EX-10.9 12 a2225009zex-10_9.htm EX-10.9 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN...
Exhibit 10.9
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
BY AND AMONG
NEOS THERAPEUTICS, INC.
AND
SHIRE LLC
DATED AS OF JULY 23, 2014
THIS LICENSE AGREEMENT (this “Agreement”) dated this the 23rd day of July, 2014 (the “Effective Date”) is hereby entered into by and between Shire LLC, a Kentucky company with offices located at 0000 Xxxxxxxxxx Xxxxx, Xxxxxxxx, XX 00000 (“Shire”), and Neos Therapeutics, Inc., a corporation organized and existing under the laws of Delaware with offices located at 0000 Xxxxx Xxxxxxx 000 #000, Xxxxx Xxxxxxx, XX 00000 (“Neos”). Each of Shire and Neos is sometimes referred to herein, individually, as a “Party” and, collectively, as the “Parties.”
R E C I T A L S:
1.1. “Act” shall mean the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, and the rules, regulations and guidelines promulgated thereunder.
1.2. “Affiliate” shall mean a Person that controls, is controlled by or is under common control with a 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 at least fifty percent (50%) 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.
1.3. “Business Day” shall mean 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.
1.4. “Commercially Reasonable Efforts” shall mean efforts and diligence in accordance with the subject Party’s reasonable and sound business, legal, medical and scientific judgment and in accordance with the efforts and resources such Party would use in other aspects of its business that have similar commercial value and market potential, taking into account the competitiveness of the marketplace, the business life-cycle, the proprietary position of the company and the profitability of the pertinent product.
1.5. “Compound” shall mean the amphetamine polistirex active pharmaceutical ingredient in the Neos Product of the Neos NDA as of the Effective Date.
1.6. “Confidential Information” shall mean 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 this Agreement. For the avoidance of doubt, this Agreement and each of its terms is Confidential Information.
1.7. “Covenant Not to Xxx” shall have the meaning assigned to such term in Section 3.2.
1.8. “FDA” shall mean the United States Food and Drug Administration or any successor agency thereof.
1.9. “Force Majeure” shall mean any circumstances reasonably beyond a Party’s control, including, without limitation, acts of God, civil disorders or commotions, acts of aggression, acts of terrorism, fire, explosions, floods, drought, war, sabotage, embargo, unexpected safety or efficacy results obtained with the Neos Product, utility failures, supplier failures, material shortages, labor disturbances, a national health emergency, or appropriations of property.
1.10. “GAAP” shall mean generally accepted accounting principles in effect in the United States from time to time, consistently applied.
1.11. “Governmental Authority” shall mean 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.
1.12. “Label” shall mean any Package (immediate container) 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.
1.13. “Law” or “Laws” shall mean all laws, statutes, rules, codes, regulations, orders, judgments and/or ordinances of any Governmental Authority.
1.14. “License” shall have the meaning assigned to such term in Section 2.1.
1.15. “Licensed Patents” shall mean United States Reissued Patent Nos. RE 42,096 and RE 41,148, and United States Patent No. 6,913,768 and any patent that issues as a result of a reexamination, inter partes review or reissue thereof.
1.16. “Losses” means any liabilities, damages, costs or expenses, including reasonable attorneys’ fees and expert fees, incurred by any Party that arise from any claim, lawsuit or other action by a Third Party.
1.17. “Manufacture” shall mean all activities related to the manufacturing of a pharmaceutical product, or any ingredient thereof, including but not limited to manufacturing Compound or supplies for development, manufacturing Neos 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.
1.18. “Market” shall mean to distribute, promote, advertise, import, market and sell, to a Third Party and “Marketing” or “Marketed” shall have the correlated meaning.
1.19. “NDA” shall mean a New Drug Application filed with the FDA pursuant to and under 21 U.S.C. § 355(b) of the Act, together with the FDA’s implementing rules and regulations.
1.20. “Neos NDA” shall mean NDA 204326, and any amendment or supplement thereto.
1.21. “Neos Product” shall mean the extended release orally disintegrating tablets of the Compound developed, made, used, sold, offered for sale, imported or exported pursuant to the Neos NDA.
1.22. “Net Sales” shall mean [***]
[***]
* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.
[***]
[***]
[***]
[***]
[***]
[***]
1.23. “Party” or “Parties” shall have the meaning assigned to such term in the recitals.
1.24. “Package” shall mean 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.
1.25. “Person” shall mean any individual, partnership, association, corporation, limited liability company, trust, or other legal person or entity.
1.26. “Regulatory Approval” shall mean final Marketing approval by the FDA for the sale and Marketing of a pharmaceutical product in the Territory.
1.27. “Shire’s NDA” shall mean Shire’s NDA No. 21-303 and any amendment or supplement thereto.
* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.
1.28. “Term” shall have the meaning assigned to such term in Section 12.1.
1.29. “Territory” shall mean the United States of America, and its territories, districts and possessions, including the Commonwealth of Puerto Rico.
1.30. “Third Party” or “Third Parties” shall mean any Person or entity other than a Party or its Affiliates.
1.31. “Valid Claim” shall mean an issued and unexpired patent claim to the extent such claim has not been revoked, held to be invalid or unenforceable by a court of competent jurisdiction in a final unappealable decision and which claim has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination, disclaimer, dedication to the public or otherwise.
2.1. Subject to the terms, conditions and limitations hereof, including the conditions set forth in Section 3, Shire hereby grants to Neos a non-exclusive license under the Licensed Patents to develop, make, use, offer to sell, sell, Manufacture, have Manufactured, import, export and Market the Neos Product in the Territory.
2.2. The licenses granted in Article 2 of this Agreement are referred to herein as the “License.” Except to the extent permitted pursuant to Section 13.3, Neos shall not have the right to sublicense, assign or transfer any of its rights under the License.
3. Conditions
3.1. (a) Subject to Section 3.1(b), in the event that during the Term Neos challenges the validity or enforceability of any of the Licensed Patents, or otherwise actively assists, enables or participates with any Third Party in challenging the validity or enforceability of any of the Licensed Patents, Shire shall be free to terminate the License, the Covenant Not to Xxx and/or this Agreement pursuant to Section 12.2.
(b) Nothing set forth in Section 3.1(a) shall prohibit Neos from: (i) filing [***] a new regulatory application containing a Paragraph IV certification to any or all of the Licensed Patents, [***].
* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.
3.2. Shire covenants that it will not xxx, assert any claim or counterclaim against, otherwise participate in any action or proceeding against Neos or any of its shareholders, licensees, sublicensees, customers, suppliers, importers, manufacturers, distributors, insurers, or any heirs, administrators, executors, predecessors, successors, or assigns of the foregoing, or cause or authorize any person or entity to do any of the foregoing, in each case claiming or otherwise asserting that the development, Manufacture, use, sale, offer for sale, exportation, importation or Marketing of the Neos Product under the License infringes the Licensed Patents (the “Covenant Not to Xxx”). Shire will impose the foregoing Covenant Not to Xxx on any Third Party to which Shire may transfer any of Licensed Patents. The Covenant Not to Xxx shall not apply in the event that Shire validly terminates this Agreement because Neos has breached this Agreement or the Settlement Agreement.
3.3. In the event Neos files a new NDA that references data from Shire’s NDA, [***]. This Section 3.3 shall not apply to any Abbreviated New Drug Application filed by Neos that references data from Shire’s NDA.
3.4. [***]. For the avoidance of doubt, Neos specifically reserves the right to conduct the activities set forth in Section 3.1(b).
4.1. Neos shall, at its sole cost and expense, utilize all Commercially Reasonable Efforts in Marketing the Neos Product in the Territory to maximize sales of the Neos Product.
4.2. It is the intent of the Parties that Neos will seek to sell Neos Product for [***]. Neos will have sole discretion, however, in [***]. Neos also agrees that if it prices Neos Product in order to gain or maintain sales of other products, then for purposes of calculating the payments due hereunder, the Net Sales of such Neos Product shall be adjusted to [***].
5. Approval Fee; Shire Net Sales Share
5.1. Neos will pay Shire a lump-sum, non-refundable fee of [***] [***] due and payable no later than thirty (30) days after receiving Regulatory Approval for the Neos NDA.
* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.
5.2. Neos shall pay a royalty to Shire of [***] of Net Sales of the Neos Product sold in the Territory during the Term.
5.3. Payments due under this Section 5 shall be made [***]. All such payments shall include a report detailing the calculation of gross sales, Net Sales and the royalties payable hereunder.
5.4. Maintenance of Records. During the Term, and for a period of [***] thereafter, Neos shall keep at either its normal place of business, or at an off-site storage facility, detailed, accurate and up to date:
(a) records and books of account sufficient to confirm the calculation of the Net Sales and royalties payable hereunder; and
(b) information and data contained in any invoices or reports accompanying any payment to Shire provided to Shire in connection with this Agreement.
5.5. Inspection. On [***] notice from Shire, Neos shall make all such records, books of account, information and data concerning this Agreement for a period of [***] prior to the date of notice available for inspection during normal business hours by an independent accounting firm selected by Shire and reasonably acceptable to Neos (the “external auditor”) for the purpose of general review or audit; provided that Shire may not request such inspection more than once in any calendar year. Upon reasonable belief of discrepancy or dispute, Shire’s external auditors shall be entitled to take copies or extracts from such records, books of account, information and data (but only to the extent related to the contractual obligations set out in this Agreement) during any review or audit, provided the external auditor signs a confidentiality agreement with Neos providing that such records, books of account, information and data shall be treated as Confidential Information which may be disclosed to Shire. The external auditor shall only disclose to Shire the results of the external auditors’ audit, which results shall be concurrently disclosed to Neos. Any underpayment or overpayment of amounts due hereunder as reflected by the external auditor’s results shall be promptly paid or refunded by the applicable Party.
5.6. Inspection Costs. Shire shall be solely responsible for its costs in making any such review and audit, unless Shire identifies a discrepancy in the calculation of the royalties paid to Shire under this Agreement in any calendar year from those properly payable for that calendar year of [***], in which event Neos shall be solely responsible for the reasonable cost of such review and audit and pay Shire any payment due. All information disclosed by Neos pursuant to this Section 5 shall be deemed Confidential Information.
* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.
during the Term. The confidentiality and non-disclosure obligations contained in this Agreement shall not apply to the extent that such Confidential Information is:
(a) at the time of disclosure by one Party to the other, in the public domain or otherwise publicly known;
(b) 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;
(c) 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
(d) received from a Third Party who was lawfully entitled to disclose such information free of an obligation of confidentiality.
6.2. Exceptions. Notwithstanding Section 6.1, in addition to any disclosure allowed under Section 13.5 the Party receiving Confidential Information may disclose such Confidential Information to the extent that such disclosure has been ordered by a court of law or directed by a Governmental Authority, provided that, the disclosure is limited to the extent ordered or directed and wherever practicable, the Party that owns the Confidential Information has been given sufficient written notice in advance to enable it to seek protection or confidential treatment of such Confidential Information. Additionally, Neos may also disclose the existence of this License Agreement to potential business partners who have agreed to maintain the confidentiality of such a disclosure.
* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.
7. Representations and Warranties of Both Parties
With respect to Sections 7.1 and 7.2 below, each of Shire and Neos represents, warrants, and covenants, to the other Party that:
7.2. Consents and Approvals; No Violations.
(a) Except as otherwise set forth in this Agreement or the Settlement Agreement, 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 of the transactions contemplated by this Agreement, 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.
(b) Neither the execution nor the delivery of this Agreement by such Party, nor the performance by such Party of its obligations hereunder, will (i) violate the certificate of incorporation, 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, rule, regulation, judgment, order or decree of any court or Governmental Authority applicable to such Party, except in the case of clause (ii) or (iii) for violations, breaches or defaults which would not have a material adverse effect on such Party’s ability to consummate the transactions contemplated hereby.
8. Representations and Warranties of Shire
Shire represents, warrants and covenants to Neos that:
8.1. Licensed Patents. Shire represents that it is the owner of the Licensed Patents. Shire represents that it has the right to grant to Neos the License to the License Patents as provided hereunder.
(a) [***]
(b) the breach by Shire of any of its representations or warranties contained in this Agreement;
except, in each case, to the extent that the Shire Liability is caused by the negligence, breach of the terms of this Agreement, or willful misconduct of a Neos Party.
(a) [***]
(b) [***]
(c) the breach by Neos of any of its representations or warranties contained in this Agreement; or
(d) any misuse by a Neos Party of Shire’s company name or logo or other trademark;
(b) except, in each case, to the extent that the Neos Liability is caused by the negligence, breach of the terms of this Agreement, or willful misconduct of a Shire Party.
* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.
consent of the indemnified Party prior to settling or otherwise disposing of such Claim if as a result of the settlement or Claim disposal the indemnified Party’s interests are in any way adversely affected.
9.5. Claim Information. Each Party shall promptly:
(a) inform the other by written notice of any actual or threatened Claim to which Sections 9.1 or 9.2 apply;
(b) provide to the other Party copies of all papers and official documents received in respect of any such Claim; and
(c) cooperate as reasonably requested by the other Party in the defense of any such Claim.
9.7. Limitation of Liability. [***].
9.8. Limitation on Representations, Warranties and Indemnification. NEITHER PARTY SHALL BE DEEMED TO MAKE ANY REPRESENTATIONS OR WARRANTIES, WHETHER EXPRESS OR IMPLIED, EXCEPT AS SPECIFICALLY SET FORTH HEREIN. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE HEREBY DISCLAIMED BY EACH PARTY.
* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.
excused from such of its obligations hereunder for so long as it continues to be affected by Force Majeure.
11. Trademarks and Trade Names
11.1. Neos shall have no right to use any trademark or trade dress of Shire and shall have no rights to any other intellectual property of Shire or its Affiliates other than to the extent of the License. The foregoing shall not prohibit Neos from making ordinary reference to the products and their accompanying trademarks identified in Shire’s NDA as may be necessary in filing and prosecuting any application for regulatory approval for any Neos product.
12.2. Termination by Shire. [***].
(a) the other Party commits a material breach of this Agreement, and fails to remedy it within sixty (60) days of receipt of notice from the first Party of such breach and of its intention to exercise its rights under this Section 12.3; or
(b) 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.
* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.
(a) Any notice or other document given under this Agreement shall be in writing in the English language and shall be given by hand or sent by prepaid airmail, or by confirmed fax transmission to the address of the receiving Party as set out in Section 13.2 below unless a different address or fax number has been notified to the other in writing for this purpose.
(b) 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
(iii) if sent by confirmed fax transmission be deemed to have been given when transmitted, provided that, a confirmatory copy of such fax transmission shall have been sent by prepaid overnight mail within twenty-four (24) hours of such transmission.
To Shire Address: |
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To Neos Address: |
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Shire LLC |
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Neos Therapeutics, Inc. | ||
000 Xxxxxxxxxxxx Xxxxxxxxx Xxxxx, XX 00000 |
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0000 X. Xxxxxxx 000 Xxxxx Xxxxxxx, XX 00000 | ||
Attention: |
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Attention: |
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Chief IP Counsel |
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Chief Executive Officer |
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Fax: |
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Fax: |
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(000) 000-0000 |
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(000) 000-0000 |
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(a) Subject to Section 13.3(b) and (c), Neos shall not sublicense, assign or transfer the License or any of its rights or obligations under this Agreement.
(b) The License shall, upon Shire’s written consent, [***] in the case where Shire does not consent [***], Shire will provide Neos with written rationale detailing its basis for such non-consent. [***].
(c) In addition, Neos shall be entitled, without prior written consent of Shire, to [***].
(d) Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns.
(e) Any sublicense, assignment or transfer in contravention of the terms of this Agreement shall be null and void.
* Confidential Information indicated by [***] has been omitted from this filing and filed separately with the Securities Exchange Commission.
against which enforcement of such variation, change, waiver, discharge or termination is sought.
(a) neither Party has entered into this Agreement in reliance upon any representation, warranty or undertaking of the other Party which is not expressly set out in this Agreement;
(b) neither Party shall have any remedy in respect of misrepresentation or untrue statement made by the other Party or for any breach of warranty which is not contained in this Agreement;
(c) this Section 13.6 shall not exclude any liability for, or remedy in respect of, fraudulent misrepresentation; and
(d) notwithstanding the foregoing, the Settlement Agreement shall be deemed of equal dignity to this Agreement and this Agreement shall be construed together with the Settlement Agreement in a consistent manner as reflecting a single intent and purpose.
13.7. Governing Law. This Agreement shall be governed by and construed in accordance with the internal Laws of the State of New York, without giving effect to principles of conflicts of law. The Parties irrevocably agree that the federal district courts in the state of New York shall have exclusive jurisdiction to deal with any disputes arising out of or in connection with this Agreement and that, accordingly, any proceedings arising out of or in connection with this Agreement shall be brought in the U.S. District Court for the Southern District of New York. Notwithstanding the foregoing, if there is any dispute for which the federal district courts in the state of New York do not have subject matter jurisdiction, the state courts in New York shall have jurisdiction.
particular action or agreement, the use of the words “Neos shall” or “Neos will” herein shall also mean “Neos shall cause” the particular action to be performed. Nothing in this Agreement shall operate to exclude any provision implied into this Agreement by Law and which may not be excluded by Law or limit or exclude any liability, right or remedy to a greater extent than is permissible under Law.
[Signature Page Follows]
[Signature Page to License Agreement]
IN WITNESS WHEREOF, the undersigned have executed this License Agreement as of the Effective Date.
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SHIRE LLC | |
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By: |
/s/ Xxxx Xxxxxxx |
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Name: Xxxx Xxxxxxx | |
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Title: President | |
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NEOS THERAPEUTICS, INC. | |
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By: |
/s/ Xxxxx Xxxx |
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Xxxxx Xxxx | |
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President & Chief Executive Officer |