EX-10.3 4 a17-10293_1ex10d3.htm EX-10.3 CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE OMISSIONS. EXECUTION VERSION SETTLEMENT AGREEMENT BY AND BETWEEN SUPERNUS PHARMACEUTICALS, INC....
Exhibit 10.3
CONFIDENTIAL MATERIALS OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ASTERISKS DENOTE OMISSIONS.
EXECUTION VERSION
BY AND BETWEEN
SUPERNUS PHARMACEUTICALS, INC.
AND
ACTAVIS LABORATORIES, FL, INC.,
ACTAVIS PHARMA, INC., and
XXXXXX LABORATORIES, INC.
DATED AS OF MARCH 13, 2017
THIS SETTLEMENT AGREEMENT, (this “Settlement Agreement”) is entered into as of March 13, 2017 (the “Effective Date”) by and between, Supernus Pharmaceuticals, Inc., a corporation organized and existing under the laws of Delaware, having offices located at 0000 Xxxx Xxxx Xxxxx, Xxxxxxxxx, Xxxxxxxx 00000, (“Supernus”), on the one hand, and Actavis Laboratories, FL, Inc., a corporation organized and existing under the laws of Florida having offices located at 000 Xxxxxxxxxx Xxxxxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000 (“AF”), Actavis Pharma, Inc., a corporation organized and existing under the laws of Delaware having offices located at 000 Xxxxxxxxxx Xxxxxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000 (“Actavis Pharma”), and Xxxxxx Laboratories, Inc., a corporation organized and existing under the laws of Nevada having offices located at 000 Xxxxxxxxxx Xxxxxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000 (“Xxxxxx Laboratories”) (collectively “Actavis”), on the other hand. Supernus and Actavis are collectively referred to herein as the “Parties,” or each individually as a “Party.”
RECITALS:
“Pending Litigation”);
WHEREAS, Supernus and Actavis wish to settle the Pending Litigation and have reached an agreement, encompassing the terms and conditions set forth in this Settlement Agreement together with a License Agreement (the “License Agreement,” attached hereto as Exhibit A), an agreed Stipulation of Dismissal (“Stipulation of Dismissal” attached hereto as Exhibit B), and an agreed Consent Judgment and Stipulation of Dismissal (the “Consent Judgment and Dismissal” attached hereto as Exhibit C, and with the Stipulation of Dismissal, Settlement Agreement, and the License Agreement being collectively referred to as the “Settlement Documents”);
WHEREAS, neither Supernus nor Actavis have received any consideration from the other for their entry into this Settlement Agreement other than that which is set forth in the Settlement Documents; and
7. Actavis ANDA; Actavis Product. Actavis represents and warrants that it has not granted or assigned to any Third Party, directly or indirectly, any right or license under or to the
Actavis ANDA or the Actavis Product, and covenants that it shall not do any of the foregoing, except in accordance with the License Agreement.
THE PARTIES ACKNOWLEDGE THAT THEY MAY HEREAFTER DISCOVER CLAIMS OR FACTS IN ADDITION TO OR DIFFERENT FROM THOSE WHICH THEY NOW KNOW OR BELIEVE TO EXIST WITH RESPECT TO THE RELEASED CLAIMS, THE FACTS AND CIRCUMSTANCES ALLEGED IN THE PENDING LITIGATION, AND/OR THE SUBJECT MATTER OF THIS SETTLEMENT AGREEMENT, WHICH, IF KNOWN OR SUSPECTED AT THE TIME OF EXECUTING THIS SETTLEMENT AGREEMENT, MAY HAVE MATERIALLY AFFECTED THIS SETTLEMENT AGREEMENT. NEVERTHELESS, UPON THE EFFECTIVENESS OF THE RELEASE OF THE RELEASED CLAIMS AS SET FORTH IN THIS SECTION ABOVE, THE PARTIES HEREBY ACKNOWLEDGE THAT THE RELEASED CLAIMS INCLUDE WAIVERS OF ANY RIGHTS, CLAIMS OR CAUSES OF ACTION THAT MIGHT ARISE AS A RESULT OF SUCH DIFFERENT OR
ADDITIONAL CLAIMS OR FACTS. THE PARTIES ACKNOWLEDGE THAT THEY UNDERSTAND THE SIGNIFICANCE AND POTENTIAL CONSEQUENCES OF SUCH A RELEASE OF UNKNOWN UNITED STATES JURISDICTION CLAIMS AND OF SUCH A SPECIFIC WAIVER OF RIGHTS. THE PARTIES INTEND THAT THE CLAIMS RELEASED BY THEM UNDER THIS RELEASE BE CONSTRUED AS BROADLY AS POSSIBLE TO THE EXTENT THEY RELATE TO UNITED STATES JURISDICTION CLAIMS. THE PARTIES ARE AWARE OF CALIFORNIA CIVIL CODE SECTION 1542, WHICH PROVIDES AS FOLLOWS:
“A general release does not extend to claims which the creditor does not know or suspect to exist in his or her favor at the time of executing the release, which if known by him or her, must have materially affected his or her settlement with the debtor.”
THE PARTIES AGREE TO EXPRESSLY WAIVE ANY RIGHTS THEY MAY HAVE UNDER THIS CODE SECTION OR UNDER FEDERAL, STATE OR COMMON LAW STATUTES OR JUDICIAL DECISIONS OF A SIMILAR NATURE, AND KNOWINGLY AND VOLUNTARILY WAIVE SUCH UNKNOWN CLAIMS.
[Signature Page Follows]
[Signature Page to Settlement Agreement Regarding Extended Release Topiramate Oral Capsule Product]
SUPERNUS PHARMACEUTICALS, INC. |
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[Signature Page to Settlement Agreement Regarding Extended Release Topiramate Oral Capsule Product]
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XXXXXX LABORATORIES, INC.
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EXHIBIT A
LICENSE AGREEMENT
BY AND BETWEEN
SUPERNUS PHARMACEUTICALS, INC.
AND
ACTAVIS LABORATORIES, FL, INC.,
ACTAVIS PHARMA, INC., and
XXXXXX LABORATORIES, INC.
DATED AS OF MARCH 13, 2017
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this “License Agreement”) is entered into as of March 13, 2017 (the “Effective Date”) by and between, Supernus Pharmaceuticals, Inc., a corporation organized and existing under the laws of Delaware, having offices located at 0000 Xxxx Xxxx Xxxxx, Xxxxxxxxx, Xxxxxxxx 00000, (“Supernus”), on the one hand, and Actavis Laboratories, FL, Inc., a corporation organized and existing under the laws of Florida having offices located at 000 Xxxxxxxxxx Xxxxxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000 (“AF”), Actavis Pharma, Inc., a corporation organized and existing under the laws of Delaware having offices located at 000 Xxxxxxxxxx Xxxxxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000 (“Actavis Pharma”), and Xxxxxx Laboratories, Inc., a corporation organized and existing under the laws of Nevada having offices located at 000 Xxxxxxxxxx Xxxxxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000 (“Xxxxxx Laboratories”) (collectively “Actavis”), on the other hand. Supernus and Actavis are collectively referred to herein as the “Parties,” or each individually as a “Party.”
RECITALS:
1.1 “Actavis” shall have the meaning assigned to such term in the preamble to this License Agreement.
1.2 “Actavis ANDA” shall mean ANDA No. 206210 (together with any amendments, supplements, replacements or other changes thereto) seeking approval to engage in the Manufacture, use and sale of an extended release oral capsule product containing the Compound as its sole active ingredient.
1.3 “Actavis **” means ** of ** of the **.
1.4 “Actavis **” means, with respect to the Actavis Product, (i) the costs of ** (including ** and **), **, **, ** and other costs directly incurred by Actavis in connection with the manufacture of the Actavis Product; (ii) ** and ** (including, without limitation, ** costs, **, **, **,
** This portion has been redacted pursuant to a confidential treatment request.
** and **, ** of the ** and ** of the **) attributable to the manufacture of the Actavis Product; and (iii) the costs of ** and ** acquired by Actavis in connection with the manufacture of the Actavis Product, ** of **, to the extent not included in clause (i); in each case in accordance with GAAP as reflected in Actavis’ or one of its Affiliates’ financial statements and as applied on a consistent basis and measured in United States dollars.
1.5 “Actavis License Date” means the ** of:
1.5.1 January 1, 2023;
1.5.2 the date of a ** all of the ** of the ** then ** and ** a ** with respect to a ** that have not ** to be ** or **;
1.5.3 the date of a ** all of the ** of the ** then ** and ** a ** with respect to a ** that have not ** to be ** by a ** that has received ** or **;
1.5.4 the ** date of any ** to the ** that ** to any ** to ** in the**;
1.5.5 the date of the ** by any ** of an ** in the **;
1.5.6 the date an ** is ** by ** or any ** in the **;
1.5.7 the date the ** are ** from the ** for **;
1.5.8 the date on which ** an ** for the ** of ** or ** that is not (i) “** of ** that can be **” as ** in the ** or (ii) otherwise ** or ** by the **; or
1.5.9 the date that is the ** of (A) the date that is the ** of (i) the ** following the close of a ** in which the ** of ** during such ** are at least ** than the ** of ** (defined as the ** of ** during any such ** quarter as ** by ** (whether reported ** or **) for the ** (defined as the ** in which the ** are **) for the immediately **, (ii) the day following the ** day of a ** that is, on a **, the ** during which the ** for ** has ** at least ** as ** the **, where such ** is as ** by ** for such ** period(s), or (iii) the day following the ** day of any **, ** period during which the ** of ** has declined **, in the **, during such ** period, where such ** is as ** by ** for each of the ** included in such ** and (B) **. The foregoing shall ** in the event such ** in ** can be ** to (i) ** and ** issues (**) or (ii) a ** or **. Supernus shall provide Actavis with prompt written notice of any such ** or ** which may be expected to ** a ** in **.
1.6 “Actavis Party” shall have the meaning assigned to such term in Section 7.1.
** This portion has been redacted pursuant to a confidential treatment request.
1.7 “Actavis Product” means an extended release oral capsule product containing the Compound as its sole active ingredient, which is the subject of the Actavis ANDA, including all formulations and strengths thereof, described therein now or hereafter.
1.8 “Affiliate” means, with respect to a Party, a Person that controls, is controlled by or is under common control with such Party. For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct the management and policies of such Person, whether by the ownership of fifty percent (50%) or more of the voting interest of such Person (it being understood that the direct or indirect ownership of a lesser percentage of such interest shall not necessarily preclude the existence of control), or by contract or otherwise.
1.9 “AG Product” means a product that is not Labeled with the Trokendi XR® trademark containing the Compound as its sole active ingredient that is Marketed or supplied under the Supernus NDA, described therein now or hereafter.
1.10 “ANDA” means an Abbreviated New Drug Application to the FDA for approval to Manufacture, and Market a pharmaceutical product in or for the Territory.
1.11 “Applicable Law” means the applicable Laws, rules, regulations, guidelines and requirements of any Governmental Authority related to the development, registration, Manufacture, Marketing or importation of the Actavis Product in or for the Territory or the performance of either Party’s obligations under this License Agreement.
1.12 “Authorized Generic ANDA Product” means a ** authorized, whether pursuant to a ** or **, for Marketing pursuant to an agreement between Supernus and a Third Party. For the avoidance of doubt, if Supernus enters into an agreement with a Third Party that ** the ** of a ** in the Territory, and such agreement includes a **, **, **, ** or the like with respect to ** of such **, such ** shall not be considered an ** by virtue of such **, **, **, ** or the like, provided such ** is no longer being Marketed in the Territory.
1.13 “Average Quarterly **” means the average of the ** during any **.
1.14 “Business Day” means any day other than a Saturday, Sunday or a day on which banks in New York, New York are authorized or required by Law to close.
1.15 “Claim” means any Third Party claim, lawsuit, investigation, proceeding, regulatory action or other cause of action.
1.16 “Calendar Quarter” means the period beginning on the Effective Date and ending on the last day of the calendar quarter in which the Effective Date falls, and thereafter each successive period of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31.
** This portion has been redacted pursuant to a confidential treatment request.
1.17 “Calendar Year” means the period beginning on the Effective Date and ending on December 31 of the year in which the Effective Date falls and thereafter each successive period of twelve (12) months commencing on January 1 and ending on December 31.
1.18 “Compound” means topiramate.
1.19 “Confidential Information” means any scientific, technical, formulation, process, Manufacturing, clinical, non-clinical, regulatory, Marketing, financial or commercial information or data relating to the business, projects, employees or products of either Party and provided by one Party to the other by written, oral, electronic or other means in connection with the Settlement Documents.
1.20 “**” means ** less (i) **, (ii) ** and (iii) ** and **.
1.21 “Covenant Not to Xxx” shall have the meaning assigned to such term in Section 3.4.
1.22 “Effective Date” shall have the meaning assigned to such term in the preamble to this License Agreement.
1.23 “**” means the number of Trokendi XR ** in the ** (whether ** or **).
1.24 “FDA” means the United States Food and Drug Administration or any successor agency thereof.
1.25 “Final Court Decision” means a final decision of any Federal court from which no appeal has been taken or can be taken within the time permitted therefor (other than a petition to the United States Supreme Court for a writ of certiorari).
1.26 “First Commercial Sale” means the Shipment by a Third Party of commercial quantities of product for immediate commercial sale to major retail chains, major pharmaceutical wholesalers, or managed care providers in the Territory, which Supernus determines in good faith to have occurred, based on independent and reliable information (including information gained from reliable sources in the trade).
1.27 “**” shall have the meaning assigned to such term in **.
1.28 “Force Majeure” means any circumstances reasonably beyond a Party’s control, including, acts of God, civil disorders or commotions, acts of aggression, terrorism, fire, explosions, floods, drought, war, sabotage, embargo, utility failures, supplier failures, material shortages, labor disturbances, a national health emergency, or appropriations of property.
1.29 “GAAP” means generally accepted accounting principles in effect in the United States from time to time, consistently applied.
** This portion has been redacted pursuant to a confidential treatment request.
1.30 “Generic Equivalent Product” means an extended release oral capsule product containing the Compound as its sole active ingredient which is submitted to the FDA for Regulatory Approval pursuant to an ANDA or 505(b)(2) application as a Therapeutic Equivalent to Trokendi XR. For clarity, Generic Equivalent Product shall not include AG Product.
1.31 “Governmental Authority” means any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of: (i) any government of any country; or (ii) a federal, state, province, county, city or other political subdivision thereof.
1.32 “**” Data shall mean ** data.
1.33 “Label” means any Package labeling designed for use with a product, including the package insert for such product that is approved by the FDA, and “Labeled” or “Labeling” shall have the correlated meaning.
1.34 “Law” or “Laws” means all laws, statutes, rules, codes, regulations, orders, judgments and ordinances of any Governmental Authority.
1.35 “Licensed Patents” means: (i) the Litigated Patents and any patent that issues as a result of a continuation, continuation-in-part, divisional, reexamination or reissue thereof; and (ii) any other present or future U.S., international, or foreign patent owned or controlled by Supernus or any of its Affiliates which claims cover the Actavis Product, including any patent that may be listed in the Orange Book as covering Trokendi XR extended release capsules or its uses now or in the future.
1.36 “Litigated Patents” shall have the meaning assigned to such term in the Settlement Agreement.
1.37 “Losses” means any liabilities, damages, costs or expenses, including reasonable attorneys’ fees and expert fees, incurred by any Party that arises from any claim, lawsuit or other action by a Third Party.
1.38 “Manufacture” means all activities related to the manufacturing, development and use of a pharmaceutical product, or any ingredient thereof, including, manufacturing Compound or supplies for development, manufacturing a product for commercial sale, packaging, in-process and finished product testing, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, ongoing stability tests and regulatory activities related to any of the foregoing, and “Manufactured” or “Manufacturing” shall have the correlated meaning.
1.39 “Market” means to distribute (including through multiple tiers of distribution), promote, advertise, market, offer for sale or sell or have sold, to a Third Party, and “Marketing” or “Marketed” shall have the correlated meaning.
** This portion has been redacted pursuant to a confidential treatment request.
1.40 “NDA” means a New Drug Application (or equivalent regulatory mechanism) filed with the FDA pursuant to and under 21 U.S.C. § 355(b) (as amended, supplemented or replaced), together with the FDA’s implementing rules and regulations.
1.41 “Net Sales” shall mean, with respect to the Actavis Product sold in the Territory, the ** by Actavis and its Affiliates on an arms-length basis to Third Parties in the Territory, ** the following **, all determined in accordance with ** for other pharmaceutical products, **:
1.41.1 ** of ** in the Territory to cover ** given by Actavis (and its Affiliates);
1.41.2 reasonable ** for any ** on account of **, **, **, **, **, or other similar ** affecting the product;
1.41.3 reasonable ** for **, **, **, **, and ** to ** and other **, **, **, **, **, other ** or ** or other **;
1.41.4 reasonable ** for amounts due to ** on account of **, including **, or other ** provided, based on ** by Actavis and its Affiliates to any ** or ** in respect of ** or **, ** or similar **;
1.41.5 reasonable ** for ** and ** to ** on account of **, **, ** or **;
1.41.6 any government mandated **, including, without limitation, the ** imposed pursuant to the ** (as amended or replaced);
1.41.7 the ** associated with any ** required ** and ** for the Actavis Product; and
1.41.8 other specifically identifiable amounts that have been ** or ** the Actavis Product’s ** and are substantially similar to those ** and ** listed above.
1.42 “Orange Book” means the “Approved Drug Products with Therapeutic Equivalence Evaluations” published by FDA.
1.43 “Package” means all primary containers, including bottles, cartons, shipping cases or any other like matter used in packaging or accompanying a product, and “Packaged” or “Packaging” shall have the correlated meaning.
1.44 “Party” or “Parties” shall have the meaning assigned to such term in the preamble to this License Agreement.
** This portion has been redacted pursuant to a confidential treatment request.
1.45 “** Quarter” means the ** in which the ** are ** in the immediately ** period.
1.46 “Pending Litigation” shall have the meaning assigned to such term in the Settlement Agreement.
1.47 “Person” means any individual, partnership, association, corporation, limited liability company, trust, or other legal person or entity.
1.48 “Regulatory Approval” means final Marketing approval by the FDA for the sale and Marketing of a pharmaceutical product in the Territory.
1.49 “Settlement Agreement” shall have the meaning assigned to such term in the Recitals.
1.50 “Shipped” means, with respect to a product, when a Person has delivered shipments of such product to a common carrier for shipment to such Person’s customers for resale; in each instance, a “Shipment,” “Ship” or “Shipping” shall have the correlated meaning.
1.51 “Supernus” shall have the meaning assigned to such term in the preamble to this License Agreement.
1.52 “Supernus NDA” means Supernus’ NDA No. 201635, as amended, or supplemented, for the Regulatory Approval of the product sold under the Trokendi XR® trademark or any successor trademark thereto.
1.53 “Supernus Party” shall have the meaning assigned to such term in Section 7.2.
1.54 “Supernus’ External Auditor” shall have the meaning assigned to such term in Section 4.8
1.55 “Tentative Regulatory Approval” means notification to an applicant by FDA that an ANDA is ready for Regulatory Approval .
1.56 “Term” shall have the meaning assigned to such term in Section 10.1.
1.57 “Territory” means the United States of America, and its territories, commonwealths, districts and possessions, including the Commonwealth of Puerto Rico.
1.58 “Therapeutic Equivalent” shall have the meaning given to it by the FDA in the current edition of the Orange Book as may be amended from time to time during the Term.
1.59 “Third Party” or “Third Parties” means any Person or entity other than a Party or its Affiliates.
** This portion has been redacted pursuant to a confidential treatment request.
1.60 “Third Party Agreement” shall have the meaning assigned to such term in Section 3.9.
1.61 “Trokendi XR” means the pharmaceutical product that contains the Compound as its sole active ingredient which is approved for Marketing pursuant to the Supernus NDA and is sold in the Territory under the Trokendi XR® or any successor trademark.
1.62 “TRO/PI” shall have the meaning assigned to such term in **.
1.63 “Wholesaler or API Affiliate” means a subsidiary or Affiliate of a Party whose primary business is wholesale distribution of pharmaceutical products or the production of active pharmaceutical ingredients for incorporation into Third Parties’ finished dosage products. For clarity, Actavis’ Wholesaler or API Affiliates as of the Effective Date are **, **, **, and **. Notwithstanding the foregoing or anything to the contrary in this License Agreement, a Wholesaler Affiliate or API Affiliate shall not be deemed an ** of ** for any purposes under this License Agreement.
2.1 Supernus hereby grants to Actavis and its Affiliates a non-exclusive, non-transferable (except as set forth in Section 10.3) license, without the right to sublicense, under the Licensed Patents to: (i) on and after the applicable **, to **, **, **, ** for **, ** and ** the ** in or for the **; (ii) starting ** to a reasonably anticipated **, to **, **, and/or ** the ** solely for the purpose of ** for a ** of such Actavis Product in or for the ** on the **; and (iii) starting ** to a reasonably anticipated **, to engage in ** including ** and ** in **, and enter into ** beginning ** to a reasonably anticipated **. To the extent Supernus owns or controls any regulatory exclusivities granted by the FDA that may prevent Regulatory Approval or Marketing of the Actavis Product Supernus hereby unconditionally and irrevocably waives, effective as of the date that Actavis is licensed to conduct the applicable activity hereunder, such regulatory exclusivities and shall, if requested by Actavis and if applicable, send the FDA a written confirmation of Supernus’ agreement to waive, effective as of the date that Actavis is licensed to conduct the applicable activity hereunder, such regulatory exclusivities with respect to the Actavis Product or the Actavis ANDA. Supernus will also cooperate with Actavis to submit a letter pursuant to 21 C.F.R. §314.94(a)(12)(v), attached hereto as Attachment A.
2.2 Except as set forth in Section 2.1 or expressly set forth in this License Agreement or other Settlement Documents, there are no authorizations, licenses or rights granted by either Party under this License Agreement, by implication, estoppel or otherwise, including any right granted to Actavis or its Affiliates to Market or Manufacture any Generic Equivalent Product except under the Actavis ANDA. All rights not expressly granted by Supernus herein are hereby retained by Supernus. In addition, except as expressly set forth in this License Agreement or other Settlement Documents, ** explicitly ** the ** itself or through an Affiliate to ** an **, and ** is ** to ** a ** the ** or, subject to the requirements of **, ** to any **.
** This portion has been redacted pursuant to a confidential treatment request.
3.1 Actavis and its Affiliates hereby agree not to Market Actavis Product in the Territory prior to the applicable Actavis License Date, except pursuant to Sections 2.1(ii) and 2.1(iii). For the avoidance of doubt, nothing in this Section 3.1 (or any other provision of the Settlement Documents) shall in any way preclude or prohibit (i) any act reasonably related to obtaining FDA approval of the Actavis ANDA, (ii) any act protected by 35 U.S.C. § 271(e)(1), (iii) the manufacturing of batches of Actavis ANDA Products necessary for FDA approval (e.g., ** for the purposes of **), or (iv) ** or ** from ** or ** or ** at any time or ** the ** to any ** for ** into a **. The foregoing shall not be interpreted or construed as the ** of any ** or ** to any ** or **, and ** shall be ** to pursue **, including **, ** any of ** or ** that ** or ** a ** or ** that is not ** or ** by **.
3.2 Actavis shall not assist, coordinate with, or otherwise help any Third Parties in prosecuting, defending, or settling such Third Parties’ litigations concerning such Third Parties’ ANDAs to Market Generic Equivalent Product, except as required by Law. Actavis and its Affiliates hereby agree not to (i) subject to subsection (B) below, which allows Actavis to challenge the validity or enforceability of a Litigated Patent (including but not limited to a petition for ex parte reexamination, Inter Partes Review (IPR), and Post Grant Review (PGR)) asserted against Actavis or its Affiliates with respect to a product other than the Actavis Product or a Generic Equivalent Product, challenge the validity or enforceability of the Litigated Patents (including but not limited to a petition for ex parte reexamination, Inter Partes Review (IPR), and Post Grant Review (PGR)); (ii) aid, abet, assist, enable or participate with any Third Party in a challenge to the validity or enforceability of the Litigated Patents or the non-infringement by a Generic Equivalent Product of the Litigated Patents in or for the Territory; (iii) Market or Manufacture a Generic Equivalent Product other than the Actavis Product pursuant to the License and Authorization; or (iv) aid, abet, enable or contract with any Third Party regarding the Marketing or Manufacturing of any Generic Equivalent Product in or for the Territory other than the Actavis Product. Nothing in this Section 3.2 or elsewhere in this Agreement shall preclude Actavis or its Affiliates from (A) asserting any claim or counterclaim challenging the validity, enforceability, or infringement of any patents or patent applications
** This portion has been redacted pursuant to a confidential treatment request.
other than the Licensed Patents or (B) in the event Supernus or its Affiliates initiate suit against Actavis or its Affiliates alleging that a product other than the Actavis Product or a Generic Equivalent Product infringes the Litigated Patents, challenging the validity or enforceability of the Litigated Patent(s) (including but not limited to a petition for ex parte reexamination, Inter Partes Review (IPR), and Post Grant Review (PGR)) asserted against Actavis or its Affiliates with respect to a product other than the Actavis Product or a Generic Equivalent Product. Notwithstanding the foregoing, nothing in this Agreement precludes Actavis from (y) maintaining and/or (e.g., in the case of a recertification pursuant to 21 C.F.R.§ 314.96(d)) filing Paragraph IV certifications with respect the Actavis ANDA against the Licensed Patents, or (z) challenging the validity, enforceability and/or infringement of the Licensed Patents in connection with another ANDA or ANDA product owned or sold by Actavis that is not seeking Regulatory Approval of a Generic Equivalent Product.
3.3 Nothing set forth herein or in the other Settlement Documents shall be deemed to give Supernus any control over any Marketing exclusivity that may be granted to Actavis by the FDA in connection with the Actavis ANDA or the Actavis Product. Nothing set forth herein or in the other Settlement Documents shall be deemed to prevent or restrict Actavis from Manufacturing or Marketing any Generic Equivalent Product which would not infringe the Licensed Patents, and nothing herein shall prohibit Actavis from entering into any agreement with a Third Party related to any Generic Equivalent Product that does not infringe the Licensed Patents.
3.6 Supernus and its affiliates shall not ** or ** to ** with the FDA approval of the Actavis ANDA, or the ** of the ** as of the License Effective Date, including by: (i) **, **, **
** This portion has been redacted pursuant to a confidential treatment request.
as “**” or ** the ** prior to the ** after ** of the ** in the **; (ii) ** or ** any ** with respect to the ** from the **; (iii) ** for ** prior to the ** of the ** in the **; (iv) **, **, ** to **, or otherwise ** the ** of the ** (** due to a ** or ** issue) prior to ** of the ** in the **; (v) ** or otherwise ** any ** with the ** to ** any of the ** from the ** (** due to a ** or ** issue) prior to the ** after ** of the ** in the **; or (vi) filing any ** with the ** relating to ** the sole purpose of which is to ** in ** of the **.
3.7 Unless required or requested by the **, including in connection with any ** as referenced in the ** from ** to **, Supernus hereby covenants that, on or prior to the ** the **, neither Supernus nor any of its Affiliates will ** for ** the ** to **, **, **, ** or ** any ** of the ** in the ** other than the ** in the **.
3.8 Actavis and its Affiliates will not release (including any oral or written release or waiver of any right) or grant a waiver of conflict of interest or otherwise take any action which would allow or permit any attorney (including any of the attorneys or law firms of record in the Pending Litigation) or any expert, agent, or consultant (whether retained by Actavis, its affiliates, or by any attorney that represents Actavis) to: (i) assist, or cooperate with, any Third Party (including any current or future litigant in a litigation against Supernus) with respect to a Generic Equivalent Product, or (ii) take any action on behalf of a Third Party which, if taken by Actavis, would be prohibited.
3.10 Effect of a ** for **, ** and **. Should a ** be deemed to be a “**” (as defined in **) with respect to the **, ** and **, and such ** be deemed by ** to have ** its **, then Actavis will be a ** of ** (** as to **) for the **, ** and ** for the first ** that such ** or is otherwise entitled to sell its **, ** and **, by **, **, or **. At ** option upon written notice delivered to Supernus no ** than ** after the launch by the **, ** shall continue to ** on a ** for a period of up to ** from the date of the ** with **, ** and ** on a ** and upon ** agreed to by ** and **. Such ** may be ** upon ** by the Parties. The ** for ** will be ** in favor of **. Within ** to the ** of this **, or any **, the Parties agree to discuss in good faith a mutually agreeable ** to the ** or **, as applicable. All other terms and conditions for ** of ** will be set forth in an ** to be negotiated in good faith by the Parties. The Parties agree to negotiate and execute a ** governing the ** within ** of the execution of this Agreement. Notwithstanding the foregoing, this Section 3.11 in no way ** or ** the ** of any **.
3.11 ** to the Actavis License Date, Supernus will provide written notice to Actavis within ** each time either (i) Supernus submits a document to FDA seeking a change in the label for Trokendi XR, including any specific labeling amendments or supplements to the Supernus NDA or (ii) FDA communicates to Supernus a suggestion or directive to make a
** This portion has been redacted pursuant to a confidential treatment request.
change to the label for Trokendi XR. In each case such notice shall include the text of the proposed or directed label change.
3.12 Actavis shall use commercially reasonable efforts to obtain Regulatory Approval of the Actavis ANDA.
4. Marketing of Actavis Product
4.1 Actavis shall, at its sole cost and expense, utilize commercially reasonable efforts in Marketing the Actavis Product in the Territory to maximize sales of the Actavis Product. Actavis will have sole discretion, however, in setting the price for the sale of the Actavis Product in the Territory.
4.2 Only Actavis and its Affiliates shall be permitted to Market Actavis Product under this License Agreement.
4.3.1 ** of ** on Actavis Product sold (as determined by ** for other pharmaceutical products, **) during any period when the ** is only ** or **;
4.3.2 ** of ** on Actavis Product sold (as determined by ** for other pharmaceutical products, **) during any period when the Actavis Product is ** with ** or **;
4.3.3 ** of ** on Actavis Product sold (as determined by ** for other pharmaceutical products, **) during any period when the Actavis Product is ** with ** or **;
4.3.4 ** of ** on Actavis Product sold when there are ** or **;
4.3.5 Notwithstanding Sections 4.3.1 through 4.3.4, with respect to any Actavis Product sold pursuant to Actavis’ Restricted Right of Entry set forth in Section 2.5 of this Term Sheet, Actavis will pay a ** on the ** of such Actavis Product of **. For clarity, such ** shall ** to ** to any Actavis Product sold ** any applicable **.
4.5 ** True-Up. Within ** after the end of each ** during the Term in which fees are payable to Supernus pursuant to this Section 4, Actavis shall perform a “true up”
** This portion has been redacted pursuant to a confidential treatment request.
reconciliation (and shall provide Supernus with a written report of such reconciliation) of the ** outlined in the definition of “**.” The reconciliation shall be based on ** or ** an ** for any ** related to the product, but ** at the ** of the ** year. If the foregoing reconciliation report shows either an underpayment or an overpayment between the Parties, the Party owing payment to the other Party shall pay the amount of the difference to the other Party within ** after the date of delivery of such report.
4.6 ** True-Up. Within ** of the end of the last ** during the Term in which fees are payable to Supernus pursuant to this Section 4, Actavis shall perform a “true-up” reconciliation (and shall provide Supernus with a written report of such reconciliation) of the items comprising ** from **. If the foregoing reconciliation report shows either an underpayment or an overpayment between the Parties, the Party owing payment to the other Party shall pay the amount of the difference to the other Party within ** after the date of delivery of such report.
4.9 Inspection Costs. Supernus shall be solely responsible for its and Supernus’ External Auditor’s costs in making any such review and audit, unless Supernus’ External Auditor identifies a discrepancy, inuring to Supernus’ benefit, in the calculation of royalties paid to Supernus under this License Agreement in any calendar year from those
** This portion has been redacted pursuant to a confidential treatment request.
properly payable for that calendar year of ** or greater, in which event Actavis shall be solely responsible for the reasonable cost of such review and audit and shall pay such auditor any payment due. All information disclosed by Actavis or its Affiliates pursuant to this Section 4 shall be deemed Confidential Information.
5.1.1 at the time of disclosure by one Party to the other, in the public domain or otherwise publicly known;
** This portion has been redacted pursuant to a confidential treatment request.
5.1.2 after disclosure by one Party to the other becomes part of the public domain, other than by breach by a Party of any obligation of confidentiality;
5.1.3 information which the receiving Party can establish by competent evidence was already in its possession at the time of receipt or was independently developed by the receiving Party; or
5.1.4 received from a Third Party who was lawfully entitled to disclose such information free of an obligation of confidentiality.
6. Representations and Warranties of Parties
Supernus represents and warrants to Actavis that Supernus possess the rights and authority to grant the licenses set forth herein to Actavis and its Affiliates and, with respect to Sections 6.1 and 6.2 below, each of Supernus and Actavis represents, warrants, and covenants, to the other Party that:
perform all of its obligations hereunder. The execution and delivery of the Settlement Documents and the performance by such Party of its obligations hereunder have been authorized by all requisite action on its part. The Settlement Documents have been validly executed and delivered by such Party, and, assuming that such documents have been duly authorized, executed and delivered by the other Party, constitutes a valid and binding obligation of such Party, enforceable against such Party in accordance with its terms.
6.2 Consents and Approvals; No Violations.
6.2.1 Except as otherwise set forth in this License Agreement or other Settlement Documents, no material filing with, and no material permit, authorization, consent, or approval, of or from any Governmental Authority is required to be obtained by or on behalf of such Party with respect to the transactions contemplated by the Settlement Documents, except for those filings, permits, authorizations, consents or approvals, the failure of which to be made or obtained would not materially impair such Party’s ability to consummate the transactions contemplated hereby or materially delay the consummation of the transactions contemplated hereby.
6.2.2 Neither the execution nor the delivery of the Settlement Documents by such Party, nor the performance by such Party of its obligations hereunder, will (i) violate the certificate of incorporation, certificate of formation, by-laws or other organizational document of such Party; (ii) conflict in any material respect with or result in a material violation or breach of, or constitute a material default under, any material contract, agreement or instrument to which such Party is a party; or (iii) violate or conflict in any material respect with any material Law applicable to such Party.
7. Indemnities; Product Liability; Insurance
7.1.1 any Claim resulting from any acts of ** or ** of any Supernus Party in connection with the performance of its obligations under this License Agreement; or
7.1.2 the breach by Supernus of any of its representations or warranties contained in this License Agreement,
except, in each case, to the extent such Losses are caused by the breach of the terms of this License Agreement, or the gross negligence or willful misconduct of a Actavis Party.
** This portion has been redacted pursuant to a confidential treatment request.
7.2.1 any Claim resulting from any acts of ** or ** of any Actavis Party in connection with the performance of its obligations under this License Agreement;
7.2.2 any Claim based on or arising out of the **, **, **, ** or ** of Actavis Product, including, any ** by a ** or any ** for ** or ** by any ** Actavis Product; or
7.2.3 the breach by Actavis of any of its representations or warranties contained in this License Agreement,
except, in each case, to the extent that such Losses are caused by the breach of the terms of this License Agreement, or the ** or ** of a Supernus Party. The Parties agree that the foregoing indemnities shall expressly exclude Claims based on a ** to ** where Actavis’ product was ** by ** to have, and in fact had, ** or ** information that was the “**” (as that term is used in **) as Supernus’ ** and ** information.
7.5 Claim Information. Each Party shall promptly:
7.5.1 inform the other by written notice of any actual or threatened Claim to which Sections 7.1 or 7.2 apply;
7.5.2 provide to the other Party copies of all papers and official documents received in respect of any such Claim; and
** This portion has been redacted pursuant to a confidential treatment request.
7.5.3 cooperate as reasonably requested by the other Party in the defense of any such Claim, provided any actual out of pocket costs incurred in connection with such cooperation shall be at the expense of the indemnifying Party.
8.1 This License Agreement conveys no rights to either Party to use any trademark or trade dress of the other Party, and conveys no rights to any other intellectual property of either Party other than pursuant to the licenses granted expressly herein.
9.2.1 the other Party commits a material breach of this License Agreement, and fails to remedy it within ninety (90) days of receipt of notice from the first Party of such breach and of its intention to exercise its rights under this Section 10.2; or
9.2.2 an order is made or a resolution is passed for the winding up of the other Party (other than voluntarily for the purposes of solvent amalgamation or reconstruction) or an order is made for the appointment of an administrator to manage the other Party’s affairs, business and property or if a receiver (which expression shall include an administrative receiver) is appointed over any of the
other Party’s assets or undertaking or if circumstances arise which entitle the court or a creditor to appoint a receiver or manager or which entitle the court to make a winding-up order or if a voluntary arrangement is proposed in respect of the other Party or if the other Party takes or suffers any similar or analogous action in consequence of debt, and such order, appointment or similar action is not removed within ninety (90) days.
10.1.1 Any notice or other document given under the Settlement Documents shall be in writing in the English language and shall be given by hand or sent by prepaid overnight mail, or by confirmed fax transmission to the address of the receiving Party as set out in Section 10.2 below unless a different address or fax number has been notified to the other in writing for this purpose.
10.1.2 Each such notice or document shall:
(i) if sent by hand, be deemed to have been given when delivered at the relevant address;
(ii) if sent by prepaid mail, be deemed to have been given five (5) days after posting; or
** This portion has been redacted pursuant to a confidential treatment request.
(iii) if sent by confirmed fax transmission be deemed to have been given when transmitted, provided that, a confirmatory copy of such fax or other electronic method of transmission shall have been sent by prepaid overnight mail within one (1) Business Day of such transmission.
To Supernus
Supernus Pharmaceuticals, Inc.
0000 Xxxx Xxxx Xxxxx
Xxxxxxxxx, XX 00000
Attn: President
Fax: **
with a copy to:
Xxxxx X. Xxxx
XXXX PARTNERS LLP
000 Xxxxx Xxxxxx
Xxx Xxxx, XX 00000
Fax: (000) 000-0000
To Actavis
Xxxxx X. Xxxxx
SVP and Chief IP Counsel
Teva Pharmaceuticals USA, Inc.
000 Xxxxxx Xx.
Xxxxxx, XX 00000
with a copy to:
Xxx X. Xxxxxxxxx
Xxxxxxxx & Xxxxx LLP
000 Xxxxxxxxx Xxxxxx
Xxx Xxxx, XX 00000
Fax: (000) 000-0000
10.3.1 Subject to Section 10.3.2, neither Party shall assign or transfer any of its rights or obligations under the Settlement Documents without the prior written consent of the other Party, not to be unreasonably withheld or delayed.
** This portion has been redacted pursuant to a confidential treatment request.
10.3.2 Each Party shall be entitled, without prior written consent of the other Party, to assign all, but not less than all, of its rights or obligations under the Settlement Documents to an Affiliate or transfer such rights and obligations to a successor entity by way of merger or acquisition of substantially all of the assets of such Party (whether by consolidation, sale of assets, or otherwise); provided the Affiliate or other successor entity expressly assumes in writing those rights, duties and obligations under the Settlement Documents and the Affiliate or other successor is a financially capable business entity. The assignment of the Settlement Documents by Actavis and its Affiliates shall not in any way affect Actavis’s or its Affiliates’ duties, obligations and admissions in the Settlement Documents.
10.3.3 Subject to the foregoing, the Settlement Documents shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns. Any assignment or transfer in contravention of the terms of the Settlement Documents shall be null and void.
confidential (and such additional information as may be permitted pursuant to remainder of this Section 10.5.
10.7 Governing Law. The Settlement Documents shall be governed by the Laws of the State of New York without regard to the conflicts of law provisions thereof. The Parties irrevocably agree that the Court (as such term is defined in the Settlement Agreement) shall have exclusive jurisdiction to deal with any disputes arising out of or in connection with the Settlement Agreement. The Parties irrevocably agree that the United States District Court for the Southern District of New York shall have exclusive jurisdiction to deal with any disputes arising out of or in connection with this License Agreement and that, accordingly, any proceedings arising out of or in connection with this License Agreement shall be brought in the United States District Court for the Southern District of New York. Notwithstanding the foregoing, if there is any dispute for which the United States District Court for the Southern District of New York does not have subject matter jurisdiction, the state courts in the county and state of New York shall have jurisdiction. In connection with any dispute arising out of or in connection with this License Agreement, each Party (i) hereby expressly consents and submits to the personal jurisdiction of the federal and state courts in the State of New York and (ii) hereby irrevocably waives any right to a trial by jury.
[Signature Page Follows]
[Signature Page to Settlement Agreement Regarding Extended Release Topiramate Oral Capsule Product]
SUPERNUS PHARMACEUTICALS, INC. | ||
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[Signature Page to Settlement Agreement Regarding Extended Release Topiramate Oral Capsule Product]
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SVP Global Business Development |
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Attachment A
to
License Agreement
Draft Language for FDA Side Letter
Dear [FDA],
Pursuant to 21 C.F.R. §314.94(a)(12)(v), Supernus Pharmaceuticals, Inc. together with Actavis Laboratories FL, Inc. (collectively the “Parties”) write to inform the United States Food and Drug Administration (“FDA”) that the Parties have reached a settlement concerning the following litigation pending in the United States District Court for the District of New Jersey: Supernus Pharmaceuticals, Inc. v. Actavis, Inc. et al, (Civil Action No. 2:14-cv-06102-SDW-SCM) concerning ANDA No. 206210.
The terms of the settlement are confidential. However, provided that Actavis and Supernus abide by the settlement terms, no patent disputes between the Parties would prevent FDA from granting final approval to that ANDA
EXHIBIT B
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
SUPERNUS PHARMACEUTICALS, INC. | |||
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Plaintiff, |
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C.A. No. 2:14-cv-06102-SDW-SCM |
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v. |
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ACTAVIS, INC., xx.xx. |
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This action for patent infringement having been brought by Plaintiff Supernus Pharmaceuticals, Inc. (“Supernus”) against Defendants Actavis, Inc. (n/k/a Allergan Finance LLC), Actavis plc (n/k/a Allergan plc), Actavis Laboratories FL, Inc., Actavis Pharma, Inc., Xxxxxx Laboratories, Inc. and ANDA, Inc. .
Supernus and Actavis consent to this Judgment and Order.
IT IS HEREBY ORDERED, ADJUDGED AND DECREED:
1. Actavis, Inc. (n/k/a Allergan Finance LLC), Actavis plc (n/k/a Allergan plc), and ANDA, Inc. are dismissed from the case and are not parties to the Consent Judgment and Stipulation of Dismissal that has been or will be filed between the remaining parties.
2. Each party shall bear its own costs and attorneys’ fees with respect to the matters dismissed hereby.
XXXX XXXXX LLP |
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XXXXX XXXXX X’XXXXXX XXXXXXX LLP | ||
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Xxxxxxx X. Xxxxx |
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Xxxx X. Xxxxx | ||
Xxxxxxx X. Baton |
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Xxxxxxxxx X. Xxxxxx | ||
Xxxxx X. Xxxxxxxx |
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Xxxxxxxx Xxxxx-Xxxxx | ||
One Riverfront Plaza, Suite 1520 |
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XXXXX XXXXX X’XXXXXX XXXXXXX LLP | ||
Newark, NJ 07102-5426 |
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Xxx Xxxxxxxxxx Xxxxx | ||
xxxxxx@xxxx.xxx |
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Of Counsel |
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Attorneys for Defendants Actavis | ||
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Laboratories, FL, Inc., Actavis Pharma, Inc., | ||
Xxxxx X. Xxxx |
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Xxxxxx Laboratories, Inc. and ANDA, Inc. | ||
Xxxxxx Xxxxxxx, Ph.D. |
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Attorneys for Plaintiff Supernus |
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Pharmaceuticals, Inc. |
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SO ORDERED |
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Dated: |
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THE XXX. XXXXX X. XXXXXXXX | ||
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UNITED STATES DISTRICT JUDGE | ||
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EXHIBIT C
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
SUPERNUS PHARMACEUTICALS, INC. | |||
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C.A. No. 2:14-cv-06102-SDW-SCM |
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CONSENT JUDGMENT AND STIPULATION OF DISMISSAL
This action for patent infringement having been brought by Plaintiff Supernus Pharmaceuticals, Inc. (“Supernus”) against Defendants Actavis Laboratories FL, Inc., Actavis Pharma, Inc., Xxxxxx Laboratories, Inc. (collectively, “Actavis”).
Supernus and Actavis consent to this Judgment and Order.
IT IS HEREBY ORDERED, ADJUDGED AND DECREED:
1. The U.S. Patent Nos. 8,298,576, 8,298,580, 8,663,683, and 8,889,191, and all the claims contained therein, are not infringed by the product described in ANDA No. 206210.
2. All affirmative defenses, claims and counterclaims which have been or could have been raised by Supernus and Actavis in this action with respect to U.S. Patent Nos. 8,877,248 and 8,992,989 are dismissed with prejudice.
3. Each party shall bear its own costs and attorneys’ fees with respect to the matters dismissed hereby.
XXXX XXXXX LLP |
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Xxxxxxx X. Baton |
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Xxxxxxxxx X. Xxxxxx | ||
Xxxxx X. Xxxxxxxx |
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Xxxxxxxx Xxxxx-Xxxxx | ||
One Riverfront Plaza, Suite 1520 |
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XXXXX XXXXX X’XXXXXX XXXXXXX LLP | ||
Newark, NJ 07102-5426 |
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Xxx Xxxxxxxxxx Xxxxx | ||
xxxxxx@xxxx.xxx |
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xxxxxx@xxxx.xxx |
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Of Counsel |
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Attorneys for Defendants Actavis | ||
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Laboratories, FL, Inc., Actavis Pharma, Inc., | ||
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Xxxxxx Laboratories, Inc. and ANDA, Inc. | ||
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XXXX PARTNERS LLP |
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Attorneys for Plaintiff Supernus |
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Pharmaceuticals, Inc. |
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SO ORDERED |
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Dated: |
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THE XXX. XXXXX X. XXXXXXXX | ||
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UNITED STATES DISTRICT JUDGE | ||