Document:

Exhibit 10.22

 

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

 

FIRST AMENDMENT TO

 

THE LICENSE AGREEMENT

 

This First Amendment to the License Agreement (this “Amendment”) is made and entered into as of the 22nd day of May, 2014 (the “Effective Date”), by and among Kadmon Pharmaceuticals, LLC, a Pennsylvania limited liability company (“Kadmon”) and AbbVie Inc., a Delaware corporation (“AbbVie”). Kadmon and AbbVie may be referred to herein individually as a “Party” or collectively as the “Parties”.

 

WHEREAS the Parties entered into that certain License Agreement, dated as of June 13, 2013 (the “License Agreement”); and

 

WHEREAS the Parties desire to amend such License Agreement through this Amendment, which is an instrument in writing signed by each of the parties to the License Agreement;

 

NOW, THEREFORE, in consideration of the premises and mutual covenants, agreements and provisions contained herein and in the License Agreement, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

 

1.              Amendment. Effective as of the Effective Date, and pursuant to Section 14.9 of the License Agreement, the Parties hereby agree as follows:

 

1.1.                            The definition of Ancillary Agreements is hereby amended and restated in its entirety as follows:

 

“Ancillary Agreements” means, collectively, the Asset Purchase Agreement, the Bill of Sale, Assignment and Assumption Agreement, the Patent Assignment Agreement, the Supply Agreement, the Sublicense Agreement and the Escrow Agreement.

 

1.2.                            The first sentence of Section 6.1 of the License Agreement is hereby amended and restated in its entirety as follows:

 

“6.1. Upfront Payment. In partial consideration for the rights and licenses granted by Kadmon to AbbVie hereunder, AbbVie shall pay a one-time upfront payment of forty-nine million dollars (US$49,000,000); provided that *** of such one-time upfront payment (the “Escrow Amount”) shall be delivered by or on behalf of AbbVie by wire transfer of immediately available funds to the Escrow Agent for deposit in accordance with the terms of the Escrow Agreement in order to help secure the indemnification obligations of Kadmon under this Agreement; provided, however that the amount escrowed shall in no event limit or otherwise restrict AbbVie’s ability to collect or obtain Losses from Kadmon in excess of the Escrow Amount.”

 

2.              Sublicense Agreement. Concurrent with the execution and delivery of this Amendment, Kadmon and AbbVie shall enter into the sublicense agreement, attached hereto as Exhibit A (the “Sublicense Agreement”), under that certain License Agreement by and between Merck

 

 

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

 

& Sharp & Dohme Corp. (successor to Schering Corporation) and Kadmon Pharmaceuticals, LLC (successor to Three Rivers Pharmaceuticals, LLC), dated February 7, 2003, as amended by the First Amendment to License Agreement, dated October 28, 2013.

 

3.              Interpretation of Certain Terms. The words “this Agreement,” “herein,” “hereof” and other like words in the License Agreement from and after the effective time of this Amendment shall mean and include the License Agreement as amended hereby.

 

4.              No Further Amendment. Except as expressly provided in this Amendment, the terms and conditions of the License Agreement are and remain in full force and effect.

 

5.              Incorporation by Reference. The terms and conditions of Article 14 of the License Agreement are incorporated in this Amendment by this reference.

 

[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, duly authorized representatives of the Parties have duly executed this Agreement to be effective as of the Effective Date.

 

	
Kadmon   Pharmaceuticals, LLC
    	
 
    	
AbbVie   Inc.
    
	
 
    	
 
    	
 
    
	
By:
    	
/s/ Steven N. Gordon
    	
 
    	
By:
    	
/s/ A. Duvvur
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Steven N. Gordon
    	
 
    	
Name:
    	
A. Duvvur
    
	
 
    	
Executive Vice   President and
    	
 
    	
 
    	
 
    
	
Title:
    	
General Counsel
    	
 
    	
Title:
    	
Treasurer
    

 

 

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

 

SUBLICENSE AGREEMENT

 

This Sublicense Agreement (the “Agreement”)  is made and entered into effective as of May 22, 2014 (the “Effective Date”)  by and between Kadmon Pharmaceuticals, LLC, a Pennsylvania limited liability company (“Sublicensor”),  and AbbVie Inc., a Delaware corporation (“AbbVie”).  Sublicensor and AbbVie are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

 

RECITALS

 

WHEREAS, Sublicensor and Merck & Sharp & Dohme Corp. (“Merck”) are parties to that certain License Agreement effective February 7, 2003, as amended by that certain First Amendment to License Agreement, effective October 23, 2013 (collectively, the “Merck License Agreement”) pursuant to which Merck granted Sublicensor a license to use certain know-how, patents and other intellectual property to make, use, sell, offer to sell and import the Sublicensed Product into the Territory;

 

WHEREAS, pursuant to the Merck License Agreement, Merck expressly consented to, and authorized Sublicensor to, sublicense its rights to the Existing Patent Rights and/or utilize any third party entity as a distributor of the Sublicense Product without Merck’s prior written consent.

 

WHEREAS, Sublicensor and AbbVie are parties to certain agreements, including a License Agreement, effective June 17, 2013 (“License Agreement”), pursuant to which Sublicensor granted AbbVie and its Affiliates a license to develop and commercialize the Product in the Territory described in the License Agreement on an exclusive or non-exclusive basis;

 

WHEREAS, Sublicensor wishes to grant a sublicense to AbbVie, and AbbVie wishes to take, a sublicense under such intellectual property rights to develop and commercialize the Product in the Territory, in each case in accordance with the terms and conditions set forth below.

 

NOW, THEREFORE, in consideration of the promises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:

 

ARTICLE 1 

DEFINITIONS

 

This Agreement includes the terms and conditions of the License Agreement, which are hereby incorporated by this reference as though the same was set forth in its entirety. Any capitalized terms in this Agreement shall have the meaning ascribed to such terms under the License Agreement. In addition, for the purpose of this Agreement, unless otherwise specifically provided herein, the following terms shall have the following meanings:

 

1.1                               “AbbVie” has the meaning set forth in the preamble hereto.

 

1.2                               “Agreement” has the meaning set forth in the preamble hereto.

 

1.3                               “Effective Date” means the effective date of this Agreement as set forth in the  preamble hereto.

 

1.4                               “Existing Patent Rights” means Merck’s, its Affiliates, successors or assigns (a) issued U.S. patents listed in Schedule 1, including all reexaminations and reissues of such patents and (b) pending U.S. patent applications listed in Schedule 2, including all divisional and continuations, and continuation-in-part of such patent applications, and all reexaminations and reissues of patent that issue from such applications licensed to Sublicensor under the Merck License Agreement.

 

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1.5                               “License Agreement” has the meaning set forth in the preamble hereto.

 

1.6                               “Merck” has the meaning set forth in the preamble hereto.

 

1.7                               “Merck License Agreement” has the meaning set forth in the preamble hereto.

 

1.8                               “Sublicense” has the same meaning set forth in Section 2.1.1.

 

1.9                               “Sublicensor” has the meaning set forth in the preamble hereto.

 

1.10                        “Term” has the meaning set forth in Section 6.1.

 

1.11                        “Territory” means the United States of America, its territories, protectorates and possessions.

 

1.12                        “Third Party” means any Person other than Sublicensor, AbbVie and their respective Affiliates.

 

ARTICLE 2

GRANT OF SUBLICENSE

 

2.1                                             Grants to AbbVie. Sublicensor (on behalf of itself and its Affiliates) hereby grants to AbbVie a nonexclusive, fully-paid, royalty-free sublicense to Existing Patent Rights to make, have made and Commercialize Product in the Territory (the “Sublicense”).

 

2.2                                             Sublicenses. AbbVie shall have the right to grant sublicenses (or further rights of reference), through multiple tiers of sublicensees, under the licenses and rights of reference granted in Section 2.1, to its Affiliates and other Persons; provided that any such sublicenses shall be consistent with the terms and conditions of this Agreement and License Agreement; provided further that AbbVie shall provide written notice to Kadmon of any sublicense to a Third Party and shall remain liable to Kadmon for any breach of this Sublicense (or any sublicense hereunder) by any of AbbVie’s sublicensees.

 

2.3                                             No Other Rights. No rights are granted except as expressly set forth in this Agreement. The only rights granted under the Existing Patent Rights are stated expressly in this Agreement.

 

2.4                                             No Other Compensation. Each Party hereby agrees that the terms of this Agreement fully define all consideration, compensation and benefits, monetary or otherwise, to be paid, granted or delivered by one Party to the other Party in connection with the transactions contemplated herein. Neither Party previously has paid or entered into any other commitment to pay, whether orally or in writing, any of the other Party’s employees, directly or indirectly, any consideration, compensation or benefits, monetary or otherwise, in connection with the transaction contemplated herein.

 

2.5                                             FDA Submission. Sublicensor will provide AbbVie with prompt written notice of any patent information submitted to the FDA for listing in association with the Product upon its receipt of notice from Merck.

 

ARTICLE 3

CONFIDENTIALITY AND NON-DISCLOSURE

 

3.1                               No disclosure of the existence or terms of this Agreement may be made by either Party, and no Party shall use the name, trademark, trade name or log of the other Party, its Affiliates or their respective employee(s) in any publicity, promotion, press release or disclosure relating to this Agreement or its subject matter, without the prior express written permission of the other Party, except as may be required by Applicable Law.

 

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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

 

ARTICLE 4

REPRESENTATIONS AND WARRANTIES

 

4.1                                             Sublicensor Representations and Warranties. Sublicensor represents and warrants to AbbVie, as of the Effective Date, as follows:

 

4.1.1                     Organization. It is a limited liability company duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, limited liability company or otherwise, to execute, deliver, and perform this Agreement.

 

4.1.2                     Authorization. The execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and do not violate (a) Sublicensor’s charter documents, bylaws, or other organizational documents, (b) in any material respect, any agreement, instrument, or contractual obligation to which it is bound, (c) any requirement of any Applicable Law, or (d) any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to Sublicensor.

 

4.1.3                     Binding Agreement. This Agreement is a legal, valid, and binding obligation of Sublicensor enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity).

 

4.1.4                     No Inconsistent Obligation. It is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement, or that would impede the diligent and complete fulfillment of its obligations hereunder.

 

4.1.5                     Right to Grant Sublicense. To the best of Sublicensor’s knowledge, Merck or its Affiliates own or control all of the rights, title and interest in and to the Existing Patent Rights, and Sublicensor has the full right and authority to grant the Sublicense herein.

 

4.1.6                     Breach of Merck License Agreement. It is not in breach of the Merck License Agreement and has no knowledge of an anticipated breach of the Merck License Agreement

 

4.2                                             AbbVie Representations and Warranties. AbbVie represents and warrants to Sublicensor, as of the Effective Date, as follows:

 

4.2.1                     Organization. It is a corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction of its organization, and has all requisite power and authority, corporate or otherwise, to execute, deliver, and perform this Agreement.

 

4.2.2                     Authorization. The execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and do not violate (a) AbbVie’s charter documents, bylaws, or other organizational documents, (b) in any material respect, any agreement, instrument, or contractual obligation to which it is bound, (c) any requirement of any Applicable Law, or (d) any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to Sublicensor.

 

4.2.3                     Binding Agreement. This Agreement is a legal, valid, and binding obligation of AbbVie enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of

 

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creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity).

 

4.3                                             DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.

 

ARTICLE 5

INDEMNITY

 

5.1                                             Indemnification of AbbVie By Sublicensor. Sublicensor shall indemnify, defend and hold harmless AbbVie, its Affiliates and their respective employees, officers, directors and agents in accordance with the terms set forth in Section 11.2 of the License Agreement.

 

ARTICLE 6

TERM AND TERMINATION

 

6.1                                             Term. This Agreement shall commence on the Effective Date and, unless earlier terminated in accordance herewith, shall continue in force and effect until the earlier of (i) the date of expiration of the last to expire Existing Patent Rights, or (ii) the termination of the License Agreement.

 

6.2                                             Irrevocable Sublicense. This sublicense is irrevocable as between the Parties but is revocable upon termination by Merck under the terms of the Merck License Agreement.

 

6.3                                             Sublicensor Breach. Sublicensor shall comply with all the terms and conditions contained in the Merck License Agreement, and shall not terminate the Merck license Agreement without the prior written consent of AbbVie. Sublicensor shall not amend, modify or waive any provision of the Merck License Agreement that would negatively affect AbbVie’s rights under this Agreement without the prior written consent of AbbVie. Sublicensor will use commercially reasonable efforts to cure any Sublicensor breach of the Merck License Agreement (to the extent such breach is capable of being cured) within thirty (30) days of its receipt of Merck’s written notice requesting cure of any such breach.

 

6.4                                             Notice of Termination. Sublicensor shall promptly provide copies of any notices or correspondence between Merck and Subicensor with respect to any allegations of breach or any other matter that could potentially affect AbbVie’s rights hereunder, including reasonable details of the circumstances for termination.

 

6.5                               Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by AbbVie or Sublicensor are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, licenses of right 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 or any analogous provisions in any other country or jurisdiction. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against either Party under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, the Party hereto that is not a Party to such proceeding 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, which, if not already in the non-

 

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subject Party’s possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon the non-subject Party’s written request therefor, unless the Party subject to such proceeding elects to continue to perform all of its obligations under this Agreement, or (b) if not delivered under clause (a) above, following the rejection of this Agreement by or on behalf of the Party subject to such proceeding upon written request therefor by the non-subject Party.

 

6.6                               Accrued Rights; Surviving Obligations. Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement.

 

[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

 

THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the Effective Date.

 

	
KADMON PHARMACEUTICALS, LLC
    	
 
    	
ABBVIE INC.
    
	
 
    	
 
    	
 
    
	
By:
    	
 
    	
 
    	
By:
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
 
    	
 
    	
Name:
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
 
    	
 
    	
Title:
    	
 
    

 

 

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

 

Schedule 1

 

Issued U.S. Patents

 

1.                                      Ribavirin Compositions

 

US Patent No. 5,914,128 

US Patent No. 6,051,252 

US Patent No. 6,335,032 

US Patent No. 6,337,090

 

2.                                      Use of Ribavirin in Combination with Interferon or Pegylated Interferon

 

US Patent No. 5,908,621 

US Patent No. 6,172,046 

US Patent No. 6,177,074 

US Patent No. 6,524,570

 

3.                                      Other

 

US Patent No. 5,916,594 

US Patent No. 6,461,605 

US Patent No. 6,472,373

 

 

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

 

Schedule 2

 

Pending U.S. Applications

 

NoneExhibit 10.23

 

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EXECUTION COPY

 

AMENDMENT AND MODIFICATION AGREEMENT TO

TRANSACTION DOCUMENTS

 

This AMENDMENT AND MODIFCATION AGREEMENT dated as of October 2, 2014 (this “Amendment”) to: (i) that certain Asset Purchase Agreement by and between Kadmon Pharmaceuticals, LLC (“Kadmon”) and AbbVie Bahamas, Ltd. (the “APA”); (ii) that certain License Agreement by and between Kadmon and AbbVie Inc. (as amended by that certain Amendment No.1 to the License Agreement dated May 22, 2014, the “License Agreement”); and (iii) that certain Supply Agreement by and between Kadmon and AbbVie Bahamas, Ltd. (the “Supply Agreement”), each dated June 17, 2013, is made by and between Kadmon, on the one hand, and AbbVie Bahamas, Ltd. and AbbVie Inc., (together, “AbbVie”), on the other hand. Capitalized terms used herein and not otherwise defined shall have the meanings set forth in the Transaction Documents (as defined below).

 

WHEREAS, the Parties have entered into the APA, the License Agreement and the Supply Agreement (collectively, the “Transaction Documents”) and now desire to amend and modify certain terms of the Transaction Documents as set forth in this Amendment;

 

NOW, THEREFORE, in consideration of the premises and mutual covenants, agreements and provisions contained herein and in the Transaction Documents, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

 

1.              Amendment and Modification to Supply Agreement.

 

(a)         Effective as of the date of this Amendment, Section 10.1 of the Supply Agreement is hereby deleted in its entirety and replaced with the following:

 

“10.1                          Term. This Agreement shall become effective on the Effective Date, and unless sooner terminated in accordance with the terms herein, this Agreement shall remain in effect until December 31, 2020 (the “Term”). Thereafter, this Agreement shall only be renewed or extended by the mutual written consent of the Parties and in accordance with Section 11.8. AbbVie may terminate this Agreement at any time, without cause, upon *** months written notification to Company that AbbVie is terminating this Agreement.”

 

(b)         Effective as of the date of this Amendment, Section 1.10 of the Supply Agreement is hereby deleted in its entirety and replaced with the following:

 

“1.10                          “Applicable Percentage of AbbVie Product Requirements” shall mean: (a) from the Effective Date through December 31, 2014, at least ***% of AbbVie’s worldwide requirements for ribavirin tablets in twice daily and once daily dosage forms, as determined on a quarterly basis; (b) from January 1, 2015 through December 31, 2016, at least ***% of AbbVie’s worldwide requirements for ribavirin tablets in twice daily and once daily dosage forms, as determined on a quarterly basis; and (c) from January 1, 2017 through expiration or termination of the Agreement, a percentage of AbbVie’s worldwide

 

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requirements for ribavirin tablets in twice daily and once daily dosage forms, determined solely by AbbVie and with no minimum requirement.”

 

(c)          Effective as of the date of this Amendment, Section 1.40 and Section 1.56 of the Supply Agreement are hereby deleted in their entirety.

 

2.              Amendments and Modifications to APA.

 

(a)                                 Effective as of the date of this Amendment, Section 1.84 of the APA is hereby deleted in its entirety and replaced with the following:

 

“1.84 “Territory” means all countries in the world, other than the (i) United States, (ii) Republic of Turkey, (iii) People’s Republic of China and (iv) Russian Federation.”

 

(b)                                 Kadmon hereby acknowledges receipt of the Guaranteed Purchase Price and the Milestone Payment set forth in Sections 2.2.1 and 2.3.1(c), respectively. AbbVie hereby agrees to pay to Kadmon (or its designees), within ten (10) Business Days of the date of this Amendment, the aggregate sum of nineteen million dollars (US$19,000,000) in consideration of the following: (i) full satisfaction and release from payment of the Spain Deferred Purchase Price and the UK Deferred Purchase Price, set forth in Sections 2.2.2 and 2.2.3, respectively; (ii) *** and *** from *** of all *** under Section *** including Sections *** and *** (iii) full release from all AbbVie’s obligations under Section 2.3.3, including, but not limited to, the obligation to make the Royalty Payment; and (iv) full release from all AbbVie’s obligations under Sections 2.3.2 and 2.3.3(b), including, but not limited to, obligations to seek Regulatory Approval and launch either BID Product or the QD Formulation.

 

(c)                                  For clarity, (i) no further Guaranteed Purchase Price payment, Royalty Payments, Milestone Payments or Deferred Purchase Price payments, shall be due or owing to Kadmon under this APA; (ii) all obligations of Kadmon to assign, transfer, obtain and/or assist AbbVie with Registrations remain in effect, including with respect to those countries for which AbbVie has satisfied and been released from payment of Milestone Payments and Deferred Purchase Price payments; and (iii) full satisfaction and release from the payments and obligations set forth in Section 2(b)(i)-(iv) of this Amendment shall take effect upon the delivery to Kadmon of the aggregate sum of nineteen million dollars (US$19,000,000) referenced in Section 2(b) of this Amendment, except that the Royalty Period shall end on September 30, 2014.

 

(d)                                 Effective as of the date of this Amendment, the following new Section 2.4.1 is hereby inserted into the APA following existing Section 2.4:

 

“2.4.1. Kadmon Rights of Reference. Notwithstanding anything contained in this Agreement to the contrary, AbbVie hereby grants to Kadmon and Kadmon accepts a perpetual and irrevocable royalty-free license, with a right to grant sub-licenses, to cross-reference the EU Biostudies and any regulatory approvals, licenses, registrations, agreements, permits,

 

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exemptions, clearances, certificates, consents, authorizations, other permissions, and requests for approval for, and supplements or amendments to, relating to the Product and issued by any Governmental Authority in the European Union, for purposes of Kadmon obtaining and maintaining Regulatory Approvals for a standalone pharmaceutical product that contains Compound in the (i) Republic of Turkey, (ii) People’s Republic of China, or (iii) Russian Federation, including where applicable, applications for pricing and reimbursement approval.

 

3.              Amendments and Modifications to License Agreement.

 

(a)                                 The Parties agree that Kadmon is hereby fully released from its obligations under Section 2.4 of the License Agreement with respect to QD Product Development, and AbbVie is hereby fully released from its obligations to make the payments set forth in Section 6.2.2 and Section 6.2.3. Effective as of the date of this Amendment, Section 2.4, Section 6.2.2 and Section 6.2.3 of the License Agreement are hereby deleted in their entirety. To the extent Kadmon has any Intellectual Property Rights or Patent Rights related to QD Product, Kadmon agrees not to enforce such Intellectual Property Rights or Patent Rights against AbbVie in the event that AbbVie develops and/or Commercializes once daily immediate release formulation Ribavirin tablets for patients.

 

(b)                                 Effective as of the date of this Amendment, Section 2.5 of the License Agreement is hereby deleted in its entirety and replaced with the following:

 

“2.5. Co-Promotion of QD Product. In the event Kadmon obtains Regulatory Approval for QD Product, then within sixty (60) days after such Regulatory Approval, the Parties shall negotiate in good faith with a view to entering into a co-promotion agreement with respect to QD Product in the Territory on terms mutually acceptable to the Parties.”

 

(c)                                  The Parties agree that AbbVie is hereby fully released from any and all obligations set forth in Section 4.1 of the License Agreement, including, but not limited to, pursuing Regulatory Approval and Commercializing the Exclusive Product in the Territory. Effective as of the date of this Amendment, Section 4.1 of the License Agreement is hereby deleted.

 

(d)                                 Effective as of the date of this Amendment, Section 4.2.2 of the License Agreement is hereby deleted in its entirety and replaced with the following:

 

“4.2.2. AbbVie shall have the right to Commercialize the Co-packaged QD Product using the QD Product Trademark (in addition to such other AbbVie Product Marks as AbbVie may choose to apply), only in the event that the QD Product Trademark is approved by both the FDA and the USPTO. In the event the QD Product Trademark is not approved by both the FDA and USPTO, then AbbVie shall have no obligation to use the QD Product Trademark.”

 

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

 

(e)                                  The Parties hereby agree that AbbVie shall not be obligated as set forth in Section 6.3.1 of the License Agreement to make any Royalty Payment, and the Royalty Term as defined in such section shall not commence, prior to calendar year 2017. Thereafter, such Section 6.3.1 shall remain in full force and effect in accordance with its terms, except that the Royalty Term set forth in Section 6.3.1 shall be amended, as of the date of this Amendment, to a period of eight (8) years commencing on the day immediately following AbbVie’s first commercial sale of Exclusive Product in the Territory. For clarity, AbbVie shall not owe any royalties to Kadmon under the License Agreement after calendar year 2016, unless AbbVie Commercializes Exclusive Product.

 

(f)                                   The following new Section 6.3(A) is hereby inserted into the License Agreement immediately preceding existing Section 6.3.

 

6.3(A). 2015 and 2016 Royalties.

 

(i)             Subject to the terms of this Agreement, for calendar years 2015 and 2016 only (the “Initial Royalty Term”), AbbVie will pay Kadmon a royalty based on the number of prescriptions of High Dose BID Product dispensed for use with any other approved product sold by AbbVie for the treatment of Hepatitis C virus during each such calendar year in the Territory (the “High Dose BID Royalty”), as evidenced by the Prescription Data (as defined below) and calculated pursuant to the Royalty Formula (as defined below).

 

For the purpose of calculating the percent of AbbVie’s 3DAA product used with high dose Moderiba, “Prescription Data” shall mean IMS patient level prescription claims (LRx), and any Specialty Pharmacy data independently acquired by AbbVie and sent to IMS for the purpose of integrating such data with IMS prescription data, during the relative measurement period. For the purpose of calculating the total 200mg equivalents, “Prescription Data” shall mean IMS national prescription data (NPA). The cost of receiving any Prescription Data shall be borne by AbbVie, except that any costs associated with sharing Prescription Data with Kadmon shall be borne by Kadmon.

 

“Royalty Formula” shall mean the formula set forth in written and mathematical format in Exhibit A and Exhibit B, respectively, hereto.

 

(ii)         Within ten (10) Business Days of the date of this Amendment, AbbVie shall make a one-time payment to Kadmon in the amount of *** which amount represents a prepayment of the High Dose BID Royalty due pursuant to Section 6.3(A)(i) during the Initial Royalty Term, equal to *** per calendar year for 2015 and 2016 (each an “Annual Initial Royalty Payment”).

 

(iii)      Within *** days after the end of the first, second, and third Calendar Quarters during each calendar year within the Initial Royalty Term, AbbVie

 

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

 

will prepare and deliver to Kadmon in writing a calculation setting forth the amount of the High Dose BID Royalty due to Kadmon during such preceding Calendar Quarter (the “Quarterly Royalty Report”) based on available Prescription Data and the Royalty Formula (the “Quarterly Initial Royalties”). At such time as the sum of the Quarterly Initial Royalties as calculated for the fully completed Calendar Quarters during a particular calendar year exceeds the Annual Initial Royalty Payment, AbbVie shall pay to Kadmon the amount of such excess (“Excess Payments”). The Annual Initial Royalty Payment plus any Excess Payments paid to Kadmon during a particular calendar year shall be referred to as the “Preliminary Paid Royalties”. Any Excess Payments due to Kadmon shall be paid not later than thirty (30) days following AbbVie’s delivery to Kadmon of the Quarterly Royalty Report.

 

(iv)     Within *** days after the end of each calendar year within the Initial Royalty Term, the High Dose BID Royalty due for the preceding calendar year will be calculated by AbbVie and reported to Kadmon in writing (“Calculation Report”) based on available Prescription Data and the Royalty Formula (“Actual Owed Royalties”). To the extent that Actual Owed Royalties due to Kadmon are less than the Preliminary Paid Royalties, Kadmon shall pay to AbbVie the amount of such difference and, conversely, to the extent that Actual Owed Royalties due to Kadmon are greater than the Preliminary Paid Royalties, AbbVie shall pay to Kadmon the amount of such difference (the “Royalty Reconciliation Payment”). The Royalty Reconciliation Payment shall be paid not later than *** days following AbbVie’s delivery to Kadmon of the Calculation Report.

 

(v)        Within *** days after the end of each calendar year within the Initial Royalty Term, AbbVie shall prepare and report to Kadmon in writing (the “Samples Report”) the amount of High Dose BED Product samples expressed on an aggregate milligram basis distributed by AbbVie to health care professionals free of charge during such calendar year (“Sample Product”), based on information obtained from the sample disbursement system of record. To the extent the amount of Sample Product set forth in the Sample Report exceeds 10% of the amount of Product (as defined in the Supply Agreement) purchased by AbbVie in the Territory in the calendar year expressed on an aggregate milligram basis (the amount of such excess in milligrams of Ribavirin, the “Excess Samples”), AbbVie shall make a payment to Kadmon equal to the product obtained by multiplying (i) the quotient obtained by dividing (A) the Excess Samples by (B) 200, by (ii) $2.19. Such payment shall be paid not later than thirty (30) days following AbbVie’s delivery to Kadmon of the Samples Report.

 

(vi)      All calculations and reports delivered by AbbVie to Kadmon pursuant to this Section 6.3(A) shall be subject to Section 6.5 of the License Agreement.

 

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

 

(g)                                  Kadmon and AbbVie hereby agree to execute and deliver to the Escrow Agent within three (3) Business Days of the date of this Amendment, an Escrow Release Notice pursuant to Section 3(e) of the Escrow Agreement (License Agreement Related) dated June 17, 2013, by and among Kadmon, AbbVie and the Escrow Agent, authorizing the release to Kadmon of the Escrow Deposit *** in the form attached hereto as Exhibit C. Upon delivery of such funds and property in the Escrow Deposit to Kadmon by the Escrow Agent in accordance with Section 3(e) of the Escrow Agreement, the Escrow Agreement shall automatically terminate in accordance with its terms.

 

4.              Miscellaneous

 

(a)                                 The Transaction Documents are amended only to the extent set forth herein, and all other terms of the Transaction Documents shall remain the same and are not affected by this Amendment. In the event of any conflict between the terms of this Amendment and the terms of the Transaction Documents, the terms of this Amendment shall control.

 

(b)                                 Each reference in the Transaction Documents to “this Agreement,” “hereunder,” “hereof,” “herein” or words of like import referring to the APA, the License Agreement and the Supply Agreement, respectively, shall mean and be a reference to each such Transaction Document as further amended by this Agreement.

 

(c)                                  This Agreement shall be governed by, and interpreted in accordance with the laws of the State of New York, without reference to conflicts of laws principles; provided, however, that the validity or enforcement of Intellectual Property Rights hereunder shall be determined under the laws of that jurisdiction in which those Intellectual Property Rights are registered or for which an application for registration has been filed. The United Nations Conventions on Contracts for the International Sale of Goods shall not be applicable to this Agreement.

 

(d)                                 This Agreement, its contents and any discussions regarding its contents and the Transaction Documents constitute Confidential Information and shall continue to be governed by Section 3.1 of the APA and Section 9 of the License Agreement, respectively.

 

(e)                                  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 this Agreement.

 

(f)                                   This Agreement may be executed in any number of counterparts, each of which shall be deemed an original and all of which taken together shall be deemed to constitute one and the same instrument. An executed signature page of this Agreement delivered by facsimile or PDF transmission shall be as effective as an original executed signature page.

 

(g)                                  The Transaction Documents, together with their respective Schedules, attachments and Ancillary Agreements, as modified or amended by this Agreement, constitute the entire agreement between the Parties, and supersedes all prior agreements, understandings and communications between the Parties, with respect to the subject matter hereof and thereof.

 

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

 

No modification or amendment of this Agreement shall be binding upon the Parties unless in writing and executed by the duly authorized representative of each of the Parties.

 

[Intentionally Left Blank; Signature Page Follows]

 

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

 

IN WITNESS WHEREOF, the Parties have executed and delivered this Agreement as of the day and year first written above.

 

 

	
Kadmon   Pharmaceuticals, LLC
    	
AbbVie   Bahamas Ltd.
    
	
 
    	
 
    
	
By
    	
/s/ Steven N. Gordon
    	
 
    	
By
    	
/s/ [ILLEGIBLE]
    
	
Name:
    	
Steven N. Gordon
    	
 
    	
Name:
    	
 
    
	
Title:
    	
Executive Vice   President and General Counsel
    	
 
    	
Title:
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
AbbVie   Inc.
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
By
    	
/s/ [ILLEGIBLE]
    
	
 
    	
 
    	
 
    	
Name:
    	
 
    
	
 
    	
 
    	
 
    	
Title:
    	
 
    

 

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

 

EXECUTION COPY

 

EXHIBIT A

 

Calculation of Moderiba 200mg equivalents used with AbbVie’s 3DAA product

 

1)             For each of the different strengths of high dose Moderiba (400mg, 600mg, 800mg, l000mg and 1200mg), AbbVie will calculate the percentage of each different strength of Moderiba that are dispensed for use with AbbVie’s 3DAA product using Prescription Data (the “Applicable Percentage”). AbbVie will assume that any Moderiba prescribed to any particular patient for use during any period of time during which such patient is also prescribed AbbVie’s 3DAA product for HCV is considered as being prescribed for use with AbbVie’s 3DAA product.

 

2)             For each strength of Moderiba: multiply the Applicable Percentage by the estimated total number of Moderiba of each such strength dispensed over that period of time based on the Prescription Data, which will yield an estimate of the actual number of Moderiba of each strength used with AbbVie’s 3DAA product. On a quarterly basis, the NPA data will be used to estimate the total number of Moderiba packs of each strength dispensed.

 

3)             The number of 200mg equivalent units of Ribavirin dispensed for use with AbbVie’s 3DAA product in the estimated number of each strength of Moderiba during a quarter will be calculated and multiplied by $*** per 200mg equivalent to determine the Quarterly Initial Royalty owed for that quarter, as defined in Section 6.3(A)(iii) of the License Agreement.

 

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

 

Execution Copy

 

Exhibit B

 

All Data Sets and Calculations are Measured Quarterly

 

	
Form   IMS prescription
   data
    	
 
    	
Percent of MODERIBA
   used
   with 3D
    	
 
    	
From IMS NPA
   Data
    	
 
    	
# of 200MG Equivalents per
   MODERIBA
    	
 
    	
Total # of 200MG Equivalents in   MODERIBA used
   with 3D
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
MODERIBA 600MG + 3D
    	
=
    	
%   MODERIBA 600MG with 3D
    	
x
    	
MODERIBA   600MG
    	
=
    	
#   MODERIBA 600MG used with 3D
    	
x
    	
3   (200MG Equiv.)
    	
=
    	
# of   200MG Equiv. in MODERIBA 600MG used with 3D
    	
 
    	
 
    
	
MODERIBA 600MG
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
MODERIBA 800MG + 3D
    	
=
    	
%   MODERIBA 800MG with 3D
    	
x
    	
MODERIBA   800MG
    	
=
    	
#   MODERIBA 800MG used with 3D
    	
x
    	
4   (200MG Equiv.)
    	
=
    	
# of   200MG Equiv. in MODERIBA 800MG used with 3D
    	
 
    	
 
    
	
MODERIBA 800MG
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
MODERIBA 1000MG + 3D
    	
=
    	
%   MODERIBA 1000MG with 3D
    	
x
    	
MODERIBA   1000MG
    	
=
    	
#   MODERIBA 1000MG used with 3D
    	
x
    	
5   (200MG Equiv.)
    	
=
    	
# of   200MG Equiv. in MODERIBA 1000MG used with 3D
    	
 
    	
 
    
	
MODERIBA 1000MG
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
MODERIBA 1200MG + 3D
    	
=
    	
%   MODERIBA 1200 MG with 3D
    	
x
    	
MODERIBA   1200MG
    	
=
    	
#   MODERIBA 1200MG used with 3D
    	
x
    	
6   (200MG Equiv.)
    	
=
    	
# of   200MG Equiv. in MODERIBA 1200MG used with 3D
    	
 
    	
 
    
	
MODERIBA 1200MG
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
TOTAL   # of 200MG Equivalents in MODERIBA used with 3D x $2.19  =  “Quarterly Initial Royalty” Owed for   Quarter
    	
 
    	
 
    

 

 

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 Escrow Release Notice

 

October        , 2014

 

JPMorgan Chase Bank, N.A.

Escrow Services

420 West Van Buren, Mail Code IL1-0113

Chicago, IL 60606

Fax: (312) 954-0430

Attention: Cindy Reis

 

Ladies and Gentlemen:

 

Reference is made to the ESCROW AGREEMENT dated as June 17, 2013 (the “Agreement”), by and among AbbVie Inc. a Delaware corporation (“Licensee”), Kadmon Pharmaceuticals, LLC, a Delaware limited liability company (“Licensor”), and J.P. Morgan Chase Bank, N.A. (the “Escrow Agent”). Capitalized terms used but not defined herein have the meanings set forth in the Agreement.

 

In accordance with Section 3(e) of the Agreement, Licensee hereby notifies and instructs the Escrow Agent to remit to the account set forth below the entire Escrow Deposit ($5,000,000) from the Escrow Deposit.

 

	
Recipient:
    	
Kadmon   Pharmaceuticals, LLC
    
	
Bank   name:
    	
 
    
	
Bank   Address:
    	
 
    
	
ABA   number:
    	
 
    
	
Account   Name:
    	
Kadmon   Pharmaceuticals, LLC
    
	
Account   Number:
    	
 
    

 

Very truly yours,

 

	
AbbVie   Inc.
    	
 
    	
Kadmon   Pharmaceuticals, LLC
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
By:
    	
 
    	
 
    	
By:
    	
 
    	
 
    
	
Name:
    	
 
    	
Name:
    	
 
    
	
Title:
    	
 
    	
Title:
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
By:
    	
 
    	
 
    	
By:
    	
 
    	
 
    
	
Name:
    	
 
    	
Name:
    	
 
    
	
Title:
    	
 
    	
Title:
    	
 
    
							

 

10

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