Settlement and License Agreement

Exhibit 10.2

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

Execution Copy

Settlement and License Agreement

This Settlement and License Agreement (“Agreement”), effective September 14, 2015, is entered into by and between BioMarin Pharmaceutical Inc., a corporation organized and existing under the laws of the State of Delaware, having a principal place of business at 770 Lindaro Street, San Rafael, California 94901 (“BioMarin”), Merck & Cie, a Swiss corporation having a principal place of business at Im Laternenacker 5, 8200 Schaffhausen, Switzerland (“Merck”) (together “Plaintiffs”); and Dr. Reddy’s Laboratories, Ltd., a company organized under the laws of India, having a principal place of business at 8-2-337, Road No. 3, Banjara Hills, Hyderabad, 500 034, India and its subsidiaries, including Dr. Reddy’s Laboratories, Inc., a corporation incorporated under the laws of the State of New Jersey, having its principal place of business at 107 College Road East, Princeton, New Jersey 08540 (collectively “DRL”).  Each of BioMarin, Merck, and DRL are individually referred to herein by name or the term “Party” and collectively referred to herein as “Parties.”

WHEREAS, DRL has filed Abbreviated New Drug Application No. 207685 with the United States Food and Drug Administration (“FDA”) seeking permission to market the DRL ANDA Product in the United States and its territories, including the Commonwealth of Puerto Rico (the “Territory”) before the expiration of Plaintiffs’ Orange-Book listed United States Patent Nos. 7,566,462; 7,566,714; 7,612,073; 7,727,987; 7,947,681; 8,003,126; 8,067,416; RE43,797; and 8,318,745 (collectively, the “Listed Patents”);

WHEREAS, in response to the filing of ANDA No. 207685, Plaintiffs have filed an action against DRL in the United States District Court for the District of New Jersey, captioned BioMarin Pharmaceutical Inc., et al. v. Dr. Reddy’s Laboratories, Inc., et al., Civil Action No. 14-CV-7203 (MAS)(TJB) (the “New Jersey Litigation”), alleging infringement of seven of the Listed Patents by DRL’s generic product;

WHEREAS, DRL has no present intention of launching the DRL ANDA Product without a court order declaring that it does not infringe the Listed Patents, except as provided herein;

WHEREAS, Plaintiffs intend to continue to assert their rights under the Listed Patents to exclude the products described in ANDA No. 207685, except as provided herein;

WHEREAS, the Parties wish to fully settle the New Jersey Litigation and all issues concerning DRL’s generic version of Kuvan® upon the terms and subject to the conditions set forth below;

WHEREAS, settlement of the New Jersey Litigation will help Plaintiffs and DRL avoid the substantial uncertainty and risk involved with prolonged litigation;

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

Execution Copy

WHEREAS, settlement of the New Jersey Litigation will permit Plaintiffs and DRL to save litigation costs, as well as adhere to the judicially-recognized mandate that encourages the settlement of litigation whenever possible;

WHEREAS, settlement of the New Jersey Litigation will permit the management of Plaintiffs and DRL to refocus on running their respective companies rather than devoting substantial time and resources to litigation;

WHEREAS, under this Agreement, DRL will have the right to enter the market for sapropterin dihydrochloride products several years prior to the expiration of the Listed Patents, thereby benefiting customers by permitting generic entry that may not have occurred were the New Jersey Litigation to proceed; and

WHEREAS, the public will benefit significantly from this final settlement, as it saves judicial resources and creates certainty for Plaintiffs and DRL;

NOW, THEREFORE, in consideration of the mutual promises and covenants contained in this Agreement and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:

Article 1.Definitions.  

For purposes of this Agreement, certain words and their correlatives are defined in Article 1 or in the body of this Agreement.

[***]

Article 2.Termination of Litigation.

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

Execution Copy

Article 3.[***] 

Article 4.[***]

Article 5.[***]

Article 6.[***]

Article 7.[***]

Article 8.Confidentiality of the Agreement.

[***]

Article 9.General Provisions.  

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

Execution Copy

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

Execution Copy

Article 10.[***]

Article 11.[***]

[Signatures on the following pages]

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

Execution Copy

This Agreement is signed as indicated below by duly authorized representatives of BioMarin, Merck, and DRL, respectively, as of the Effective Date.

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

Execution Copy

[***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.

Execution Copy

Exhibit A

UNITED STATES DISTRICT COURT

DISTRICT OF NEW JERSEY

STIPULATION OF DISMISSAL, WITHOUT PREJUDICE

1.Pursuant to Rules 41(a)(1) and 41(c) of the Federal Rules of Civil Procedure, BioMarin Pharmaceutical Inc. (“BioMarin”) and Merck & Cie (“Merck”) (BioMarin and Merck are, together, the “Plaintiffs”) and Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd. (together, “DRL” or “Defendants”) hereby stipulate and agree that all claims, counterclaims and affirmative defenses asserted by Plaintiffs and Defendants against one another in the above-captioned consolidated action (the “Action”) are hereby dismissed without prejudice, and without costs, disbursements, or attorneys fees to any party.

2.This consolidated Action also involves claims between Plaintiffs and Par Pharmaceutical Inc. (see Case No. 3:15-cv-01706-MAS-JTB).  The Clerk is directed to enter this Stipulation of Dismissal, which addresses only Plaintiffs’ and DRL’s claims for relief against one another in Case No. 3:14-cv-07203-MAS-JTB, but not the claims of Plaintiffs and Par against each other in Case No. 3:15-cv-01706-MAS-JTB.  The Action will proceed on all claims as between Plaintiffs and Par.

IT IS on this ____ day of _______________, 2015: