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Drug Quality Assurance Agreement


Party A:
Party B: City Pharmaceutical Co., Ltd. strictly implements the Drug Administration Law, the Product Quality Law and relevant pharmaceutical and administrative regulations, and complies with the requirements of the Pharmaceutical Management Quality Management Regulations and its implementation rules to ensure the safety and effectiveness of drugs. Clarify the quality responsibility of both parties and sign a quality assurance agreement by consensus.
First, Party A’s responsibility
1. Party A complies with the national drug administration regulations and provides Party B with a copy of the legal and valid business license and the license for the drug business enterprise and affixes the official seal of Party A. Party A's business personnel shall issue a letter of entrustment with the official seal of the company and the seal or signature of the legal representative of the enterprise, which clearly stipulates the scope and validity of the authorization, a copy of the ID card, and conducts business activities according to the scope of the power of attorney.
2. The drugs provided by Party A are qualified drugs that meet the national drug quality standards and relevant quality requirements; the drug-attached product certificate; the drug package complies with relevant regulations and cargo transportation requirements; when Party A provides imported drugs, it also provides a prescription for Party A. The "Imported Drug Registration Certificate" or the "Pharmaceutical Product Registration Certificate" of the official seal and the "Imported Drug Inspection Report" or the "Imported Drugs Customs Declaration Form" of the same batch number.
3. If the medicine provided by Party A is a patented product, a patent certificate with the official seal of Party A and the most recent payment certificate shall be provided.
4. Party A shall provide the quality responsibility for the delivery period of the drug, in accordance with the relevant requirements of the State “Methods for the Administration of the Purchase and Sale of Pharmaceutical Commodities and the Division of Responsibilities for Transportation and Transportation”, and Party A shall be responsible for the quality problems during the validity period of the drug.
5. When Party A supplies the medicine, the medicine shall not exceed one third of its validity period from the date of production. The imported medicine and special circumstances shall be separately agreed. If the supply of medicines is less than 50 pieces, it shall not exceed 2 batch numbers, 50 pieces or more shall not exceed 3 batch numbers, and less than 1 batch number. Special circumstances are otherwise agreed.
6. After receiving the quality inquiry letter from Party B, Party A will give a reply within 24 hours, exceeding the time limit, and Party A shall be responsible for the consequences.
7. If the drug provided by Party A to Party B can be returned to Party A due to improper marketability, Party B shall return the original batch number and provide an equal number of new batch drugs if Party B is out of date.
8. The biological products provided by Party A shall be a copy of the batch of biological products "Certificate of Issuance of Biological Products" issued with the official seal of Party A at the same time as the varieties specified in the Measures for the Administration of the Issuance of Biological Products.
9. If any of the goods provided by Party A is suspected of impersonating a patent, Party B has the right to take measures such as withdrawing the cabinet and temporarily detaining the goods suspected of impersonating the patent.
10. The legal responsibility for the patent infringement dispute arising from the goods provided by Party A shall be borne by Party A.
Second, Party B’s responsibility
1. As a legally operated drug unit, Party B shall provide Party A with a copy of the legal and valid certificate of enterprise qualification certificate and affix the official seal of Party B.
2. Party B receives the drugs shipped by Party A, and if it finds shortage, damage, error, packaging pollution, appearance quality problems and imported drugs without the official seal of the “Imported Drug Registration Certificate” or “Pharmaceutical Product Registration Certificate” And the same batch of "Imported Drugs Inspection Report" or "Imported Drugs Customs Clearance", should be notified to Party A within a certain date after receipt of the drug.
3. If Party B has doubts in the business or use of the drugs provided by Party A, it shall contact Party A in time. If there is any disagreement between the two parties, the drug quality inspection report issued by the competent department shall prevail. Party B shall notify Party A within 10 days after receiving the drug inspection report, and shall deliver the report to Party A for processing. Party B shall be responsible for the consequences of overdue.
4. If Party B has quality problems in the operation or use of the drugs provided by Party A, it shall provide detailed and confirmed quality information, and actively cooperate with Party A to do the investigation and evidence collection work and the aftermath.
5. Party B promises to provide the drug storage conditions for the drugs supplied by Party A in accordance with the state regulations, and Party B shall be responsible for the losses caused by improper storage.
6. Party B undertakes to comply with the principle requirements of the State “Methods for the Administration of the Purchase and Sale of Pharmaceutical Commodities and the Division of Responsibilities for Transportation and Transportation”, and Party B shall be responsible for the quality problems that occur outside Party A’s responsibility; the seasonal control of antifreeze and heat-proof varieties shall be Regulations are enforced.
7. Party B promises to return the non-quality problems, and Party B is responsible for the costs and losses caused by the unreasonable return of the goods without the confirmation of Party A.
8. Party B finds that the stored medicine is about to expire, and Party A must be notified in advance within six months before the expiration of the medicine.
Third, the mutual responsibility and agreed terms
1. Party A and Party B work together to do a good job in market research, development and quality management.
2. Party A shall mutually safeguard each other's interests. If one party breaches the contract, the other party reserves the right to appeal or pursue civil compensation.
3. Other agreed terms
4. This Agreement shall be valid until the date of the year, and shall become effective as of the date of mutual consent, signature and seal.
Party A: Party B: Representative of the representative of City Pharmaceutical Co., Ltd.

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