Washington, D.C. 20549





Date of Report (Date of earliest event Reported): November 15, 2022

Amphastar Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)




(State or Other Jurisdiction of

(Commission File Number)

(IRS Employer Identification

11570 6th Street

Rancho Cucamonga, California


(Address of Principal Executive Offices)

(Zip Code)

Registrant's telephone number, including area code: (909) 980-9484

Not Applicable

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share


The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Item 1.01.  Entry into a Material Definitive Agreement

On November 15, 2022 (the “Effective Date”) Amphastar Nanjing Pharmaceuticals, Inc. (“ANP”), a wholly owned subsidiary of Amphastar Pharmaceuticals, Inc. (the “Company”), entered into a supply agreement (the “Agreement”) with Nanjing Letop Biotechnology Co., Ltd. (“Letop”). Pursuant to the Agreement, Letop will manufacture and deliver chemical intermediates (“Intermediates”) for ANP according to the requirements of the purchase orders confirmed by Letop (collectively, the “Transaction”). ANP is entitled to decide the quantity of the Intermediates that it purchases from Letop at its own discretion, and ANP has no obligation to purchase any minimum quantity of the Intermediates from Letop. ANP will retain ownership of all confidential information ANP shares with Letop during the term of this Agreement. Each of ANP and Letop have made customary representations, warranties and covenants in the Agreement. This Agreement will remain in full force and effect for a period of three (3) years from the Effective Date.

Payments under the Agreement will be made in Chinese yuan. The total cost of the Agreement to ANP for the three (3) year period of the agreement shall not exceed approximately $1.5 million, with payments adjusted based on actual currency exchange rates.

As previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, Henry Zhang is an immediate family member of Dr. Jack Zhang, Chief Executive Officer, President, and Director of the Company, Dr. Mary Luo, Chairman, Chief Operating Officer, and Director of the Company. Henry Zhang beneficially owns a majority of the equity interest in Letop, and the Agreement with Letop represents a related party transaction. Accordingly, the independent and disinterested members of the Audit Committee of the Board of Directors of the Company evaluated and approved the Transaction and entry into the Agreement following their review of applicable considerations.

The foregoing is a brief description of the material terms of the Agreement, does not purport to be a complete description of the rights and obligations of the parties thereunder, and is qualified in its entirety by reference to the copies of the Agreement, a copy of which is filed as Exhibit 10.1 hereto and incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits

(d) Exhibits







Supply Agreement by and between Amphastar Nanjing Pharmaceuticals, Inc. and Nanjing Letop Biotechnology Co., Ltd. dated November 15, 2022.



Cover Page Interactive Data File (embedded within the Inline XBRL document).


Certain confidential information contained in this Exhibit was omitted by means of marking such portions with brackets because the identified confidential information (i) is not material and (ii) would be competitively harmful if publicly disclosed.



Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.





Date: November 18, 2022






William J. Peters


Chief Financial Officer, Executive Vice President and Treasurer


Exhibit 10.1






This Supply Agreement (this “Agreement”) is entered into by and between the following parties on November 15, 2022 (the “Effective Date”):

本供应协议本协议由以下双方于 2022 11 15 生效日签订

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



(2) Nanjing Letop Biotechnology Co., Ltd., a limited liability company duly incorporated and validly existing under the laws of PRC, with the unified social credit code: [***] (the “Supplier”).

(2) 南京乐韬生物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:[***](“供应方”)。

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


Whereas, the Customer intends to purchase certain Products (as defined below) which are manufactured by the Supplier in the Territory based on Specifications and formula provided by the Customer, and the Supplier intends to accept such purchase order.


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




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

1.2Additional agreements necessary to effectuate this Agreement may be executed between the Parties.  In the event of conflicting terms, the terms of this Agreement shall prevail.

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

(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.

(b)Applicable Law” means all ordinances, rules, regulations, laws, and requirements of any authority applicable to the Manufacture, supply, use of the Products and/or other activities under this Agreement, as amended from time-to-time, including 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.

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


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

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

(h)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.

(i)Products” mean any or all of the products listed in Appendix A hereof.

(j)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 Products.

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

(l)Term” means the period during which this Agreement is in effect as set forth in Section 11.

(m)Territory” means the PRC.

(n)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.

2.The Customer’s Rights and Obligations

2.1The Customer shall issue purchase orders to the Supplier.  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 the Supplier with a delivery period of no less than ninety (90) days.  The Supplier shall confirm within ten (10) business days after receipt of the purchase order.
2.2The Customer is entitled to decide the quantity of Products that it purchases from the Supplier at its own discretion, and the Customer has no obligation to purchase any minimum quantity of


Products from the Supplier.


3.The Supplier’s Rights and Obligations

3.1The Supplier shall deliver the Products to the Customer according to the requirements of the purchase orders confirmed by the Supplier, 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 the Supplier’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.

3.2The Supplier shall Manufacture and deliver the Products in conformance with the Applicable Law and regulations and Specifications.

4.Contract Price, Invoice and Payment

4.1The Supplier shall issue invoices within five (5) business days after shipment, unless the Parties determine that the Products do not conform to the Specifications, payment shall be due thirty (30) days after the date of an invoice from the Supplier.
4.2During 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 Supplier provides the Customer with two (2) months prior written notice of such proposed Contract Price adjustment and Customer agrees with such adjustment.



4.3If the Supplier’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 the Supplier.  During the negotiation of Contract Price change, the Supplier 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 the Supplier to purchase designated raw materials and packaging materials, the Contract Price shall be adjusted accordingly.  

5.Supply of the Products

5.1The Supplier 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 the Supplier’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 the Supplier.

6.Inspection of the Products

6.1All Products 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 Products (“Inspection Period”).  The Customer will notify the Supplier if the results of any inspection or testing indicate that the Products do not conform to the applicable Specifications or the other requirements under this Agreement.  The Supplier 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 Products to be nonconforming, then at the Customer’s sole discretion, the Supplier shall (a) promptly deliver, at the Supplier’s sole expense, the replacement Products that conform 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 Supplier’s sole discretion, return or destroy the nonconforming Products at the Supplier’s sole expense, including without limitation transportation and handling costs.

7.Facility Qualification

7.1The Supplier shall, take all commercially reasonable actions to qualify (and thereafter to maintain qualification of) the facility at which the Supplier Manufactures the Products, as required under Applicable Law, to enable the Customer to obtain and maintain all applicable Regulatory Dossiers in relation to the Products.  The Supplier will permit the Customer and its agents, at the Customer’s expense, during normal business hours and upon reasonable prior notice to the Supplier, and no more than once per year, to inspect the Facility where the Products are 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 Products and all Manufacturing, handling, storage, and test records regarding the Products.  The Supplier 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.  

8.Manufacturing Practices

8.1The Supplier shall Manufacture the Products in conformance with the Specifications.  The Supplier shall provide the Customer with such information, including analytical and manufacturing documentation, requested by the Customer regarding quality control of the Products supplied hereunder.  The Supplier will solely be responsible for keeping proper records and documentation of the manufacturing and testing of the Products, intermediates, and starting materials, including batch records, testing records, laboratory notebooks, equipment usage, starting material batch numbers, and certifications.  The Supplier will be responsible for investigating any test results or in-process testing of the Products that do not conform with the Specification.  The Supplier will conduct such laboratory investigation, which must be approved by the Supplier’s quality unit, and the Supplier will promptly notify the Customer of any adverse reactions or other safety or toxicity problems known to or reasonably suspected by the Supplier regarding the Products or its use.  The Supplier will promptly notify the 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 Products to the Customer.




9.1During 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 Product (a “Recall”), the Supplier 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 Products shall be made by the Customer; provided, however, that the Supplier 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 the Supplier 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 the Supplier if a Recall is incurred attributable to it, the Customer shall bear all costs incurred thereby.

10.Certificate of Analysis

10.1The Supplier 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 the Supplier have agreed to such changes in writing prior to adoption of the modified Specifications.



11.Term, Amendment and Termination

11.1This Agreement will remain in full force and effect for a period of three (3) Contract Years (the “Term”).  Prior to the expiry of the Term, the Parties may, in their discretion, agree to extend the Term for a mutually agreed period.

11.2During 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.

11.3Unless 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.


(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(ii) 实际上已不存在纠正违约行为的可能(iii) 存在违约行为导致不能实现协议目的

11.4This Agreement may be terminated by mutual written consent of the Parties.

11.5Upon expiration or termination of this Agreement, the Supplier 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 the Supplier within thirty (30) days from the date of invoice.  

11.6Termination 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.

11.7Either 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.



11.8Unless otherwise provided for herein, after termination or expiration of this Agreement, section 1 (General), this section 11 (Term, Amendment and Termination), section 12 (Intellectual Property Rights), section 13 (Warranties), section 14 (Indemnities), section 15 (Confidential Information), section 16 (Force Majeure), section 17 (Notices), section 18 (Binding Effect), section 19 (Governing Law and Dispute Resolution), section20 (Assignment), section 21 (Severability), section 22 (Entire Agreement), section 23 (Waiver), section 24 (Publicity), section 25 (Appendices), section 26 (Counterparts and Language) shall survive.

12.Intellectual Property Rights

12.1The Supplier will retain ownership of all the Supplier’s 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 Products (and all know-how of such process).

12.2The Customer will retain ownership of all Confidential Information the Customer shares with the Supplier during the Term of this Agreement.


13.1The Supplier warrants that the Products 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, and that it holds all necessary intellectual property rights and licenses, filings or approvals required by all Applicable Law for the Manufacture, supply, use of the Products and/or other activities under this Agreement.  The Supplier 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 Products being provided hereunder, including without limitation, those enforced by the NMPA.  

13.2The Parties are not authorized to, and shall not, incur any liability for which the other Party may become directly, indirectly or contingently liable, nor shall they, except as explicitly provided in this Agreement, hold themselves out as having authority to represent or act on behalf of the other Party in any capacity whatsoever, nor shall the relationship between the Parties be construed as a co-partnership, joint venture or principal-agent relationship.


14.1Unless arising from the willful misconduct of the Supplier, the Customer will defend, indemnify and hold the Supplier 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) the Customer’s material breach of this Agreement or (ii) the Customer’s breach of any warranty made under this Agreement.
14.1除非因供应方故意不当行为引起(i)买方实质性违反本协议(ii) 买方违反其在本协议项下的任何保证时买方应为供应方及供应方关联方供应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供应方及供应方前述主体免受任何责任判决



14.2Unless arising from the willful misconduct of the Customer, the Supplier 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) the alleged or actual negligence or wilful misconduct of the Supplier; (ii) the Supplier’s material breach of this Agreement; (iii) the Supplier’s breach of any warranty made under this Agreement; or (iv) any infringement of any third party intellectual property rights in relation to the Products.
14.2除非因买方故意不当行为引起(i) 供应方存在被指称的或实际的过失或故意不当行为(ii) 供应方实质性违反本协议(iii) 供应方违反其在本协议项下的任何保证(iv) 供应方存在与产品有关的侵犯任何第三方知识产权的情形供应方应为买方及买方关联方买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买方及买方前述主体免受损害

14.3Each 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 14.  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.



14.4Unless otherwise provided for herein, if the Customer pays the Contract Price under this Agreement which are overdue, the Supplier shall have the right to require the Customer to pay 0.05% interest of the overdue payment per day as liquidated damages.

15.Confidential Information

15.1The 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.



15.2Each 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.

15.3This 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.



15.4The 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.

16.Force Majeure

16.1If 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.

16.2In 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.


17.1.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:

If to the Customer:

If to the Supplier:

Address: Amphastar Nanjing Pharmaceuticals, Inc.

No. 5 Xinghe Road

Nanjing Economic and Technological Development Zone

Jiangsu, China

Attn: General Manager

Post Code: 210038

Address: Nanjing Letop Biotechnology Co., Ltd.

Building C5,No.9 Weidi Road,Xianlin University Town,Xianlin Street,Qixia District,Nanjing City,Jiangsu Province

Attn:Eric Xu

Post Code: 210033




联系人General Manager







18.Binding Effect

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

19.Governing Law and Dispute Resolution

19.1The Agreement shall be construed, interpreted and governed by the laws of the PRC.

19.2This 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.

19.3The 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.


20.1Neither 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.

20.2No assignment will relieve any Party of the responsibility for the performance of any obligation hereunder.


21.1.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.



22.Entire Agreement

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


23.1.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.


24.1.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.


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



26.Counterparts and Language
26.1.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.


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


Amphastar Nanjing Pharmaceuticals, Inc.

Nanjing Letop Biotechnology Co., Ltd.




/s/Perky Qiu


/s/ Eric Xu


银华 Perky Qiu


徐勇 Eric Xu


总经理 General Manager


总经理 General Manager











Selling Price/Unit (RMB)


Phytol VK01-A0








Chloracetyl Catechol




Epinephrine Bitrartrate 酒石酸肾上腺素




Cholic acid








1-(2, 2-dimethyl-4h-1,3-benzodioxin--6-yl)-2-(1-phenylethylamine)ethanol SM-8




1-[4-[(6-Bromohexyl)oxy]butyl]benzene SM-10




1-Hydroxy-2-naphthoic Acid




17-BETA CARBOXYLIC ACID; 6a,9a-difluoro-l1~-hydroxy-l6a-methyl-l7apropionyloxy-3-oxo F6B-A0








Benzenemethanol S2B-A0



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.



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.