[including Artemisia! 】Sunflower pharmaceutical and Suzhou Yusen signed a new drug technology transfer contract for Xiaoer Haoqin Kanggan granules

Sunflower Pharmaceutical Group (Xiangyang) Longzhong Co., Ltd (hereinafter referred to as "Longzhong pharmaceutical" or "party a"), a holding subsidiary of sunflower Pharmaceutical Group, recently transferred six new Chinese medicine drugs "Xiaoer Haoqin Kanggan granules" with a total amount of RMB 28 million, according to the announcement released in the afternoon of October 9 Suzhou Yusen new drug development Co., Ltd (hereinafter referred to as "Party B") has signed the "technology transfer contract of Xiaoer Haoqin Kanggan granule new drug" with respect to the technical research and development achievements and relevant government approval documents of the approved new drug certificate "Xiaoer Haoqin Kanggan Granule" is a six class new traditional Chinese medicine independently developed by Yusen, Suzhou This variety has applied to the State Food and Drug Administration for clinical trial approval (acceptance No cxzl130020), and applied for an invention patent (patent name: a traditional Chinese medicine composition for treating upper respiratory tract infection in children, preparation method and application; patent No.: 20121041372; ownership Person: Suzhou Yusen new drug development Co., Ltd.), which has obtained the clinical approval document (approval document No.: 2015l01322) on July 7, 2015 The prescription of Xiaoer Haoqin Kanggan granules is made up of the addition and subtraction of "Haoqin Qingdan Decoction" in the book of re ordering popular typhoid fever It is composed of 8 kinds of drugs, such as Artemisia, Scutellaria, Folium Isatidis, Zhuru, Qingqiao, jiangbanxia, Qingpi, Poria, etc it is the traditional Chinese medicine prescription that has been used in Shuguang Hospital for many years It has the effect of clearing away heat and resolving surface, and is used for the treatment of children's exogenous wind heat cold The original formula of this product has been used in children's acute upper respiratory tract infection for a long time, which has a good antipyretic effect on children's acute upper respiratory tract infection with fever The preclinical pharmacodynamic study showed that this product has the functions of antiviral, antibacterial, antipyretic, anti-inflammatory and analgesic, cough and phlegm relieving, among which antipyretic effect has the characteristics of fast antipyretic time and stable antipyretic effect It is reported that compared with the adult cold medicine, the pediatric cold medicine market is relatively small and there are relatively few brands to choose Many manufacturers are reluctant to produce children's cold medicine because of the high cost and low success rate of research and development of children's cold medicine, resulting in the lack of children's cold medicine In addition to a few well-known brands, other common cold medicines for children are mostly produced based on the successful experience of adult cold medicines On the other hand, in recent years, the demand of cold drugs for children is increasing Throughout the domestic cold medicine market, children's cold medicine market has a broad prospect Sunflower pharmaceutical purchases the new drug technology of Xiaoer Haoqin Kanggan granules If the follow-up research and development progress is smooth and the drug approval number is obtained and put into production smoothly, the brand influence of "xiaosunflower" children's medicine will be further enhanced and the overall business performance of the company will be improved Announcement Stock Code: 002737 stock abbreviation: sunflower pharmaceutical Announcement No.: 2015-071 announcement of sunflower Pharmaceutical Group Co., Ltd on signing the new drug technology transfer contract of Xiaoer Haoqin Kanggan granule announcement that the company and all members of the board of directors guarantee the authenticity, accuracy and integrity of the information disclosure, without any false record Containing or misleading statements or material omissions 1、 Recently, sunflower Pharmaceutical Group Co., Ltd (hereinafter referred to as "the company" or "the company"), a holding subsidiary of sunflower Pharmaceutical Group Co., Ltd (formerly known as "Hubei Xiangyang Longzhong Pharmaceutical Group Co., Ltd.", hereinafter referred to as "Longzhong pharmaceutical" or "party a"), paid a total amount of RMB 2, 8 million yuan has been transferred to Suzhou Yusen new drug development Co., Ltd (hereinafter referred to as "Party B") for the technical research and development achievements of "Xiaoer Haoqin Kanggan Granule", a new drug of six categories of traditional Chinese medicine, as well as the relevant government approval documents of the approved new drug certificate, and has signed a new drug technology transfer contract for Xiaoer Haoqin Kanggan granule (hereinafter referred to as "the contract") with Suzhou Yusen new drug development Co., Ltd (hereinafter referred to as "Party B") "Xiaoer Haoqin Kanggan Granule" is a six class new traditional Chinese medicine independently developed by Party B, which has applied to the State Food and Drug Administration for approval of clinical trials of drugs (acceptance No cxzl130020), and applied for an invention patent (patent name: a traditional Chinese medicine composition for the treatment of children's upper respiratory tract infection, its preparation method and response With; patent No.: 20121041372; owner: Suzhou Yusen new drug development Co., Ltd.), the product has obtained the clinical approval document (approval document No.: 2015l01322) on July 7, 2015 2、 Counterparty 1 Company Name: Suzhou Yusen new drug development Co., Ltd 2 Registration No.: 320594000089817 3 Address: No 80, Wupu Road, Shengpu Town, Suzhou Industrial Park 4 Legal representative: Xuan Zhenyu 5 Registered capital: 68210526 RMB 6 Company type: limited liability company (joint venture between Taiwan, Hong Kong, Macao and China) 7 Date of establishment: October 19, 2007 8 Business term: to October 20, 2057 9 Business scope: technology research and development, technology transfer, technical service and technical consultation of drugs, health food and cosmetics; production: tablet (production address: C30 floor, biological nano technology park, 218 Xinghu street, Suzhou Industrial Park) (for projects subject to approval according to law, business activities can only be carried out with the approval of relevant departments) the controlling shareholders, actual controllers, directors, supervisors and senior managers of the company have no relationship with the company and Longzhong sunflower Three The main contents of the contract 1 The technical research and development achievements of the six categories of new Chinese medicine "xiaohaoqin Kanggan Granule" and the relevant government approval documents of the approved new drug certificate, including but not limited to: pre clinical research data, all clinical trial approval documents, and clinical two Phase III and phase III clinical research reports, including all technical materials, invention patents and approved new drug certificates involved in the whole research and development process, all approval documents issued by the government departments related to the drug technology and intellectual property rights generated (hereinafter referred to as "Xiaoer Haoqin Kanggan granule new drug technology") 2 Transfer fee and payment method: Party A and Party B have agreed on the transfer of new drug technology of xiaoerhaoqinkanggan granules, and determined that the total transfer fee of new drug technology is RMB 28 million The method of installment is as follows: phase I: within ten working days after the contract is signed and takes effect, Party A shall pay Party B the first phase of technology transfer The fee is 5 million yuan (clinical approval technology transfer fee) After receiving the payment, Party B shall timely hand over the original clinical approval document and the full set of clinical application materials of the project of "Xiaoer Haoqin Kanggan granule new drug technology" at the request of Party A, and within one month, Party B shall complete the patent change procedures and submit them to the State Intellectual Property Office Phase II: Party B produces phase II clinical products, and at the same time hand over the process at Party A's production site Within ten working days after Party B starts phase II clinical research and holds phase II clinical kick-off meeting, Party A shall pay phase II technology transfer fee to Party B, totaling 4 million yuan Party B completes the phase II clinical trial and study, which meets the phase II clinical requirements of class VI new drugs of traditional Chinese medicine, and can prove to continue the phase III clinical study Party A shall pay another 1 million yuan of transfer fee for clinical approval documents to the account designated by Party B Phase III: After Party B completes the phase II clinical study, it will hold the phase III clinical kick-off meeting, and within ten working days after handing over the copies of all technical materials and reports involved in the phase II clinical study process to Party A, Party A will pay the phase III technology transfer fee to the account designated by Party B, totaling 6 million yuan Phase IV: within ten working days after Party B completes the phase III clinical research and meets the clinical evaluation requirements for class VI new drugs of traditional Chinese medicine, and hand over all copies of technical materials and reports involved in the phase III clinical research process to Party A, Party A shall pay Party B the phase IV Technology transfer fee, totaling RMB 3 million Phase V: Party B cooperates with Party A to apply for the new drug certificate of Xiaoer Haoqin Kanggan granules, and Party A submits the production approval application Within ten working days after both parties have successfully obtained the new drug certificate and production approval of Xiaoer Haoqin Kanggan granules issued by the State Food and drug administration, Party A shall pay Party B the technology transfer fee of phase V, totaling 9 million yuan 3 Main rights and obligations of both parties (1) after the contract comes into effect, the ownership of the technical achievements (including clinical approval, patent, new drug certificate and production approval) of "Xiaoer Haoqin Kanggan granule new drug technology" belongs to Party A in essence, and Party B is only in name The owner of the new drug certificate shall be signed by both parties The ownership of the new drug certificate shall belong to Party A, and Party A shall have the right of disposal If Party A transfers any third party, Party B shall provide all necessary formalities free of charge The production approval shall be owned exclusively by Party A and shall not be disposed of or used without the authorization of Party A If the project fails, the clinical approval and patent shall be returned to Party B (2) After the contract comes into effect, the existing and future new technological achievements, relevant government approvals and benefits of the project belong to Party B in name, but the actual owner is Party A, and Party B shall not dispose and use them without permission (3) After the contract comes into effect, Party B, acting for Party A, continues to carry out the follow-up clinical trial research of "Xiaoer Haoqin Kanggan granule new drug technology" project in the name of Party A, apply for the new drug certificate jointly with Party A, and apply for the drug production approval document at the same time, until the new drug certificate and production approval document of the project are finally obtained (4) After the signing of the contract, Party B shall be responsible for all the research costs of the project from the application of clinical research stage to the application of new drug certificate to the relevant national departments Party A shall apply for the production approval document at the same time as Party B applies for the new drug certificate The cost of producing three batches of samples and drug inspection shall be paid by Party A Party A shall be responsible for the registration fee of new drugs applied for production (5) Party B shall be responsible for responding to the review opinions put forward by the drug review center of the State Food and Drug Administration (hereinafter referred to as CDE) on the declared production materials of the project within the specified time limit until the new drug certificate and production approval document issued by SFDA are obtained through the CDE review of the project 4 Liability for breach of contract and risk bearing (1) if either party violates any provision of this contract, the breaching party shall compensate the observant party for all losses arising therefrom (2) If the future clinical phase II and phase III research results and relevant reports show that the clinical is invalid, or phase II is valid, but there is a significant difference between phase III and phase II clinical results, and Party B cannot continue to carry out the follow-up application for new drug certificate and production registration, Party A shall not pay the later technology transfer fee, which shall be returned by Party B 50% of the total amount has been paid, so that the risk and loss of the project R & D shall be borne by both parties, and this transfer contract shall be terminated (3) If the contract cannot be performed due to Party A's reason, Party B shall return all the payments paid by Party A, Party A shall pay Party B a penalty of 50% of the total transfer fee, and all the achievements related to "Xiaoer Haoqin Kanggan granule new drug technology" shall still belong to Party B （4） Party A shall pay the technology transfer fee of each phase on time according to the agreement of this contract If the time exceeds 30 days, it shall be deemed as Party A's breach of contract, and Party A shall pay liquidated damages of 5/10000 of the current payable amount for each day of delay Party B fails to deliver according to the time limit and method stipulated in the contract or required by Party A