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| Guangdong Bencao Medicine Group Co., Ltd. v. Bruschettini S.R.L. (case of dispute over product liabilities) | | 广东本草药业集团有限公司诉贝斯迪大药厂（BruschettiniS.R.L.）产品责任纠纷案 |
| Supreme People's Court of PRC | | 中华人民共和国最高人民法院 |
| Civil Judgment | | 民事判决书 |
| (2019) ZuiGaoFaShangChu No. 1 | | (2019)最高法商初1号 |
Plaintiff: Guangdong Bencao Medicine Group Co., Ltd.
Domicile: Floor 2&3&4, Building 2, No. 1146, Sanyuanli Avenue, Baiyun District, Guangzhou, Guangdong Province, People's Republic of China. | | 原告：广东本草药业集团有限公司，住所地中华人民共和国广东省广州市白云区三元里大道某某自编某某楼某某。 |
| Legal representative: Wu Chusheng, Chairman of the board of directors. | | 法定代表人：吴楚升，该公司董事长。 |
| Attorney: Huang Huijin, Guangdong Fair Strategy Law Firm. | | 委托诉讼代理人：黄辉金，广东正大方略律师事务所律师。 |
| Attorney: Wu Linyin, Guangdong Fair Strategy Law Firm. | | 委托诉讼代理人：吴林茵，广东正大方略律师事务所律师。 |
| Defendant: Bruschettini S.R.L..Domicile:ViaIsonzo, 6-16100 Genova, Italy. | | 被告：贝斯迪大药厂（BruschettiniS.R.L.），住所地意大利热那亚nzo,6-16100Genova,Italy）。 |
| Legal representative: Augusto Bruschettini, Chairman of the board of directors of Bruschettini S.R.L.. | | 法定代表人：AugustoBruschettini，该公司董事长。 |
| Attorney: Li Qing, Junhe LLP (Beijing). | | 委托诉讼代理人：李清，北京市君合律师事务所律师。 |
| Attorney: Zou Delong, Junhe LLP (Beijing). | | 委托诉讼代理人：邹德龙，北京市君合律师事务所律师。 |
| This case of product liability dispute between the plaintiff Guangdong Bencao Medicine Group Co., Ltd. (hereinafter as "Bencao") and the defendant Bruschettini S.R.L. (hereinafter as "Bruschettini"), was first accepted by Guangzhou Intermediate People's Court of Guangdong Province on October 11, 2018, with case number (2018) Yue01MinChu No.1068. In accordance with Paragraph 1 of Article 38 of the Civil Procedure Law of the People's Republic of China and Paragraph 5 of Article 2 of the Provisions of the Supreme People's Court on Several Issues concerning the Establishment of International Commercial Court, this court on December 28, 2018 with ruling(2018) ZuiGaoFaMinXia No.183 ruled that this case shall be heard by the First International Commercial Court. After the case was accepted on February 19, 2019, this court applied the ordinary procedure according to law and held public hearing afterwards. Huang Huijin and Wu Linying, attorneys entrusted by Bencao, the plaintiff, and Li Qing and Zou Delong, attorneys entrusted by Bruschettini, the defendant participated the court hearing. Neither party challenged the jurisdiction of the First International Commercial Court over this case. | | 原告广东本草药业集团有限公司（以下简称本草公司）与被告贝斯迪大药厂（BruschettiniS.R.L.）（以下简称贝斯迪药厂）产品责任纠纷一案，广东省广州市中级人民法院于2018年10月11日立案，案号为（2018）粤01民初1068号，本院依照《中华人民共和国民事诉讼法》第三十八条第一款、《最高人民法院关于设立国际商事法庭若干问题的规定》第二条第五项之规定，于2018年12月28日作出（2018）最高法民辖183号民事裁定，裁定本案由本院第一国际商事法庭审理。本院日立案后，依法适用普通程序，公开开庭进行了审理。原告本草公司的委托诉讼代理人黄辉金、吴林茵，被告贝斯迪药厂的委托诉讼代理人李清、邹德龙到庭参加诉讼。双方当事人对本院第一国际商事法庭管辖本案均未表示异议。 |
| Both Bencao and Bruschettini agreed at the hearing to apply the laws of the People's Republic of China to this case. Article 3 of the Law of the People's Republic of China on the Law Applicable to Foreign-Related Civil Relationships provides that: "The parties may explicitly choose the laws applicable to foreign-related civil relations in accordance with the provisions of law."Paragraph 1 of Article 8 of the Interpretation of the Supreme People's Court on Several Issues Concerning the Application of the “Law of the People's Republic of China on the Law Applicable to Foreign-Related Civil Relationships” stipulates that: "Where the parties agree to choose or change the choice of applicable law before the ending of the court debate in the first instance, the people's court shall permit it." Therefore, this court shall hear this case by applying the laws of the People's Republic of China. The trial of this case has now been concluded. | | 本草公司和贝斯迪药厂在庭审时均表示同意本案适用中华人民共和国法律进行审理。《中华人民共和国涉外民事关系法律适用法》第三条规定：“当事人依照法律规定可以明示选择涉外民事关系适用的法律。"《最高人民法院关于适用若干问题的解释（一）》第八条第一款规定：“当事人在一审法庭辩论终结前协议选择或者变更选择适用的法律的，人民法院应予准许。"故本院适用中华人民共和国法律对本案进行审理。本案现已审理终结。 |
| Basic Facts | | 基本案情 |
| Bencao brought the following claims against Bruschettini: 1. To rule that Bruschettini compensate for the losses of its inventory of bacterial lysate “Lantigen” (hereinafter as “Lantigen”) totaling RMB 21,124,710 (234,719 bottles × RMB 90/bottle) andits interest amounting to RMB712,481.48 as of August 31, 2018 (taking RMB 21,124,710 as the base amount according to the basic loan interest rate of the same kind as that of the People's Bank of China for the same period from November 22, 2017 to the date of actual payment of compensation). 2. To rule that Bruschettini compensate for the loss of RMB 4,012,076.80, including RMB 700,156.80 resulting from the sample spot-check of the imported “Lantigen” (10,080 bottles × average import price of RMB 69.46/bottle) and RMB 3,311,920 resulting from testing expenses. 3. To rule that Bruschettini compensate in the total RMB 88,000, including the notary fee of RMB 8,000 and the attorney fee of RMB 80,000 incurred from this litigation for compensation against Bruschettini; 4. To rule that Bruschettini immediately dispose of the stocks of expired “Lantigen” held at Bencao and bear all expenses arising from their disposal; 5. To rule that Bruschettini compensate Bencao for its loss of RMB 52,298,347.06 resulting from the liability of the Civil Judgment (2017) YueMinZhong No. 3184 rendered by Guangdong High People's Court. 6. To rule that Bruschettini compensate Bencao for the expense of RMB1,085,637 resulting from Bencao's dispute with Shanghai Mainland Pharmaceutical Co. Ltd. (hereinafter as "Mainland Company"), including the case acceptance fees of the first and second instances of RMB 645,071, the preservative measures fee of RMB 5,000 and the attorney fee of RMB 435,566. 7. To rule that Bruschettini indemnify Bencao for the notary fee of RMB8,000 arising from its claim for compensation against Bruschettini. 8. To rule that Bruschettini to bear the entire litigation cost of this case. | | 本草公司向本院提出诉讼请求：1.判令贝斯迪药厂赔偿其库存细菌溶解物Lantigen“兰菌净"（以下简称“兰菌净"）的损失合计人民币21,124,710元（234,719瓶×人民币90元/瓶）及其利息（以人民币21,124,710元为基数按中国人民银行同期同类贷款基准利率自2017年11月22日起计至实际给付赔偿款之日止，暂计至2018年8月31日为人民币712,481.48元）；2.判令贝斯迪药厂赔偿其因进口“兰菌净"抽检而产生的样品损耗人民币700,156.80元（10,080瓶×进口平均价人民币69.46元）以及检测费用损失人民币3,311,920元，合计人民币4,012,076.80元；3.判令贝斯迪药厂赔偿其因向贝斯迪药厂追偿产生的公证费人民币8,000元、律师费人民币80,000元，合计人民币88,000元；4.判令贝斯迪药厂立刻依法处理已过有效期的在本草公司处的库存“兰菌净"并承担全部处理费用；5.判令贝斯迪药厂赔偿其因承担广东省高级人民法院（2017）粤民终3184号民事判决所确定赔偿责任产生的损失人民币52,298,347.06元；6.判令贝斯迪药厂赔偿其因与上海大陆药业有限公司（以下简称大陆公司）纠纷一案而支出的一、二审案件受理费人民币645,071元、诉讼保全费人民币5,000元、律师费人民币435,566元，合计人民币1,085,637元；7.判令贝斯迪药厂赔偿其因向贝斯迪药厂追偿损失而产生的公证费人民币8,000元；8.判令贝斯迪药厂承担本案全部诉讼费用。 |
| Alleged facts and Grounds: On June 13, 2008, Bruschettini issued a power of attorney to Aprontech Co. Ltd. (hereinafteras “Aprontech”) to sell the “Lantigen” produced by Bruschettini in China. On September 30, 2009, the China Food and Drug Administration (hereinafter as "CFDA") issued the Registration Certificate for Imported Drugs and the Drug Registration Permit for "Lantigen". The registration was valid until September 29, 2014. On July 30, 2014, the CFDA renewed the corresponding Registration Certificate for Imported Drugs and Drug Registration Permit for “Lantigen”, the validity term of the registration was from July 30, 2014 to July 29, 2019. On December 15, 2009, Guangdong Food and Drug Administration issued Pharmaceutical Supply Certificate to Bencao approving it to engage in the pharmaceutical wholesale business, valid from December 15, 2009 until December 14, 2014. On August 18, 2014, Guangdong Food and Drug Administration renewed the Pharmaceutical Supply Certificate to Bencao, valid from August 18, 2014 to August 17, 2019. On November 6, 2013, Bencao and Aprontech signed the Exclusive Distribution Agreement, agreeing that Bencao would be exclusive in importing "Lantigen" produced by Bruschettini from Aprontech and would be exclusive in importing, promoting, selling and distributing such "Lantigen" in mainland China. On December 10, 2013, Bruschettini issued the General Agency Authorization Letter, pursuant to which Bencao was authorized to act as the general agent of "Lantigen" in China to be responsible for all bidding and distribution matters. The term of authorization was from December 10, 2013 to July 29, 2018. Between November 28, 2013 and March 15, 2015, Bencao and Aprontech entered into purchase contracts in succession at the price of USD 10 or Euro 7.3 per bottle for a total of 1,566,632 bottles of "Lantigen". Between 2014 and 2015, Bencao sold “Lantigen” mentioned above at the price of RMB 90/bottle. On January 18, 2016, the CFDA issued the Announcement on Cessation of Importation of Four Drugs including Cerebroprotein Hydrolysis Injection etc. [No.13 (2016)], which ordered to cease the import and to recall drugs with potential safety risks since first, the actual production process of "Lantigen" produced by Bruschettini was inconsistent with the registered process; second, laboratory data had integrity problems, and; third, there were risks of cross-contamination during the production. On July 19, 2016, the CFDA convened a working meeting on the recall of "Lantigen" participated by Guangdong Food and Drug Administration, Bencao and other entities, requiring Bencao to stop selling "Lantigen" and Bruschettini to actively recall "Lantigen". From then, Bencao notified Bruschettini of the decision of the aforesaid meeting and sent notices to Bruschettini for many times demanding its voluntary recall, but Bruschettininever published or implemented any recall plans or measures. Due to Bruschettini's delayed to exercise its statutory recall obligation, the CFDA issued to Bruschettini the Notice on Ordering the Recall and Rectification on November 22, 2017, specifying that the products of “Lantigen”produced by Bruschettini had safety risks, demanding that their imports be stopped and ordering Bruschettini to recall them. On July 13, 2018, Bencao entrusted a lawyer to send a letter to urge Bruschettini to fulfill its recall obligation. However, Bruschettini has not fulfilled its obligation to carry out the recall to date. Bencao believes that Bruschettini's failure to recall "Lantigen" with potential safety hazards, violated the relevant provisions of the Regulated Measures for Drug Recalls and infringed Bencao's legitimate rights and interests. | | 事实和理由：2008年6月13日，贝斯迪药厂向AprontechCO.LTD（以下简称Aprontech公司）出具授权书，授权其在中国销售贝斯迪药厂生产的“兰菌净"。2009年9月30日，国家食品药品监督管理总局（以下简称国家食药监管总局）就“兰菌净"颁发了相应的《进口药品注册证》《药品注册批件》，注册证有效期至2014年9月29日。2014年7月30日，国家食药监管总局就“兰菌净"再次颁发了相应的《进口药品注册证》《药品注册批件》，注册证有效期自2014年7月30日至2019年7月29日。2009年12月15日，广东省食品药品监督管理局向本草公司颁发《药品经营许可证》，有效期为2009年12月15日至2014年12月14日，批准本草公司从事药品批发业务。2014年8月18日，广东省食品药品监督管理局再次向本草公司颁发《药品经营许可证》，有效期自2014年8月18日至2019年8月17日。2013年11月6日，本草公司与Aprontech公司签订《独家经销协议》，约定本草公司独家从Aprontech公司进口贝斯迪药厂生产的“兰菌净"，在中国大陆地区独家进口、推广、销售、分销。2013年12月10日，贝斯迪药厂作出《总代理授权书》，授权本草公司作为“兰菌净"在中国的总代理，负责投标及经销有关一切事宜，授权期限为2013年12月10日至2018年7月29日。2013年11月28日至2015年3月15日期间，本草公司与Aprontech公司相继签订采购合同，以10美元/瓶或7.3欧元/瓶的价格采购共计1,566,632瓶“兰菌净"。在2014年至2015年间，本草公司以人民币90元/瓶的价格销售上述“兰菌净"。2016年1月18日，国家食药监管总局发布《关于停止进口脑蛋白水解物注射液等4个药品的公告》（2016年第13号），贝斯迪药厂生产的“兰菌净"实际生产工艺与注册工艺不一致，实验室存在数据完整性问题，生产过程中存在交叉污染风险，要求停止进口，并责令召回存在安全隐患的药品。2016年7月19日，国家食药监管总局召集广东省食品药品监督管理局、本草公司等单位召开关于“兰菌净"召回工作会议，要求本草公司停止销售“兰菌净"、贝斯迪药厂主动召回“兰菌净"。此后，本草公司派人前往告知贝斯迪药厂前述会议决定，并多次发函要求其主动召回，但贝斯迪药厂一直未公布并实施任何召回计划和措施。由于贝斯迪药厂怠于履行法定召回义务，2017年11月22日，国家食药监管总局向贝斯迪药厂发出《关于责令召回和整改的通知》，明确贝斯迪药厂生产的“兰菌净"存在安全隐患，要求停止进口，责令贝斯迪药厂召回。2018年7月13日，本草公司委托律师发函敦促贝斯迪药厂履行召回义务。然而，贝斯迪药厂时至今日仍未履行召回义务。本草公司认为，贝斯迪药厂未召回存在安全隐患“兰菌净"，违反了《药品召回管理办法》的相关规定，侵害了本草公司的合法权益。 |
| In addition, on April 20, 2015, Mainland Company and Bencao entered into the Distribution Contract, by which Mainland Company became the distributor of "Lantigen" in mainland China. In 2015, Mainland Company paid RMB 47,966,080 to Bencao from April to October to purchase 599,576 bottles of "Lantigen". As a result of the safety problems of “Lantigen”, Mainland Company ceased selling "Lantigen" and returned the unsold 592,456 bottles of “Lantigen” to Bencao and simultaneously filed a lawsuit against Bencao for compensation. On September 12, 2017, the Guangzhou Intermediate People's Court of Guangdong Province made the Civil Judgment (2017) Yue01MinChu No.58, deciding: I. The Distribution Contract between Mainland Company and Bencao on April 20,2015 shall be rescinded. II. Bencao shall repay Mainland Company RMB 47,408,800 plus interest within 10 days of the effective date of the Judgment(interest is to be paid taking RMB 47,408,800 as the base amount according to the basic loan interest rate of the People's Bank of China for the same period starting from 23 September 2016 to the date of entry into force of the Judgment). III. Bencao shall pay Mainland Company RMB 79,200 for the freight of the returned goods within 10 days of the effective date of the Judgment. IV. Reject other claims of Mainland Company. The case acceptance fees for the first instance were RMB 373,176, of which RMB 101,281 were to be borne by Mainland Company and the rest RMB 271,895 were to be borne by Bencao. The preservation fee of RMB 5,000was to be borne by Bencao. On October 12, 2018, Guangdong High People's Court rendered the Civil Judgment (2017) YueMinZhong No. 3184 for this case dismissing Bencao's appeal and upheld the judgment of the first instance, deciding Bencao should bear the case acceptance fee of second instance of RMB 373,176. Bencao claims that in accordance with Article 3 of the Regulatory Measures for Drug Recalls and Articles 15 and 46 of the Tort Law of the People's Republic of China (hereinafter referred to as the "Tort Law"), Bruschettini should compensate for all the property losses and the costs paid by Bencao arising from its failure to fulfill the recall obligations. | | 另，2015年4月20日，大陆公司与本草公司签订《分销合同》，大陆公司成为“兰菌净"在中国大陆的分销商，并在2015年4月至10月期间共向本草公司支付货款人民币47,966,080元采购599,576瓶“兰菌净"。因“兰菌净"存在安全隐患，大陆公司停止了销售“兰菌净"并将尚未售卖的592,456瓶“兰菌净"退回本草公司，同时起诉要求本草公司赔偿损失。2017年9月12日，广东省广州市中级人民法院作出（2017）粤01民初58号民事判决，判决：一、解除大陆公司与本草公司于2015年4月20日签订的《分销合同》；二、本草公司于判决生效之日起10日内返还大陆公司已经支付的货款人民币47,408,800元及利息（利息以人民币47,408,800元为本金，自2016年9月23日起计算至判决生效之日止，按中国人民银行同期贷款利率计算）；三、本草公司于判决生效之日起10日内支付大陆公司退货时产生的运费人民币79,200元；四、驳回大陆公司的其他诉讼请求。一审案件受理费人民币373,176元，由大陆公司负担人民币101,281元，本草公司负担人民币271,895元。诉讼保全费人民币5,000元，由本草公司负担。2018年10月12日，广东省高级人民法院就该案作出（2017）粤民终3184号民事判决，判决驳回上诉，维持原判。二审案件受理费人民币373,176元由本草公司承担。本草公司认为，根据《药品召回管理办法》第三条及《中华人民共和国侵权责任法》（以下简称侵权责任法）第十五条、第四十六条等规定，贝斯迪药厂应赔偿未履行召回义务而导致本草公司遭受的全部财产损失和因此支付的费用。 |
| Bruschettini argued that (Ⅰ) Bencao had breached its commitments on the claim for compensation. The General Agency Authorization Letter submitted by Bencao was forged and only had a seal but no signature on it; Bruschettini never issued to Bencao any General Agency Authorization Letter. Bencao has concealed the fact that it signed with Aprontech the Exclusive Distribution Agreement on December 5, 2013 and the Schedule to the Exclusive Distribution Agreement dated December 5, 2013 on March 21, 2014, in which Bencao waives its right of claim against Bruschettini in the 18th (d) (e) of the Schedule. (II) Under the current Chinese law, Bencao, rather than Bruschettini, was responsible for the recall of "Lantigen". First of all, only the drugs with potential safety hazards need to be recalled, and the evidence presented by Bencao can hardly prove that "Lantigen" falls under the circumstance of "endangering human health and life" prescribed in Article 4 of the Regulatory Measures for Drug Recalls. Secondly, the responsible party for the recall is not specified in Article 3 of the Regulatory Measures for Drug Recalls. Thirdly, according to Paragraph 2 of Article 15 of the Regulatory Measures for Drug Recallsthat "if the recall is carried out within the territory, the importer shall be responsible for the implementation in accordance with the provisions of the Measures", therefore, the person responsible for the recall shall be Bencao, the importer. (III) The losses claimed by Bencaoare commercial losses rather than losses from product liability, as Bencao and Bruschettini have no contractual relationship and it has no right toclaim for commercial damages towards Bruschettini. First, the losses claimed by Bencaoare commercial losses, rather than losses from product liability. Bencao initiated this case to claim damages due to the product defect in accordance with Article 46 of the Tort Law. In accordance with the provisions of Articles 41 and 44 of the Product Quality Law of the People's Republic of China (hereinafter referred to as the "Product Quality Law"), the first claim of Bencao on the losses resulting from the inventory "Lantigen" are in fact the total purchase price plus the expected resale profits, which should be classified as commercial losses rather than losses from product liability. The rest of Bencao's claims are based on the first claim, and none of them is valid. Second, Bencao and Bruschettini have no contractual relationship, and therefore, Bencao is not entitled to claims for commercial losses against Bruschettini. Bencao shall file a commercial claim against Aprontech with whom it has contractual relationship. Thirdly, there is a boundary between the Tort Law and the Contract Law of the People's Republic of China (hereinafter referred to as the "Contract Law"), so commercial claims shall not be made under the Tort Law. Under the Tort Law and the Product Quality Law, "property damage caused by product defects" is defined as the property damage other than the defective products themselves and does not include the damage or destruction of such products. However, Bencao's claim is not "damage caused by product defects". The main purpose of the Tort Law is to protect the consumer in a weaker position, not the buyer of goods in commercial transactions. In normal commercial transactions, decrease or loss of profits of commercial transactions and other problems due to product quality shall be regarded as the situation in which the buyer fails to achieve the expected purpose of the contract. It falls within the scope of the Contract Law. In conclusion, Bruschettini requested that this court shall reject all the claims by Bencao. | | 贝斯迪药厂辩称，（一）本草公司对其提出索赔请求违背了承诺。本草公司提交的《总代理授权书》系伪造的，上面仅有签章没有签字，贝斯迪药厂从未向本草公司出具过《总代理授权书》。本草公司隐瞒了其与Aprontech公司在2013年12月5日签订的《独家经销协议》以及2014年3月21日签订的《2013年12月5日之独家经销协议之附录》，在附录的18（d）（e）中本草公司放弃了对贝斯迪药厂的索赔权。（二）在现行中国法律下，召回“兰菌净"的责任人是本草公司而非贝斯迪药厂。首先，只有存在安全隐患的药品才需召回，本草公司提交的证据远不能证明“兰菌净"存在《药品召回管理办法》第四条规定的“危及人体健康和生命安全"情形。其次，《药品召回管理办法》第三条未明确召回的责任主体。再次，根据《药品召回管理办法》第十五条第二款“在境内进行召回的，进口单位按照本办法的规定负责具体实施"之规定，召回的责任人应是进口单位本草公司。（三）本草公司索赔的损失属于商业损失而非产品责任损失，其与贝斯迪药厂之间没有合同关系，无权向贝斯迪药厂主张商业损失赔偿。首先，本草公司索赔的损失为商业损失而非产品责任损失。本草公司是依据侵权责任法第四十六条之规定，因产品缺陷造成损害而提起本案索赔。根据《中华人民共和国产品质量法》（以下简称产品质量法）第四十一条、第四十四条的规定，本草公司主张的第一项库存“兰菌净"损失实质上是库存“兰菌净"的采购价格加其预期转售利润，该损失属于商业损失而非产品责任损失。本草公司的其余诉请均系建立在第一项诉请的基础上，也均不能成立。其次，本草公司与贝斯迪药厂之间不存在合同关系，其无权向贝斯迪药厂提出商业损失索赔。本草公司应当向与其有合同关系的Aprontech公司提出商业索赔。再次，侵权责任法和《中华人民共和国合同法》（以下简称合同法）之间存在界限，商业索赔不应当根据侵权责任法提出。侵权责任法和产品质量法将“产品缺陷造成的财产损害"限定为缺陷产品以外的财产损害，并不包括产品本身的损伤或损毁。而本草公司提出的索赔并不属于“产品缺陷造成的损害"。侵权责任法的主要目的是保护处于弱势地位的消费者，而非商业交易中的货物买方。在普通的商业交易行为中，产品质量问题引起的商业交易利润减少或丧失等问题属于买方未能实现合同预期目的的情形，属于合同法的调整范围。综上，请求本院驳回本草公司的全部诉讼请求。 |
| The parties submitted to this court evidence concerning the claims according to the law, and this court organized the parties to conduct evidence exchange and cross-examination. This court confirmed the evidence to which the parties raised no objection, and kept the evidence on record. In respect of the evidence and facts in dispute, the court finds that: | | 当事人围绕诉讼请求依法提交了证据，本院组织当事人进行了证据交换和质证。对当事人无异议的证据，本院予以确认并在卷佐证。对有争议的证据和事实，本院认定如下： |
| 1.The first set of evidence submitted by Bencao includes the Pharmaceutical Supply Certificate (No. Yue AA0200747) and the Pharmaceutical Supply Certificate (No. Yue AA0200747), intended to prove that Guangdong Food and Drug Administration licensed Bencao to engage in the wholesale of drugs. Bruschettini recognizes its legitimacy and relevance, and requests this court to determine its authenticity ex officio. Based on the above situation, this court admits this set of evidence. | | 1.本草公司提交的第一组证据为《药品经营许可证》（证号：粤AA0200747）、《药品经营许可证》（证号：粤AA0200747），拟证明广东省食品药品监督管理局许可本草公司从事药品批发。贝斯迪药厂质证认为，认可其合法性、关联性，请法院依职权认定其真实性。综合双方举证、质证情况，本院对该组证据予以采信。 |
| 2. The second set of evidence submitted by Bencao includes the Registration Certificate for Imported Drugs (No. S20090088), the Drug Registration Permit (No. S03364), the Registration Certificate for Imported Drugs (No.S20140066) and the Drug Registration Permit (No.S00706), intended to prove that the import of the drug "Lantigen" manufactured by Bruschettini has been approved by the CFDA, valid from September 30, 2009 to September 29, 2014,and July 30, 2014 to July 29, 2019. Bruschettini recognizes the legitimacy, relevance and authenticity of this set of evidence. The court admits this set of evidence. | | 2.本草公司提交的第二组证据为《进口药品注册证》（注册证号：S20090088）、《药品注册批件》（批件号：2009S03364）、《进口药品注册证》（注册证号：S20140066）、《药品注册批件》（批件号：2014S00706），拟证明贝斯迪药厂生产的“兰菌净"经国家食药监管总局批准进口，有效期为2009年9月30日至2014年9月29日及2014年7月30日至2019年7月29日。贝斯迪药厂质证认为，对本组证据的三性均予以认可。本院对该组证据予以采信。 |
| 3. The third set of evidence submitted by Bencao includes the General Agency Authorization Letter (December 10, 2013), intended to prove Bruschettini's authorization of Bencao to be the exclusive distributor in mainland China for “Lantigen” produced by Bruschettini for a period from December 10, 2013 to July 29, 2018. Bruschettini doesn't recognize the legitimacy, relevance and authenticity of this set of evidence. It argues that General Agency Authorization Letter is forged, bearing only the company seal in Bruschettini's name without any signature, which is not the normal manner for Bruschettini to issue documents. Besides, the date of such authorization letter is December 10, 2013, when Aprontech was still discussing with Bruschettini by mail on whether to issue an Authorization Letter to Bencao or not until January 23, 2014. The court finds that Bruschettini does not accept the authenticity of the evidence and there is no evidence indicating that Bruschettini and Bencao had consulted on the establishment of the agency relationship. The General Agency Authorization Letter, as a sole evidence, is insufficient to prove the existence of a contractual relationship between Bencao and Bruschettini. This court doesn't admit this set of evidence. | | 3.本草公司提交的第三组证据为《总代理授权书》（2013年12月10日），拟证明贝斯迪药厂授权本草公司在中国大陆地区独家经销贝斯迪药厂生产的“兰菌净"，授权期限自2013年12月10日至2018年7月29日。贝斯迪药厂质证认为，对其三性均不予认可，该《总代理授权书》系伪造的，上面仅有贝斯迪药厂名义上的公司章，无任何人的签字，不符合贝斯迪药厂出具文件的正常方式；且此份授权书上注明日期为2013年12月10日，但Aprontech公司直到2014年1月23日仍在和贝斯迪药厂通过邮件讨论是否向本草公司出具授权书。本院认为，贝斯迪药厂对该份证据的真实性不予认可，且没有证据表明双方曾经就建立代理关系进行过协商，《总代理授权书》作为一份孤证，不足以证明本草公司与贝斯迪药厂之间存在合同关系，本院不予采信。 |
| 4. The fourth set of evidence submitted by Bencao includes the Exclusive Distribution Agreement (November 6, 2013), the Supplementary Agreement (May 4, 2014) and TO WHOM IT MAY CONCERN and the translation thereof and the Declaration Letter (August 1, 2014), intended to prove that Aprontech signed the Exclusive Distribution Agreement with Bencao with the authorization of Bruschettini, agreeing that Bencao would be the exclusive distributor of "Lantigen" in mainland China. Bruschettini cross-examined this evidence and did not recognize the authenticity of the Exclusive Distribution Agreement (November 6, 2013), Supplementary Agreement (May 4, 2014) and the Declaration Letter (August 1, 2014). But it recognized the authenticity of the TO WHOM IT MAY CONCERN and the translation thereof without acknowledging the relevance and the evidentiary purposes. It argues that Bencao has only contractual relationship with Aprontech, and has no contractual relationship with Bruschettini. Hence, the losses claimed by Bencao should be regarded as commercial ones rather than losses from product liability, and Bencao shall have no right to claim against Bruschettini. This court believes that this set of evidence submitted by Bencao can prove that "Lantigen" sold by it was produced by Bruschettini and admits this set of evidence. | | 4.本草公司提交的第四组证据为《独家经销协议》（2013年11月6日）、《补充协议》（2014年5月4日）、《TOWHOMITMAYCONCERN》及翻译本、《声明函》（2014年8月1日），拟证明Aprontech公司经贝斯迪药厂授权，与本草公司签订《独家经销协议》，约定由本草公司在中国大陆地区独家经销“兰菌净"。贝斯迪药厂质证认为，《独家经销协议》（2013年11月6日）、《补充协议》（2014年5月4日）及《声明函》的真实性无法确认，《TOWHOMITMAYCONCERN》及翻译本的真实性认可，不认可该组证据的关联性和证明目的，本草公司仅与Aprontech公司之间存在合同关系，与贝斯迪药厂之间没有任何合同关系，本草公司索赔的损失属于商业损失而非产品责任损失，其无权向贝斯迪药厂索赔。本院认为，本草公司提交的本组证据能够证明其销售的“兰菌净"系贝斯迪药厂生产，对本组证据予以采信。 |
| 5. The fifth set of evidence submitted by Bencao includes the batch of EXCLUSIVE DISTRIBUTION AGREEMENT (signed on November 28, 2013, May 4, 2014, June 3, 2014, July 7, 2014, July 9, 2014, July 15, 2014, December 1, 2014, January 15, 2015, March 15, 2015), Payment Application and Payment Notice to Corporate Customer (dated December 6, 2013, Amount: USD 3,000,000), Payment Application and International Remittance Debit Advice and Payment Notice to Corporate Customer (dated May 7, 2014, Amount: USD 525,000), Payment Application and Payment Notice to Corporate Customer (dated May 22, 2014, Amount: USD 975,000), Payment Applicationand International Remittance Debit Advice (dated June 19, 2014, payment: USD 750,000), Payment Application and Customer Receipt for Debit (dated July 22, 2014, Amount: EUR 730,000),Approval Paper for Cheque Requisition and International Remittance Debit Advice (dated October 8, 2014, Amount: EUR 365,000), Approval Paper for Cheque Requisition and International Remittance Debit Advice (dated November 3, 2014, Amount: EUR 1,095,000),Approval Paper for Cheque Requisition and International Remittance Debit Advice (dated November 20, 2014, Amount: EUR 1,095,000), Approval Paper for Cheque Requisition and Letter to Inform Change of Account Number and International Settlement Debit Advice (dated December 22, 2014, Amount: EUR 1,049,134.10), Approval Paper for Cheque Requisition and International Settlement Debit Advice and Payment Notice to Corporate Customer (dated 3 February 2015, Amount: EUR 1,089,298.70), Approval Paper for Cheque Requisition and International Settlement Debit Advice and Payment Notice to Corporate Customer(dated March 9, 2015, Amount: EUR 1,089,564.50), Approval Paper for Cheque Requisition and International Settlement Debit Advice (dated May 7, 2015, Amount: EUR 1,090,919.30),Guangzhou Customs Bills of Payment for Import Duties and Guangzhou Customs Bills of Payment for Import VAT and the transfer voucher (Payment date: April 28, 2014, May 8, 2014,June 23, 2014, August 26, 2014, September 23, 2014, February 2, 2015, March 17, 2015 and July 22, 2015), Purchase Acceptance Records and Statistical Table of Purchase Acceptance Records of “Lantigen” (Guangdong Bencao Medicine Group Co., Ltd.), intended to prove that Bencao, during the period 2013 to 2015, purchased 1,566,632 bottles of “Lantigen” of 126 Batch numbers from Aprontech and paid USD 5,250,000, EUR 7,603,913.6 (equivalent to RMB 89,010,364.41) for goods, RMB 3,653,666.64 for import duties and RMB 16,149,206.55 for import value-added tax. Bruschettini argues that the authenticity of this set of evidence could not be verified, and doesn't acknowledge its relevance and evidenciary purpose. Therefore, Bencao and Bruschettini have no contractual relationship and Bencao should make a claim against Aprontech. This court admits this set of evidence, which proves the quantity of "Lantigen" purchased by Bencao and the amount of payment, the customs duties and the value-added taxes. | | 5.本草公司提交的第五组证据为《EXCLUSIVEDISTRIBUTIONAGREEMENT》（2013年11月28日签订、2014年5月4日签订、2014年6月3日签订、2014年7月7日签订、2014年7月9日签订、2014年7月15日签订、2014年12月1日签订、2015年1月15日签订、2015年3月15日签订）、《付款申请单》《对公客户付款通知单》（2013年12月6日，付款：3,000,000美元）、《付款申请单》《国际汇款借记通知书》《对公客户付款通知单》（2014年5月7日，付款：525,000美元）、《付款申请单》《对公客户付款通知单》（2014年5月22日，付款：975,000美元）、《付款申请单》《国际汇款借记通知书》（2014年6月19日，付款：750,000美元）、《付款申请单》《客户借记回单》（2014年7月22日，付款：730,000欧元）、《领用支票审批单》《国际汇款借记通知书》（2014年10月8日，付款：365,000欧元）、《领用支票审批单》《国际汇款借记通知书》（2014年11月3日，付款：1,095,000欧元）、《领用支票审批单》《国际汇款借记通知书》（2014年11月20日，付款：1,095,000欧元）、《领用支票审批单》《账号变更函》及《国际结算借记通知》（2014年12月22日，付款：1,049,134.10欧元）、《领用支票审批单》《国际结算借记通知》《对公客户付款通知单》（2015年2月3日，付款：1,089,298.70欧元）、《领用支票审批单》《国际结算借记通知》《对公客户付款通知单》（2015年3月9日，付款：1,089,564.50欧元）、《领用支票审批单》《国际结算借记通知》（2015年5月7日，付款：1,090,919.30欧元）、《广州海关进口关税专用缴款书》《广州海关进口增值税专用缴款书》及转账凭证（付款时间：2014年4月28日、2014年5月8日、2014年6月23日、2014年8月26日、2014年9月23日、2015年2月2日、2015年3月17日、2015年7月22日）、《购进验收记录》及《兰菌净购进验收记录统计表（广东本草药业集团有限公司）》，拟证明本草公司自2013年至2015年间向Aprontech公司采购“兰菌净"共计126个批号、1,566,632瓶，合计支付货款5,250,000美元、7,603,913.6欧元（折合人民币约89,010,364.41元），支付进口关税人民币3,653,666.64元、进口增值税人民币16,149,206.55元。贝斯迪药厂质证认为，该组证据真实性无法核实，不认可其关联性和证明目的，本草公司和贝斯迪药厂之间没有合同关系，本草公司应向Aprontech公司提出索赔。本院对该组证据予以采信，该组证据证明了本草公司采购“兰菌净"的数量及支付货款、关税、增值税的金额。 |
6. The sixth set of evidence submitted by Bencao includes the Notice on Drug Inspection Fee(August 14, 2014), Remittance Voucher, General Payment Certificate of Non-tax Income (Receipt)(August 14, 2014, Amount: RMB 315,840), Notice on Drug Inspection Fee(November 28, 2014), Bank Transaction Details and General Payment Certificate of Non-tax Income (Receipt)(December 12, 2014, Amount: RMB 947,520),Notice on Drug Inspection Fee (November 28, 2014), Bank Transaction Details and General Payment Certificate of Non-tax Income (Receipt)(December 12, 2014), Amount:RMB 789,600), Notice on Drug Inspection Fee (March 11, 2016), Acknowledgement of Payment and General Payment Certificate of Non-tax Income (Receipt) (March 22, 2016, Amount:RMB1,258,960), intended to prove that Bencao paid inspection fee of RMB 3,311,920 for importing "Lantigen". Bruschettini argues that the authenticity of this set of evidence cannot be ascertained, and its relevance and proving purposes cannot be acknowledged. There is no contractual relationship between Bencao and Bruschettini, and Bencao should claim against Aprontech. Based on the above situation, this court admits this set of evidence, which proves the inspection fee paid by Bencao for the importing of "Lantigen".
．．．．．． | | 6.本草公司提交的第六组证据为《药品检验收费通知单》（2014年8月14日）、《汇款凭证》《非税收入一般缴款书（收据）》（2014年8月14日，付款：人民币315,840元）、《药品检验收费通知单》（2014年11月28日）、《交易流水》《非税收入一般缴款书（收据）》（2014年12月12日，付款：人民币947,520元）、《药品检验收费通知单》（2014年11月28日）、《交易流水》《非税收入一般缴款书（收据）》（2014年12月12日，付款：人民币789,600元）、《药品检验收费通知单》（2016年3月11日）、《付款回单》《非税收入一般缴款书（收据）》（2016年3月22日，付款：人民币1,258,960元），拟证明本草公司因进口“兰菌净"，产生检验费合计人民币3,311,920元。贝斯迪药厂质证认为，无法确认该组证据的真实性，不认可其关联性和证明目的，本草公司和贝斯迪药厂之间没有合同关系，本草公司应向Aprontech公司提出索赔。综合双方举证、质证情况，本院对该组证据予以采信，该组证据证明了本草公司进口“兰菌净"产生的检验费用。
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