Document:

cbmg_ex1045.htm

Exhibit 10.45

 

 

Patent Transfer Agreement

 

among

 

China Pharmaceutical University

 

(as the Transferor)

 

and

 

Cellular Biomedicine Group (Shanghai) Ltd.

 

(As the Transferee)

 

November 16, 2015

 

  

1

  

 

This Agreement (as defined below) was made and entered into in Shanghai on November 16, 2015 by and between:

 

Transferor: China Pharmaceutical University

 

Contact Person: Wang Min  Mobile:+862583271395; Zhang Juan Mobile:+862583271483

 

Address: No.24,Tongjia Lane,Nanjing,Jiangsu Province

 

Transferee: Cellular Biomedicine Group (Shanghai) Ltd.

 

Contact Person: Cao Wei  Mobile:+862154069990

 

Address: 5/F, No.1 Building, No.333 Guiping Road, Xuhui District, Shanghai

 

Article I Patent Transfer

 

1.1 Subject Matter

 

According to the conditions agreed herein, the Transferor agrees to transfer, and the Transferee agrees to purchase all the patants and relative technologies listed in the appendix I (including any technical secrets in relation to the invention in respect of these technologies), and all patent application rights, preemptive rights, patent rights, rights to use, right to license, income rights and other related intellectual property rights and benefits. All the information about the patents are listed in the appendix I.

 

1.2 Method of Transfer and Transitional Arrangement

 

1.2.1 Full Transfer of all the patents mentioned above, but the name of inventors remain unchanged.

 

1.2.2 The transferee will owed the said patents legally since the transfer application was made to the Patent Office. The transferee has the right, including, but not limited to, the rights to implement, utilize, use and license such technologies for production, manufacture, sales, offer to sell and commercialization, as well as subsequent research and development, improvement and innovation (all technological results and intellectual property rights incurred therefrom shall be owned by the Transferee).

 

1.2.3 The transferor should keep the pantents valid before the register of the patents transfer were made.

 

  

2

  

 

Article II Consideration of Transfer

 

2.1 Consideration of Transfer

 

As the Consideration for the Subject Patents transferred under Article 2.1, the Transferee shall pay the Consideration to the Transferor totaling RMB 700 thousand (in words: say RMB seven hundred thousand only).

 

2.2 Payment Arrangement

 

2.2.1 Initial Payment: The Transferee shall make the initial payment within 3 Business Days from the Effective Date of this agreement, totaling RMB 300 thousand (“Initial Payment”);

 

2.2.2 Second Payment: The Transferee shall, within 3 Business Days from the date on which all the conditions in Article IV are met and the transfer registeration are accomplished, make the Second Payment, totaling RMB 400 thousand (“Second Payment”).

 

2.2.3 The Transferor’s Bank Account Details:

 

Beneficiary: China Pharmaceutical University

 

A/C No.: 4301011019001029831

 

Bank: Industrial and Commercial Bank of China, Nanjing Hu Nan Road Branch

 

Article III Research Funds

 

3.1 Transferee Provides Research Funds

 

3.1.1 The Transferee promises to provide research funds to professor Wang Min’s lab in China Pharmaceutical University according to Artical 3.1.2. The research funds should be used in the development and research of the stipulated patents.

 

3.1.2 The term of the research funds providing should be 3 years since the patent transfer is accomplished. The annual amounts shall be 300 thousand. The research funds of the first year should be paid at the same time with the Second Payment of the consideration of transfer. The rest research funds should be paid annually.

 

3.1.3 The Transferee has the priority perchasing right of the technology achievements of the Transferor and relative team. The transfer price shall be settled through negotiation between two Parties.

 

  

3

  

 

Article IV Closing

 

4.1 Delivery of Subject Technologies

 

All Parties shall not disclose or permit any associated party (present or future) to disclose the agreement except for disclosure to any governmental institution according to the compulsory requirements; the disclosure shall be only limited to the compulsory disclosure scope; the disclosure made by any laws, regulations or stipulations shall be excluded. The transferee shall, as a listed company, have the responsibility to disclose agreement signing and execution matters to the general public in a timely manner; the transferor and main inventor shall understand this and shall be willing to coordinate positively and assist the transferee with information disclosure

 

4.2 Registration of Changes in Patent Application

 

4.2.1 The Transferor shall, within 10 days from the making of the Initial Payment by the Transferee, apply for the approval/ registration of changes in respect of the transfer of the Subject Technologies with the Patent Office and other competent authorities, including:

 

4.2.2 If the Transferor fail to complete the whole patent transfer process, the Transferor can apply to the Transferee for appropriate relaxation term. If the Transferor still can not complete the whole patent transfer process in the appropriate relaxation term, the Transferee has the right to terminate this agreement. Under this circumstance, the Transferor should return all the consideration money and technical documents in 5 business days after the termination of the agreement.

 

4.3 Amendment to the Patent License Contract

 

In the event there is any license contract made with others to license them to implement the patent prior to the Effective Date, such contract shall be terminated or the rights and obligations under such contract shall be transferred to the Transferee in whole, and the royalty fee received shall be also transferred to the Transferee in respect of the license.

 

Article V Confidentiality

 

All Parties shall not disclose or permit any associated party (present or future) to disclose the agreement except for disclosure to any governmental institution according to the compulsory requirements; the disclosure shall be only limited to the compulsory disclosure scope; the disclosure made by any laws, regulations or stipulations shall be excluded. The transferee shall, as a listed company, have the responsibility to disclose agreement signing and execution matters to the general public in a timely manner; the transferor and main inventor shall understand this and shall be willing to coordinate positively and assist the transferee with information disclosure.

 

  

4

  

 

Article VI Breach Responsibilities

 

Regardless of conduct or no conduct, any party shall constitute breach event if it fails to fulfill total or partial obligations or fails to properly fulfill the obligations or any party breaches against any assurance in the agreement.In case of breach event specified in Article 8.1, the breach party shall compensate for total direct losses, damage, expenses or responsibilities in other party arising from breach; if the responsibilities lie in all Parties, they shall bear respective responsibilities and losses according to the actual conditions. If the Transferor delay to pay the second payment, the Transferee has the right to retreve the initial payment and the patent.

 

Article VII Governing Laws and Dispute Settlement

 

7.1 Governing laws

 

The agreement’s signing, validation, interpretation, revision, supplementation, termination and execution is governed by and interpreted according to the Chinese laws.

 

7.2 Dispute settlement

 

All Parties shall negotiate for the settlement of any dispute arising from or related to the agreement; in case of negotiation failure, any party shall submit the dispute to China International Economic Trade Arbitration Committee for arbitration in Shanghai according to the contemporary and effective arbitration regulations. The arbitration award shall be final and legally binding upon all Parties. Any party shall have the right to apply to the people’s court with administrative right for compulsory execution.

 

Article VIII Supplementary Provisions

 

8.1 Expense and tax

 

8.2.1 All Parties shall bear its incurred expenses for agreement transaction separately, including drafting, signing, delivery and execution of this agreement and related matters.

 

8.2.2 All Parties shall bear its taxes for the transaction of the agreementseparately.

 

8.2 Validation and copy

 

8.2.1 The agreement shall become valid as of the signature or official seal/personal chop by the authorized representatives. All Parties shall register this agreement in the patent administrative department of the State Council; the patent administrative department of the State Council shall make an announcement.

 

8.2.2 The agreement shall include seven (6) original copies, each party holding one (1) respectively; the other four (4) copies shall be adopted to handle the transfer registration formalities of patent application . The original copy and appendix shall constitute an inseparable part of the agreement and enjoy the same legal validity.

 

[No Text Below]

 

  

5

  

 

[Signature Page]

 

All Parties shall hereby confirm that said contents have accurately expressed unanimous intention; they have required authorized representatives to sign the agreement on the date clearly specified in the front page.

 

 

Transferor: China Pharmaceutical University(Seal affixed)

 

Authorized representative (Signature): Lai Mao De (Seal affixed)

 

Project Leader: /s/ Zhang Juan (Signature) /s/ Wang Min (Signature)   November 16, 2015

 

 

 

Transferee: Cellular Biomedicine Group (Shanghai) Ltd (Seal affixed)

 

Authorized representative (Signature): /s/ Wei Cao (Signature)         November 16, 2015

 

  

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Appendix I: List of target technologies

 

	
SN

	 	
Patent applicant

	 	
Category

	 	
Inventor

	 	
Patent application date (application No.)

	 	
Name of invention

	 	
Legal status

	 	
Introduction of patent

	
1

	 	
PersonGen Biomedicine (Suzhou) Co., Ltd.

	 	
Invention

	 	
Yang Lin, Li Yafen, Zong Yunhui

	 	
2015. 01. 06

	 	
Improved aAPC technology and its application in immune cell preparation (pending, the ultimate name depends on the actual application result)

	 	
under application

	 	
It is applicable to the production and preparation of CAR—T cell, CAR—NK cell

	
2

	 	
PersonGen Biomedicine (Suzhou) Co., Ltd.

	 	
Invention

	 	
Yang Lin, Chu Fuliang, Zong Yunhui

	 	
2014. 11. 06 (201410613502.1)

	 	
SN of PD—1 resistant single cloning antibody variable area; preparation methods and application

	 	
Applied already

	 	
It is able to block PD—1 from integrating with the body; it is applicable to the immune treatment of numerous malignant tumors.

	
3

	 	
PersonGen Biomedicine (Suzhou) Co., Ltd.

	 	
Invention

	 	
Yang Lin, Zou Jianxuan, Chen Dan

	 	
2015. 01. 06

	 	
SN of CD 19 resistant single cloning antibody variable area; preparation methods and application (pending, the ultimate name depends on the actual application result)

	 	
under application

	 	
It is applicable to building CAR—T of targeted leukemia and lymphoma; double specific antibody of CD3/CD19 gene project.

	
4

	 	
PersonGen Biomedicine (Suzhou) Co., Ltd

	 	
Invention

	 	
Yang Lin, You Fengtao, Jiang Licui

	 	
2015. 01. 10

	 	
Application of 3rd generation of CAR  (pending, the ultimate name depends on the actual application result)

	 	
under application

	 	
It is applicable to the cell treatment of malignant tumors.

 

  

7

  

 

Appendix II: Delivery list of technical documents

 

	
1.

	
The patent application documents of target technologies shall include (but not limited to):

 

	
1)

	
All the patent application documents submitted to the National Patent Office, including specification, right claim, attached drawings, abstract and its attached drawings, letter of request, statement of opinions, changes in document matters, audit and approval decision of right resuming upon lose of rights and authorized consignment letter.

 

	
2)

	
All the documents distributed by National Patent Office to the transferor, including acceptance notice, midterm documents and authorization decision.

 

	
3)

	
Patent application and execution permit contract (if applicable) approved by the transferor to other party, including contract appendix (technical and process documents related to patent application).

 

	
4)

	
Effective certificate on patent application right issued by National Patent Office: Latest voucher of patent application and maintenance expense (or registration booklet of National Patent Office on patent legal status).

 

	
5)

	
Certificate of National Patent Office or other competent department adopted to approve transfer of target technologies to the transferee.

 

	
  

	
2. Technical documents of each target technology

 

	
1)

	
Technical secret and ingredient

 

	
2)

	
Product production process route

 

	
3)

	
Standard production flow

 

	
4)

	
Quality control standard of products

 

	
5)

	
Test data, test report and technical documentary

 

	
  

	
3. aAPC technology

 

	
1)

	
Structural drawing

 

	
2)

	
Building methods

 

	
3)

	
Preparation SOP of cell T

 

	
4)

	
Preparation SOP of cell NK

 

	
5)

	
aAPC cell line

 

	
  

	
4. PD—1 technology

 

	
1)

	
scFv sequence

 

	
2)

	
Biological function data

 

  

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3)

	
Biochemical parameters and data

 

	
4)

	
PD—1 single cloning antibody hybridoma cell line

 

	
5)

	
PD—1 antigen (standard PD—1 antigen protein in 5mg or re-organized particle adopted to efficiently express solutable human gene re-organized PD—1 protein)

 

	
  

	
5. CD 19 technology

 

	
1)

	
scFv sequence

 

	
2)

	
Biological data

 

	
3)

	
CD 19 single cloning antibody hybridoma cell line

 

	
4)

	
CD 19 antigen (standard CD 19 antigen protein in 5mg or re-organized particle adopted to efficiently express solutable human gene re-organized CD 19 protein)

 

	
  

	
6. 3rd generation of CAR technology

 

	
1)

	
Structural drawing

 

	
2)

	
Full sequence

 

	
3)

	
SOP building

 

	
4)

	
Carrier DNA (10 ug)

 

 

  

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Appendix III: Statement and assurance of transferor and main inventor

 

	
1.

	
Legality. The transferor shall refer to a limited liability company registered and existent according to the Chinese laws; it shall possess the legal person’s qualification.

 

	
2.

	
Legal authorization. On the agreement signing date, the transferor and main inventor have obtained legal and effective internal and external authorization aimed at the agreement; the signet on behalf of the transferor shall refer to the transferor’s legal representative or legal authorized representative.

 

	
3.

	
Compulsory execution. According to the agreement articles and conditions, the agreement shall be legal and effective to the transferor and main inventor and shall be legally binding and enjoy compulsory execution.

 

	
4.

	
No right defect

 

	
1)

	
The list of target technologies in Appendix I has disclosed all the intellectual property rights of target technologies transferred by the transferor.

 

	
2)

	
Before the agreement signing date and closing date, the transferor shall refer to the legal patentee of target technologies and exclusive patent application patentee; it shall enjoy complete intellectual property right and equity to all the target technologies; such rights shall be favorable, complete, sustainably effective and compulsorily executed.

 

	
3)

	
The relationship between inventor and target technology listed in Appendix I shall refer to the relationship of working post invention and creation; it shall not enjoy any patent application right, patent right or other property right to the target technology. The main inventor, transferor’s research and development delegate, other employees, consultants, associated parties or any other third party shall not raise any right claim or request to the assignee. The target technology and intellectual property right shall not suffer from any pledge, reservation or other form of assurance or right burden.

 

	
4)

	
The target technology shall enjoy advanced, practical and reliable properties and shall not infringe or steal any third party’s intellectual property right or other legal rights and not suffer from conflict against any third party’s intellectual property right. No third party has ever raised any objection or claim to the transferor by reason of infringement upon target technology.

 

	
5)

	
By the end of the agreement signing date and delivery date, no entity is engaged in the infringement upon transferor’s any intellectual property right on target technology according to the knowledge of transferor and main inventor. The target technology and intellectual property right shall not be restricted by any verdict or any property of command; there shall be no suspended or potential objection, lawsuit, investigation, appeal, claim or request affecting the legality, execution feasibility, use right or ownership of intellectual property right.

 

	
6)

	
The transferor and main inventor shall not offer (spoken or written) any third party with the use permit or other right on target technology; shall not personally or permit any third party to make patent application and obtain patent registration in any country and region.

 

	
7)

	
The transferor and main inventor have adopted adequate and effective confidential measures to the technical secrets of target technology and failed to disclose target technology to any other person beyond the core technical team.

 

  

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Appendix IV: Transferee’s statement and assurance

 

 

	
1.

	
Legality. The transferee shall refer to a limited liability company registered and existent according to the Chinese laws; it shall possess the legal person’s qualification.

 

	
2.

	
Legal authorization. On the agreement signing date, the transferee has obtained legal and effective internal and external authorization aimed at the agreement; the signet on behalf of the transferee shall refer to the transferee’s legal representative or legal authorized representative.

 

	
3.

	
Compulsory execution. According to the agreement articles and conditions, the agreement shall be legal and effective to the transferee and shall be legally binding and enjoy compulsory execution.

 

	
4.

	
The transferee shall promise to provide any documents or materials for the transferor based on all the agreement rights and obligations in a true and effective manner.

 

 

11cbmg_ex1046.htm

Exhibit 10.46

 

Clinical Trial Agreement

 

Party A: Cellular Biomedicine Group (Shanghai) Ltd

Legal address: Floor 5, No. 1 Building, Juke Biotech Park, No. 333, Guiping Road, Xuhui District, Shanghai

Fax number: 021-54069991

Party B: Renji Hospital Shanghai Jiaotong University School of Medicine

Legal address: No. 145, Middle Shandong Road, Huangpu District, Shanghai

Fax number: 021-58752345

Whereas,

 

	
1  

	
Since Party A, as the sponsor, expects that Party B conducts clinical trial under the clinical research scheme of Single Center, Random and Double Bland Stage I Clinical Research on Evaluation of Safety and Effectiveness of Autologous Adipose-derived Mesenchymal Cell Therapy of KOA (hereinafter referred to as “clinical trial” or “trial”) through Prof. Bao Chunde, an investigator jointly approved by the two parties;

 

	
2  

	
Since Party B and the investigator Prof. Bao Chunde agree to conduct clinical trial under the clinical research scheme of Single Center, Random and Double Bland Stage I Clinical Research on Evaluation of Safety and Effectiveness of Autologous Adipose-derived Mesenchymal Cell Therapy of KOA for Party A;

In this regard, the two parties hereby enter into this agreement according to the following conditions and terms:

Chapter 1 Clinical Trial Scheme

 

Article 1 Title of scheme: Single Center, Random and Double Bland Stage I Clinical Research on Evaluation of Safety and Effectiveness of Autologous Adipose-derived Mesenchymal Cell Therapy of KOA

 

Article 2 Scheme number: CBMG-Allo-haMPCs-KOA-1.1

 

Article 3 Date of finalizing of scheme: September 10, 2015

Chapter 2 Clinical Trial Center and Requirements

 

Article 1 Clinical trial center: Renji Hospital Shanghai Jiaotong University School of Medicine

 

Article 2 Person in charge of clinical trial (investigator): Bao Chunde

 

Article 3 Number of clinical trial cases: 18

 

	
1  

	
The number of qualified cases selected shall be at least 18;

	
2  

	
The number of qualified cases completing all courses of treatment and follow-up visits shall be at least 18.

 

Article 4 Progress requirements:

 

	
1  

	
The date of selection of the final qualified case is June 30, 2016.

	
2  

	
The date when the final qualified case completes all courses of treatment and follow-up visits is June 30, 2017.

 

  

1

  

 

Chapter 3 Rights and Obligations of Party A and Party B

Article 1 Party A:

 

	
1  

	
Take charge of initiating, applying, organizing, subsidizing and supervising this clinical trial.

 

	
2  

	
Join hands with Party B to formulate a clinical trial scheme.

 

	
3  

	
Follow relevant laws and regulations of the People’s Republic of China on clinical trials and Declaration of Helsinki and start to organize clinical trial according to clinical trial scheme after obtaining the consent from ethics committee of trial unit or ethics committee of group leader unit.

 

	
4  

	
Provide an investigator manual introducing detailed information of new medical technologies used in this clinical trial.

 

	
5  

	
Provide new medical technologies complying with relevant regulations including national laws and regulations.

 

	
6  

	
Supervise, audit and inspect this trial on a regular basis according to relevant laws and regulations including Measures for Administration of Clinical Application of Medical Technologies and Quality Management Code of Drug Clinical Trial. Such supervision, audit and inspection can be carried out by supervisor, auditor and inspector designated by Party A and accepted by Party B, or personnel from review institution designated by Ministry of Health and China Food and Drug Administration.

 

	
7  

	
Provide Party B with clinical trial fund according to stipulations set out in Article 9 of this agreement.

 

	
8  

	
Take charge of establishing clinical trial quality control and quality assurance system and organizing supervision and audit of clinical trial when necessary to ensure quality.

 

	
9  

	
Join hands with Party B to quickly investigate serious adverse events incurred, take necessary measures to ensure the safety of the subjects, timely report to relevant supervision management department, and meanwhile notify serious adverse events to other investigators involved in clinical trial of same medical technology.

 

	
10  

	
Submit summary report of trial to medical technology review institution designated by Ministry of Health, China Food and Drug Administration or relevant governmental department or put forward report of trial termination and reasons.

 

	
11  

	
When Party B conducts clinical trial without following the approved scheme, Measures for Administration of Clinical Application of Medical Technologies and Quality Management Code of Drug Clinical Trial or relevant regulations, Party A shall point out to correct Party B’s behavior. If the situation is serious or continuously remains unchanged, Party B shall be terminated to participate in clinical trial and report to relevant supervision management department.

 

	
12  

	
Party A shall have already provided relevant insurance according to Quality Management Code of Drug Clinical Trial in order to undertake therapy expenses and relevant economic compensation for damages or deaths taking place to patients complying with selection standards during participation in research as having cause-and-effect relationship with clinical trial. Party A shall actively rescue patients during research process if serious adverse events and adverse events beyond the compensation provisions of the insurance policy and offer relevant economic compensation.

 

	
13  

	
Party A will not compensate any damage caused to the patients due to medical accident caused by Party B or investigator or violation of clinical trial scheme according to the requirements of Quality Management Code of Drug Clinical Trial.

 

  

2

  

 

	
14  

	
Abide by Measures for Administration of Clinical Application of Medical Technologies, Quality Management Code of Drug Clinical Trial and relevant laws and regulations of the People’s Republic of China.

Article 2 Party B and/or trial director:

 

	
1  

	
Acquire and maintain the qualification to engage in clinical trial and have professional knowledge, experience, etc. required in trial scheme.

 

	
2  

	
Select cases, organize implementation and keep detailed records according to specific requirements of clinical trial under this agreement.

 

	
3  

	
Abide by Measures for Administration of Clinical Application of Medical Technologies, Quality Management Code of Drug Clinical Trial and relevant laws and regulations as well as provisions of Clinical Trial Scheme and coordinate with trial supervisor/auditor/inspector to ensure trial quality.

 

	
4  

	
Ensure sufficient time, qualified place and disposable personnel with clinical trial qualification to take charge of and complete clinical trial within a time limit stipulated in the scheme.

 

	
5  

	
Explain detailed conditions of relevant clinical trial agreed by ethics committee for disclosure to the subjects and acquire its properly signed informed consent form.

 

	
6  

	
Take charge of making medical decisions related to clinical trial to ensure that the subjects are properly treated when adverse event occurs during clinical trial.

 

	
7  

	
Take necessary measures to guarantee safety and proper recording of the subjects. If a serious adverse event takes place during clinical trial, Party B shall immediately take proper therapeutic measures to the subjects, meanwhile report drug supervision management department, Party A and ethics committee and sign its name and specify the date on the report.

 

	
8  

	
Before terminating or suspending clinical trial ahead of time, Party B must inform the subjects, Party A, ethics committee, China Food and Drug Administration, or relevant government department and explain the reasons.

 

	
9  

	
If the subjects die or suffer from serious damages due to violation of Clinical Trial Scheme and Quality Management Code of Drug Clinical Trial by Party B or investigator, or due to medical accident caused by Party B or investigator, Party B shall undertake treatment expenses and relevant compensatory liability therefore incurred beyond the compensation scope of insurance.

 

	
10  

	
Draft summary report and take charge of publication of dissertation after completion of clinical trial, sign name, specify relevant date and then send a copy to Party A.

 

	
11  

	
Confidentiality

 

	
●   

	
Party B (including trial director and all personnel involved in the trial) shall take active measures to remain strictly confidential for the confidential information during effective term of this agreement and within ten years after termination of this agreement. Party B shall not disclose such information to any third party or use such information for any other purpose beyond this agreement unless otherwise stipulated herein.

 

	
●   

	
Confidential information refers to classified information received by Party B (including trial director and all personnel involved in clinical trial) from Party A during effective term of this agreement or classified information generated, created or acquired during performing of this agreement and related to the trial, including but not limited to clinical trial scheme, research specimen, research results and reports.

 

  

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Chapter 4 Disclosure and Publication of Clinical Trial Results

 

Article 1 Party B and the investigator from the research unit hereby acknowledge and agree that Party A has the right to publicize, publish or make public of clinical trial scheme, research method and research results in seminars, national or regional academic meetings, professional magazines, dissertations, nationwide records where the public can acquire and access, or by other means that can be decided by Party A itself, including but not limited: Party B and the investigator from the research unit agree that Party A may, according to relevant provisions of standard operation flow concerning publicity and disclosure of results of clinical trial of new medical technologies applied by Party A, publicize the trial contents in form of abstract or by other means in the website of Clinical trials of NIH, website of International clinical trials of WHO and “Clinical trial record” of official website of Party A’s company before (or after) the abovementioned publicity or publication. If Party A coordinates with the implementation of multicenter publication, Party B as the main research unit and Party B’s main investigator as signing author participate in this publication. Besides, the research institute and investigator from research unit agree that Party A may, at any time, publicize name of investigator from the research unit, details of research institute and/or details of research institutes related to the investigator in one or multiple records where the public nationwide can acquire and access.

 

Article 2 If Party B publishes, introduces, extracts and compiles, post or discloses by other means the results of clinical trial for the teaching purpose, it shall offer at least 60 days to Party A for review and discuss with Party A concerning the contents ready to disclose. Party A has the right to delete or modify confidential information contained in the abovementioned published and introduced data. Party B shall not engage in any disclosure or publication until Party A’s written consent is obtained.

Chapter 5 Intellectual Property

 

Article 1 All confidential information involved in this clinical trial as well as all intellectual property generated from the trial (including but not limited to copyright, invention, discovery, patent and know-how) are all Party A’s property.

 

 

Article 2 Party B and/or trial director shall timely disclose any intellectual property generated according to this agreement to Party A and promise that they will not use such intellectual property for any other purpose beyond this agreement unless otherwise approved by Party A in writing.

 

Article 3 The intellectual property generated from service invention by Party B’s investigator or other personnel of Party B involved in trial belongs to Party A. Party B is responsible for granting reward and remuneration (if involved) of relevant personnel.

Chapter 6 Equipment Necessary to Clinical Trial (Experimental Equipment/Electronic Case

Report/Information System, etc.)

 

Article 1 Party A shall provide equipment necessary to clinical trial, including laboratory consumables, cell transportation cases, etc. and other equipment necessary to this clinical trial; Party B shall assist Party A in using the therapy place.

 

  

4

  

 

	
1  

	
Party A has the right to decide if the equipment necessary to this clinical trial is necessary to this clinical trial and if equipment necessary to this clinical trial is provided at its discretion;

 

	
2  

	
Equipment necessary to this clinical trial can only be used in clinical trial in a way instructed by Party A in writing;

 

	
3  

	
Equipment necessary to this clinical trial must be put in a safe place. Only research personnel designated by the research are responsible for entering research data;

 

	
4  

	
Information related to the interviewed subjects shall be handled using stipulated method within three days after the subjects are accessed or detection data of subjects is received (if applicable);

 

	
5  

	
All data inquiry requirements of Party A shall be completed and returned to Party B within three days (within three days during final data sorting period) or within other time limit stipulated by Party A;

 

	
6  

	
Party B will take proper measures and methods to prevent equipment necessary to this clinical trial and/or software system from being stolen, damaged and lost;

 

	
7  

	
After completion of clinical trial, Party B will return training data and documents related to equipment necessary to the clinical trial as provided for Party B or research personnel.

Article 2 About this equipment

 

The ownership of equipment necessary to this clinical trial belongs to Party A. Besides, equipment necessary to this clinical trial can only be used in clinical trial. Party B shall immediately return equipment necessary to this clinical trial to Party A upon end of clinical trial or upon Party A’s request.

Chapter 7 Supervision, Audit and Preservation of Research Data

 

Article 1 Under the precondition that all applicable laws and regulations are followed and Party A informs Party B ahead of time, Party B shall make sure that Party A’s supervisor is able to access research records at any time within a reasonable time limit to supervise and verify the data sources.

 

Article 2 According to Party A’s reasonable requirements and with a written notice sent seven days ahead of time, Party B shall allow Party A’s audit personnel to retrieve and check research records, relevant data and research facilities every year.

 

Article 3 According to provisions of Quality Management Code of Drug Clinical Trial of the People’s Republic of China and Party A’s policy, all identification codes, archives, clinical trial data and relevant documents of subjects related to clinical trial as subsidized by Party A shall be properly kept by Party B for 5 years after end of clinical trial. After expiry of 5-year period, the two parties shall agree to confirm the keeping method.

Chapter 8 Clinical Trial Fund

 

Article 1 Clinical trial fund

 

The following clinical trial fund paid by Party A to Party B includes:

 

	
I.

	
Principal investigator (PI) coordination fee: RMB 50,000.00 Yuan in total.

 

	
II.

	
Clinical research fee of department of rheumatism: RMB 18,500.00 Yuan/each qualified case. The total clinical research fee of 18 cases is RMB 333,000.00 Yuan, including:

 

  

5

  

 

	
1.

	
Clinical observation and treatment fee: RMB 15,000.00 Yuan/each qualified case. See Appendix 1 for details;

 

	
2.

	
Case examination fee: RMB 3,500.00 Yuan/each qualified case. See Appendix 2 for details.

 

	
III.

	
Amount of screening fee paid by Party A is RMB 2,000.00 Yuan/each failed case (it shall be in line with signing of informed consent form and completion of relevant examinations. After end of clinical trial, Party A and Party B shall pay the amount together with the final installment after confirmation of actual circumstances). This fee is included in case observation fee of department of rheumatism.

 

	
IV.

	
If the selection progress of patients is obviously slow (i.e. the number of grouped cases in each month is less than 4), Party A may discuss and negotiate with PI concerning relevant arrangements.

 

	
V.

	
As for cases involved in loss to follow-up and drop-out during clinical follow-up visit, observation fee and examination fee will be paid for this case according to the visit stage completed. The payment of statistically eliminated cases in clinical trial shall be made according to cases with clinical trial completed. The clinical observation fee and clinical examination fee are detailed in the appendix.

 

	
VI.

	
If Party A provides equipment necessary to clinical trial, the equipment will be returned to Party A after end of clinical trial and upon closing of the research center. Handover sheet of equipment necessary to clinical trial of the two parties in clinical trial shall prevail.

 

Article 2 Clinical trial fund will be paid in different times according to research stages and completion conditions:

 

	
1  

	
Before startup of clinical trial, PI coordination fee and 20% of clinical research fee of department of rheumatism will be paid as initial capital of clinical research of department of rheumatism (i.e. RMB 116,600.00 Yuan).

 

	
2  

	
After completion of selection of cases as stipulated, 50% of clinical research fee of department of rheumatism (RMB 166,500.00 Yuan) will be paid.

 

	
3  

	
After receiving all trial data and final test summary report, Party A shall pay about 30% of clinical research fee of department of rheumatism (approximately RMB 99,900.00 Yuan) to Party B according to the conditions of actually screened and selected cases.

 

	
4  

	
The transportation subsidy of the subjects shall be paid by the sponsor separately.

 

	
5  

	
If long-term follow-up visit evaluation is needed after end of trial, Party A shall sign a supplementary agreement with Party B separately and pay necessary clinical research fee to Party B. Party B promises that the charging standard of clinical research fee separately supplemented is not higher than the price system of this agreement.

 

	
6  

	
If the number of qualified cases selected by Party B fails to reach the stipulated number after end of test and there is still remaining amount of clinical trial fund prepaid by Party A according to actually selected cases after deduction of relevant clinical trial fee, Party B shall return the remaining amount to Party A.

Article 3 Payment

 

Party A will pay relevant expenses to Party B in form of telegraphic transfer or check upon the abovementioned stipulated time respectively. After receiving remittance, Party B shall timely provide a relevant amount of formal invoice stamped with seal of financial bureau.

 

  

6

  

 

Chapter 9 Anticorruption

 

Article 1 Party B and the investigator acknowledge the receiving of “Anticorruption-Third Party Guide” (Appendix 4) and agree to perform their obligations under this agreement according to principles demonstrated in this guide.

 

Article 2 Party B and the investigator shall always completely abide by all applicable laws and regulations including but not limited to applicable anticorruption laws in the region where Party B and Party A launch business.

 

Article 3 Party B and the investigator agree that they never and guarantee that they will not promise, authorize, approve, provide or promote any payment or transfer any valuable article to (1) any persons including government officials (defined below); or (2) intermediaries paying any persons including government officials: or (3) any political party directly or indirectly concerning performing of this agreement. Intention of each party shall not make, promise, authorize, approve or provide any payment or value transfer with purpose or effect of public or commercial bribery, accepting or default of blackmailing and kickback or seeking for illegitimate interests, or other illegal or illegitimate approaches means acquiring or maintaining business.

 

Article 4 For the purpose of this paragraph, “government officials” refer to (1) any officials or employees of government or any government department, agency or institution; (2) any individuals acting as officials on behalf of such government or government department, agency or institution; (3) any officials or employees of companies or businesses entirely or partly owned by government; (4) any officials or employees of any public international organizations such as the World Bank or the United Nations; (5) officials or employees of any political party or any individuals acting as officials on behalf of political parties; and/or (6) Candidates of any political entities.

 

Article 5 Party B and the investigator shall not contact with or meet any government officials by other means concerning any transaction required herein under the condition that Party A’s written approval is not obtained ahead of time. Furthermore, upon the request of Party A, Party B and the investigator can only contact with or meet the government officials with the witnessing of Party A’s designated representative.

 

Article 6 Party B and the investigator hereby represent that they were never convicted or pleaded guilty for a criminal offense, including crimes involving fraud, corruption or violation of morality. To the best of knowledge, such crime is currently not a subject investigated by any government. Besides, it is currently not prohibited or suspended by any government agency or planned to be suspended or prohibited, or be disqualified in inclusion of government projects by other means.

 

Article 7 Party B and the investigator hereby represent and warrant that, except written disclosure, (1) there is no interest that directly or indirectly conflicts with proper and moral performing of this agreement and (2) they shall maintain a fair relationship with all third parties (including government officials) communicating for Party A or on behalf of Party A (or during performing of this agreement).

 

Article 8 Party A shall have the right to investigate and audit Party B and the investigator within term of this agreement so as to supervise Party B and the investigator to abide by terms of this chapter. Party B and the investigator shall fully coordinate with such investigation or audit, and scope, method, nature and duration of such investigation or audit shall be fully and reasonably decided by Party A.

 

Article 9 Party B shall ensure that all transactions under this agreement are properly and accurately recorded in its accounts and records in all material aspects. Besides, each document used as basis for inclusion of the foregoing in such accounts and records is complete and accurate in all material aspects. Party B shall maintain a reasonably designed internal accounting control system to ensure that no off-the-book accounts exist.

 

  

7

  

 

Article 10 Party B and the investigator agree that Party A may fully disclose information related to possible violation of terms of this agreement to any related government authorities and their agencies and any person that shall be legally informed of in Party A’s opinion at any time and due to any reason.

 

Article 11 If Party B or the investigator fails to perform its obligations according to this chapter, Party A will have the right to inform Party B in writing to immediately terminate this agreement. Party B and the investigator shall not request any compensation from Party A. If Party A has to pay any of such compensation to Party B and the investigator due to termination of this agreement according to provisions of relevant regional laws (and within a scope legally permitted above), Party B and the investigator hereby definitely agree to waive such compensation (within a scope legally permitted above) or repay any such compensation or indemnity to Party A.

Chapter 10 Name of Other Party’s Name

 

Article 1 The two parties hereby agree that either party shall not use the other party’s name for any purpose unless otherwise approved by the two parties in writing ahead of time. However, the other party shall not approve for no reason.

Chapter 11 Severability

 

Article 1 If any term of this agreement are recognized as ineffective, illegal or unenforceable due to any reason, this term shall not be deemed as deleted from this agreement, while the remaining terms in this agreement shall remain continuously and completely effective.

Chapter 12 Applicable Law and Arbitration

 

Article 1 This agreement is interpreted by and subject to laws of the People’s Republic of China.

 

Article 2 All disputes arising from or related to this agreement shall be solved by the two parties through amicable negotiation. If either party is not willing to negotiate or the disputes cannot be solved through negotiation within 30 days after commencement of negotiation, the disputes shall be submitted to Shanghai International Economic and Trade Arbitration Commission for arbitration according to its then effective arbitration rules.

 

Article 3 The arbitral award is final and binding on both parties. The arbitration expenses shall be borne by the losing party unless otherwise stipulated in the arbitral award.

 

Article 4 During amicable negotiation and arbitration process, except parts disputes by the two parties and currently being arbitrated, other parts of this agreement shall be continuously performed.

Chapter 13 Force Majeure

 

Article 1 If either party under this agreement suffers from force majeure (e.g. war, serious fire, flood, typhoon, earthquake or other events unanimously recognized by the two parties) to result in the failure to execute this agreement, this party will not therefore undertake any liability. Term for execution of this agreement will be postponed for a period same as duration of force majeure.

 

  

8

  

 

Article 2 The affected party shall inform the other party by fax or telex within a time limit as short as possible after occurrence of force majeure and send a certificate issued by relevant authority to other party by registered airmail within 14 days to make it convenient for the other party confirms.

Chapter 14 Modification

 

Article 1 Any modification of this agreement and appendixes may take effect only after authorized representatives of the two parties sign their names and stamp seals.

Chapter 15 Entire Agreement

 

Article 1 This agreement and its appendixes constitute the entire agreement reached by the two parties in this clinical trial and replace any previous agreements, understandings or arrangements reached by the two parties.

Chapter 16 Execution, Term and Premature Termination of Agreement

 

Article 1 This agreement takes effect since the date when authorized representatives of the two parties sign their names and stamp seals. The effective term of this agreement ends when the clinical trial is completed and rights and obligations of the two parties under this agreement are fully performed.

 

Article 2 Before Party A (suspends) terminates a clinical trial, it shall inform the investigator, ethics committee and Health of Ministry or China Food and Drug Administration and clearly explain the reasons. Upon termination of trial, Party A shall pay clinical trial fund according to all work already conducted or completed by the investigator before date of termination and actual expenditures.

 

Article 3 Prof. Bao Chunde (doctor), the investigator, signs name in this agreement to confirm that he is subject to this agreement and enjoys and undertakes relevant rights and obligations of investigator.

This agreement is made in four copies with same legal effect.

This agreement is signed and sealed by authorized representatives of the two parties and the investigator in [Shanghai].

 

	

Party A: Cellular Biomedicine Group (Shanghai) Ltd

Cellular Biomedicine Group (Shanghai) Ltd Special Seal for Contract (seal)

	

Party B: Renji Hospital Shanghai Jiaotong University School of Medicine

Renji Hospital Shanghai Jiaotong University School of Medicine *** (seal)

	
Authorized representative (signature and seal): /s/ Dai Chengxiang (signature)

	
Authorized representative (signature and seal): *** (signature)

	
Project director:

	
Investigator: *** (signature)

	
Unit (official seal):

	
Unit (official seal):

	
Date: December 14, 2015

	
Date: December 15, 2015

 

  

9

  

 

Appendix 1: Clinical Observation Fee

 

 

	 
Screening-48W

	 	 
Screening

	 	 	 
0W

Observation fee and treatment fee

	 	 	 
1W

	 	 	   
2W

	 	 	3W 
Observation fee and treatment fee

	 	 	 
4W

	 	 	   
6W

	 	 	 
8W

	 	 	 
12W

	 	 	 
24W

	 	 	 
36W

	 	 	 
48W

	 	 	   
Total

	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Case screening and observation and treatment fee of department of rheumatism	 	 	 
2000

	 	 	 	 
2000

	 	 	 	 
1000

	 	 	 	 
1000

	 	 	 	 
2000

	 	 	 	 
1000

	 	 	 	 
1000

	 	 	 	 
1000

	 	 	 	 
1000

	 	 	 	 
1000

	 	 	 	 
1000

	 	 	 	 
1000

	 	 	 	 
15000

	 

 

Appendix 2: Detailed List of Expenses of Laboratory Examination Items

 

	  	 	
Unit price

	 	 	
Price of follow-up visit

	 	 	
Expense

	 
	
Item

	 	
Price

	 	 	V1	 	 	V2	 	 	V3	 	 	V4	 	 	V5	 	 	V6	 	 	V7	 	 	V8	 	 	V9	 	 	V10	 	 	V11	 	 	 V12	 	 	
Case-time

	 	 	
Expense

	 
	
Joint X-ray

	 	 	140	 	 	
√

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	18	 	 	 	2520	 
	
ECG

	 	 	25	 	 	
√

	 	 	 	 	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	18*8	 	 	 	3600	 
	
Virology examination

	 	 	290	 	 	
√

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	18	 	 	 	5220	 
	HIV antibody (40)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Syphilis (60)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	HCV (40)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	HBV (130)	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
Immunologic test

	 	 	180	 	 	
√

	 	 	 	 	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	18*8	 	 	 	25920	 
	
Blood sugar

	 	 	15	 	 	
√

	 	 	 	 	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	18*8	 	 	 	2160	 
	
Blood fat

	 	 	35	 	 	
√

	 	 	 	 	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	18*8	 	 	 	5040	 
	
LRFT

	 	 	43	 	 	
√

	 	 	 	 	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	18*8	 	 	 	6192	 
	
HCG

	 	 	15	 	 	
√

	 	 	 	 	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	18*8	 	 	 	2160	 
	
Blood routine

	 	 	20	 	 	
√

	 	 	 	 	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	18*8	 	 	 	2880	 
	
Urine routine

	 	 	30	 	 	
√

	 	 	 	 	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	
√

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	18*8	 	 	 	4320	 
	
Blood coagulation

	 	 	55	 	 	
√

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	18	 	 	 	990	 
	Total	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	61002	 

 

The total examination fee of each subject amounts to RMB 3,389 Yuan. In consideration of loss during test process, the examination fee actually paid amounts to RMB 3,500 Yuan/case.

 

10

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