmuneCyte equipment, support and maintenance services at the Company’s cost plus 15%.  The Supply Agreement will have a 20-year term, subject to early termination by either party in the event of an uncured material breach, bankruptcy, insolvency, or certain other events.

 

 

Stockholders’ Agreement.  The Company, Healthbanks, and ImmuneCyte entered into a Stockholders’ Agreement (the “Stockholders’ Agreement”) which provides for certain restrictions on the ability of the Company and Healthbanks to transfer their stock in ImmuneCyte, including a prohibition on transfers to competitors.  The Stockholders’ Agreement also has a take-along provision that obligates an ImmuneCyte stockholder to participate in any sale transaction that is approved by the holders of a majority of ImmuneCyte stock and the ImmuneCyte board of directors.  As provided in the Stockholders’ Agreement, the Company will have the right to appoint at least one member of the board of directors of ImmuneCyte (until such time as ImmuneCyte receives an investment from an institutional investor in an amount in excess of $1.0 million at a pre-money valuation of at least $25 million), and the approval of all directors of ImmuneCyte will be required in order to effect any sale of ImmuneCyte or in order for ImmuneCyte to amend its Certificate of Incorporation, issue any additional equity securities, or increase or decrease the size of its board of directors.

 

The foregoing descriptions of the Contribution Agreement, Supply Agreement, and Stockholders’ Agreement  do not purport to be complete and are qualified in their entirety by reference to the full text of such agreements, which are attached hereto as Exhibits 10.1, 10.2, and 10.3, respectively, and incorporated herein by reference.

 

Item 7.01. Regulation FD Disclosure.

 

On November 26, 2019, the Company issued a press release announcing the closing of the above-described joint venture transaction. A copy of the press release is attached hereto as Exhibit 99.1.

 

 

 

 

Item 9.01.

Financial Statements and Exhibits.

   

(d) Exhibits

 

Exhibit No.

Description

   

Exhibit 10.1.

Supply Agreement, dated November 22, 2019, between ThermoGenesis Holdings, Inc. and ImmuneCyte Life Sciences Inc.

   

Exhibit 10.2

Contribution Agreement, dated November 22, 2019, between ThermoGenesis Holdings, Inc. and ImmuneCyte Life Sciences Inc.

   

Exhibit 10.3

Stockholder’s Agreement, dated November 22, 2019, among ThermoGenesis Holdings, Inc., Healthbanks Biotech (USA) Inc. and ImmuneCyte Life Sciences Inc.

   

Exhibit 99.1

Press Release, dated November 26, 2019.

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

   

THERMOGENESIS HOLDINGS, INC.

   

(Registrant)

     

Dated: November 27, 2019

 

 /s/ Xiaochun (Chris) Xu, Ph.D.

   

 Xiaochun (Chris) Xu, Ph.D.

 Chief Executive Officer

 (Principal Executive Officer)

 

 

Exhibit 10.1

 

 

 

 

THIS SUPPLY AGREEMENT (the “Agreement”) is made and entered into as of the 22nd day of November, 2019 (“Effective Date”), between ThermoGenesis Holdings, Inc. (“ThermoGenesis”), a Delaware corporation with principal office 2711 Citrus Road, Rancho Cordova, CA 95742, USA and ImmuneCyte Life Sciences Inc. (“ImmuneCyte”), a Delaware corporation with principal office at 185 Technology Drive Suite 150 Irvine, CA 92618.

 

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 AutoXpress®, POCXpress®, CAR-TXpress® and BioArchive® technology for the processing and cryostorage of biological and clinical substances, including the concentration and cryopreservation of tissue and blood components (together, the “ThermoGenesis Technology”).

 

B.     ImmuneCyte has facilities and experience in operating a cellular bank and intends to use ThermoGenesis Technology and Product (defined below) exclusively for its cell banking services worldwide and non-exclusively for other cellular process development and manufacturing services (CDMO) 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.

 

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.

 

Rev. S.

 

 

Page 2 of 28


 

Effective Date” means the date first written above.

 

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

 

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.

 

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.

 

“Term” means the time duration as stated in Section 2 of this Agreement.

 

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

 

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

 

2.        RIGHTS AND OBLIGATIONS.

 

2.1     Rights to Use the Products. ThermoGenesis enters into joint venture agreement with HealthBanks Biotech (USA) Inc. to form ImmuneCyte for immune cell banking and cell based contract development and manufacturing (CDMO) services. ThermoGenesis hereby grant ImmuneCyte full rights to use ThermoGenesis’ Product(s), and parts that are components thereof, for the Field of Use and Territory identified in Exhibit A. The rights and obligations as to use the Product(s), and parts that are components thereof, shall be effective as of the Effective Date of Agreement.

 

2.2      Term of Duration. Unless terminated earlier based on terms agreed by both parties, this agreement shall be considered perpetual from the Effective Date of this Agreement (the “Term”).

 

2.3     No Appointment of Sub-Distributors. Except for using for its own use, in its network, or by its affiliates, ImmuneCyte 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 ImmuneCyte’s rights hereunder, and any attempt to delegate to any such Person any or all of ImmuneCyte’s obligations hereunder shall be null and void, and will not bind ThermoGenesis.

 

Rev. S. 2  
 

 

 

Page 3 of 28


 

2.4     Use of ThermoGenesis Marks. ImmuneCyte may refer to and advertise itself as an “Authorized User” 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 User” 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). ImmuneCyte shall provide to ThermoGenesis a rolling quarterly forecast of ImmuneCyte'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 ImmuneCyte 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 ImmuneCyte will mutually determine the annual Quotas for each Product. Thereafter, ThermoGenesis retains the right to reevaluate the Quotas and, with ImmuneCyte, mutually determine and update the Quotas at least once per year or at such greater frequency as the parties may mutually agree in writing.

 

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

 

2.6     Trademark License. ThermoGenesis hereby grants to ImmuneCyte the non-exclusive, royalty-free right and license to use designated ThermoGenesis Marks associated with the Product(s) in connection with the distribution, technical service and support of the Product(s). ImmuneCyte 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, ImmuneCyte’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 ImmuneCyte any right, title or interest in the ThermoGenesis Marks, which right, title and interest shall remain fully and solely vested in ThermoGenesis. ImmuneCyte shall immediately notify ThermoGenesis if, during the term of this Agreement, ImmuneCyte 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 ImmuneCyte 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. ImmuneCyte may not duplicate, translate, decompile, reverse engineer or adapt the Product(s) without ThermoGenesis’ prior written consent.

 

Rev. S. 3  
 

 

 

Page 4 of 28


 

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

 

3.        APPOINTMENT AS SERVICE PROVIDER AND OBLIGATIONS.

 

3.1     Appointment as Authorized Service provider. ThermoGenesis hereby authorize ImmuneCyte as a non-exclusive service provider to repair and service the Product(s), and parts that are components thereof, including warranty service as applicable, within the Territory.

 

3.1.1     Localized Depot Service Center Quality Requirement. In addition to the obligations as stated in Agreement, ImmuneCyte 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 B).

 

3.2      Application Support Specialist and Technical Service Personnel Qualifications, Training, and Availability. Subject to Section 3.1.1, ImmuneCyte shall have qualified application support specialist and technical service personnel that have appropriate experience in the troubleshooting, problem solving, user 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 Product(s) 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 ImmuneCyte location. Special training qualification is required in order to perform installation and operator training of the Product(s).

 

3.3     Application Support Specialist and Technical Service Personnel Training. ThermoGenesis shall provide application support and technical service training for ImmuneCyte’s field service personnel to enable ImmuneCyte to perform post-installation troubleshooting problem solving user training and field service, technical assistance and support for its users, 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 ImmuneCyte’s facilities in Territory. ThermoGenesis will provide such training without charge; provided, however, that ImmuneCyte 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 ImmuneCyte’s facilities in Territory. In addition, ThermoGenesis will provide Product(s) updates and service bulletins as they become available in English.

 

Rev. S. 4  
 

 

 

Page 5 of 28


 

3.4     Facilities and Inventory; Repair and Replacement Parts Stock. Subject to Section 3.1.1, it will be ImmuneCyte’s responsibilitity to maintain sufficient spare parts, warehousing facilities and service centers within the Territory to fulfill the needs to maintain its cell processing and manufacturing services, including maintaining an adequate supply of extra spare units to be used in connection with service repairs in cases where a unit requires return to a manufacture site for repair.

 

3.5     Other Information Reporting. Subject to Section 3.1.1, ImmuneCyte shall provide to ThermoGenesis, at ImmuneCyte’s expense and in English, each and every quality and/or service complaint within three (3) business days after receipt of such complaint by using the Product(s). The complaint reporting form defined in Exhibit F should be used for reporting the information to ThermoGenesis. In addition, ImmuneCyte 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     Application Support and Field Service, Technical Assistance, Support and Warranty Service. ImmuneCyte shall provide to its network post-installation application support and field technical service, technical assistance and support for Product(s) used in the Territory. The cost of any field service or other support for any Product(s) performed by ImmuneCyte after the expiration of the applicable warranty period for such Product(s) shall be agreed upon between ImmuneCyte and the users, unless such user had previously agreed to the cost prior to the date hereof, and in such case the cost shall be the previously agreed price until ImmuneCyte and ThermoGenesis agree on subsequent new price. ImmuneCyte shall document all service visits and work performed (as defined in Exhibit G) and ImmuneCyte shall furnish to ThermoGenesis copies of any written reports prepared by ImmuneCyte with respect to repairs made by ImmuneCyte to the Product(s). ImmuneCyte 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.

 

Rev. S. 5  
 

 

 

Page 6 of 28


 

4.2     Prices. All prices for Product(s) purchased by ImmuneCyte hereunder shall be Ex Works (EXW), ThermoGenesis’ Point of Shipment. The initial price to ImmuneCyte 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 ImmuneCyte for such Product(s) may be increased or decreased by ThermoGenesis upon sixty (60) days’ prior written notice to ImmuneCyte.

 

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 ImmuneCyte 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 ImmuneCyte’s invoice and paid by ImmuneCyte to ThermoGenesis, unless ImmuneCyte 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’ Website or by e-mail. ThermoGenesis shall notify ImmuneCyte in writing within a reasonable period of time from submission of the purchase order of any rejected order. ThermoGenesis shall have no liability to ImmuneCyte with respect to purchase orders that are not accepted.

 

4.5     Invoicing; Payment. ThermoGenesis shall submit an invoice to ImmuneCyte with each shipment of Product(s) ordered by ImmuneCyte. 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 ImmuneCyte’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 ImmuneCyte’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 ImmuneCyte hereunder. ImmuneCyte 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. ImmuneCyte shall not take any credits or offsets against amounts billed ImmuneCyte by ThermoGenesis without ThermoGenesis’ prior written consent.

 

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 ImmuneCyte’s sole discretion, in ThermoGenesis’ standard shipping cartons, marked for shipment to such location or locations as ImmuneCyte may designate, and delivered to ImmuneCyte or its carrier, EXW, ThermoGenesis’ Point of Shipment. Risk of loss of Product(s) shall pass to ImmuneCyte upon delivery to the carrier at the EXW Point of Shipment.

 

Rev. S. 6  
 

 

 

Page 7 of 28


 

4.6.2     ThermoGenesis shall ship all Product(s) in accordance with ImmuneCyte’s delivery instructions specified in ImmuneCyte’s purchase orders; provided, however, that if ImmuneCyte 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 ImmuneCyte. ImmuneCyte 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 ImmuneCyte’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 ImmuneCyte, 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     Omitted

 

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 ImmuneCyte 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 ImmuneCyte shall be sent directly to ThermoGenesis and be insured by ImmuneCyte. 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 ImmuneCyte.

 

6.        ADDITIONAL OBLIGATIONS OF IMMUNECYTE.

 

6.1     Compliance with Laws. ImmuneCyte shall comply in all material respects with the laws and regulations (including, without limitation, health and safety regulations) applicable to the distribution, use and service of Product(s) within the Territory. ImmuneCyte 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 ImmuneCyte shall have a defined process for tracking user shipments by lot and/or serial number to assist ThermoGenesis in event of a field corrective action.

 

Rev. S. 7  
 

 

 

Page 8 of 28


 

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, ImmuneCyte shall, at its expense, apply for and use its commercially reasonable efforts to obtain all registrations, licenses and permits that ImmuneCyte deems necessary to distribute and service the Product(s) within such Territory. ImmuneCyte 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 ImmuneCyte for the expenses reasonably incurred to transfer the same.

 

6.3     U.S. Export Controls. ImmuneCyte 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. ImmuneCyte agrees to cooperate with ThermoGenesis, including, without limitation, providing required documentation, in order to obtain export licenses or exemptions therefrom.

 

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

 

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

 

6.5.1     Quarterly Volume Analysis Report. ImmuneCyte shall provide a quarterly volume analysis containing relevant device and disposable product data, including part number and unit quantity for all users in the Territory. The volume 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 - 3rd quarter, April to June - 4th quarter, July to September - 1st quarter and October to December - 2nd quarter.

 

6.6      Development of the Immune Cell Processing, Cryopreservation and Storage Services ImmuneCyte will exert commercially reasonable best efforts to develop immune cell banking service in the Territory, and shall maintain a competent and adequate technical service force trained in the maintenance and repair of the Product(s).

 

Rev. S. 8  
 

 

 

Page 9 of 28


 

6.6.1     ImmuneCyte 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 technical service personnel to maintain its services.

 

6.6.2      Omitted.

 

6.7     No Conflicting Commitments. ImmuneCyte may not enter into any third party commitments or contracts that 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 ImmuneCyte concerning technical aspects and use of the Product(s) from time to time as reasonably requested by ImmuneCyte. Post warranty technical support and service assistance shall be provided to ImmuneCyte as described in Exhibit B, attached and incorporated herein.

 

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

 

7.4     Product(s) Training. ThermoGenesis shall provide Product(s) training for ImmuneCyte’s product managers and application support specialists on an as-needed basis to enable ImmuneCyte to promote the use of Product(s) and parts and to perform post-installation field service, user training, technical assistance and support for its users. Such Product(s) training shall be conducted, at ThermoGenesis’ election, at ThermoGenesis’ facilities or at ImmuneCyte’s facilities in Territory, and will be free of charge, provided, however, that ImmuneCyte 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 ImmuneCyte’s personnel while attending such training in California. In the case that ThermoGenesis provides training at ImmuneCyte’s facilities in Territory at ImmuneCyte’s request, ImmuneCyte 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 ImmuneCyte’s facilities in Territory. In addition, ThermoGenesis will provide Product(s) updates and service bulletins as they become available.

 

7.5     Information Reporting. ThermoGenesis shall provide to ImmuneCyte, 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. ImmuneCyte is responsible for disseminating the information to its users and service representatives as appropriate.

 

Rev. S. 9  
 

 

 

Page 10 of 28


 

7.6     Responsible Person. ImmuneCyte 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 ImmuneCyte'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 ImmuneCyte 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 ImmuneCyte. 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, the operating plan and budget, on hand inventory levels, user 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 ImmuneCyte 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.

 

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 ImmuneCyte hereunder, without the consent of any other Person.

 

Rev. S. 10  
 

 

 

Page 11 of 28


 

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

 

9.2.1     ImmuneCyte is a is a corporation duly incorporated, validly existing and in good standing under the laws of the State of Delaware, and has all power and authority to own, lease and operate its properties and to carry on its businesses as currently conducted. ImmuneCyte 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 ImmuneCyte.

 

9.2.2     The execution, delivery and performance by ImmuneCyte of this Agreement and the consummation of the transactions contemplated hereby do not violate or conflict with the Certificate of Incorporation or Bylaws of ImmuneCyte, any material contract, agreement or instrument to which ImmuneCyte 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 ImmuneCyte is bound, or any law, rule or regulation applicable to ImmuneCyte.

 

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

 

 

10.      TERM AND TERMINATION.

 

10.1    Term. The term of this Agreement shall commence on the Effective Date hereof and shall continue for twenty (20) years, unless earlier terminated pursuant to Section 10.2.

 

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 ImmuneCyte breaches any of its material representations, warranties, covenants, annual growth minimums, payment terms or obligations under this Agreement.

 

10.2.3     ImmuneCyte 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 ImmuneCyte setting forth the nature of such breach; provided, however, that in the event such breach is not cured within such sixty (60) day period, ImmuneCyte 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 ImmuneCyte.

 

Rev. S. 11  
 

 

 

Page 12 of 28


 

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 ImmuneCyte fails to complete application specialist support and technical service training within three (3) months from Effective date of Agreement.

 

10.2.6     ImmuneCyte may have the right to manufacturing the products for its own use if this contract is terminated based on 10.2.3, 10.2.4, or a Change of Control.

 

 

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, ImmuneCyte shall provide to ThermoGenesis a complete inventory of Product(s) and parts in ImmuneCyte’s possession, in transit between ImmuneCyte’s authorized locations or in transit to ImmuneCyte from ThermoGenesis or otherwise in ImmuneCyte’s control. ThermoGenesis may inspect ImmuneCyte’s Product(s) inventory and audit ImmuneCyte's records in the manner provided herein above.

 

10.3.3     Notwithstanding the expiration or earlier termination of this Agreement, ImmuneCyte may continue to use and distribute Product(s) and parts within the Territory after the expiration or earlier termination of this Agreement until the earlier of (i) the date that ImmuneCyte has consumed 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, ImmuneCyte may not enter into any new service contracts as an authorized service provider; provided, however, that ImmuneCyte may continue to provide service and repairs under existing service contracts through the then current terms of such contracts. ImmuneCyte may not renew such existing contracts, and upon the expiration of the then current term shall transfer each such contract to ThermoGenesis. Additionally, ImmuneCyte shall not be reimbursed for warranty work performed after the expiration or termination of this Agreement unless pre-approved by ThermoGenesis. ThermoGenesis and ImmuneCyte 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.

 

Rev. S. 12  
 

 

 

Page 13 of 28


 

10.4     Return of Marketing Materials. ImmuneCyte shall return to ThermoGenesis all promotional materials for Product(s) previously furnished by ThermoGenesis and in ImmuneCyte’s possession at the time that ImmuneCyte is no longer entitled to distribute any Product(s) hereunder and at this time ImmuneCyte shall no longer use the designations “Authorized ImmuneCyte” 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.

 

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.

 

Rev. S. 13  
 

 

 

Page 14 of 28


 

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.

 

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 ImmuneCyte 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 ImmuneCyte, 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. ImmuneCyte 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. ImmuneCyte 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.

 

Rev. S. 14  
 

 

 

Page 15 of 28


 

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 ImmuneCyte:

 

ImmuneCyte Life Sciences Inc.

   

185 Technology Drive, Suite 150
Irvine, CA 92618

   

Attn: Billie Ahluwalia

Principal Accounting Officer

Email: bahluwalia@healthbanks.us

     

If to ThermoGenesis

 

ThermoGenesis

   

2711 Citrus Rd.

   

Rancho Cordova, CA 95742

   

Attn: Jeff Cauble

Principal Accounting Officer

   

Email: jcauble@thermogenesis.com

     

 

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 ImmuneCyte’s prior written consent. ImmuneCyte 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.

 

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.

 

Rev. S. 15  
 

 

 

Page 16 of 28


 

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, 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.

 

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. 

 

Rev. S. 16  
 

 

 

Page 17 of 28


 

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.

 

 

[Remainder of Page Intentionally Left Blank]

 

Rev. S. 17  
 

 

 

Page 18 of 28


 

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

 

 

ThermoGenesis:

 

 ThermoGenesis

 
       
       
   

 /s/ Jeff Cauble

 
   

 Jeff Cauble

 Vice President of Finance and Principal Accounting Officer

 
       
   

 11/22/19

 
   

 Date:

 
       
       

ImmuneCyte:

 

 /s/ Billie Ahluwalia

 
   

 Billie Ahluwalia

 Principal Accounting Officer

 
   

 

 11/22/19

 
   

 Date:

 

 

Rev. S. 18  
 

 

 

Page 19 of 28


 

EXHIBIT A

PRODUCT LINES & PRICING

 

Products

 

For Immune Cell Banking Applications:

 

PXP-1000 System – an automated, fully closed cell separation system for isolating and retrieving immune cells from peripheral blood.

 

 

BioArchive® Automated Cryopreservation System – an automated, robotic, liquid nitrogen controlled-rate-freezing and cryogenic storage system for cord blood samples and cell therapeutic products used in clinical applications.

 

 

For Other BioBanking Applications:

 

AXP® Automated Cell Separation System – an automated, fully closed cell separation system for isolating and retrieving stem and progenitor cells from umbilical cord blood.

 

 

BioArchive® Automated Cryopreservation System – an automated, robotic, liquid nitrogen controlled-rate-freezing and cryogenic storage system for cord blood samples and cell therapeutic products used in clinical applications.

 

For Cell Based Contract Development and Manufacturing (CDMO):

 

CAR-TXpress™ Platform – a modular designed, functionally closed platform that addresses the critical unmet need for large scale cellular processing and chemistry, manufacturing and controls (CMC) needs for manufacturing chimeric antigen receptor (CAR) T cell therapies.

 

 

Pricing 

 

 

Product Price will be ThermoGenesis standard cost plus 15%.

 

 

Service work performed by ThermoGenesis employees will be billed at salary cost plus benefits (25%) plus a 15% surcharge.

 

 

Field of Use & Territory

 

 

Exclusive use of PXP-1000 product, accessories and its substitute for cell banking services, worldwide.

 

 

Non-exclusive use of all other products for cell based contract development and manufacture services (CDMO), worldwide.

 

Rev. S. 19  

 

 

 

 

Page 20 of 28


 

 

EXHIBIT B

 

LOCALIZED DEPOT SERVICE CENTER QUALITY REQUIREMENTS

 

 

1.           QUALITY SYSTEM REQUIREMENTS FOR IMMUNECYTES

 

 

1.1

ImmuneCyte agreement adds a quality set of requirements for the consistent supply of product(s) and/or service(s).

 

1.1.1

ImmuneCyte 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

ImmuneCyte 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. ImmuneCyte 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.

 

1.1.4

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

 

 

Rev. S. 20  
 

 

 

Page 21 of 28


 

 

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: ImmuneCyte 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 ImmuneCyte will be performing. ImmuneCyte agrees to comply with mutually agreed requirements.

 

4.1.2

Equipment and facility qualification will be the responsibility of ImmuneCyte 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

ImmuneCyte must allow ThermoGenesisemployees 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

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

 

4.2.3

At the conclusion of the audit, a closing meeting will be held with representatives from ThermoGenesis and ImmuneCyte to discuss significant audit findings. A written audit report will be provided to ImmuneCyte. ImmuneCyte 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.

 

 

Rev. S. 21  
 

 

 

Page 22 of 28


 

 

 

4.3.2

ImmuneCyte 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

ImmuneCyte must have a procedure for cleaning equipment.

 

4.3.5

ImmuneCyte 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

ImmuneCyte 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

ImmuneCyte 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

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

 

 

 

6.

QUALITY ASSURANCE

 

6.1

General Procedures: ImmuneCyte’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, ImmuneCyte will alert the ThermoGenesis Quality Management contact. ThermoGenesis may request that the documentation or portions of the documentation be forwarded to ThermoGenesis for archiving.

 

6.3

Change Management:

 

6.3.1

ImmuneCyte 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

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

 

6.4.2

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

 

 

Rev. S. 22  
 

 

 

Page 23 of 28


 

 

 

6.4.3

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

 

 

 

7.

REGULATORY COMPLIANCE.

 

7.1

Regulatory Inspections and Correspondence:

 

7.1.1

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

 

7.1.2

ImmuneCyte will allow a ThermoGenesis representative to be present

 

7.1.3

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

 

7.1.4

ImmuneCyte 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.

 

 

 

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.

 

Rev. S. 23  
 

 

 

Page 24 of 28


 

 

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. 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 ImmuneCyte from which you purchased your ThermoGenesis product(s), or if you purchased directly from ThermoGenesis or are unable to locate the appropriate vendor/ImmuneCyte, 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.

 

 

Rev. S. 24  
 

 

 

Page 25 of 28


 

 

EXHIBIT D

Medical Devices Vigilance System

 

It is ImmuneCyte’s responsibility to:

 

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

 

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

 

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

 

ImmuneCyte 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 and the ImmuneCyte are in compliance with the MDD 93/42/ECC and with European Medical Device Reporting Regulations (MEDDEV 2.12/1, Rev 7).

 

ThermoGenesis 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 user 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 ImmuneCyte 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 Holdings Inc., 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

 

 

Rev. S. 25  
 

 

 

Page 26 of 28


 

 

EXHIBIT E

PAYMENT TERM

 

 

Net sixty (60) 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.

 

 

Rev. S. 26  
 

 

 

Page 27 of 28


 

 

EXHIBIT F

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:                                                                                                                                      

 

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])

 

Rev. S. 27  
 

 

 

Page 28 of 28


 

 

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:

 

 

 

 

 

 

 

 

 

Parts Used:

 

 

 

 

 

 

 

 

 

 

Rev. S. 28  

 

Exhibit 10.2

 

CONTRIBUTION AGREEMENT

 

This Contribution Agreement (this “Agreement”) dated as of the 22nd day of November, 2019 (the “Effective Date”), is between ThermoGenesis Holdings Inc., a Delaware corporation formerly known as Cesca Therapeutics Inc. (“Contributor”), and ImmuneCyte Life Sciences Inc., a Delaware corporation (the “Company”).

 

1.     Assets. The Company hereby accepts from Contributor, and Contributor hereby transfers and conveys to the Company, free and clear of all liens, claims, and encumbrances, all of the assets listed on Exhibit A attached hereto (the “Assets”).

 

2.     No Representations. The Company is acknowledging that Contributor has not made, and disclaims any and all, representations and warranties to the Company with respect to the Assets, other than for Contributor’s representations (made hereby) that: (i) Contributor has sole, exclusive, good and marketable title free and clear of all liens to the Assets; and (ii) Contributor has all requisite corporate power and authority to execute, deliver and perform this Agreement and the transactions contemplated hereby, without violating any known third party rights, and when executed by Contributor, the Agreement will be enforceable against Contributor. The Company agrees that, subject to the foregoing representations, it is taking the Assets on an “as is”/ “where is” basis.

 

3.     Further Assurances. From and after the Effective Date, each party shall take all actions and duly execute and deliver or cause to be executed and delivered all instruments of sale, conveyance, transfer, assignment, or assumption, and all notices, releases, acquittances, and other documents that may be necessary or advisable to consummate the transactions contemplated in this Agreement, or more fully to sell, convey, transfer, assign, and deliver to and vest in Purchaser the Assets sold, conveyed, transferred, assigned, and delivered pursuant hereto or intended so to be.

 

4.     Miscellaneous. This Agreement constitutes the sole and entire agreement of Contributor and the Company with respect to the matters described herein and supersedes all prior and contemporaneous understandings and agreements, both written and oral, with respect to such matters. This Agreement may be amended or modified only by a written instrument signed by Contributor and the Company. Neither Contributor nor the Company may assign its rights or obligations hereunder without the prior written consent of the other. This Agreement shall be governed and construed in accordance with the laws of the State of Delaware, without regard to the conflicts of laws principles thereof.

 

 

 

[Signature Page Follows]

 

 

 

 

IN WITNESS WHEREOF, Contributor and the Company have caused this Agreement to be executed as of the Effective Date.

 

 

 

 

 

ThermoGenesis Holdings Inc. 

 

ImmuneCyte Life Sciences Inc.

 

   

 

 

 

 

           
   

 

 

 

 

By: /s/ Jeff Cauble

 

By:

/s/ Billie Ahluwalia

 

Name: Jeff Cauble

 

Name: Billie Ahluwalia

 

Title: Principal Accounting Officer      Title: Principal Accounting Officer  

 

Page 2 of 2

 

 

EXHIBIT A

 

Patents:

 

CESCA REF.

FILE NUMBER

TITLE

COUNTRY

STATUS

APPL. NO.

FILE DATE

PAT. NO.

GRANT DATE

CALC. EXP. DATE

AMI

P262641.CN-HK.01

RAPID INFUSION OF AUTOLOGOUS BONE MARROW DERIVED STEM CELLS

Hong Kong

Published

16105929.7

May 24, 2016

 

 

 

AMI

P262641.EP.01

RAPID INFUSION OF AUTOLOGOUS BONE MARROW DERIVED STEM CELLS

European Patent Office

To Be Abandoned

14738001.8

Jan 8, 2014

 

 

 

AMI

P262641.US.01

RAPID INFUSION OF AUTOLOGOUS BONE MARROW DERIVED STEM CELLS

U.S.A.

Issued

14/296,360

Jun 4, 2014

9,439,930

Sep 13, 2016

Jan 29, 2033

AMI

P262641.US.02

RAPID INFUSION OF AUTOLOGOUS BONE MARROW DERIVED STEM CELLS

U.S.A.

Issued

14/297,565

Jun 5, 2014

9,402,867

Aug 2, 2016

Jan 12, 2033

AMI

P262641.US.03

RAPID INFUSION OF AUTOLOGOUS BONE MARROW DERIVED STEM CELLS

U.S.A.

Issued

14/297,557

Jun 5, 2014

9,393,269

Jul 19, 2016

Jan 12, 2033

AMI

P262641.WO.01

RAPID INFUSION OF AUTOLOGOUS BONE MARROW DERIVED STEM CELLS

PCT

Completed

PCT/US2014/010745

Jan 8, 2014

 

 

 

AMI

P262641.WO-CN.01

RAPID INFUSION OF AUTOLOGOUS BONE MARROW DERIVED STEM CELLS

China

Issued

201480014602.0

Jan 8, 2014

ZL201480014602.0

Aug 27, 2019

 

AMI

P262641.WO-IN.01

RAPID INFUSION OF AUTOLOGOUS BONE MARROW DERIVED STEM CELLS

India

Pending

7120/DELNP/2015

Jan 8, 2014

 

 

 

AMI

P262641.WO-JP.01

RAPID INFUSION OF AUTOLOGOUS BONE MARROW DERIVED STEM CELLS

Japan

Issued

2015-552751

Jan 8, 2014

6525889

May 17, 2019

 

CLI

P262642.EP.01

INTRAMUSCULAR ADMINISTRATION OF AUTOLOGOUS BONE MARROW FOR TREATMENT

European Patent Office

To Be Abandoned

16789796.6

Apr 28, 2016

 

 

 

CLI

P262642.US.01

INTRAMUSCULAR ADMINISTRATION OF AUTOLOGOUS BONE MARROW FOR TREATMENT

U.S.A.

Completed

62/156,126

May 1, 2015

 

 

May 1, 2016

CLI

P262642.WO.01

INTRAMUSCULAR ADMINISTRATION OF AUTOLOGOUS BONE MARROW FOR TREATMENT

PCT

Completed

PCT/US2016/029863

Apr 28, 2016

 

 

 

CLI

P262642.WO-CN.01

INTRAMUSCULAR ADMINISTRATION OF AUTOLOGOUS BONE MARROW FOR TREATMENT

China

Published

201680038228.7

Apr 28, 2016

 

 

 

CLI

P262642.WO-IN.01

INTRAMUSCULAR ADMINISTRATION OF AUTOLOGOUS BONE MARROW FOR TREATMENT

India

Pending

201717039350

Apr 28, 2016

 

 

 

CLI

P262642.WO-US.01

INTRAMUSCULAR ADMINISTRATION OF AUTOLOGOUS BONE MARROW FOR TREATMENT

U.S.A.

Published

15/571,244

Apr 28, 2016

 

 

Apr 28, 2036

RES-Q

P264021.EP.01

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

European Patent Office

Issued

08878638.9

Dec 4, 2008

2376232

Mar 22, 2017

 

RES-Q

P264021.EP-DE.01

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

Germany

Issued

08878638.9

Dec 4, 2008

602008049404.7

Mar 22, 2017

 

 

Exhibit A Page 1 of 9

 

 

CESCA REF.

FILE NUMBER

TITLE

COUNTRY

STATUS

APPL. NO.

FILE DATE

PAT. NO.

GRANT DATE

CALC. EXP. DATE

RES-Q

P264021.EP-FR.01

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

France

Issued

08878638.9

Dec 4, 2008

2376232

Mar 22, 2017

 

RES-Q

P264021.EP-GB.01

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

UK

Issued

08878638.9

Dec 4, 2008

2376232

Mar 22, 2017

 

RES-Q

P264021.EP-HK.01

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

Hong Kong

Issued

12103643.1

Dec 4, 2008

1163009

Jun 1, 2018

 

RES-Q

P264021.WO.01

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

PCT

Completed

PCT/US2008/013377

Dec 4, 2008

 

 

 

RES-Q

P264021.WO-CN.01

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

China

Issued

200880132763.4

Dec 4, 2008

200880132763.4

Jul 22, 2015

 

RES-Q

P264021.WO-JP.01

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

Japan

Abandoned

2011-539483

Dec 4, 2008

5355707

Aug 20, 2013

 

RES-Q

P264021.WO-JP.02

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

Japan

Issued

2013-147790

Dec 4, 2008

5714063

Mar 20, 2015

 

RES-Q

P264021.WO-KR.01

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

Republic of Korea

Issued

10-2011-7015481

Dec 4, 2008

10-1609226

Mar 30, 2016

 

RES-Q

P264021.WO-MX.01

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

Mexico

Issued

MXA/2011/005876

Dec 4, 2008

329045

Mar 30, 2015

 

RES-Q

P264021.WO-MX.02

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

Mexico

Pending

MX/A/2014/009681

Dec 4, 2008

 

 

 

RES-Q

P264022.US.01

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

U.S.A.

Issued

12/315,722

Dec 4, 2008

8,177,072

May 15, 2012

Dec 4, 2028

RES-Q

P264022.US.02

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

U.S.A.

Issued

13/374,988

Jan 24, 2012

8,511,479

Aug 20, 2013

Dec 4, 2028

RES-Q

P264022.US.03

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

U.S.A.

Issued

13/374,983

Jan 26, 2012

8,506,823

Aug 13, 2013

Dec 4, 2028

RES-Q

P264022.US.04

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

U.S.A.

Issued

13/506,145

Mar 30, 2012

8,511,480

Aug 20, 2013

Dec 4, 2028

RES-Q

P264022.US.05

APPARATUS AND METHOD FOR SEPARATING AND ISOLATING COMPONENTS OF A BIOLOGICAL FLUID

U.S.A.

Issued

13/969,313

Aug 16, 2013

9,375,661

Jun 28, 2016

Dec 4, 2028

CXP

P264348.EP.01

Devices and Methods for Bio-Processing Cellular Samples

European Patent Office

Pending

18736645.5

Jan 8, 2018

 

 

 

CXP

P264348.US.01

Devices and Methods for Bio-Processing Cellular Samples

U.S.A.

Completed

62/443,785

Jan 8, 2017

 

 

Jan 8, 2018

CXP

P264348.WO.01

Devices and Methods for Bio-Processing Cellular Samples

PCT

Expired

PCT/US2018/012817

Jan 8, 2018

 

 

 

CXP

P264348.WO-CN.01

Devices and Methods for Bio-Processing Cellular Samples

China

Pending

201880016661.X

Jan 8, 2018

 

 

 

CXP

P264348.WO-US.01

Devices and Methods for Bio-Processing Cellular Samples

U.S.A.

Pending

16/475,952

Jan 8, 2018

 

 

Jan 8, 2038

 

Exhibit A Page 2 of 9

 

 

Trademarks:

 

T262473.IB.01

499658-00033

Cesca Therapeutics Inc.

CESCA THERAPEUTICS

International Bureau

(WIPO)

Registered

To Be Abandoned

1209995

May 6, 2014

1209995

May 6, 2014

 

010:

Medical devices and equipment, namely, containers sold empty for storing and thawing thermolabile products in the nature of blood, blood plasma, and derivatives from blood and fibrinogen.

 

T262472.US.01

499658-00013

Cesca Therapeutics, Inc.

CESCA THERAPEUTICS

United States of

America

Registered

 

86/310,884

Jun 16, 2014

5200261

May 9, 2017

 

010:

Medical devices and equipment, namely, automated blood and bone marrow processing systems comprised of electromechanical cell purification modules and companion disposable products, namely, polymer based sterilized medical bag sets comprised of a plasma bag, red blood cell bag and final product storage bag all sold empty and interconnected through a valve that enables the separation, processing and preservation of cell and tissue therapy products.

 

T262455.US.01

499658-00020

Cesca Therapeutics, Inc.

CESCA THERAPEUTICS & Design

 

United States of

America

Registered

 

86/310,928

Jun 16, 2014

5200262

May 9, 2017

 

010:

Medical devices and equipment, namely, automated blood and bone marrow processing systems comprised of electromechanical cell purification modules and companion disposable products, namely, polymer based sterilized medical bag sets comprised of a plasma bag, red blood cell bag and final product storage bag all sold empty and interconnected through a valve that enables the separation, processing and preservation of cell and tissue therapy products.

 
     

T262476.IB-EM.01

499658-00031

Cesca Therapeutics, Inc.

RES-Q

European Union

Registered

 

1093048

Sep 2, 2011

1093048

Aug 22, 2012

 

010:

Medical device that is used for isolation and capturing of biological cells from fluids and aspirates from humans.

 

T264223.IN.01

499658-00089

Cesca Therapeutics Inc.

RES-Q

India

Opposed

To Be Abandoned

2219946

Oct 14, 2011

 

 

010:

Medical device that is used for isolation and capturing of biological cells from fluids and aspirates from humans.

 

T262476.IB.01

499658-00031

Cesca Therapeutics, Inc.

RES-Q

International Bureau

(WIPO)

Registered

 

1093048

Sep 2, 2011

1093048

Sep 2, 2011

 

010:

Medical device that is used for isolation and capturing of biological cells from fluids and aspirates from humans.

 

Note: The lists above contain patents and trademarks for Res-Q. As part of a settlement agreement with Harvest (Terumo BCT) in an intellectual property infringement suit signed in June 2015, the Company has relinquished its rights to manufacture or sell Res-Q products in the United States. With the inclusion of these patents and trademarks, both parties agree that the joint venture has no right to and will not manufacture or sell Res-Q in the United States. Additionally, if the joint venture violates the settlement, it agrees to indemnify the Company of any potential legal ramifications.

 

Exhibit A Page 3 of 9

 

 

Exhibit 10.3

 

STOCKHOLDERS’ AGReEMENT

 

THIS STOCKHOLDERS’ AGREEMENT (this “Agreement”) is made and entered into effective as of the 22nd day of November, 2019 by and among ImmuneCyte Life Sciences Inc., a Delaware corporation (the “Company”), and each of the Stockholders named on Schedule A (the “Stockholders”).

 

WHEREAS, the Stockholders are the beneficial owners of shares of Capital Stock (as defined below) of the Company; and

 

WHEREAS, the Company and the Stockholders deem it to be in their best interests to provide for continuity in the control and operation of the Company to regulate certain of their rights in connection with their interests in the Company and to restrict the sale, assignment, transfer, encumbrance or other disposition of the equity securities of the Company owned or held by the Stockholders from time to time, and desire to enter into this Agreement in order to effectuate those purposes.

 

NOW, THEREFORE, in consideration of the mutual covenants set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are acknowledged, the Company and the Stockholders agree as follows:

 

1.     Definitions.

 

(a)     “Affiliate” shall mean with respect to any Person, any Person which, directly or indirectly, controls, is controlled by or is under common control with such Person, including, without limitation any partner, officer, director, or member of such Person.

 

(b)     “Board” means the Board of Directors of the Company.

 

(c)     “Capital Stock” means (i) shares of Common Stock (whether now outstanding or hereafter issued in any context), and (ii) shares of Common Stock issued or issuable upon exercise or conversion, as applicable, of warrants or other convertible securities of the Company, in each case now owned or subsequently acquired by any Stockholder or their respective successors or permitted transferees or assigns.

 

(d)     “Common Stock” means shares of Common Stock of the Company, par value $0.001 per share, regardless of whether such shares are Class A-1 Common Stock, Class A-2 Common Stock, or Class B Common Stock.

 

(e)     “Entity” means any general partnership, limited partnership, corporation, association, cooperative, joint stock company, trust, limited liability company, business trust, joint venture, unincorporated organization and governmental entity (or any department, agency or political subdivision thereof).

 

(f)     “Person” means any natural person, Entity or any other natural person or entity in its own or any representative capacity.

 

 

 

 

(g)     “Proposed Stockholder Transfer” means any proposed Transfer by any Stockholder; provided that a Proposed Stockholder Transfer shall not include (i) any merger, consolidation or like transfer effected pursuant to a vote of the holders of Capital Stock of the Company; (ii) any Transfer effected pursuant to Section 4 of this Agreement; or (iii) any Transfer effected pursuant to Section 2(b) hereof.

 

(h)     “Prospective Transferee” means any person to whom a Stockholder proposes to make a Proposed Stockholder Transfer.

 

(i)     “Sale of Company” means the occurrence of any one of the following events:

 

(1)     the acquisition of the Company by another entity by means of any transaction or series of related transactions (including, without limitation, any reorganization, merger or consolidation or stock transfer, but excluding any such transaction effected primarily for the purpose of changing the domicile of the Company), unless the Company’s stockholders of record immediately prior to such transaction or series of related transactions hold, immediately after such transaction or series of related transactions, at least fifty percent (50%) of the voting power of the surviving or acquiring entity (provided that the sale by the Company of its securities for the purposes of raising additional funds shall not constitute a Sale of Company hereunder); or

 

(2)     a sale of all or substantially all of the assets of the Company, other than such transaction effected primarily for the purpose of changing the domicile of the Company.

 

(j)     “SEC” means the Securities and Exchange Commission.

 

(k)     “Transfer” shall mean to sell, assign, transfer, convey, exchange, pledge, grant a security interest in or otherwise dispose of any Capital Stock or right therein, in each case, whether made directly or indirectly, voluntarily or involuntarily, absolutely or conditionally, or by operation of law or otherwise.

 

(l)     “Transfer Stock” means shares of Capital Stock subject to a Proposed Stockholder Transfer.

 

2.     Restrictions on Transfer of Securities.

 

(a)     Voluntary Transfer. No Stockholder may Transfer all or any part of the Capital Stock owned or held by such Stockholder, unless such Transfer is fully disclosed to, and approved by, the Board. Any Prospective Transferee shall agree in writing with the Company, as a condition to such Transfer, to be bound by all of the provisions of this Agreement to the same extent as if such Prospective Transferee were a Stockholder of the Company. Any Capital Stock Transferred as permitted under this Section 2 shall nevertheless remain subject to the terms of this Agreement in the hands of the Prospective Transferee. Notwithstanding anything else contained herein to the contrary, no Stockholder may Transfer Capital Stock to any person that is a competitor of the Company, except upon a Sale of the Company pursuant to Section 4. The Board in its discretion shall determine in good faith whether a Prospective Transferee is a competitor of the Company, which determination shall be binding; provided, however, a director who is a Transferring Stockholder or any employee of the Transferring Stockholder shall excuse himself or herself from such determination.

 

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(b)     Involuntary Transfer. If any Capital Stock owned by any Stockholder shall be subject to sale or other Transfer by reason of (a) bankruptcy or insolvency proceedings, whether voluntary or involuntary, (b) incompetency or insanity or (c) distraint, levy, execution or other involuntary transfer whether by operation of law or otherwise (an “Involuntary Transfer”), then such Stockholder shall give the Company written notice thereof promptly following the occurrence of such event stating the terms of such proposed transfer, the identity of the proposed transferee, the price or other consideration, if readily determinable, for which the shares of Capital Stock are proposed to be transferred and the number of shares of Capital Stock subject to such Involuntary Transfer. Whenever the Company has any other actual notice or actual knowledge of any such attempted, impending or consummated Involuntary Transfer, it may give written notice thereof to the affected Stockholder. In either case, the Stockholder agrees to disclose in writing immediately to the Company all pertinent information in his, her, or its possession relating to such Involuntary Transfer. If any shares of Capital Stock are subject to any Involuntary Transfer, the Company shall at all times have the immediate and continuing right and option for a period of ninety (90) days after the Company first receives actual notice of such Involuntary Transfer to purchase such Capital Stock at the Determined Value as set forth in Section 2(b)(1) of this Agreement, or as otherwise agreed by the parties thereto upon the giving of written notice to such effect to the Stockholder.

 

(1)     Company Option. If a Stockholder’s Capital Stock is subject to the Company’s purchase option governed by Section 2(b) hereof, the Company shall at all times have the immediate and continuing right and option for a period of ninety (90) days after the Company first receives actual notice of such Transfer to purchase such shares of Capital Stock, in accordance with the provisions of this Section 2(b), at the Determined Value (as hereinafter defined). The “Determined Value” shall be the fair market value agreed upon by the Transferring Stockholder (or its successors and assigns) and the Company or, if such agreement is not reached within ten (10) days, the per share price determined by an appraisal prepared by an investment bank or appraisal firm of national recognition (the “Appraiser”) mutually selected by the Transferring Stockholder (or its successors and assigns) and the Company. If the parties are unable to agree on an Appraiser, each party to the transaction shall choose an Appraiser, and the Appraisers so chosen shall promptly (not to exceed five (5) business days) select a single Appraiser whose determination of fair market value shall govern and shall be binding and conclusive. The appraisal shall determine the fair market value of such Capital Stock as of the Valuation Date (as hereinafter defined), taking into consideration whether such shares of Capital Stock constitute less than a majority of the outstanding shares of Capital Stock (determined on a fully-diluted basis) and such other factors as reasonably determined appropriate by the Appraiser. For purposes of this Section 2(b)(1), the “Valuation Date” shall mean the date on which the Company first receives actual notice or actual knowledge of the Involuntary Transfer. Unless otherwise agreed by the parties to the transaction, the appraisal costs shall be borne by the Transferring Stockholder (or its successors and assigns).

 

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(2)     Assignment of Company Purchase Option. The Board may freely assign the Company’s purchase option under Section 2(b) hereof, in whole or in part. If the Board elects to assign such purchase option to the Company’s Stockholders, any such assignment shall first be made pro-rata to all Stockholders based on their respective percentage ownership of the Company’s outstanding Capital Stock. Any Stockholder who accepts an assignment of the Company’s purchase option under Section 2(b) hereof shall assume all of the Company’s rights and obligations under this Section 2(b).

 

(c)     Effect of Failure to Comply.

 

(1)     Any Proposed Stockholder Transfer not made in compliance with the requirements of this Agreement shall be null and void ab initio, shall not be recorded on the books of the Company or its transfer agent and shall not be recognized by the Company. Each party hereto acknowledges and agrees that any breach of this Agreement would result in substantial harm to the other parties hereto for which monetary damages alone could not adequately compensate. Therefore, the parties hereto unconditionally and irrevocably agree that any non-breaching party hereto shall be entitled to protective orders, injunctive relief and other remedies available at law or in equity (including, without limitation, specific performance or the rescission of purchases, sales and other transfers of Capital Stock not made in strict compliance with this Agreement).

 

(2)     If any Stockholder becomes obligated to sell any Capital Stock to the Company under this Agreement and fails to deliver such Capital Stock in accordance with the terms of this Agreement, the Company may, at its option, in addition to all other remedies it may have, send to such Stockholder the purchase price for such Capital Stock as is herein specified and cancel on its books the certificate or certificates representing the Capital Stock to be sold.

 

3.     Exempt Transfers. Notwithstanding the foregoing or anything to the contrary herein, the provisions of Section 2 shall not apply, upon a transfer by a Stockholder to (i) its stockholders, members, partners or other equity holders, or (ii) an Affiliate of such Stockholder; provided, however, notwithstanding any such permitted Transfer, such transferred Capital Stock shall remain Capital Stock for all purposes hereunder, and such transferee shall be treated as a Stockholder (but only with respect to the securities so transferred to the transferee) for all purposes of this Agreement (including the obligations of a Stockholder with respect to Proposed Stockholder Transfers of such Capital Stock pursuant to Section 2); and provided, further, in the case of any transfer pursuant to clause (i) or (ii) above, that such Transfer is made pursuant to a transaction in which there is no consideration actually paid for such Transfer; and provided, further in a case of any transfer pursuant to this Section 3, such transferee shall become a party to this Agreement by executing a joinder hereto; and provided, further, that each Stockholder proposing to make a Transfer permitted by this Section shall deliver a notice to the Company and each Stockholder not later than thirty (30) days prior to the consummation of such Transfer setting forth the name of the proposed transferee and the terms and conditions of such Transfer; and provided, further, all such permitted Transfers shall be made in compliance with applicable federal and state securities laws.

 

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4.     Sale of Company.

 

(a)     Subject to Section 6, if the Board and the holders of a majority of the shares of Capital Stock approve a Sale of the Company, each Stockholder will consent to and raise no objections to the proposed transaction, waive any appraisal or dissenters’ rights in respect of such transaction, and take all other actions reasonably necessary or desirable to cause the consummation of such Sale of the Company on the terms proposed by the Board, including without limitation, (i) if the Sale of the Company is structured as a sale of all outstanding Capital Stock, each Stockholder will sell all of his, her or its Capital Stock on the terms and conditions approved by the Board, (ii) if the Sale of the Company is structured as a merger or consolidation, each Stockholder will vote in favor thereof and will not exercise any dissenters’ rights of appraisal he, she or it may have under any applicable law, and (iii) if the Sale of the Company is structured as a sale of all or substantially all of the assets of the Company, each Stockholder will vote in favor thereof, will not exercise any dissenters’ rights of appraisal he, she or it may have under any applicable law and, if applicable, will vote in favor of the subsequent dissolution and liquidation of the Company. Each Stockholder shall be severally obligated to join (on a basis not to exceed such Stockholder’s pro rata share of the proceeds from such Sale of the Company) in any indemnification or other obligations to which the Board agrees in connection with such Sale of the Company (other than any such obligations that relate specifically to a particular Stockholder, such as indemnification with respect to representations and warranties given by a Stockholder regarding such Stockholder’s title to and ownership of Capital Stock, as to which obligations each such Stockholder shall be solely liable). No Stockholder will be required to make any representation or warranty other than with respect to the ownership of such Stockholder’s stock or the authorization and binding effect of the applicable transaction documents relating to such Stockholder, and no Stockholder will be required to enter into any restrictive covenant agreement other than those which are reasonable in scope and duration and are required to protect the interests of the Company.

 

(b)     The obligations of the Stockholders with respect to a Sale of the Company are subject to the satisfaction of the following conditions: (i) upon the consummation of the Sale of the Company, all of the Stockholders holding a particular class or series of Capital Stock shall receive the same form and amount of consideration per share of Capital Stock, or if any Stockholders of a particular type, class or series of Capital Stock are given an option as to the form and amount of consideration to be received, all Stockholders of such type, class or series will be given the same option, and (ii) all Stockholders of then currently exercisable Capital Stock equivalents will be given an opportunity to either (A) exercise such rights prior to the consummation of the Sale of the Company and participate in such sale as holders of such Capital Stock or (B) upon the consummation of the Sale of the Company, receive in exchange for such rights consideration equal to the amount determined by multiplying (1) the same amount of consideration per share of Capital Stock received by the Stockholders of such type and class of Capital Stock in connection with the Sale of the Company less the exercise price per share or the amount of such rights to acquire such Capital Stock by (2) the number of shares Capital Stock or the aggregate amount of shares represented by such rights.

 

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(c)     If the Company enters into any negotiation or transaction for which Rule 506 promulgated by the SEC (or any similar rule then in effect) may be available with respect to such negotiation or transaction (including a merger, consolidation or other reorganization), the Stockholders that are not an “accredited investor” (within the meaning of Rule 501(a) promulgated by the SEC) will, at the request of the Board, appoint a purchaser representative (as such term is defined in Rule 501 promulgated by the SEC) reasonably approved by the Board and the Company will pay the fees of such purchaser representative. If any such Stockholder declines to appoint the purchaser representative approved by the Board, such Stockholder will appoint another purchaser representative reasonably acceptable to the Board, and such Stockholder will be responsible for the fees of the purchaser representative so appointed.

 

(d)     Each Stockholder will bear his, her or its pro-rata share of the reasonable costs of any sale of Capital Stock pursuant to a Sale of the Company (but only if such Sale of the Company is actually consummated) to the extent such costs are incurred for the benefit of all Stockholders and are not otherwise paid by the Company or the acquiring party. Costs incurred by or on behalf of a Stockholder for its or his sole benefit will not be considered costs of the transaction hereunder.

 

5.     Election of Directors.

 

(a)     Each of the parties hereto shall vote (whether at a meeting or by written consent) all of the Common Stock of the Company now owned or hereafter acquired by such party (and attend, in person or by proxy, all meetings of stockholders called for the purpose of electing directors), and the Company agrees to take all actions (including, but not limited to the nomination of specified persons) to cause and maintain the election to the Board, to the extent permitted pursuant to the Company’s Certificate of Incorporation, of one (1) Director designated in writing by ThermoGenesis Holdings Inc., a Delaware corporation formerly known as Cesca Therapeutics Inc. (“ThermoGenesis”). At any election of Directors, in the absence of any designation from ThermoGenesis, the director previously designated by ThermoGenesis and then serving shall be reelected at the annual shareholder’s meeting if still eligible to serve as provided herein.

 

(b)     No party hereto shall vote to remove any member of the Board designated in accordance with the aforesaid procedure without the written consent of ThermoGenesis but, at the written request of ThermoGenesis, the parties hereto shall take any action needed to cause the removal, and replacement (by an individual identified by ThermoGenesis), of any director so designated. Any vacancy on the Board created by the resignation, removal, incapacity or death of any person designated under this Section 5 shall be filled by another person designated in a manner so as to preserve the constituency of the Board as provided above.

 

(c)     The provisions of this Section 5 shall be null and void and of no further effect upon the occurrence of a Qualified Issuance, as defined in the Company’s Certificate of Incorporation.

 

6.     Approval of Certain Actions by the Board. The Company shall not take any of the following actions unless approved unanimously by all Directors then in office:

 

(a)     effect any Sale of the Company, or enter into any agreement committing the Company to such Sale;

 

6

 

 

(b)     amend the Certificate of Incorporation of the Company, dated as of the date hereof;

 

(c)     issue, or commit to issue, and shares of Capital Stock or securities convertible into Capital Stock; or

 

(d)     to increase or decrease the size of the Board of Directors.

 

7.     Legend.

 

(a)     Each certificate representing shares of Capital Stock held by the Stockholders or issued to any permitted transferee in connection with a transfer permitted by this Agreement shall be endorsed with the following legend:

 

THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE “ACT”) AND MAY NOT BE OFFERED, SOLD OR OTHERWISE TRANSFERRED, PLEDGED OR HYPOTHECATED UNLESS AND UNTIL REGISTERED UNDER THE ACT OR, IN THE OPINION OF COUNSEL SATISFACTORY TO THE COMPANY OF THESE SECURITIES, SUCH OFFER, SALE OR TRANSFER, PLEDGE OR HYPOTHECATION OTHERWISE COMPLIES WITH THE ACT.

 

THE SHARES REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO CERTAIN RESTRICTIONS ON TRANSFER, A MARKET STANDOFF PROVISION, A RIGHT OF FIRST REFUSAL, AND, FOR SOME OF THE SHARES REPRESENTED BY THIS CERTIFICATE, A REPURCHASE OPTION HELD BY THE COMPANY OR ITS ASSIGNEE(S) AS SET FORTH IN THE stockholders’ AGREEMENT BETWEEN THE COMPANY AND THE ORIGINAL HOLDER OF THESE SHARES, A COPY OF WHICH MAY BE OBTAINED AT THE PRINCIPAL OFFICE OF THE COMPANY. SUCH TRANSFER RESTRICTIONS, MARKET STANDOFF PROVISION, RIGHT OF FIRST REFUSAL AND REPURCHASE OPTION ARE BINDING ON TRANSFEREES OF THESE SHARES.

 

(b)     Each Stockholder agrees that the Company may instruct its transfer agent to impose transfer restrictions on the shares represented by certificates bearing the legend referred to in Section 7(a) above to enforce the provisions of this Agreement, and the Company agrees to promptly do so. The legend shall be removed upon termination of this Agreement at the request of the holder.

 

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8.     Miscellaneous.

 

(a)     Term. This Agreement shall terminate upon the Sale of Company or as mutually agreed by Healthbanks and ThermoGenesis (regardless of whether any other Person has since the date hereof become a Stockholder).

 

(b)     Ownership. Each Stockholder represents and warrants that it is the sole legal and beneficial owner of the shares of Capital Stock subject to this Agreement and that no other person has any interest in such shares.

 

(c)     Notices. All notices and other communications given or made pursuant to this Agreement shall be in writing and shall be deemed effectively given (a) upon personal delivery to the party to be notified, (b) when sent by confirmed electronic mail or facsimile if sent during normal business hours of the recipient, and if not so confirmed, then on the next business day, (c) five days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt. All communications shall be sent to the respective parties at their address as set forth on the signature page or Schedule A, or to such e-mail address, facsimile number, or address as subsequently modified by written notice given in accordance with this Section 8(c). Each Stockholder subject to this Agreement acknowledges and agrees to receive any communications given or made by the Company in accordance with applicable law or this Agreement by electronic mail or other electronic transmission in accordance with the email address or facsimile numbers provided to the Company. In the event that a Stockholder changes his, her or its email address or facsimile number, such Stockholder agrees, upon request from the Company, to supply an alternative email address, if one is available.

 

(d)     Entire Agreement. This Agreement (including the Exhibits hereto, if any) constitutes the full and entire understanding and agreement between the parties with respect to the subject matter hereof, and any other written or oral agreement relating to the subject matter hereof existing between the parties are expressly canceled.

 

(e)     Delays or Omissions. No delay or omission to exercise any right, power or remedy accruing to any party under this Agreement, upon any breach or default of any other party under this Agreement, shall impair any such right, power or remedy of such non-breaching or non-defaulting party nor shall it be construed to be a waiver of any such breach or default, or an acquiescence therein, or of or in any similar breach or default thereafter occurring; nor shall any waiver of any single breach or default be deemed a waiver of any other breach or default theretofore or thereafter occurring. Any waiver, permit, consent or approval of any kind or character on the part of any party of any breach or default under this Agreement, or any waiver on the part of any party of any provisions or conditions of this Agreement, must be in writing and shall be effective only to the extent specifically set forth in such writing. All remedies, either under this Agreement or by law or otherwise afforded to any party, shall be cumulative and not alternative.

 

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(f)     Amendment. This Agreement may be amended or modified and the observance of any term hereof may be waived (either generally or in a particular instance and either retroactively or prospectively) only by a written instrument executed by the Company, Healthbanks and ThermoGenesis. Any amendment or waiver so effected shall be binding upon the Company, the Stockholders and all of their respective successors and permitted assigns whether or not such party, assignee or other stockholder entered into or approved such amendment or waiver. Notwithstanding the foregoing, Schedule A hereto may be amended by the Company from time to time to add information regarding additional investors or other Stockholders without the consent of the other parties hereto. The Company shall give prompt written notice of any amendment or termination hereof or waiver hereunder to any party hereto that did not consent in writing to such amendment, termination or waiver. No waivers of or exceptions to any term, condition or provision of this Agreement, in any one or more instances, shall be deemed to be, or construed as, a further or continuing waiver of any such term, condition or provision. Any amendment, termination or waiver effected in accordance with this subsection shall be binding on all parties hereto, even if they do not execute such consent.

 

(g)     Transfers, Successors and Assigns.

 

(1)     The terms and conditions of this Agreement shall inure to the benefit of and be binding upon the respective successors and assigns of the parties. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.

 

(2)     The rights of the Stockholders hereunder are not assignable without the Company’s written consent, except by each Stockholder to any constituent, partner, member or stockholder of such Stockholder or to an entity or entities controlled by, or under common control with, such Stockholder. Except as expressly set forth herein or in connection with an assignment by the Company by operation of law to the acquirer of the Company, the rights and obligations of the Company hereunder may not be assigned under any circumstances.

 

(h)     Severability. The invalidity of unenforceability of any provision hereof shall in no way affect the validity or enforceability of any other provision. Each Stockholder acknowledges and agrees that each Stockholder hereto will be irreparably damaged in the event any of the provisions of this Agreement are not performed by the Stockholders in accordance with their specific terms or are otherwise breached. Accordingly, it is agreed that each of the Company and the Stockholders shall be entitled to an injunction to prevent breaches of this Agreement and to specific enforcement of this Agreement and its terms and provisions in any action instituted in any court of the United States or any state having subject matter jurisdiction, in addition to any other remedy to which the Stockholders may be entitled at law or in equity.

 

(i)     Additional Stockholders. Notwithstanding anything to the contrary contained herein, (i) if the Company issues additional shares of the Company’s Capital Stock after the date hereof or (ii) if the Company issues any additional shares of the Company’s Capital Stock after the date hereof pursuant to the terms and provisions of the Company’s Stock Option Plan(s), any purchaser of such shares of Capital Stock shall become a party to this Agreement by executing and delivering a joinder hereto, and thereafter shall be deemed an “Stockholder” for all purposes hereunder.

 

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(j)     Governing Law. This Agreement shall be governed by the internal substantive laws, but not the choice of law rules, of Delaware.

 

(k)     Titles and Subtitles. The titles and subtitles used in this Agreement are used for convenience only and are not to be considered in construing or interpreting this Agreement.

 

(l)     Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may also be executed and delivered by facsimile signature or other electronic transmission, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

(m)     Stock Split. All references to numbers of shares in this Agreement shall be appropriately adjusted to reflect any stock dividend, split, combination or other recapitalization affecting the Capital Stock occurring after the date of this Agreement.

 

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IN WITNESS WHEREOF, the undersigned have executed this Stockholders’ Agreement as of the date first above written.

 

STOCKHOLDERS:

 

 

Healthbanks Biotech (USA) Inc.

 

 

By: /s/ Billie Ahluwalia

Name: Billie Ahluwalia

Title: Principal Accounting Officer

 

 

ThermoGenesis Holdings, Inc.

 

 

By: /s/ Jeff Cauble

Name: Jeff Cauble

Title: Principal Accounting Officer

 

 

 

 

THE COMPANY:

 

 

ImmuneCyte Life Sciences Inc.

 

 

By: /s/ Billie Ahluwalia

Name: Billie Ahluwalia

Title: Principal Accounting Officer

 

 

SIGNATURE PAGE TO STOCKHOLDERS’ AGREEMENT

 

 

 

 

SCHEDULE A

 

Stockholders

 

 

 

Name and Address

 
   
   

ThermoGenesis Holdings, Inc.

2711 Citrus Road

Rancho Cordova, CA 95742

Attention: Jeff Cauble, Principal Accounting Officer

 

 

Healthbanks Biotech (USA) Inc.,

185 Technology Drive, Suite 150
Irvine, CA 92618
Attention: Billie Ahluwalia, Principal Accounting Officer

 

 

Schedule A-1

 

 

 

 

Exhibit 99.1

  

THERMOGENESIS HOLDINGS CLOSES JOINT VENTURE AGREEMENT WITH HEALTHBANKS BIOTECH (USA) TO FORM IMMUNECYTE LIFE SCIENCES

 

ImmuneCyte to Begin Operations by Year End 2019

 

RANCHO CORDOVA, Calif., Nov. 26, 2019 -- ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, today announced that the company has closed on its joint venture agreement with HealthBanks Biotech (USA) Inc., a leading stem cell bank network. The joint venture, called ImmuneCyte Life Sciences, Inc. (“ImmuneCyte”), has been formed in order to commercialize ThermoGenesis’ proprietary cell processing platform, CAR-TXpress™, for use in immune cell banking as well as for cell-based contract development and manufacturing services (CMO/CDMO).

 

Under the terms of the previously announced joint venture agreement, ImmuneCyte will initially be owned 80% by HealthBanks Biotech and 20% by ThermoGenesis. In addition to contributing to ImmuneCyte exclusive rights to use ThermoGenesis’ proprietary cell processing technology for the immune cell banking business and non-exclusive rights for other cell-based contract development and manufacturing services, ThermoGenesis has contributed its clinical development assets to ImmuneCyte, divesting these programs in order to focus exclusively on the device business. ImmuneCyte, which is expected to be operational by the end of the fourth quarter of 2019, will be among the first immune cell banks in the U.S. and offer customers the ability to preserve younger, healthier and uncontaminated immune cells for future potential use in dendritic and chimeric antigen receptor (CAR-T) cell therapies, in a GMP compliant processing environment.

 

"The closing of this joint venture represents an important step in our quest to become a preferred cell processing and manufacturing solution provider in the cell and gene therapy field,” said Dr. Chris Xu, Chairman and Chief Executive Officer of ThermoGenesis. “Immunotherapy remains one of the fastest growing research areas with over 800 clinical trials now underway in CAR-T therapy alone. The challenges in developing these therapies are well known, including high manufacturing costs and low patient accessibility. Our CAR-TXpress platform addresses these issues with the ability to increase cell processing efficiency significantly versus traditional, labor-intensive methods. As important, by providing the ability to bank younger, healthier immune cells, ImmuneCyte will help ensure the future benefit of cell and gene therapy to everyone in need.”

 

 

 

 

About HealthBanks Biotech (USA) Inc.

HealthBanks Biotech, headquartered in Irvine, CA, is one of the leading stem cell bank networks in the world and offers services globally through its sister companies located in the United States and other regions and nations. HealthBanks Biotech is accredited by the FDA, AABB, and CAP. The HealthBanks Biotech group was originally founded in 2001 with a vision that stem cells and cell and gene therapies could transform modern medicine. HealthBanks Biotech is a subsidiary of Boyalife Group, Inc. (USA), an affiliate of ThermoGenesis Holdings, Inc. For more information about HealthBanks Biotech (USA) Inc., please visit: www.healthbanks.us.

 

About ImmuneCyte Life Sciences Inc.

ImmuneCyte will provide clients with the opportunity to bank their own immune cells when the cells are “healthy and unaffected” as a future resource for cellular immunotherapies, such as CAR-T. ImmuneCyte utilizes a proprietary CAR-TXpress™ platform, a GMP compliant close-system capable of automated separating and cryopreserving different components from blood. For more information about ImmuneCyte Life Sciences Inc., please visit: www.immunecyte.com.

 

About ThermoGenesis Holdings, Inc.

ThermoGenesis Holdings, Inc., formerly known as Cesca Therapeutics Inc., develops, commercializes and markets a range of automated technologies for CAR-T and other cell-based therapies. The company currently markets a full suite of solutions for automated clinical biobanking, point-of-care applications, and automation for immuno-oncology, including its semi-automated, functionally closed CAR-TXpress™ platform, which streamlines the manufacturing process for the emerging CAR-T immunotherapy market. For more information about ThermoGenesis, please visit: www.thermogenesis.com.

 

Company Contact: 
Wendy Samford
916-858-5191
ir@thermogenesis.com

 

Investor Contact: 
Paula Schwartz, Rx Communications
917-322-2216
pschwartz@rxir.com