Document:

Exhibit 10.22

 

SETTLEMENT AGREEMENT

 

This Settlement Agreement (including Exhibits A, B, and C, the “Agreement”) is made and entered into this 21st day of December, 2018 (the “Execution Date”), by and between, on the one hand, Neos Therapeutics, Inc. and Neos Therapeutics, LP (collectively, “Neos”), and on the other hand, Teva Pharmaceuticals USA, Inc. (“Teva”) (collectively, the “Parties,” or each separately, a “Party”).

 

RECITALS

 

A.                                    WHEREAS Neos owns U.S. Patent Nos. 8,840,924 (“the ‘924 Patent”), 9,072,680 (“the ‘680 patent”), and 9,089,496 (“the ‘496 Patent”), which patents are listed in the U.S. Food and Drug Administration (“FDA”) publication Approved Drug Products With Therapeutic Equivalence Evaluations in connection with COTEMPLA XR-ODTTM brand methylphenidate extended-release orally disintegrating tablets, which products Neos sells in the United States of America, including its territories, possessions, and the Commonwealth of Puerto Rico (the “Territory”), under New Drug Application (“NDA”) No. 205489;

 

B.                                    WHEREAS Teva provided notice to Neos that it has submitted a 21 U.S.C. § 355(j)(2)(A)(vii)(IV) certification (“Paragraph IV Certification”) to, and seeks approval from, the FDA to market the generic extended-release orally disintegrating tablets containing 8.6 mg, 17.3 mg, or 25.9 mg of methylphenidate that are described in Abbreviated New Drug Application (“ANDA”) 210924, prior to the expiration of the ‘924 Patent, the ‘680 Patent, and the ‘496 Patent;

 

C.                                    WHEREAS Neos has prosecuted, and Teva has defended, an action for patent infringement in the United States District Court for the District of Delaware (the “Court”) regarding the generic extended-release orally disintegrating tablets that are described in ANDA 210924 and the Paragraph IV Certification, which action is captioned Neos Therapeutics, Inc. et al. v. Teva Pharmaceuticals USA, Inc., Civil Action No. 17-1793-CFC (the “Action”);

 

D.                                    WHEREAS, subject to the terms and conditions herein, Neos has agreed to grant Teva a non-exclusive license and sublicense, as applicable, to manufacture, have manufactured, use, sell, offer to sell, import, and distribute the generic extended-release orally disintegrating tablets described in  the Teva ANDA (as defined in the License Agreement) in or for the Territory as of the date, and upon the terms, set forth in the License Agreement defined and referred to in Section 2 of this Settlement Agreement;

 

E.                                     WHEREAS, as a result of this Settlement Agreement, there may be supply and sales in or for the Territory of the generic extended-release orally disintegrating tablets described in the Teva ANDA in advance of the expiration of the above-identified patents, which supply and sales otherwise may not have occurred until after the expiration of the asserted patents; and

 

F.                                      WHEREAS the Parties are willing to settle the Action on the terms set forth herein.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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NOW THEREFORE, in consideration of the promises and mutual covenants set forth herein, the sufficiency of which is hereby acknowledged, the Parties hereby agree as follows.

 

1.                                      Stipulation And Order.  In consideration of the mutual benefits of entering into this Agreement, the Parties shall enter into and cause to be filed with the Court, within three (3) days of the Execution Date, a stipulation and order resolving the Action, substantially in the form annexed hereto as Exhibit A (the “Stipulation And Order”).  If the Court does not grant the Stipulation And Order substantially in the form annexed hereto as Exhibit A, the Parties agree to confer in good faith and revise that document consistent with the requirements of the Court.

 

2.                                      License Agreement.  Contemporaneously with the execution of this Agreement, Neos and Teva shall enter into a non-exclusive license and sublicense agreement in the form annexed hereto as Exhibit B (the “License Agreement”).

 

3.                                      Legal Fees.  Each Party shall pay its own fees and costs, including attorney fees, incurred in connection with the Action and in connection with the preparation, execution, and performance of this Agreement.

 

4.                                      Legal Compliance.  The Parties shall submit this Agreement, the License Agreement, the Stipulation And Order, and Exhibit C (the “Settlement Documents”) to the appropriate personnel at the Federal Trade Commission (“FTC”) and the Antitrust Division of the Department of Justice (the “DOJ”) as soon as practicable after the Execution Date, and in no event later than ten (10) days after the Execution Date.

 

(a)     To the extent that any legal or regulatory issue or barrier arises with respect to the Settlement Documents, or any subpart thereof, the Parties shall use commercially reasonable efforts to modify the Settlement Documents to address any such legal or regulatory issue or barrier (including for example any objection by the FTC or DOJ) while maintaining the material terms of the transaction.  Should the FTC or DOJ, as the case may be, object to any such modification, the Parties agree to continue to use commercially reasonable efforts to modify, as many times as necessary, the Settlement Documents as required above in this Section 4.

 

(b)     For purposes of the Settlement Documents, “commercially reasonable efforts” shall mean such reasonable, diligent, and good-faith efforts as a Party would normally use to accomplish a similar objective under similar circumstances.

 

5.                                      Released Claims.  In addition to the dismissal of the Action, as set forth in the Stipulation And Order, and in consideration of the representations, warranties, and covenants contained in this Settlement Agreement and the License Agreement, Neos and Teva make the following releases, which shall be effective upon the entry of the Stipulation And Order by the Court in the Action:

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(a)  Teva for itself and its Affiliates hereby irrevocably releases and discharges Neos and its Affiliates, predecessors, successors, assigns, directors, officers, employees, agents, suppliers, distributors, importers, manufacturers, and customers from all causes of action, demands, claims, damages, and liabilities of any nature, whether known or unknown, arising between Teva and/or its Affiliates and Neos and/or its Affiliates from or in connection with the Action, the Teva ANDA, the generic products described by the Teva ANDA, and/or Neos’s COTEMPLA XR-ODTTM brand methylphenidate extended-release orally disintegrating tablet products and accruing or occurring prior to the Execution Date, including, without limitation, all claims, defenses, and/or counterclaims that Teva and/or its Affiliates have asserted or could have asserted in the Action or in any other court or patent office proceeding in connection with the Teva ANDA or the products described by the Teva ANDA that any of the Licensed Patents, as defined in the License Agreement, is invalid, unenforceable, not properly listed in Approved Drug Products With Therapeutic Equivalence Evaluations (“the Orange Book”), not subject to the proper use codes in the Orange Book, and/or not infringed by the filing of the Teva ANDA and/or the sale of the generic products described by the Teva ANDA in the Territory (all of the above collectively, the “Teva Released Claims”).  For the avoidance of doubt, the release granted under this Section 5(a) shall not apply to any product aside from the products described by the Teva ANDA or NDA 205489, or to any ANDA other than the Teva ANDA.  Teva retains all rights set forth in Section 10 of the License Agreement.

 

(b)     Neos for itself and its Affiliates hereby irrevocably releases and discharges Teva and its Affiliates, predecessors, successors, assigns, directors, officers, employees, agents, suppliers, distributors, importers, manufacturers, and customers from all causes of action, demands, claims, damages, and liabilities of any nature, whether known or unknown, arising between Neos and/or its Affiliates and Teva and/or its Affiliates from or in connection with the Action, the Teva ANDA, the generic products described by the Teva ANDA, and/or Neos’s COTEMPLA XR-ODTTM brand methylphenidate extended-release orally disintegrating tablet products and accruing or occurring prior to the Execution Date, including, without limitation, all claims that Neos and/or its Affiliates have asserted or could have asserted in the Action or in any other proceeding that any of the Licensed Patents, as defined in the License Agreement, is infringed by the Teva ANDA and/or the sale of the generic products described by the Teva ANDA in the Territory (all of the above collectively, the “Neos Released Claims”).  For the avoidance of doubt, the release granted under this Section 5(b) shall not apply to any product aside from the products described by the Teva ANDA or NDA 205489, or to any ANDA other than the Teva ANDA.  Neos retains all rights set forth in Section 10 of the License Agreement.

 

(c)      this Agreement shall constitute a final settlement between the Parties in the Territory in connection with the Action and the Teva ANDA, and neither Teva nor its Affiliates shall institute any new challenge or litigation against Neos and/or its Affiliates with respect to any of the Licensed Patents, as defined in the License Agreement, and ANDA 210924, or actively assist or cooperate with any other party in any such challenge or litigation unless so ordered by the Court or compelled by law.  Notwithstanding this Section 5, Teva may (1) re-certify and/or maintain a “Paragraph IV Certification” in the Teva ANDA (as defined in the

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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License Agreement) with respect to the Licensed Patents or amend the Teva ANDA to contain a “Paragraph IV Certification” with respect to any patent listed in the Orange Book for COTEMPLA XR-ODTTM brand methylphenidate extended-release orally disintegrating tablets (and send corresponding notice of such certification); (2) challenge the infringement, validity, enforceability or patentability of any claim of the Licensed Patents in any litigation or proceeding in any court with respect to any product other than the Licensed Products (as defined in the License Agreement) or any ANDA other than the Teva ANDA; or (3) file a petition with the U.S. Patent and Trademark Office requesting reexamination, inter partes review, or other post grant review of any claims of any Licensed Patents for which Neos or its Affiliates initiates a district court litigation against Teva with a claim of infringement with respect to any product other than the Licensed Products, as defined by the License Agreement, or any ANDA other than the Teva ANDA.  Further, notwithstanding this Section 5, the Neos Released Claims do not preclude Neos from asserting infringement of any of the Licensed Patents, as defined in the License Agreement, in any action or proceeding against Teva and/or any of its Affiliates involving any Teva product other than the Licensed Products, as defined in the License Agreement.

 

(d)  Neither Party shall release any agent or consultant retained by the Party in connection with the Action or any attorney who represented such Party in the Action from maintaining the confidentiality of non-public information to which such agent, consultant or attorney had access in connection with the Action or grant any waivers with respect to such maintenance, unless so ordered by the Court or compelled by law; and

 

(e)  to the extent necessary, each Party shall cooperate with the other to enforce the obligations of such agents, consultants, or attorneys referred to under Section 5(d) herein.

 

6.                                      ACKNOWLEDGMENTS.  Teva and Neos acknowledge as follows:

 

(a)         TEVA ACKNOWLEDGES THAT IT MAY HEREAFTER DISCOVER CLAIMS OR FACTS IN ADDITION TO OR DIFFERENT FROM THOSE WHICH IT NOW KNOWS OR BELIEVES TO EXIST WITH RESPECT TO THE TEVA RELEASED CLAIMS, THE FACTS AND CIRCUMSTANCES ALLEGED IN THE ACTION, AND/OR THE SUBJECT MATTER OF THIS AGREEMENT, WHICH, IF KNOWN OR SUSPECTED AT THE TIME OF EXECUTING THIS AGREEMENT, MAY HAVE MATERIALLY AFFECTED THIS AGREEMENT.  NEVERTHELESS, UPON THE EFFECTIVENESS OF THE RELEASE OF THE TEVA RELEASED CLAIMS AS SET FORTH IN SECTION 5 ABOVE, TEVA HEREBY ACKNOWLEDGES THAT THE TEVA 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.  TEVA ACKNOWLEDGES THAT IT UNDERSTANDS THE SIGNIFICANCE AND POTENTIAL CONSEQUENCES OF SUCH A RELEASE OF UNKNOWN UNITED STATES JURISDICTION CLAIMS AND OF SUCH A SPECIFIC WAIVER OF RIGHTS.  TEVA INTENDS THAT THE CLAIMS RELEASED BY IT UNDER THIS RELEASE BE

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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CONSTRUED AS BROADLY AS POSSIBLE TO THE EXTENT THEY RELATE TO UNITED STATES JURISDICTION CLAIMS.  TEVA IS 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.”

 

TEVA AGREES TO EXPRESSLY WAIVE ANY RIGHTS IT 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 WAIVES ALL SUCH UNKNOWN CLAIMS.

 

(b)         NEOS ACKNOWLEDGES THAT IT MAY HEREAFTER DISCOVER CLAIMS OR FACTS IN ADDITION TO OR DIFFERENT FROM THOSE WHICH IT NOW KNOWS OR BELIEVES TO EXIST WITH RESPECT TO THE NEOS RELEASED CLAIMS, THE FACTS AND CIRCUMSTANCES ALLEGED IN THE ACTION, AND/OR THE SUBJECT MATTER OF THIS AGREEMENT, WHICH, IF KNOWN OR SUSPECTED AT THE TIME OF EXECUTING THIS AGREEMENT, MAY HAVE MATERIALLY AFFECTED THIS AGREEMENT.  NEVERTHELESS, UPON THE EFFECTIVENESS OF THE RELEASE OF THE NEOS RELEASED CLAIMS AS SET FORTH IN SECTION 5 ABOVE, NEOS HEREBY ACKNOWLEDGES THAT THE NEOS 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.  NEOS ACKNOWLEDGES THAT IT UNDERSTANDS THE SIGNIFICANCE AND POTENTIAL CONSEQUENCES OF SUCH A RELEASE OF UNKNOWN UNITED STATES JURISDICTION CLAIMS AND OF SUCH A SPECIFIC WAIVER OF RIGHTS.  NEOS INTENDS THAT THE CLAIMS RELEASED BY IT UNDER THIS RELEASE BE CONSTRUED AS BROADLY AS POSSIBLE TO THE EXTENT THEY RELATE TO UNITED STATES JURISDICTION CLAIMS.  NEOS IS 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.”

 

NEOS AGREES TO EXPRESSLY WAIVE ANY RIGHTS IT 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 WAIVES ALL SUCH UNKNOWN CLAIMS.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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7.                                      Confidentiality.  The terms of this Settlement Agreement shall be maintained in strict confidence by the Parties except:  (a) as provided by Section 4 of this Agreement; (b) that Neos may disclose such terms as may be necessary or useful in connection with any litigation or other proceeding relating to any of the Licensed Patents (as defined in the License Agreement), so long as Neos notifies Teva 14 days prior to such disclosure and such disclosure is made pursuant to either:  (1) the highest level of confidentiality under a protective order; or (2) a confidentiality agreement that restricts access to outside counsel only; (c) that any Party may disclose such terms if and as required by law, including, without limitation, SEC reporting requirements, disclosure requirements to a Party’s bondholders, noteholders, or debtholders, or the disclosure requirements of any stock exchange that a Party is subject to; (d) that Teva may disclose such terms to the FDA or to its manufacturers, suppliers and distributors as may be necessary or useful in obtaining and maintaining final approval of the Teva ANDA and launching the generic products that are the subject of the Teva ANDA when and as permitted by the License Agreement, so long as Teva requests that the FDA and such manufacturers, suppliers and distributors, as applicable, maintain such terms in confidence; (e) that any party may disclose the terms of this Agreement to its Affiliates and/or any Third Party in connection with a potential or actual merger, reorganization, investment, change of control, or sale of all or substantially all of the applicable business or assets of the party to which this Agreement relates, and/or to any Third Party in connection with any divestiture of the Teva ANDA, Neos NDA, or any of the Licensed Patents, so long as such disclosure is made pursuant to a confidentiality agreement that is at least as restrictive with respect to access as the terms of this Agreement; (f) that any Party may disclose such terms to its accountants, auditors, and/or attorneys as required for them to perform their duties, so long as such disclosure is made subject to a confidentiality agreement or professional confidentiality obligation; and (g) that the Parties may each issue a press release disclosing that the Parties have settled the Action, and that Teva has received a license under the Licensed Patents, as defined in the License Agreement, that will permit Teva to commercially launch the Licensed Products on the Launch Date, as those terms are defined in the License Agreement, or earlier in certain circumstances, so long as such press release is approved by the other Parties, which approval shall not be unreasonably delayed, conditioned, or withheld.  The Parties acknowledge and agree that, upon its filing with the Court, the Stipulation And Order will be a matter of public record and shall not be subject to any confidentiality restrictions.  The Parties further agree that, upon the filing of the Stipulation And Order with the Court, the fact that the Parties have settled the Action will be a matter of public record and shall not be subject to any confidentiality restrictions, but that the terms of such settlement shall be maintained in confidence as provided by this Section 7.

 

8.                                      Term and Termination.  This Agreement shall continue from the Execution Date until the earlier of:  (a) the expiration of the last to expire of the Licensed Patents, as defined by the License Agreement; or (b) the date of a Final Court Decision, as defined by the License Agreement, that all of the claims of all of the Licensed Patents, as defined by the License Agreement, are invalid, not infringed, or unenforceable.  The releases and discharges set forth in Section 5 of this Agreement shall survive the expiration or termination of this Agreement and the confidentiality obligations set forth in Section 7 of this Agreement shall survive for a

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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period of fifteen (15) years from the Execution Date, notwithstanding any earlier expiration or termination of this Settlement Agreement.  The License Agreement shall remain in full force and effect pursuant to its own terms notwithstanding the expiration or termination of this Agreement.

 

9.                                      No Assignment.  This Agreement may not be assigned or transferred to a Third Party, as defined in the License Agreement, without the express prior written consent of the other Parties hereto, which shall not be unreasonably withheld, conditioned, or delayed, except to a successor to all or substantially all of the business of the assigning or transferring Party to which this Agreement pertains (whether by sale of stock or assets, merger, consolidation, reorganization, divestiture, change in control, or otherwise) in which case the Party shall assign this Agreement to such successor.  The covenants, rights, and obligations of a Party under this Agreement shall inure to the benefit of and be binding upon any successor or permitted assignee of the Party.  Any purported assignment in violation of this Section 9 of the Agreement shall be null and void ab initio and of no force or effect.

 

10.                               Notice.  Any notice required or permitted to be given or sent under this Agreement shall be hand delivered or sent by express delivery service to the Parties at the addresses indicated below.

 

	
If to Neos, to:
    	
Mr. Richard   Eisenstadt
    
	
 
    	
Chief Financial Officer
    
	
 
    	
Neos Therapeutics, Inc.
    
	
 
    	
2940 North Highway 360
    
	
 
    	
Suite 400
    
	
 
    	
Grand Prairie, Texas   75050
    
	
 
    	
 
    
	
with a copy to:
    	
Peter J. Armenio, P.C.
    
	
 
    	
Quinn Emanuel   Urquhart & Sullivan, LLP
    
	
 
    	
51 Madison Avenue
    
	
 
    	
New York, New York   10010
    
	
 
    	
 
    
	
If to Teva, to:
    	
Colman B. Ragan, Esq.
    
	
 
    	
Vice   President & General Counsel
    
	
 
    	
North   America Intellectual Property Litigation
    
	
 
    	
Teva Pharmaceuticals   USA, Inc.
    
	
 
    	
400 Interpace Parkway
    
	
 
    	
Parsippany, NJ 07054
    
	
 
    	
 
    
	
with a copy to:
    	
Michael   Nutter, Esq.
    
	
 
    	
Winston &   Strawn LLP
    
	
 
    	
35 W. Wacker Drive
    
	
 
    	
Chicago, IL 60601
    

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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Any such notice shall be deemed to have been received on the date actually received.  Either Party may change its notice information above by giving the other Parties written notice, delivered in accordance with this Section.

 

11.                               Entire Agreement.  This Agreement, as defined herein to include Exhibits A, B, and C, constitutes the complete and final agreement between the Parties with respect to the subject matter hereof and supersedes and terminates any prior or contemporaneous agreements and/or understandings between the Parties, whether oral or in writing, relating to such subject matter.  There are no covenants, promises, agreements, warranties, representations, conditions, or understandings, either oral or written, between the Parties relating to such subject matter other than as are set forth in this Agreement.  No alteration, amendment, change, waiver, or addition to this Agreement shall be binding upon any of the Parties unless reduced to writing and signed by an authorized officer of each Party.  Each Party in deciding to execute this Agreement has retained counsel and has not relied on any understanding, agreement, representation, or promise by any Party that is not explicitly set forth herein.

 

12.                               Governing Law.  This Agreement shall be governed, interpreted, and construed in accordance with the laws of the State of Delaware, without giving effect to choice of law principles.  The Parties irrevocably agree that the federal district court in the State of Delaware shall have exclusive jurisdiction to deal with any disputes arising out of or in connection with this Agreement and that, accordingly, any proceeding arising out of or in connection with this Agreement shall be brought in the United States District Court for the District of Delaware.  Notwithstanding the foregoing, if there is any dispute for which the federal district court in the State of Delaware does not have subject matter jurisdiction, the state courts in Delaware shall have jurisdiction.  In connection with any dispute arising out of or in connection with this Agreement, each Party hereby expressly consents and submits to the personal jurisdiction of the federal and state courts in the State of Delaware.

 

13.                               Severability.  Subject to the provisions and the mechanisms of Section 4 above, if any provision of this Agreement is declared illegal, invalid, or unenforceable by a court having competent jurisdiction, it is mutually agreed that this Agreement shall endure except for the part declared invalid or unenforceable by order of such court; provided, however, that in the event that the terms and conditions of this Agreement are materially altered, the Parties will, in good faith, renegotiate the terms and conditions of this Agreement to reasonably replace such invalid or unenforceable provisions in light of the intent of this Agreement.

 

14.                               Waiver.  Any delay or failure in enforcing a Party’s rights under this Agreement, or any acquiescence as to a particular default or other matter, shall not constitute a waiver of such Party’s rights to the enforcement of such rights, nor operate to bar the exercise or enforcement thereof at any time or times thereafter, except as to an express written and signed waiver as to a particular matter for a particular period of time.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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15.                               Counterparts.  This Agreement shall become binding when any one or more counterparts hereof, individually or taken together, bears the signatures of all of the Parties.  This Agreement may be executed in any number of counterparts (including facsimile or e-mail counterparts), each of which shall be an original as against a Party whose signature appears thereon, but all of which taken together shall constitute one and the same instrument.

 

16.                               Representations and Warranties.  Each Party hereby represents and warrants that:  (a) it has approved the execution of this Agreement and has authorized and directed the signatory officer below to execute and deliver this Agreement; (b) it has the full right and power to enter into this Agreement, and there are no other persons or entities whose consent or joinder in this Agreement is necessary to make fully effective those provisions of this Agreement that obligate, burden, or bind it; (c) when executed by it, this Agreement shall constitute a valid and binding obligation of the Party, enforceable in accordance with its terms; and (d) it has not transferred, assigned, or pledged to any third party, whether or not Affiliated, the right to bring, pursue, or settle any of the claims, defenses, or counterclaims in the Action.

 

17.                               Construction.  This Agreement has been jointly negotiated and drafted by the Parties through their respective counsel and no provision shall be construed or interpreted for or against any of the Parties on the basis that such provision, or any other provision, or the Agreement as a whole, was purportedly drafted by a particular Party.  Unless specified otherwise, all references to periods of days for taking certain actions in this Agreement shall be construed to refer to business days.  All references to an Affiliate or Affiliates in this Agreement shall have the meaning provided by Section 1.4 of the License Agreement.

 

*                                         *                                         *                                         *                                         *

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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IN WITNESS WHEREOF, and intending to be legally bound, this Agreement has been executed by the duly authorized representatives of the Parties.

 

	
NEOS THERAPEUTICS, INC.
    	
 
    	
NEOS THERAPEUTICS, LP
    
	
 
    	
 
    	
 
    
	
By: 
    	
/s/ Richard Eisenstadt
    	
 
    	
By: 
    	
/s/ Richard Eisenstadt
    
	
Name: 
    	
Richard Eisenstadt
    	
 
    	
Name: 
    	
Richard Eisenstadt
    
	
Title: 
    	
Chief Financial Officer
    	
 
    	
Title: 
    	
Chief Financial Officer
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
TEVA PHARMACEUTICALS   USA, INC.
    	
 
    	
TEVA PHARMACEUTICALS   USA, INC.
    
	
 
    	
 
    	
 
    
	
By: 
    	
/s/ Hafrun   Fridriksdottir
    	
 
    	
By: 
    	
/s/ Colman Ragan
    
	
Name: 
    	
Hafrun Fridriksdottir
    	
 
    	
Name: 
    	
Colman Ragan
    
	
Title: 
    	
EVP Global R&D
    	
 
    	
Title: 
    	
VP & GC North   America
    
	
 
    	
 
    	
 
    	
 
    	
IP   Litigation
    

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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EXHIBIT A

 

Stipulation And Order

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

 

IN THE UNITED STATES DISTRICT COURT
 FOR THE DISTRICT OF DELAWARE

 

	
NEOS   THERAPEUTICS, INC.
    	
)
    
	
and NEOS THERAPEUTICS,   LP,
    	
)
    	
Civil Action   No. 17-1793-CFC
    
	
 
    	
Plaintiffs,
    	
)
    
	
 
    	
)
    
	
 
    	
v.
    	
)
    
	
 
    	
)
    
	
TEVA PHARMACEUTICALS   USA, INC.,
    	
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Defendant.
    	
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STIPULATION AND ORDER

 

The Court, upon the consent and request of Plaintiffs Neos Therapeutics, Inc. and Neos Therapeutics, LP (collectively, “Plaintiffs”) and Defendant Teva Pharmaceuticals USA, Inc. (“Teva”), hereby acknowledges the following Stipulation and issues the following Order.

 

STIPULATION

 

1.              This Court has subject matter jurisdiction over the above-captioned patent infringement action (the “Action”) and personal jurisdiction over Plaintiffs and Teva for purposes of this Action only.  Venue is proper in this Court as to Plaintiffs and Teva for purposes of this Action only.

 

2.              In the Action, Plaintiffs have asserted claims against Teva for infringement of U.S. Patent Nos. 8,840,924 (“the ‘924 patent”), 9,072,680 (“the ‘680 patent”); and 9,089,496 (“the ‘496 patent”), in connection with Teva’s submission of Abbreviated New Drug Application (“ANDA”) No. 210924 directed to generic extended-release orally

 

 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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

 

disintegrating tablets containing 8.6 mg, 17.3 mg, or 25.9 mg of methylphenidate to the U.S. Food and Drug Administration (“FDA”).

 

3.              In response to Plaintiffs’ charges of patent infringement, Teva has denied Plaintiffs’ claims and alleged certain defenses and counterclaims, including that the ‘924 patent, ‘680 patent, and the ‘496 patent are invalid and/or not infringed by the generic extended-release orally disintegrating tablet products that are the subject of ANDA No. 210924.  To date, no decision has been obtained in the Action regarding Plaintiffs’ claims of infringement, the validity of the ‘924 patent, ‘680 patent, and the ‘496 patent, and/or whether any commercial making, using, selling, or offering to sell within the United States, or importing into the United States, of the generic products described by ANDA No. 210924 would infringe those patents.

 

4.              For purposes of resolving the Action, Teva admits that the submission of ANDA No. 210924 to the FDA for the purpose of obtaining regulatory approval to engage in the commercial manufacture, use, and/or sale of the generic methylphenidate products described therein within the United States before the expiration the ‘924 patent, ‘680 patent, and the ‘496 patent was a technical act of infringement of each of those patents under 35 U.S.C. § 271(e)(2)(A).  This admission is without prejudice to any claim, defense, or counterclaim in any possible future action or proceeding between Teva and Plaintiffs regarding the ‘924 patent, the ‘680 patent, and/or the ‘496 patent and a product other than the generic products described by ANDA No. 210924.

 

 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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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5.              Both parties agree that all other claims, defenses, and counterclaims set forth in the pleadings in the Action, including the allegations and averments contained therein, should be dismissed, without prejudice.

 

ORDER

 

Accordingly, pursuant to the above Stipulation, and upon the consent and request of Plaintiffs and Teva, IT IS HEREBY ORDERED, ADJUDGED AND DECREED THAT:

 

1.              The filing of ANDA No. 210924 was a technical act of infringement of the ‘924 patent, ‘680 patent, and the ‘496 patent under 35 U.S.C. § 271(e)(2)(A).  No decision in the Action has been obtained by either party regarding the validity of the ‘924 patent, ‘680 patent, and the ‘496 patent and/or whether any commercial making, using, selling, or offering to sell within the United States, or importing into the United States, of the generic products described by ANDA No. 210924 would infringe those patents.

 

2.              All other claims, defenses, and counterclaims set forth in the pleadings in the Action, including the allegations and averments contained therein, are hereby dismissed, without prejudice.

 

3.              Teva, its officers, agents, servants, employees, and attorneys, and all other persons in active concert or participation with any of them who receive actual notice of this Order by personal service or otherwise, are hereby enjoined from commercially manufacturing, using, offering to sell, or selling within the United States, or importing into the United States, the generic extended-release orally disintegrating tablet products described by ANDA No. 210924

 

 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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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during the life of the ‘924 patent, ‘680 patent, and the ‘496 patent, including any extensions and pediatric exclusivities, absent a license agreement or other authorization by Plaintiffs.

 

4.              Plaintiffs and Teva each expressly waive any right to appeal or otherwise move for relief from this Stipulation And Order.

 

5.              Each party is to bear its own attorneys’ fees and costs.

 

6.              This Court retains jurisdiction over Plaintiffs and Teva for purposes of enforcing this Stipulation And Order.

 

7.              This Stipulation And Order shall finally resolve the Action.

 

8.              This Stipulation And Order is without prejudice to any claim, defense, or counterclaim in any possible future action or proceeding between Teva and Plaintiffs regarding the ‘924 patent, ‘680 patent, and the ‘496 patent and a product other than the generic extended-release orally disintegrating tablet products described by ANDA No. 210924.

 

9.              Nothing herein prohibits or is intended to prohibit:  (a) Teva from maintaining any “Paragraph IV Certification” pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) or pursuant to 21 C.F.R. § 314.94(a)(12) with respect to ANDA No. 210924; or (b) the U.S. Food and Drug Administration from granting final approval of Teva’s ANDA No. 210924 at any time.

 

10.       The Clerk of the Court is directed to enter this Stipulation And Order forthwith.

 

 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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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SO ORDERED:

 

This        day of                  ,      

 

	
 
    	
 
    
	
 
    	
HONORABLE COLM F. CONNOLLY
    
	
 
    	
UNITED STATES DISTRICT JUDGE
    

 

 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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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EXHIBIT B

 

License Agreement

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

 

LICENSE AGREEMENT

 

This License Agreement (including Exhibit C, the “License Agreement”) is made and entered into this 21st day of December, 2018 (the “Execution Date”), by and between, on the one hand, Neos Therapeutics, Inc. and Neos Therapeutics, LP (collectively, “Neos”), and on the other hand, Teva Pharmaceuticals USA, Inc. (“Teva”) (collectively, the “Parties,” or each separately, a “Party”).

 

RECITALS

 

A.            WHEREAS Neos owns certain U.S. patents listed in the FDA publication Approved Drug Products With Therapeutic Equivalence Evaluations in connection with the COTEMPLA XR-ODTTM brand methylphenidate extended-release orally disintegrating tablets sold in the Territory, as hereinafter defined, under the Neos NDA, as hereinafter defined; and

 

B.            WHEREAS Teva has sought approval from the U.S. Food and Drug Administration (“FDA”) to market generic extended-release orally disintegrating tablets containing 8.6 mg, 17.3 mg, or 25.9 mg of methylphenidate in the Territory under the Teva ANDA, as hereinafter defined; and

 

C.            WHEREAS Teva has represented that it is a First Filer, as hereinafter defined; and

 

D.            WHEREAS, pursuant to the settlement agreement to which this License Agreement is Exhibit B (the “Agreement”), executed contemporaneously with this License Agreement, Neos and Teva have agreed to settle the patent infringement litigation described therein related to Teva’s filing of the Teva ANDA with the FDA; and

 

E.            WHEREAS, as part of such settlement, Neos and Teva agreed to enter into this License Agreement, which, as of the date and upon the terms set forth herein, grants Teva a non-exclusive license and sublicense, as applicable, under the Licensed Patents, as hereinafter defined, to manufacture and/or sell in the Territory the Licensed Products, as hereinafter defined.

 

NOW THEREFORE, in consideration of the promises and mutual covenants set forth herein, the sufficiency of which is hereby acknowledged, the Parties hereby agree as follows.

 

1.             Definitions

 

1.1          “‘924 Patent” shall mean U.S. Patent No. 8,840,924, including all corrections, extensions, and pediatric exclusivities, and any continuations, continuations-in-part, divisionals, reissues, or reexaminations thereof, in each case whether granted or allowed before, on, or after the Execution Date.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

 

1.2          “‘680 Patent” shall mean U.S. Patent No. 9,072,680, including all corrections, extensions, and pediatric exclusivities, and any continuations, continuations-in-part, divisionals, reissues, or reexaminations thereof, in each case whether granted or allowed before, on, or after the Execution Date.

 

1.3          “‘496 Patent” shall mean U.S. Patent No. 9,089,496, including all corrections, extensions, and pediatric exclusivities, and any continuations, continuations-in-part, divisionals, reissues, or reexaminations thereof, in each case whether granted or allowed before, on, or after the Execution Date.

 

1.4          “Affiliate” shall mean any person or legal entity directly or indirectly, through one or more intermediary, controlling, controlled by, or under common control with the Party, where control shall mean:  (a) in the case of a corporate entity, the direct or indirect ownership of more than fifty percent (50%) of the outstanding voting securities of an entity or such other relationship as results in the actual control over the management, assets, business, and affairs of an entity; and (b) in the case of a non-corporate entity, the direct or indirect power to either:  (i) direct the management and policies of the non-corporate entity; or (ii) elect more than fifty percent (50%) of the members of the governing body of such non-corporate entity.  The term “Affiliate” does not include API Affiliate or Wholesaler Affiliate, as defined below.

 

1.5          “ANDA” shall mean an Abbreviated New Drug Application.

 

1.6          “API Affiliate” shall mean a subsidiary or Affiliate of a Party whose primary business is the manufacture and sale of active pharmaceutical ingredients (“API”).  An API Affiliate shall not be deemed to be an Affiliate of a Party for purposes of this Agreement.  For clarity, Teva’s API Affiliates as of the Execution Date include, without limitation, Teva API Inc.

 

1.7          “Authorized Generic” shall mean a generic product:  (a) having the Compound as the sole active ingredient; (b) that is Marketed in the Territory without the Trademark; and (c) that is Marketed under the Neos NDA.

 

1.8          “Compound” shall mean methylphenidate.

 

1.9          “Effective Date” shall mean the date that the Stipulation And Order is entered by the Court.

 

1.10        “FDA” shall mean the U.S. Food and Drug Administration or any successor agency.

 

1.11        “Final Court Decision” shall mean a decision of a court or the U.S. Patent Trial and Appeal Board from which no appeal has been or can be taken, excluding any petition for a writ of certiorari or other proceedings before the United States Supreme Court.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.12        “First Filer” shall mean any party that filed a substantially complete ANDA seeking FDA approval to Market a Generic Equivalent in the Territory before the expiration of one or more of the Licensed Patents with the FDA on the same day that the first such ANDA was filed with the FDA.

 

1.13        “Generic Equivalent” shall mean:  (a) a pharmaceutical product that has been approved by or submitted for approval to FDA for Marketing in the Territory pursuant to an ANDA or a paper NDA (an application under 21 U.S.C. § 355(b)(2)) as a generic equivalent to any of the NDA Products; or (b) an Authorized Generic.

 

1.14        “GMPs” shall mean then current good manufacturing practice regulations promulgated by the FDA.

 

1.15        “Launch Date” shall mean July 1, 2026, unless accelerated as explicitly provided herein.

 

1.16        “Licensed Patents” shall mean, collectively, the ‘924 Patent, the ‘680 Patent, and the ‘496 Patent, and any other patents either owned, in-licensed, or acquired, now or in the future, by Neos or any of its Affiliates that would, in the absence of the Teva License granted under this License Agreement, be infringed by the Manufacture, having Manufactured, and/or Marketing by Teva of the Licensed Products in or for the Territory as of the Launch Date, including any corrections, extensions, pediatric exclusivities, continuations, continuations-in-part, divisionals, reissues, or reexaminations thereof.

 

1.17        “Licensed Products” shall mean the extended-release orally disintegrating tablets that are the subject of the Teva ANDA, as that term is defined in Section 1.27.

 

1.18        “Manufacture” shall mean to make, or to have made, a pharmaceutical product in accordance with GMPs and the provisions of an ANDA or NDA covering such product, and “Manufacturing” shall have a corresponding meaning.

 

1.19        “Market” shall mean to offer, sell, or offer to sell a pharmaceutical product in accordance with all applicable laws and/or to use, import, or export such product for such purposes under all applicable laws, and “Marketing” shall have a corresponding meaning.

 

1.20        “NDA Products” shall mean the extended-release orally disintegrating tablets containing 8.6 mg, 17.3 mg, or 25.9 mg of methylphenidate Marketed under the Trademark in the Territory that contain the Compound as the sole active ingredient and that are approved for Marketing in the Territory pursuant to the Neos NDA, as defined below.

 

1.21        “Neos NDA” shall mean New Drug Application No. 205489.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.22        “Officially Discontinue” shall mean any of:  (a) delisting the products described in Neos NDA with the FDA; (b) delisting the Licensed Patents from the Orange Book unless Neos reasonably determines in good faith that such delisting is required under applicable law; (c) seeking action with the FDA to withdraw COTEMPLA XR-ODTTM from the market, unless required, requested or recommended by the FDA or another governmental authority to do so; or (d) deleting, removing, or canceling any National Drug Code(s) for COTEMPLA XR-ODTTMfrom the applicable National Drug File.

 

1.23        “Permitted Modification” shall mean any supplement of, modification to, or replacement of, ANDA No. 210924 that does not change the active ingredient, dosage form, reference listed drug (unless the reference listed drug is first changed for NDA No. 205489), or AB rating of any generic product defined by said ANDA.  For the avoidance of doubt, a modification or replacement of ANDA No. 210924 to change the active ingredient or add a second active ingredient is not a Permitted Modification.  For the avoidance of doubt, a modification or replacement of ANDA No. 210924 to change the dosage form to an oral liquid dosage form is not a Permitted Modification.

 

1.24        “Stipulation And Order” shall mean the document attached to the Settlement Agreement as Exhibit A.

 

1.25        “Term” shall mean the period of time from the Execution Date of this License Agreement until the date on which this License Agreement expires or terminates as provided in Section 12 of this License Agreement.

 

1.26        “Territory” shall mean the United States of America, including its territories, possessions, and the Commonwealth of Puerto Rico.

 

1.27        “Teva ANDA” shall mean Teva’s ANDA No. 210924 as supplemented and amended as of the Execution Date of this License Agreement and including any Permitted Modification after the Execution Date of this License Agreement.

 

1.28        “Teva License” shall have the meaning assigned to such term in Section 2.1 of this License Agreement.

 

1.29        “Third Party” shall mean any person or entity other than the Parties and their Affiliates.

 

1.30        “Trademark” shall mean the trademark COTEMPLA XR-ODTTM.

 

1.31        “Wholesaler Affiliate” shall mean a subsidiary or Affiliate of a Party whose primary business is wholesale distribution of pharmaceutical products.  A Wholesaler Affiliate shall not be deemed to be an Affiliate of a Party.  For clarity, Teva’s Wholesaler Affiliates as of the Execution Date include, without limitation, Anda, Inc.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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2.             Teva License/Waiver of Exclusivities

 

2.1          Licensed Products.  Effective on and after the Launch Date, Neos grants to Teva and its Affiliates (and to the extent necessary, its suppliers, distributors, and customers, as the case may be):

 

(a)           a non-exclusive, fully paid up, royalty-free license and sublicense, as applicable, under the Licensed Patents to Manufacture, have Manufactured, and Market the Licensed Products in or for the Territory; and

 

(b)           a waiver of any regulatory, statutory, or other exclusivities necessary to effectuate the license and sublicense provided in Section 2.1(a) with respect to the Licensed Products.

 

In addition, during the period of one hundred eighty (180) consecutive calendar days prior to the Launch Date, Neos grants to Teva a non-exclusive license and sublicense, as applicable, to Manufacture or have Manufactured Licensed Products in or for the Territory solely to the extent reasonably necessary to enable Teva to launch such Licensed Products in the Territory on or after the Launch Date.  Teva may Manufacture Licensed Products earlier to the extent necessary and related to FDA approval.  The licenses and sublicenses granted under this Section 2.1 are referred to herein as the “Teva License.”  Teva shall not have any right to sublicense, transfer, or assign any of its rights under the Teva License, except to the extent expressly permitted under Section 13.2 of this License Agreement.

 

2.2          Pre-Booking Activities.  Notwithstanding anything to the contrary contained in this License Agreement, prior to the Launch Date, Teva may engage in the following pre-booking activities:

 

(a)           Discussions with potential customers to make them aware of the upcoming availability of the Licensed Products from Teva as of the Launch Date, starting not earlier than [***] consecutive calendar days prior to the Launch Date;

 

(b)           Importation of the Licensed Products into the Territory starting not earlier than [***] consecutive calendar days prior to the Launch Date.

 

(c)           Offering the Licensed Products for sale and entering into non-binding contracts starting not earlier than [***] consecutive calendar days prior to the Launch Date.

 

For avoidance of doubt, the performance by Teva of any of the activities expressly provided for in this Section 2.2 during the times expressly provided for in this Section 2.2 shall not be construed as Marketing of the Licensed Products prior to the Launch Date for purposes of Section 12.2(a) of this License Agreement.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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2.3          Regulatory Delay.  No provision of this License Agreement shall be affected by any delay in the approval of the Teva ANDA by the FDA, or the failure of Teva to obtain FDA approval of the Teva ANDA, except to the extent that such provision is affected by the delay of the Launch Date.

 

2.4          No Interference; No Discontinuation.  Subject to Teva’s compliance with the terms of this License Agreement and the Settlement Agreement — and except for good faith reasons of safety and/or efficacy based on legitimate, objective evidence or pursuant to an FDA request or court order — Neos and/or its Affiliates shall not, directly or indirectly, seek to interfere with Teva’s efforts to:  (a) obtain FDA approval of the Licensed Products; or (b) Market the Licensed Products as of the date and under the terms provided by this License Agreement.  Subject to Teva’s compliance, neither shall Neos nor any of its Affiliates Officially Discontinue the products described in the Neos NDA prior to the expiration of the Licensed Patents, unless required, requested, or recommended to do so by the FDA or other governmental authority or applicable law.

 

2.5          Confirmation of Regulatory Waiver.  During the Term, within ten (10) business days of receiving a written request from Teva delivered in accordance with Section 13 of this License Agreement, Neos shall submit to the FDA, and/or shall cause its Affiliates to submit to the FDA, appropriate and reasonable documentation (in a form acceptable to FDA and all subject to review by Teva prior to submission) evidencing the licenses, covenants not to sue and waivers set forth in this agreement, including but not limited to a letter in the form provided in Exhibit C to the Settlement Agreement.  If requested in writing by Teva or the FDA, Neos shall further authenticate any true and correct copy of the Settlement Documents provided to the FDA by Teva.  Should the FDA request additional confirmation or documentation of the licenses, covenants not to sue and waivers set forth in this agreement, the Parties agree to use commercially reasonable efforts to reach agreement with respect to providing any such requested additional confirmation or documentation.

 

2.6          No Consent For FDA Approval.  Nothing in this License Agreement or any of the other Settlement Documents shall be interpreted as Neos or its Affiliates consenting to the accuracy or sufficiency of any scientific, medical, bioequivalence, regulatory, or other information contained in the Teva ANDA and/or consenting to the FDA approving the Teva ANDA on the basis of any such information.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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3.             No Unauthorized Manufacturing or Marketing.  Except to the extent expressly permitted by Section 2.1, Section 2.2, Section 5, or Section 6 of this License Agreement, unless this License Agreement is earlier terminated in accordance with the terms thereof, neither Teva, nor any of its Affiliates, nor any of its API Affiliates, nor any of its Wholesaler Affiliates shall under any circumstances commercially Manufacture or Market any Licensed Product in the Territory prior to the expiration of all of the Licensed Patents, including any extensions and pediatric exclusivities.

 

4.             Neos’s Retained Rights

 

4.1          Retained Rights.  Except for the non-exclusive licenses and sublicenses granted to Teva under Section 2.1 of this License Agreement, and the additional rights granted under Section 2.2 of this License Agreement, nothing herein shall be construed as granting or conveying to Teva any licenses, sublicenses, or other rights under the Licensed Patents or any other of Neos’s intellectual property, all such rights being retained by Neos.

 

4.2          Third Party Licenses.  Teva hereby acknowledges that Neos’s retained rights include, without limitation, the right to grant licenses and/or sublicenses, as applicable, to any Third Party under any of the Licensed Patents to, among other things, Manufacture and/or Market in the Territory any Generic Equivalent.

 

4.3          Authorized Generics.  Teva hereby acknowledges that Neos’s retained rights include, without limitation, the right to grant licenses and/or sublicenses, as applicable, to any Third Party under any of the Licensed Patents to, among other things, Manufacture and/or Market in the Territory an Authorized Generic.  Teva further acknowledges that Neos’s retained rights include, without limitation, the right to Manufacture and/or Market in the Territory an Authorized Generic.

 

5.             Potential Acceleration Of The Launch Date

 

5.1          Effect Of Certain Agreements Or An Authorized Generic

 

(a)           [***]

 

(b)           [***]

 

5.2          Effect Of A Final Court Decision.  If there is a Final Court Decision regarding a Generic Equivalent holding all then asserted, adjudicated, and unexpired claims of the Licensed Patents invalid, canceled, unenforceable, and/or not infringed by a Generic Equivalent, then the Launch Date shall automatically be amended to the date of such Final Court Decision provided such Final Court Decision precedes the existing Launch Date.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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5.3          Effect Of A Market Erosion.  In the event that there is a Market Erosion, as defined in Section 5.3(a) of this License Agreement, and there is no extenuating Force Majeure Event, as defined in Section 5.3(b) of this License Agreement, then the Launch Date in this License Agreement shall automatically be amended as defined in Section 5.3(c) of this License Agreement.

 

(a)           [***]

 

(b)           If any Market Erosion defined by Section 5.3(a) of this License Agreement occurs as the result of a Force Majeure Event, and Neos timely provides notice and documentation of such Force Majeure Event to Teva, then it will be deemed as if no such Market Erosion has occurred.  For purposes of this Section 5.3(b), a “Force Majeure Event” shall be defined as any of the following:  fire, explosion, earthquake, flood, other natural disasters, or other acts of God; new acts, regulations, or Laws of any Governmental Entity; war (whether or not declared), acts of terrorism, or failure of public utilities; or insolvency of any Third-Party manufacturer of the Compound or any of the NDA Products.  In the event of a Force Majeure Event, Neos shall timely notify Teva and take reasonable steps to mitigate or otherwise remedy the impact of such event.

 

(c)           [***]

 

5.4          Effect Of Multiple Accelerations.  In the event that more than one of the automatic amendments of the Launch Date provided for by Sections 5.1, 5.2 and/or 5.3 occurs during the Term, the Launch Date shall be the earliest such amended date.

 

6.             Effect Of A Launch At Risk

 

6.1          [***]

 

(a)           [***]

 

(b)           [***]

 

[***]

 

6.2          [***]

 

6.3          In response to any At Risk Launch, including during any Teva At Risk Period, Neos shall be entitled to authorize any Third Party to Market an Authorized Generic in the Territory, and/or Market an Authorized Generic in the Territory itself or through an Affiliate, all without any notice or compensation to Teva.  Section 5.1(b) of this License Agreement shall not be triggered by any such action unless the Authorized Generic in question is still being

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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shipped within or into the Territory by Neos or its authorized Third Party more than ten (10) days after the expiration of the Teva At Risk Period.

 

6.4          [***]

 

7.             Quality Assurance.  Teva represents and warrants to Neos that all Licensed Products Marketed by Teva will be commercially Manufactured, stored, shipped, handled, and Marketed by it and its designees in accordance with then-current GMPs and all applicable laws, rules, and regulations.

 

8.             Confidentiality.  The terms of this License Agreement shall be maintained in strict confidence by the Parties except:  (a) as provided by Section 4 of the Settlement Agreement; (b) that Neos may disclose such terms as may be necessary or useful in connection with any litigation or other proceeding relating to any of the Licensed Patents, so long as Neos notifies Teva 14 days prior to such disclosure and such disclosure is made pursuant to either:  (1) the highest level of confidentiality under a protective order; or (2) a confidentiality agreement that restricts access to outside counsel only; (c) that any Party may disclose such terms if and as required by law, including, without limitation, SEC reporting requirements, disclosure requirements to a Party’s bondholders, noteholders, or debtholders, or the disclosure requirements of any stock exchange that a Party is subject to; (d) that Teva may disclose such terms to the FDA or to its manufacturers, suppliers and distributors as may be necessary or useful in obtaining and maintaining final approval of the Teva ANDA and launching the generic products that are the subject of the Teva ANDA when and as permitted by the License Agreement, so long as Teva requests that the FDA and such manufacturers, suppliers and distributors, as applicable, maintain such terms in confidence; (e) that any party may disclose the terms of this Agreement to its Affiliates and/or any Third Party in connection with a potential or actual merger, reorganization, investment, change of control, or sale of all or substantially all of the applicable business or assets of the party to which this Agreement relates, and/or to any Third Party in connection with any divestiture of the Teva ANDA, Neos NDA, or any of the Licensed Patents, so long as such disclosure is made pursuant to a confidentiality agreement that is at least as restrictive with respect to access as the terms of this Agreement; (f) that any Party may disclose such terms to its accountants, auditors, and/or attorneys as required for them to perform their duties, so long as such disclosure is made subject to a confidentiality agreement or professional confidentiality obligation; and (g) that the Parties may each issue a press release disclosing that the Parties have settled the Action, and that Teva has received a license under the Licensed Patents that will permit Teva to commercially launch the Licensed Products on the Launch Date, or earlier in certain circumstances, so long as such press release is approved by the other Parties, which approval shall not be unreasonably delayed, conditioned, or withheld.  The Parties acknowledge and agree that, upon its filing with the Court, the Stipulation And Order will be a matter of public record and shall not be subject to any confidentiality restrictions.  The Parties further agree that, upon the filing of the Stipulation And Order with the Court, the fact that the Parties have settled the Action will be a matter of public record and shall not be subject

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

9

 

to any confidentiality restrictions, but that the terms of such settlement shall be maintained in confidence as provided by this Section 8.

 

9.             Representations

 

9.1          Teva represents that, to the best of its knowledge and belief, Teva is a First Filer, as defined by Section 1.12 of this License Agreement.

 

9.2          Neos represents that, as of the Execution Date, Neos has not entered into any agreement with any Third Party granting such party a license to Market a Generic Equivalent in the Territory.

 

9.3          Each Party represents and warrants to the other Parties that the execution and delivery by such Party of this License Agreement and the performance of its obligations under this License Agreement and the Settlement Agreement have been duly authorized by all necessary corporate action and do not conflict with the terms of any other contract, agreement, arrangement, or understanding to which such Party is a party.

 

9.4          Neos represents and warrants that it has the right to license and/or sublicense, as applicable, the Licensed Patents to Teva under the terms and conditions set forth in the Agreement and this License Agreement.

 

9.5          Neos represents and warrants that the terms of the License Agreement being offered to Teva are and will be equivalent to or better than the terms being offered by Neos or its Affiliates to any Third Party with respect to any license(s) or other permissions(s) to Generic Equivalent(s) (“Third Party Agreement”) with respect to Sections 2.1, 2.2, 5, and 6 of this License Agreement (License, Pre-Booking Activities, Accelerators, and At Risk Launch).  If Neos and/or its Affiliates enters into a Third Party Agreement providing such Third Party with more favorable terms with respect to Sections 2.1, 2.2, 5, and/or 6, of this License Agreement, then the applicable terms in this License Agreement will be automatically amended to provide such more favorable terms to Teva.  Neos shall notify Teva of any more favorable terms within five (5) business days.

 

9.6          Each Party represents and warrants to the other Parties that the explicit terms of the Agreement and this License Agreement reflect the sole consideration being exchanged between or among any of the Parties in connection with settling the Action and resolving their dispute regarding the Teva ANDA and that no other form of compensation or other accommodation has been made between or among any of the Parties.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

10

 

10.          Covenants; Patent Challenges and Listings; Limitations on Representations

 

10.1        Covenants; Patent Listings and Paragraph IV Certifications.

 

(a)           [***]

 

(b)           During the Term, and provided that Teva and its Affiliates comply with the terms of this License Agreement and the Settlement Agreement, Neos and its Affiliates covenant not to sue Teva or its Affiliates, or any of their predecessors, successors, parents, subsidiaries, shareholders, assigns, licensees, sublicensees, agents, administrators, attorneys, directors, officers, employees, representatives, manufacturers, importers, suppliers, distributors, customers, and insurers, or support or encourage any Third Party to sue, for infringement of any United States or foreign patents owned, exclusively licensed or otherwise controlled, wholly or in part, now or in the future, by Neos and/or any of its Affiliates in connection with the making, using, selling, or offering for sale of the Licensed Products in the Territory and/or the making or having made the Licensed Products outside of the Territory solely for importation into the Territory for subsequent use, sale, or offer for sale in the Territory.  Neos and its Affiliates shall impose this covenant not to sue on any Third Party to which Neos or any of its Affiliates may after the Execution Date assign, license or otherwise transfer or grant any patent rights subject to this covenant not to sue.

 

(c)           For all patents listed in the FDA publication Approved Drug Products With Therapeutic Equivalent Evaluations now or in the future for COTEMPLA XR-ODTTM and/or the Neos NDA, the foregoing covenant not to sue shall hereby be treated as a non-exclusive license to such patents in connection with the Teva ANDA solely for the purpose of allowing Teva and/or its Affiliates to file and maintain with the FDA a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) with respect thereto.  In connection with the Teva ANDA, Teva shall have the right to maintain its existing certifications and/or re-certify under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) against any Licensed Patents listed in the FDA publication Approved Drug Products With Therapeutic Equivalent Evaluations in connection with COTEMPLA XR-ODTTM as of the Execution Date.  In connection with the Teva ANDA, Teva also shall have the right to file a new certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (as amended or replaced) against any Licensed Patents listed in the FDA publication Approved Drug Products With Therapeutic Equivalent Evaluations in connection with COTEMPLA XR-ODTTM after the Execution Date.

 

10.2        Limitation on Representations and Warranties.  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, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED BY EACH PARTY.  IN NO EVENT SHALL EITHER PARTY HAVE ANY LIABILITY TO THE OTHER FOR INDIRECT, PUNITIVE, CONSEQUENTIAL, OR OTHER REMOTE MEASURES OF DAMAGES IN CONNECTION WITH ANY LICENSED PRODUCTS SOLD OR

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

11

 

DISTRIBUTED BY SUCH PARTY OR OTHERWISE ARISING IN RESPECT OF THIS LICENSE AGREEMENT.

 

10.3        Certain Rights Unaffected.  The Parties acknowledge that nothing set forth in this License Agreement, including, without limitation, the provisions of Section 10.2 above, shall be deemed to limit or otherwise affect the availability of any rights or remedies arising at law or equity to which Neos may be entitled as a result of the sale or distribution in the Territory by Teva or any Affiliate of the Licensed Products or any Generic Equivalent prior to the Launch Date set forth in this License Agreement.

 

11.          Trademarks and Trade Names

 

11.1        Teva shall have no right to use the Trademark or any of Neos’s or its Affiliates’ corporate names, brands, or logos and shall have no rights to or under any intellectual property or regulatory exclusivities or approvals held by Neos or its Affiliates (including patents or other intellectual property relating to the consistency, formulation, or manufacturing processes for the NDA Product) other than to the extent of the Teva License.

 

12.          Term and Termination

 

12.1        Expiration.  Unless earlier terminated in accordance with the terms hereof, the term of this License Agreement (the “Term”) shall extend from the Effective Date until the earlier of:  (a) the expiration of the last to expire of the Licensed Patents; or (b) the date of a Final Court Decision that all of the Licensed Patents are invalid or unenforceable.  For the avoidance of doubt, the Licensed Patents include all extensions and pediatric exclusivities, in each case whether granted or allowed before, on, or after the Execution Date, and the Term shall run until the last to expire of such extensions and pediatric exclusivities, whenever granted.

 

12.2        Breach.  Each Party may terminate this License Agreement and its obligations hereunder in the event of a material breach by the other Party that remains uncured for thirty (30) calendar days after the other Party specifies in reasonable detail in writing the nature of the breach and demands its cure.

 

(a)           The Parties acknowledge and agree that any Marketing by Teva and/or any of its Affiliates, API Affiliates, or Wholesaler Affiliates of any of the Licensed Products in the Territory prior to the Launch Date (as such Launch Date may be accelerated pursuant to the explicit terms of Section 5 above, and with the exception of Pre-Booking Activities described in Section 2.2) and outside of any Teva At Risk Period specifically provided for by Section 6 above shall constitute such a significant breach of this License Agreement that Neos may terminate this License Agreement immediately without any notice or opportunity to cure.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

12

 

12.3        Expiration or termination of this License Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination.  Any expiration or early termination of this License Agreement shall be without prejudice to the rights of any Party against any other Party accrued or accruing under this License Agreement prior to termination.

 

13.  Miscellaneous

 

13.1        Notice.  Any notice required or permitted to be given or sent under this License Agreement shall be hand delivered or sent by express delivery service to the Parties at the addresses indicated below.

 

	
If to Neos, to:
    	
Mr. Richard   Eisenstadt
    
	
 
    	
Chief Financial Officer
    
	
 
    	
Neos   Therapeutics, Inc.
    
	
 
    	
2940 North Highway 360
    
	
 
    	
Suite 400
    
	
 
    	
Grand Prairie, Texas   75050
    
	
 
    	
 
    
	
with a copy to:
    	
Peter J. Armenio, P.C.
    
	
 
    	
Quinn Emanuel   Urquhart & Sullivan, LLP
    
	
 
    	
51 Madison Avenue
    
	
 
    	
New York, New York   10010
    
	
 
    	
 
    
	
If to Teva, to:
    	
Colman B.   Ragan, Esq.
    
	
 
    	
Vice   President & General Counsel
    
	
 
    	
North   America Intellectual Property Litigation
    
	
 
    	
Teva Pharmaceuticals   USA, Inc.
    
	
 
    	
400 Interpace Parkway
    
	
 
    	
Parsippany, NJ 07054
    
	
 
    	
 
    
	
with a copy to:
    	
Michael   Nutter, Esq.
    
	
 
    	
Winston & Strawn   LLP
    
	
 
    	
35 W. Wacker Drive
    
	
 
    	
Chicago, IL 60601
    

 

Any such notice shall be deemed to have been received on the date actually received.  Either Party may change its notice information above by giving the other Parties written notice, delivered in accordance with this Section.

 

13.2        Assignment.  This License Agreement shall not be assignable in whole or in part by any Party to any Third Party without the prior written consent of the other Parties,

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

13

 

which shall not be unreasonably withheld, delayed, or conditioned.  Notwithstanding the foregoing, any Party may assign its rights and obligations under the Settlement Agreement and/or this License Agreement to any of its Affiliates.  Further, Teva may assign this License Agreement to any successor to all or substantially all of the business of Teva, whether through a merger, reorganization, consolidation, change of control, sale of stock, sale of all or substantially all of the applicable business or assets of Teva to which this Agreement relates, so long as such successor agrees in writing for the benefit of Neos and its Affiliates to assume all of the obligations of Teva hereunder.  In addition, Neos may assign this License Agreement to any Third Party successor or assign of any of the Licensed Patents or the COTEMPLA XR-ODTTM business generally, so long as such successor agrees in writing for the benefit of Teva and its Affiliates to assume all of the obligations of a Plaintiff hereunder.  This License Agreement shall be binding upon, and inure to the benefit of, the permitted successors and assigns of each Party.  Any purported assignment of a Party’s rights or obligations under the Settlement Agreement and/or this License Agreement in violation of the foregoing shall be null and void ab initio and of no force or effect.

 

13.3        Amendment.  This License Agreement may not be changed, waived, discharged, or terminated orally, but only by an instrument in writing signed by the Party against which enforcement of such change, waiver, discharge or termination is sought.

 

13.4        Superiority of Agreements.  The Parties agree that the provisions of this License Agreement, together with the Agreement and any permitted amendments to either such agreement, supersede and shall prevail over any statements, understandings, promises, or provisions contained in any prior discussions, arrangements, or communications between the Parties or in any documents passing between the Parties.  Notwithstanding anything herein to the contrary, the Agreement and this License Agreement shall be construed together in a consistent manner as reflecting a single intent and purpose.

 

13.5        Governing Law.  This License Agreement shall be governed, interpreted, and construed in accordance with the laws of the State of Delaware, without giving effect to choice of law principles.  The Parties expressly exclude application of the United Nations Convention for the International Sale of Goods.  The Parties irrevocably agree that the federal district court in the State of Delaware shall have exclusive jurisdiction to deal with any disputes arising out of or in connection with this License Agreement and that, accordingly, any such proceeding arising out of or in connection with this License Agreement shall be brought in the United States District Court for the District of Delaware.  Notwithstanding the foregoing, if there is any dispute for which the federal district court in the State of Delaware does not have subject matter jurisdiction, the state courts in Delaware shall have jurisdiction.  In connection with any dispute arising out of or in connection with this License Agreement, each Party hereby expressly consents and submits to the personal jurisdiction of the federal and state courts located in the State of Delaware.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

14

 

13.6        Counterparts.  This License Agreement may be executed simultaneously in several counterparts, including facsimile and/or e-mail counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

13.7        Captions.  The captions of this License Agreement are solely for convenience of reference and shall not affect its interpretation.

 

13.8        Negation of Agency.  Nothing contained herein shall be deemed to create any relationship, whether in the nature of agency, joint venture, partnership, or otherwise, between Teva and Neos.  No Party shall be authorized to bind or obligate any other Party in any manner.  Nothing in this License Agreement, the Settlement Agreement, or any of the Settlement Documents shall be interpreted as Neos or its Affiliates consenting to the accuracy or sufficiency of any scientific, medical, bioequivalence, regulatory, or other information contained in the Teva ANDA and/or consenting to the FDA approving the Teva ANDA on the basis of any such information.  Nothing in this License Agreement, the Settlement Agreement, or any of the Settlement Documents shall be interpreted as Teva or its Affiliates consenting to the accuracy or sufficiency of any scientific, medical, bioequivalence, regulatory, or other information contained in NDA 205489 and/or consenting to the FDA approving NDA 205489 on the basis of any such information.

 

* * * * *

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

15

 

IN WITNESS WHEREOF, and intending to be legally bound, the undersigned have executed this License Agreement as of the date and year first above written.

 

	
NEOS THERAPEUTICS, INC.
    	
NEOS   THERAPEUTICS, LP
    
	
 
    	
 
    
	
 
    	
 
    
	
By:
    	
/s/   Richard Eisenstadt
    	
 
    	
By:
    	
/s/ Richard Eisenstadt
    
	
Name:
    	
Richard   Eisenstadt
    	
 
    	
Name:
    	
Richard Eisenstadt
    
	
Title:
    	
Chief   Financial Officer
    	
 
    	
Title:
    	
Chief Financial Officer
    
	
 
    	
 
    
	
 
    	
 
    
	
TEVA PHARMACEUTICALS USA, INC.
    	
TEVA PHARMACEUTICALS   USA, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
By:
    	
/s/   Hafrun Fridriksdottir
    	
 
    	
By:
    	
/s/ Colman Ragan
    
	
Name:
    	
Hafrun   Fridriksdottir
    	
 
    	
Name:
    	
Colman Ragan
    
	
Title:
    	
EVP   Global R&D
    	
 
    	
Title:
    	
VP & GC North   America
    
	
 
    	
 
    	
 
    	
 
    	
IP Litigation
    

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

16

 

EXHIBIT C

 

Confirmatory Letter To FDA

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

17

 

Dear [FDA],

 

Pursuant to 21 C.F.R. § 314.94(a)(12)(v), Neos Therapeutics, Inc. and Neos Therapeutics, LP (collectively, “Neos”) hereby state that:

 

1.             Neos is the owner of New Drug Application No. 205489 and U.S. Patent Nos. 8,840,924; 9,072,680; and 9,089,496; and

 

2.             Neos and Teva Pharmaceutical USA, Inc. (“Teva”) have reached a settlement of the following litigation pending in the U.S. District Court for the District of Delaware concerning ANDA No. 210924:  Neos Therapeutics, Inc. et al. v. Teva Pharmaceuticals USA, Inc., Civil Action No. 17-1793-CFC (D. Del.); and

 

3.             Under the confidential terms of the settlement agreed to by Neos and Teva, and using the exact language of 21 C.F.R. § 314.94(a)(12)(v), Neos “has a licensing agreement” with Teva that permits Teva to sell the generic product defined by ANDA No. 210924 as of July 1, 2026 under license from Neos.  Given this licensing agreement, and under the terms and conditions set forth therein, Neos “consents to approval of ANDA No. 210924” as soon as it is otherwise eligible for FDA approval.  Given the licensing agreement referenced above, there are no patent disputes preventing effective approval of ANDA No. 210924 as soon as it is otherwise eligible for FDA approval.

 

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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

18Exhibit 10.18

 

Confidential
Treatment Requested

 

EXECUTION
COPY

 

License
Agreement

 

This LICENSE AGREEMENT (“Agreement”) is entered
into as of November 4, 2018 (“Effective Date”) by and between REGENXBIO Inc., a corporation organized under
the laws of the State of Delaware, with offices at 9600 Blackwell Road, Suite 210, Rockville, MD 20850 (“Licensor”),
and Abeona Therapeutics Inc., a corporation organized under the laws of the State of Delaware, with offices at 1330 Avenue of the
Americas, 33rd Floor, New York, NY 10019 (“Licensee”). Licensor and Licensee are hereinafter referred to individually
as a “Party” and collectively as the “Parties.”

 

WHEREAS, Licensor has rights under certain Licensed Patents
(as defined herein) pertaining to adeno-associated virus serotype 9;

 

WHEREAS, Licensee desires to obtain from Licensor an exclusive
license under the Licensed Patents under the terms set forth herein; and

 

WHEREAS, the Licensee has determined, and the Licensor has relied
upon such determination, that the Agreement does not require regulatory approval under the Hart-Scott-Rodino Antitrust Improvements
Act of 1976, as amended.

 

NOW, THEREFORE, in consideration of the promises and covenants
contained in this Agreement, and intending to be legally bound, the Parties hereby agree as follows:

 

Article
1: Definitions

 

1.1          “AAV9”
means (a) the recombinant adeno-associated virus serotype 9 vector with the specified sequence set forth in GenBank **** and (b)
any recombinant adeno-associated virus derivatives of such serotype 9 vector that are covered by the claims of the Licensed Patents.

 

1.2          “Affiliate”
means any legal entity directly or indirectly, during the term of this Agreement, controlling, controlled by, or under common control
with another entity. For purposes of this Agreement, “control” means the direct or indirect ownership of more than
50% of the outstanding voting securities of a legal entity, or the right to receive more than 50% of the profits or earnings of
a legal entity, or the right to control the policy decisions of a legal entity. An entity may be or become an Affiliate of an entity
and may cease to be an Affiliate of an entity, in each case, during the term of this Agreement.

 

1.3          “Calendar
Quarter” means each three-month period or any portion thereof, beginning on January 1, April 1, July 1, and October 1.

 

    	****Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
 

     

    

 

Confidential
Treatment Requested

 

1.4         “Change
of Control” means (i) any transaction or series of related transactions following which the holders of Licensee’s
capital stock or membership or equity interests immediately prior to such transaction or series of related transactions collectively
are the owners of less than 50% of the outstanding equity interests of Licensee entitled to (a) vote with respect to the election
of directors (or positions having a similar function) or (b) receive the proceeds upon any sale, liquidation or dissolution of
Licensee; (ii) a sale, transfer, or other disposition, in a single transaction or series of related transactions, of all or a material
portion of Licensee’s interest in the Licensed Products; (iii) a sale, transfer, or other disposition, in a single transaction
or series of related transactions, of all or a material portion of Licensee’s right title, or interest in its assets taken
as a whole; or (iv) the merger of Licensee with a Third Party by operation of law or otherwise.

 

1.5         “CLN1
Field” means the treatment of Neuronal Ceroid Lipfuscinosis-1, also known as infantile Batten disease, in humans by in
vivo gene therapy using AAV9 to deliver the PPT1 gene.

 

1.6         “CLN3
Field” means the treatment of Neuronal Ceroid Lipfuscinosis-3, also known as juvenile Batten disease, in humans by in
vivo gene therapy using AAV9 to deliver the CLN3 gene.

 

1.7         “Confidential
Information” means and includes all technical information, inventions, developments, discoveries, software, know-how,
methods, techniques, formulae, animate and inanimate materials, data, processes, finances, business operations or affairs, and
other proprietary ideas, whether or not patentable or copyrightable, of either Party that are (a) marked or otherwise identified
as confidential or proprietary at the time of disclosure in writing; or (b) if disclosed orally, visually, or in another non-written
form, identified as confidential at the time of disclosure and summarized in reasonable detail in writing as to its general content
within 30 days after original disclosure. The Parties acknowledge that (i) the terms and conditions of this Agreement and (ii)
the records and reports referred to in Section 3.6 will be deemed the Confidential Information of both Parties, regardless of whether
such information is marked or identified as confidential. In addition, information provided to Licensee pursuant to the provisions
of Section 7.1 will be deemed the Confidential Information of Licensor, regardless of whether such information is marked or identified
as confidential. Notwithstanding the foregoing, Confidential Information will not include the following, in each case, to the extent
evidenced by competent written proof of the Receiving Party:

 

1.7.1        information
that was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure by
the Disclosing Party;

 

1.7.2        information
that was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving
Party;

 

1.7.3        information
that became generally available to the public or otherwise part of the public domain after its disclosure, other than through any
act or omission of the Receiving Party in breach of this Agreement;

 

1.7.4        information
that is independently discovered or developed by the Receiving Party without the use of Confidential Information of the Disclosing
Party; or

 

1.7.5        information
that was disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation
to the Disclosing Party not to disclose such information to others.

 

    	****Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
2

     

    

 

Confidential
Treatment Requested

 

1.8         “Conflicting
License” means the license agreement **** that licenses rights under the Licensed Technology on a non-exclusive, sublicensable
basis for the treatment of MPSIII Type A in human beings by in vivo administration.

 

1.9         “Disclosing
Party” has the meaning set forth in Section 5.1.

 

1.10       “Domain
Antibody” ****.

 

1.11       “FDA”
means the United States Food and Drug Administration, or a successor agency in the United States with responsibilities comparable
to those of the United States Food and Drug Administration.

 

1.12       “Fields”
means the CLN1 Field, the CLN3 Field, the MPS IIIA Field and the MPS IIIB Field (individually, the CLN1 Field, the CLN3 Field,
the MPS IIIA Field and the MPS IIIB Field are hereinafter referred to as a “Field”).

 

1.13       “GSK
Agreement” means that certain License Agreement entered into between Licensor and SmithKline Beecham Corporation, effective
on March 6, 2009, as amended by that certain Amendment to License Agreement dated April 15, 2009, and as further amended from time
to time.

 

1.14       “First
Commercial Sale” of a Licensed Product means the first transfer by Licensee, its Affiliates or Sublicensees for value
in an arms’-length transaction to an independent third party distributor, agent or end user in a country after obtaining
all approvals from Regulatory Authorities necessary for such transfer in such country. For clarity, sales or transfers of a product
for clinical trial purposes, compassionate or similar use or indigent programs shall not constitute a “First Commercial Sale”
hereunder.

 

1.15       “Know-How”
means any and all ideas, information, know-how, data, research results, writings, inventions, discoveries, and other technology
(including any proprietary materials), whether or not patentable or copyrightable.

 

1.16       Licensed
Back Improvements” has the meaning ascribed to it in Section 2.5.2.

 

1.17       “Licensed
Know-How” means any Know-How Licensor provides to Licensee pursuant to Section 2.6.

 

1.18       “Licensed
Patents” means, to the extent they cover AAV9, (a) all United States patents and patent applications listed in Exhibit
A, including patents arising from such patent applications; (b) any re-examination certificates thereof; (c) the foreign counterparts
of the patents and patent applications in subsections (a) and (b); (d) extensions, continuations, divisionals, and re-issue applications
of the patents and patent applications in subsections (a) through (c); and (e) continuations-in-part to the extent that the continuations-in-part
contain one or more claims directed to the invention or inventions disclosed in the patent and patent applications in subsections
(a) through (c); provided that “Licensed Patents” will not include any claim of a patent or patent application covering
any Manufacturing Technology.

 

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1.19       “Licensed
Product” means (a) any AAV9 product that is made, made for, used, sold, offered for sale, or imported by Licensee, its
Affiliates, and any of its or their Sublicensees, (i) the manufacture, use, sale, offer for sale, or import of which product, in
the absence of the license granted pursuant to this Agreement, would infringe or is covered by at least one Valid Claim in the
country of manufacture, use, sale, offer for sale, or import, including products manufactured by a process that would infringe
or is covered by at least one Valid Claim in the country of manufacture, use, sale, offer for sale, or import or (ii) that incorporates,
was developed using, or is produced or manufactured through the use of Licensed Know-How (it being understood that Licensee shall
be deemed to be using Licensed Know-How based upon the license it receives under this Agreement); or (b) any service sold by Licensee,
its Affiliates, and any of its or their Sublicensees with respect to the administration of any AAV9 product to patients that (i)
in the absence of the license granted pursuant to this Agreement, would infringe or is covered by at least one Valid Claim in the
country of sale or (ii) that incorporates, was developed using, or is produced or manufactured through the use of Licensed Know-How
(it being understood that Licensee shall be deemed to be using Licensed Know-How based upon the license it receives under this
Agreement).

 

1.20       “Licensed
Technology” means, collectively, the Licensed Patents and Licensed Know-How.

 

1.21       “Manufacturing Technology” means any and all patents, patent applications, Know-How, and all intellectual property
rights associated therewith that are owned or controlled by Licensor, and including all tangible embodiments thereof, that claim,
cover or relate to the manufacture of adeno-associated viruses, adeno-associated virus vectors, research or commercial reagents
related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the
methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications,
scale up methods, any and all improvements, modifications, and changes thereto, and any and all activities associated with such
manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided
to Regulatory Authorities and the information contained therein are deemed Manufacturing Technology.

 

1.22       “MPS
IIIA Field” means the treatment of Mucopolysaccharidosis type IIIA, also known as Sanfilippo Syndrome Type A, in humans
by in vivo gene therapy using AAV9 to deliver the SGSH gene.

 

1.23       “MPS
IIIB Field” means the treatment of Mucopolysaccharidosis type IIIB, also known as Sanfilippo Syndrome Type B, in humans
by in vivo gene therapy using AAV9 to deliver the NAGLU gene.

 

1.24       “Net
Sales” means the gross receipts from sales or other disposition of a Licensed Product (including fees for services within
the definition of “Licensed Product”) by Licensee and/or its Affiliates and/or any Sublicensees to Third Parties less
the following deductions that are directly attributable to a sale, specifically and separately identified on an invoice or other
documentation and actually borne by Licensee, its Affiliates, or any Sublicensees: ****. In the event consideration other than
cash is paid to Licensee, its Affiliates, or any Sublicensees, for purposes of determining Net Sales, the Parties shall use the
cash consideration that Licensee, its Affiliates, or any Sublicensees would realize from an unrelated buyer in an arm’s length
sale of an identical item sold in the same quantity and at the time and place of the transaction, as determined jointly by Licensor
and Licensee based on transactions of a similar type and standard industry practice, if any.

 

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1.25       “Penn
Agreement” means that certain License Agreement entered into between Licensor and The Trustees of the University of Pennsylvania,
effective on February 24, 2009, as amended by that letter agreement dated March 6, 2009, by that certain Second Amendment to License
Agreement effective on September 9, 2014, and by that certain Third Amendment to License Agreement effective on April 29, 2016,
and as further amended from time to time.

 

1.26       “Prosecute”
means preparation, filing, and prosecuting patent applications and maintaining patents, including any reexaminations, reissues,
oppositions, inter partes review, and interferences.

 

1.27       “Receiving
Party” has the meaning set forth in Section 5.1.

 

1.28       “REGENXBIO
Licensors” means SmithKline Beecham Corporation (or any successor thereto under the GSK Agreement) and The Trustees of
the University of Pennsylvania (or any successor thereto under the Penn Agreement), if any Licensed Technology is sublicensed from
the Penn Agreement.

 

1.29       “Regulatory
Authority” means any national, supra-national, regional, state or local regulatory agency, department, bureau, commission,
council or other governmental entity with authority over (a) the distribution, importation, exportation, manufacture, production,
use, storage, transport, clinical testing or sale of a Licensed Product, including the FDA, or (b) setting the price and/or reimbursement
for a Licensed Product.

 

1.30       “Retained
Rights” has the meaning set forth in Section 2.2.

 

1.31       “Sublicensee”
means (i) any Third Party or Affiliate to whom Licensee grants a sublicense of some or all of the rights granted to Licensee under
this Agreement as permitted by this Agreement; and (ii) any other Third Party or Affiliate to whom a sublicensee described in clause
(i) has granted a further sublicense as permitted by this Agreement.

 

1.32       “Third
Party” means any person or entity other than a Party to this Agreement or Affiliates of a Party to this Agreement.

 

1.33       “Valid
Claim” means a claim of an issued and unexpired patent (including any patent claim the term of which is extended by any
extension, supplementary protection certificate, patent term restoration, or the like) included within the Licensed Patents or
a claim of a pending patent application included within the Licensed Patents, that has not lapsed, been abandoned, been held revoked,
or been deemed unenforceable or invalid by a non-appealable decision or an appealable decision from which no appeal was taken within
the time allowed for such appeal of a court or other governmental agency of competent jurisdiction.

 

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Article
2: License Grants

 

2.1         License
Grant. Subject to the terms and conditions of this Agreement, including the Retained Rights, Licensor hereby grants to Licensee
an exclusive, sublicensable (as provided in Section 2.4 only), non-transferable (except as provided in Section 10.2), royalty-bearing,
worldwide license under the Licensed Technology to make, have made, use, import, sell, and offer for sale Licensed Products using
AAV9 solely in the Fields, including, for the avoidance of doubt, the right to conduct research and development; provided that
with respect to the MPSIIIA Field, the license granted under this Section 2.1 shall be exclusive with the exception of those rights
Licensor has granted under the Conflicting License.

 

2.2         Retained
Rights. Except for the rights and licenses specified in Section 2.1, no license or other rights are granted to Licensee under
any intellectual property of Licensor, whether by implication, estoppel, or otherwise and whether such intellectual property is
subordinate, dominant, or otherwise useful for the practice of the Licensed Technology. Notwithstanding anything to the contrary
in this Agreement, Licensor may use and permit others to use the Licensed Technology for any research, development, commercial,
or other purposes outside of the Fields. Without limiting the foregoing, and notwithstanding anything in this Agreement to the
contrary, Licensee acknowledges and agrees that the following rights are retained by Licensor and the REGENXBIO Licensors (individually
and collectively, the “Retained Rights”), whether inside or outside the Fields:

 

2.2.1        The
rights and licenses granted in Section 2.1 shall not include any right (and Licensor and the REGENXBIO Licensors retain the exclusive
(even as to Licensee), fully sublicensable right) under the Licensed Technology to make, have made, use, sell, offer to sell, and
import Domain Antibodies that are expressed by an adeno-associated vector, including AAV9.

 

2.2.2        Licensor
and the REGENXBIO Licensors retain the following rights with respect to the Licensed Technology:

 

		(a)	A non-exclusive, sublicensable right under the Licensed Technology to make, have made, use, sell, offer to sell, and import
products that deliver RNA interference and antisense drugs using an adeno-associated vector, including AAV9; and

 

		(b)	A non-exclusive right for the REGENXBIO Licensors (which right is sublicensable by the REGENXBIO Licensors) to use the Licensed
Technology for non-commercial research purposes and to use the Licensed Technology for such REGENXBIO Licensors’ discovery
research efforts with non-profit organizations and collaborators.

 

2.2.3       The
rights and licenses granted in Section 2.1 shall not include any right (and Licensor retains the exclusive (even as to Licensee),
fully sublicensable right) under the Licensed Technology:

 

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		(a)	to conduct commercial reagent and services businesses, which includes the right to make, have made, use, sell, offer to sell,
and import research reagents, including any viral vector construct; provided that, for clarity, such rights retained by Licensor
shall not include the right to conduct clinical trials in humans in the Fields; or

 

		(b)	to use the Licensed Technology to provide services to any Third Parties; provided that Licensee’s license under Section
2.1 does include the right to provide the service of the administration of Licensed Products to patients.

 

2.2.4        Licensor
retains the fully sublicensable right under the Licensed Technology to grant non-exclusive research and development licenses to
Affiliates and Third Parties; provided that such research and development rights granted by Licensor shall not include the right
to conduct clinical trials in humans in the Fields or any rights to sell products in the Fields.

 

2.2.5        The
Trustees of the University of Pennsylvania may use and permit other non-profit organizations or other non-commercial entities to
use the Licensed Technology for educational and research purposes.

 

2.3         Government
Rights. Licensee acknowledges that the United States government retains certain rights in intellectual property funded in whole
or part under any contract, grant, or similar agreement with a federal agency. The license grants hereunder are expressly subject
to all applicable United States government rights, including any applicable requirement that products resulting from such intellectual
property sold in the United States must be substantially manufactured in the United States.

 

2.4         Sublicensing.

 

2.4.1        The
license granted pursuant to Section 2.1 is sublicensable by Licensee to any Affiliates or Third Parties; provided that any such
sublicense must comply with the provisions of this Section 2.4 (including Section 2.4.2).

 

2.4.2        The
right to sublicense granted to Licensee under this Agreement is subject to the following conditions:

 

		(a)	Licensee may only grant sublicenses pursuant to a written sublicense agreement with the Sublicensee. Licensor must receive
written notice as soon as practicable following execution of any such sublicenses. Any further sublicenses granted by any Sublicensees
(to the extent permitted hereunder) must comply with the provisions of this Section 2.4 (including Section 2.4.2) to the same extent
as if Licensee granted such sublicense directly.

 

		(b)	In each sublicense agreement, the Sublicensee must be required to comply with the terms and conditions of this Agreement to
the same extent as Licensee has agreed and must acknowledge that Licensor is an express third party beneficiary of such terms and
conditions under such sublicense agreement.

 

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		(c)	The official language of any sublicense agreement shall be English.

 

		(d)	Within **** after entering into a sublicense, Licensor must receive a copy of the sublicense written in the English language
for Licensor’s records and to share with the REGENXBIO Licensors. The copy of the sublicense may be redacted to exclude confidential
information of the applicable Sublicensee, but such copy shall not be redacted to the extent that it impairs Licensor’s (or
the REGENXBIO Licensors’) ability to ensure compliance with this Agreement; provided that, if either of the REGENXBIO Licensors
requires a complete, unredacted copy of the sublicense, Licensee shall provide such complete, unredacted copy.

 

		(e)	Licensee’s execution of a sublicense agreement will not relieve Licensee of any of its obligations under this Agreement.
Licensee is and shall remain **** to Licensor for all of Licensee’s duties and obligations contained in this Agreement and
for any act or omission of an Affiliate or Sublicensee that would be a breach of this Agreement if performed or omitted by Licensee,
and Licensee will be deemed to be in breach of this Agreement as a result of such act or omission.

 

2.5         Improvements.

 

2.5.1        Licensee
hereby grants to Licensor a non-exclusive, worldwide, royalty-free, transferable, sublicensable, irrevocable, perpetual license:

 

		(a)	to use any Licensed Back Improvements (and any intellectual property rights with respect thereto) consummate in scope to the
Retained Rights, and

 

		(b)	to practice the Licensed Back Improvements (and any intellectual property rights with respect thereto) in connection with AAV9,
including the right to research, develop, make, have made, use, offer for sale, and sell products and services; provided that Licensor
shall have no right, under the license in this Section 2.5.1(b), to practice the Licensed Back Improvements in the Fields.

 

2.5.2        For
purposes of this Agreement, “Licensed Back Improvements” means any patentable modifications or improvements
developed by Licensee, any Affiliates, or any Sublicensees to any vector that is the subject of a claim within the Licensed Patents.

 

2.5.3        Licensee
agrees to provide prompt notice to Licensor upon the filing of any patent application covering any Licensee Invention and/or any
Licensed Back Improvement, together with a reasonably detailed description of, or access to, such Licensee Inventions and/or Licensed
Back Improvement to permit the practice of any such invention or improvement.

 

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2.6         Transfer
of Licensed Know-How. During the **** following the Effective Date, at Licensee’s sole expense, to the extent not previously
disclosed or provided to Licensee, (a) Licensor will deliver to Licensee copies of Licensed Know-How set forth in Exhibit B
in the form that such Licensed Know-How then exists; and (b) Licensor will disclose to Licensee any development Know-How, including
through in-person or telephonic meetings at such times and places as agreed to by the Parties, relating to the Licensed Products
that Licensor agrees to provide to Licensee following a written request from Licensee. Licensee acknowledges and agrees that all
Licensed Know-How disclosed pursuant to this Section 2.6 will be deemed “Confidential Information” of Licensor,
regardless of whether such information is marked or identified as confidential and without an obligation to summarize oral information.

 

2.7         Regulatory
Rights. Upon request, Licensee shall grant Licensor a “right of reference” for the FDA or any equivalent foreign
regulatory body to any submissions containing ****. Upon request, Licensor shall grant Licensee a “right of reference”
for the FDA or any equivalent foreign regulatory body to any submissions containing ****.

 

2.8         Collaboration
Activities. Solely upon the written request of Licensee, Licensor may, in its sole discretion after receipt of such request,
engage in collaboration activities with Licensee related to ****.

 

2.9         Section
365(n) of the Bankruptcy Code. All rights and licenses granted to Licensee or Licensor under or pursuant to this Agreement
are and will otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code (Title 11, U.S. Code),
as amended (the “Bankruptcy Code”) or any comparable law outside the United States, licenses of rights to “intellectual
property” as defined in Section 101(35A) of the Bankruptcy Code. The Parties will retain and may fully exercise all of their
respective rights and elections under the Bankruptcy Code and any comparable law outside the United States.

 

Article
3: Consideration

 

3.1        Initial
Fee. In partial consideration of the rights and licenses granted to Licensee under this Agreement, Licensee shall pay Licensor
an initial fee of $20,000,000, which shall be payable as follows: (a) $10,000,000 within **** after the Effective Date; and (b)
$10,000,000 within twelve (12) months of the Effective Date; provided that any unpaid portion of the initial fee shall be immediately
payable upon termination of this Agreement or a Change of Control.

 

3.2        Annual
Fees. In partial consideration of the rights and licenses granted to Licensee under this Agreement, Licensee shall pay Licensor
annual fees of $100,000,000, which shall be payable as follows: (i) $20,000,000 on the second anniversary of the Effective Date;
(ii) $20,000,000 on the third anniversary of the Effective Date; (iii) $20,000,000 on the fourth anniversary of the Effective Date;
(iv) $20,000,000 on the fifth anniversary of the Effective Date; and (v) $20,000,000 on the sixth anniversary of the Effective
Date. In the event of termination of the Agreement prior to the second anniversary of the Effective Date, Licensee shall pay Licensor
any unpaid amounts recited in (i) within **** of such termination. In the event of a Change of Control and to the extent that payments
(i), (ii), (iii), (iv) and/or (v) above have not been received by Licensor from Licensee, Licensee shall pay Licensor any such
unpaid amounts recited in (i), (ii), (iii), (iv) or (v) (subject to adjustments in amounts due for any terminated Fields in accordance
with Section 6.6.6, provided such termination is effective prior to the Change of Control) within **** of the Change of Control.

 

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3.3         Milestone
Fees. In partial consideration of the rights and licenses granted to Licensee under this Agreement, Licensee shall pay Licensor
the following milestone payments:

 

	 Milestone	Milestone Payment
	1.  Cumulative Net Sales of Licensed Products first reaching ****	****
	2.  Cumulative Net Sales of Licensed Products first reaching ****	****
	Total:	$60,000,000

 

3.3.1        For
clarity, each milestone payment set forth in Section 3.3 is payable only once.

 

3.4         Royalties.
In further consideration of the rights and licenses granted to Licensee under this Agreement, Licensee shall pay to Licensor a
royalty of **** on Net Sales of Licensed Products, subject to the reductions in royalty rates set forth in Section 3.4.1.

 

3.4.1        Third
Party Royalties Stacking Provision. If Licensee must obtain a license from a Third Party to avoid infringement of such Third
Party’s rights in order to manufacture, use, or commercialize a given Licensed Product and if the royalties required to be
paid to such Third Party for such license, together with those royalties payable to Licensor, in the aggregate, exceed **** of
Net Sales for any Licensed Product, then the royalty owed to Licensor for that Licensed Product will be reduced by an amount calculated
as follows:

 

STACKING ROYALTY CALCULATIONS

 

R = (C * (A / (A+B)))

 

Where

R = reduction of Licensor royalty,

A = unreduced Licensor royalty,

B = sum of all Third Party royalties,

C = increment of projected total royalty above ****.

 

Example Calculation:

 

	Assume:	i)    all Third Party royalties = ****
	 	ii)   unreduced Licensor royalty = ****
	 	iii)  projected total royalty = ****

 

R = (**** - ****) * (**** / (**** + ****))

R = (**** * ****)

R = ****

Licensor Stacked Royalty = **** – **** = ****
(but subject to the cap described below which limits the reduction to **** in the aggregate)

 

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Notwithstanding the foregoing, Licensee will pay to
Licensor no less than **** of the royalties that Licensee would otherwise pay to Licensor with respect to Net Sales of Licensee
if there were no royalties due to Third Parties.

 

3.4.2        Adjustment
of Royalties For Licenses. On a Licensed Product-by-Licensed Product, country-by-country basis, upon the date on which the
manufacture, use, sale, offer for sale, or import of a Licensed Product does not infringe or is not covered by a Valid Claim in
such country, then the royalty percentage applicable to Net Sales of such Licensed Product under this Section 3.4 in such country
shall be reduced by ****.

 

3.4.3        Royalty
Payment Period. Licensee’s obligation hereunder for payment of a royalty under this Section 3.4 on the Net Sales of Licensed
Products in a given country will end on a country-by-country, Licensed Product-by-Licensed Product basis on the later of: (i) expiration,
lapse, abandonment, or invalidation of the last Valid Claim of the Licensed Patents to expire, lapse, become abandoned or become
unenforceable for the applicable Licensed Product in the applicable country, or (ii) **** from the First Commercial Sale of the
applicable Licensed Product in the applicable country.

 

3.5         Sublicense
Fees.

 

3.5.1        In
further consideration of the rights and licenses granted to Licensee under this Agreement, Licensee will pay Licensor **** of any
sublicense fees (****) received by Licensee or its Affiliates from a Third Party for the Licensed Technology from any Sublicensee
or from any person or entity granted any option to obtain a sublicense (“Sublicensing Revenue”).

 

3.5.2        With
respect to the obligations under this Section 3.5, Licensee shall not be required to submit any amounts received from a Third Party
for the following:

 

		(a)	Reimbursement or payment of Licensee’s actual costs or on an arm’s length cost plus arrangement for research, development,
and/or manufacturing activities performed by Licensee or its Affiliates corresponding directly to the research, development and/or
manufacturing of Licensed Products pursuant to a specific agreement;

 

		(b)	Any and all amounts paid to Licensee or its Affiliates by a Sublicensee as royalties on sales of
Licensed Product sold by the Sublicensee under a sublicense agreement; and

 

		(c)	Consideration received for the purchase of an equity interest in Licensee or its Affiliates at
fair market value or in the form of loans at arm’s length rates of interest.

 

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3.5.3        If
Licensee or its Affiliates receives sublicense fees from Sublicensees or from any person or entity granted any option to obtain
a sublicense under this Agreement in the form of non-cash consideration, then Licensee shall pay Licensor a cash payment as required
under Section 3.5 determined based on the fair market value of such non-cash consideration. If Licensee or its Affiliate enters
into any sublicense that is not an arm’s length transaction, fees due under this Section 3.5 will be calculated based on
the fair market value of such transaction, at the time of the transaction, assuming an arm’s length transaction made in the
ordinary course of business, as determined jointly by Licensor and Licensee based on transactions of a similar type and standard
industry practice, if any.

 

3.5.4        To
the extent Licensee or its Affiliates receives payment from a Third Party relating to one or more of the milestone events set forth
in the table in Section 3.3, then the amount of the payment made to Licensor under such Section 3.3 with respect to such milestone
event shall not be deemed sublicense fees under this Section 3.5; instead, the amounts due under this Section 3.5 shall be calculated
by applying the applicable sublicense fee rate set forth in Section 3.5 above to the sublicense fees received by Licensee or its
Affiliates from such Third Party after deducting the amount of the payment under Section 3.3.

 

3.6         Reports
and Records.

 

3.6.1        Licensee
must deliver to Licensor within **** after the end of each Calendar Quarter after the First Commercial Sale of a Licensed Product
a report setting forth the calculation of the royalties due to Licensor for such Calendar Quarter on a Licensed Product by Licensed
Product basis, including:

 

		(a)	Number of Licensed Products included within Net Sales, listed by country;

 

		(b)	Gross consideration for Net Sales of Licensed Product, including all amounts invoiced, billed, or received, listed by country;

 

		(c)	Qualifying costs to be excluded from the gross consideration, as described in Section 1.24, listed by category of cost and
by country;

 

		(d)	Net Sales of Licensed Products listed by country;

 

		(e)	A detailed accounting of any royalty reductions applied pursuant to Section 3.4.1;

 

		(f)	Royalties owed to Licensor; and

 

		(g)	The computations for any applicable currency conversions.

 

3.6.2        Licensee
shall pay the royalties due under Section 3.4 within **** following the last day of the Calendar Quarter in which the royalties
accrue. Licensee shall send the royalty payments along with the report described in Section 3.6.1.

 

3.6.3        Within
**** after the occurrence of a milestone event described in Section 3.3, Licensee must deliver to Licensor a report describing
the milestone event that occurred, together with a payment of the applicable amount due to Licensor pursuant to Section 3.3.

 

3.6.4        Within
**** after the receipt of any fees from any Third Party as described in Section 3.5, Licensee must deliver to Licensor a report
describing the fees received, together with a payment of the applicable amount due to Licensor pursuant to Section 3.5.

 

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3.6.5        All
financial reports under this Section 3.6 will be certified by the chief financial officer of Licensee or Licensee’s qualified
financial representative.

 

3.6.6        Licensee
shall maintain and require its Affiliates and all Sublicensees to maintain, complete, and accurate books and records that enable
the royalties, fees, and payments payable under this Agreement to be verified. The records must be maintained for **** after the
submission of each report under Article 3. Upon reasonable prior written notice to Licensee, Licensee and its Affiliates and all
Sublicensees will provide Licensor and/or the REGENXBIO Licensors (and their respective accountants) with access to all of the
relevant books, records, and related background information required to conduct a review or audit of the royalties, fees, and payments
payable to Licensor under this Agreement to be verified. Access will be made available: (a) during normal business hours; (b) in
a manner reasonably designed to facilitate the auditing party’s review or audit without unreasonable disruption to Licensee’s
business; and (c) no more than once each calendar year during the term of this Agreement and for a period of **** thereafter. Licensee
will promptly pay to Licensor the amount of any underpayment determined by the review or audit, plus accrued interest. If the review
or audit determines that Licensee has underpaid any payment by **** or more, then Licensee will also promptly pay the costs and
expenses of Licensor and the REGENXBIO Licensors and their respective accountants in connection with the review or audit. If the
review or audit determines that Licensee has overpaid any payment, then Licensor shall refund the overpayment to Licensee.

 

3.7         Currency,
Interest.

 

3.7.1        All
dollar amounts referred to in this Agreement are expressed in United States dollars. All payments to Licensor under this Agreement
must be made in United States dollars.

 

3.7.2        If
Licensee receives payment in a currency other than United States dollars for which a royalty or fee or other payment is owed under
this Agreement, then (a) the payment will be converted into United States dollars at the conversion rate for the foreign currency
as published in the eastern edition of the Wall Street Journal, N.Y. edition or other equivalent publication as mutually
agreed upon by the Parties, as of the last business day of the Calendar Quarter in which the payment was received by Licensee;
and (b) the conversion computation will be documented by Licensee in the applicable report delivered to Licensor under Section
3.6.

 

3.7.3       All
amounts that are not paid by Licensee when due will accrue interest from the date due until paid at a rate equal to 1.5% per month
(or the maximum allowed by law, if less).

 

3.8         Taxes
and Withholding.

 

3.8.1       All
payments hereunder will be made free and clear of, and without deduction or deferment in respect of, and Licensee shall pay and
be responsible for, and shall hold Licensor harmless from and against, any taxes, duties, levies, fees, or charges, including sales,
use, transfer, excise, import, and value added taxes (including any interest, penalties, or additional amounts imposed with respect
thereto) but excluding withholding taxes to the extent provided in Section 3.8.2. At the request of Licensee, Licensor will give
Licensee such reasonable assistance, which will include the provision of documentation as may be required by the relevant tax authority,
to enable Licensee to pay and report and, as applicable, claim exemption from or reduction of, such tax, duty, levy, fee, or charge.

 

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3.8.2        If
any payment made by Licensee hereunder becomes subject to withholding taxes with respect to Licensor’s gross or net income
under the laws of any jurisdiction, then Licensee will deduct and withhold the amount of such taxes for the account of Licensor
to the extent required by law and will pay the amounts of such taxes to the proper governmental authority in a timely manner and
promptly transmit to Licensor appropriate proof of payment of such withholding taxes. At the request of Licensor, Licensee will
give Licensor such reasonable assistance, which will include the provision of appropriate certificates of such deductions made
together with other supporting documentation as may be required by the relevant tax authority, to enable Licensor to claim exemption
from or reduction of, or otherwise obtain repayment of, such withholding taxes, and will upon request provide such additional documentation
from time to time as is reasonably required to confirm the payment of withholding tax.

 

Article
4: Diligence

 

4.1         Diligence
Obligations. Licensee will use commercially reasonable efforts to develop, commercialize, market, promote, and sell Licensed
Products in the Field. Commercially reasonable efforts means efforts equivalent to those utilized by ****. Without limiting the
foregoing, Licensee will meet the following: acceptance by the FDA or foreign equivalent of an investigational new drug application
for a Licensed Product in the CLN1 Field and CLN3 Field by no later than****; provided, however, that, if Licensee expects not
to achieve the milestone on or before the specified deadline in either the CLN1 Field or the CLN3 Field, Licensee may extend any
deadline in either or both Field(s) for an additional **** per extension by paying Licensor an extension fee of **** per Field
on or before such deadline and the deadline shall then be extended by an additional ****. Licensee will only be****.

 

4.2         Development
Plans.

 

4.2.1       
For each Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development
Plan”). The initial Development Plans for the Licensed Product in the Field will be delivered within **** after the Effective
Date.

 

4.2.2        Each
Development Plan will cover the next 2 years, and will include future development activities to be undertaken by Licensee, its
Affiliates, or any Sublicensees during the next reporting period under Section 4.3 relating directly to the Licensed Product, Licensee’s
strategy to bring the Licensed Product to commercialization, and projected timeline for completing the necessary tasks to accomplish
the goals of the strategy.

 

4.2.3        Following
receipt by Licensor of each Development Plan, Licensor will promptly notify Licensee of any comments or requested revisions, and
the Parties will thereupon negotiate any appropriate revisions in good faith. With respect to development milestones to be set
forth in the initial Development Plans for the Field, the Parties will agree upon reasonable milestones and completion dates to
be set forth in the Development Plan (and any amendments thereto).

 

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4.3         Reporting.
Within **** after the Effective Date and within **** of each December 1 thereafter, Licensee shall provide Licensor with written
progress reports, setting forth in such detail as Licensor may reasonably request, the progress of the development, evaluation,
testing, and commercialization of each Licensed Product. Licensee will also notify Licensor within **** of the First Commercial
Sale by Licensee, its Affiliates, or any Sublicensees of each Licensed Product. Such a report (“Development Progress Report”),
setting forth the current stage of development of Licensed Products, shall include:

 

4.3.1        Date
of Development Progress Report and time covered by such report;

 

4.3.2        Major
activities and accomplishments completed by Licensee, its Affiliates, and any Sublicensees relating directly to the Licensed Products
since the last Development Progress Report;

 

4.3.3        Significant
research and development projects relating directly to the Licensed Products currently being performed by Licensee, its Affiliates,
and any Sublicensees and good faith, but non-binding, projected dates of completion;

 

4.3.4        A
development plan covering the next two years at least, which will include future development activities to be undertaken by Licensee,
its Affiliates, or any Sublicensees during the next reporting period relating directly to the Licensed Products, Licensee’s
strategy to bring the Licensed Products to commercialization, and projected timeline for completing the necessary tasks to accomplish
the goals of the strategy;

 

4.3.5        Projected
total development remaining before product launch of each Licensed Product; and

 

4.3.6        Summary
of significant development efforts using the Licensed Technology being performed by Third Parties, including the nature of the
relationship between Licensee and such Third Parties.

 

4.4         Confidential
Information. The Parties agree that Development Progress Reports shall be deemed Licensee’s Confidential Information;
provided that Licensor may share a copy of such reports with the REGENXBIO Licensors.

 

4.5         Improvements.
Simultaneously with the Development Progress Report, Licensee shall deliver a detailed description of any Licensed Back Improvements,
if not previously provided pursuant to Section 2.5.3.

 

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Article
5: Confidentiality

 

5.1         Treatment
of Confidential Information. Each Party, as a receiving party (a “Receiving Party”), agrees that it will
(a) treat Confidential Information of the other Party (the “Disclosing Party”) as strictly confidential; (b)
protect the Confidential Information of the Disclosing Party with at least the same degree of care as it protects its own confidential
and proprietary information, and in any event with not less than a reasonable degree of care; (c) not disclose such Confidential
Information to Third Parties without the prior written consent of the Disclosing Party, except as may be permitted in this Agreement;
provided that any disclosure permitted hereunder shall be under confidentiality agreements with provisions at least as stringent
as those contained in this Agreement; and (d) not use such Confidential Information for purposes other than those authorized expressly
in this Agreement. The Receiving Party agrees to ensure that its employees who have access to Confidential Information are obligated
in writing to abide by confidentiality obligations at least as stringent as those contained under this Agreement.

 

5.2         Public
Announcements.

 

5.2.1        The
Parties agree they will issue a joint press release in the form attached hereto as Exhibit C. Except as provided in Section
5.2.2, any press releases by either Party with respect to the other Party or any other public disclosures concerning the existence
of or terms of this Agreement shall be subject to review and approval by the other Party. Once the joint press release or any other
written statement is approved for disclosure by both Parties, either Party may make subsequent public disclosure of the contents
of such statement without the further approval of the other Party.

 

5.2.2        Notwithstanding
Section 5.2.1, Licensor has the right to publish (through press releases, scientific journals, or otherwise) and refer to any clinical,
regulatory, or research results related to Licensee’s Licensed Product or AAV9 program that have been publicly disclosed
by Licensee, including referring to Licensee by name as a licensee of Licensor, which publication or referral by Licensor shall
not require the prior consent of Licensee.

 

5.3         Authorized
Disclosure. Notwithstanding the provisions of Section 5.1 or 5.2, either Party may disclose the other’s Confidential
Information or make such a disclosure of the existence of and/or terms of this Agreement to any ****; provided that, in each case,
such recipient of Confidential Information is obligated to keep such information confidential on terms no less stringent than those
set forth in this Agreement. Furthermore, Licensee agrees that Licensor may share a copy of this Agreement, reports and notices
provided by Licensee to Licensor pursuant to the terms of this Agreement, and copies of sublicense agreements provided to Licensor
hereunder, with the REGENXBIO Licensors to the extent required by the GSK Agreement and the Penn Agreement, under confidentiality.
In the event that the Receiving Party receives service of legal process that purports to compel disclosure of the Disclosing Party’s
Confidential Information or becomes obligated by law, rule, regulation or rules of a security exchange, to disclose the Confidential
Information of the Disclosing Party or the existence of or terms of this Agreement to any governmental authority, then, to the
extent legally permitted, the Receiving Party shall promptly notify the Disclosing Party, so that the Disclosing Party may seek
an appropriate protective order or other remedy with respect to narrowing the scope of such requirement and/or waive compliance
by the Receiving Party with the provisions of this Agreement. The Receiving Party will, at the Disclosing Party’s request
and expense, provide the Disclosing Party with reasonable assistance in obtaining such protective order or other remedy. If, in
the absence of such protective order or other remedy, the Receiving Party is nonetheless required by law, rule, regulation or rules
of a security exchange, to disclose the existence of or terms of this Agreement or other Confidential Information of the Disclosing
Party, then the Receiving Party may disclose such Confidential Information without liability hereunder; provided that the Receiving
Party shall furnish only such portion of the Confidential Information that is legally required to be disclosed and only to the
extent required by law.

 

5.4         Term
of Confidentiality. The obligations of this Article 5 shall continue for a period of **** following the expiration or termination
of this Agreement.

 

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Article
6: TERM AND Termination

 

6.1         Term
of Agreement. This Agreement will commence on the Effective Date and continue in effect on a country-by-country, Licensed Product-by-Licensed
Product basis until the later of: (i) the expiration, lapse, abandonment, or invalidation of the last Valid Claim of the Licensed
Patents to expire, lapse, become abandoned, become unenforceable for the applicable Licensed Product in the applicable country,
or (ii) 10 years from the First Commercial Sale of the applicable Licensed Product in the applicable country, unless sooner terminated
in accordance with Section 6.2, Section 6.3, Section 6.4 or Section 6.5 of this Agreement. Upon expiration of the Agreement with
respect to a Licensed Product in a country, the license grant to Licensee pursuant to Section 2.1 shall become irrevocable, perpetual,
fully paid-up and royalty-free with respect such Licensed Product and such country.

 

6.2         Licensee’s
Right to Terminate. Licensee may, upon six months’ prior written notice to Licensor, terminate this Agreement for any
reason, with or without cause. In exercising such termination right, Licensee may terminate the Agreement in its entirety or, if
desired, Licensee may specify in the written notice that this Agreement is terminating only with respect to one or more Field.

 

6.3         Termination
for Breach.

 

6.3.1        Licensor
may terminate this Agreement, if Licensee is late in paying to Licensor royalties, fees, or any other monies due under this Agreement,
and if Licensee does not pay Licensor in full within 15 days upon written demand from Licensor, which termination shall be effective
immediately upon the expiration of such 15-day cure period.

 

6.3.2        Either
Party may terminate this Agreement, if the other Party materially breaches this Agreement and does not cure such material breach
within 30 days after written notice of the breach, which termination shall be effective immediately upon the expiration of such
30-day cure period. Notwithstanding the above, if Licensee disputes in good faith that such material breach exists, and gives Licensor
written notice of such dispute within 30 days following Licensee’s receipt of Licensor’s notice of default, then, Licensor
may not terminate this agreement until the dispute is resolved in accordance with Section 10.6; provided that Licensor shall be
entitled to terminate this Agreement at the end of the original 30-day cure period, without waiting for resolution of the dispute
in accordance with Section 10.6, if the breach by Licensee of this Agreement would cause Licensor to be in breach of the GSK Agreement
or the Penn Agreement.

 

6.4         Termination
for Insolvency. Licensor shall have the right to terminate this Agreement, upon notice to the Licensee, in the event that:

 

(a)            Licensee
shall have: (i) voluntarily commenced any proceeding or filed any petition seeking relief under the bankruptcy, insolvency or other
similar laws of any jurisdiction, (ii) applied for, or consented to, the appointment of a receiver, trustee, custodian, sequestrator,
conciliator, administrator or similar official for it or for all or substantially all of its property, (iii) filed an answer admitting
the material allegations of a petition filed against or in respect of it in any such proceeding, (iv) made a general assignment
for the benefit of creditors of all or substantially all of its assets, (v) admitted in writing its inability to pay all or substantially
all of its debts as they become due, or (vi) taken corporate action for the purpose of effecting any of the foregoing; or

 

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(b)           An involuntary
proceeding shall have been commenced, or any involuntary petition shall have been filed, in a court of competent jurisdiction seeking:
(i) relief in respect of Licensee, or of its property, under the bankruptcy, insolvency or similar laws of any jurisdiction, (ii)
the appointment of a receiver, trustee, custodian, sequestrator, conciliator, administrator or similar official for the Licensee
or for all or substantially all of its property, or (iii) the winding-up or liquidation of the Licensee; and, in each case, such
proceeding or petition shall have continued undismissed for 60 days, or an order or decree approving or ordering any of the foregoing
shall have continued unstayed, unappealed and in effect for 30 days.

 

6.5         Patent
Challenge.

 

6.5.1        Licensor
may terminate this Agreement, effective immediately upon written notice to Licensee, upon the commencement by Licensee or any of
its Affiliates of a Patent Challenge.

 

6.5.2        Licensee
shall include in each sublicense agreement entered into with a Sublicensee a right of Licensee to terminate such sublicense agreement
if such Sublicensee commences a Patent Challenge; and Licensee shall terminate the sublicense agreement, effective immediately
upon written notice to the Sublicensee, if the Sublicensee commences a Patent Challenge. If a Sublicensee commences a Patent Challenge
and Licensee fails to terminate the applicable sublicense agreement, then Licensor may terminate this Agreement, effective immediately
upon written notice to the Licensee.

 

6.5.3        For
purposes of this Section 6.5, “Patent Challenge” means any action against Licensor or the REGENXBIO Licensors,
including an action for declaratory judgment, to declare or render invalid or unenforceable the Licensed Patents, or any claim
thereof.

 

6.6         Effects
of Termination. The effects of termination by Licensee pursuant to Section 6.2, by either Party, as applicable, under Section
6.3, or by Licensor pursuant to Section 6.4 or 6.5 shall be as follows:

 

6.6.1        The
applicable licenses granted by Licensor hereunder shall terminate, and Licensee, its Affiliates, and (unless the sublicense agreement
is assigned pursuant to Section 6.6.2) all Sublicensees shall cease to make, have made, use, import, sell, and offer for sale all
Licensed Products and shall cease to otherwise practice the Licensed Technology under the terminated licenses; provided that Licensee,
its Affiliates, and its Sublicensees shall have the right to continue to sell their existing inventories of Licensed Products under
the terminated licenses for a period not to exceed **** after the effective date of such termination;

 

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6.6.2        If
termination is by Licensor pursuant to Sections 6.3, 6.4 or 6.5, then, at Licensor’s request, Licensee shall assign to Licensor
any or all sublicenses granted to Third Parties to the extent of the rights licensed to Licensee hereunder and sublicensed to the
Sublicensee; provided that (i) prior to such assignment, Licensee shall advise Licensor whether such Sublicensee is then in full
compliance with all terms and conditions of its sublicense and continues to perform thereunder, and, if such Sublicensee is not
in full compliance or is not continuing to perform, Licensor may elect not to have such sublicense assigned; and (ii) following
such assignment, Licensor shall not be liable to such Sublicensee with respect to any obligations of Licensee to the Sublicensee
that are not consistent with, or not required by, Licensor’s obligations to Licensee under this Agreement; and all sublicenses
not requested to be assigned to Licensor shall terminate. If termination is for any other reason, then all sublicenses shall terminate;

 

6.6.3        If
termination is by Licensee pursuant to Section 6.2 or by Licensor pursuant to Section 6.3, 6.4, or 6.5, then Licensee shall grant,
and hereby grants, to Licensor a non-exclusive, perpetual, irrevocable, worldwide, royalty-free, transferable, sublicensable license
under any patentable modifications or improvements (and any intellectual property rights with respect thereto) developed by Licensee,
any Affiliates, or any Sublicensees to any vector that is the subject of a claim within any of the Licensed Patents, for use by
Licensor for the research, development, and commercialization of products in any therapeutic indication;

 

6.6.4        Licensee
shall pay all monies then-owed to Licensor under this Agreement;

 

6.6.5        Each
Receiving Party shall, at the Disclosing Party’s request, return all Confidential Information of the Disclosing Party. Notwithstanding
the foregoing, one copy may be kept by either Party for a record of that Party’s obligations; and

 

6.6.6        If
termination is with respect to one or more Field, but not all Fields, then the provisions of this Section 6.6 shall only apply
with respect to the terminated Field(s), and this Agreement shall continue with respect to the non-terminated Field(s); provided
that if termination is by Licensee pursuant to Section 6.2 with respect to one or more Fields, but not all Fields at any time,
then the amount of any unpaid annual fee(s) due under Section 3.2 shall be reduced by **** for each terminated Field; provided
further that such reduction shall not apply to the amount due under Section 3.2(i).

 

6.7           Survival.
Licensee’s obligation to pay all monies due and owed to Licensor under this Agreement that have matured as of the effective
date of termination or expiration shall survive the termination or expiration of this Agreement. In addition, the provisions of
Section 2.2, (Retained Rights), Section 2.3 (Government Rights), Section 2.5 (Improvements), Article 3 (Consideration) (with respect
to any final reports or to the extent any amounts are due but unpaid), Section 3.6 (Reports and Records), Section 4.4 (Confidential
Information), Article 5 (Confidentiality), Article 6 (Term and Termination), Section 8.4 (Disclaimer of Warranties, Damages), Section
8.5 (Indemnification), Section 8.6 (Insurance), Article 9 (Use of Name), and Article 10 (Additional Provisions) shall survive such
termination or expiration of this Agreement in accordance with their respective terms.

 

Article
7: Patent Maintenance; Patent Infringement

 

7.1         Prosecution
of Licensed Patents. As between Licensor and Licensee, the Parties agree as follows:

 

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7.1.1        Licensor
shall have the sole right, but not the obligation, to Prosecute patent applications and issued patents within Licensed Patents,
in Licensor’s sole discretion. Subject to Section 7.1.3, Licensor shall provide Licensee with a reasonable opportunity to
review and provide comments in connection with the Prosecution of the Licensed Patents; and Licensor shall keep Licensee reasonably
informed as to all material developments with respect to such Licensed Patents and shall supply to Licensee copies of material
communications received and filed in connection with the Prosecution of such Licensed Patents.

 

7.1.2        Nothing
in this Agreement obligates Licensor to continue to Prosecute any patent applications or issued patents, and Licensee acknowledges
that Licensor shall have no obligation to undertake any inter-party proceedings, such as oppositions, inter partes review, or interferences,
or to undertake any re-examination or re-issue proceedings, in either case, with respect to the Licensed Patents.

 

7.1.3        Licensee
acknowledges that The Trustees of the University of Pennsylvania control Prosecution of the Licensed Patents, with Licensor having
certain rights to review. Licensee acknowledges and agrees that (a) the rights and obligations under this Section 7.1 are subject
to the rights of the REGENXBIO Licensors set forth in the GSK Agreement and Penn Agreement with respect to the Licensed Patents,
and (b) Licensor’s obligations under this Agreement only apply to the extent of Licensor’s rights with respect to participation
in Prosecuting the Licensed Patents under the GSK Agreement and the Penn Agreement. Licensor shall have the sole right, but not
the obligation, to Prosecute patent applications and issued patents within Licensed Patents, in Licensor’s sole discretion.

 

7.2         Infringement
Actions Against Third Parties.

 

7.2.1        Licensee
is responsible for notifying Licensor promptly of any infringement of Licensed Patents (other than Retained Rights) that may come
to Licensee’s attention, including any “patent certification” filed in the United States under 21 U.S.C. §
355(b)(2) or 21 U.S.C. § 355(j)(2) or similar provisions in other jurisdictions alleging the invalidity, unenforceability
or non-infringement of any Licensed Patents, and any notification received pursuant to subsection (k) of 42 U.S.C. § 262 for
any Licensed Product that becomes a “reference product.” However, Licensee is under no obligation to search for potential
infringers.

 

7.2.2        As
between Licensor and Licensee, but subject to any obligations of Licensor to the REGENXBIO Licensors, Licensor shall have the sole
right, but not the obligation, to prosecute any such infringement ****. In any action to enforce any of the Licensed Patents, Licensee,
at the request and expense of Licensor, shall cooperate to the fullest extent reasonably possible, including in the event that,
if Licensor is unable to initiate or prosecute such action solely in its own name, Licensee shall join such action voluntarily
and shall execute all documents necessary to initiate litigation to prosecute, maintain, and settle such action. Nothing in this
Agreement obligates Licensor to bring or prosecute lawsuits against Third Parties for infringement of any Licensed Patents.

 

7.2.3        Licensee
shall have no right to undertake prosecution of any such infringement.

 

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7.3         Defense
of Infringement Claims. In the event Licensee or Licensor becomes aware that Licensee’s or any of its Affiliates’
or any Sublicensees’ practice of the Licensed Patents is the subject of a claim for patent infringement by a Third Party,
that Party shall promptly notify the other, and the Parties shall consider the claim and the most appropriate action to take. Licensee
shall cause each of its Affiliates and each Sublicensee to notify Licensee promptly in the event such entity becomes aware that
its practice of the Licensed Patents is the subject of a claim of patent infringement by another. To the extent Licensor takes
any action, Licensor (or the REGENXBIO Licensors) shall have the right to require Licensee’s reasonable cooperation in any
such suit, upon written notice to Licensee; and Licensee shall have the obligation to participate upon Licensor’s request,
in which event, Licensor shall bear the cost of Licensee’s participation. Without Licensor’s prior written permission,
which shall not be unreasonably withheld or denied, Licensee must not settle or compromise any such suit in a manner that imposes
any material obligations or restrictions on Licensor or the REGENXBIO Licensors or grants any rights to the Licensed Patents other
than rights that Licensee has the right to grant under this Agreement.

 

Article
8: COVENANTS, Warranties; Indemnification

 

8.1         Covenant
not to Sue. Licensor agrees that it shall not commence any action against Licensee or any Third Party solely for the work that
Third Party is performing on behalf of Licensee for **** prior to the Effective Date.

 

8.2         Representations
and Warranties by Licensor. Licensor represents and warrants to Licensee as of the Effective Date:

 

8.2.1        Licensor
has the right, power, and authority to enter into this Agreement and to grant to Licensee the rights specified in this Agreement;

 

8.2.2        This
Agreement when executed shall become the legal, valid, and binding obligation of it, enforceable against it, in accordance with
its terms;

 

8.2.3        There
are no actions, suits, proceedings, or arbitrations pending or, to Licensor’s knowledge, threatened against Licensor relating
to the Licensed Patents that would be inconsistent with the rights granted to Licensee under this Agreement;

 

8.2.4        To
Licensor’s knowledge, (a) the Licensed Patents are solely owned by The Trustees of the University of Pennsylvania, and (b)
no Third Party (other than the REGENXBIO Licensors) has any right, interest, or claim in or to such Licensed Patents in the Fields
that are inconsistent with those granted to Licensee in the Fields under this Agreement (it being understood that the rights previously
granted in the Conflicting License shall not be deemed to conflict with the licenses granted under this Agreement);

 

8.2.5        Licensor
has not received any written notice from any Third Party patentee alleging infringement of such Third Party’s patents by
the practice of the Licensed Patents in the Fields; and

 

8.2.6        Licensor
shall not, without the prior written consent of Licensee (such consent not to be unreasonably withheld or delayed), amend the Conflicting
License in a manner that would materially and adversely affect Licensee’s rights and benefits under this Agreement during
the term of this Agreement.

 

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8.3         Representations
and Warranties by Licensee. Licensee represents and warrants to Licensor as of the Effective Date that:

 

8.3.1        Licensee
has the right, power, and authority to enter into this Agreement and to grant the rights granted by it hereunder;

 

8.3.2        This
Agreement when executed shall become the legal, valid, and binding obligation of it, enforceable against it, in accordance with
its terms;

 

8.3.3        Licensee
has the ability and the resources, including financial resources, necessary to carry out its obligations under this Agreement;
and

 

8.3.4        There
are no actions, suits, proceedings, or arbitrations pending or, to Licensee’s knowledge, threatened against Licensee that
would impact Licensee’s activities under this Agreement.

 

8.4           Disclaimer
of Warranties, Damages. EXCEPT AS SET FORTH IN SECTION 8.2, THE LICENSED TECHNOLOGY, LICENSED PRODUCTS, AND ALL RIGHTS LICENSED
UNDER THIS AGREEMENT ARE PROVIDED ON AN “AS IS” BASIS, AND LICENSOR MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS
OR IMPLIED, WITH RESPECT THERETO. BY WAY OF EXAMPLE BUT NOT OF LIMITATION, EXCEPT AS SET FORTH IN SECTION 8.2, LICENSOR MAKES NO
REPRESENTATIONS OR WARRANTIES, AND HEREBY DISCLAIMS ALL EXPRESS AND IMPLIED REPRESENTATIONS AND WARRANTIES, (i) OF COMMERCIAL UTILITY,
ACCURACY, COMPLETENESS, PERFORMANCE, TITLE, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OR ENFORCEABILITY OF THE
LICENSED TECHNOLOGY, AND PROFITABILITY; OR (ii) THAT THE USE OF THE LICENSED TECHNOLOGY, OR LICENSED PRODUCTS WILL NOT INFRINGE
ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS OF THIRD PARTIES. EXCEPT AS SET FORTH HEREIN, NONE OF LICENSOR AND
THE REGENXBIO LICENSORS SHALL BE LIABLE TO LICENSEE, LICENSEE’S SUCCESSORS OR ASSIGNS, ANY SUBLICENSEES, OR ANY THIRD PARTY
WITH RESPECT TO: (a) ANY CLAIM ARISING FROM USE OF THE LICENSED TECHNOLOGY, LICENSED PRODUCTS, AND ANY OR ALL RIGHTS LICENSED UNDER
THIS AGREEMENT OR FROM THE DEVELOPMENT, TESTING, MANUFACTURE, USE, OR SALE OF LICENSED PRODUCTS; OR (b) ANY CLAIM FOR LOSS OF PROFITS,
LOSS OR INTERRUPTION OF BUSINESS, OR FOR INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY, PUNITIVE, OR CONSEQUENTIAL DAMAGES OF ANY KIND,
INCLUDING ANY ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT OR THE EXERCISE OF RIGHTS HEREUNDER, REGARDLESS OF ANY NOTICE
OF SUCH DAMAGES. NOTHING IN THIS SECTION 8.4 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER
PARTY UNDER SECTION 8.5 OR TO LIMIT A PARTY’S LIABILITY FOR BREACHES OF ITS OBLIGATION REGARDING CONFIDENTIALITY UNDER ARTICLE
5.

 

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8.5         Indemnification.

 

8.5.1        By
Licensee. Licensee shall defend, indemnify, and hold harmless Licensor, the REGENXBIO Licensors, and their respective shareholders,
members, officers, trustees, faculty, students, contractors, agents, and employees (individually, a “Licensor Indemnified
Party” and, collectively, the “Licensor Indemnified Parties”) from and against any and all Third Party
liability, loss, damage, action, claim, fee, cost, or expense (including attorneys’ fees) (individually, a “Third
Party Liability” and, collectively, the “Third Party Liabilities”) suffered or incurred by the Licensor
Indemnified Parties from claims of such Third Parties that result from or arise out of: ****; provided, however, that Licensee
shall not be liable for claims to the extent based on any breach by Licensor of the representations, warranties, or obligations
of this Agreement or the gross negligence or intentional misconduct of any of the Licensor Indemnified Parties. Without limiting
the foregoing, Licensee must defend, indemnify, and hold harmless the Licensor Indemnified Parties from and against any Third Party
Liabilities resulting from:

 

(a)          any
**** or other claim of any kind related to the **** by a Third Party of a Licensed Product that **** by Licensee, its Affiliates,
any Sublicensees, their respective assignees, or vendors;

 

(b)         any
claim by a Third Party that the ****; and

 

(c)         ****
conducted by or on behalf of Licensee, its Affiliates, any Sublicensees, their respective assignees, or vendors relating to the
Licensed Technology or Licensed Products, including any claim by or on behalf of a ****.

 

8.5.2        Indemnification
Procedure. Licensee, as an indemnifying party (an “Indemnifying Party”), shall not be permitted to settle
or compromise any claim or action giving rise to Third Party Liabilities in a manner that imposes any restrictions or obligations
on Licensor, the REGENXBIO Licensors or any indemnified party (an “Indemnified Party”) without Licensor’s
prior written consent that grants any rights to the Licensed Technology or Licensed Products other than those Licensee has the
right to grant under this Agreement without Licensor’s prior written consent. The Indemnifying Party shall be permitted to
control any litigation or potential litigation involving the defense of any claim subject to indemnification pursuant to this Section
8.5, including the selection of counsel, with the reasonable approval of the Indemnified Party. If an Indemnifying Party fails
or declines to assume the defense of any such claim or action within **** after notice thereof, then the Indemnified Party may
assume the defense of such claim or action at the cost and risk of the Indemnifying Party, and any Third Party Liabilities related
thereto shall be conclusively deemed a Third Party Liability of the Indemnifying Party. The indemnification rights of an Indemnified
Party contained in this Agreement are in addition to all other rights that such Indemnified Party may have at law or in equity
or otherwise. The Indemnifying Party will pay directly all Third Party Liabilities incurred for defense or negotiation of any claim
hereunder or will reimburse the Indemnified Party for all documented Third Party Liabilities incident to the defense or negotiation
of any such claim within **** after the Indemnifying Party’s receipt of invoices for such fees, expenses, and charges.

 

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8.6         Insurance.
Licensee will procure and maintain insurance policies for the following coverages with respect to product liability, personal injury,
bodily injury, and property damage arising out of Licensee’s (and its Affiliates’ and any Sublicensees’) performance
under this Agreement: (a) during the term of this Agreement, comprehensive general liability, including broad form and contractual
liability, in a minimum amount of **** combined single limit per occurrence (or claim) and **** in the aggregate annually; (b)
prior to the commencement of clinical trials involving Licensed Products and thereafter for a period of not less than **** (or
such longer period as Licensee is required by applicable law to continue to monitor the participants in the clinical trial), clinical
trials coverage in amounts that are reasonable and customary in the U.S. pharmaceutical industry, subject always to a minimum limit
of **** combined single limit per occurrence (or claim) and **** in the aggregate annually; and (c) from prior to the First Commercial
Sale of a Licensed Product until **** after the last sale of a Licensed Product, product liability coverage, in amounts that are
reasonable and customary in the U.S. pharmaceutical industry, subject always to a minimum limit of **** combined single limit per
occurrence (or claim) and **** in the aggregate annually. Licensor may review periodically the adequacy of the minimum amounts
of insurance for each coverage required by this Section 8.6, and Licensor reserves the right to require Licensee to adjust the
limits accordingly. The required minimum amounts of insurance do not constitute a limitation on Licensee’s liability or indemnification
obligations to the Licensor Indemnified Parties under this Agreement. The policies of insurance required by this Section 8.6 will
be issued by an insurance carrier with an A.M. best rating of **** or better and will name Licensor as an additional insured with
respect to Licensee’s performance (and its Affiliates’ and any Sublicensees’) under this Agreement. Licensee
will provide Licensor with insurance certificates evidencing the required coverage within **** after the Effective Date and the
commencement of each policy period and any renewal periods. Each certificate will provide that the insurance carrier will notify
Licensor in writing at least **** prior to the cancellation or material change in coverage. Licensee will cause all Sublicensees
to comply with the terms of this Section 8.6 to the same extent as Licensee.

 

Article
9: Use of Name

 

9.1         Licensee,
its Affiliates, any Sublicensees, and all of its and their employees and agents must not use Licensor’s, the University of
Pennsylvania’s, or SmithKline Beecham Corporation’s name, seal, logo, trademark, or service mark (or any adaptation
thereof) or the name, seal, logo, trademark, or service mark (or any adaptation thereof) of any of such entities’ representative,
school, organization, employee, or student in any way without the prior written consent of Licensor or such entity, as applicable,
unless required to do so pursuant to applicable law, rule, regulation or rules of a securities exchange; provided, however that
Licensee may acknowledge the existence and general nature of this Agreement, subject to Section 5.2 or 5.3, as applicable.

 

9.2         Licensor
and all of its employees and agents must not use Licensee’s name, seal, logo, trademark, or service mark (or any adaptation
thereof) in any way without the prior written consent of Licensee; provided, however that Licensor may acknowledge the existence
and general nature of this Agreement, subject to Section 5.2 or 5.3, as applicable, and refer to Licensee as a licensee of Licensor.

 

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Article
10: Additional Provisions

 

10.1       Relationship.
Nothing in this Agreement shall be deemed to establish a relationship of principal and agent between Licensee and Licensor, nor
any of their agents or employees for any purpose whatsoever, nor shall this Agreement be construed as creating any other form of
legal association or arrangement which would impose liability upon one Party for the act or failure to act of the other Party.

 

10.2       Assignment.
The rights and obligations of Licensee and Licensor hereunder shall inure to the benefit of, and shall be binding upon, their respective
permitted successors and assigns. Licensee may not assign or otherwise transfer (by operation of law or otherwise) this Agreement
or any of its rights or obligations under this Agreement without the prior written consent of Licensor, which consent is in the
absolute discretion of Licensor (except Licensee shall have the right to assign this Agreement without Licensor’s consent
to a wholly owned Affiliate, in which case Licensee shall remain responsible for the performance of this Agreement by such Affiliate);
provided, however, Licensee shall be permitted to transfer (by operation of law or otherwise) this Agreement without Licensor’s
consent in connection with a Change of Control; provided that, Licensee: (i) requires any transferee or successor to agree in writing
to be legally bound by this Agreement to the same extent as Licensee and provides Licensor with a copy of such undertaking; (ii)
provides Licensor with written notice of the Change of Control to Licensor within five days of the consummation of the transaction
resulting in a Change of Control of Licensee; (iii) provides Licensor with a copy of the definitive agreement for the Change of
Control of Licensee with five days of the consummation of the transaction (provided, that Licensee shall be entitled to include
customary redactions in such copy provided to Licensor, to the extent such redacted information is not necessary to verify compliance
with the terms of this Agreement or otherwise required by the Penn Agreement and/or GSK Agreement); and (iv) makes all payments
required as a result of a Change of Control under Article 3. Notwithstanding anything to the contrary in this Agreement, for clarity,
in case of a Licensee Change of Control, in no event shall any intellectual property rights owned or controlled by the acquirer
or its Affiliates immediately prior to such Licensee Change of Control be included in any of the licenses granted to Licensor under
this Agreement. Licensor may assign this Agreement and its rights and obligations without the consent of Licensee. No assignment
shall relieve the assigning Party of responsibility for the performance of any accrued obligations that it has prior to such assignment.
Any attempted assignment by Licensee in violation of this Section 10.2 shall be null and void and of no legal effect.

 

10.3       Waiver.
A waiver by either Party of a breach of any provision of this Agreement will not constitute a waiver of any subsequent breach of
that provision or a waiver of any breach of any other provision of this Agreement.

 

10.4       Notices.
Notices, payments, statements, reports, and other communications under this Agreement shall be in writing and shall be deemed to
have been received as of the date received if sent by public courier (e.g., Federal Express), by Express Mail, receipt requested,
by facsimile, or by electronic mail (with a copy of such facsimile or electronic mail also sent by one of the other methods of
delivery) and addressed as follows:

 

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	If for Licensor:	with a copy to:
	 	 
	REGENXBIO Inc.

9600 Blackwell Road

Suite 210

Rockville, MD 20850

USA

Attn:  Chief Executive Officer

Telephone:240-552-8181

Facsimile:240-652-9692	REGENXBIO Inc.

9600 Blackwell Road

Suite 210

Rockville, MD 20850

USA

Attn:  General Counsel

Telephone:240-552-8181

Facsimile:240-652-9692
	 	 
	If for Licensee:	with a copy to:
	 	 
	
        Abeona Therapeutics Inc.

        1330 Avenue of the Americas, 33rd Floor

        New York, NY 10019

        USA

        Attention: Chief Executive Officer

        Telephone: 646-813-4713

        Facsimile:
	
        Morgan, Lewis & Bockius LLP

        One Federal Street

        Boston, MA 02210

        USA

        Attention: Jack Concannon, Esq.

        Telephone: 617-951-8000

        Facsimile: 617-951-7326

 

Either Party may change its official address upon written notice
to the other Party in accordance with this Section 10.4.

 

10.5       Applicable
Law. This Agreement shall be construed and governed in accordance with the laws of the State of New York, without giving effect
to conflict of law provisions that may require the application of the laws of another jurisdiction. Subject to Section 10.6, the
Parties hereby submit to the exclusive jurisdiction of and venue in the courts located in the State of Delaware with respect to
any and all disputes concerning the subject of this Agreement.

 

10.6       Dispute
Resolution. In the event of any controversy or claim arising out of or relating to this Agreement, the Parties shall first
attempt to resolve such controversy or claim through good faith negotiations for a period of not less than **** following notification
of such controversy or claim to the other Party. If such controversy or claim cannot be resolved by means of such negotiations
during such period, then such controversy or claim shall be resolved by binding arbitration administered by the American Arbitration
Association (“AAA”) in accordance with the Commercial Arbitration Rules of the AAA in effect on the date of
commencement of the arbitration, subject to the provisions of this Section 10.6. The arbitration shall be conducted as follows:

 

10.6.1      The
arbitration shall be conducted by three arbitrators, each of whom by training, education, or experience has knowledge of the research,
development, and commercialization of biological therapeutic products in the United States. The arbitration shall be conducted
in English and held in New York, New York.

 

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10.6.2      In
its demand for arbitration, the Party initiating the arbitration shall provide a statement setting forth the nature of the dispute,
the names and addresses of all other parties, an estimate of the amount involved (if any), the remedy sought, otherwise specifying
the issue to be resolved, and appointing one neutral arbitrator. In an answering statement to be filed by the responding Party
within **** after confirmation of the notice of filing of the demand is sent by the AAA, the responding Party shall appoint one
neutral arbitrator. Within **** from the date on which the responding Party appoints its neutral arbitrator, the first two arbitrators
shall appoint a chairperson.

 

10.6.3      If
a Party fails to make the appointment of an arbitrator as provided in Section 10.6.2, the AAA shall make the appointment. If the
appointed arbitrators fail to appoint a chairperson within the time specified in Section 10.6.2 and there is no agreed extension
of time, the AAA shall appoint the chairperson.

 

10.6.4      The
arbitrators will render their award in writing and, unless all Parties agree otherwise, will include an explanation in reasonable
detail of the reasons for their award. Judgment upon the award rendered by the arbitrators may be entered in any court having jurisdiction
thereof, including in the courts described in Section 10.5. The arbitrators will have the authority to grant injunctive relief
and other specific performance; provided that the arbitrators will have no authority to award damages in contravention of this
Agreement, and each Party irrevocably waives any claim to such damages in contravention of this Agreement. The arbitrators will,
in rendering their decision, apply the substantive law of the State of Delaware, without giving effect to conflict of law provisions
that may require the application of the laws of another jurisdiction. The decision and award rendered by the arbitrators will be
final and non-appealable (except for an alleged act of corruption or fraud on the part of the arbitrator).

 

10.6.5      The
Parties shall use their reasonable efforts to conduct all dispute resolution procedures under this Agreement as expeditiously,
efficiently, and cost-effectively as possible.

 

10.6.6      All
expenses and fees of the arbitrators and expenses for hearing facilities and other expenses of the arbitration will be borne equally
by the Parties unless the Parties agree otherwise or unless the arbitrators in the award assess such expenses against one of the
Parties or allocate such expenses other than equally between the Parties. Each of the Parties will bear its own counsel fees and
the expenses of its witnesses except to the extent otherwise provided in this Agreement or by applicable law.

 

10.6.7      Compliance
with this Section 10.6 is a condition precedent to seeking relief in any court or tribunal in respect of a dispute, but nothing
in this Section 10.6 will prevent a Party from seeking equitable or other interlocutory relief in the courts of appropriate jurisdiction,
pending the arbitrators’ determination of the merits of the controversy, if applicable to protect the confidential information,
property, or other rights of that Party or to otherwise prevent irreparable harm that may be caused by the other Party’s
actual or threatened breach of this Agreement.

 

10.7         No
Discrimination. Licensee, its Affiliates, and Licensee shall use reasonable efforts to require that any Sublicensees, in their
respective activities under this Agreement, shall not discriminate against any employee or applicant for employment because of
race, color, sex, sexual, or affectional preference, age, religion, national, or ethnic origin, handicap, or because he or she
is a disabled veteran or a veteran (including a veteran of the Vietnam Era).

 

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10.8       Compliance
with Law. Licensee (and its Affiliates’ and any Sublicensees’) must comply with all prevailing laws, rules, and
regulations that apply to its activities or obligations under this Agreement. Without limiting the foregoing, it is understood
that this Agreement may be subject to United States laws and regulations controlling the export of technical data, computer software,
laboratory prototypes, and other commodities, articles, and information, including the Arms Export Control Act as amended in the
Export Administration Act of 1979 and that Licensee’s obligations are contingent upon compliance with applicable United States
export laws and regulations. The transfer of certain technical data and commodities may require a license from the cognizant agency
of the United States Government and/or written assurances by Licensee that Licensee shall not export data or commodities to certain
foreign countries without prior approval of such agency. Licensor neither represents that a license is not required nor that, if
required, it will issue.

 

10.9       Entire
Agreement. This Agreement embodies the entire understanding between the Parties relating to the subject matter hereof and supersedes
all prior understandings and agreements, whether written or oral, including that certain Mutual Non-Disclosure Agreement dated
May 16, 2018 between the Parties. All “Confidential Information” (as defined in such Mutual Non-Disclosure Agreement)
disclosed by one Party to the other Party pursuant to such Mutual Non-Disclosure Agreement shall be deemed “Confidential
Information” of such disclosing Party under this Agreement (unless and until it falls within one of the exclusions set forth
in Section 1.7). This Agreement may not be varied except by a written document signed by duly authorized representatives of both
Parties.

 

10.10     Marking.
Licensee, its Affiliates, and any Sublicensees shall mark any Licensed Product (or their containers or labels) made, sold, or otherwise
distributed by it or them with any notice of patent rights necessary or desirable under applicable law to enable the Licensed Patents
to be enforced to their full extent in any country where Licensed Products are made, used, sold, offered for sale, or imported.

 

10.11     Severability
and Reformation. If any provision of this Agreement is held to be invalid or unenforceable by a court of competent jurisdiction,
then such invalid or unenforceable provision will be automatically revised to be a valid or enforceable provision that comes as
close as permitted by law to the Parties’ original intent; provided that, if the Parties cannot agree upon such valid or
enforceable provision, then the remaining provisions of this Agreement will remain in full force and effect, unless the invalid
or unenforceable provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the Parties
would not have entered into this Agreement without the invalid or unenforceable provisions.

 

10.12     Further
Assurances. Each Party hereto agrees to execute, acknowledge, and deliver such further instruments, and to do all other reasonable
acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

 

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10.13     Interpretation;
Construction. The captions to the several Articles and Sections of this Agreement are included only for convenience of reference
and shall not in any way affect the construction of, or be taken into consideration in interpreting, this Agreement. In this Agreement,
unless the context requires otherwise, (a) the word “including” shall be deemed to be followed by the phrase “without
limitation” or like expression; (b) references to the singular shall include the plural and vice versa; (c) references to
masculine, feminine, and neuter pronouns and expressions shall be interchangeable; (d) the words “herein” or “hereunder”
relate to this Agreement; (e) “or” is disjunctive but not necessarily exclusive; (f) the word “will” shall
be construed to have the same meaning and effect as the word “shall”; (g) all references to “dollars” or
“$” herein shall mean U.S. Dollars; (h) unless otherwise provided, all reference to Sections, Articles, and exhibits
in this Agreement are to Sections, Articles, and exhibits of and in this Agreement; and (i) whenever this Agreement refers to a
number of days, such number shall refer to calendar days unless business days are specified. Business days shall mean a day on
which banking institutions in Washington, D.C. are open for business. Each Party represents that it has been represented by legal
counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof. In interpreting and
applying the terms and provisions of this Agreement, the Parties agree that no presumption will apply against the Party which drafted
such terms and provisions.

 

10.14     Cumulative
Rights and Remedies. The rights and remedies provided in this Agreement and all other rights and remedies available to either
Party at law or in equity are, to the extent permitted by law, cumulative and not exclusive of any other right or remedy now or
hereafter available at law or in equity. Neither asserting a right nor employing a remedy shall preclude the concurrent assertion
of any other right or employment of any other remedy, nor shall the failure to assert any right or remedy constitute a waiver of
that right or remedy.

 

10.15     Counterparts.
This Agreement may be executed in one or more counterparts, each of which will be deemed an original, but all of which together
will constitute one and the same instrument.

 

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IN WITNESS WHEREOF, the Parties, intending
to be legally bound, have caused this License Agreement to be executed by their duly authorized representatives.

 

	REGENXBIO INC.	 	ABEONA THERAPEUTICS INC.
	 	 	 
	By:	/s/ Kenneth Mills	 	By:  	/s/ Frank Carsten Thiel
	Name:	Kenneth Mills	 	Name:  	Frank Carsten Thiel
	Title:	President & CEO	 	Title:  	Chief Executive Officer

 

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Exhibit A

Licensed Patents (****)

 

	Application #	Patent #	Filing Date	Country	Status
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****
	****	****	****	****	****

 

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Exhibit B

Licensed Know-How

 

****

 

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Exhibit C

Press Release

 

REGENXBIO and Abeona Therapeutics Announce
Worldwide Exclusive Licenses for the Treatment of Four Rare Lysosomal Storage Disorders Using NAV AAV9 Vector

 

		·	REGENXBIO grants Abeona new licenses to NAV AAV9 for the development and commercialization of treatments for MPS IIIA, MPS
IIIB, CLN1 and CLN3 Batten Disease 

		·	REGENXBIO could receive up to $180 million, including $40 million in guaranteed payments 

 

ROCKVILLE, Md., Nov. 5, 2018 (PRNEWSWIRE)
— REGENXBIO Inc. (Nasdaq:RGNX), a leading clinical-stage biotechnology company seeking to improve lives through
the curative potential of gene therapy based on its proprietary NAV® Technology Platform, and Abeona Therapeutics
Inc. (Nasdaq: ABEO), a leading clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for
life-threatening rare genetic diseases, today announced a license agreement to REGENXBIO’s NAV AAV9 vector for the treatment
of four diseases: Sanfilippo syndrome type A (MPS IIIA), Sanfilippo syndrome type B (MPS IIIB), Infantile Batten Disease, also
known as neuronal ceroid lipofuscinosis type 1 (CLN1 Disease), and Juvenile Batten Disease, also known as neuronal ceroid lipofuscinosis
type 3 (CLN3 Disease).

 

Under the terms of the agreement, REGENXBIO
has granted Abeona an exclusive worldwide license (subject to certain non-exclusive rights previously granted for MPS IIIA), with
rights to sublicense, to REGENXBIO’s NAV AAV9 vector for the development and commercialization of gene therapies for the
treatment of MPS IIIA, MPS IIIB, CLN1 Disease and CLN3 Disease. In return for these rights, REGENXBIO will receive a guaranteed
$20 million upfront payment, $10 million of which will be paid upon signing and $10 million of which will be paid within 12 months
of the effective date. In addition, REGENXBIO will receive a total of $100 million in annual fees, payable upon the second through
sixth anniversaries of the agreement, $20 million of which is guaranteed. REGENXBIO is also eligible to receive potential commercial
milestone payments of up to $60 million. REGENXBIO will also receive low double-digit royalties on net sales of products incorporating
the licensed intellectual property.

 

“This license agreement further validates the potential
of NAV AAV9 for the treatment of systemic and CNS manifestations of lysosomal storage diseases, as well as the strength of our
intellectual property portfolio,” said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. “We are
pleased to initiate our partnership with Abeona as they continue to advance multiple programs using NAV AAV9 through and towards
clinical trials in indications with significant unmet medical need.”

 

“This agreement is an important milestone that underpins
the therapeutic potential we see in our Sanfilippo syndrome and Batten disease programs featuring the NAV AAV9 vector, which have
the potential to transform the lives of patients,” said Carsten Thiel, Ph.D., Chief Executive Officer of Abeona. “Data
from our clinical and preclinical programs and the success of the NAV AAV9 vector observed in other indications strongly positions
the platform as a leading technology for investigational gene therapies for the systemic and CNS manifestations of lysosomal storage
diseases.”

 

About Sanfilippo Syndrome 

Sanfilippo syndrome, or MPS type III, is a group of rare genetic
lysosomal storage diseases with no approved treatments. MPS III is characterized by aggressive behavior, seizures, loss of speech
or vision, an inability to sleep, and premature death. An estimated 70% of children with MPS III do not reach age 18. The underlying
cause of the syndrome is a missing enzyme that is essential to breaking down heparan sulfate. As a result, partially synthesized
heparan sulfate accumulates in the central nervous system, including the brain and spinal cord, causing progressive damage. MPS
III is categorized by the single gene defects associated with each type of the syndrome - A, B, C or D. The hallmark feature of
MPS IIIA is a deficiency in the SGSH enzyme, while MPS IIIB is distinguished by a marked decrease in NAGLU enzyme activity.

 

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About Batten Disease

Infantile and juvenile forms of Batten disease, known as CLN1
and CLN3, are rare autosomal recessive genetic disorders with no approved treatments. Batten disease is fatal, and most do not
live past their twenties or thirties. The underlying cause of the disorder is a deficiency in proteins critical to lysosomal function
that lead to abnormal buildup of lipopigments, and result in neuroinflammation and neurodegeneration. CLN1 and CLN3 are differentiated
by mutations of their respective genes, yet the first noticeable sign of all forms of Batten disease is often vision impairment
that can progress to blindness. Developmental regression is another hallmark of the disease, as children lose the ability to speak
in complete sentences and to walk or sit, among other manifestations. Later in life, affected children may have recurrent seizures,
heart problems, behavioral problems, and difficulty sleeping.

 

About REGENXBIO Inc.

REGENXBIO is a leading clinical-stage
biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO's NAV Technology
Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel
AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees
are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.

 

About Abeona Therapeutics Inc. 

Abeona Therapeutics Inc. is a clinical-stage
biopharmaceutical company developing cell and gene therapies for life-threatening rare genetic diseases. Abeona's lead programs
include EB-101 (gene-corrected skin grafts) for recessive dystrophic epidermolysis bullosa (RDEB), ABO-102 (AAV-SGSH), an adeno-associated
virus (AAV) based gene therapy for Sanfilippo syndrome type A (MPS IIIA) and ABO-101 (AAV-NAGLU), an adeno-associated virus (AAV)
based gene therapy for Sanfilippo syndrome type B (MPS IIIB). Abeona is also developing ABO-201 (AAV-CLN3) gene therapy for CLN3
disease, ABO-202 (AAV-CLN1) for treatment of CLN1 disease, EB-201 for epidermolysis bullosa (EB), ABO-301 (AAV-FANCC) for Fanconi
anemia (FA) disorder and ABO-302 using a novel CRISPR/Cas9-based gene editing approach to gene therapy for rare blood diseases.
In addition, Abeona is developing a proprietary vector platform, AIMTM, for next generation product candidates. For more information,
visit www.abeonatherapeutics.com.

 

REGENXBIO Forward-Looking Statements

This press release includes "forward-looking
statements," within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. These statements express a belief, expectation or intention and are generally accompanied
by words that convey projected future events or outcomes such as "believe," "may," "will," "estimate,"
"continue," "anticipate," "design," "intend," "expect," "could," "plan,"
"potential," "predict," "seek," "should," "would" or by variations of such words
or by similar expressions. The forward-looking statements include statements relating to, among other things, REGENXBIO's future
operations and cash flow. REGENXBIO has based these forward-looking statements on its current expectations and assumptions and
analyses made by REGENXBIO in light of its experience and its perception of historical trends, current conditions and expected
future developments, as well as other factors REGENXBIO believes are appropriate under the circumstances. However, whether actual
results and developments will conform with REGENXBIO's expectations and predictions is subject to a number of risks and uncertainties,
including the timing of enrollment, commencement and completion and the success of clinical trials conducted by REGENXBIO, its
licensees and its partners, the timing of commencement and completion and the success of preclinical studies conducted by REGENXBIO
and its development partners, the timely development and launch of new products, the ability to obtain and maintain regulatory
approval of product candidates, the ability to obtain and maintain intellectual property protection for product candidates and
technology, trends and challenges in the business and markets in which REGENXBIO operates, the size and growth of potential markets
for product candidates and the ability to serve those markets, the rate and degree of acceptance of product candidates, and other
factors, many of which are beyond the control of REGENXBIO. Refer to the "Risk Factors" and "Management's Discussion
and Analysis of Financial Condition and Results of Operations" sections of REGENXBIO's Annual Report on Form 10-K for the
year ended December 31, 2017 and comparable "risk factors" sections of REGENXBIO's Quarterly Reports on Form
10-Q and other filings, which have been filed with the U.S. Securities and Exchange Commission (SEC) and are available on the SEC's
website at www.sec.gov. All of the forward-looking statements made in this press release are expressly qualified by the cautionary
statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially
realized, they may not have the expected consequences to or effects on REGENXBIO or its businesses or operations. Such statements
are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking
statements. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. These
forward-looking statements speak only as of the date of this press release. REGENXBIO does not undertake any obligation, and specifically
declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events
or otherwise.

 

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REGENXBIO CONTACT:

 

Investors

Natalie Wildenradt, 646-681-8192

natalie@argotpartners.com

Media

Adam Pawluk, 202-591-4063

apawluk@jpa.com

 

    	****Certain information has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

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