1. Basic project situation

(I) Project name: Immune cell preparation and transformation platform purified water system and air conditioner upper computer system verification service procurement.

(2) Project location: Jinfeng Laboratory.

(III) Procurement method: inquiry and purchase.

(IV) Procurement content: Immune cell preparation and transformation platform purified water system and air conditioner upper computer system verification service.

(V) Total project limit:189000Yuan, the total price of the quotation shall not be higher than the limit price.

(VI) The quotation includes all tools and equipment costs, taxes, freight, testing costs, and material costs, and the total cost is included in the budget amount.

2. Supplier qualification requirements

(1) Suppliers should have complete qualifications, have independent legal person qualifications, and must hold a legal person business license within the valid period, and the business scope clearly includes the scope of service such as "consultation services" or "technical services".

(2) Suppliers should have cases of independently completing large-scale verification projects, with consulting service contracts of more than 200,000, and the number should not be less than 1. (Proof of the project's double-chapter contract is required).

(III) The supplier project manager must have certain management and coordination skills and team-leading skills, be able to fully understand NMPA GMP and European and American regulations/guidelines, and have project experience in guiding the construction of new factories of large pharmaceutical companies (no less than 3). The project manager should have project experience in verifying project management in the entire factory (no less than 2). The project manager has a construction engineer certificate of a level 2 or above in the electromechanical installation project. The project manager can only be appointed after passing the procurement trial. If the project manager's ability cannot meet Party A's needs, the purchaser has the right to request replacement.

(4) The supplier equips the project team members according to the needs of the purchaser and has the relevant professional level, qualifications and experience of the project. The main members of the project team must undergo A-level test and have at least 5 years of work experience. The team personnel must professionally cover all aspects of verification required for the construction of a new biopharmaceutical factory, such as public systems, instruments and equipment, factories, computerized systems, production auxiliary verification, etc.

(5) Comply with Article 22 of the "Government Procurement Law of the People's Republic of China".

(VI) The business license is within the validity period.

3. Other requirements

(I) Acceptance and delivery

1. All work carried out by the supplier should ensure that the requirements of NMPA, EU, WHO, and FDA GMP are met. The implementation process is based on the relevant requirements of ISPE Baseline "Commissioning & Qualification". The verification of electronic and automation systems should refer to the requirements of GAMP5. The commissioning and verification of engineering equipment should refer to the relevant requirements of ISPE GEP (Good Engineering Practice).

2. Suppliers shall strictly protect all confidentiality involving the purchaser and enter into a confidentiality agreement with the purchaser.

3. Any plans, standards and documents provided by the supplier shall be approved or approved by the quality manager of the Purchaser or other management and technical personnel entrusted by him, other relevant stakeholders of the Purchaser, and technical consultants hired by the Purchaser.

4. The supplier ensures that the real data is recorded and responds to real problems (when verifying the service company's response, it is necessary to describe in detail how to ensure the data integrity during the verification process).

5. All personnel of the supplier must communicate with the purchaser and sign and confirm before entering/departing the site. The changes in personnel will not have a substantial impact on the project progress.

6. Verification samples (petri dishes, pharmaceutical water samples, etc.) can be tested by a third-party testing company audited by the service provider and qualified. The audit report needs to be provided to the laboratory.

7. Suppliers provide verification instruments, consumables and culture laboratories. Such as petri dishes, biological indicators, preparation of water intake tools, culture chambers, etc. Verifying consumable brands must be audited by qualified suppliers.

8. Provide verification solutions, verification services and verification reports that meet the satisfaction of the demand party. Delivery within [30] days from the date of signing of the contract. All documents should also provide electronic templates, electronic version plans and written printed version plans.

9. The ownership of all data, records, documents, etc. generated during the service process belongs to Party A and the supplier shall not use it other than others.

(II) After-sales service

1. Service period: The deadline for the third-party audit compliance report is passed from the date of signing the contract to the end of passing the third-party audit; the latest end time for the contract shall not exceed six months from the date of project acceptance.

2. During the inspection process of the regulatory department, it is clear that the responsible party is the defect of the service company and must be responsible for all subsequent rectification and guidance (including on-site rectification, rectification of relevant documents and plans, and preparation of rectification reports, etc.).

3. If an emergency technical problem occurs during the project execution, after the laboratory makes a service request, the service company should respond within 2 hours, arrive at the site within 24 hours, propose the best solution, and follow up until it is resolved.

(III) Warranty period

6 months from the date of project acceptance.

(IV) Time and method to raise objections to the service

According to the service plan, if the purchaser has objections to this verification/test, the supplier shall resolve the issue within one working day from the date of the purchaser's objection and bear all costs incurred.

(V) Payment settlement

Within 30 days of signing the contract, Party B will pay [60]% of the advance payment, Party B will complete the acceptance of the consultation service, and after passing the third-party audit compliance report, the remaining [40]% of the goods will be paid to Party B. The latest payment time for the final payment shall not exceed 6 months from the date of project acceptance.

4. Inquiry schedule

(I) Inquiry release time: 12:00 on June 11, 2025

(2) Inquiry deadline: 12:00 on June 13, 2025

The supplier shall send the quotation list and related attachments (need to be stamped with official seal and scanned in color) to the contact email kangqian@jflab.ac.cn before the inquiry deadline. Those who have not quoted before the inquiry deadline will be deemed to have automatically given up.

The decompression password of the compressed packet will be sent to the contact email kangqian@jflab.ac.cn within 30 minutes after the inquiry deadline. If the decompression password is not sent within 30 minutes, it will be deemed to be automatically given up.

Related attachments are as follows:

1. Copy of business license or proof documents of other organizational entities;

2. Certificate of qualification of legal representative (Appendix 1);

3. Authorization letter of the legal representative (Appendix 2);

4. Statement (Appendix 3);

5. Commitment letter (Appendix 4).

5. Service requirements list

6. Contact information

Contact person and contact information: Kangxi 15931898057

Contact address: No. 313, Gaoteng Avenue, Jiulongpo District, Chongqing

appendix:

Attachment 1: Certificate of Qualification of Legal Representative

Attachment 2: Authorization letter of the legal representative

Annex 3: Statement

Attachment 4: Commitment letter

Attachment 5: Immune cell preparation and transformation platform Purification water system and air conditioning system upper computer system verification service quotation template