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LICENSE AND DISTRIBUTION AGREEMENT

Distribution Agreement

LICENSE AND DISTRIBUTION AGREEMENT | Document Parties: ANESIVA, Inc | Lee's Pharmaceutical (HK) Limited You are currently viewing:
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ANESIVA, Inc | Lee's Pharmaceutical (HK) Limited

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Title: LICENSE AND DISTRIBUTION AGREEMENT
Governing Law: Delaware     Date: 8/11/2008
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENSE AND DISTRIBUTION AGREEMENT, Parties: anesiva  inc , lee's pharmaceutical (hk) limited
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Exhibit 10.67

C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 406 OF THE S ECURITIES A CT OF 1933, AS AMENDED .

L ICENSE AND D ISTRIBUTION A GREEMENT

T HIS L ICENSE AND D ISTRIBUTION A GREEMENT is made and entered into as of 21 st day of July 2008, by and between ANESIVA, Inc., a Delaware corporation, having a principal place of business at 650 Gateway Boulevard, South San Francisco, California 94080, United States (hereinafter referred to collectively as, “ANESIVA”) and Lee’s Pharmaceutical (HK) Limited with its principal place of business at Unit 110-111, Bio-Informatics Centre, No. 2 Science Park West Avenue, Hong Kong Science Park, Shatin, New Territories, Hong Kong (hereinafter referred to as “LPL”), which hereby agree as follows:

RECITALS

W HEREAS ANESIVA owns or holds exclusive rights to patents, the Specifications and Test Methods relating to the manufacture and use of their proprietary Product (as such term is hereinafter defined), and development, marketing, sales and distribution rights for the Product; and

W HEREAS ANESIVA owns certain trade names, trademarks, logos, emblems and indicia of origin which are used in association with the Product, and

W HEREAS LPL is desirous of obtaining from ANESIVA the exclusive right and license to market and sell the Product as well as the methods and Specifications and Test Methods (as such term is hereinafter defined) in the Territory (as such term is hereinafter defined) under the Proprietary Marks (as such term is hereinafter defined), upon the terms and subject to the conditions hereinafter set forth; and

N OW , T HEREFORE , this Agreement witnesses that in consideration of the mutual covenants and agreements herein contained and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto hereby covenant and agree with each other as follows:

 

1.

Definitions

Where used in this Agreement the following terms shall have the following meanings:

1.1. “Affiliate” means, with respect to any Person, any other Person who directly or indirectly controls, is controlled by, or is under direct or indirect common control with, such Person, and includes any Person in like relation to an Affiliate. A Person is deemed to control another Person if such Person possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of such other Person, whether through the ownership of voting securities, by contract or otherwise; and the term “controlled” has a corresponding meaning.

1.2. “Agreement” means this Agreement as is or it may be amended or supplemented from time to time, and the expressions “hereof”, “herein”, “hereto”, “hereunder”, “hereby” and similar expressions refer to this Agreement and not to any particular Section (hereinafter “§”)or other portion of this Agreement.

 

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1.3. “Business Day” shall mean a day other than Saturday, Sunday or any day on which banks located in the Territory, are authorized or obligated to close. Whenever this Agreement refers to a number of days, such number shall refer to calendar days unless Business Days are specified.

1.4. “Commercially Reasonable” shall mean a Party’s reasonable efforts and diligence in manufacturing and commercializing the Product in accordance with its business, legal, medical and scientific judgment, such reasonable efforts and diligence to be in accordance with the efforts and resources the Party would use for a product owned by it or to which it has rights, which is of similar market potential at a similar stage in its product life, taking into account the competitiveness of the marketplace, the ability of a contract manufacturer to deliver product, the proprietary position of the compound, the regulatory structure involved, the profitability of the applicable Product, and other relevant factors including, without limitation, technical, legal, scientific, clinical or medical factors.

1.5. “Documents” means, collectively, all books, pamphlets, bulletins, memoranda, letters, notices or other publications or documents prepared by or on behalf of ANESIVA for use by LPL setting forth information, standards, requirements, operating procedures, instructions or policies relating to release testing for the Product.

1.6. “Effective Date” shall mean the date of last signature of the Parties hereto.

1.7. “Field of Use” means use of Product as a topical local anesthetic.

1.8. “GMP” shall mean current Good Manufacturing Practices promulgated by U.S. Food and Drug Administration.

1.9. “Government Regulatory Authority” shall mean any court, tribunal, arbitrator, authority, agency, commission, official or other instrumentality of the United States of America, SFDA in the Territory and/or other political subdivision in the Territory or other governmental instrumentality of a United Nations recognized sovereign state having subject matter jurisdiction over the Product(s) as the case may be.

1.10. “Generally Accepted Accounting Principles” shall mean accounting rules used to prepare, present, and report financial statements for a wide variety of entities, including publicly-traded and privately-held companies, non-profit organizations, and governments. Generally GAAP includes local applicable Accounting Framework, related accounting law, rules and Accounting Standard.

1.11. “Gross Margin” means the difference between the Gross Sales and Manufacturing Cost.

1.12. “Gross Sales” shall mean, in accordance with the Generally Accepted Accounting Principles published by the Financial Accounting Standards Board of the United States, the amount invoiced by LPL or its Affiliates for sales of the Product in the Territory to a third party, other than to Affiliates, less the value-added tax and other similar sales taxes related to the sale of the Licensed Product to the extent included in the gross invoice.

 

C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 406 OF THE S ECURITIES A CT OF 1933, AS AMENDED .

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1.13. “Improvements” means any future innovations, inventions, designs, plans, drawings, specifications, techniques, data and technical information relevant to the use (indications) or sale of the Product including, but not limited to, modified packaging.

1.14. “Law” or “Laws” , as the case may be, shall mean all laws, statutes, rules, regulations, ordinances, guidelines and other pronouncements having the effect of law in any country with jurisdiction over either of the Parties and/or Product(s) or any domestic or foreign state, province, county, city or other political subdivision or of any Health Registration Authority or Regulatory Authority in the Territory.

1.15. “License” shall mean the right granted by ANESIVA to LPL for the distribution of the Product in the Territory either on its own or through LPL’s third party distributors.

1.16. “Exchange Rate” shall mean the spot Exchange Rate published in The Wall Street Journal as quoted by Reuters at 4:00 PM on the prior Business Day.

1.17. “Manufacturing Cost” shall mean, with respect to Product, the sum of the following, all of which shall be calculated in accordance with U.S. Generally Accepted Accounting Principles:

(a) The amounts paid by ANESIVA to any third party for (i) providing raw materials and packaging materials for producing the Product, (ii) manufacturing, filling and/or finishing Product or any component thereof, (iii) storing, insuring and packaging Product, and (iv) release and stability testing Product, including with respect to the foregoing, all taxes (other than income taxes) and customs duty charges imposed by governmental authorities with respect thereto, to the extent paid by ANESIVA and not reimbursed or refunded by a third party;

(b) The direct costs and charges incurred by ANESIVA in connection with the manufacture, filling, finishing, testing (including direct quality control and quality assurance activities), storing, insuring and packaging Product not otherwise accounted for pursuant to subsection (a) above; and

(c) A reasonable allocation of indirect labor, administration costs and facilities costs (including electricity, water, sewer, waste disposal, property taxes and depreciation over the expected life of buildings and equipment) attributable to the manufacture, filling, finishing, testing, storing, insuring and packaging of Product; provided that such indirect labor, administration costs and facilities costs shall only include an allocation, to the units or sections directly engaged in the activities listed in the subsection (b) above, of such indirect labor, administration costs and/or facilities costs incurred by ANESIVA.

Without limiting the generality of the foregoing provisions of this §1.17, Manufacturing Costs shall exclude, all costs and charges related to or occasioned by unused manufacturing capacity; the manufacture of other products at ANESIVA’s or a third party contractor’s facility; depreciation of property, plant or equipment not specifically related to manufacturing Product; allocation of administrative costs and general corporate overhead of ANESIVA or its third party contractors; ANESIVA’s cost of capital, whether or not such capital is attributable to the manufacturing of any Product; and any employee costs associated with equity incentive plans.

 

C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 406 OF THE S ECURITIES A CT OF 1933, AS AMENDED .

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1.18. “Marketing Authorization” shall mean the final approval of registrations and permits required by applicable Government Regulatory Authority in the Territory. In the People’s Republic of China, the Imported Drug License shall serve as the Marketing Authorization. In Hong Kong and Macau, the Certificate of Drug/Product Registration shall serve as the Marketing Authorization.

1.19. “Party” means a Party to this Agreement and any reference to a Party includes its successors and permitted assigns; “Parties” means every Party together.

1.20. “Person” shall mean any legal person including, for example, an individual, corporation, partnership, Limited Liability Company, trust, business trust, association, Joint Stock Company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, governmental authority or any other form of entity.

1.21. “Product” means ANESIVA’s powder intradermal injection system, comprising lidocaine hydrochloride monohydrate, 0.5 mg, indicated for use on intact skin to provide topical local analgesia prior to venipuncture or peripheral intravenous cannulation and marketed in the United States under the brand name Zingo™.

1.22. “Proprietary Marks” means the marks, trademarks, trade names and other commercial symbols and related logos relating to the Product for use in the Territory, together with such other trade names, trademarks, symbols, logos, distinctive names, service marks, marks, logo designs, insignia or otherwise which may be designated by ANESIVA. The trademark for the Product is “Zingo”.

1.23. “Quality Assurance Department” or “QA” shall mean the group or department that performs the quality review functions. QA reviews and approves quality-related documents and procedures.

1.24. “Specifications and Test Methods” means the Specifications, the documents, and all information and data relating to techniques for, methods of or practices of release testing for the Product.

1.25. “Specifications” means all specifications, methods, applications, criteria, qualities, requirements and all other information in connection with the use, handling, distribution, marketing and/or sale of the Product published, promulgated or conveyed by or on behalf of ANESIVA to LPL in any manner whatsoever, including any manual, specification booklet, letter, notice, memorandum or other written from, from time to time.

1.26. “Serious Adverse Events” shall mean any adverse experience that result in any of the following outcomes: death, a life-threatening experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening or require hospitalization may be considered a Serious Adverse Event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

 

C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 406 OF THE S ECURITIES A CT OF 1933, AS AMENDED .

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1.27. “SFDA” means the Chinese State Food and Drug Administration.

1.28. Trademark License . ANESIVA shall grant to LPL an exclusive license to use and display one or more of ANESIVA’s trademarks in the Territory as set forth in §2.4, consistent with ANESIVA’s trademark usage guidelines ( Guidelines”). All Products shall be branded and marked as specified by the Guidelines.

1.29. “Term” of the Agreement shall have the meaning set forth in §2.1.

1.30. “Territory” shall mean People’s Republic of China, Hong Kong and Macau.

1.31. “Transfer Price” shall have the meaning set forth in §4.5.

1.32. [*] shall mean a [*] used for [*] of a [*] device. The [*] is not intended to work as a [*] and does not provide any [*].

2. Terms, Grant of Licences, Regulatory Submissions and Drug Release Testing, and Governance

2.1. The sole and exclusive license granted in this §2 shall have a Term composed of the [*] and any [*] or [*].

2.2. The Initial Term shall begin as of the Effective Date of this Agreement between the Parties and shall continue in effect until [*] from the date of the first launch of the Product in the Territory [*].

2.3. [*] shall be the [*] of this Agreement for [*] of [*] from [*] or [*], unless [*] notifies the [*] that it does not intend to [*] no less than [*] prior to the [*] of the [*] or any [*].

2.4. Subject to the provisions of this Agreement, and solely during the Term, ANESIVA hereby:

(a) covenants and agrees to license exclusive right to the Product [*] to LPL in the Territory to enable LPL to promote, market and sell the Product in the Territory;

(b) grants to LPL the exclusive right and license to use the Proprietary Marks and trademarks in connection with the marketing, distribution and sale of the Product within the Territory; and

(c) grants LPL a royalty-bearing license to all intellectual property related to the Product including, but not limited to, the Proprietary Marks for LPL’s use in the Territory as may be necessary and required under the Laws and regulations and a fully paid license to all governmental authorizations, product documentation, marketing materials and the like. All costs associated with registering or maintaining the Proprietary Marks or other intellectual property will be [*].

 

C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 406 OF THE S ECURITIES A CT OF 1933, AS AMENDED .

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2.5. During the Term of the Agreement, LPL shall be responsible for the application, prosecution and maintenance of Marketing Authorizations in the Territory for the Product, with the Imported Drug License being held in ANESIVA’s name in the People’s Republic of China and the Certificate of Drug/Product Registration being held in LPL’s name in Hong Kong and Macau under the following conditions:

(a) LPL agrees to [*] the Marketing Authorization application and maintenance [*] which are [*] to SFDA, including [*] related to any required amendments to the initial application. LPL shall be responsible for filing an application for a Marketing Authorization in the Territory for the Product as soon as LPL prepares an approvable dossier, but in no event [*] as well as the sNDA for the adult indication now under US FDA review from ANESIVA and after ANESIVA’s initial discussions with the Chinese SFDA for its Product manufacturing Joint Venture. LPL will keep ANESIVA updated regarding the status of the Approvals and will provide ANESIVA with copies of all Approvals upon issuance. Upon termination of the Agreement, LPL will assign or cause to be assigned to ANESIVA (or another entity designated by ANESIVA) all Approvals, to the extent such assignment is legally permissible.

(b) ANESIVA agrees to provide LPL with a current and complete copy of the U.S. approved regulatory dossier for the Product and to supplement this regulatory dossier as new data or information becomes available. LPL agrees to modify this dossier in accordance with the requirements of the Territory for submission in the Territory. In order to facilitate ANESIVA’s support, LPL shall provide copies of the SFDA correspondence documents and any submissions to SFDA translated into English with appropriate certification.

(c) ANESIVA agrees to support LPL in addressing any SFDA questions subsequent to submission and approval.

(d) LPL and ANESIVA will [*] of any SFDA manufacturing site inspection that requires longer than [*] on site at ANESIVA or ANESIVA’s contract manufacturer. In the case where SFDA requires a manufacturing change that is not required by either U.S. or EU regulatory authorities, then this change will be paid for by [*].

(e) The Parties shall [*] determine the specific drug release testing requirements for the Territory pursuant to Territory Law and shall negotiate in good faith the [*] and costs for such release testing for shipment of Product for human use in the Territory.

2.6. Both Parties shall appoint a project leader within [*] of signing this Agreement, through which all communications regarding this Agreement will be initially directed. The project leaders will facilitate direct communication between functional experts, decision making individuals and other personnel as needed to manage activities under this Agreement.

 

C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 406 OF THE S ECURITIES A CT OF 1933, AS AMENDED .

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3.

Proprietary Rights

3.1. ANESIVA shall register the Proprietary Marks and such other intellectual property rights as required for the Territory within a Commercially Reasonable time after its execution of this Agreement if such Proprietary Marks and other intellectual property rights have not already been registered. All registrations shall be at [*].

3.2. LPL confirms that all rights, title and interest in the Proprietary Marks or related to the Proprietary Marks are the sole property of ANESIVA, and this Agreement shall not operate to convey any interest or rights in the Proprietary Marks to LPL.

3.3. ANESIVA shall include the applicable Proprietary Marks on all packages of the Product delivered to LPL (or as directed by LPL to its customs brokers). LPL shall make use of the Proprietary Marks in all materials and activities related to the marketing, sale and distribution of the Product. The Proprietary Marks used by LPL shall comply with the form of the Proprietary Marks as registered in the Territory.

3.4. At all times, LPL shall use the ANESIVA registered trademarks in reference to the applicable Product in the Territory unless prohibited by Law of the Territory. In any such event, ANESIVA and LPL shall meet to resolve any such legal prohibition in accordance with the Laws and regulations of the Territory.

 

4.

Payment and Prices

4.1. LPL shall pay ANESIVA a [*] of [*] will be paid within [*] of signing of this Agreement.

4.2. LPL shall pay ANESIVA a [*] of [*] upon the [*] for the Product in the Territory [*]. The [*] will be paid within [*] from issuance of the Imported Drug License.

4.3. LPL shall purchase the Product from ANESIVA at ANESIVA’s Manufacturing Cost. Such payments shall be made [*] after the Product is received by LPL and subject to inspection by LPL.

4.4. Royalty on Sales: LPL shall pay a [*] royalty rate of [*] of Gross Margin as royalty payment to ANESIVA, to be paid in US Dollars at the end of every calendar quarter.

4.5. Transfer Price: ANESIVA shall supply the Product at Manufacturing Cost. Transfer Price for the Product shall in no instance be [*] per unit during the term of the Agreement. At the end of any [*] but not later than [*] after the end of the year, ANESIVA shall deliver to LPL a true and accurate report of actual Manufacturing Costs for such calendar year together with a detailed description of Manufacturing Costs for such year.

4.6. At the end of any [*] and within [*] after the publication of LPL quarterly report but not later than [*] after the end of the [*], LPL shall deliver to ANESIVA a true and accurate report of royalties payable for such [*], including the calculation of Gross Margins. Any payments due under this Agreement shall be made in United States Dollars, calculated based on Exchange Rate at the date of the report of Manufacturing Costs for such quarter submitted by ANESIVA under §4.5 and shall be

 

C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 406 OF THE S ECURITIES A CT OF 1933, AS AMENDED .

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paid by wire transfer to a bank and account designated in writing by ANESIVA. For payments, ANESIVA will submit written invoices. Payment of each such invoice not subject to a good faith dispute will be due in full within [*] following receipt of invoice. Invoices shall be sent to the following address:

Lee’s Pharmaceutical (HK) Limited

Unit 110-111, Bio-Informatics Centre,

No. 2 Science Park West Avenue,

Hong Kong Science Park,

Shatin, New Territories, Hong Kong

Wire instructions to ANESIVA are as follows or as amended on sent invoices:

 

 

 

 

Account Name:

  

[*]

    Bank Name:

  

[*]

 

  

[*]

 

  

[*]

 

  

[*]

 

  

[*]

Routing/ABA Number:

  

[*]

4.7 ANESIVA shall have the right to audit Gross Sales by giving a [*] notice to LPL. LPL shall allow access to all sales and accounting records related to the Product to ANESIVA’s appointed audit firm. Such audit is limited to [*] time per calendar year and could cover a period of [*]. In the event that actual Gross Sales are more than [*] less than LPL reported for any calendar quarter audited, then LPL shall bear the cost of the audit.

 

5.

Product Supply, Shipping, Ordering

5.1. Product sold to LPL for use in the Territory shall be in [*] for commercial sale and are FCA (INCOTERMS 2000) ANESIVA’s manufacturing plant (or any plant of a designated contrac


 
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