Document:

Exhibit 10.30

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Execution Copy

 

COLLABORATION AND LICENSE AGREEMENT

 

THIS COLLABORATION AND LICENSE AGREEMENT (this “Agreement”) is entered into as of November 20, 2015 (the “Effective Date”), by and between Kadmon Corporation, LLC, a limited liability company organized and existing under the laws of the State of Delaware (“Kadmon”), and Jinghua Pharmaceutical Group Co., Ltd., a company organized and existing under the laws of the People’s Republic of China (“Jinghua”).  Kadmon and Jinghua may each be referred to in this Agreement individually as a “Party,” and collectively as the “Parties.”

 

WHEREAS, Kadmon is a biopharmaceutical company engaged in the development and commercialization of drugs that target the molecular mechanism of disease and has certain skill(s) and know-how useful for the discovery of human monoclonal antibodies (the “Technology”);

 

WHEREAS, Jinghua engages in the research and development, manufacture, and sale of pharmaceutical products, and desires to develop products using human monoclonal antibodies for commercialization in the Territory (as defined below).

 

WHEREAS, the Parties are entering into this Agreement for Jinghua to use the Technology to discover fully human monoclonal antibodies and to use such Licensed Antibodies (as defined below) to develop products for commercialization in the Territory.

 

NOW, THEREFORE, in consideration of the premises and mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:

 

ARTICLE 1

DEFINITIONS

 

1.1                               “Affiliate” means, with respect to a Party, any Person that controls, is controlled by or is under common control with such Party, for so long as such control exists.  For purposes of this definition only, “control” shall mean direct or indirect ownership of fifty percent (50%) or more (or, if less than fifty percent (50%), the maximum ownership interest permitted by applicable Law) of the stock or shares having the right to vote for the election of directors of such corporate entity, or the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such entity, whether through the ownership of voting securities, by contract or otherwise.

 

1.2                               “Antibody Intellectual Property” means all Intellectual Property conceived, discovered, developed, produced or reduced to practice by or on behalf of Jinghua resulting from the performance of work connected to the VEGFR2 or PDL-1 monoclonal antibodies.

 

1.3                               “Business Day” means a day other than (a) a Saturday or Sunday, (b) a bank or other public holiday in New York, New York, United States, or (c) a bank or other public holiday in Nantong, China.

 

1.4                               “CFDA” means the China Food and Drug Administration and any successor agency thereto.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

1.5                               “Change of Control” means, with respect to a party: (a) the sale of all or substantially all of such Party’s tangible and intangible assets or business relating to this Agreement; (b) a merger or reorganization involving such Party in which the voting securities of such Party outstanding immediately prior thereto cease to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger or reorganization; or (c) any transaction or series of transactions in which a Person or group of Persons, acting in concert, acquire more than fifty percent (50%) of the voting equity securities or management control of such Party.

 

1.6                               “Clinical Trial” means any human clinical trial of a Product.

 

1.7                               “Commercialization” means activities directed to marketing, promoting, distributing, importing or selling a Product.  Commercialization shall not include any activities relating to Development or Manufacturing.  “Commercialize” and “Commercializing” shall have their correlative meanings.

 

1.8                               “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by any Party with respect to any objective, those reasonable, diligent, good faith efforts to accomplish such objective as such Party would under similar circumstances normally use to accomplish a similar objective that such Party is highly motivated to achieve.  With respect to any objective relating to the Development or Commercialization of a Product, “Commercially Reasonable Efforts” shall mean those efforts and resources normally used by such Party with respect to a product owned or controlled by such Party and considered by it to be among its principal or lead products.

 

1.9                               “Confidential Information” of a Party means all Know How or other information, including, without limitation, proprietary information and materials (whether or not patentable) regarding such Party’s technology, products, business information or objectives, that is communicated in any way or form by one Party to the other Party, either prior to or after the Effective Date of this Agreement, and whether or not such Know-How or other information is identified as confidential at the time of disclosure; provided that, information not identified as confidential by the disclosing Party shall be deemed to be Confidential Information of the disclosing Party if the Receiving Party knows, or should have had a reasonable expectation, that the information communicated by the disclosing Party is Confidential Information of the disclosing Party.  The terms and conditions of this Agreement shall be considered Confidential Information of both Parties.

 

1.10                        “Control” or “Controlled” means with respect to any item of Know-How, or intellectual property right, the possession (whether by ownership or license, other than a license granted by one Party to the other pursuant to this Agreement) by a Party of the ability to grant to the other Party a license or to extend other rights as provided herein, under such item or right without violating the terms of any agreement or other arrangements with any Third Party.

 

1.11                        “Cover” means, with respect to a Product, the manufacture, use, sale, offering for sale or importation of such product which would infringe a Valid Claim of a Patent at the time

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

thereof, but for the licenses granted or assignment made of such Patent under this Agreement.

 

1.12                        “Development” means, with respect to the Product, any and all processes and activities conducted to obtain and maintain Regulatory Approval for the Product, including pre- and post-marketing approval Clinical Trials, and activities relating to development or preparation of such Product for Commercialization.  “Develop” and “Developing” shall have their correlative meanings.

 

1.13                        “Development Plan” means the written plan for the Development of the Products in the Territory, as such plan is updated from time to time.

 

1.14                        “Dollars” or “$” means the currency of the United States.

 

1.15                        “Dyax Agreement” means that certain Antibody Library License Agreement between Dyax Corp. and Kadmon dated July 22, 2011, as amended.

 

1.16                        “GAAP” means generally accepted accounting principles in the United States, as consistently applied by the relevant Party.

 

1.17                        “Good Clinical Practices” or “GCP” means the then-current good clinical practice standards, practices and procedures adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) set forth in the guideline entitled “Guideline for Good Clinical Practice E6: Consolidated Guidance,” and comparable regulatory standards, practices and procedures as such are updated from time to time.

 

1.18                        “Good Manufacturing Practices” or “GMP” means the then-current good manufacturing practice standards practices and procedures adopted by the ICH set forth in the guideline entitled “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, “ and comparable regulatory standards, practices and procedures as such are updated from time to time.

 

1.19                        “IND” means an investigational new drug application submitted prior to initiating Clinical Trials.

 

1.20                        “Intellectual Property” means Patents and Know-How.

 

1.21                        “Kadmon Patents” means the Patents Controlled by Kadmon as of the Effective Date, which are listed on Exhibit B.

 

1.22                        “Know-How” means any data, results, and information of any type whatsoever, in any tangible or intangible form, including, without limitation, know-how, trade secrets, practices, techniques, methods, processes, inventions, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, clinical and non-clinical study reports, regulatory submission summaries and regulatory submission documents, expertise, technology, test data including pharmacological, biological,

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

chemical, biochemical, toxicological, and clinical test data, analytical and quality control data, stability data, studies and procedures.

 

1.23                        “Law” means all relevant laws, statutes, rules, regulations, guidelines, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign.

 

1.24                        “Licensed Antibodies” means (a) the VEGFR2 and PDL-1 monoclonal antibodies generated by Kadmon, and (b) any and all human monoclonal antibodies developed by Jinghua using the Technology.

 

1.25                        “Manufacture” means activities directed to producing, manufacturing, processing, filling, finishing, packaging, labeling, quality assurance testing and release, shipping and delivery of the Product, including process development in connection with such activities or scale up thereof (in each case, whether for purposes of Development or Commercialization of the Product).  “Manufacturing” shall have the correlative meaning.

 

1.26                        “Net Sales” means mean all amounts invoiced on sales of Products by Jinghua, its Affiliates or sublicensees to Third Parties, less the following deductions actually allowed and taken by such Third Parties and not otherwise recovered by or reimbursed to the seller whose sales are being measured:

 

(a)                                 ***, and ***;

 

(b)                                 *** and *** (including those to *** and ***), and *** to *** on *** of *** or *** or ***;

 

(c)                                  *** and *** including *** and *** to the *** to the *** and set forth *** as such in the ***; and

 

(d)                                 *** and ***, other *** and *** to the *** to the *** and set forth *** as such in the ***.

 

Sales between Jinghua and its Affiliates or sublicensees for resale shall be excluded from the computation of Net Sales.  In any other sale of Products that is made on other than arms’-length terms, the amounts invoiced shall be deemed, for purposes of this definition, no less than the amount that would be invoiced in a substantially contemporaneous, arms’-length transaction.

 

1.27                        “Patent” means any of the following, whether existing now or in the future anywhere in the world:  (a) issued patent; (b) pending patent applications, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals and all patents granted thereon; (c) all patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms,

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

including supplementary protection certificates or the equivalent thereof; (d) inventor’s certificates; and (e) all United States and foreign counterparts of any of the foregoing.

 

1.28                        “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision, department or agency of a government.

 

1.29                        “Phase II Clinical Trial” means a Clinical Trial for the purpose of preliminary evaluation of clinical efficacy and safety, and to determine dosage regimen.

 

1.30                        “Phase III Clinical Trial” means a Clinical Trial designed to establish the safety and efficacy of a product for the purposes of enabling the preparation and submission of applications for Regulatory Approval.  Phase III shall include any other Clinical Trial intended as a pivotal trial for Regulatory Approval purposes whether or not such trial is a traditional Phase III (e.g., a Phase II/III clinical trial).

 

1.31                        “Product” means a product that contains one (1) or more Licensed Antibodies.

 

1.32                        “Regulatory Approval” means the technical, medical and scientific licenses, registrations, authorizations and approvals (including approvals of new drug applications, supplements and amendments, pre- and post-approvals, pricing and reimbursement approvals, and labeling approvals) of the Regulatory Authority necessary for the Development, Manufacture and Commercialization of Product in any country in the Territory.

 

1.33                        “Regulatory Authority” means the CFDA, the TFDA and any other national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in each country of the Territory involved in the granting of Regulatory Approval.

 

1.34                        “Royalty Term” means, on a Product-by-Product and country-by-country basis, on the later of (i) ten(10) years after the first commercial sale of the Product in such country, or (ii) the date on which there is no longer a Valid Claim within the Kadmon Patents that Cover the Licensed Antibody contained in the Product in such country.

 

1.35                        “Sublicense Agreement” means a written agreement between Jinghua and a Third Party pursuant to which Jinghua grants to the Third Party rights granted by Kadmon to Jinghua under this Agreement.

 

1.36                        “Sublicense Revenue” means (a) all upfront payments received by Jinghua pursuant to a Sublicense Agreement; (b) all milestone payments received by Jinghua pursuant to a Sublicense Agreement; and (c) all other payments received by Jinghua pursuant to a Sublicense Agreement.

 

1.37                        “Territory” means Greater China, i.e., the People’s Republic of China, Hong Kong, Macau, and Taiwan.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

1.38                        “TFDA” means the Taiwan Food and Drug Administration and any successor agency thereto.

 

1.39                        “Third Party” means any Person other that Kadmon, Jinghua or any Affiliate of either Party.

 

1.40                        “Valid Claim” means (a) a claim of an issued and unexpired Patent which has not been disclaimed, revoked, held unenforceable or invalid by a decision of a court or other government agency of competent jurisdiction, which decision is not appealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise, and (b) a claim in a pending Patent application that has not been pending for more than seven (7) years from the earliest date from which such application claims priority of or the benefit of the filing date of, and, in any case, which has not been canceled, withdraw from consideration, finally determined to be unallowable by the applicable governmental authority or court for whatever reason (and from which no appeal is or can be taken), or abandoned.

 

ARTICLE 2
 COLLABORATION MANAGEMENT

 

2.1                               Management.  Each of Kadmon and Jinghua will, by notice to the other Party, designate a senior manager as its representative (each, an “Alliance Manager,” and together, the “Alliance Managers”) to be the primary point of contact between the Parties with respect to the collaboration undertaken pursuant to this Agreement.  Each Party may change its Alliance Manager from time to time in its sole discretion, effective upon notice to the other Party of such change.

 

2.2                               Responsibilities.  The Alliance Managers shall be responsible for discussing and coordinating the Parties’ activities under this Agreement and shall, in particular: (a) oversee and manage transfer of Know-How described in this Agreement; (b) oversee and manage transfer of information and data from Clinical Trials; (c) review the Development Plan and discuss the status of activities undertaken for the Development of Products; and (d) review and discuss the status and strategy on the Commercialization of the Product.

 

ARTICLE 3
 LICENSES

 

3.1                               Grants.

 

(a)                                 Licensed Antibodies.

 

(i)                                     Subject to the terms and conditions of this Agreement, Kadmon hereby grants to Jinghua an exclusive license, with the right to grant sublicenses in accordance with Section 3.2, under the Intellectual Property Controlled by Kadmon as of the Effective Date, including the Kadmon Patents, to use, have used, Develop, have Developed, Manufacture, have Manufactured, Commercialize and have Commercialized Products in the Territory.  For the avoidance of doubt, to the extent a Third Party

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

contributed to the Licensed Antibody, no such license shall be granted to the extent (1) Kadmon does not have the right to do so under its  contractual relationship with such Third Party, or (2) if doing so causes Kadmon to incur any payment obligation to any Third Party.

 

(ii)                                  Further, subject to the terms and conditions of this Agreement, Kadmon hereby grants to Jinghua an exclusive license, with the right to grant sublicenses in accordance with Section 3.2 all Know-How arising from the research, discovery and development activities related to the Licensed Antibodies undertaken by or on behalf of Kadmon during the term of this Agreement, which Know-How is incorporated into any Product or useful for the making of a Product.

 

(iii)                               Kadmon shall assign to Jinghua all Patents in the Territory arising from the research, discovery and development activities relating to the Licensed Antibodies undertaken by or on behalf of Kadmon during the term of this Agreement (the “Kadmon Assigned Patents”), using the form of patent assignment attached hereto as Exhibit C.

 

(b)                                 Technology.  Subject to the terms and conditions of this Agreement, Kadmon hereby grants Jinghua a non-exclusive license, without the right to grant sublicenses, under Intellectual Property Controlled by Kadmon to use the Technology to research and discover Licensed Antibodies.  For the avoidance of doubt, to the extent a Third Party contributed to the Technology, no such license shall be granted to the extent (i) Kadmon does not have the right to do so under its contractual relationship with such Third Party, or (ii) if doing so causes Kadmon to incur any payment obligation to any Third Party.

 

(c)                                  Grant Back.  Subject to the terms and conditions of this Agreement, Jinghua hereby grants to Kadmon a fully paid-up, royalty-free, perpetual, exclusive license, with the right to grant sublicenses through multiple tiers, to (i) antibodies discovered by Jinghua as a result of its use of the Technology, (ii) Intellectual Property in such discovered antibodies Controlled by Jinghua, and (iii) all Antibody Intellectual Property, to use, develop, have developed, make, have made, use, have used, import, sell, and offer for sale in all countries outside the Territory:

 

3.2                               Sublicenses.  Jinghua may grant sublicenses under the rights granted to it in Section 3.1(a); provided, however, that (a) each such Sublicense Agreement is consistent with the terms and conditions of this Agreement, including provisions that provide for intellectual property ownership, records and audit rights, indemnification and confidentiality consistent with this Agreement; (b) at least *** days prior to execution of a proposed Sublicense Agreement, Jinghua shall provide to Kadmon a complete copy of such proposed Sublicense Agreement for Kadmon’s review and approval, which approval shall not be unreasonably withheld, and within *** days after it becomes effective, a complete copy of the fully executed Sublicense Agreement; and (c) Jinghua shall

 

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remain liable for any breach of any provisions of this Agreement caused by such sublicensee.

 

3.3                               No Implied Rights.  Jinghua and Kadmon acknowledge that the rights and licensed granted under this Article 3 are limited to the scope expressly granted,  Accordingly, except for the rights expressly granted under this Article 3, no right, title or interest under any Intellectual Property of Kadmon or its Affiliates, of any nature whatsoever, is granted whether by implication, estoppel, reliance or otherwise, by Kadmon to Jinghua.  All rights with respect to the Technology that are not specifically granted herein are reserved to Kadmon.

 

3.4                               Technology Transfer.  Within *** days after the Effective Date or as otherwise agreed upon by the Alliance Managers, Kadmon shall use diligent efforts to transfer to Jinghua all Know-How necessary for Jinghua to use the Technology pursuant to the rights granted under Section 3.1(b).

 

ARTICLE 4
 DEVELOPMENT

 

4.1                               Efforts; Development Plan.  Jinghua shall use Commercially Reasonable Efforts to Develop the Products in the Territory.  Such Development shall be consistent with the Development Plan.  Within *** days after the Effective Date, Jinghua shall deliver to Kadmon for its review a copy of the initial Development Plan.  Jinghua shall submit an updated Development Plan to Kadmon no less than annually for Kadmon’s review.  In addition, Jinghua will meet the diligence milestones shown in Exhibit A, and notify Kadmon in writing as each milestone is met.  The efforts of Affiliates and Sublicensees shall be treated as the efforts of Jinghua when evaluating Jinghua’s compliance with the foregoing diligence obligations.  Each Development Plan will include the following information, to the extent such information is available at the time such Development Plan is proposed:

 

(a)                                 Proposed overall plan and strategy for Development of Products to support Regulatory Approval in the Territory;

 

(b)                                 Scope and target timelines for performance of all Development studies, including Clinical Trial protocols, Product stability studies, enrollment numbers and submission dates;

 

(c)                                  Estimated dates of meetings with Regulatory Authorities for the Product; and

 

(d)                                 Estimated timing of Regulatory Approval for each Product.

 

4.2                               Clinical Trials.

 

(a)                                 Jinghua shall sponsor and conduct or have conducted, in compliance with GCP, all necessary Clinical Trials in support of seeking and maintaining Regulatory Approval of the Products in the Territory, including post-marketing studies after receipt of Regulatory Approval.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

(b)                                 Jinghua shall, upon completion of each Clinical Trial (i.e., database lock), promptly provide to Kadmon, as requested by Kadmon and at no cost or expense to Kadmon, access to and copies of Clinical Trial information and data.

 

4.3                               Regulatory Activities.  Jinghua shall prepare and file all documentation and materials to obtain and maintain Regulatory Approvals that are necessary for the Development and Commercialization of the Products in the Territory and otherwise interact with Regulatory Authorities as appropriate with respect to the Product.

 

4.4                               Right to Reference.  Jinghua hereby grants to Kadmon a royalty-free, exclusive, perpetual right and license to use and reference outside the Territory (a) all toxicology and safety information, (b) Clinical Trial information and data, and (c) materials submitted to Regulatory Authorities in the Territory, which are created or obtained by Jinghua concerning the Licensed Antibodies and the Products, including in connection with efforts by Jinghua, its Affiliates or any sublicensees.  At the request of Kadmon and at no cost or expense to Kadmon, except as set forth in Section 4.5, Jinghua shall promptly provide access to and copies of all such information, data and materials.

 

4.5                               Development Costs.  Jinghua shall be solely responsible for, and shall pay, all Development costs, including registration fees, incurred by it with respect to its Development of Products in the Territory.  In the event that Kadmon utilizes toxicology data that forms a part of the Antibody Intellectual Property, Kadmon will reimburse Jinghua an amount equal to ***% of the actual costs incurred by Jinghua in connection with the studies that produced the toxicology data.

 

ARTICLE 5
 COMMERCIALIZATION

 

Jinghua shall, at its own cost, promote, market, sell, obtain any necessary pricing and reimbursement approval, and otherwise Commercialize the Product in the Territory.  Jinghua shall use Commercially Reasonable Efforts to Commercialize the Product in the Territory in a timely manner after receipt of Regulatory Approval.

 

ARTICLE 6
 MANUFACTURING AND SUPPLY

 

6.1                               In the Territory.  Jinghua shall be solely responsible for Manufacturing of Licensed Antibodies and Product as necessary for the Development activities undertaken by Jinghua and Commercialization of such Products in the Territory.

 

6.2                               Outside the Territory.

 

(a)                                 As requested by Kadmon, Jinghua shall supply Licensed Antibodies to Kadmon, its Affiliates or licensees, for non-commercial purposes, i.e., for pre-clinical and clinical through Phase II Clinical Trials.  Such supply shall be pursuant to written orders submitted by Kadmon that specify the Licensed Antibody, quantity, delivery address and other elements necessary to ensure timely deliver.  The Licensed Antibodies shall be supplied by Jinghua at a transfer price equal to ***

 

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***% of Jinghua’s entire manufacturing costs based on GAAP.  All payments for Licensed Antibody shall be paid by Kadmon within thirty (30) days after receipt of the ordered Licensed Antibodies and invoice.  Payments shall be made by Kadmon in accordance with Section 7.6.

 

(b)                                 Upon request of Kadmon, Jinghua agrees to negotiate a definitive supply agreement on commercially reasonable terms for the supply of Licensed Antibodies to Kadmon, its Affiliates or licensees, for Phase III Clinical Trials and commercial purposes.

 

ARTICLE 7
 CONSIDERATION AND PAYMENTS

 

7.1                               Equity Investment.  In partial consideration for the rights granted under this Agreement, Jinghua or its Affiliate shall subscribe to Units of Class I Preferred Membership Units, Series E-1 (“Units”), of Kadmon Holdings, LLC at Eleven Dollars and Fifty Cents ($11.50) per Unit for an aggregate purchase price of Ten Million Dollars ($10,000,000) pursuant to the terms and conditions of a Subscription Agreement to be entered into between Kadmon Holdings, LLC and Jinghua as of the Effective Date.

 

7.2                               Collaboration Fee.  In partial consideration of the rights granted under this Agreement, Jinghua shall pay to Kadmon ($***) for each Licensed Antibody generated by Kadmon (i.e., VEGFR2 and PDL-1), payable as follows:

 

	
Event
    	
 
    	
Payment Amount
    	
 
    
	
(a) *** of the   *** from *** to ***
    	
 
    	
$
    	
***
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
(b) *** from the   ***
    	
 
    	
$
    	
***
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
(c) *** of the   ***
    	
 
    	
$
    	
***
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
(d) *** of the   ***
    	
 
    	
$
    	
***
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
(e) *** of the   first *** from the ***
    	
 
    	
 
    	
***
    	
 
    

 

The occurrence of each event shall be reasonably determined by Kadmon.  For the avoidance of doubt, the total collaboration fees payable by Kadmon under this Agreement shall not exceed Forty Million Dollars ($40,000,000).

 

7.3                               Royalties.  In partial consideration of the rights granted under this Agreement, Jinghua shall pay royalties during the Royalty Term to Kadmon as follows:

 

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(a)                                 *** of Net Sales of each Product in the Territory to Kadmon; and

 

(b)                                 *** of Net Sales of each Product in the Territory to Dyax Corp.

 

7.4                               Sharing of Sublicense Revenue.  In addition to the amounts payable pursuant to Sections 7.2 and 7.3, Jinghua agrees to pay Kadmon a percentage of Sublicense Revenue.  Such percentage shall be determined based on the development stage of the Product at the time the particular Sublicense Agreement is executed by the parties thereto, as follows:

 

	
Development Stage at Time of Sublicense Agreement
   Execution
    	
 
    	
Share of Sublicense
   Revenue
    
	
*** to *** of   the *** in a *** for the ***
    	
 
    	
***
    
	
 
    	
 
    	
 
    
	
*** to *** for   *** the ***
    	
 
    	
***
    
	
 
    	
 
    	
 
    
	
*** of the ***
    	
 
    	
***
    

 

7.5                               Reports and Payments.

 

(a)                                 Collaboration Fee.  Jinghua shall promptly notify Kadmon of the achievement of any of the events achieved in accordance with Section 7.2.  All collaboration fees shall be due within *** days after achievement of the applicable event and are non-refundable and non-creditable against any other payments due hereunder.

 

(b)                                 Royalties.  Within *** days after the end of each quarter, Jinghua shall deliver to Kadmon a report setting forth for such quarter the following information:  (i) the gross sales amount for each Product; (ii) the net Sales for the Product, including each deduction taken from gross sales to arrive at such Net Sales; (iii) the royalty amount due hereunder for the sale of each Product.  No such reports shall be due for ay Product before the first commercial sale of the Product.  The total royalty due for the sale of the Product during such quarter shall be remitted no later than *** days after the end of each such quarter in conjunction with the submission of the report.

 

(c)                                  Sublicense Revenue.  Any fees owed under Section 7.4 shall be paid, with respect to particular Sublicense Revenue received by Jinghua, within *** days after Jinghua’s receipt of the applicable Sublicense Revenue.

 

7.6                               Payment Method.   Payments made under this Agreement shall be paid by wire transfer or electronic funds transfer in immediately available funds to a bank account designed by Kadmon at least *** days in advance of such payment.  Regardless of the amounts of any royalties or other payments due under this agreement or any other agreement between the Parties of their Affiliates, all amounts payable under this Agreement shall be paid in full.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

7.7                               Currency.  All amounts payable and calculations hereunder shall be in Dollars.  Conversion of sales recorded in local currencies to Dollars will be performed in a manner consistent with Jinghua’s normal practices used to prepare its financial statements and consistent with GAAP.

 

7.8                               Taxes and Withholding.  All payments due from Jinghua to Kadmon under this Agreement will be made without any deduction or withholding for or on account of any tax unless such deduction or withholding is required by applicable Law to be assessed against Kadmon.  If Jinghua is so required to deduct or withhold, Jinghua will (a) promptly notify Kadmon of such requirement, (b) pay to the relevant authorities the full amount required to be deducted or withheld promptly upon the earlier of determining that such deduction or withholding is required or receiving notice that such amount has been assessed against Kadmon; (c) promptly forwarding to Kadmon an official receipt (or certified copy) of other documentation reasonably acceptable to Kadmon evidencing such payment to such authorities, and (d) otherwise reasonably cooperate with Kadmon in connection with Kadmon’s attempts to obtain favorable tax treatment and credit therefor (where appropriate) in accordance with applicable Law.

 

7.9                               Interest on Past Due Amounts.  Any payments or portions thereof due from Jinghua hereunder that are not paid on or before the date such payment is due shall bear interest, to the extent permitted by applicable Law, at the average one-month London Inter-Bank Offering Rate (LIBOR) for the Dollar as reported from time to time in The Wall Street Journal, plus ***, effective for the first date on which payment was delinquent and calculated on the number of days such payment is overdue or, if such rate is not regularly published, as published in such source as the Parties agree.

 

7.10                        Maintenance of Records.  Jinghua shall keep accurate books and accounts of record in connection with the sale of Product and the calculation of payments to be made under this agreement in sufficient detail to permit accurate determination of all figures necessary for verification of royalties and other payments to be paid from Jinghua to Kadmon under this Agreement.  Jinghua shall maintain all such records for a period of at least seven (7) year after the end of the fiscal year in which they were generated.

 

7.11                        Audits.  Kadmon shall have the right, at its own expense and no more than once per year (except for cause), to have an independent, certified public accountant, selected by Kadmon and reasonably acceptable to Jinghua, review all records maintained in accordance with Section 7.10 upon reasonable notice and during regular business hours and under obligations of strict confidence, for the sole purpose of verifying the basis and accuracy of payments required and made under this Agreement within the prior *** month period.  No quarter may be audited more than one time.  Jinghua shall receive a copy of each audit report promptly from Kadmon.  Should the inspection lead to the discovery of a discrepancy to Kadmon’s detriment, Jinghua shall pay the amount of the discrepancy in Kadmon’s favor plus interest accrued, compounded semi-annually from the day the relevant payment(s) were due, within *** days after being notified thereof.  Kadmon shall pay the full cost of the inspection unless the discrepancy is greater than ***, in which case Jinghua shall pay to Kadmon the actual cost charged by such accountant for such inspection.  If such audit shows a discrepancy in

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Jinghua’s favor, then Jinghua may credit the amount of such discrepancy against subsequent amounts owed to Kadmon, or if no further amounts are owed under this Agreement, then Kadmon shall pay Jinghua the amount of the discrepancy without interest within *** days after being notified thereof.

 

ARTICLE 8
 INTELLECTUAL PROPERTY

 

8.1                               Ownership of Antibody Intellectual Property.  Rights to the Antibody Intellectual Property, whether or not patentable, shall be owned by Jinghua.

 

8.2                               Maintenance of Kadmon Assigned Patents.  Jinghua shall have the first right, but not the obligation, to undertake (at Jinghua’s sole cost) the preparation, prosecution and maintenance of the Kadmon Assigned Patents in the Territory. In the event and to the extent Jinghua elects not to prosecute and maintain such Kadmon Assigned Patents, including allowing any such Kadmon Assigned Patents to lapse or become abandoned or unenforceable, then Jinghua shall promptly notify Kadmon, which notice shall be at least *** days prior to the lapse or abandonment of such Kadmon Assigned Patents.  Thereafter, Kadmon may, but is not required to, undertake, at its sole expense and in its sole discretion, the prosecution and maintenance of such Kadmon Assigned Patents.  For the avoidance of doubt, all such Kadmon Assigned Patents in the Territory shall be in Jinghua’s name.

 

8.3                               Enforcement; Patent Challenge.  Subject to the provisions of this Section 8.3, in the event that a Party reasonably believes that any Kadmon Patent or Kadmon Assigned Patent is being infringed by a Third Party or is subject to a declaratory judgment action arising from such infringement (“Declaratory Judgment”) or becomes aware of any actual or threatened challenge by a Third Party with respect to the scope, validity or enforceability of any such Kadmon Patent or Kadmon Assigned Patent in the Territory (“Third Party Challenge”), such Party shall promptly notify the other Party.  In such event, Jinghua shall have the sole right (but not the obligation) to enforce such Kadmon Patent or Kadmon Assigned Patent with respect to such infringement, to defend any such Declaratory Judgment or Third Party Challenge (an “Enforcement Action”), at Jinghua’s expense and using Commercially Reasonable Efforts.  Kadmon shall have the right to join any such Enforcement Action at its own expense.  If Jinghua does not bring an Enforcement Action within ninety (90) days after notification after the Declaratory Judgment or Third Party Challenge, then Kadmon shall have the right to initiate an Enforcement Action against the Third Party.  In such event, Kadmon shall bear all costs and expenses with respect to any such Enforcement Action.

 

8.4                               Defense of Infringement Claims.  If the Product becomes the subject of a Third Party’s claim or assertion of infringement of a Patent relating to Development, Manufacture or Commercialization of the Product in the Territory (each, an “Infringement Claim”), the Party first having notice of the claim or assertion shall promptly notify the other Party, and the Parties shall promptly confer to consider the claim or assertion and the appropriate course of action.  Unless the Parties otherwise agree in writing, Jinghua shall have the right to defend any Infringement Claim using Commercially Reasonable Efforts,

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

and shall keep Kadmon reasonably informed with respect to the progress of any such litigation.  Jinghua shall not enter into any settlement of any Infringement Claim that adversely affects Kadmon’s rights and interests without Kadmon’s written consent, which consent shall not be unreasonably conditioned, withheld or delayed.

 

ARTICLE 9
 CONFIDENTIALITY

 

9.1                               Confidentiality Obligations.  Each Party receiving Confidential Information hereunder (a “Receiving Party”) will maintain in confidence and not disclose to any Third Party any Confidential Information of the other Party except to the extent expressly authorized by this Agreement or otherwise agreed by the Parties in writing.

 

9.2                               Exceptions.  Notwithstanding the foregoing, Confidential Information shall not be deemed to include information or materials to the extent that it can be established by written documentation by the Receiving Party that such information or material:

 

(a)                                 was already known to or possessed by the Receiving Party, other than under an obligation of confidentiality (except to the extent such obligation has expired or an exception is applicable under the relevant agreement pursuant to which such obligation established), at the time of disclosure;

 

(b)                                 was generally available to the public or otherwise part of the public domain at the time of its first disclosure to the Receiving Party;

 

(c)                                  became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the Receiving Party in breach of this Agreement;

 

(d)                                 was independently developed by the Receiving Party as demonstrated by documented evidence prepared contemporaneously with such independent development; or

 

(e)                                  was disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the disclosing Party not to disclose such information to others.

 

9.3                               Authorized Use and Disclosure.  Each Party may use and disclose Confidential Information of the other Party as follows:

 

(a)                                 under appropriate confidentiality provisions substantially equivalent to those in this Agreement, in connection with the performance of its obligations or exercise of rights granted to such Party in this Agreement; and

 

(b)                                 to the extent such disclosure is reasonably necessary in (i) prosecuting and maintaining Patents, copyrights and trademarks (including applications therefor) in accordance with this Agreement, (ii) prosecuting or defending litigation, (iii) conducting Development hereunder, including obtaining and maintaining

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Regulatory Approvals, or (iv) complying with applicable Law, court orders, governmental regulations, or the rules of a recognized stock exchange or automated quotation system applicable to such Party; provided, however, that if a Receiving Party is required pursuant to clause (iv) to make any such disclosure of the other Party’s Confidential Information it will, except where impracticable (for  example, in the event of medical emergency), give reasonable advance notice to the other Party of such disclosure requirement and, except to the extent inappropriate in the case of Patent applications, will use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed.

 

9.4                               Public Announcements.  Except as otherwise mutually agreed by the Parties or as required by applicable Law or the rules of any stock exchange, no Party shall issue or cause the publication of any other press release or public announcement with respect to the transactions contemplated by this Agreement without the express prior approval of the other Parties, which approval shall not be unreasonably withheld or delayed; provided, however, that each Party may make any public statement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst calls, or issue press releases, so long as any such public statement or press release is not inconsistent with prior public disclosures or public statements approved by the Parties pursuant to this Section 9.4 and which do not reveal non-public information about the other Party.

 

ARTICLE 10
 TERM AND TERMINATION

 

10.1                        Term.  This Agreement is effective as of the Effective Date and, unless earlier terminated to the provisions set forth in Section 10.2, shall continue in full force and effect until the date of expiration of the last to expire Royalty Term.

 

10.2                        Termination.

 

(a)                                 Breach.  If either Party is in material breach of any provision of this Agreement and such breach is not cured within *** days after receiving written notice from the other Party with respect to such breach detailing the alleged breach and stating explicitly that the writing is a notice under this Section 10.2(a), the non-breaching Party shall have the right to terminate this Agreement by giving written notice to the Party in breach.  Termination under this Section 10.2(a), if disputed by the non-terminating Party, shall not be effective until the dispute or contest is resolved under Article 13, and then only if the arbitrator finds that the termination is proper.

 

(b)                                 Insolvency; Rights under Bankruptcy Code.  Either Party may immediately terminate this Agreement on written notice in the event any of the following occurs with respect to the other Party (the “Bankrupt Party”):  (i) such Bankrupt Party files a petition in bankruptcy or makes a general assignment for the benefit of creditors or otherwise acknowledges in writing insolvency, or is adjudged

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

bankrupt, and such Bankrupt Party (1) fails to assume this Agreement in any such bankruptcy proceeding within *** days after filing or (2) assumes and assigns this Agreement to a Third Party; (ii) such Bankrupt Party goes into or is placed in a process of complete liquidation; (iii) a trustee or receiver is appointed for any substantial portion of such Bankrupt Party’s business and such trustee or receiver  is not discharged within *** days after appointment; (iv) any case or proceeding shall have been commenced or other action taken against such Bankrupt Party in bankruptcy or seeking liquidation, reorganization, dissolution, a winding-up arrangement, composition or readjustment of its debts or any other relief under any bankruptcy, insolvency, reorganization or similar act or law of any jurisdiction now or hereafter in effect and is not dismissed or converted into a voluntary proceeding within *** days after filing; or (v) there shall have been issued a warrant of attachment, execution, distraint or similar process against any substantial part of the property of such Bankrupt Party and such event shall have continued for a period of *** days and none of the following has occurred: (1) it is dismissed, (2) it is bonded in a manner reasonably satisfactory to the other Party, or (3) it is discharged.  All rights and licenses granted under or pursuant to this Agreement by Kadmon and Jinghua are, and shall be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code.  The Parties agree that the Parties, as licensees of such rights under this Agreement, shall retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code.  The Parties further agree that, in the event that Kadmon is the Bankrupt Party, then Jinghua shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, and the same, if not already in Jinghua’s possession, shall be promptly delivered to Jinghua upon any such commencement of a bankruptcy proceeding upon its written request therefor.  The foregoing sentence shall apply mutatis mutandis to allow Kadmon to receive duplicates, access and the like in the same manner, if Jinghua is the Bankrupt Party.

 

10.3                        Effects of Expiration or Termination.

 

(a)                                 Expiration or termination of this Agreement for any reasons shall not release any Party of any obligation or liability which, at the time of such expiration or termination, has already accrued or which is attributable to a period prior to such expiration or termination.

 

(b)                                 Upon expiration of the Royalty Term with respect to a Product and payment in full of all amounts owned under this Agreement with respect to such Product, Jinghua shall have a fully paid-up, royalty-free, non-exclusive licensed under the Know-How Controlled by Kadmon to Develop, Manufacture and Commercialize such Product in the Territory.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

(c)                                  Notwithstanding anything herein to the contrary, termination of this Agreement by a Party shall be without prejudice to other remedies such Party may have at law or equity.

 

(d)                                 The following provisions shall survive expiration or termination of this Agreement and continue to be enforceable:  Article 1 (Definitions), Article 9 (Confidentiality) for the period set forth therein, Article 12 (Indemnification, Liability and Insurance), Article 13 (Dispute Resolution), and Article 14 (General Provisions), and Section 3.1(c) (Grant Back), 4.4 (Right to Reference), Section 7.9 (Interest on Past Due Amounts), Section 7.10 (Maintenance of Records) for the period set forth therein, Section 7.11 (Audits) for the period set forth therein, and Section 10.3 (Effects of Expiration or Termination).

 

ARTICLE 11
 REPRESENTATIONS AND WARRANTIES

 

11.1                        General Representations and Warranties.  Each Party represents and warrants to the other that:

 

(a)                                 it is duly organized and validly existing under the Laws of the jurisdiction of its incorporation or continuance, as the case may be, and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;

 

(b)                                 it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the individual executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate action;

 

(c)                                  this Agreement is legally binding upon it and enforceable in accordance with its terms;

 

(d)                                 the execution, delivery and performance of this Agreement by it does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material applicable Law;

 

(e)                                  it has not granted, and shall not grant during the Term, any right to any Third Party which would conflict with the rights granted to the other Party hereunder;

 

(f)                                   it is not aware of any action, suit or inquiry or investigation instituted by any Person which questions or threatens the validity of this Agreement; and

 

(g)                                  no consent or approval from any Third Party (including any governmental or administrative body or court) is necessary to consummate this Agreement, grant the rights and licenses contemplated to be granted by it to the other Party, or to its knowledge, to conduct the activities contemplated hereunder.

 

11.2                        Representations, Warranties and Covenants of Kadmon.  Kadmon hereby represents and warrants to Jinghua, as of the Effective Date:

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

(a)                                 the total royalty obligation to Dyax Corp. on the Licensed Antibodies, if any, under the Dyax Agreement is ***% of Net Sales; and

 

(b)                                 it has the full legal rights and authority to grant the licenses and rights granted to Jinghua under this Agreement.

 

11.3                        Representations, Warranties and Covenants of Jinghua.  Jinghua hereby represents, warrants and covenants to Kadmon:

 

(a)                                 it shall, at its sole cost and expense, obtain and maintain in full force and effect during the term of this Agreement, all necessary licenses, permits and other authorizations required by applicable Law in order to carry out its duties and obligations hereunder;

 

(b)                                 it shall, at all times, conduct its activities under this Agreement in accordance with applicable Law and accepted pharmaceutical industry business practices, including GCP and GMP, as applicable; and

 

(c)                                  without limiting the generality of Section 11.3(b), (i) it has been at all times and will continue to be in compliance with all potentially applicable anti-bribery and anti-corruption laws, including the U.S. Foreign Corrupt Practices Act of 1977, and (ii) it represents, warrants and agrees that no bribes, payments, kickbacks, gifts, hospitality, donations, loans, or anything of value have been or will be made or received, offered, promised, or authorized, directly or indirectly, to improperly influence any act or decision of any person or entity, induce any person or entity to do or omit to do any act in violation of any person’s or entities’ lawful duties, or secure any improper advantage.

 

11.4                        Disclaimer.  EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING TO ANY WARRANTY OF ACCURACY, COMPLETENESS, PERFORMANCE, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, COMMERCIAL UTILITY, NON INFRINGEMENT OR TITLE IS MADE OR GIVEN BY OR ON BEHALF OF A PARTY.  EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

 

ARTICLE 12
 INDEMNIFICATION, LIABILITY AND INSURANCE

 

12.1                        Indemnification by Jinghua.  Jinghua shall defend and indemnify Kadmon and its Affiliates, and their respective directors, officers, employees, representatives, agents and counsel, and the successors and assigns of the foregoing (the “Kadmon Indemnitees”), from and against any and all liabilities, damages, losses, costs or expenses (including reasonable attorneys’ and professional fees and other expenses of litigation and/or arbitration) (collectively, “Losses”) in connection with any and all claims, suits or proceedings brought by a Third Party against a Kadmon Indemnitee, arising from or

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

occurring as a result of: (a) the Development, Manufacture or Commercialization of the Products conducted by Jinghua, its Affiliates or sublicensees, (b) Jinghua’s breach of any of its representations, warranties or covenants under this Agreement, (c) any claim of product liability or damage to person or property or death resulting from the use or consumption of a Product, or (d) the negligence or willful misconduct of Jinghua, its  Affiliates or sublicensees, in each case, except to the extent that Kadmon is obligated to indemnify Jinghua under Section 12.2.

 

12.2                        Indemnification by Kadmon.  Kadmon shall defend and indemnify Jinghua and its Affiliates and their respective directors, officers, employees, representatives, agents and counsel and the successors and assigns of the foregoing (the “Jinghua Indemnitees”), from and against any and all Losses in connection with any and all claims, suits or proceedings brought by a Third Party against a Jinghua Indemnitee, arising from or occurring as a result of: (a) Kadmon’s breach of any of its representations, warranties or covenants under this Agreement, or (b) the negligence or willful misconduct of Kadmon, except, in each case, to the extent that Jinghua is obligated to indemnify Kadmon under Section 12.1.

 

12.3                        Indemnification Procedures.  The obligations to indemnify, defend, and hold harmless set forth in Sections 12.1 and 12.2 shall be contingent upon the Party seeking indemnification (the “Indemnitee”): (a) promptly notifying the indemnifying Party of any Losses or discovery of fact upon which such Indemnitee intends to base a request for indemnification within ten (10) days of receipt of same; provided, however, that Indemnitee’s failure or delay in providing such notice shall not relieve the indemnifying Party of its indemnification obligation except to the extent the indemnifying Party is prejudiced thereby; (b) allowing the indemnifying Party and/or its insurers the right to assume direction and control of the defense of any such claim, demand or suit; (c) using its best efforts to cooperate with the indemnifying Party and/or its insurers, at the indemnifying Party’s expense, in the defense of such claim, demand or suit; and (d) agreeing not to settle or compromise any claim, demand or suit without prior written authorization of the indemnifying Party.  The Indemnitee shall have the right to participate in the defense of any such claim, demand or suit referred to in this Section utilizing attorneys of its choice, at its own expense, provided, however, that the indemnifying Party shall have full authority and control to handle any such claim, demand or suit.

 

12.4                        Limitation on Liability.  NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE IN LAW, EQUITY, CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OR LOSS OF PROFITS OR OPPORTUNITIES OR DIMINUTION OF GOODWILL SUFFERED BY THE OTHER PARTY OR ANY OF ITS AFFILIATES, EXCEPT TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS A RESULT OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS ARTICLE 12.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

12.5                        Insurance.  Each Party shall have and maintain such types and amounts of liability insurance as is normal and customary in the industry generally for parties similarly situated and shall upon request provide the other Party with a copy of its policies of insurance in that regard, along with any amendments and revisions thereto.

 

ARTICLE 13
 DISPUTE RESOLUTION

 

13.1                        General.  Any controversy, claim or dispute arising out of or relating to this Agreement shall be settled, if possible, through good faith negotiations between the Parties.  If, however, the Parties are unable to settle such dispute after good faith negotiations, the matter shall be referred to an executive officer of each Party to be resolved by negotiation in good faith as soon as is practicable but in no event later than thirty (30) days after referral.

 

13.2                        Failure of Executive Officers to Resolve Dispute.  If the executive officers are unable to settle the dispute after good faith negotiation, the matter (a) shall be resolved in accordance with Section 13.3, and (b) either Party may seek injunctive or other equitable relief in any court in any jurisdiction where appropriate.

 

13.3                        Binding Arbitration.

 

(a)                                 Matters under Section 13.2 which are to be resolved through binding arbitration shall be resolved through binding arbitration in New York, New York, administered by the International Chamber of Commerce (“ICC”) pursuant to the arbitration rules of the ICC then in effect (the “Rules”).

 

(b)                                 There shall be one (1) arbitrator; provided that if either Party requests, the arbitration shall be conducted by a panel of three (3) arbitrators.  Each arbitrator shall have experience in the pharmaceutical business.  In the case of a sole arbitrator, the Parties shall attempt jointly to select such arbitrator within thirty (30) days after notice of arbitration is given.  If the Parties cannot reach an agreement regarding the sole arbitrator within that time, ICC shall appoint the sole arbitrator.  In the case of three (3) arbitrators, each Party shall appoint one (1) arbitrator meeting the foregoing criteria by written notice to the other Party and the two Party-appointed arbitrators shall select the third arbitrator within thirty (30) days of their appointment.  If the Party-appointed arbitrators are unable to agree upon the third arbitrator or if either Party fails to appoint a Party-appointed arbitrator within thirty (30) days after notice of arbitration is given, the remaining arbitrator(s) shall be appointed by ICC.

 

(c)                                  The language of the arbitration (including all evidence and submissions) shall be in English.

 

(d)                                 Judgment upon the opinion rendered by such arbitrators shall be binding on the Parties and may be entered by any court having jurisdiction thereof.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

(e)                                  The written decision of the arbitrators shall state the panel’s findings of material facts and the grounds for its conclusions and shall be final, conclusive and binding on the Parties and enforceable by any court of competent jurisdiction.  The arbitrators shall be required to comply with, and their award shall be limited by, any express provisions of this Agreement relating to damages or the limitation thereof.

 

(f)                                   Each Party shall bear its own costs and expenses (including legal fees and expenses) relating to the arbitration proceeding, except that the fees of the arbitrators and other related costs of the arbitration shall be shared equally by the Parties, unless the arbitration panel determines that a Party has incurred unreasonable expenses due to vexatious or bad faith positions taken by the other Party, in which event the arbitration panel may make an award of all or any portion of such expenses so incurred.

 

13.4                        No Jury Trial.  THE PARTIES EXPRESSLY WAIVE AND FOREGO ANY RIGHT TO TRIAL BY JURY.

 

ARTICLE 14
 GENERAL PROVISIONS

 

14.1                        Governing Law.  This Agreement and any non-contractual obligations arising out of or in connection with it shall be governed by and interpreted in accordance with the laws of the State of Delaware without regard to conflict of law principles thereof

 

14.2                        Assignment.

 

(a)                                 This Agreement and its rights or obligations may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed.

 

(b)                                 Notwithstanding Section 14.2(a), either Party may, without the consent of the other Party, assign this Agreement or any of its rights or obligations (i) to any Affiliate, or (ii) in connection with (1) the sale of all or substantially all of such Party’s tangible and intangible assets or business relating to this Agreement; or (2) the merger, consolidation, sale of substantially all of such Party’s assets or similar transaction or series of transactions, as a result of which such Party’s shareholders before such transaction or series of transactions own less than fifty percent (50%) of the total number of voting securities of the surviving entity immediately after such transaction or series of transactions; provided, however, that such Party’s rights and obligations under this Agreement shall be assumed in writing by its successor in interest in any such transaction and shall not be transferred separate from all or substantially all of its other business assets, including those business assets that are the subject of this Agreement.

 

(c)                                  Any permitted assignee will assume all obligations of its assignor under this Agreement.  Any attempted assignment in contravention of this Section 14.2 will be null and void. Subject to the terms of this Agreement, this Agreement will be

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. Any permitted assignment will not relieve either Party of responsibility for performance of any obligation of either Party that has accrued at the time of the assignment.

 

14.3                        Further Actions.  Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of the Agreement.

 

14.4                        Force Majeure.  Except with respect to payment of money, no Party shall be liable to the other Party for failure or delay in the performance of any of its obligations under this Agreement for the time and to the extent such failure or delay is caused by earthquake, riot, civil commotion, war, terrorist acts, strike, flood, or governmental acts or restriction, or other cause that is beyond the reasonable control of the respective Party (“Force Majeure”).  The Party affected by such Force Majeure will provide the other Party with full particulars thereof as soon as it becomes aware of the same (including its best estimate of the likely extent and duration of the interference with its activities), and will use Commercially Reasonable Efforts to overcome the difficulties created thereby and to resume performance of its obligations as soon as practicable.  If the performance of any such obligation under this Agreement is delayed owing to an event of Force Majeure for any continuous period of more than ninety (90) days, the Parties will consult with respect to an equitable solution.

 

14.5                        Notices.  Any notice, request, delivery, approval or consent required or permitted to be given under this Agreement shall be in writing and shall be deemed to have been sufficiently given if delivered in person or by express courier service (signature required) or five (5) days after it was sent by registered letter, return receipt requested (or its equivalent), provided that no postal strike or other disruption is then in effect or comes into effect within two (2) days after such mailing, to the Party to which it is directed at its address shown below or such other address as such Party will have last given by notice to the other Party.

 

If to Kadmon:                  Kadmon Corporation, LLC
 450 East 29th Street
 New York, NY 10016
 U.S.A.
 Attn: President and Chief Executive Officer

 

With a copy to:

 

Kadmon Corporation, LLC
 450 East 29th Street
 New York, NY 10016
 U.S.A.
 Attn: Office of General Counsel

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

If to Jinghua:                        Jinghua Pharmaceutical Group Co., Ltd
 9 Xingtai Road
 Gangzha Economic Development Zone
 Nantong, Jiangsu, 226005
 China
 Attn:

 

14.6                        Interpretation.  In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption shall exist or be implied against the Party which drafted such terms and provisions.

 

14.7                        Entire Agreement; Amendment.  This Agreement, together with all attached Exhibits, contain the entire agreement between the Parties with respect to the Technology, Licensed Antibodies and Products, and supersedes all prior and contemporaneous discussions, agreements and writings in respect thereto.  No amendment, modification or supplement of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized representative of each Party.

 

14.8                        Waiver.  No provision of the Agreement shall be waived by any act, omission or knowledge of a Party or its agents or employees except by an instrument in writing expressly waiving such provision and signed by a duly authorized officer of the waiving Party.  The waiver by a Party of any breach of any provision hereof by the other Party shall not be construed to be a waiver of any succeeding breach of such provision or a waiver of the provision itself.

 

14.9                        Severability.  If any clause or portion thereof in this Agreement is for any reason held to be invalid, illegal or unenforceable, the same shall not affect any other portion of this Agreement, as it is the intent of the Parties that this Agreement shall be construed in such fashion as to maintain its existence, validity and enforceability to the greatest extent possible.  In any such event, this Agreement shall be construed as if such clause of portion thereof had never been contained in this Agreement, and there shall be deemed substituted therefor such provision as will most nearly carry out the intent of the Parties as expressed in this Agreement to the fullest extent permitted by applicable Law.

 

14.10                 Headings; Rules of Construction.  The captions and headings to this Agreement are for convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement.  Unless specified to the contrary, references to Articles, Sections or Exhibits shall refer to the particular Articles, Sections or Exhibits of or to this Agreement and references to this Agreement include all Exhibits hereto.  Unless context otherwise clearly requires, whenever used in this Agreement: (a) the words “include” or “including” shall be construed as incorporating, also, “but not limited to” or “without limitation;” (b) the word “day,” “quarter” or “year” means a calendar day, calendar quarter or calendar year unless otherwise specified (and “annual” or “annually” refer to a calendar year); (c) the word “notice” means notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement; (d) the word “hereof,” “herein,” “hereby” and derivative or similar word refers to this Agreement (including any Exhibits and

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Schedules); (e) the word “or” has its inclusive meaning identified with the phrase “and/or;” (f) the words “shall” and “will” have the same obligatory meaning; (g) provisions that require that a Party or the Parties “agree,” “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter or otherwise; (h) words of any gender include the other gender; and (i) words using the singular or plural number also include the plural or singular number, respectively.

 

14.11                 Independent Status.  The Parties agree that the relationship of Kadmon and Jinghua established by this Agreement is that of independent contractors.  Furthermore, the Parties agree that this Agreement does not, is not intended to, and shall not be construed to, establish an employment, agency, partnership or any other relationship.  Except as may be specifically provided herein, no Party shall have any right, power or authority, nor shall they represent themselves as having any authority to assume, create or incur any expense, liability or obligation, express or implied, on behalf of any other Party, or otherwise act as an agent for any other Party for any purpose.

 

14.12                 Third Party Beneficiaries.  Except for the rights to indemnification provided for a Party’s Indemnitees pursuant to Article 12, all rights, benefits and remedies under this Agreement are solely intended for the benefit of the Parties (including any successor in interest or permitted assigns), and except rights to indemnification expressly provided pursuant to Article 12, no Third Party shall have any rights whatsoever to (a) enforce any obligation contained in this Agreement (b) seek a benefit or remedy for any breach of this Agreement, or (c) take any other action relating to this Agreement under any legal theory, including but not limited to, actions in contract, tort (including but not limited to negligence, gross negligence and strict liability), or as a defense, setoff or counterclaim to any action or claim brought or made by the Parties.  Without limiting the foregoing, a person who is not a Party to this Agreement may not enforce any of its terms under the Contracts (Rights of Third Parties) Act 1999.

 

14.13                 Counterparts.  This Agreement may be executed in one (1) or more counterparts, each of which shall be deemed to be an original but all of which together shall constitute one and the same instrument.  Signatures to this Agreement that are transmitted by facsimile, electronic mail in “portable document format” (“.pdf”), or by any other electronic means intended to present the original graphic and pictorial appearance of this Agreement will have the same effect as physical delivery of the paper document bearing an original signature.

 

[Signature page follows]

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

In witness whereof, the Parties hereto have executed this Agreement by their respective duly authorized officers as of the dates set forth below.

 

	
KADMON   CORPORATION, LLC
    	
 
    	
JINGHUA   PHARMACEUTICAL GROUP CO., LTD.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/   Harlan W. Waksal, M.D.
    	
 
    	
By:
    	
/s/   [ILLEGIBLE]
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Harlan   W. Waksal, M.D.
    	
 
    	
Name:
    	
[ILLEGIBLE]
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
President   and CEO
    	
 
    	
Title:
    	
General   Manager
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:
    	
10/28/2015
    	
 
    	
Date:
    	
10/29/2015
    

 

25

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Execution Copy

 

EXHIBIT A

 

DILIGENCE OBLIGATIONS

 

For each Licensed Antibody generated by Kadmon (i.e., VEGFR2 and PDL-1), Jinghua will be required to file an IND with the CFDA within 24 months of the receipt by jinghua of the respective master cell bank in accordance with Section 7.2(a).

 

If Jinghua (or an Affiliate or Sublicensee, as the case may be) fails to satisfy any one of the obligations set forth above, Kadmon may treat such failure as a material breach in accordance with Section 10.2(a).

 

26

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Execution Copy

 

EXHIBIT B

 

KADMON PATENTS

 

Chinese Application based on United States 62/061097 (PCT Conversion 7 Oct 2015) HUMAN ANTI-VEGFR-2/KDR ANTIBODIES

 

Chinese Application 201380062991.X HUMAN ANTI-VEGFR-2/KDR ANTIBODIES

 

Chinese Application 201580000119.1 IMMUNOMODULATORY AGENTS (PDL-1 ANTIBODIES)

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Execution Copy

 

EXHIBIT C

 

FORM OF PATENT ASSIGNMENT

 

THIS ASSIGNMENT OF PATENT RIGHTS (this “Assignment”) effective as of                 , 201   (“Effective Date”), is by and between Kadmon Corporation, LLC, a limited liability company organized and existing under the laws of the State of Delaware (“Assignor”), and Jinghua Pharmaceutical Group Co., Ltd., a company organized and existing under the laws of the People’s Republic of China (“Assignee”).

 

WHEREAS, Assignor is the owner of all right, title and interest in and to the patents and patent applications identified below (collectively, the “Patents” ),

 

WHEREAS, Assignee desires to acquire the entire right, title and interest in and to the Patents.

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby expressly acknowledged, the parties agree as follows:

 

1.                                      Assignor, as of the Effective Date, hereby assigns, transfers and delivers to Assignee all right, title and interest in and to any and all subject matter of the inventions disclosed in the Patents listed on Schedule 1 hereto and in and to said applications, all continuations, continuations in part and divisions thereof, and the exclusive right to make application for patents, reissues, renewals and extensions thereof, and in and to all patents and all convention and treaty rights of all kinds, in the United States of America and all other countries throughout the world, for all such subject matter.

 

2.                                      Assignor requests the applicable official having authority to issue the Patents or corresponding rights to issue same on the subject matter of the said inventions to Assignee and, if called upon by Assignee or its legal representatives, Assignor agrees to promptly sign all documents necessary to secure all such Patents and rights and for issuance of same to Assignee.

 

3.                                      Assignor confirms that no agreement has been entered into that conflicts with this Assignment. Assignor further agrees to provide information within Assignor’s knowledge or belief, and to do all other relevant things that Assignee or its legal representatives deem necessary or desirable and request of Assignor in connection with obtaining or maintaining any such Patents, or in order to perfect Assignee’s ownership of the right, title and interest conveyed by this Assignment, or in connection with this Assignment, on the understanding that Assignee will bear all reasonable expenses actually incurred for or in connection with such matters after the date hereof. This Assignment and the obligations of Assignor hereunder shall be binding on Assignor’s successors and assigns.

 

4.                                      Assignor hereby represents and warrants that it has full right to convey the entire right, title and interest in the Patents herein assigned.

 

5.                                      This Assignment may be executed in any number of counterparts,  all such counterparts shall be deemed to constitute one and the same instrument, and each of the executed counterparts shall be deemed an original hereof.

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

6.             This Assignment shall be governed and construed in accordance with the laws of the State of Delaware without regard to conflicts of laws principles thereof and all questions concerning the validity and construction hereof shall be determined in accordance with the laws of Delaware.

 

[Signature page follows]

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

IN WITNESS  WHEREOF, Assignor and Assignee have caused this Assignment to be executed and delivered as of the Effective Date.

 

	
Kadmon Corporation, LLC
    	
Jinghua Pharmaceutical   Group Co., Ltd.
    
	
 
    	
 
    
	
 
    	
 
    
	
By:
    	
 
    	
 
    	
By:
    	
/s/ Illegible
    
	
Print Name:
    	
 
    	
 
    	
Print Name:
    	
Illegible
    
	
Title:
    	
 
    	
 
    	
Title:
    	
General Manager
    

 

ACKNOWLEDGMENT

 

	
STATE OF
    	
)
    	
 
    	
 
    
	
 
    	
) ss:
    	
 
    	
 
    
	
County of
    	
)
    	
 
    	
 
    

 

The foregoing instrument was acknowledged before me this       day of       , 201       , by         , the duly elected and acting         of  Kadmon Corporation, LLC, a Delaware limited liability company, on behalf of the company.

 

	
 
    	
 
    	
 
    
	
 
    	
 
    	
Notary Public
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
My Commission Expires:                        
    

 

30Exhibit 10.31

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

confidential

 

SUPPLY AND DISTRIBUTION AGREEMENT

 

This Supply and Distribution Agreement (“Agreement”) made effective as of February 23, 2016 (the “Effective Date”) is made between Kadmon Pharmaceuticals, LLC., a Pennsylvania Limited Liability Company (“KADMON”), with its principal place of business at 119 Commonwealth Drive, Warrendale, PA 15086 and Camber Pharmaceuticals, Inc., a Delaware company (“CAMBER”), with its principal place of business at 1031 Centennial Avenue, Piscataway, NJ 08854. CAMBER and KADMON are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

 

RECITALS

 

A.                                    WHEREAS, CAMBER has Regulatory Approval to manufacture, sell, and distribute tetrabenazine under an Abbreviated New Drug Application (“ANDA”) number *** (the “Product”) , and has, either directly or through its Affiliates, the capability to Manufacture the Product as further described in the Product Appendix in the Facility;

 

B.                                    WHEREAS, KADMON wishes to obtain commercial supplies of the Product from CAMBER for distribution by KADMON in the Territory; and

 

C.                                    WHEREAS, CAMBER desires to appoint KADMON, and KADMON desires to accept such appointment by CAMBER, as a Distributor for the purposes of marketing, selling and distributing the Product in the Territory, subject to the terms and conditions of this Agreement.

 

NOW, THEREFORE, in consideration of the representations, warranties and covenants set forth herein, the Parties agree as follows:

 

I.                                        DEFINITIONS.

 

In addition to the other terms defined elsewhere in this Agreement, the following terms will have the following meanings when used herein (any term defined in the singular will have the same meaning when used in the plural and vice versa, unless stated otherwise):

 

1.1                               “Affiliate” means an entity that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by, or is under common control with a Party.  For purposes of this definition, “control” means the legal or beneficial ownership of more than fifty percent (50%) of the voting or equity interests, or the power or right to direct the management and affairs of the business (including acting as the general partner of a limited partnership),

 

1.2                               “Applicable Law” means the applicable laws, rules, and regulations, including, without limitation, any rules, regulations, guidelines or other requirements of Regulatory Authorities relating to the Manufacture, use, marketing, storage, distribution and sale of the Product, that may be in effect from time to time in a jurisdiction in which the Product is Manufactured, used, distributed, stored, marketed or sold.

 

1.3                               “Batch” means a defined quantity of a Product that is (a) uniform in character and in quality; (b) identified by a unique identifier (either through a unique number or a number in

 

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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

combination with the relevant Product code); (c) of a certain amount; and (d) Manufactured during a defined cycle of Manufacture, The specific definition of a Batch will be consistent with CAMBER’S customary practices for the Product,

 

1.4                               “Business Day” means all days excluding Saturdays, Sundays, and any other public holidays in the state to which the notice or other document is being sent.

 

1.5                               “Calendar Quarter” means each successive period of three (3) consecutive calendar months commencing on January 1, April 1, July 1 and October 1.

 

1.6                               “Change” means any regulatory or other substantive changes to any Materials, Specifications, quantitative formulae or any other aspect of Manufacturing process and testing methods,

 

1.7                               “Confidential Information” means (i) all information and materials received by either Party from the other Party pursuant to this Agreement, (ii) all Confidential Information disclosed pursuant to the Confidential Disclosure Agreement between the Parties dated October 5 2015, and (iii) the terms of this Agreement, in each case other than that portion of such information or materials that:

 

(a)                                 is publicly disclosed by the disclosing Party, either before or after it becomes known to the receiving Party;

 

(b)                                 was known to the receiving Party, without obligation to keep it confidential, prior to when it was received from the disclosing Party, as evidenced by competent written proof;

 

(c)                                  is subsequently disclosed to the receiving Party by a Third Party lawfully in possession of and not in breach of any obligation to keep it confidential;

 

(d)                                 has been publicly disclosed other than by the disclosing Party and without breach of an obligation of confidentiality with respect thereto;

 

(e)                                  has been independently developed by the receiving Party without the aid, application or use of Confidential Information of the disclosing Party, as evidenced by competent written proof; or

 

(f)                                   are required to be disclosed by either Party to any government or regulatory agency or national securities exchange.

 

1.8                               “Commercially Reasonable Efforts” means, with respect to the commercialization or other exploitation of the Product, the efforts and resources a Party and its Affiliates typically devote to a product of similar market potential, taking into account all relevant factors including, as applicable, efficacy and safety relative to competitive products in the marketplace, actual or anticipated regulatory approval, cost and availability of supply, the competitiveness of the marketplace, the nature and extent of market exclusivity (including patent coverage and regulatory exclusivity) and actual or projected profitability.

 

2

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

1.9                               “Control”, “Controls” and “Controlled” means, for a particular item of information or intellectual property right, ownership or possession of the ability to grant a license or sublicense without violating the terms of any agreement or other arrangement with any Third Party.  With respect to any intellectual property rights owned by a Third Party and Controlled under the terms of a license or other agreement, a Party will be deemed to Control such intellectual property rights solely to the extent that the applicable agreement remains in effect and permits such Control, and the grant of rights in such intellectual property is conditioned on the acceptance by the Party granted such rights of any undertaking or obligations established by the applicable license or other agreement.

 

1.10                        “Country” means any country and, to the extent it is not a country, any jurisdiction or territory that is part of the Territory.

 

1.11                        “Dispute” has the meaning set forth in Section 11.6.

 

1.12                        “Distributor” means an entity with rights to promote, market, offer for sale, sell, have sold, distribute and have distributed the Product within the Territory during the Term (as set forth in Section 9.1).

 

1.13                        “Documentation” has the meaning set forth in Section 2.3.

 

1.14                        “KADMON Forecast” has the meaning set forth in Section 2.7(a).

 

1.15                        “Facility” means the GMP validated manufacturing facility or facilities approved for Manufacture of the Product by the FDA owned or operated by CAMBER or its Affiliates.

 

1.16                        “FDA” means the United States government agency known as the Food and Drug Administration or any successor thereto.

 

1.17                        “Force Majeure” means conditions beyond the reasonable control of the Parties, including without limitation, an act of nature or terrorism, voluntary or involuntary compliance with any regulation, law or order of any government, war, civil commotion, labor strike or lock- out, epidemic, failure or default of public utilities or common carriers, shortages of Materials beyond the reasonable control of the parties, or destruction of production facilities or Materials by fire, earthquake, storm or like catastrophe.

 

1.18                        ‘‘Good Manufacturing Practices” or “GMP” means the current good manufacturing practices as promulgated by any relevant Regulatory Authority and Applicable Laws in the Territory for the manufacture and testing the Product.

 

1.19                        “Intellectual Property” means any intellectual property rights including, without limitation, rights in Patents, Know-How, trademarks, trademark applications, trade secrets, copyright and industrial designs.

 

1.20                        “CAMBER Intellectual Property” means the Intellectual Property Controlled by CAMBER, including the CAMBER Marks (defined in Section 1.23).

 

3

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

1.21                        “Know-How” means (i) all information, techniques and data specifically relating to Manufacture of the Product, including, but not limited to, inventions, practices, methods, knowledge, know-how, skill, experience, test data (including without limitation pharmacological, toxicological, clinical, analytical and quality control data, regulatory submissions, correspondence and communications, and marketing, pricing, distribution, cost, sales, manufacturing, patent and legal data or descriptions), and (ii) compositions of matter, assays and biological materials specifically relating to development, Manufacture, use or sale of the Product.

 

1.22                        “Manufacture, Manufactured or Manufacturing” means all such activities as may be required for the manufacture of the Product, including without limitation (as appropriate) the planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, labeling, testing, sample retention, stability testing, release and dispatch of the Product, and the disposal of waste material and such other matters as may be prescribed for the manufacture and supply of Product by the relevant Specifications and regulatory submissions requirements.

 

1.23                        “CAMBER Marks” means any word, name, symbol, or design, or any combination thereof, used to identify and distinguish CAMBER or the Product, including those identified on Exhibit E attached hereto.

 

1.24                        “Materials” means all raw materials, intermediate and active compounds and packaging components used in the Manufacture and transportation of the Product,

 

1.25                        “Patent(s)” means (i) unexpired letters patent that have not been held invalid or unenforceable by a court of competent jurisdiction from which no appeal can be taken or has been taken within the required time period, including without limitation any substitution, extension, registration, confirmation, reissue, re-examination, renewal or any like filing thereof and (ii) pending applications for letters patent, including without limitation any provisional, converted provisional, continued prosecution application, continuation, divisional or continuation-in-part thereof.

 

1.26                        “Procedures” means the processing steps required to Manufacture the Product.

 

1.27                        “Product Appendix” means the appendix attached hereto as Exhibit A, which further describes and identifies the Product and any other mutually agreed information or parameters relating to Manufacture and distribution of such Product pursuant to this Agreement,

 

1.28                        “Production Standards” has the meaning set forth in Section 2.1.

 

1.29                        “Regulatory Applications” means all applications for Regulatory Approval submitted to or filed with a Regulatory Authority with respect to a Product,

 

1.30                        “Regulatory Approval” means all approvals (including without limitation supplements, amendments and pricing and reimbursement approvals), licenses, registrations or authorizations of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the manufacture, distribution, use or sale of the Product in a regulatory jurisdiction.

 

4

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

1.31                        “Regulatory Authority” means the FDA or any successor agencies to the foregoing, in each case with jurisdiction over Regulatory Approvals or the Manufacture of the Product.

 

1.32                        “Shelf Life” means a period measured from the initiation of Manufacture beyond which the Product must not be used, as set by CAMBER consistent with regulatory filings for the Product.

 

1.33                        “Specifications” means the procedures, test results, requirements, standards and other data and documentation with respect to the Product,

 

1.34                        “Territory” means the United States of America,

 

1.35                        “Third Party” means any entity other than KADMON or CAMBER or an Affiliate of either of KADMON or CAMBER,

 

1.36                        “Warranty” has the meaning set forth in Section 10.2(a).

 

II.                                   MANUFACTURE AND SUPPLY OF PRODUCT.

 

2.1                               General Manufacturing Obligations.  CAMBER will Manufacture the Products only at the approved Facility in accordance with the Approved Application, Specifications, GMP and Applicable Law (collectively the “Production Standards”).  CAMBER will maintain sufficient Manufacturing capacity at the Facility to satisfy the Product requirements set out in the then-current KADMON Inventory Forecast provided pursuant to Section 2.7, CAMBER is responsible for any and all quality oversight requirements and activities in connection with Product.  CAMBER agrees to notify Kadmon immediately of any quality or regulatory actions which may adversely impact Kadmon and its distribution of the Product.

 

2.2                               Materials.  CAMBER will purchase all Materials and maintain the Facility (including all Regulatory Approvals in connection with Manufacturing Product at such Facility) at its sole expense.  All Materials, including raw materials and components, shall meet the Regulatory Approval Specifications, as amended or supplemented from time to time.  CAMBER will test all Materials at CAMBER’s sole expense in accordance with the applicable specifications.

 

2.3                               Documentation.  CAMBER will keep complete, accurate and authentic accounts, notes, data and records of the Manufacturing including but not limited to all relevant information and records relating to the Manufacture of the Product under this Agreement that may be required from time to time to be provided to any Regulatory Authority pursuant to Applicable Laws, and all Manufacturing development information relating to the Product (to the extent such information is in CAMBER’s possession) (collectively, the “Documentation”).  CAMBER will maintain complete and adequate records in accordance with and to the full extent required by Production Standards pertaining to the methods and the facility used for the Manufacture, holding and distribution of the Product.  Upon written request by KADMON with reasonable notice, CAMBER will provide to representatives of KADMON, during normal business hours, reasonable access to Documentation, where such access is necessary or reasonably useful to permit KADMON to comply with Applicable Laws.  CAMBER will maintain Documentation

 

5

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

until the later of (a) when such Documentation is no longer required by Applicable Law or other obligation to be maintained by CAMBER or KADMON, or (b) one (1) year after expiration of the Shelf Life for the applicable Batch.

 

2.4                               Compliance with Laws.  CAMBER will comply with all Applicable Laws including, without limitation, those applicable to (a) the transportation, storage, use, handling and disposal of hazardous materials, (b) the Manufacture of Products and (c) CAMBER’s performance of its obligations under this Agreement.  CAMBER specifically represents and warrants that it does not and will not use, in any capacity, the services of any person that is debarred under the provisions of the United States Generic Drug Diversion Act or applicable regulations under that law.  CAMBER represents and warrants to KADMON that it has and will maintain during the term of this Agreement, all government permits, licenses, registrations and approvals, including without limitation, health, safety and environmental permits, legally required for the conduct of the actions and procedures that it undertakes pursuant to this Agreement.

 

2.5                               Compliance with Anti-Bribery Laws.  Without limiting the generality of the foregoing, CAMBER represents, warrants, and covenants to KADMON that:  (a) it has been at all times and shall continue to be in compliance with all potentially applicable anti-bribery and anti-corruption laws, including the U.S. Foreign Corrupt Practices Act of 1977; (b) no bribes, payments, kickbacks, gifts, hospitality, donations, loans, or anything of value have been or shall be made or received, offered, promised, or authorized, directly or indirectly, to improperly influence any act or decision of any Person, induce any Person or entity to do or omit to do any act in violation of any Person’s lawful duties, or secure any improper advantage; and (c) it has implemented a compliance and ethics program (including obligations to train contractors and sub-contractors interacting with officials of any governmental authority in connection with this Agreement) designed to prevent and detect violations of applicable anti-bribery and anti- corruption laws through its operations and the operations of its Affiliates, contractors and sub- contractors that have responsibility for Manufacturing, Products, payments or services pursuant to this Agreement, and covenants that it will maintain and enforce such compliance and ethics program at all times.

 

2.6                               Product Supply.  CAMBER shall supply Product to KADMON in the Territory pursuant to the following terms and conditions:

 

(a)                                 Delivery of Products.  CAMBER shall deliver each shipment at the location designated by KADMON within *** Business Days of the receipt of the purchase order relating to such shipment.  Title and risk of loss as to all materials shipped by CAMBER pursuant to this Agreement will pass to KADMON upon delivery to the location designated by KADMON on the applicable purchase order.

 

(b)                                 Invoice.  For each shipment of Product, CAMBER shall submit to KADMON an invoice for such shipment of Product, with pricing as set forth in Section 4.2.

 

(c)                                  Product Dating.  CAMBER agrees not to ship Product with less than *** months dating unless approved by KADMON.

 

6

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

(d)                                 Returns—KADMON will have the right to return all Product to CAMBER for full credit according to CAMBER’s Return Policy, attached hereto as Exhibit B.  Upon termination of the Agreement, CAMBER shall pay KADMON a full cash refund for any debit balance or credits CAMBER owes to KADMON and/or for any excess inventory of Product held by KADMON in its distribution centers.  CAMBER shall pay any such cash refund within *** days of the termination date of the Agreement.

 

2.7                               Forecasts and Purchase Orders.

 

(a)                                 Within the first *** days of the start of each Calendar Quarter, KADMON will work with CAMBER to prepare in good faith a non-binding rolling *** Calendar Quarter forecast with respect to the inventory of the Product (each, a “KADMON Inventory Forecast”).

 

(b)                                 CAMBER will use Commercially Reasonable Efforts to fulfill such purchase orders as submitted and will include in its response to KADMON the amount (of such purchase order that CAMBER will supply.  If, despite using Commercially Reasonable Efforts, CAMBER cannot fulfill (and thus cannot accept) purchase orders for Product, the Parties will discuss and agree on appropriate steps and both Parties will act reasonably in such circumstance.

 

(c)                                  All purchase orders will be sent by KADMON to CAMBER at the following address:  1031 Centennial Avenue, Piscataway, NJ 08854. CAMBER will acknowledge and either accept or reject purchase orders within *** days of receipt via email or fax to:  dan.yerace@kadmon.com or 724-778-6101.

 

2.8                               Pricing to KADMON for supply of Product will be as set forth in Section 4.2.

 

III.                              APPOINTMENT AS DISTRIBUTOR

 

3.1                               Appointment.  Subject to the terms and conditions set forth herein, CAMBER hereby:  (a) appoints KADMON during the term as a Distributor to promote, market, offer to sell, sell and/or distribute the Product within the Territory.

 

3.2                               Regulatory, Sales and Distribution Activities by KADMON and CAMBER.

 

(a)                                 KADMON will:

 

(i)                                     use its Commercially Reasonable Efforts to market, promote, sell and distribute the Product in the Territory during the Term;

 

(ii)                                  Notwithstanding the foregoing, the Parties acknowledge and agree that KADMON shall have no obligation to use Commercially Reasonable Efforts to sell or distribute the Product during any Calendar Quarter when CAMBER is not able to manufacture or supply the Product.

 

3.3                               Customer Non-Compete.  During the Term, CAMBER agrees not to directly sell the Product to those KADMON Customers set forth on Exhibit C attached hereto, In the event

 

7

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

CAMBER receives any inquiries from a KADMON Customer.  CAMBER agrees to redirect such inquires to KADMON.

 

IV.                               FEES AND PRODUCT PRICING.

 

4.1                               Purchase and Sale of Product.  During the Term, CAMBER shall sell and deliver to KADMON, and KADMON shall purchase and take delivery of the Product.

 

4.2                               Pricing and Invoicing.  CAMBER will manufacture and supply Product to KADMON at the prices set forth on Exhibit D attached hereto (the “Contract Price”).  CAMBER shall invoice KADMON for Product purchased by KADMON upon delivery.  Payment terms for such invoices will be ***%, *** net *** days from the date of the invoice.

 

4.3                               Price Protection.  CAMBER agrees to work closely with KADMON to monitor market conditions as it relates to product competitiveness throughout the term of the agreement.  Upon review and in agreement with KADMON, CAMBER will make necessary adjustments to support current customer competitiveness and new sales opportunities.  In the event that the Parties agree to reduce the Contract Price, CAMBER will pay a shelf stock adjustment to KADMON to reflect the difference between then current Contract Price and newly adjusted Contract Price.  This shelf stock adjustment will apply to both future purchases of Product and, Product then currently held by KADMON in its inventory held in KADMON’s distribution centers.

 

4.4                               General.  With respect to any payments to be made by one Party to the other pursuant to this Agreement (“Payments”), the Party making a Payment (the “Paying Party”) shall deduct or withhold from the Payments any Taxes that it is required by Applicable Law to deduct or withhold.

 

4.5                               Mode of Payment.  All Payments by the Paying Party under this Agreement shall be made by check in United States Dollars to the address noted on the relevant invoice,

 

4.6                               Accounting Records.  Each Party shall keep, or shall cause to be kept, for a period of three (3) years after the expiration or termination hereof or such shorter period as required by such Party’s records management policies and practices (to the extent consistent with Applicable Law), complete and accurate books and records pertaining to the performance of its obligations hereunder, including records of Detail and sampling performance, reimbursable costs and expenses incurred, sales of the Product, and alt information reasonably necessary to calculate and verify all amounts payable hereunder.

 

4.7                               Audit.  At the request of either Party, the other Party shall, and shall cause its and their respective Affiliates to, permit an independent certified public accountant designated by such Party, at reasonable times and upon reasonable notice, to audit the books and records maintained pursuant to Section 4.6 to ensure the other Party’s compliance of its obligations hereunder and to verify all amounts payable hereunder, including the accuracy of all reports and payments made hereunder.  CAMBER may request such audit at the end of the Initial Term.  Thereafter either Party may request an audit no more than once during any *** consecutive month period during the Term and a period of *** months thereafter and no more than once with respect to any period so examined; provided that if any such audit reveals that the audited Party

 

8

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

is or was not in material compliance with the terms of this Agreement, the auditing Party shall have the right to conduct such additional audits as may be reasonably required by such Party to determine whether the other Party has appropriately remedied such non-compliance.  The cost of any such audit shall be borne by the auditing Party, unless with respect to an audit of payments made hereunder, the audit reveals a variance of more than (***)% from reported amounts, in which case the audited Party shall bear the cost of the audit.  If any such audit concludes that additional payments were owed or that excess payments were received during such period, the owing Party shall pay the additional payments or the receiving Party shall reimburse such excess payments within *** days after the date on which such audit is completed.  For clarity, this Section 4.7 is not intended and shall not be construed to apply to records with respect to the manufacture of Product by or on behalf of CAMBER.

 

4.8                               Government Price Reporting.  CAMBER will be responsible for all government price reporting obligations related to the Product, including all related expenses.

 

V.                                    MARKETING.

 

5.1                               CAMBER agrees to work with KADMON to develop and agree on marketing plans, promotions and sales materials to support market opportunities for KADMON.

 

5.2                               The Product will carry the CAMBER Marks, KADMON may, but is not required to, use CAMBER Marks in all promotion of Products and in all Product promotional literature, in compliance with applicable laws, rules and regulations and in a manner reflecting favorably on and preserving the CAMBER Marks’ integrity.  All marketing and promotional materials that KADMON proposes to use for the Products will be subject to CAMBER review and approval prior to use.  Except as provided in this Section 5.2, KADMON will not:  (a) adopt or use any trademarks, brand names, words, logos, symbols, letters, designs or marks that are combined with CAMBER Marks so as to create combination marks, or that would be confusingly similar to CAMBER Marks; (b) modify CAMBER Marks in any way; or (c) use CAMBER Marks on or in connection with goods or services other than the Product.

 

VI.                               CONFIDENTIALITY.

 

6.1                               Treatment of Confidential Information.  During the term of this Agreement, and for a period of two (2) years after this Agreement expires or terminates, a Party receiving Confidential Information of the other Party will (i) maintain in confidence such Confidential information to the same extent such Party maintains its own proprietary industrial information of similar kind and value (but at a minimum each Party will use Commercially Reasonable Efforts to maintain Confidential Information in confidence); (ii) not disclose such Confidential Information to any Third Party without prior written consent of the disclosing Party; and (iii) not use such Confidential Information for any purpose except those purposes permitted by this Agreement.

 

6.2                               Authorized Disclosure.  Notwithstanding any other provision of this Agreement, each Party may disclose Confidential Information of the other Party as follows:

 

(a)                                 to the extent and to the persons and entities required by an applicable governmental law, rule, regulation or order; provided, however, that the Party required to

 

9

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

disclose Confidential Information will first have given prompt notice to the other Party hereto to enable it to seek any available exemptions from or limitations on such disclosure requirement and will reasonably cooperate in such efforts by the other Party;

 

(b)                                 as necessary to file or prosecute patent applications, prosecute or defend litigation or otherwise establish rights or enforce obligations under this Agreement, but only to the extent that any such disclosure is necessary;

 

(c)                                  as necessary to file or maintain Regulatory Applications and Regulatory Approvals under this Agreement, but only to the extent that any such disclosure is necessary;

 

(d)                                 as necessary for a Party to disclose the terms of this Agreement to bona fide potential investors, or acquirers who are bound in writing by obligations of non- disclosure and non-use of the terms of this Agreement at least as stringent as those contained in this Section 6;

 

(e)                                  to the extent a Party is obligated or choses to do so pursuant to applicable U.S. governmental securities laws, rules and regulations by filing a copy of this Agreement with the US Securities and Exchange Commission (the “SEC”) or any national securities exchange.

 

VII.                          DISTRIBUTION SAFEGUARDS; RECALLS.

 

7.1                               Counterfeit Products.  KADMON will exercise due diligence to detect counterfeit, substandard, or otherwise adulterated or misbranded versions of the Product and to prevent those versions from entering the distribution system and reaching patients.

 

7.2                               Recall/Field Alert.  CAMBER shall notify KADMON as soon as practically possible of any decision that could potentially lead to a recall of Product.

 

VIII.                     INSPECTION RIGHTS.

 

8.1                               KADMON will maintain complete and accurate records of all transactions involving its purchase or sale of Products.  KADMON will permit CAMBER or its authorized representative to inspect at KADMON’s place of business any records relevant to assessing KADMON’s compliance with this Agreement and to inspect its facilities.  CAMBER will conduct any inspection upon reasonable notice to KADMON and during regular business hours

 

8.2                               CAMBER may inspect any facility at which KADMON receives or stores Products to verify compliance with this Agreement.  CAMBER will conduct any inspection upon reasonable notice to KADMON and during regular business hours.

 

IX.                               TERM AND TERMINATION.

 

9.1                               Term and Termination Date.  This term of this Agreement begins as of the Effective Date and continues for twelve (12) months thereafter (the “Initial Term”), unless earlier

 

10

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

terminated in accordance with this Section 9 or otherwise mutually agreed in writing by the Parties.

 

9.2                               Termination.

 

(a)                                 If either Party believes that the other is in material breach of this Agreement, then the Party holding such belief (the “Non-breaching Party”) may deliver notice of such breach to the other Party (the “Notified Party”).  The Notified Party will have *** days to cure such breach, or, if cure of such breach other than non- payment cannot reasonably be effected within such thirty (30) day period, to deliver to the Non-breaching Party a plan reasonably calculated to cure such breach within a timeframe that is reasonably prompt in light of the circumstances then prevailing.  Following delivery of such a plan, the Notified Party will devote Commercially Reasonable Efforts to carry out the plan and cure the breach,

 

(b)                                 If the Notified Party fails to cure a material breach of this Agreement as provided for in Section 9.2(a), then the Non-breaching Party may terminate this Agreement in its entirety upon written notice to the Notified Party.

 

9.3                               Effect of Termination.  Expiration or termination of this Agreement will not affect the Parties’ accrued rights and obligations.  The following provisions shall survive expiration or termination of this Agreement:  Articles I, V, VI and X, and Sections 2.6(d), 4.2, 11.2 and 11.6.  Nothing in this Section 9.3 shall be construed to give KADMON the right after expiration or termination of this Agreement to distribute or sell Product, other than to CAMBER for liquidation by KADMON of its Product inventory, or to return any inventory in accordance with Section 2.6(d).

 

X.                                    REPRESENTATIONS, WARRANTIES AND INDEMNITIES.

 

10.1                        Each Party hereby represents and warrants to the other Party as of the Effective Date as follows:

 

(a)                                 Such Party (i) is duly formed and in good standing under the laws of the jurisdiction of its formation, (ii) has the power and authority and the legal right to enter into this Agreement and perform its obligations hereunder, and (iii) has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder.  This Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid and binding obligation of such Party and is enforceable against it in accordance with its terms, subject to the effects of bankruptcy, insolvency or other similar laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered in a proceeding at law or equity.

 

(b)                                 All necessary consents, approvals and authorizations of all regulatory and governmental authorities required to be obtained by such Party in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder have been obtained.

 

11

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

(c)                                  The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder (1) do not and will not conflict with or violate any requirement of Applicable Law or any provision of the articles of incorporation, bylaws, limited partnership agreement or other similar documents of such Party, and (2) do not and will not conflict with, violate, or breach, or constitute a default or require any consent under, any contractual obligation or court or administrative order by which such Party is bound.

 

10.2                        CAMBER further represents and warrants that:

 

(a)                                 Ali Product delivered hereunder shall (i) as of delivery and for the duration of the Product’s Shelf Life, comply with the Production Standards (“Warranty”); (ii) be free and clear of any and all encumbrances, liens or other third party claims; (iii) be Manufactured in compliance with applicable Regulatory Standards; (iv) not be adulterated or misbranded within the meaning of the FD&C Act, and (v) not be articles that, under the provisions of Sections 404 and 505 of the FD&C Act, may not be introduced into interstate commerce.

 

(b)                                 CAMBER has the unrestricted right and authority to appoint KADMON as a Distributor of the Product in the Territory, and KADMON’s registration, importation, labeling, packaging, exporting, promotion, marketing, offering for sale, sale, and distribution of the Product shall not infringe or misappropriate the intellectual property rights of any Third Party.

 

(c)                                  The foregoing warranties shall survive any inspection, delivery, acceptance or payment by KADMON and shall be enforceable by KADMON and its Affiliates, their successors, assigns, subcontractors, distributors, dealers, agents and customers and all other entities selling or using the Product or goods into which the Products have been incorporated.

 

10.3                        KADMON Indemnity.  KADMON will defend, indemnify and hold harmless CAMBER, its Affiliates, its employees and agents from and against any third party claims, demands, actions, suits or proceedings (“Third Party Claims”) to the extent (a) arising out of the gross negligence or willful misconduct of KADMON or its employees, agents or contractors, in connection with its performance of its obligations under this Agreement in connection with the Product.

 

10.4                        CAMBER Indemnity.  CAMBER will defend, indemnify and hold harmless KADMON, its Affiliates, its employees and agents from and against any Third Party Claims to the extent (a) arising out of the failure of the Product to meet Production Standards at delivery for the duration of the Shelf Life; (b) arising out of the gross negligence, willful misconduct, violation of Applicable Law or regulation or breach of this Agreement by CAMBER or its employees, agents or contractors, (c) arising from any claim for patent infringement arising out of the use of the Products by KADMON under this Agreement, (d) arising from actual or alleged trade mark or trade name infringement resulting from the exercise or use by KADMON of any rights or licenses granted to it in respect of the CAMBER Marks under this Agreement, (e) and any Losses resulting from such Third Party Claims described in clauses (a) through (d), except,

 

12

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

in each case, to the extent that KADMON has responsibility, liability or an obligation of indemnity under Section 10.3 for all or part of such Third Party Claims.

 

10.5                        Indemnity Procedures.  A party seeking indemnity under Sections 10.3 or 10.4 will promptly notify the other party of the Third Party Claim, provide it with full authority over the defense and settlement, cooperate at its reasonable request and expense in providing information and assistance in settlement and/or defense, and will not without its express prior written consent settle, admit liability for or otherwise compromise defense or settlement of the Third Party Claim; provided that the party seeking indemnity may be represented by separate counsel at its own expense in Third Party Claim legal proceedings.

 

10.6                        Limitation of Damages.  NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.  NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS PARAGRAPH IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTIONS 10.3 AND 10.4, OR DAMAGES AVAILABLE FOR BREACHES OF THE CONFIDENTIALITY OBLIGATIONS SET FORTH IN ARTICLE 7.

 

10.7                        Insurance.  Each Party agrees to maintain, during the term of this Agreement and for a period of two (2) years after the or termination of this Agreement, at its sole cost and expense, with a financially solvent insurance company, a commercial general liability insurance policy that includes products liability coverage that is sufficient to cover its obligations under this Agreement.

 

XI.                               MISCELLANEOUS.

 

11.1                        Independent Contractor.  The Parties acknowledge and agree that KADMON is an independent contractor and this Agreement creates no joint venture, partnership or agency relationship between the Parties, other than expressly contemplated regarding Regulatory Approvals.  KADMON will make no representations or warranties that are binding upon CAMBER with respect to Products or otherwise.  KADMON will have no authority, and do nothing, to bind CAMBER in any way.

 

11.2                        Notice.  Any notice required or permitted shall be delivered upon receipt and sent by (i) delivery in person; (ii) internationally-recognized, bonded courier for next-day delivery; (iii) postal mail, certified and return receipt requested or (iv) facsimile, to the receiving party at its address or facsimile below, or to such other address of which such Party gives notice.

 

	
To KADMON:
    	
 
    	
Kadmon Pharmaceuticals, LLC
    
	
 
    	
 
    	
Attention:  General   Counsel
    
	
 
    	
 
    	
119 Commonwealth Drive
    
	
 
    	
 
    	
Warrendale, PA 15086
    
	
 
    	
 
    	
 
    
	
With Copy to:
    	
 
    	
Kadmon Corporation, LLC
    

 

13

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

	
 
    	
 
    	
Office of General Counsel
    
	
 
    	
 
    	
450 East 29th Street, 16th Floor
    
	
 
    	
 
    	
New York, NY 10017
    
	
 
    	
 
    	
 
    
	
To CAMBER:
    	
 
    	
Camber Pharmaceuticals. Inc.
    
	
 
    	
 
    	
Attention:  Edward   Smith
    
	
 
    	
 
    	
1031 Centennial Avenue
    
	
 
    	
 
    	
Piscataway, NJ 08854
    

 

11.3                        Force Majeure.  Neither Party shall be liable for non-performance or delay in performance caused by an Event of Force Majeure.  The non-performing Party shall notify the other Party of such event of Force Majeure within seven (7) days after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration, and any action being taken to avoid or minimize its effect.  The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use, throughout the period of suspension of performance, commercially reasonable efforts to remedy its inability to perform; provided, however, that in the event the suspension of performance continues for ten (10) days after the date such Force Majeure commences, the Parties shall meet to discuss in good faith how to proceed in order to carry out the intent of this Agreement.  For purpose of this Agreement a Force Majeure shall not include:  (i) a Party’s failure to commit sufficient resources, financial or otherwise, to its activities under this Agreement, or (ii) general market or economic conditions.

 

11.4                        Assignment.  Neither Party may assign this Agreement in whole or part without the other Party’s prior written consent; any attempted or purported assignment without that consent shall be void.

 

11.5                        Severability:  No Waiver.  A finding that a provision of this Agreement is invalid shall not affect the validity of this Agreement’s other provisions, which shall remain in effect.  The Parties will replace the invalid provision with a valid provision that best accomplishes the Parties’ original intent.  A Party’s failure or omission to invoke a right under this Agreement in connection with an event or occurrence shall not be a waiver or affect the Party’s ability to assert that right for future events or occurrences.

 

11.6                        Governing Law and Dispute Resolution.  The laws of the State of Delaware, USA shall govern this Agreement and its construction.  The Parties expressly disclaim the applicability of the International Convention on the Sale of Goods to this Agreement, and it shall not apply to this Agreement.  The Parties will resolve any dispute, controversy or claim arising out of or relating to the validity, formation, enforceability, performance, breach or termination of this Agreement (“Dispute”) in accordance with this Section 11.6, with the resolution commencing by a Party notifying the other Party in writing of any Dispute it intends to so resolve.  The Parties will attempt to resolve any Dispute amicably through good faith discussions between an appropriate CAMBER associate or more senior officer and a senior executive of KADMON.

 

11.7                        Entire Agreement and Amendments.  This Agreement represents the Parties’ entire agreement on this subject matter and supersedes any prior agreements.  This Agreement

 

14

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

may be amended only by a writing signed and delivered by the Parties’ authorized representatives.

 

[Intentionally left blank; signature page follows]

 

15

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

The Parties have entered this Agreement as of the Effective Date by their duly authorized representatives,

 

	
 
    	
 
    
	
KADMON PHARMACEUTICALS, LLC
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
By:
    	
/s/ Eva Heyman
    	
 
    
	
 
    	
Eva Heyman, Chief Commercial Officer
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
CAMBER, INC,
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ [ILLEGIBLE]
    	
 
    

 

16

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

EXHIBIT A: PRODUCT APPENDIX

 

	
Product
    	
 
    	
Dosage
    	
 
    	
Unit
    	
 
    	
NDC
    	
 
    
	
Tetrabenazine
    	
 
    	
12.5MG
    	
 
    	
112 CT Bottle
    	
 
    	
31722-821-11
    	
 
    
	
Tetrabenazine
    	
 
    	
25MG
    	
 
    	
112 CT Bottle
    	
 
    	
31722-822-11
    	
 
    

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

EXHIBIT B: CAMBER RETURN POLICY

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

	

    	
CAMBER PHARMACEUTICALS
    	
 
    

 

RETURN GOODS POLICY

 

POLICY STATEMENT

 

Camber Pharmaceuticals requires that all returns be approved by an authorized Camber Pharmaceuticals representative and accompanied by a completed Return Authorization Request. Please request Return Authorizations from our selected returns processor: Qualanex, LLC. Return Authorizations can be made by accessing the Qualanex Website at: www.qualanex.com, via telephone at 1-800-505-9291, email to customerservice@qualanex.com, or Fax at 847-775-7258. All returns require prior Camber Pharmaceuticals approval. Camber Pharmaceuticals will only accept returns from purchasers who have purchased products directly from Camber Pharmaceuticals.

 

RETURN GOODS POLICY

 

·                  Credit, less rebates and any other discounts and allowances, will be issued based on the original net purchase price, the lowest catalogue price during the previous 24 months, or the current catalogue price, whichever is lower

·                  Credit for returned product(s) will be in the form of a Credit Memo issued in a timely manner; no cash returns, and no deductions from any Invoice can be made

·                  Credit will not be issued for product(s) that has been destroyed by the purchaser without prior approval (All third party return processors must contact Qualanex for Return Authorization)

·                  Camber Pharmaceuticals representatives are prohibited from picking up or transporting product(s) for return

·                  Camber Pharmaceuticals reserves the right to destroy, without recourse, all unauthorized product(s) returned

 

RETURN GOODS (CREDIT)

 

·                  In-date product(s) with less than six (6) months of remaining shelf life and expired product(s) not more than 12 months past expiration date, in original, unopened packages. Partials will not be accepted (exception would be returns from the states of Georgia, Mississippi, and North Carolina).

·                  Concealed damage claims made within 14 days of receipt

·                  Product(s) received in error or damaged in shipping (accompanied by signed Bill of Lading noting damage) if reported to an authorized Camber Pharmaceuticals representative within fourteen (14) days of receipt and returned within thirty (30) days

·                  Products received in error or damaged in shipping to consignee (accompanied by a signed bill of lading noting such damage) if reported to Camber customer service within 5 days of receipt and returned within 30 days.

·                  Prior written approval is required for all return of all overstocked product with greater than 12 months expiration dating. All products with 12 month dating will be subject to a 15% restocking fee.

 

NON-RETURNABLE GOODS (NO CREDIT)

 

·                  Product(s) returned without prior Camber Pharmaceuticals authorization

·                  Product(s) sold on a non-returnable basis, “stickered”, marked, coded, dated, damaged, deteriorated, soiled, or adulterated in any way

·                  Product(s) involved in a sacrifice or bankruptcy sale

·                  Product(s) provided free of charge as a promotional incentive

·                  Product(s) discontinued more than one (1) year

·                  Returns received 60 days or more after date of Return Authorization

·                  Products sold that constitute “Special Handling”

·                  Product(s) purchased or distributed contrary to federal, state, or local law or Camber Pharmaceuticals policy

 

TRANSPORTATION CHARGES

 

·                  Transportation and insurance charges on all returned product(s) are the responsibility of the purchaser except when due to Camber Pharmaceuticals error as determined by Camber Pharmaceuticals.

·                  All returned product(s) must be traceable

 

Return Goods Policy (contd.)

 

Rev. 4/21/15

 

1

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

CAMBER PHARMACEUTICALS

 

Return Goods Policy (contd.)

 

THIRD PARTY RETURN PROCESSING

 

Third party return processors and all returns must comply and be in accordance with all requirements of the Camber Pharmaceuticals Return Goods Policy. Any returns from non-authorized purchasers will be destroyed as stated above. Camber Pharmaceuticals will not reimburse any service fees to the purchaser or third party return processor, i.e. handling, processing, etc., or freight charges incurred. All products must be returned to Qualanex for Destruction. It is the purchaser’s responsibility to insure that third party return processors comply with the Camber Pharmaceuticals’ Return Goods Policy. All returns must be in agreement with the approved Return Authorization Request. Please request Return Authorizations from our selected returns processor: Qualanex, LLC. Return Authorizations can be made by accessing  the Qualanex Website at: www.qualanex.com, via telephone at 1-800-505-9291, email to customerservice@qualanex.com, or Fax at 847-775-7258.

 

PROCEDURE FOR RETURNING MERCHANDISE

 

Step 1: Requesting a Return Authorization

 

a)             Direct purchasers: Please request Return Authorizations from our selected returns processor: Qualanex, LLC.
  All Return Goods requests must contain the following:

 

Product description (name, strength, package size)

NDC # of each item to be returned

Quantity of each item to be returned

Product Lot Number

Product Expiration Date

Shipper’s complete address with contact person, telephone number and fax number

Reason for Return

 

b)             Return authorization will be issued for products in unopened packages within 6 months of remaining shelf life and 12 months past the expiration date.

 

c)              Any product return not detailed on the completed RGA will not receive credit, will not be accepted for return, and will be destroyed by Qualanex.

 

d)             RGA Numbers are good for 60 days from the date issued.

 

Step 2: Returning Merchandise

 

a)             Once approved, please enclose a copy of the RGA form in your shipment.

 

b)             Ship merchandise fully insured and freight pre-paid to:

 

Camber Pharmaceuticals

C/o Qualanex LLC

1410 Harris Road

Libertyville, IL 60048

 

DISCLAIMER

 

Camber Pharmaceuticals reserves the right to amend this statement of policy by written notification to the purchaser. This  statement of policy shall supersede and/or serve as notice of termination of any previous agreement or policy, whether written, oral, or established through course of dealing between purchaser and Camber Pharmaceuticals with respect to the subject matter hereof.

 

2

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

EXHIBIT C: LIST OF KADMON CUSTOMERS

 

ACARIAHEALTH

ALLCARE PLUS PHARMACY

ALLCARE SPECIALTY PHARMACY LLC

AMBER PHARMACY

APEX SPECIALTY PHARMACY

APOTHECARY BY DESIGN

AUREUS HEALTH SERVICES, LLC

AVELLA

AXIUM HEALTHCARE PHARMACY

BASCOM PHARMACY

BENEVERE PHARMACY

BIOCURE, LLC

BIOPLUS SPECIALTY PHARMACY SERVICES

BIOSCRIP

BLOUNT DISCOUNT PHARMACY

BOSWELL PHARMACY

BRADLEY DRUGS

BRIOVA RX

BURMAN’S

CEDRA PHARMACY

CENTRAL DRUGS

CITY DRUGS PHARMACY

COMMCARE PHARMACY

CORRECT RX PHARMACY SERVICESS

DIAMOND DRUGS INC.

DOLPHIN HEALTH

ELWYN SPECIALTY CARE

EMPIRE SPECIALTY PHARMACY CORP.

ENCOMPASS RX

ENTRUST RX

EXACTUS PHARMACY SOLUTIONS

FIRST HEALTH PHARMACY, INC.

GIANNOTTO’S SPECIALTY PHARMACY

GLEN ROCK

GOOD HEALTH, INC.

GRUBBS CARE PHARMACY NW INC

H.C. PHARMACY CENTRAL, INC.

HCTC PHARMACY

HEALY PHARMACY

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

HEPCARE PHARMACY

INTEGRATED CARE SYSTEMS

ISLAND CARE PHARMACY

KERR HEALTH LLC

KINGS PARK SLOPE

LIV-WELL PHARMACY

MAXOR NATIONAL PHARMACY SERVICES CORP.

MED-CENTER SPECIALTY PHARMACY

MEDS IN MOTION

MEDSCRIPTS MEDICAL PHARMACY

MISSION ROAD

NATIONAL PHARMACEUTICAL (EIRIS)

NEW YORK STATE DOCS CENTRAL PHARMACY

OPTIMED SPECIALTY PHARMACY

PARKWAY PHARMACY

PAVILION PHARMACY

PHARM BLUE, LLC

PHARMACEUTICAL SPECIALTIES

PHARMACY MANAGEMENT GROUP

PHARMACY SPECIALTY GROUP

PHYSICIANS PARK PHARMACY

PRECISION HEALTHCARE

PRESCRIPTIONS SOLUTIONS

PRIME AID PHARMACY CORP.

PRIME THERAPEUTICS SPECIALTY

PROFESSIONAL HOME

QUALITY RX

RECEPT PHARMACY 

RELIANT MEDICAL LLC

REEVES-SAIN

RIVER MEDICAL

ROBERTS SOUTH BANK PHARMACY

RX 21 LLC

SALVEO PHARMACY INC.

SKYEMED INC.

SKYEMED ORLANDO JUST RX

SOUTHSIDE INFUSION PHARMACY

SPECIALTY SCRIPTS PHARMACY

TLCRX, LLC

Transcript Pharmacy

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

US BIOSERVICES

VASCO RX

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

EXHIBIT D: PRICING

 

	
Product
    	
 
    	
Dosage
    	
 
    	
Unit
    	
 
    	
NDC
    	
 
    	
Price
    
	
Tetrabenazine
    	
 
    	
12.5 MG
    	
 
    	
112 CT Bottle
    	
 
    	
31722-821-11
    	
 
    	
$
    	
*** per unit
    
	
Tetrabenazine
    	
 
    	
25 MG
    	
 
    	
112 CT Bottle
    	
 
    	
31722-822-11
    	
 
    	
$
    	
*** per unit
    

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

Exhibit E: CAMBER Marks

 

[TO BE PROVIDED BY CAMBER]

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

***

 

 

CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

***

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