License Agreement, dated January 13, 2022, by and among MSN Pharmaceuticals Inc., MSN Laboratories Private Limited, Impax Laboratories LLC and the registrant

Contract Categories: Intellectual Property - License Agreements
EX-10.1 2 vndaex101msnlicenseagreeme.htm EX-10.1 Document
EXHIBIT 10.1
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND IS OF THE TYPE THAT VANDA TREATS AS PRIVATE OR CONFIDENTIAL. SUCH EXCLUDED INFORMATION HAS BEEN MARKED WITH “[***].”
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this “Agreement”) dated as of January 13, 2022 (the “Effective Date”) is entered into between Vanda Pharmaceuticals Inc., a Delaware corporation with an address at 2200 Pennsylvania Avenue, N.W., 300E, Washington, DC 20037, on behalf of itself and its Affiliates (collectively, “Vanda”), MSN Pharmaceuticals Inc., a corporation organized and existing under the laws of Delaware, with a place of business at 20 Duke Road, Piscataway, New Jersey 08854, and MSN Laboratories Private Limited, a corporation organized and existing under the laws of India, with a place of business at MSN House, Sy No: 10 & 11 Whitefields, HITEC City, Hyderabad, Telangana, India 500081, on behalf of themselves and each of their Affiliates (collectively, “MSN”), and Impax Laboratories LLC (f.k.a. Impax Pharmaceuticals, Inc.), a limited liability company organized and existing under the laws of Delaware, with a place of business at 400 Crossing Boulevard, Third Floor, Bridgewater, NJ 08807, on behalf of itself and its Affiliates (collectively “Impax”).
WHEREAS Vanda is the owner of the Patent Rights (as the term is defined below) and has sued MSN in the actions captioned Vanda Pharmaceuticals Inc. v. MSN Pharmaceuticals Inc. et al., Case Nos. 1:18-cv-690 (CFC), 1:19-cv-926 (CFC), 1:20-cv-235 (CFC), 1:20-cv-318 (CFC), 1:20-cv-1334 (CFC), and 1:21-cv-00283 (CFC) (the “Litigation”) which is pending in the United States District Court, District of Delaware (the “Court”), in which Vanda alleges that MSN’s filings of Abbreviated New Drug Application (“ANDA”) No. 211654 infringes U.S. Patent Nos. RE46,604, 9,060,995, 9,539,234, 9,549,913, 9,730,910, 9,855,241, 10,149,829, 10,071,977, 10,376,487, 10,449,176, 10,610,510, 10,610,511, 10,829,465, and 10,611,744 (“the asserted patents”);
WHEREAS Impax and MSN are Parties to a certain Finished Dosage Development, Commercial Supply and Distribution Agreement dated as of February 12, 2018 (the “Supply Agreement”), which grants to Impax an exclusive license to use, import, offer for sale, sell and have sold Generic Product under MSN’s ANDA No. 211654;
WHEREAS the Supply Agreement grants Impax the authority to control the Litigation, negotiate settlement terms and settle the Litigation; and
WHEREAS the parties desire to settle the Litigation and MSN and Impax desire to receive, and Vanda desires to grant to MSN and Impax, a non-exclusive, [***] license under the Patent Rights to make, use, sell, offer for sale and import Generic Product (as the term is defined below), all on the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:








1.DEFINITIONS.
1.1Affiliate” means, with respect to any entity, any other entity that directly or indirectly controls, is controlled by, or is under common control with, such entity. An entity shall be regarded as in control of another entity if it owns, or directly or indirectly controls, at least fifty percent (50%) of the voting stock or other ownership interest of the other entity, or if it directly or indirectly possesses the power to direct or cause the direction of the management and policies of the other entity by any means whatsoever.
1.2[***]” shall mean [***] (as defined below).
1.3Authorized Generic” shall mean any product that is sold, offered for sale or distributed in the United States pursuant to NDA No. [***] but not under the Hetlioz® tradename or another trademark or tradename owned by Vanda or its Affiliates.
1.4Business Day” shall mean any day other than a Saturday, a Sunday or a day on which the state or federal courts located in the State of Delaware are authorized or obligated by law or executive order to be closed.
1.5Confidential Information” means all non-public materials, information and data concerning the disclosing party and its operations that is disclosed by the disclosing party to the receiving party pursuant to this Agreement, orally or in written, electronic or tangible form, or otherwise obtained by the receiving party through observation or examination of the disclosing party’s operations. Confidential Information includes, but is not limited to, information about the disclosing party’s financial condition and projections; business, marketing or strategic plans; sales information; customer lists; price lists; databases; trade secrets; product prototypes and designs; techniques, formulae, algorithms and other non-public process information. Notwithstanding the foregoing, Confidential Information of a party shall not include that portion of such materials, information and data that, and only to the extent, that the recipient can establish by written documentation: (a) is known to the recipient as evidenced by its written records before receipt thereof from the disclosing party, (b) is disclosed to the recipient free of confidentiality obligations by a Third Party who has the right to make such disclosure without obligations of confidentiality, (c) is or becomes part of the public domain through no fault of the recipient, or (d) the recipient can reasonably establish is independently developed by persons on behalf of recipient without the use of the information disclosed by the disclosing party.
1.6Hetlioz Product” means the form, formulation, and dosage of the current FDA-approved Hetlioz® capsule product listed on Exhibit A. For the avoidance of doubt, the Hetlioz Product shall not include [***].
1.7FDA” means the United States Food and Drug Administration or any successor entity thereto.
1.8“Generic Product” means—regardless of whether a product is considered generic, branded, private-labeled or otherwise—a product for which FDA approval is sought as, or that has been deemed by FDA to be, bioequivalent to the Hetlioz Product and has the same strength and dosage form as the Hetlioz Product. For the avoidance of doubt, “Generic Product” does not include the Hetlioz Product itself but does include any Authorized Generic.
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1.9Orange Book” means the current edition (in electronic or hard copy form) of the FDA’s publication Approved Drug Products with Therapeutic Equivalence Evaluations, as may be amended from time to time, and any successor publication thereto.
1.10Patent Rights” means (a) the patents listed on Exhibit B to this Agreement and the patent applications giving rise thereto, (b) all provisional applications, divisionals, continuations, continuations-in-part, reissues and renewals that claim priority to, or common priority with, any patent application that resulted in the patents described in clause (a) above, and all patents granted thereon, (c) all patents that have issued or in the future issue from any of the foregoing patent applications, including utility, model and design patents and certificates of invention, together with any reexamination certificates (including any amended claims from an inter partes review or post-grant review proceeding), reissues, renewals, extensions, and extended exclusivities or restorations by existing or future extension or restoration mechanisms, or additions thereto, and (d) all other relevant patents and patent applications, if any, that cover the Hetlioz Product or an approved use of the Hetlioz Product.
1.11Third Party” means any person or entity other than Vanda, MSN or Impax or their respective Affiliates.
1.12“Trigger Date” means, with respect to a Generic Product for which MSN has an approved ANDA, on a Generic-Product-by-Generic-Product basis, the earliest of:
(a)    March 13, 2035; provided however, that if Vanda obtains pediatric exclusivity pursuant to 21 U.S.C. § 355A, then the date for purposes of this subsection 1.12(a) shall be July 27, 2035;
(b)    the date on which (i) a final decision by a court from which no appeal can be taken, other than a petition for a writ of certiorari, is entered such that all of the then-asserted claims within the Patent Rights as to such Generic Product are finally held to be unpatentable or invalid or unenforceable or not infringed by the applicable Generic Product or have lapsed (for the avoidance of doubt, a court of appeals’ judgment or order is not “final” until issuance of the mandate); (ii) the last to expire patent containing a then-asserted claim within the Patent Rights as to such Generic Product, which claim has not been finally held to be unpatentable or invalid or unenforceable or not infringed by the applicable Generic Product, expires or lapses; or (iii) a final decision by the U.S. Patent and Trademark Office, from which no appeal can be taken, is entered such that all of the claims within the Patent Rights as to such Generic Product are finally held to be unpatentable or invalid or unenforceable or have lapsed (for the avoidance of doubt, a court of appeals’ judgment or order is not “final” until issuance of the mandate);
(c)    the date on which such Generic Product is first sold in the United States by a Third Party that holds or is otherwise licensed under an approved ANDA to manufacture and/or sell such Generic Product in the United States (“Third Party ANDA Holder”) after the Effective Date, provided that (i) [***] , and (ii) [***] either (A) [***] , or (B) [***], then in each case of clauses (A) and (B) [***];


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(d)    the first date when such Generic Product is licensed to be sold in the United States by a Third Party who is under authority or license of Vanda; and
(e)    the first date an Authorized Generic is licensed to be sold in the United States.
[***] shall not constitute [***], provided that [***], if: (i) [***], (ii) [***], and (iii) [***].
If [***] with any [***] and such [***] in order to [***].
1.13United States” means the United States of America, including its territories and possessions.
1.14Valid Claim” means a claim in an issued patent within the Patent Rights that has not (a) expired; (b) been disclaimed (but, if terminally disclaimed, only after the patent to which the terminal disclaimer is tied has expired); (c) been declared invalid or unenforceable in a final decision of a court, or (d) been declared invalid or unenforceable in a final decision by the U.S. Patent and Trademark Office, from which no appeal can be taken (for the avoidance of doubt, a court of appeals’ judgment or order is not “final” until issuance of the mandate).
1.15Vanda NDA” means the New Drug Application [***] and any supplements or amendments thereto.
2.RELEASE; PATENT RIGHTS; COVENANTS.
2.1Release. MSN and Impax, on their own behalves and on behalf of any person or entity within their respective control or with whom they contract in any way with respect to the ANDA and/or any Generic Product, represent and warrant that, as of the Effective Date, neither MSN nor Impax nor any person or entity within their control or with whom they have contracted with respect to the ANDA and/or Generic Product, has manufactured, used, sold, offered for sale, imported or distributed in the United States any Generic Product except for purposes that would not constitute infringement of the Patent Rights as a result of the application of 35 U.S.C. § 271(e)(1). In consideration for the covenants set forth in this Agreement, and in reliance on the representation and warranty in the preceding sentence, Vanda hereby as of the Effective Date fully, finally, and irrevocably releases MSN, Impax [***] (collectively, the “MSN Releasees”) from all claims and other Losses (as that term is defined below) arising from the manufacture, use, sale, offer for sale, importation or distribution of MSN’s Generic Product prior to the Effective Date (the “Released Claims”).
2.2Prior to Trigger Dates.
2.2.1Commencing on the Effective Date and continuing until the Trigger Date, neither MSN nor Impax shall —directly or indirectly encourage or assist any Third Party to develop, make, use, sell, offer for sale, or import into the United States any Generic Product. Notwithstanding the foregoing, [***], in order to [***] (as that term is defined below), provided that such [***]. For the avoidance of doubt, and further notwithstanding the foregoing, [***]: (a) [***], (b) [***], and (c) [***], provided that [***].


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2.2.2If Vanda enters into any agreement allowing a Third Party ANDA Holder to engage in the activities identified in Section 2.2.1 earlier than MSN and Impax are authorized to engage in such activities, then this Agreement shall automatically be amended to authorize such earlier activities, and Vanda shall provide MSN or Impax with notice of any such earlier dates [***] after entering into any agreement providing for such earlier dates.
2.2.3If any license or settlement agreement between Vanda and a Third Party allows or causes to allow a Third Party rights under the Patent Rights to sell Generic Product on a specific date that is earlier than the operative date under subsection 1.12(a), 1.12(b), 1.12(c), 1.12(e), and as to any entity under 1.12(d), above (each an “Earlier Trigger Date”), then Vanda shall notify MSN or Impax in writing of the Earlier Trigger Date within [***] of learning of or granting of the Earlier Trigger Date, including, but not limited to, within [***] of learning of the activation of a corresponding “trigger date” in a settlement agreement or license agreement with a Third Party or Affiliate of Vanda, and this Agreement shall automatically be amended to include such Earlier Trigger Date, and further providing that to the extent reasonably practicable, and without imposing any restrictions on Vanda’s ability to settle any lawsuit with any Third Party ANDA Holder on such terms as Vanda chooses, notice shall be given to MSN or Impax no less than [***] before any such Earlier Trigger Date, if such Earlier Trigger Date is within Vanda’s control.
2.2.4Nothing in this Agreement shall be construed as prohibiting MSN or Impax from engaging in any activity that would not constitute infringement of the Patent Rights as a result of the application of 35 U.S.C. § 271(e)(1).
2.3Validity of Vanda’s Patents. MSN and Impax hereby admit that, solely with respect to its Generic Product, the claims of the Patent Rights are valid and enforceable. MSN and Impax hereby admit that, absent a license or applicable exemption under 21 U.S.C. § 271(e)(1), the commercial making, using, offering to sell, selling, and/or importation into the United States of a Generic Product is covered by one or more claims of the Patent Rights under 35 U.S.C. § 271. Within five days of the Effective Date, Vanda and MSN shall execute and cause to be filed with the Court in the Litigation a consent judgment in the form attached hereto as Exhibit C (the “Consent Judgment and Injunction”). The foregoing admissions and the Consent Judgment and Injunction shall be binding on MSN and Impax and admissible against MSN and Impax in any dispute or litigation between the parties regarding the Patent Rights, and MSN and Impax shall not challenge such admission. MSN and Impax shall not assist any Third Party in an action to invalidate or render unenforceable any Valid Claim, and MSN and Impax shall not disclose any of its proprietary or confidential information relating to the validity or enforceability of any Valid Claim, except to the extent required by court order or other applicable law. This paragraph is limited to (a) the claims of issued patents within the Patent Rights as they exist as of the Effective Date and (b) the claims of patent applications within the Patent Rights as such claims are drafted as of the Effective Date and the claims issuing therefrom to the extent such issued claims are the same as drafted as of the Effective Date. For the avoidance of doubt, MSN and Impax’s admissions in this Section as to the Patent Rights are limited to its Generic Product, and MSN and Impax reserve all rights to challenge, petition, claim, or counterclaim against the Patent Rights for the non-infringement, invalidity, and/or unenforceability as to any drug product other than its Generic Product. Nothing herein shall prevent MSN from maintaining a “Paragraph IV Certification” pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) for its Generic Product with respect to the Patent Rights on the basis that any sale by MSN or Impax in accordance with this Agreement will be a licensed sale.
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2.4Vanda Covenants. Vanda, for itself and its Affiliates, hereby covenants as of the Effective Date of this Agreement and thereafter during the time that this Agreement is in effect:
a)Not to sue, not to assign to any other entity a right to sue, and not to authorize any other entity to sue, any MSN Releasee [***] on any Released Claims;
b)Not to assert, with respect to the sale of Generic Product on or after the Trigger Date in accordance with this Agreement, any patent remedies to which they would be entitled under 35 U.S.C. § 271(e)(4) or any other U.S. patent law if the Court had found that MSN infringed the asserted patents, and/or any patent claim with respect to the Patent Rights; and
c)Upon MSN’s written request, to provide the FDA with written confirmation of the Trigger Date and the licenses, covenants, and waivers herein.
2.5MSN and Impax Covenants. Unless and until MSN or Impax submits an Abbreviated New Drug Application for a product in which tasimelteon is the active pharmaceutical ingredient but which is not a Generic Product, MSN and Impax, for themselves and their Affiliates, hereby covenants as of the Effective Date of this Agreement and thereafter during the time that this Agreement is in effect that MSN and Impax will not challenge the validity or patentability of any of the Patent Rights, or provide any support to a challenge to the validity patentability of any of the Patent Rights by any other entity before any court, tribunal, or administrative body, including but not limited to the United States Patent and Trademark Office. MSN and Impax, for themselves and their affiliates, further covenants as of the Effective Date of this Agreement and thereafter during the time that this Agreement is in effect that if MSN or Impax successfully challenge the validity or patentability of any patent listed in the Orange Book with respect to Hetlioz®, MSN and Impax will not rely on such challenge, or the legal result of such challenge, including for purposes of determining a Trigger Date under Section 1.12 of this Agreement, to develop, make, use, sell, offer for sale, or import into the United States any Generic Product. For avoidance of doubt, if MSN successfully challenges the validity or patentability of any patent listed in the Orange Book with respect to Hetlioz® as permitted under this Agreement, MSN and Impax may rely on such challenge, or the legal result of such challenge, in order to develop, make, use, sell, offer for sale, or import into the United States any product that is not a Generic Product.
3.LICENSE; EXCLUSIVITY WAIVER
3.1License Grants. Subject to the terms and conditions of this Agreement, and effective on the Trigger Date, Vanda hereby grants to MSN and Impax a non-exclusive[***] license under the Patents Rights to make, have made, use, sell, offer for sale and import the applicable Generic Products and [***]. For the avoidance of doubt, the use or resale of a Generic Product by a supplier or customer of MSN or Impax following the Trigger Date, to the extent such Generic Product was first manufactured and sold by or on behalf of MSN or Impax within the scope of the foregoing license, shall not constitute an infringement of the Patent Rights as set forth in this Agreement.


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3.2Waiver of Exclusivities. With respect to the sale of Generic Product in accordance with this Agreement on or after the Trigger Dates provided for in Sections 1.12(a) and Sections 1.12(b), Vanda hereby grants to MSN a waiver of any and all statutory or regulatory exclusivities necessary to effectuate the licenses contained herein.
3.3No Other Licenses. Except as otherwise provided herein, nothing in this Agreement shall be construed as: (a) an obligation to bring or prosecute actions or suits against Third Parties for infringement of any patent, whether within the Patent Rights or otherwise; (b) granting a license or conferring any right under any patent with respect to actions taken wholly after the expiration of such patent; (c) conferring a right to use in advertising, publicity, promotion or otherwise any of Vanda’s trademarks, including in the trademark Hetlioz®, trade dresses, service marks, or other intellectual property other than the Patent Rights; or (d) granting by implication, estoppel or otherwise, any licenses or rights under the Patent Rights or any other patents.
3.4Effect of an At-Risk Launch. For the avoidance of doubt, in the event that any entity other than Vanda or its Affiliates, or MSN or its Affiliates, or Impax or its Affiliates, sells an unlicensed Generic Product on a date prior to the Trigger Date (the "Unlicensed Launch Date"), then the terms of Section 1.12(c) shall apply.
4.TERM AND TERMINATION.
4.1Term. Subject to Sections 4.2 and 4.3, this Agreement shall expire on the expiration of the last to expire of the Patent Rights; provided, however, that if there are no valid, issued patents within the Patent Rights, but there are at such time pending patent applications within the Patent Rights, then subject to the terms and conditions of this Agreement, the term of this Agreement shall continue for the pendency of such pending patent applications.
4.2Termination for Cause. Either party may terminate this Agreement upon or after the material breach of any material provision of this Agreement by the other party if the other party has not cured such breach within [***] after receipt of express written notice thereof by the non-breaching party. If this Agreement is terminated as the result of a material breach by MSN or Impax prior to expiration of the last of the Patent Rights, then neither MSN nor Impax shall make, have made, use, sell, offer for sale, import or distribute the applicable Generic Product until (i) there are no Valid Claims covering the Generic Product, (ii) a final decision by a court from which no appeal can be taken is entered holding that all of the said applicable Patent Rights as to such Generic Product are unpatentable or invalid or unenforceable or not infringed by the applicable Generic Product (for the avoidance of doubt, a court of appeals’ judgment or order is not “final” until issuance of the mandate); or (iii) a final decision by the U.S. Patent and Trademark Office, from which no appeal can be taken, is entered holding that all the said applicable Patent Rights as to such Generic Product are unpatentable, invalid or unenforceable (for the avoidance of doubt, a court of appeals’ judgment or order is not “final” until issuance of the mandate).





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4.3Termination for Challenge. Vanda shall have the right to immediately terminate this Agreement at any time after the Effective Date in the event MSN or Impax contests or challenges, or supports or assists any Third Party to contest or challenge, with the U.S. Patent Office or any U.S. court, U.S. regulatory agency or other forum, Vanda’s ownership of or rights in, or the validity, enforceability or scope of, any of the Patent Rights in connection with a Generic Product.
4.4Effect of Expiration or Termination. Expiration or termination of this Agreement shall not relieve the parties of any obligation accruing prior to such expiration or termination, and the provisions of Sections 1, 2.1, 2.2, 2.3, 3.2, 4.2, 4.4, 5, 7 and 8 shall survive the expiration or termination of this Agreement. No other provisions shall survive expiration or termination of this Agreement.
5.CONFIDENTIALITY.
5.1Confidentiality. Except as otherwise provided herein, until the date that is five (5) years after the expiration or earlier termination of this Agreement—except with respect to any Confidential Information constituting a trade secret, in which case the receiving party’s obligation pursuant to this paragraph continues in perpetuity, provided such receiving party has been informed as to the status of such Confidential Information as a trade secret—each party shall maintain in confidence all Confidential Information disclosed by the other party and the terms of this Agreement, and shall not use, grant the use of, or disclose to any Third Party any Confidential Information of the other party other than as expressly permitted hereby. Each party shall notify the other promptly upon discovery of any unauthorized use or disclosure of the other party’s Confidential Information or the terms of this Agreement.
5.2Permitted Disclosures. Either party may disclose Confidential Information of the disclosing party (a) on a need-to-know basis, to such party’s directors, officers and employees to the extent such disclosure is reasonably necessary in connection with such party’s activities as expressly authorized by this Agreement, and (b) to those agents and consultants, and contract manufacturers who need to know such information to accomplish the purposes of this Agreement (collectively, “Permitted Recipients”); provided such Permitted Recipients are bound to maintain such Confidential Information in confidence at least to the same extent as set forth in Section 5.1.
5.3Litigation and Governmental Disclosure. Each party may disclose Confidential Information of the other party to the extent such disclosure is reasonably necessary for prosecuting or defending litigation or complying with a court order or applicable law, governmental regulations or investigation, provided that if a party is required by court order, law or regulation (except for disclosure requested or required by the I.R.S., or disclosure required under securities laws as described in Section 5.5) to make any such disclosure of the other party’s Confidential Information it will give reasonable advance notice to the other party of such disclosure requirement and will use good faith efforts to assist such other party to secure a protective order or confidential treatment of such Confidential Information required to be disclosed.



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5.4Return of Confidential Information. Upon expiration or termination of this Agreement for any reason, the receiving party, upon receipt of a written request from the Disclosing Party, shall return to the Disclosing Party all copies of the Confidential Information received from the Disclosing Party hereunder, provided, however, that the receiving party’s legal counsel may retain one copy of such Confidential Information in a secure location solely for purposes of determining the receiving party’s continuing obligations under this Agreement.
5.5Publicity. Except as expressly authorized hereunder, neither party shall make any publicity releases, interviews or other dissemination of information concerning this Agreement or its terms, or either party’s performance hereunder, to communication media, financial analysts or others without the prior written approval of the other party, which approval shall not be unreasonably withheld, delayed or conditioned. Notwithstanding anything to the contrary in this Agreement, the parties understand and agree that either party, may disclose the existence and/or terms of this Agreement or other Confidential Information of the other party (a) to comply with its obligations under the law, including, without limitation, the United States Securities Act of 1933, as amended and the United States Securities Exchange Act of 1934, as amended (the “Exchange Act”); (b) in order to comply with the listing standards, rules, regulations or agreements of any national or international securities exchange, The NASDAQ Global Market or New York Stock Exchange or other similar laws, rules or regulations of a governmental or regulatory authority; (c) to respond to an inquiry of a governmental authority or regulatory authority as required by law; or (d) in a judicial, administrative or arbitration proceeding. In any such event the party making such disclosure shall (i) provide the other party with as much advance notice as reasonably practicable of the required disclosure, (ii) cooperate with the other party in any reasonable attempt to prevent or limit the disclosure, and (iii) limit any disclosure to the specific purpose at issue. In furtherance of the foregoing, the parties acknowledge that Vanda will be permitted pursuant to the rules and regulations promulgated under the Exchange Act to file a Current Report on Form 8-K disclosing the entry into this Agreement by Vanda and a description of the terms and conditions hereof and thereof. In connection with any filing of a copy of this Agreement with the Securities and Exchange Commission, the filing party shall endeavor to obtain confidential treatment of economic and trade secret information, and shall keep the other party informed as to the planned filing (including, but not limited to providing the other party with the proposed filing reasonably in advance of making the planned filing) and consider the reasonable requests of the other party regarding such confidential treatment. For avoidance of doubt, any information that has been publicly disclosed in accordance with this Section shall no longer be deemed Confidential Information.
6.REPRESENTATIONS AND WARRANTIES.
6.1Representations. Each party hereby represents and warrants as of the Effective Date to the other party that (a) the person executing this Agreement is authorized to execute this Agreement; (b) this Agreement is legal and valid and the obligations binding upon such party are enforceable by their terms; and (c) the execution, delivery and performance of this Agreement does not conflict with any agreement, instrument or understanding, oral or written, to which such party may be bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.


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6.2Disclaimer of Warranties. Except as explicitly set forth herein, neither party makes any warranty, written, oral, express or implied, with respect to this Agreement. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT HEREBY ARE DISCLAIMED BY BOTH PARTIES.
6.3Limitation of Liability. WITH THE EXCEPTION OF DAMAGES RESULTING FROM A PARTY’S BREACH OF ITS CONFIDENTIALITY OBLIGATIONS UNDER THIS AGREEMENT OR ITS OBLIGATIONS UNDER SECTION 7 (INDEMNIFICATION), OR A BREACH BY MSN OR IMPAX OF SECTION 2, UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE LIABLE FOR LOSS OF USE OR PROFITS OR OTHER COLLATERAL, SPECIAL, CONSEQUENTIAL, INCIDENTAL OR PUNITIVE DAMAGES IN CONNECTION WITH THIS AGREEMENT, WHETHER SUCH CLAIMS ARE FOUNDED IN TORT OR CONTRACT.
6.4Equitable Relief Against MSN and Impax. MSN and Impax acknowledge and agree that the obligations and undertakings of MSN and Impax pursuant to Section 2 of this Agreement are reasonable and necessary to protect the legitimate interests of Vanda, that Vanda would not have entered into this Agreement in the absence of such provisions, and that MSN or Impax’s material breach or threatened breach or failure to comply with Section 2 shall cause Vanda significant and irreparable harm, the amount of which shall be extremely difficult to estimate and ascertain, and for which money damages shall not be adequate. MSN and Impax further acknowledge and agree that Vanda shall have the right to apply to any court of competent jurisdiction for an injunction order restraining any material breach or threatened breach of Section 2 of this Agreement and specifically enforcing the terms and provisions of such Sections of this Agreement. MSN and Impax agree that neither of them shall challenge any of the foregoing acknowledgements and agreements in this Section concerning injunctive relief in any proceeding brought by Vanda.
7.INDEMNIFICATION.
7.1MSN and Impax shall indemnify, defend and hold harmless Vanda, its directors, managers, members, officers, employees, authorized subcontractors and agents (collectively the “Vanda Indemnified Parties”) from and against any and all liabilities, losses, damages, costs and expenses (including, without limitation, reasonable attorney’s fees and costs) (collectively, “Losses”) incurred as a result of any claims, demands, actions or other proceedings by a [***] against a Vanda Indemnified Party, [***]. MSN and Impax’s obligation to indemnify Vanda Indemnified Parties shall exclude any claim asserted by any [***].
7.2A Vanda Indemnified Party that intends to claim indemnification under this Section 7 shall promptly notify MSN or Impax, as the case may be, in writing of any claim, demand, action, or other proceeding in respect of which the Vanda Indemnified Party intends to claim such indemnification; provided, however, that failure to provide such notice within a reasonable period of time shall not relieve MSN or Impax of any of its obligations hereunder except to the extent MSN or Impax is prejudiced by such failure. The Vanda Indemnified Party shall permit MSN or Impax, at its discretion, to settle any such action, claim or other matter. Notwithstanding the foregoing, MSN or Impax shall not enter into any settlement that would adversely affect the Vanda Indemnified Party’s rights hereunder, or impose any obligations on the Vanda Indemnified Party in addition to those set forth herein, in order for it to exercise such
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rights, without the Vanda Indemnified Party’s prior written consent, which shall not be unreasonably withheld or delayed. No such action, claim or other matter shall be settled without the prior written consent of MSN or Impax, which shall not be unreasonably withheld or delayed. The Vanda Indemnified Party shall reasonably cooperate with MSN or Impax and its legal representatives in the investigation and defense of any claim, demand, action, or other proceeding covered by the indemnification obligations of this Section 7. The Vanda Indemnified Party shall have the right, but not the obligation, to be represented in such defense by counsel of its own selection at its own expense.
7.3Vanda shall indemnify, defend and hold harmless MSN, Impax, their Affiliates, directors, managers, members, officers, employees, authorized subcontractors and agents (collectively the “MSN/Impax Indemnified Parties”) from and against any and all Losses (as defined above) incurred as a result of any claims, demands, actions or other proceedings by a [***] against an MSN/Impax Indemnified Party, [***]. Vanda’s obligation to indemnify MSN/Impax Indemnified Parties shall exclude any claim asserted by any [***].
7.4An MSN/Impax Indemnified Party that intends to claim indemnification under this Section 7 shall promptly notify Vanda in writing of any claim, demand, action, or other proceeding in respect of which the MSN/Impax Indemnified Party intends to claim such indemnification; provided, however, that failure to provide such notice within a reasonable period of time shall not relieve Vanda of any of its obligations hereunder except to the extent Vanda is prejudiced by such failure. The MSN/Impax Indemnified Party shall permit Vanda, at its discretion, to settle any such action, claim or other matter. Notwithstanding the foregoing, Vanda shall not enter into any settlement that would adversely affect the MSN/Impax Indemnified Party’s rights hereunder, or impose any obligations on the MSN/Impax Indemnified Party in addition to those set forth herein, in order for it to exercise such rights, without the MSN/Impax Indemnified Party’s prior written consent, which shall not be unreasonably withheld or delayed. No such action, claim or other matter shall be settled without the prior written consent of Vanda, which shall not be unreasonably withheld or delayed. The MSN/Impax Indemnified Party shall reasonably cooperate with Vanda and its legal representatives in the investigation and defense of any claim, demand, action, or other proceeding covered by the indemnification obligations of this Section 7. The MSN/Impax Indemnified Party shall have the right, but not the obligation, to be represented in such defense by counsel of its own selection at its own expense.
8.GENERAL PROVISIONS.
8.1Notices. All notices hereunder shall be delivered by overnight delivery with a reputable overnight delivery service, to the following address of the respective parties:
If to Vanda:        Vanda Pharmaceutical Corporation
2200 Pennsylvania Avenue, N.W.
Washington, DC 20037
Attn:    Chief Executive Officer

11


with a copy to:        Vanda Pharmaceutical Corporation
2200 Pennsylvania Avenue, N.W.
Washington, DC 20037
Attn:    General Counsel

If to MSN:        MSN Pharmaceuticals Inc.
Attn: Kondal Reddy
20 Duke Rd
Piscataway, NJ 08854

If to Impax:        Impax Laboratories LLC
Attn: General Counsel
400 Crossing Blvd.
Bridgewater, NJ 08807

Notices shall be effective on the day of receipt. A party may change its address listed above by notice to the other party given in accordance with this Section 8.1.
8.2Entire Agreement. The parties hereto acknowledge that this Agreement sets forth the entire agreement and understanding of the parties and supersede all prior written or oral agreements or understandings with respect to the subject matter hereof. No modification of any of the terms of this Agreement, or any amendments thereto, shall be deemed to be valid unless in writing and signed by an authorized agent or representative of both parties hereto. No course of dealing or usage of trade shall be used to modify the terms and conditions herein. This Agreement shall be binding on each of MSN, Impax and Vanda and their respective permitted successors and assigns.
8.3Waiver. None of the provisions of this Agreement shall be considered waived by any party hereto unless such waiver is agreed to, in writing, by authorized agents of such party. The failure of a party to insist upon strict conformance to any of the terms and conditions hereof, or failure or delay to exercise any rights provided herein or by law shall not be deemed a waiver of any rights of any party hereto.
8.4Obligations to Third Parties. Each party warrants and represents that this Agreement does not conflict with any contractual obligations, expressed or implied, undertaken with any Third Party.
8.5Assignment. Neither party shall assign this Agreement or any part hereof or any interest herein (whether by operation of law or otherwise) to any Third Party (or use any subcontractor) without the written approval of the other party, which shall not be unreasonably withheld, conditioned, or delayed; provided, however, that either party may assign this Agreement without such consent (i) to any Affiliate; and (ii) in the case of a merger, consolidation, change in control or sale of all or substantially all of the assets related to this Agreement, provided further that with respect to MSN or Impax, any such Affiliate or Third Party agrees to be bound by the terms and conditions of this Agreement. No assignment shall be valid unless the permitted assignee(s) assumes all obligations of its assignor under this Agreement. No assignment shall relieve any party of responsibility for the performance of its obligations hereunder. Any purported assignment in violation of this Section 8.5 shall be void.
12


8.6Governing Law. Any action brought regarding the validity, construction or enforcement of this Agreement shall be governed in all respects by the laws of the State of Delaware, without regard to the principles of conflicts of laws. The federal and state courts in the State of Delaware shall have exclusive jurisdiction over the parties hereto in all such actions, and each party irrevocably consents to the personal jurisdiction of those courts and agrees not to challenge the venue of such courts or to seek to transfer any such action to any other forum.
8.7Severability. If any term or provision of this Agreement shall for any reason be held invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other term or provision hereof, and this Agreement shall be interpreted and construed as if such term or provision, to the extent the same shall have been held to be invalid, illegal or unenforceable, had never been contained herein.
8.8Headings, Interpretation. The headings used in this Agreement are for convenience only and are not part of this Agreement.
8.9Counterparts. The Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
[Remainder of this page intentionally blank]
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IN WITNESS WHEREOF, the parties hereto have each caused this Agreement to be executed by their duly-authorized representatives effective as of the Effective Date.


VANDA PHARMACEUTICALS INC.

By:    /s/ Mihael H. Polymeropoulos    
Name:    Mihael H. Polymeropoulos, M.D.    
Title:    President and Chief Executive Officer


MSN PHARMACEUTICALS INC.

By:    /s/ Kondal Reddy Bairy        
Name:    Kondal Reddy Bairy            
Title:    Senior Director            


MSN LABORATORIES PRIVATE LIMITED

By:    [/s/ Srinivasan Thirumalai Rajan    ]
Name:    Srinivasan Thirumalai Rajan        
Title:    Head IPM & Technical        


IMPAX LABORATORIES LLC

By:    /s/ Andrew S. Boyer            
Name:    Andrew S. Boyer            
Title:    EVP, CCO – Generics            




EXHIBIT A

Hetlioz Products

PRODUCT
[***]





EXHIBIT B

Patent Rights

U.S. Patent No. RE46,604
U.S. Patent No. 9,060,995
U.S. Patent No. 9,539,234
U.S. Patent No. 9,549,913
U.S. Patent No. 9,730,910
U.S. Patent No. 9,855,241
U.S. Patent No. 10,071,977
U.S. Patent No. 10,149,829
U.S. Patent No. 10,376,487
U.S. Patent No. 10,449,176
U.S. Patent No. 10,610,510
U.S. Patent No. 10,610,511
U.S. Patent No. 10,829,465
U.S. Patent No. 10,611,744


Any patents issuing to or assigned to Vanda that claim priority
to any of the applications for the patents listed above.






EXHIBIT C

Consent Judgement

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

VANDA PHARMACEUTICALS INC.,

Plaintiff,

v.

MSN PHARMACEUTICALS INC.
ET AL.,

Defendants.
)
)
)
)
)
)
)
)
)




C.A. No. 18-690 (CFC)
CONSOLIDATED

STIPULATION FOR ENTRY OF CONSENT JUDGMENT AND
PERMANENT INJUNCTION AS TO MSN PHARMACEUTICALS INC. AND MSN LABORATORIES PRIVATE LIMITED.
Plaintiff Vanda Pharmaceuticals Inc. and Defendants MSN Pharmaceuticals Inc. and MSN Laboratories Private Limited. having met, conferred, and agreed to resolve their dispute upon execution of a separate License Agreement, hereby stipulate to entry of the executed Consent Judgment and Permanent Injunction submitted herewith, subject to the Court’s approval.




Morris, Nichols, Arsht &
Tunnell LLP

________________________________________
Karen Jacobs (#2881)
Derek J. Fahnestock (#4705)
1201 North Market Street
P.O. Box 1347
Wilmington, DE 19899
(302) 658-9200
kjacobs@mnat.com
dfahnestock@mnat.com
Attorneys for Plaintiff
Vanda Pharmaceuticals Inc.


OF COUNSEL:

Nicholas Groombridge
Eric Alan Stone
Josephine Young
Daniel J. Klein
Jennifer Rea Deneault
Paul, Weiss, Rifkind, Wharton
& Garrison LLP
1285 Avenue of the Americas
New York, NY 10019
(212) 373-3000
Winston & Strawn LLP


_____________________________________
Maureen L. Rurka
35 W. Wacker Drive
Chicago, IL 60601-9703
(312) 558-7936
MRurka@winston.com

Attorneys for Defendants MSN Pharmaceuticals Inc. and MSN Laboratories Private Limited.






IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

VANDA PHARMACEUTICALS INC.,

Plaintiff,

v.

MSN PHARMACEUTICALS INC.
ET AL.,

Defendants.
)
)
)
)
)
)
)
)
)




C.A. No. 18-690 (CFC)
CONSOLIDATED


CONSENT JUDGMENT AND PERMANENT INJUNCTION
AS TO MSN PHARMACEUTICALS INC. AND MSN LABORATORIES PRIVATE LIMITED.
.

This matter is before the Court on the unopposed motion of Plaintiff Vanda Pharmaceuticals Inc. (“Vanda”) and Defendants MSN Pharmaceuticals Inc. and MSN Laboratories Private Limited. (together, “MSN”).
WHEREAS, Vanda owns U.S. Patent Nos. RE46,604, 9,060,995, 9,539,234, 9,549,913, 9,730,910, 9,855,241, 10,149,829, 10,071,977, 10,376,487, 10,449,176, 10,610,510, 10,610,511, 10,829,465, and 10,611,744 (“the asserted patents”).
WHEREAS, MSN submitted Abbreviated New Drug Application No. 211654 (“MSN’s ANDA”) to the FDA under 21 U.S.C. § 355(j) seeking to obtain approval to commercially manufacture and sell generic tasimelteon for the treatment of Non-24-Hour Sleep-Wake Disorder.
WHEREAS, in this Action, Vanda alleges that MSN infringed one or more of claims 1-3 and 6-8 of U.S. Patent No. RE46,604, claim 1 of U.S. Patent No. 9,060,995, claims 1-5 of U.S. Patent No. 9,539,234, claims 1-6 and 11-14 of U.S. Patent No. 9,549,913, claims 1-5



of U.S. Patent No. 9,730,910, claims 1-6 and 9 of U.S. Patent No. 9,855,241, claims 1-14 of U.S. Patent No. 10,149,829, claims 1-4 and 13-22 and 24 of U.S. Patent No. 10,071,977, claims 1-2 and 4-7 and 9-20 of U.S. Patent No. 10,376,487, claims 1-9 of U.S. Patent No. 10,449,176, claims 1-13 of U.S. Patent No. 10,610,510, claims 1-2 and 4-19 of U.S. Patent No. 10,610,511, claims 1 and 3-20 of U.S. Patent No. 10,829,465, and claims 1-2 and 4-9 of U.S. Patent No. 10,611,744 under 35 U.S.C. § 271(e)(2) by virtue of MSN’s submission of MSN’s ANDA to the FDA.
WHEREAS, in this Action, Vanda alleges that it would be irreparably harmed if MSN were not enjoined from infringing or actively inducing or contributing to infringement of one or more of claims 1-3 and 6-8 of U.S. Patent No. RE46,604, claim 1 of U.S. Patent No. 9,060,995, claims 1-5 of U.S. Patent No. 9,539,234, claims 1-6 and 11-14 of U.S. Patent No. 9,549,913, claims 1-5 of U.S. Patent No. 9,730,910, claims 1-6 and 9 of U.S. Patent No. 9,855,241, claims 1-14 of U.S. Patent No. 10,149,829, claims 1-4 and 13-22 and 24 of U.S. Patent No. 10,071,977, claims 1-2 and 4-7 and 9-20 of U.S. Patent No. 10,376,487, claims 1-9 of U.S. Patent No. 10,449,176, claims 1-13 of U.S. Patent No. 10,610,510, claims 1-2 and 4-19 of U.S. Patent No. 10,610,511, claims 1 and 3-20 of U.S. Patent No. 10,829,465, and claims 1-2 and 4-9 of U.S. Patent No. 10,611,744.
WHEREAS, in this Action, Vanda requested that this Court enter a permanent injunction enjoining MSN from infringing the asserted patents.
WHEREAS, in this Action, MSN has denied that the asserted patents are valid, enforceable, and infringed by the product described in MSN’s ANDA.
WHEREAS, Vanda and MSN have reached an agreement to finally settle the Litigation as set forth in this Consent Judgment and Permanent Injunction as to MSN and a



separate License Agreement (“License Agreement”) which is contemporaneously and separately being executed.
WHEREAS, final settlement of this Action will help Vanda and MSN avoid the substantial uncertainty and risks involved with prolonged litigation.
WHEREAS, final settlement of this Action will permit Vanda and MSN to save litigation costs, as well as adhere to the judicially recognized mandate that encourages the settlement of litigation whenever possible.
WHEREAS, final settlement of the Action serves the public interest by saving judicial resources and avoiding the risks to each of Vanda and MSN associated with infringement.
WHEREAS, Vanda and MSN each consent to personal jurisdiction in Delaware for purposes of enforcing the License Agreement.
IT IS HEREBY ORDERED, DECREED, and ADJUDGED as follows:
1.The Court has jurisdiction over Vanda and MSN and the subject matter of this litigation.
2.MSN acknowledges Vanda’s ownership and standing to sue for infringement of the asserted patents.
3.MSN acknowledges that the asserted patents are valid and enforceable, as described more fully and subject to the restrictions contained in the License Agreement.
4.MSN acknowledges that it has infringed the asserted patents under 35 U.S.C. § 271(e)(2) and that Vanda did not authorize the manufacture, use, sale, offer for sale, importation and distribution of the product described in MSN’s ANDA.



5.MSN and its successors, assigns, and affiliates, and partners or joint-venturers with are permanently enjoined as of the date hereof from infringing the asserted patents by the commercial manufacture, use, offer to sell, sale, importation, or distribution of any generic tasimelteon products that are the subject of MSN’s ANDA that is not pursuant to a license granted by Vanda or otherwise exempt from infringement under 35 U.S.C. § 271(e)(1), and from inducing others to infringe or contributing to the infringement of the asserted patents by inducing others to manufacture, use, offer to sell, sale, import, or distribute or contributing to others’ manufacture, use, offer for sale, sale, importation, or distribution of any generic tasimelteon products that are the subject of MSN’s ANDA that is not pursuant to a license granted by Vanda or otherwise exempt from infringement under 35 U.S.C. § 271(e)(1).
6.All claims in this Action are hereby dismissed without prejudice.
7.Each party shall bear its own costs and attorneys’ fees.
8.This Court shall retain jurisdiction over MSN and Vanda for the purpose of enforcing the terms of this Consent Judgment and Permanent Injunction and over any matters related to or arising from the interpretation or enforcement of the License Agreement or any legal or equitable claim concerning the License Agreement by any third party.

IT IS SO ORDERED, DECREED AND ADJUDGED this __________ day of ____, 2022 by:


__________________________________________
The Honorable Colm F. Connolly
United States District Judge





Agreed to:

Morris, Nichols, Arsht &
Tunnell LLP

________________________________________
Karen Jacobs (#2881)
Derek J. Fahnestock (#4705)
1201 North Market Street
P.O. Box 1347
Wilmington, DE 19899
(302) 658-9200
kjacobs@mnat.com
dfahnestock@mnat.com
Attorneys for Plaintiff
Vanda Pharmaceuticals Inc.


OF COUNSEL:

Nicholas Groombridge
Eric Alan Stone
Josephine Young
Daniel J. Klein
Jennifer Rea Deneault
Paul, Weiss, Rifkind, Wharton
& Garrison LLP
1285 Avenue of the Americas
New York, NY 10019
(212) 373-3000
Winston & Strawn LLP


_____________________________________
Maureen L. Rurka
35 W. Wacker Drive
Chicago, IL 60601-9703
(312) 558-7936
MRurka@winston.com

Attorneys for Defendants MSN Pharmaceuticals Inc. and MSN Laboratories Private Limited.