Contract Manufacturing Agreement by and between Amphastar Nanjing Pharmaceuticals, Inc. and Nanjing Hanxin Pharmaceutical Technology Co., Ltd, dated April 19, 2022

EX-10.1 2 amph-20220630xex10d1.htm EX-10.1 SUPPLY AGREEMENT

Exhibit 10.1

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS ([***]), HAS BEEN OMITTED BECAUSE

THE INFORMATION (I) IS NOT MATERIAL AND

(II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

CONTRACT MANUFACTURING AGREEMENT

委托生产协议

This Contract Manufacturing Agreement (this “Agreement”) is entered into by and between the following parties on April 19, 2022 (the “Effective Date”):

本委托生产协议（“本协议”）由以下双方于 2022 年 4 月19日（“生效日”）签订：

(1) Nanjing HanXin Pharmaceutical Technology Co., Ltd., a limited liability company duly incorporated and validly existing under the laws of PRC, with the Unified Social Credit Code: ****************** (the “Customer”); and

(1)

南京汉欣医药科技有限公司, 一家根据中国法律注册并存续的有限责任公司，社会统一信用代码为：******************（“委托方”）；及

(2) Amphastar Nanjing Pharmaceuticals, Inc., a limited liability company duly incorporated and validly existing under the laws of PRC, with the unified social credit code: ****************** (“ANP”).

(2) 美药星（南京）制药有限公司，一家根据中国法律注册并存续的有限责任公司，社会统一信用代码为：******************（“ANP”）。

ANP and the Customer are sometimes referred to herein collectively as the “Parties” and individually as a “Party”.

本协议项下ANP和委托方合称为“双方”，单独称为“一方”。

Whereas, the Customer intends to engage ANP to manufacture certain active pharmaceutical ingredients and/or finished pharmaceutical product based on specifications and formula provided by the Customer, and ANP intends to accept such engagement.

鉴于，委托方有意委托ANP依照其质量标准及规程进行相关活性药物成分和/或成品药的生产，ANP有意接受该等委托。

Therefore, based on the principle of good faith, the Parties hereby agree as follows:

因此，双方基于诚实信用原则达成如下约定：

1.	General

总则

1.1	Headings or titles of this Agreement are used solely for convenience and shall be given no effect in the construction or interpretation of this Agreement.

1.1	本协议标题仅为方便查阅而设，不影响对本协议的解读或解释。

1.2	Additional agreements necessary to effectuate this Agreement, including but not limited to, a Quality Agreement, may be executed between the Parties. In the event of conflicting terms, the terms of this Agreement shall prevail.

1.2	双方可以签署为实现本协议所必需的附属协议，包括但不限于质量协议。如有冲突，则以本协议的约定为准。

1.3	When used in this Agreement, the following terms shall have the meanings set forth in this section:

1.3	本协议中使用的术语含义解释如下：

(a)

“Affiliate” means any person or entity which controls, is controlled by or is under the common control of a Party. As used in this Agreement, “control” means (i) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors, or (ii) in the case of non-corporate entities, the direct or indirect power to manage, direct or cause the direction of the management and policies of the non-corporate entity.

(a)	关联方：指控制一方、受一方控制或与一方受共同控制的任何个人或实体。在本协议中，“控制”指(i)在公司实体中，直接或间接持有该实体不少于百分之五十(50%)的有权选举董事的投票权的股权或股份；或(ii)在非公司实体中，拥有直接或间接参与该实体的管理、决定或指导该实体管理政策的方向的权力。

(b)	“Applicable Law” means all ordinances, rules, regulations, laws, and requirements of any authority applicable to the Manufacture, supply and/or use of the Product, as amended from time-to-time, including cGMP.

(b)	适用的法律：指不断修订的适用于产品的制造、供应和/或使用的任何监管机构的所有法令、规则、法规、法律和要求，包括 cGMP。

(c)

“Confidential Information” means technical and business information relating to inventions, proprietary ideas and/or patentable ideas, patent applications, background intellectual property, techniques, scientific knowledge, know-how processes, existing and/or contemplated products and services, software, biological material, schematics, research and development, production, costs, profit and margin information, finances and financial projections, customers, clients, licensees, marketing, and current or future business plans and models, regardless of whether such information is designated as “Confidential Information” at the time of disclosure. The term “Confidential Information” does not include such information which:

(i)

is or becomes generally available to the public, other than through the receiving party’s disclosure,

(ii)

was within the receiving party’s possession prior to it being furnished by or on behalf of the disclosing party, provided that receiving party’s source had no obligation of confidentiality to the disclosing party,

(iii)

becomes available to the receiving party on a non-confidential basis from an information provider other than the disclosing party, provided that the information provider did not have a duty of confidentiality to the disclosing party, or

(iv)

is or becomes independently developed by an employee of the receiving party without access to the Confidential Information and without violating any of the receiving party’s obligations under this Agreement, as can be demonstrated by the receiving party’s written records.

(c)	保密信息：指与发明、专有思想和/或可转化为专利思想、专利申请、底层知识产权、技术、科学知识、专有技术流程、现有的和/或预期的产品和服务、软件、生物材料、示意图、研究和开发、生产、成本及利润信息、财务和财务预测、顾客、客户、被许可方、市场销售以及当前或未来的商业计划和模式有关的技术和商业信息，无论该等信息在披露时是否被指定为“保密信息”。“保密信息”不包括以下信息：

(i)

在接收方披露前，已是公开或公众普遍可用的，

(ii)

在披露方提供或代表披露方提供信息之前，接收方已拥有的信息，前提是接收方的信息来源对披露方没有保密义务，

(iii)

接收方在非保密的基础上已从披露方以外的信息提供方获得的信息，前提是信息提供方对披露方没有保密义务，或

(iv)

接收方的员工在未接触保密信息且未违反接收方在本协议项下的任何义务的情况下，已独立开发获得的信息，且有接收方的书面记录证明。

(d)	“Contract Year” means each consecutive twelve (12) month period during the Term, the first of which shall commence on the Launch Date and shall end on the first anniversary thereof.

(d)	合同年：指协议期限内每一连续的十二（12）个月，第一个合同年从上市日期开始至一周年后结束。

(e)	(e)“Finished Product” means for each Product, packaged with primary packaging and/or secondary packaging, in a commercially presented outer carton labelled for the purpose of sale or use in the Territory.

(e)	“成品”：指就每项产品而言，用商业展示的贴有标签外纸箱进行初级包装和/或次级包装，以用于在区域内销售或使用。

(f)

“Force Majeure” means an event beyond the reasonable control of a Party including but not limited to, a breakdown of machinery or equipment, fire, flood, sabotage, shipwreck, embargo, strike, explosion, labor trouble, pandemic and related restrictions, accident, riot, act of governmental authority (including without limitation, acts relating to raw material or product allocation, and government drug files), acts of God, acts of war and delays or failures in obtaining materials, supplies, equipment or transportation.

(f)	不可抗力：指超出一方合理控制范围的事件，包括但不限于机器或设备损毁、火灾、洪水、破坏、海难、禁运、罢工、爆炸、罢工、流行病和相关限制、事故、暴乱，政府当局的行为（包括但不限于与原材料或产品分配有关的行为，以及政府药事文件）、天灾、战争行为以及材料、供应品、设备或运输的延误或损坏。

(g)	“NMPA” means the National Medical Products Administration and any successor agency having substantially the same functions.

(g)	NMPA：指国家药品监督管理局，或具备相同职能的任一下属机构。

(h)	“Launch Date” means, with respect to each Product under this Agreement, the date of the first commercial sale of such Product by the Customer or its Affiliates or their respective designees in the Territory.

(h)	上市日期：指就本协议项下的某一产品，委托方或其关联方或各自的指定人员在区域内首次商业化销售本协议中该产品的日期。

(i)	“Manufacture” and “Manufacturing” means any steps, processes and activities necessary to produce the Product, including without limitation, the manufacturing, processing, bulk packaging and labeling, quality control testing, release and storage of the Product.

(i)	生产：指产品生产所需的任何步骤、流程及操作，包括但不限于产品的制造、加工、批量包装和贴签、质量控制测试、放行和储存。

(j)

“Marketing Authorization” means, with respect to each Product, the regulatory filing made by or on behalf of the Customer with, and approved by, the NMPA, that allows the Customer to market products comprised of or containing such Product in the Territory, including without limitation, any supplements or amendments thereto.

(j)	上市许可：就某一产品而言，指由委托方或委托方代表向NMPA提交并经NMPA批准的监管文件，该文件允许委托方在区域内销售由该产品组成或含有该产品的药品，包括但不限于针对该等文件内容的任何补充和修改。

(k)	“PRC” means the People’s Republic of China, but solely for the purposes of this Agreement, excluding the Hong Kong Special Administrative Region, the Macau Special Administrative Region and the islands of Taiwan.

(k)	中国：指中华人民共和国，仅为本协议之目的，不包括香港特别行政区、澳门特别行政区和台湾地区。

(l)	“Product” means the active pharmaceutical ingredients or finished pharmaceutical product listed in Appendix A hereof.

(l)	产品：指本协议附录A中列明的活性药物成分和成品药。

(m)

“Regulatory Dossiers” means all registration, permits, licenses, authorizations, approvals, presentations, notifications or filings (together with all applications therefore), which are filed with or granted by the governing health authority of any country, and which are required to develop, make, use, or sell the Product.

(m)	监管档案：指产品的研发、生产、销售及使用所需的，向任一国家的卫生政府部门提交的或由任一国家的卫生政府部门授权的所有注册、许可、执照、授权、批准、介绍、通知或备案文件（及其全部申请材料）。

(n)	“Specifications” means the specifications set fort in Appendix B hereof, as such specifications may be adjusted from time to time by mutual written consent of the Parties.

(n)	质量标准：指本协议附录B列明的质量标准，可经由双方共同书面同意不时调整。

(o)	“Term” means the period during which this Agreement is in effect as set forth in Section 13.

(o)	协议期限：指本协议第13条所约定的本协议的生效期限。

(p)	“Territory” means the PRC. No other territory rights are granted or applicable to this Agreement. The Customer is specifically prohibited from making any use of the Product outside of the PRC.

(p)	区域：指中国。其他地区规定的权利不适用于本协议。委托方禁止在中国境外使用产品。

(q)	“Contract Price” means, with respect to each Product, the Selling Price for each Product as provided in Appendix A, as such selling price may be adjusted based on the terms and conditions of this Agreement.

(q)	合同价格：指附录A列明的每项产品的销售价格，可根据本协议的条款和条件进行调整。

2.	The Customer’s Rights and Obligations

2.	委托方权利义务

2.1

At least thirty (30) days prior to the Launch Date, and the first day of each calendar quarter after such Launch Date, the Customer shall provide ANP with a good faith estimate of the Customer’s projected quantity requirements of such Product for delivery during each of the following four (4) calendar quarters (each such estimate being a “Forecast”). The Forecast corresponding to the first two (2) calendar quarters shall be legally binding on the Customer and shall not be amended without prior written consent of ANP. ANP will prepare and deliver a manufacture plan (“Manufacture Plan”) to the Customer within thirty (30) business days after receipt of the Forecast provided by the Customer. The Customer shall confirm or raise objections (if any) within ten (10) business days after receipt of the Manufacture Plan. If the Customer fails to confirm or raise an objection within the aforementioned period, it shall be deemed that the Customer agrees to the Manufacture Plan formulated by ANP, and the Manufacture Plan of the first two (2) calendar quarters of the Manufacture Plan confirmed or deemed to be agreed by the Customer shall bind the Customer to purchase at least the amount of Product specified in the Manufacture Plan from ANP.

2.1	于产品上市日期前至少三十（30）日，以及于上市日期后的每个日历季度的首日，委托方应向ANP提供关于委托方在随后四（4）个日历季度中每一（1）季度该等产品数量需求的

善意预估（该等预估称为“预测”）。前两（2）个日历季度对应预测对委托方具备法律约束力，未经ANP事先书面同意，不得变更。ANP在收悉委托方提供的预测后的 30 个工作日内制订生产计划（“生产计划”）并提供给委托方。委托方应当在收悉ANP生产计划后10日内进行确认，如存在异议的，应当于前述期限内提出。如委托方未能于前述期限内确认或提出异议的，视为委托方同意ANP制定的生产计划，委托方确认或视为同意的生产计划中前两（2）个日历季度的生产计划对委托方具备法律约束力，委托方有义务向ANP购买不低于前述生产计划约定数量的产品。

2.2

The Customer shall issue purchase orders to ANP in accordance with the Manufacture Plan set forth in section 2.1. The purchase order shall specify the quantity, standard, expected delivery date and other matters mutually agreed by the Parties. The Parties hereby agree that the Customer shall provide ANP with a delivery period of no less than ninety (90) days. ANP shall confirm within ten (10) business days after receipt of the purchase order, and in the event that the purchase order does not conforms to this Agreement, or quantity of the Product is less than or exceeds the committed quantity agreed in the Manufacture Plan, ANP shall be entitled to reject such order. In the event that the Customer does not issue purchase orders for all of the committed quantity in any quarter, ANP may bill the Customer at the end of the quarter for the balance of the binding quantity for such calendar quarter and the Customer shall remit payment to ANP upon receipt of the invoice.

2.2	委托方应根据本协议第2.1条约定的生产计划向ANP发出采购订单，采购订单中应明确委托生产药品的数量、规格、拟要求交付时间以及其他双方共同同意的事项。双方确认，委托方应为ANP提供至少九十（90）日的交货周期。ANP应当于收悉委托方采购订单10个工作日内进行确认，如委托方采购订单不符合本协议约定、低于或超出生产计划约定的数量，ANP有权拒绝。如果委托方于任一季度未能下达满足本协议约定的所有承诺需求的采购订单，ANP可在该季度末向委托方开具该季度承诺需求对应的费用发票，委托方应在收悉发票后支付相应款项。

2.3

The Customer shall purchase from ANP the minimum quantities of the Product (the “Committed Purchase Quantities”) at the Contract Price in each calendar year as provided in the table set forth below. In the event that the Customer fails to meet the Committed Purchase Quantities in any given calendar year, the Customer shall pay ANP for the difference between the amount of the Committed Purchase Quantities and the actual amount purchased for the corresponding calendar year (such difference, the “Committed Purchase Difference”). ANP shall issue an invoice and the Customer shall pay the Committed Purchase Difference no later than thirty (30) days after the end of the

corresponding calendar year.

2.3	委托方应按合同价格在每个日历年度向ANP购买不低于如下表所示的最低数量的产品（“承诺采购数量”）。如果委托方在任何特定日历年度未能满足承诺采购数量，委托方应向ANP支付承诺采购数量金额与实际采购数量金额之间的差额（该等差额称为“承诺采购差额”）。ANP应不迟于相应日历年度结束后三十（30）日内就该等差额向委托方开具发票，且委托方应不迟于前述日期向ANP支付承诺采购差额。

Calendar Year

日历年度

Committed Purchase Quantities (Units)

承诺采购数量(单位)

Contract Price (per Unit)

合同价格(每单位)

2024 -2028

To be agreed by both parties after the Launch Date

Selling Price as provided in Appendix A

3.	ANP’s Rights and Obligations

3.	ANP权利义务

3.1

ANP shall deliver the Product to the Customer according to the requirements of the purchase orders confirmed by ANP, and FCA rules under International Rules for the Interpretation of Trade Terms 2020 (Incoterms 2020) shall apply to such delivery. The Parties hereby agree that ANP’s additional costs arising from such delivery (including but not limited to, costs for transportation, customs and late receipt of the Customer’s designated carrier) shall be borne by the Customer.

3.1	ANP应根据ANP确认的订单要求向委托方交付产品，产品交付方式依照《国际贸易术语解释通则（2020年版）》FCA术语规则。双方确认，ANP因产品交付产生的额外费用成本（包括但不限于运输费用、出口清关费用、委托方指定承运人逾期收货费用）应由委托方承担。

3.2	ANP shall Manufacture and deliver the Product in conformance with the Applicable Law and regulations and Specifications.

3.2	ANP应依据适用法律、法规及质量标准的相关规定生产和交付产品。

3.3	ANP shall make commercially reasonable efforts to ensure that it can supply the Customer with sufficient quantities of the Product pursuant to the Forecast.

3.3	ANP应尽合理商业努力以确保交付满足委托方预测数量的产品。

4.	Contract Price, Invoice and Payment

4.	合同价格、开票及结算

4.1	ANP shall issue invoices within five (5) business days after shipment, unless the Parties determine that the Product does not conform to the Specifications, payment shall be due thirty (30) days after the date of an invoice from ANP.

4.1	ANP应在发货后五（5）个工作日内向委托方开具发票，除非经由双方确认产品不符合质量标准，委托方应在ANP开具发票后三十（30）日内完成付款。

4.2	During the Term of this Agreement and not more than once during any twelve (12) month period, the Contract Price may be subject to an adjustment, provided that ANP provides the Customer with two (2) months prior written notice of such proposed Contract Price adjustment.

4.2	于协议期限内，ANP可经提前两（2）个月向委托方发出书面通知调整合同价格，该等合同价格调整在每十二（12）个月内不得超过一（1）次。

4.3

If ANP’s manufacturing costs rise due to increased costs (e.g., due to increased power or labor costs, increased standards on environmental protection), the Parties shall separately agree on the Contract Price change after the Customer’s verification of the increased costs using information supplied by ANP. During the negotiation of Contract Price change, ANP shall provide the relevant staff salary information, power cost invoices, environmental protection expenditure information, or other supporting materials. If the Customer adjusts the Specifications or relevant requirements unilaterally, or direct ANP to purchase designated raw materials and packaging materials, the Contract Price shall be adjusted accordingly. For the avoidance of doubt, the adjustment of the Contract Price under this section 4.3 shall not be subject to the advance notice and time limit set forth in section 4.2 hereof.

4.3	如果ANP的生产成本因相关成本增加（例如因能耗、人工成本增加、环境保护标准提高等原因增加），双方应在委托方核实ANP提供的成本增加的相关信息后另行商定合同价格的变更。在双方合同价格变更沟通期间，ANP应提供相关人员工资信息、电费发票、环保支出信息等配套材料。如果委托方要求单方变更质量标准或产品要求，或向ANP指定原材料、包材的采购，合同价格需相应调整。为免疑义，本第4.3条合同价格调整不受限于本协议第4.2条约定的提前通知期限及次数限制。

5.	Quality Agreement

质量协议

5.1	The Parties will separately enter into a Quality Agreement setting forth in detail the certain rights and responsibilities divided among themselves that relate to the quality of the Product.

5.1	双方将另行签订质量协议以详细约定彼此之间与产品质量相关的权利义务的划分。

6.	Supply of the Product

产品供应

6.1

ANP shall promptly notify the Customer of any circumstances that result or are likely to result in any failure or delay in the supply or delivery of any Product in writing. If the Parties have a good faith belief, after mutual communication, that such circumstances may result in the failure or delay in the supply or delivery of such Product for more than ninety (90) days from the date of ANP’s written notice, the Customer shall have the right to terminate such delivery after the full payment of costs and expenses of such Product to ANP.

6.1	ANP应将任何导致或可能导致任何产品交付失败或延误的问题及时书面告知委托方，双方经沟通后认为该等情形将导致ANP无法于ANP发出书面通知之日起九十（90）日内完成产品交付的，委托方有权在支付ANP该等产品成本及费用的情况下终止该等产品的该等交付。

7.	Inspection of the Product

产品检验

7.1

All Product received by the Customer will be subject to inspection and testing by the Customer, in accordance with the Customer’s quality assurance program, within a period of thirty (30) days from the date of receipt of such Product (“Inspection Period”). The Customer will notify ANP if the results of any inspection or testing indicate that the Product does not conform to the applicable Specifications or the other requirements under this Agreement. ANP will have ten (10) business days to respond to the Customer’s notice of non-conformance. Disputes between the Parties not resolved within ten (10) business days will be resolved by an independent laboratory selected by mutual consent of the Parties. A laboratory will be appointed not later than fifteen (15) business days after the expiry of the ten (10) business day period. If the laboratory finds the Product to be nonconforming, then at ANP’s sole discretion, ANP will (a) promptly deliver, at ANP’s sole expense, the replacement Product that conforms to the requirements under this Agreement, or (b)

refund or credit to the Customer all payments made by the Customer with respect of such nonconforming shipment. The Customer will, at the ANP’s sole discretion, return or destroy the nonconforming Product at ANP’s sole expense, including without limitation transportation and handling costs.

7.1

收悉产品的三十（30）天内（“检验期”），委托方将根据其质量保证程序对产品质量进行检验与测试。若检验或测试结果显示产品不符合质量标准或本协议的其他要求，委托方将通知ANP。ANP应在十（10）个工作日内进行回复。若在十（10）个工作日内双方未达成一致，争议将通过经双方一致认可的独立实验室解决。双方将在上述十（10）个工作日期限届满后的十五（15）个工作日内就独立实验室的选择达成一致。若实验室检验结果仍不合格，ANP应做出下列选择：(a)立即进行产品更换且费用自理，更换的产品应满足本协议要求；(b)将委托方就此类不合格产品支付的所有款项退还给委托方或调整为对委托方的应付款。经由ANP决定，委托方将退回或销毁不合格产品，相关费用由ANP承担，包括但不限于运输和处理费用。

8.	Regulatory Matters

监管条款

8.1

The Customer is responsible for filing and obtaining any Marketing Authorization that is required for the marketing and sale of the Product supplied by ANP; however, ANP shall reasonably cooperate with the Customer in such activities. Each Party shall notify the other Party promptly upon becoming aware of any (a) defective, adulterated or misbranded Product or of any information which may suggest that any Product is or may be defective, adulterated or misbranded, or (b) the Product which fails to meet the Specifications, the requirements of the applicable Marketing Authorization and Applicable Law. ANP will make reasonable commercial efforts to assist the Customer in investigating adverse experiences and customer complaints relating to the Product. ANP agrees to notify the Customer promptly of any inspections by the NMPA or any other authority which pertain to or have any quality implications for the Product. ANP will provide the Customer with any necessary authorization to allow the NMPA or any other authority to inspect, audit and review the facilities at which the Product is Manufactured. ANP will retain originals of all batch documentation, any and all other records or documentation generated by ANP in connection with the manufacturing and testing of the Product under the terms of this Agreement, and all records which may be reasonably necessary to assist the Customer in the event of the Product Recall or adverse drug event, for the longer of (a) two (2) years after the expiration date of the batch

of the Product to which they pertain or (b) the period required by Applicable Law. The costs and expenses incurred by ANP in cooperating with the Customer in investigations, inspections and obtaining relevant Marketing Authorization set forth in this section 8.1 shall be borne by the Customer.

8.1

委托方负责申请和获得ANP所生产产品的上市许可，ANP应与委托方充分合作以获得该等许可。一方发现任何问题，应立即通知另一方，包括：(1) 产品有缺陷、掺货、贴错标签或任何可能表明产品存在或可能存在缺陷、假货或贴错标签的情形；(2) 产品不符合质量标准、相关上市许可及适用法律要求的情形。ANP将尽合理商业努力协助委托方调查与产品相关的不良体验和投诉问题。ANP应将NMPA或任何其他机构进行的与产品有关或能反应产品质量的所有检查通知给委托方。ANP将向委托方提供必要范围的授权，以允许NMPA和其他机构对ANP产品设施进行必要检查、审计和审查。ANP将保留所有与产品相关的必要的审批记录的原件，所有与本协议项下产品生产或测试有关的记录或文件，以及所有为协助委托方完成产品召回或产品不良反应调查而合理需要的记录文件，该等文件的保留时间应按(a) 每批产品到期日后两（2）年或(b) 适用法律规定的时限（以较长者为准）。本8.1条项下ANP因配合委托方相关调查、检查、获得相关上市许可所产生的费用应由委托方承担。

9.	Facility Qualification

设施资质

9.1

ANP shall, take all commercially reasonable actions to qualify (and thereafter to maintain qualification of) the facility at which ANP Manufactures the Product, as required under Applicable Law, to enable the Customer to obtain and maintain all applicable Regulatory Dossiers for the Customer’s Finished Product. ANP will permit the Customer and its agents, at the Customer’s expense, during normal business hours and upon reasonable prior notice to ANP, and no more than once per year, to inspect the Facility where the Product is Manufactured, handled, stored, or tested, as well as all batch records (without making any copies) and processes relating to the Manufacture, storage, handling, or testing of the Product and all Manufacturing, handling, storage, and test records regarding the Product. ANP will respond to any non-conformances noted by the Customer, within thirty (30) business days of the written notification of such non-conformances, by submitting to the Customer a written report stating causes and corrective actions planned, and providing a timetable for the correction. Notwithstanding the foregoing, all data relating to the process which is contained in the closed part of the DMF will remain confidential and Customer

has no right to review or receive such information during any inspection, audit, or review described in this Section 9.1.

9.1

ANP应根据相关法律要求，采取一切商业上合理的措施使其生产产品的设施获得（并维持）相应资质，以确保委托方能够获得并维持所有与药品成品有关的监管档案。ANP应允许委托方及其代理商在事先通知的情况下，在正常工作时间内对与产品生产、处理、贮存或测试相关的设施、或与产品生产、贮存、处理或测试相关的批次记录（不可复制副本）和工艺流程、以及产品的所有生产、处理、贮存或测试记录进行每年不超过一（1）次的检查，相关费用由委托方承担。ANP应在收到委托方的不合格书面通知后三十（30）个工作日内向委托方进行回复，通过纸质报告说明不合格原因与相应改正措施，并提供改正的具体时间安排。尽管有上述约定，就药品主文件中已经封闭的部分中与工艺相关的全部数据应保密，且委托方无权在第9.1条约定的任何检查、审计或审查过程中要求审阅或获取该等信息。

10.	Manufacturing Practices

10.

生产操作

10.1

ANP shall Manufacture the Product in conformance with the Specifications and the Marketing Authorization. ANP shall provide the Customer with such information, including analytical and manufacturing documentation, requested by Customer regarding quality control of Product supplied hereunder. ANP will solely be responsible for keeping proper records and documentation of the manufacturing and testing of the Product, intermediates, and starting materials, including batch records, testing records, laboratory notebooks, equipment usage, starting material batch numbers, and certifications. ANP will be responsible for investigating any test results or in-process testing of the Product that does not conform with the Specification. ANP will conduct such laboratory investigation, which must be approved by ANP’s quality unit, and ANP will promptly notify the Customer of any adverse reactions or other safety or toxicity problems known to or reasonably suspected by ANP regarding the Product or its use. ANP will promptly notify Customer of the results of any regulatory inspection, comments, responses or notices received from the NMPA or other applicable regulatory authorities, which relate to or may impact the Manufacture and supply of the Product to the Customer.

10.1ANP应按照质量标准和上市许可进行生产，应委托方书面要求，ANP应向委托方提供本协议项下供应产品质量控制的相关信息，包括分析和生产文件。ANP将负责适当保存与产品、中间体和起始物料的生产与测试有关的记录和文件，包括：审批记录、测试记录、实

验记录、设备使用记录、起始物料批号以及检验报告。ANP将负责调查产品发生任何不符合质量标准的测试结果或过程测试，该等调查采取实验室调查，须经ANP质量部门批准方可进行。ANP将及时通知委托方针对产品已知的或合理怀疑的不良反应或其他安全或毒性问题以及自NMPA或其他机构收悉的可能影响产品生产及交付的检查、意见、答复或通知。

11.	Recall

11.

召回

11.1

During the Term, if either Party believes that it may be necessary to conduct a recall, field correction, market withdrawal, stock recovery, or other similar actions with respect to any Customer’s Finished Product containing the Product (a “Recall”), ANP and the Customer shall consult with each other as to how best to proceed. The Parties hereby agree that the final decision as to any Recall of any such Customer’s Finished Product shall be made by the Customer; provided, however, that ANP will not be prohibited hereunder from taking any action that is required by Applicable Law. The Customer shall be in charge of the Recall and establish a product recall system and recall management procedures, and ANP shall cooperate with the Customer as required by Applicable Law. In the event of a Recall, the Parties shall jointly find out and confirm reasons for the Recall, and except for reasonable costs borne by ANP if a Recall incurred solely attribute to it, the Customer shall bear all costs incurred thereby.

11.1于协议期限内，如果任一方认为有必要对任何产品的成品进行召回、现场更正、市场撤回、库存回收或其他类似行动（“召回”），双方应协商达成最佳解决方案。双方同意，该等方案的最终决定权归委托方所有，但前提是ANP也可根据相关法律要求采取相应行动。委托方应当建立产品召回体系及召回管理程序，并负责召回工作，ANP在适用法律要求的范围内配合委托方。产品发生召回的，由双方共同确认产品召回原因，除因ANP单方原因导致的产品召回由ANP承担合理费用外，任何与召回有关的费用由委托方承担。

12.	Certificate of Analysis

12.

检验报告

12.1ANP shall supply the same information on the certificate of analysis as is listed in the Specifications incorporated as Appendix B. No changes in Specifications will be made unless the Customer and ANP have agreed to such changes in writing prior to adoption of the modified Specifications.

12.1ANP应在检验报告中提供与附录B中所列质量标准相同的信息。除非经双方事先书面同

意，否则质量标准不得更改。

13.	Term, Amendment and Termination

13.	协议期限、变更、解除或终止

13.1This Agreement will remain in full force and effect for a period of five (5) Contract Years.

13.1本协议五合同年内保持完全效力。

13.2During the Term, due to changes in laws and regulations, Specifications, Manufacturing procedures or other substantive conditions, this Agreement may be amended by the mutual written consent of the Parties. Any Amendment to this Agreement and its appendices hereto shall come into force with an instrument in writing signed by the Parties.

13.2于协议期限内，因法律法规、质量标准、生产规程或其他实质性条件发生变化，经双方一致同意可对本协议进行变更，对本协议及其附件的修改，须经双方签署书面协议方能生效。

13.3Unless otherwise provided for herein, either Party (the “Terminating Party”) may immediately terminate this Agreement by notifying the other Party (the “Terminated Party”) in writing when one of the following situations occurs:

(a)

The Terminated Party breaches this Agreement and (i) does not rectify its default within thirty (30) days on the date of receiving written notice from the Terminating Party requiring for rectification; or (ii) there is no realistic possibility to rectify such default; or (iii) such default has resulted in the inability to achieve the purpose of this Agreement;

(b)

The Terminated Party suffers a Force Majeure event which makes it impossible to achieve the purpose of this Agreement;

(c)

The Terminated Party expresses clearly or by behavior that it will not perform its obligations hereunder, or delays the performance of its obligations and has not fully performed the obligations after being notified;

(d)

The Terminated Party loses the ability to perform its obligations hereunder, including but not limited to, entering bankruptcy proceedings, liquidation proceedings, being dissolved, being winding up, being revoked, or losing appropriate qualifications.

13.3除本协议另有约定外，任一方（“解除方”）可在出现下述情形之一时书面通知另一方（“被解除方”）立即解除本协议：

(a)

被解除方违反本协议约定且(i) 在收悉解除方书面通知要求其纠正违约行为之日起三

十（30）日内未纠正其违约行为的；或(ii) 实际上已不存在纠正违约行为的可能或(iii) 存在违约行为导致不能实现协议目的；

(b)

被解除方遭遇不可抗力且不可抗力致使不能实现协议目的；

(c)

被解除方明确表示或以行为表明不履行本协议义务，或者迟延履行本协议义务且经催告后仍未全面履行的；

(d)

被解除方丧失协议履行能力，包括但不限于，进入破产程序、清算程序、被解散、被注销、被吊销、丧失相应资质。

13.4This Agreement may be terminated by mutual written consent of the Parties.

13.4本协议可经由双方共同书面同意而终止。

13.5Upon expiration or termination of this Agreement, ANP will promptly complete and invoice for all deliverables of open and accepted purchase orders received from the Customer prior to the termination or expiration of this Agreement, and the Customer shall pay to ANP within thirty (30) days from the date of invoice. If there is any inventory of raw and packaging materials purchased by ANP according to the Manufacturing Plan confirmed by the Customer, the Customer shall purchase such inventory from ANP in accordance with the actual purchase amount. If there is any inventory of Product, the Customer shall pay ANP corresponding fees in accordance with the amount agreed herein.

13.5本协议到期或终止时，ANP应根据本协议到期或终止前已接受但未完成的委托方采购订单交付产品并开具发票，委托方应在ANP前述开票之日起三十日内支付ANP款项。若存在ANP按照委托方确认的生产计划所采购产品的原辅料、包材等库存的，委托方应按照ANP实际采购金额向ANP购买，若存在产品的成品库存的，委托方应按照本协议约定金额向ANP支付相应费用。

13.6ANP may terminate this Agreement prior to the expiration of this Agreement in the event that the Customer fails to receive Marketing Authorization for the Customer’s Finished Product within five (5) years from the Effective Date

13.6如果委托方在生效日起五（5）年内未取得产品的上市许可，ANP有权通知委托方单方终止本协议。

13.7Termination or expiration of this Agreement shall not relieve either Party of any obligation accruing prior to such termination or expiration, including, without limitation, any breach of such

obligation, or from any surviving obligation under this Agreement.

13.7本协议的解除、终止或到期不免除任一方在该等解除、终止或到期前产生的任何义务，包括但不限于对该等义务的任何违约，或本协议项下的任何存续义务。

13.8Either Party shall return or destroy all documents and materials in its possession which contain Confidential Information of the other Party within thirty (30) days after termination or expiration of this Agreement. The receiving party may retain one copy of documents and materials which contain the disclosing party's Confidential Information for the purpose of verifying the receiving party's compliance with its obligations under this Agreement but for no other purpose whatsoever.

13.8任何一方应在本协议解除、终止或到期后三十（30）日内归还或销毁其持有的包含另一方保密信息的所有文件和材料。接收方可以保留包含披露方保密信息的文件和材料的一份副本，以核实接收方是否遵守其在本协议项下的义务，但不得以任何其他目的。

13.9Unless otherwise provided for herein, after termination or expiration of this Agreement, section 1 (General), this section 13 (Term, Amendment and Termination), section 14 (Intellectual Property Rights), section 15 (Warranties), section 16 (Indemnities), section 18 (Force Majeure), section 19 (Notices), section 20 (Binding Effect), section 21 (Governing Law and Dispute Resolution), section 22 (Assignment), section 23 (Severability), section 24 (Entire Agreement), section 25 (Waiver), section 26 (Publicity), section 27 (Appendices), section 28 (Limitation of liability), section 29 (Counterparts and Language) shall survive.

13.9除本协议另有约定外，本协议解除、终止、到期后，本协议第1条（总则）、本13条（协议期限、变更、解除或终止）、第14条（知识产权）、第15条（保证）、第16条（赔偿）、第17条（保密信息）、第18条（不可抗力）、第19条（通知）、第20条（合同约束力）、第21条（适用法律及争议解决）、第22条（转让）、第23条（可分割性）、第24条（完整协议）、第25条（弃权）、第26条（宣传）、第27条（附件）、第28条（责任限制）及第29条（副本和语言）仍持续有效。

14.	Intellectual Property Rights

14.

知识产权

14.1ANP will retain ownership of all ANP Confidential Information that may be shared with the Customer during the Term of this Agreement, including retention of any manufacturing and production process for the Product (and all know-how of such process).

14.1ANP将保留在执行本协议的过程中可能与委托方共享的所有ANP保密信息的所有权，包括保留任何产品的生产和制作流程（以及相应的专有技术）。

14.2The Customer will retain ownership of all Confidential Information the Customer shares with ANP during the Term of this Agreement.

14.2委托方将保留在执行本协议过程中与ANP共享的所有委托方保密信息的所有权。

14.3In the course of Manufacturing, ANP shall have the right to improve the Manufacturing technology based on the technical information provided by the Customer. The Parties hereby agree that the derivative intellectual property rights arising from such improvement shall be owned by ANP. If any derivative intellectual property is created by relying upon Customer confidential information, ANP may provide to Customer a non-exclusive license to the derivative intellectual property. Customer shall not disclose the improved technology to any third party without the prior written consent of ANP. If the improved technology applies for the protection of intellectual property rights, ANP may make applications and act as the right holder of such derivative intellectual property rights at ANP’s expense.

14.3在委托生产过程中，ANP有权基于委托方提供的技术资料，对生产产品的技术进行改进。双方一致同意，如ANP对产品技术进行改进的，因技术改进产生的知识产权，归ANP所有。若有技术改进的知识产权是基于委托方的保密信息产生的，ANP可以向委托方提供该技术改进知识产权的非排他性许可。未经ANP事先书面同意，委托方不得将改进后的技术对外披露。如改进后的技术需申请知识产权保护的，ANP可以申请并作为该知识产权的权利人，费用由ANP承担。

15.	Warranties

15.

保证

15.1ANP warrants that the Product delivered to the Customer and pursuant to this Agreement shall at the time of such delivery not be adulterated or misbranded within the meaning of the Applicable Law. ANP represents and warrants that it will comply with all present and future statutes, laws, ordinances and regulations relating to the Manufacture, assembly and supply of the Product being provided hereunder, including without limitation, those enforced by the NMPA. ANP makes no other warranties, expressed or implied, with respect to the Product. All other warranties, expressed or implied, including without limitation, the implied warranties of merchantability and fitness for

a particular purpose are hereby disclaimed by ANP. It is the sole responsibility of the Customer to determine the suitability of the Product delivered by ANP for any intended use.

15.1ANP保证其根据本协议所交付的产品不会因违背任何法律而被视为假药或贴错标签。ANP声明并保证其将遵守与本协议中产品的生产、制备和供应相关的所有现行和未来法令、法律、法规和条例，包括但不限于NMPA的法规。除此之外，ANP对产品不做任何明示或暗示的保证，包括但不限于适销性和和为特定用途下的适用性。委托方自行负责确定ANP交付的产品是否符合其预期用途。

15.2The Customer warrants that it has obtained all licenses, filings or approvals required by all Applicable Law regarding the entrusted manufacturing of the Product hereunder, all Product shall be transported, warehoused, stored, processed, handled and marketed by the Customer and its distributors in accordance with the Specifications and Applicable Law. The Customer warrants that it will not put on the market any Product with known or assumed defects. The Customer warrants that all advertising and promotional materials as well as user manuals and other information, instructions and directions of use relating to safety and risk issues, use, transport, handling, and storage of the Product shall comply with this Agreement, including, without limitation, the Specifications, and all Applicable Law, and will be adequate, accurate and not misleading in all material respects. The Customer warrants that before Manufacture, packaging, promotion, labeling, marketing, supply, import, offer to sell, sale, distribution or use of the Product, the Customer will perform any risk analyses required by Applicable Law related to the Product and will continue to perform such analyses as long as required by Applicable Law. The Customer further warrants that its provision of technical materials, design packaging, labels, manuals and other documents and information to ANP will not infringe any rights of any third party, and the Customer shall indemnify and hold harmless ANP for any losses incurred resulting from claims threatened or initiated against ANP for the Manufacture, sale, or distribution of the Product.

15.2委托方声明并保证，就本协议项下产品的委托生产已取得所有适用法律、法规相关的许可、备案或审批，所有产品均由委托方及其经销商依照质量标准和所有适用法律进行运输、仓储、储存、加工、处理和销售；委托方将不会将任何已知或可能存在缺陷的产品投放市场，所有产品相关的广告、宣传材料、用户手册、说明及其他信息均应符合本协议、质量标准及所有适用法律的规定，同时在所有重要方面充分、准确、不具误导性；在产品的制造、包装、促销、贴标、营销、供应、进口、要约销售、销售、分销或使用之前，委托方将根据适用法律的要求进行与产品相关的任何风险分析，并将在适用法律要求的情况下持续进行该等分析以监测产品风险。委托方进一步保证，其提供予ANP的技术资料、设计包

装、标签及说明书等文件及信息不会侵犯任何第三方合法权利，对于因生产、销售或分销产品引发的针对ANP的索赔造成的任何损失，应当由委托方负责赔偿并使ANP免受损失。

16.	Indemnities

16.

赔偿

16.1Unless arising from the willful misconduct of ANP, the Customer will defend, indemnify and hold ANP and its Affiliates and their respective employees, servants and agents harmless against any liability, judgment, demand, action, suit, loss, damage, cost or other expense (including reasonable attorneys’ fees and other costs of defense) resulting from: (i) any third party claims made or proceedings brought against ANP, including claims of intellectual property infringement, relating to a Product set forth herein; (ii) the Customer’s material breach of this Agreement and (iii) the Customer’s breach of any warranty made under this Agreement.

16.1除非因ANP故意不当行为引起，当(i) 任何第三方对ANP提出的与本协议项下产品有关的，包括知识产权侵权相关的主张或诉讼；(ii) 委托方实质性违反本协议；或(iii) 委托方违反其在本协议项下的任何保证时，委托方应为ANP及ANP关联方、ANP及其关联方的雇员、服务人员、代理商提供抗辩及赔偿，以使得ANP及ANP前述主体免受任何责任、判决、要求、行为、诉讼、损失、损害或费用支出（包括合理的律师费及其他辩护费用）。

16.2Unless arising from the willful misconduct of the Customer, ANP will defend, indemnify and hold the Customer and their Affiliates and their respective employees, servants and agents harmless against any liability resulting from any third party claims made or proceeding brought against the Customer to the extent that such liability arises from (i) ANP’s gross negligence in the Manufacture, storage or delivery of Product; (ii) ANP’s material breach of this Agreement; or (iii) ANP’s breach of any warranty made under this Agreement.

16.2除非因委托方故意不当行为引起，当(i) ANP在产品的生产、贮存、运输方面存在重大过失；(ii) ANP实质性违反本协议；或(iii) ANP违反其在本协议项下的任何保证，ANP应为委托方及委托方关联方、委托方及其关联方的雇员、服务人员、代理商提供抗辩及赔偿，以使得委托方及委托方前述主体免受损害。

16.3Each indemnified party agrees to give the indemnifying party prompt written notice of any matter upon which such indemnified party intends to base a claim for indemnification (an “Indemnity Claim”) under Section 16. The indemnifying party will have the right to participate jointly with the indemnified party in the indemnified party’s defense, settlement or other disposition of any

Indemnity Claim. With respect to any Indemnity Claim relating solely to the payment of money damages and which could not result in the indemnified party’s becoming subject to injunctive or other equitable relief or otherwise adversely affect the business of the indemnified party in any manner, and as to which the indemnifying party will have acknowledged in writing the obligation to indemnify the indemnified party hereunder, the indemnifying party will have the sole right to defend, settle or otherwise dispose of such Indemnity Claim, on such terms as the indemnifying party, in its sole discretion, will deem appropriate, provided that the indemnifying party will provide reasonable evidence of its ability to pay any damages claimed and with respect to any such settlement will have obtained the written release of the indemnified party from the Indemnity Claim. The indemnifying party shall apply for a written release from the indemnified party prior to ceasing to defend, settling or otherwise disposing of any Indemnity Claim. If as a result thereof the indemnified party has been subject to injunctive or other equitable relief or the business of the indemnified party has been adversely affected in any matter, the application for exemption will be rejected.

16.3受偿方同意立即书面通知赔偿方，其根据本协议第16条拟提起的赔偿主张（“赔偿主张”）。赔偿方有权参与受偿方对任何赔偿的辩护、和解或其他方式处理赔偿主要的活动。对于任何仅与经济赔偿有关且不会导致受偿方受限于禁令或其他衡平法救济，也不会以任何形式对受偿方的业务活动产生不利影响的赔偿主张，同时赔偿方已通过书面形式确认了其在本协议项下对受偿方的赔偿义务，则赔偿方拥有以其自行认为合理的方式辩护、和解或以其他方式处理上述赔偿主张的权利，但前提是赔偿方提供合理的证据证明其有能力支付任何被主张的损害赔偿，并且就任何此类和解已获得受偿方的书面免责声明。赔偿方应在辩护、和解或其他处理方式结束之前，向受偿方申请书面免责声明，若受偿方已获得禁令、衡平法救济或其业务活动已受到不利影响，免责申请将被拒绝。

16.4Unless otherwise provided for herein, if the Customer pays the entrusted manufacturing fees under this Agreement which are overdue, ANP shall have the right to require the Customer to pay interest of the overdue payment per day as liquidated damages. If the payment is overdue for more than thirty (30) days, except for the aforementioned liquidated damages, ANP shall be entitled to terminate this Agreement without any liabilities and the Customer shall compensate ANP for any loss incurred thereof.

16.4除本协议另有约定外，委托方逾期支付ANP本协议项下委托生产费用，每逾期一天，ANP有权要求委托方支付逾期付款部分利息作为违约金，如逾期付款超过三十（30）日的，在有权获得前述违约金的同时，ANP有权解除本协议且不承担任何违约责任，如委托方因

此给ANP造成任何损失的，委托方应当赔偿ANP全部损失。

17.	Confidential Information

17.

保密信息

17.1The receiving party will treat as confidential and secret all information which has been or may hereafter be disclosed by the disclosing party, directly or indirectly, to the receiving party, either orally, in writing or through inspection. The receiving party shall use the Confidential Information received only to the extent necessary to execute the Purpose of this Agreement. The receiving party will not disclose to anyone any Confidential Information received from the disclosing party, and will use the same degree of care, but no less than a reasonable degree of care, to prevent the disclosure of the Confidential Information to others as it uses to prevent the disclosure of its own Confidential Information. Upon request from the disclosing party, the receiving party will promptly return to the disclosing party or destroy all drawings, data, memoranda and information in physical form relating to the Confidential Information.

17.1接收方应对披露方直接或间接以口头、书面或检查的形式提供的所有信息（保密信息）进行保密。接收方仅可在履行与本协议目的所必需的范围内使用收悉的保密信息。接收方不得向任何人披露其从披露方收悉的任何保密信息，并将采取任何可行的措施保护保密信息的保密性，程度不得低于其对自身保密内容或同样性质内容的保护，并避免泄露和非授权使用。在披露方要求下，接收方应立即向披露方返还或销毁所有与保密信息有关的图纸、数据、备忘录和实物形式的信息。

17.2Each Party agrees to keep the Confidential Information confidential, which includes (but is not limited to) not disclosing the disclosing party’s Confidential Information, or any part thereof (except as otherwise may be provided herein), absent the disclosing party’s prior written consent, unless required to do so by Applicable Law, act or a valid order of a court or other governing, regulatory body with authority over the receiving party (“Required Disclosure”); provided that the receiving party will first give reasonable written notice to the disclosing party prior to any Required Disclosure and will exercise its best efforts to obtain an order or other reliable assurance that the Confidential Information disclosed will be treated at the highest level of confidentiality. Upon receipt of notice from the receiving party of any Required Disclosure, the disclosing party may, at the disclosing party’s expense, seek to quash or restrict the disclosure of the disclosing party’s Confidential Information and the receiving party will not oppose or seek to impede the disclosing party’s efforts to obtain such relief.

17.2每一方同意对保密信息予以保密，包括（但不限于）不得在未经披露方书面同意（除非本协议另有规定），披露披露方提供的保密信息，除非适用法律、法令或对接收方有管辖权的法院或其他管理、监管机构的有效命令要求披露（“必要披露”）。前提是接收方应在任何必要披露前向披露方发出书面通知，且需尽最大努力获得法令或其他可靠保证以确保所披露的信息得到最高级别的保密处理。在收悉接收方发出的任何必要披露的通知时，披露方可在自行承担费用的情况下寻求撤销或限制对披露方保密信息的披露，接收方不得反对或阻碍披露方获得该等救济。

17.3This provision of confidentiality is not intended to grant or transfer any rights to the Confidential Information to the receiving party and does not transfer or convey any rights under a patent, trademark, copyright, or other intellectual property right to or in the Confidential Information. All Confidential Information (including all copies thereof) will at all times remain the property of the disclosing party. Further, and unless otherwise provided in this Agreement, the disclosure of Confidential Information to a receiving party does not create, and is not intended to create, any form or type of agency by and between the disclosing party and the receiving party.

17.3本保密条款无意向接收方授予或转让任何保密信息的任何权利，也无意于转让任何专利、商标、版权或其他知识产权项下的保密信息的任何权利。所有保密信息（包括其所有复印件）将始终为披露方所有。此外，除非本协议另有规定，不会向接收方披露保密信息，也不会产生披露方和接收方之间的任何形式或类型的代理。

17.4The receiving party agrees that its obligations hereunder are necessary and reasonable to protect the disclosing party, and expressly agrees that monetary damages would be inadequate to compensate the disclosing party for any breach of any covenant or agreement set forth herein and that, in addition to any and all other remedies available at law or in equity, the disclosing party will be entitled to seek equitable relief, including injunction and specific performance, as a remedy for any actual or threatened breach of this Agreement, and no bond or other security will be required in connection with any such equitable relief. In the event of litigation relating to this Agreement, if a court of competent jurisdiction determines that a Party has breached this Agreement, then the non-breaching party may seek recovery of its reasonable legal fees, including any appeal, in addition to any other remedies to which the non-breaching party may be entitled.

17.4接收方同意本协议项下的义务对于保护披露方均为必要且合理的，如违反本协议约定，不仅应赔偿披露方经济损失，除法律或衡平法上可获得的任何和所有其他救济之外，披露方有权针对任何实际或可能违反本协议的行为寻求衡平法救济，包括禁令和特别履行，并且无需对该等衡平法救济提供任何保函或担保。如发生与本协议有关的诉讼，如果有管辖

权的法院判定一方违反了本协议，则守约方有权要求获得合理的律师费（含上诉）及采取其他补救措施。

18.	Force Majeure

18.

不可抗力

18.1If the performance by either Party of any obligation under this Agreement, other than the payment of money, is prevented or impaired by a Force Majeure event, such Party will be excused from performance so long as such situation continues to prevent or impair performance, provided the Party claiming such excuse must promptly notify the other Party of the existence, nature, duration and other details of the Force Majeure event and will at all times use reasonable efforts consistent with its normal business practices to resume a complete performance.

18.1协议双方除履行付款义务外，因不可抗力的持续造成一方无法履行协议约定的义务时，该方可免除履行义务，前提是一方应立即告知另一方不可抗力的性质、持续时间及其他具体细节，并始终依照行业惯例尽合理的商业努力以恢复协议义务的履行。

18.2In the event of a Force Majeure event, the exempting party will advise the other Party from time to time as to the progress in remedying the situation and as to the time when the exempting party expects to resume its obligations. The exempting party shall promptly inform the other Party of elimination of such Force Majeure event.

18.2不可抗力免责方应定期告知另一方补救措施的进展以及预计何时恢复履行义务。不可抗力事件结束后，免责方应立即告知另一方。

18.3In the event of a Force Majeure event affecting ANP, ANP may prorate and allocate manufacturing capacity among its Affiliates, in such manner as may be deemed fair and reasonable based upon purchases of the Product over the past year.

18.3若不可抗力对ANP造成影响，ANP可根据过去一（1）年的产品采购情况，以公平合理的方式在其关联公司之间合理分配生产力。

19.	Notices

19.

通知

19.1.All notices hereunder shall be in writing and shall be delivered personally, mailed by overnight delivery, registered or certified mail, postage prepaid, or given by facsimile to the following addresses of the respective Parties:

General Manager

210033

ANP Nanjing Pharmaceuticals, Inc.

General Manager

210038

If to the Customer:

Nanjing HanXin Pharmaceutical Technology Co., Ltd.

Address: Building C5, No.9 Weidi Road, Xianlin University Town, Qixia District, Nanjing, Jiangsu, China

Attn: Bob Bao

Post Code: 210033

Amphastar Nanjing Pharmaceuticals, Inc.

Address: No. 5 Xinghe Road, Nanjing Economic and Technological Development Zone, Jiangsu, China

Attn: Perky Qiu

Post Code: 210038

If to ANP:

19.1.本协议项下的所有通知均采用书面形式，应通过亲自递送、隔夜递送、挂号信、预付邮资或传真方式发送至各方的地址，具体如下：

委托方：南京汉欣医药科技有限公司

地址：中国江苏省南京市栖霞区仙林大学城纬地路9号C5栋

联系人：鲍海涛

邮箱：2110033

ANP：美药星（南京）制药有限公司

地址：中国江苏省南京经济技术开发区兴和路5号

联系人：邱银华

邮编：210038

20.Binding Effect

20.合同约束力

20.1.This Agreement shall be binding upon and inure to the benefit of the Parties and their respective assigns and successors in interest.

20.1.本协议将对双方及其各自的受让人和利益继承人具有约束力并及于其各自之利益。

21.Governing Law and Dispute Resolution

21.管辖法律及争议解决

21.1The Agreement shall be construed, interpreted and governed by the laws of the PRC.

21.1本协议应受中国法律管辖并解释。

21.2This Agreement and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims) (the “Disputes”) shall first be resolved through consultation. If the Disputes cannot be resolved through negotiation, the Dispute (including a Dispute in connection with the validity or continuity of this Agreement) shall be submitted to arbitration in Shanghai under the auspices of the Shanghai International Economic and Trade Arbitration Commission with its then effective arbitration rules. The arbitration tribunal shall be consisted by three (3) members. One (1) arbitrator shall be appointed by the Party initiating the arbitration, one (1) arbitrator shall be appointed by the other Party, and the third arbitrator shall be jointly selected by the two (2) appointed arbitrators.

21.2本协议以及因本协议及其内容或成立而引起的或与之相关的任何争议或诉请（包括非合同争议或诉请）（以下简称“争议”）应由双方通过友好协商解决。如不能通过协商解决的，则该争议（包括有关本协议有效性或存续性的争议）应提交上海国际经济贸易仲裁委员会，按照其届时有效的仲裁规则在上海进行仲裁。仲裁庭由三（3）名成员组成。其中一（1）名仲裁员由提起仲裁方指定，一（1）名仲裁员由答辩方指定，第三名仲裁员由该两名仲裁员共同选定。

21.3The award of the arbitration tribunal shall be final and binding upon the Parties, and each Party may apply to a court of competent jurisdiction for enforcement of such award. Except for matters in the Dispute during a Dispute which is being resolved in accordance with this Agreement, the Parties shall continue to perform their obligations hereunder.

21.3仲裁裁决应为终局的，对双方均具有约束力，并可根据有关条款规定强制执行。在按照本协议约定解决争议期间，除争议所涉事项外，双方应继续履行其在本协议项下的义务。

22.	Assignment

22.

转让

22.1Neither Party shall assign or transfer its rights and obligations hereunder to any other party without the prior written consent of the other Party. Notwithstanding the foregoing, this Agreement and the rights and obligations herein may be assigned by each Party to any of its Affiliate, and either Party, may assign or sell the same in connection with the transfer or sale of substantially its entire business to which this Agreement pertains or in the event of its merger or consolidation with

another company without such consent. Any permitted assignee will assume all obligations of its assignor under this Agreement.

22.1未经另一方事先书面同意，任何一方均不得转让本协议。尽管有前述约定，一方可将其本协议项下权利义务转让给其关联方，且一方转让或出售其与本协议有关的绝大部分业务或与另一家公司合并时转让本协议则无需征得另一方同意。任一获准受让人应承担其转让人在本协议项下的所有义务。

22.2No assignment will relieve any Party of the responsibility for the performance of any obligation hereunder.

22.2任何形式的转让都不会免除任何一方履行本协议项下任何义务的责任。

23.	Severability

23.

可分割性

23.1.In the event that any term or provision of this Agreement is held invalid or unenforceable by a court of competent jurisdiction, the remaining terms shall be valid and enforced to the fullest extent permitted by Applicable Law. If any term or provision of this Agreement is deemed by a court to be unenforceable because such provision is too broad in scope, the provision shall be construed in a limited scope to make it enforceable.

23.1.若本协议的任何条款或约定被有管辖权的法院认定为无效或不可强制执行，其余条款将在适用法律允许的最大范围内有效并可强制执行。如果本协议的任何条款或约定因适用范围过宽而被法院认定为不可强制执行，则该条款将在有限范围内进行解释以使其具有可强制执行性。

24.	Entire Agreement

24.

完整协议

24.1.This Agreement constitutes the entire agreement between the Parties concerning the subject matter and supersedes all prior agreements or understandings between the Parties.

24.1.本协议构成双方之间关于就本协议主题事项的全部约定，并取代双方之前所有的约定或谅解。

25.	Waiver

25.

弃权

25.1.No waiver or modification of any of the terms of this Agreement shall be valid unless in writing and signed by authorized representatives of both Parties. Failure by either Party to enforce any rights under this Agreement shall not be construed a waiver of any rights, nor will a waiver by a Party in one instance be construed as a continuing waiver or a waiver in other instances.

25.1.除非由双方授权代表书面签署，否则对本协议任何条款的放弃或修改均无效。任何一方未能行使本协议项下的权利不应被解释为在该情况下或任何其他情况下放弃此类权利。任何一方在某种情况下的弃权也不应被解释为持续性弃权或视为在其它情况下的弃权。

26.	Publicity

26.

公开发布

26.1.Other than as required by Applicable Law, in the absence of specific agreement between the Parties, neither Party shall originate any publicity, news release or other public announcement, written or oral, whether to the public press, to stockholders or otherwise relating to this Agreement.

26.1.除适用法律要求外，在双方间无具体协议或约定的情况下，任何一方不得向公众媒体、股东或以其他方式发起与本协议相关的任何书面或口头的宣传、新闻发布或其他公告。

27.	Appendices

27.

附录

27.1.All appendices referenced herein are made a part of this Agreement.

27.1.本协议中所有附录均构成本协议的一部分。

28.	Limitation of Liability

28.

责任限制

28.1In no event, however, to the extent permitted by the applicable law, shall either Party be liable to the other Party or to any third party, under this Agreement, in contract, tort (including negligence), or other-wise howsoever, and whatever the cause thereof, for lost profits, goodwill, the cost of procurement of substitute goods or for any consequential or indirect damages. This limitation shall apply even where a Party has been advised of the possibility of such damage and notwithstanding the failure of the essential purpose of any limited remedy stated herein.

28.1在法律允许的范围内，本协议项下一方对于另一方或任何第三方就利润损失、商誉、替代商品的采购成本或任何后续或间接损害均不承担赔偿责任，不论是基于合同、侵权（包括过失）或其他方式，且不论是何种原因造成。即使一方已被告知该等损害的可能性，且

本协议规定的任何有限救济的基本目的未能实现，该等限制仍应适用。

28.2To the extent permitted by Applicable Law and subject to the provisions of this Section 28.1 each Party’s total liability under this Agreement shall be limited to an amount of a half million US Dollars (US$500,000.00) in the aggregate, excluding insurance coverage, provided, however that each Party is only liable to the other Party, if such Party has materially fulfilled all of its relevant obligations under this Agreement at the time of the breach of this Agreement.

28.2在适用法律允许的范围内，且受限于本协议第28.1条之约定，任一方在本协议项下的合计责任金额应以500,000美元为限（不包括保险赔付的金额），但违约一方仅在其违约行为发生时另一方已经实质履行其在本协议项下全部相关义务的情况下，对另一方承担违约责任。

29.	Counterparts and Language

29.

副本和语言

29.1.

This Agreement may be executed in several duplicates, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. For the avoidance of doubt, this Agreement is concluded both in Chinese version and English version. In the event of any discrepancy between the Chinese version and the English version, the English version shall prevail.

29.1.

本协议可签署多份副本，每一份副本均应被视为原件，且所有副本应共同构成同一文件。为避免疑义，本协议以中文和英文书就。若中文版本和英文版本之间存在不一致之处，应以英文版本为准。

In Witness whereof, the Parties have executed this Agreement by their duly authorized representatives.

兹证明，双方已由其正式授权代表签署本协议。


Amphastar Nanjing Pharmaceuticals, Inc.		Nanjing Hanxin Pharmaceutical Technology Co., Ltd.
美药星（南京）制药有限公司		南京汉欣医药科技有限公司

By/签署:	/s/Perky Qiu	By/签署:	/s/Bob Bao

Name/姓名:	Perky Qiu 邱银华	Name/姓名:	Bob Bao 鲍海涛

Title/职位:	General manager 总经理	Title/职位:	Vice General Manager 副总经理

Date/日期:	2022-04-18	Date/日期:	2022-04-18

APPENDIX A: PRODUCT AND CONTRACT PRICE

附录A：产品及合同价格

Product:

************** ********

Selling Price means, with respect to each Product, an amount equal to the sum of (i) the Direct Costs to manufacture such Product, plus (ii) **% of the amount of such Direct Costs plus any applicable taxes.

出售价格: 金额等于产品直接成本加上直接成本的**%以及所适用税款的总和。

“Direct Costs” means, with respect to a Product, the actual cost of raw materials, packaging components, overhead expense applied on a consistent basis with other products manufactured by ANP, and direct labor used to produce such Product. In no event will Direct Costs include expenses related to unutilized facility capacity, or allocations for corporate overheads.

直接成本：指乙方用于产品生产及相关的实际费用，包括：原材料，包装材料，管理及人工费用。任何情况下，直接成本都不包括未参与生产的设施费用，或公司内部管理费用。

APPENDIX B: SPECIFICATIONS

附录B：质量标准

Part of the product development works.