Document:

rgnx-ex101_128.htm

EXHIBIT 10.1

 

EXECUTED VERSION

Certain identified information has been excluded from this exhibit because such information both (i) is not material and (ii) would likely cause competitive harm if publicly disclosed. Excluded information is indicated with brackets and asterisks.

COLLABORATION AND LICENSE AGREEMENT

BETWEEN

regenxbio inc.

AND

ABBVIE GLOBAL ENTERPRISES LTD.

DATED AS OF September 10, 2021

 

 

 

TABLE OF CONTENTS

 

		
	
ARTICLE 1 DEFINITIONS
	
1

	
ARTICLE 2 EFFECTIVENESS OF THIS AGREEMENT
	
2

	
2.1Effective Date
	
2

	
2.2Antitrust Cooperation
	
2

	
2.3Delay in Effective Date
	
4

	
ARTICLE 3 DEVELOPMENT AND REGULATORY ACTIVITIES
	
4

	
3.1Development Activities
	
4

	
3.2Development Plan
	
5

	
3.3Development Expenses
	
5

	
3.4Records and Reports
	
6

	
3.5Development Subcontracting
	
6

	
3.6Regulatory Approvals and Communications
	
7

	
3.7Recalls, Suspensions or Withdrawals
	
7

	
3.8Pharmacovigilance Agreement
	
8

	
3.9Global Safety Database
	
8

	
ARTICLE 4 COMMERCIALIZATION
	
8

	
4.1Commercialization Activities
	
8

	
4.2Commercialization Strategies and Plans
	
8

	
4.3Diligence
	
9

	
4.4Commercialization Records and Reports
	
9

	
4.5Commercialization Costs; Booking of Sales; Distribution
	
10

	
4.6Commercial Subcontracting
	
10

	
4.7Compliance with Applicable Law
	
11

 

i

 

 

		
	
4.8Markings
	
11

	
ARTICLE 5 MANUFACTURING AND SUPPLY
	
11

	
5.1Clinical Supply
	
11

	
5.2Commercial Supply
	
12

	
5.3Certain Components
	
14

	
ARTICLE 6 EXCLUSIVITY
	
14

	
6.1Generally
	
14

	
6.2[****]
	
14

	
6.3[****]
	
14

	
ARTICLE 7 GOVERNANCE
	
14

	
7.1Joint Development Committee
	
14

	
7.2Joint Commercialization Committee
	
15

	
7.3Joint Manufacturing Committee
	
16

	
7.4General Provisions Applicable to Joint Committees
	
17

	
ARTICLE 8 PAYMENTS AND RECORDS
	
18

	
8.1Upfront Payment
	
18

	
8.2Milestones
	
18

	
8.3Royalties
	
21

	
8.4United States Profit and Loss Share
	
23

	
8.5Calculation and Payment of US Net Sales, Allowable US Expenses and Allowable Development Expenses Share
	
23

	
8.6Mode of Payment; Offsets
	
24

	
8.7Reimbursement
	
25

	
8.8Finance Working Group
	
25

	
8.9Taxes
	
26

 

ii

 

 

		
	
8.10Interest on Late Payments
	
27

	
8.11Financial Records
	
27

	
8.12Audit
	
27

	
8.13Audit Dispute
	
28

	
ARTICLE 9 LICENSES; INTELLECTUAL PROPERTY
	
28

	
9.1License Grant to PARTNER
	
28

	
9.2[****]
	
28

	
9.3Government Rights
	
29

	
9.4Sublicensing
	
29

	
9.5License Grant to REGENX
	
29

	
9.6Section 365(n) of the Bankruptcy Code
	
30

	
9.7Obligations Under Third Party Agreements
	
30

	
9.8Ownership and Disclosure of Intellectual Property
	
30

	
9.9Prosecution
	
33

	
9.10Infringement Actions Against Third Parties
	
34

	
9.11Defense of Infringement Claims
	
38

	
9.12Invalidity or Unenforceability Defenses or Actions
	
38

	
9.13Third Party Patent Rights
	
39

	
9.14International Nonproprietary Name
	
40

	
9.15Product Trademarks
	
40

	
9.16[****]
	
40

	
ARTICLE 10 CONFIDENTIALITY AND NON-DISCLOSURE
	
40

	
10.1Confidentiality Obligations
	
40

	
10.2Permitted Disclosures
	
42

 

iii

 

 

		
	
10.3Use of Name
	
42

	
10.4Public Announcements
	
43

	
10.5Publications
	
44

	
10.6Return of Confidential Information
	
44

	
ARTICLE 11 REPRESENTATIONS, WARRANTIES AND COVENANTS
	
45

	
11.1Mutual Representations and Warranties
	
45

	
11.2Additional Representations and Warranties of REGENX
	
45

	
11.3Additional Representation and Warranty of PARTNER
	
49

	
11.4DISCLAIMER OF WARRANTIES
	
49

	
11.5REGENX Covenants
	
49

	
11.6Mutual Covenants
	
50

	
11.7Anti-Bribery and Anti-Corruption Compliance
	
50

	
11.8Debarment
	
50

	
11.9Data Privacy and Security
	
51

	
ARTICLE 12 INDEMNITY
	
53

	
12.1Indemnification of REGENX
	
53

	
12.2Indemnification of PARTNER
	
53

	
12.3Certain Losses
	
53

	
12.4Indemnification Procedures
	
53

	
12.5Special, Indirect and Other Losses
	
55

	
12.6Insurance
	
55

	
ARTICLE 13 TERM AND TERMINATION
	
56

	
13.1Term and Expiration
	
56

	
13.2Termination
	
57

 

iv

 

 

		
	
13.3Rights in Bankruptcy
	
59

	
13.4Consequences of Termination
	
59

	
13.5Remedies
	
62

	
13.6Alternative Remedy in Lieu of Termination
	
62

	
13.7Assumption of Development and Manufacturing Activities Following Termination of Third Party License Agreements
	
63

	
13.8Accrued Rights; Surviving Obligations
	
64

	
ARTICLE 14 MISCELLANEOUS
	
64

	
14.1Force Majeure
	
64

	
14.2Export Control
	
65

	
14.3Assignment
	
65

	
14.4Severability
	
65

	
14.5Dispute Resolution
	
66

	
14.6Governing Law, Jurisdiction and Service
	
66

	
14.7Notices
	
67

	
14.8Entire Agreement; Amendments
	
68

	
14.9English Language
	
68

	
14.10Equitable Relief
	
69

	
14.11Waiver and Non-Exclusion of Remedies
	
69

	
14.12No Benefit to Third Parties
	
69

	
14.13Further Assurances
	
69

	
14.14Relationship of the Parties
	
69

	
14.15References
	
69

	
14.16Construction
	
70

	
14.17Counterparts
	
70

 

v

 

 

SCHEDULES

	
Schedule 1
	
(Definitions)

	
Schedule 1.50
	
(Corporate Names)

	
Schedule 1.163
	
(Penn Patents)

	
Schedule 1.188
	
(REGENX Existing Patents)

	
Schedule 3.2.1
	
(Development Plan)

	
Schedule 3.3
	
(Allocation of Reimbursable Development Expenses)

	
Schedule 5.1.1
	
(Existing Inventory)

	
Schedule 5.1.2
	
(Clinical Supply Terms)

	
Schedule 5.2.2(a)
	
(Commercial Supply Terms)

	
Schedule 5.3
	
(Certain Component Terms)

	
Schedule 8.4
	
(United States Profit and Loss Share)

	
Schedule 9.7
	
(Additional Applicable Provisions)

	
Schedule 10.4
	
(Press Release)

	
Schedule 11.2(b)
	
(Disclosure of Claims and Allegations on IP)

	
Schedule 11.2(r)
	
(Third Party License Agreements)

Schedule 11.5.5    (Certain Reimbursement Obligations of REGENX)

Schedule 14.5.2(ADR Procedures)

 

vi

 

 

 

 

 

COLLABORATION AND LICENSE AGREEMENT

This Collaboration and License Agreement (the “Agreement”) is made and entered into as of September 10, 2021 (the “Execution Date”) by and between REGENXBIO Inc., a corporation organized under the laws of the State of Delaware (“REGENX”) and AbbVie Global Enterprises Ltd., a Bermuda company (“PARTNER”). REGENX and PARTNER are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

Recitals

WHEREAS, REGENX has developed RGX-314 (as defined herein); 

WHEREAS, REGENX owns and controls certain REGENX Patents (as defined herein) and REGENX Know-How (as defined herein) and other intellectual property rights with respect to RGX-314 in the Territory (as defined herein), as well as methods for its administration, manufacture and therapeutic uses; and 

WHEREAS, REGENX and PARTNER wish to collaborate with respect to the Exploitation (as defined herein) of Licensed Products (as defined herein) in the Licensed Field (as defined herein) in the Territory in accordance with and subject to the terms and conditions set forth below; and

WHEREAS, PARTNER desires to obtain from REGENX an exclusive license under the REGENX Patents (as defined herein) and REGENX Know-How (as defined herein) under the terms set forth herein to Exploit Licensed Products in the Licensed Field in the Territory; and

WHEREAS, REGENX and PARTNER have contemporaneously herewith entered into a sublicense agreement pursuant to which REGENX has granted and PARTNER has accepted a license under the Penn Patents (as defined herein) to further Exploit Licensed Products in the Licensed Field in the Territory (the “Penn Sublicense Agreement”), in each case in accordance with the terms and conditions set forth below and in the Penn Sublicense Agreement.

NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions set forth herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:

ARTICLE 1
DEFINITIONS

Unless otherwise specifically provided herein, capitalized terms used in this Agreement have the meanings attributed to them in Schedule 1 (Definitions).

 

 

 

 

 

 

ARTICLE 2
EFFECTIVENESS OF THIS AGREEMENT

2.1Effective Date.  Notwithstanding anything to the contrary in this Agreement, except for the provisions of ARTICLE 1, this ARTICLE 2, ARTICLE 10, ARTICLE 11, and ARTICLE 14 which shall take effect as of the Execution Date and except as set forth in Section 2.1 (Effect of Agreement) of the Penn Sublicense Agreement, neither this Agreement nor the Penn Sublicense Agreement shall be binding on the Parties or otherwise take effect until the Effective Date.  As used herein, the “Effective Date” means the first Business Day following such time as all of the following express conditions precedent to the effectiveness of this Agreement have been satisfied, including any and all of the following conditions that relate to the HSR Act and any other applicable Competition Laws: 

2.1.1The Parties shall have complied with all applicable requirements of the HSR Act and any applicable Competition Laws in connection with this Agreement and the Penn Sublicense Agreement;

2.1.2the waiting or suspension period under the HSR Act and any applicable Competition Laws shall have expired or been terminated early, and any necessary consents or approvals under any applicable Competition Laws shall have been obtained;

2.1.3the Parties are under no antitrust-related obligation to refrain from consummating the transaction under a timing agreement entered into with a reviewing Governmental Authority that prevents closing before a specified date or without specified notice; 

2.1.4no judicial or administrative proceeding opposing consummation of all or any part of this Agreement or Penn Sublicense Agreement is pending; 

2.1.5no injunction (whether temporary, preliminary or permanent) prohibiting consummation of the transactions contemplated by this Agreement, the Penn Sublicense Agreement or any material portion hereof is in effect; and

2.1.6no requirements or conditions shall have been formally requested or imposed by the DOJ, FTC or any Governmental Authority in connection therewith that are not reasonably and mutually satisfactory to the Parties.

2.2Antitrust Cooperation.

2.2.1Obligations.  Both Parties shall promptly file, as soon as reasonably practicable and advisable following the Execution Date (and in any event, within [****] after the Execution Date, unless the Parties mutually agree otherwise in writing), their respective notification and report forms with the FTC and DOJ pursuant to the HSR Act.  PARTNER will make all mandatory filings (if any) required of it or any of its Affiliates under any other applicable Competition Laws in connection with this Agreement and the transactions contemplated hereby as soon as reasonably practicable, but in any event no later than [****] following the Effective Date, it being understood that such filing(s) may be made in draft where the submission of a draft filing is customary, and in the event that a Governmental Authority commences an investigation of the transaction(s) on its own initiative, or refers the transactions to 

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the European Commission, PARTNER will submit any required filing by the date on which a competition regulator asserts that a filing is required. [****].  Each Party shall promptly inform the other Party of any communication (whether oral or written) made to, or received by, such Party from any Governmental Authority regarding any of the transactions contemplated hereby, and promptly provide a copy of any such written communication, or a summary of any such oral communication, to the other Party.

2.2.2Reasonable Efforts.  

(a)If any objections are raised or asserted with respect to the transactions contemplated hereby under the HSR Act or any other applicable Competition Laws or if any action is instituted (or threatened to be instituted) by any Governmental Authority challenging the transactions contemplated hereby as being in violation of the HSR Act or any other applicable Competition Laws or which would otherwise prevent, impede or delay the consummation of the transactions contemplated hereby, the Parties shall use their commercially reasonable efforts to resolve any such objections or actions so as to permit consummation of the transactions contemplated hereby as soon as reasonably practicable; provided that, and notwithstanding anything to the contrary set forth herein, no Party shall be required to enter into any agreements or commitments or take any other actions to resolve any such objections or actions if such agreement, commitment or other action would reasonably be expected, individually or in the aggregate, to (i) prevent consummation of the transactions contemplated hereby, (ii) result in the transactions contemplated hereby being rescinded following the Execution Date, (iii) limit or otherwise adversely affect the right of PARTNER to be granted the licenses and other rights contemplated under this Agreement or the Penn Sublicense Agreement, or (iv) require or compel PARTNER or any Affiliate of PARTNER to (A) divest, dispose of, license or hold separate any portion of the businesses, operations, assets or product lines of PARTNER or its Affiliates (or a combination of the respective businesses, operations, assets or product lines of PARTNER and its Affiliates), (B) restrict, prohibit or limit the ability of PARTNER or any of its Affiliates to conduct their business or own their assets, or (C) impose limitations on the ability of PARTNER or any of its Affiliates to exercise the licenses or other rights granted to PARTNER or any of its Affiliates as contemplated under this Agreement or the Penn Sublicense Agreement. Notwithstanding the foregoing or any other provision of this Agreement to the contrary, in no event shall PARTNER or any of its Affiliates be obligated to (I) enter into any settlement, undertaking, consent decree, stipulation or agreement with any Governmental Authority in connection with the transactions contemplated hereby or (II) litigate or participate in the litigation of any action, whether judicial or administrative, brought by any Governmental Authority challenging or seeking to restrain, prohibit or place conditions on the consummation of the transactions contemplated hereby or the ownership or operation by PARTNER or any of its Affiliates of all or any portion of their respective businesses as presently conducted and as currently proposed to be conducted.  

(b)The Parties agree to use reasonable efforts to consult and cooperate with one another, and consider in good faith the views of one another, in connection with any analyses, appearances, meetings, discussions, presentations, memoranda, briefs, filings, arguments, and proposals made by or on behalf of either Party before any Governmental Authority or the staff or regulators of any Governmental Authority in connection with the transactions contemplated hereby.  Each Party shall use reasonable efforts to give sufficient notice to the other Party hereto with respect to any meeting, discussion, appearance or contact with any Governmental 

3

 

Authority or the staff or regulators of any Governmental Authority in order to provide the other Party with the opportunity to attend and participate in such meeting, discussion, appearance or contact.  Nothing in this Section 2.2.2(b) shall require (i) either Party to furnish copies of its respective filing under the HSR Act to the other Party, (ii) either Party to provide any Confidential Information contained in any other filing under applicable Competition Laws, or (iii) either Party to provide access to, or disclose any information to, the other Party or any of its Affiliates if such access or disclosure, in the good faith reasonable belief of such Party, (x) would cause significant competitive harm to such Party if the activities contemplated hereby are not consummated, (y) would result in the waiver of any legal privilege, or (z) would be in violation of Applicable Laws or the provisions of any agreement to which either Party is a party.

2.2.3Costs.  [****].

2.3Delay in Effective Date.  In the event that each of the conditions precedent to the Effective Date specified in Section 2.1 are not satisfied within [****] after the Execution Date, then either Party may terminate this Agreement and the Penn Sublicense Agreement and rescind its obligation to enter into the transactions contemplated by this Agreement and the Penn Sublicense Agreement upon written notice to the other Party and all provisions of this Agreement and the Penn Sublicense Agreement shall be of no force or effect.

ARTICLE 3
DEVELOPMENT AND REGULATORY ACTIVITIES

3.1Development Activities.  

3.1.1Development Diligence Obligations.  

(a)Subject to the terms and conditions of this Agreement, commencing on the Effective Date, the Parties shall use Commercially Reasonable Efforts to Develop, with the goal of receiving Regulatory Approval, one (1) Licensed Product for the treatment of each of (a) nAMD by means of nAMD Suprachoroidal Treatment, (b) nAMD by means of nAMD Subretinal Treatment, and (c) DR, in each case, in the United States. In addition, subject to the terms and conditions of this Agreement, following the achievement of both of the Initial Registration Enabling Trial Milestone Events, the Parties shall use Commercially Reasonable Efforts to Develop one (1) Licensed Product for the treatment of one (1) Additional Indication in the United States. 

(b)Subject to the terms and conditions of this Agreement, commencing on the Effective Date, PARTNER shall use Commercially Reasonable Efforts to Develop, with the goal of receiving Regulatory Approval, one (1) Licensed Product for the treatment of each of (a) nAMD by means of nAMD Suprachoroidal Treatment, (b) nAMD by means of nAMD Subretinal Treatment, and (c) DR, in each case, in [****].  In addition, subject to the terms and conditions of this Agreement, following the achievement of both of the Initial Registration Enabling Trial Milestone Events, PARTNER shall use Commercially Reasonable Efforts to Develop one (1) Licensed Product for the treatment of one (1) Additional Indication in [****].

3.1.2Development Plan Activities.  Each Party shall use Commercially Reasonable Efforts to perform its Development activities set forth in the Development Plan and in accordance with the timelines set forth in the Development Plan.  In addition, each Party shall perform or cause to be performed the Development activities allocated to it under the Development Plan in good scientific manner and in compliance with all Applicable Law.  For clarity, no material Development activities relating to any Licensed Product for use in the Licensed Field shall be conducted by or on behalf of either Party except as set forth in the Development Plan [****].

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3.2Development Plan.  

3.2.1Development Plan.  The Development Plan is attached hereto as Schedule 3.2.1 and describes the allocation of activities between the Parties for the initial Development of Licensed Products for use in the Licensed Field in the Territory, in each case as applicable for a Licensed Product for use in a particular Indication in the Licensed Field [****].

3.2.2Development Plan Updates.  The JDC shall review the Development Plan [****] for the purpose of considering appropriate amendments thereto, including revisions to existing Development activities and the addition of new Development activities.  In addition, either Party, through its representatives on the JDC, may propose amendments to the Development Plan at any time.  Any proposed amendment to the Development Plan shall be reviewed by the JDC.  Any amendment to the Development Plan will not be binding on either Party until approved by the JDC [****] and upon such approval by the JDC [****], the updated Development Plan shall be deemed to be incorporated into this Agreement.  With respect to any amendment to the Development Plan to add new Development activities (including any Development activities that are required to be conducted by a Regulatory Authority to support Regulatory Approval of a Licensed Product in a given jurisdiction) or modify any Development activities in a manner that would change the cost of such activities, such amendment shall include a corresponding amendment to the Budget for the Development Plan; [****].

3.2.3Implementation.  Without limitation of the foregoing, the Party responsible for activities in connection with the Development of Licensed Products for use in the Licensed Field as set forth in the Development Plan shall have the right, without seeking JDC approval, to make operational decisions consistent with the terms of this Agreement that reasonably implement the Development Plan but do not require a change thereto. 

3.2.4[****]

3.3Development Expenses.  

3.3.1Reimbursable Development Expenses.  Each Party shall be responsible for its share of Allowable Development Expenses plus Allowable Overruns (collectively, “Reimbursable Development Expenses”) incurred by both Parties in connection with the Development of Licensed Products for use in the Licensed Field in the Territory as set forth in Schedule 3.3.  The Development Plan attached hereto as Schedule 3.2.1 includes a detailed Budget for the initial period upon commencement of Development activities pursuant to Section 3.1.1 until [****].  

3.3.2Excess Development Expenses; Budget Amendments.  In the event either Party incurs (or anticipates that it will incur) costs or expenses in the conduct of Development activities under the Development Plan that exceed the Reimbursable Development Expenses (“Excess Development Expenses”), [****].

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3.4Records and Reports.

3.4.1Development Records.  Each Party shall, and shall require its Affiliates and its and their sublicensees and Third Party subcontractors to, maintain, in good scientific manner, complete and accurate books and records pertaining to Development of Licensed Products for use in the Licensed Field (“Development Records”), in sufficient detail to verify compliance with its obligations under this Agreement.  Such books and records shall (a) be appropriate for patent and regulatory purposes, (b) be in compliance with Applicable Law, (c) properly reflect all work done and results achieved in the performance of its Development activities hereunder, (d) record only such activities and not include or be commingled with records of activities outside the scope of this Agreement and (e) be retained, with respect to Development Records of a Party, by such Party for at least [****] after the expiration or termination of this Agreement in its entirety or for such longer period as may be required by Applicable Law.  Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all Development Records of a Party maintained pursuant to this Section 3.4.1 for the purpose of confirming compliance with this Agreement and fulfilling its obligations under this Agreement; provided that such Party shall maintain such records and information disclosed therein in confidence in accordance with ARTICLE 10 [****]. Without limiting the foregoing, each Party shall maintain such Development Records as is necessary to comply with each of the applicable provisions in this Agreement.  

3.4.2Development Reports. 

(a)Each Party shall record and account for its FTE Costs and Out-of-Pocket Costs for the Development activities, in each case, in a manner that allocates costs to the extent possible to a specific activity in the Development Plan.  [****].  Without limitation of Section 3.4.1, within [****] following the end of each [****] during which a Party is conducting Development activities hereunder, such Party shall provide the JDC with a detailed written report of (i) all Development activities such Party has performed, or caused to be performed during [****] and (ii) such Party’s Reimbursable Development Expenses incurred in the performance of such Development activities during such [****], whereby it shall specify in reasonable detail all amounts included in such Reimbursable Development Expenses.  

(b)[****], each Party further shall provide to the other Party a high-level summary of such Party’s Development activities in process and anticipated Development activities during the following [****] period, in each case, for the Licensed Products in the Licensed Field in any jurisdiction(s) in the Territory.  

3.5Development Subcontracting.  Subject to Section 9.4, (a) PARTNER shall have the right to subcontract its Development activities to a Third Party [****] and (b) REGENX shall have the right to subcontract its Development activities [****].  No such permitted subcontracting shall relieve either Party of any obligation (except to the extent such obligation is performed by such subcontractor) or any liability hereunder and such Party shall be and remain 

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fully responsible and liable therefor.  Any agreement pursuant to which a Party engages any Third Party subcontractor must (a) be consistent in all material respects with the applicable terms and conditions of this Agreement and (b) contain terms obligating such subcontractor to comply with the confidentiality, intellectual property and all other relevant provisions of this Agreement.  In addition, each Party shall use commercially reasonable efforts to contractually obligate such subcontractor to permit the other Party rights of inspection, access and audit substantially similar to those provided to the other Party in this Agreement.  Each Party hereby waives any requirement that the other Party exhaust any right, power or remedy, or proceed against any subcontractor for any obligation or performance under this Agreement, prior to proceeding directly against such first Party.

3.6Regulatory Approvals and Communications. 

3.6.1Responsibility for Regulatory Approvals.  [****]

3.6.2Meetings with Regulatory Authorities.  [****]  

3.6.3Regulatory Filings. [****] 

3.6.4Regulatory Costs.  For clarity, any Reimbursable Development Expenses incurred by the Parties to conduct the regulatory activities contemplated under this Section 3.6 shall be borne by the Parties in accordance with Section 3.3 and Schedule 3.3.

3.7Recalls, Suspensions or Withdrawals.  Each Party shall notify the other Party promptly (but in no event later than [****]) following its determination that any event, incident or circumstance has occurred that may result in the need for a recall, market suspension or market withdrawal of a Licensed Product for use in the Licensed Field in the Territory and shall include in such notice the reasoning behind such determination and any supporting facts.  As between the Parties, PARTNER shall have the right to make the final determination of whether to voluntarily implement any such recall, market suspension or market withdrawal in the Licensed Field in the Territory; provided that prior to any implementation of such a recall, market suspension or market withdrawal in the United States, PARTNER shall consult with REGENX and shall consider REGENX’s comments in good faith.  If a recall, market suspension or market withdrawal is mandated by a Regulatory Authority in the Territory, as between the Parties, PARTNER shall initiate such a recall, market suspension or market withdrawal in compliance with Applicable Law.  Any costs and expenses incurred by the Parties in the event of any recall, market suspension or market withdrawal of a Licensed Product for use in the Licensed Field will be borne by the Parties as follows:

3.7.1in the event that a recall, market suspension, or market withdrawal resulted from a Party’s or its Affiliate’s breach of its obligations hereunder, under the Clinical Supply Agreement, the Commercial Supply Agreement, the Clinical Quality Agreement or the Commercial Quality Agreement or from such Party’s or its Affiliate’s gross negligence or willful misconduct, such Party shall bear the expense of such recall, market suspension, or market withdrawal; 

3.7.2subject to clause (a) above, in the event that a recall, market suspension, or market withdrawal occurs in a country prior to Marketing Authorization in such 

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country from the applicable Regulatory Authority, the expenses incurred by the Parties as a result of such recall, market suspension, or market withdrawal shall be included in the Allowable Development Expenses hereunder;

3.7.3subject to clauses (a) and (b) above, with respect to any recall, market suspension, or market withdrawal of a Licensed Product in the United States, the expenses incurred by the Parties as a result of such recall, market suspension, or market withdrawal in the United States shall be included in Allowable US Expenses hereunder; and

3.7.4subject to clause (a) above, with respect to any recall, market suspension, or market withdrawal of a Licensed Product that occurs in a country other than the United States after Marketing Authorization in such country from the applicable Regulatory Authority, PARTNER shall be responsible for any expenses incurred by the Parties as a result of such recall, market suspension, or market withdrawal.

3.8Pharmacovigilance Agreement.  [****] the Parties will execute a pharmacovigilance agreement [****] that will provide, among other things, [****] guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports and any other information as determined by the Parties.  Such guidelines and procedures shall be in accordance with, and enable the Parties to comply with and fulfill, all Applicable Laws and all local and national regulatory reporting obligations to Regulatory Authorities and other Governmental Authorities. 

3.9Global Safety Database.  PARTNER shall establish, hold and maintain the global safety database for Licensed Products for use in the Licensed Field.  REGENX shall provide PARTNER with information in the Control of REGENX as necessary for PARTNER to comply with its pharmacovigilance responsibilities in the Territory, including, as applicable, any adverse drug experiences (including those events or experiences that are required to be reported to the FDA under 21 C.F.R. sections 312.32 or 314.80 or to foreign Regulatory Authorities under corresponding Applicable Law outside the United States), from its Development of a Licensed Product, in each case, in the form reasonably requested by PARTNER.  [****]. 

ARTICLE 4
COMMERCIALIZATION

4.1Commercialization Activities.  Subject to the remainder of this ARTICLE 4, as between the Parties, PARTNER shall have the sole right to Commercialize Licensed Products in the Licensed Field throughout the Territory.  REGENX shall participate in the Commercialization of Licensed Products in the Licensed Field in the United States with the scope of such participation determined in advance by the JCC (subject to the applicable decision-making provisions of Section 7.4.3(g)).

4.2Commercialization Strategies and Plans.

4.2.1Global Commercialization Strategy.  [****] PARTNER shall develop and provide to REGENX through the JCC a global commercialization strategy for such Licensed Product in a particular Indication throughout the Territory (each, a “Global Commercialization Strategy”), which Global Commercialization Strategy shall include [****].  

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For the avoidance of doubt, this Section 4.2.1 shall apply for each Licensed Product for use in a particular (different) Indication in the Licensed Field (e.g. if a Global Commercialization Strategy has been established for a Licensed Product for use in nAMD, this Section 4.2.1 shall apply again for a Licensed Product for use in DR).  Each Global Commercialization Strategy shall be non-binding and shall be used solely to facilitate discussion between the Parties regarding PARTNER’s Commercialization plans in the Territory.

4.2.2Commercialization Plans.  [****] the JCC shall develop an initial comprehensive plan and Budget for Commercialization of such Licensed Product in the United States for such Indication (each, a “Commercialization Plan”), which initial Commercialization Plan shall cover [****] of Commercialization activities after the First Commercial Sale of such Licensed Product in the United States for such Indication and shall include (in each case, for such Indication and solely with respect to the United States): [****].  The JCC shall review each Commercialization Plan [****] and shall develop any amendments to each Commercialization Plan.

4.3Diligence. 

4.3.1In the case of any Commercialization activities performed in or for the United States, each Party shall use Commercially Reasonable Efforts to Commercialize such Licensed Product in the United States in accordance with the applicable Commercialization Plan for such Licensed Product for such Indication.  Once an application for Regulatory Approval for a Licensed Product in an Indication has been submitted to a Regulatory Authority in [****].  

4.3.2Following receipt of Regulatory Approval for a Licensed Product for a given Indication in the United States, [****], PARTNER shall use Commercially Reasonable Efforts to Commercialize such Licensed Product for the treatment of such Indication in the Licensed Field in such country; provided that such obligation with respect to [****].  For clarity, with respect to any Indication, the Parties acknowledge that the foregoing diligence obligations shall not require separate Commercially Reasonable Efforts with respect to different delivery methods (e.g., subretinal and suprachoroidal) for the treatment of the same Indication. 

4.4Commercialization Records and Reports.  

4.4.1Commercialization Records.  Without limitation of Section 8.11, each Party shall maintain complete and accurate books and records pertaining to its Commercialization of Licensed Products hereunder, in sufficient detail to verify compliance with its obligations under this Agreement, which books and records shall be in compliance with Applicable Law and properly reflect all work done and results achieved in the performance of its Commercialization activities.  Such records shall be retained by a Party for at least [****] after the expiration or termination of this Agreement in its entirety or for such longer period as may be required by Applicable Law.  Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all such books and records maintained by the other Party pursuant to this Section 4.4.1 for the sole purpose of confirming compliance with this Agreement; provided that each Party shall maintain such records and information disclosed therein in confidence in accordance with ARTICLE 10, [****].  

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4.4.2Commercialization Updates.  Without limitation of Section 4.4.1, for the time period during which a Party is conducting Commercialization activities hereunder, such Party shall update the JCC at each regularly scheduled meeting of the JCC regarding its Commercialization activities with respect to the Licensed Products in the Licensed Field in the United States  Each such update will summarize such Party’s significant Commercialization activities with respect to Licensed Products in the Licensed Field in the United States to the extent that such Party has the right to disclose such information to the other Party without violating any confidentiality or other obligations to any Third Party. 

4.5Commercialization Costs; Booking of Sales; Distribution.

4.5.1Global Commercialization Costs.  As between the Parties, PARTNER shall be responsible for all costs and expenses in connection with the Commercialization of Licensed Products in the Licensed Field throughout all countries in the Territory other than the United States.

4.5.2United States Commercialization Costs.  The Parties shall be responsible for all Allowable US Expenses in accordance with Section 8.4.  All expenses incurred by PARTNER that would be Allowable US Expenses save for the fact that such expenses were not provided in or consistent with the Commercialization Plan or related Budget shall be deemed Allowable US Expenses under this Agreement.  In the event REGENX incurs (or anticipates that it will incur) costs or expenses in the conduct of Commercialization activities under the Commercialization Plan that exceed the Allowable US Expenses for such activities under the Commercialization Plan (“Excess Commercialization Expenses”), REGENX may provide notice of the expected Excess Commercialization Expenses to the JCC which notice shall include reasonable detail and background information sufficient to enable the JCC to evaluate the basis for such Excess Commercialization Expenses.  The Parties shall, through the JCC, discuss in good faith whether to amend the Budget for the Commercialization Plan or whether to otherwise treat such Excess Commercialization Expenses as Allowable US Expenses.  [****].

4.5.3Booking of Sales; Distribution.  Subject to the Commercialization Plan (solely with respect to the United States), PARTNER shall invoice and book Net Sales, establish all terms of sale (including pricing and discounts) and warehouse and distribute Licensed Products for use in the Licensed Field in the Territory and perform or cause to be performed all related services.  Subject to Section 3.7, PARTNER shall be responsible for conducting and managing all returns, recalls, suspensions or withdrawals, order processing, invoicing, collection, distribution and inventory management with respect to Licensed Products for use in the Licensed Field in the Territory.

4.6Commercial Subcontracting.  Subject to Section 9.4, (a) PARTNER shall have the right to subcontract its Commercial activities to a Third Party [****] and (b) REGENX shall have the right to subcontract its Commercial activities to a Third Party [****]. No such permitted subcontracting shall relieve either Party of any obligation (except to the extent satisfactorily performed by such subcontractor) or any liability hereunder and such Party shall be and remain fully responsible and liable therefor.  Any agreement pursuant to which a Party engages any Third Party subcontractor must (x) be consistent in all material respects with this Agreement and (y) contain terms obligating such subcontractor to comply with the confidentiality, intellectual 

10

 

property and all other relevant provisions of this Agreement.  In addition, each Party shall use commercially reasonable efforts to contractually obligate such subcontractor to permit the other Party rights of inspection, access and audit substantially similar to those provided to the other Party in this Agreement.  Each Party hereby waives any requirement that the other Party exhaust any right, power or remedy, or proceed against any subcontractor for any obligation or performance under this Agreement prior to proceeding directly against such first Party.

4.7Compliance with Applicable Law.  Each Party shall, and shall require its Affiliates and sublicensees to, comply with all Applicable Law with respect to the Exploitation of Licensed Products in the Licensed Field in the Territory. 

4.8Markings.  To the extent requested by REGENX in writing and permitted under Applicable Law or otherwise required by Applicable Law, the Promotional Materials (including web and social media content), packaging and Product Labeling for a Licensed Product used by PARTNER, its Affiliates and its and their Sublicensees in connection with Commercialization in the United States shall contain the Corporate Name (and logo) as designated by REGENX with equal prominence to the Trademarks of PARTNER or its Affiliates, in a manner approved in writing by the Parties.

ARTICLE 5
MANUFACTURING AND SUPPLY

5.1Clinical Supply.  

5.1.1In General.  Except as expressly set forth in this Agreement, REGENX shall Manufacture and supply, or supply from Existing Inventory, all requirements of Licensed Products (including Licensed Compounds therein) necessary for the Parties to conduct their Development activities under this Agreement (“Clinical Supply”).  REGENX represents and warrants that it has the amounts of Licensed Product on hand as of the Execution Date (such Licensed Product, “Existing Inventory”) as set forth on Schedule 5.1.1 and that all Existing Inventory satisfies the Product Warranty as of the Execution Date.  REGENX hereby represents, warrants and covenants that the Existing Inventory will satisfy the Product Warranty upon its delivery to PARTNER for use, or upon its use by or on behalf of REGENX, in Development activities under this Agreement.  REGENX will supply Existing Inventory for the conduct of Development activities under this Agreement and will use Existing Inventory solely for such purpose.  Subject to Section 5.1.2, REGENX will deliver, or cause to be delivered, all requirements of Clinical Supply to sites conducting any of the Clinical Trials under the Development Plan.  A material breach of REGENX’s obligations under this Section 5.1.1 will be deemed a Material Breach.  Upon the effective date of the Clinical Supply Agreement, the provisions of this Section 5.1 shall be replaced and superseded by the terms and conditions of the Clinical Supply Agreement.  [****].  

5.1.2Clinical Supply Agreement.  [****] the Parties shall enter into (a) one or more clinical supply agreement(s) (the “Clinical Supply Agreement”) pursuant to which REGENX shall Manufacture and supply Clinical Supply and supply Delivery Systems for such Clinical Supply to PARTNER for Development activities under this Agreement, including Clinical Trials under the Development Plan, and (b) [****] quality assurance agreement setting 

11

 

forth the terms and conditions on which the Parties shall conduct their quality activities in connection with the applicable Clinical Supply Agreement (the “Clinical Quality Agreement”). [****]. Without limitation of the foregoing, the Clinical Supply Agreement(s) shall include terms and conditions that conform in all material respects to those set forth on Schedule 5.1.2 and in the event that Clinical Supply or Delivery Systems for such Clinical Supply are required by PARTNER prior to the execution of the Clinical Supply Agreement, this Agreement, including the terms set forth on Schedule 5.1.2, shall govern the Manufacture and supply of such Clinical Supply. 

5.1.3Clinical Manufacturing Costs.  Any Reimbursable Development Expenses incurred by the Parties to Manufacture Clinical Supply under this Section 5.1, including [****], will be allocated to the Parties in accordance with Section 3.3 and Schedule 3.3; [****]. 

5.1.4Use of Clinical Supply.  The Parties agree that: (a) any Clinical Supply shall be used solely for the Development of Licensed Products in the Licensed Field pursuant to this Agreement; and (b) any Clinical Supply shall not be made available by either Party to any Third Party except in connection with Clinical Trial(s) pursuant to the Development Plan or as expressly consented to in writing by the other Party, such approval not to be unreasonably withheld, delayed or conditioned.

5.2Commercial Supply.  

5.2.1In General.  

(a)Commencement of Commercial Supply Discussions.  [****] the Parties, through their representatives on the JCC and JMC, shall (i) discuss the timing for commencing Process Development activities for commercial supply of such Licensed Product (and Licensed Compound therein)  in the Territory (or, as indicated where appropriate, in the United States or outside of the United States) (the “Commercial Supply”), (ii) discuss the timing for commencing Manufacture and supply of such Commercial Supply in the Territory, taking into account anticipated global sales of such Licensed Product and such other factors as may be determined by the JCC and JMC, and (iii) commence good faith negotiations to enter into a Commercial Supply Agreement and quality assurance agreement in respect of such Commercial Supply, as further described in Section 5.2.2.  For the avoidance of doubt, this Section 5.2.1(a) shall apply for each Licensed Product for use in a particular (different) Indication in the Licensed Field (e.g. if the Parties have discussed timing for commencing Process Development and Manufacture and Commercial Supply for a Licensed Product for use in nAMD, Section 5.2.1(a) shall apply again for a Licensed Product for use in DR). 

(b)Commercial Supply in the United States Subject to the remainder of this Section 5.2 and the terms and conditions of the Commercial Supply Agreement: (i) REGENX shall Manufacture (or have Manufactured) and supply [****] of the Parties’ requirements of Commercial Supply for Licensed Products (including Licensed Compounds therein) for use in the Licensed Field in the United States, and shall perform Process Development with respect thereto; and (ii) PARTNER shall Manufacture (or have Manufactured) and supply [****] of the Parties’ requirements of Commercial Supply for Licensed Products (including 

12

 

Licensed Compounds therein) for use in the Licensed Field in the United States except as otherwise mutually agreed by the Parties.  The Commercial Supply Agreement will set forth in further detail the allocation of Commercial Supply responsibilities between the Parties in the United States, but will in all cases be consistent with the foregoing sentence except as otherwise mutually agreed by the Parties.  The JCC and the JMC shall determine the timeline pursuant to which commercial Process Development shall commence with respect to the first Licensed Product for use in the Licensed Field and shall provide written notice of such determination to REGENX.

(c)Commercial Supply Outside of the United States Subject to the remainder of this Section 5.2 and the terms and conditions of the Commercial Supply Agreement: (i) REGENX shall Manufacture (or have Manufactured) and supply [****] of the requirements of the Commercial Supply for Licensed Products (including Licensed Compounds therein) for use in the Licensed Field outside of the United States; and (ii) PARTNER shall Manufacture (or have Manufactured) and supply [****] of the Parties’ requirements of Commercial Supply for Licensed Products (including Licensed Compounds therein) for use in the Licensed Field outside of the United States, in each case except as mutually agreed by the Parties.  The Commercial Supply Agreement will set forth in further detail the allocation of Commercial Supply responsibilities between the Parties in the Territory outside of the United States, but will in all cases be consistent with the foregoing sentence except as mutually agreed by the Parties. 

(d)Reassessment of Commercial Supply Allocation.  In the event that there is no Manufacturing facility (whether of REGENX or a CMO designated by REGENX) both fully enabled to Manufacture Commercial Supply and approved by the applicable Regulatory Authority for the Manufacture of Commercial Supply as of a reasonable period of time prior to launch of a Licensed Product using such Commercial Supply, then the JMC will reassess and determine the appropriate split in such Commercial Supply production volumes between the Parties from the production volumes set forth in this Agreement.

5.2.2Commercial Supply Agreement.

(a)In accordance with the timelines set forth in Section 5.2.1(a) above, the Parties shall [****] (i) enter into one or more commercial supply agreement(s) (the “Commercial Supply Agreement”) setting forth the terms and conditions on which REGENX shall Manufacture and supply the Commercial Supply of Licensed Products (including Licensed Compounds therein) and Delivery Systems for Commercial Supply, and (ii) enter into [****] quality assurance agreement setting forth the terms and conditions on which the Parties shall conduct their quality activities in connection with the Commercial Supply Agreement (the “Commercial Quality Agreement”). [****].  Without limitation of the foregoing, the Commercial Supply Agreement shall include terms and conditions that conform in all material respects with this Section 5.2 and to those set forth on Schedule 5.2.2(a).  Upon the effective date of the Commercial Supply Agreement, the provisions of Section 5.2.1 and this Section 5.2.2 shall be replaced and superseded by the terms and conditions of the Commercial Supply Agreement.  In the event that Commercial Supply or Delivery Systems for Commercial Supply are required to be Manufactured or supplied in PARTNER’s reasonable discretion prior to the execution of the Commercial Supply Agreement, this Agreement, including the terms set forth on Schedule 5.2.2(a), shall govern the Manufacture and supply of such Commercial Supply.

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(b)[****]

5.2.3[****]

5.2.4Commercial Manufacturing Costs.  

(a)The costs and expenses relating to the Manufacture of Commercial Supply shall be incurred and paid pursuant to the Commercial Supply Agreement or, if no Commercial Supply Agreement is in place, under the terms of this Agreement.  For the avoidance of doubt, any such costs and expenses with respect to any given unit of Licensed Product shall be payable only once (whether under this Agreement or under the Commercial Supply Agreement).

(b)[****].

5.3Certain Components.  With respect to certain components, the Parties agree to comply with the terms of Schedule 5.3.

ARTICLE 6
EXCLUSIVITY

6.1Generally.  Subject to Sections 6.2 and 6.3, in any country in the Territory, no Party will, and each Party will cause its Affiliates to not, for a period of [****] following the Effective Date, (a) directly or indirectly, Develop, Manufacture, Commercialize or otherwise Exploit or (b) license, authorize, appoint or otherwise enable any Third Party to directly or indirectly, Develop, Manufacture, Commercialize or otherwise Exploit, in either case of (a) or (b), any AAV-based delivery product or service that targets VEGF in the field of ophthalmology (such product “Competing Products”, and such activities “Competing Activities”). 

6.2[****]

6.3[****]

ARTICLE 7
GOVERNANCE

7.1Joint Development Committee.  Within [****] after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or “JDC”), which shall consist of [****] representatives from each of the Parties, each with the requisite experience and seniority to enable such person to make decisions on behalf of the Parties with respect to the issues falling within the jurisdiction of the JDC.  From time to time, each Party may substitute [****] of its representatives to the JDC on written notice to the other Party.  [****] shall appoint [****] of its representatives to serve as a co-chairperson of the JDC, and [****] may change its appointed co-chairperson from time to time upon written notice [****].  The JDC shall:

7.1.1serve as a forum for discussing and coordinating Development of Licensed Products for use in the Licensed Field in the United States and discussing Development of Licensed Products for use in the Licensed Field in the Royalty Territory, including 

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by overseeing the conduct of the Development activities as set forth in Section 3.1 and reviewing Development reports as set forth in Section 3.4.2;

7.1.2[****];

7.1.3[****];

7.1.4develop and determine whether to approve any amendment to the Development Plan and corresponding Budget as set forth in Section 3.2.2 or, if applicable, 3.3.2; 

7.1.5review and discuss the Parties’ regulatory activities in the United States, including any updates regarding any material, non-recurring submissions and filings (e.g., INDs, BLAs, major supplements or amendments to the foregoing, material labeling supplements, Regulatory Authority meeting requests and core data sheets and filings related to new Indications and proposed labeling) that PARTNER proposes to submit or has submitted to any Regulatory Authority in the United States;

7.1.6[****];

7.1.7conduct responsibilities delegated to another Joint Committee under this Agreement if such Joint Committee is not yet formed; and

7.1.8perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

7.2Joint Commercialization Committee.  [****] the Parties shall establish a joint commercialization committee (the “Joint Commercialization Committee” or “JCC”), which shall consist of [****] representatives from each of the Parties, each with the requisite experience and seniority to enable such person to make decisions on behalf of the Parties with respect to the issues falling within the jurisdiction of the JCC.  From time to time, each Party may substitute [****] of its representatives to the JCC upon written notice to the other Party.  [****] shall appoint [****] of its representatives to serve as a co-chairperson of the JCC, and [****] may change its appointed co-chairperson from time to time upon written notice [****].  The JCC shall:

7.2.1discuss the Global Commercialization Strategy prepared by PARTNER and submitted in accordance with Section 4.2.1;

7.2.2serve as a forum for discussing and coordinating the Commercialization of Licensed Products in the Licensed Field in the United States as set forth in Section 4.3;

7.2.3discuss, together with the JMC, the timing for commencement of Manufacturing and supply of Commercial Supply and commercial Process Development in the Territory and serve as a forum for discussing and coordinating the Manufacturing and supply as set forth in Section 5.2.1;

15

 

7.2.4develop the Commercialization Plans and the Budgets therefor for Licensed Products for use in the Licensed Field in the United States and any amendments thereto as set forth in Section 4.2.2 or, if applicable, 4.5.2; 

7.2.5discuss and determine Commercialization activities under the Commercialization Plan for which REGENX is responsible;

7.2.6[****];

7.2.7[****]; 

7.2.8with respect to the Commercialization of Licensed Products for use in the Licensed Field in the United States, review and discuss the Commercialization costs and expenses incurred by the Parties in connection with such Commercialization, including against Budgets set forth in Commercialization Plans; and

7.2.9perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement.

7.3Joint Manufacturing Committee.  [****] the Parties shall establish a joint manufacturing committee (the “Joint Manufacturing Committee” or “JMC”), which shall consist of [****] representatives from each of the Parties, each with the requisite experience and seniority to enable such person to make decisions on behalf of the Parties with respect to the issues falling within the jurisdiction of the JMC.  From time to time, each Party may substitute [****] of its representatives to the JMC on written notice to the other Party.  [****] shall appoint [****] of its representatives to serve as a co-chairperson of the JMC, and [****] may change its appointed co-chairperson from time to time upon written notice [****].  The JMC shall:

7.3.1discuss, together with the JCC, the timing for commencement of Manufacturing and supply of Commercial Supply and commercial Process Development in the Territory; and serve as a forum for discussing and coordinating the Manufacturing and supply as set forth in Section 5.2.1;

7.3.2discuss and develop the plan of Clinical Supply, Commercial Supply (at least [****] prior to anticipated applicable launch) [****];

7.3.3[****];

7.3.4with respect to the Manufacturing of a Licensed Product for use in the Licensed Field, review and discuss the Clinical Supply costs, Commercial Supply costs, Process Development costs and other expenses incurred by the Parties in connection with such Manufacturing, including against Budgets developed by the JDC and JCC therefor; 

7.3.5[****]; and

7.3.6perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this 

16

 

Agreement.

7.4General Provisions Applicable to Joint Committees 

7.4.1Meetings and Minutes.  Each Joint Committee shall hold meetings at such times as the Parties shall determine, but in no event less frequently than [****] during the Term or as otherwise agreed by the Parties, with respect to the JDC, JCC and JMC, commencing from and after the time such Joint Committee is established as provided herein.  Meetings of each Joint Committee may be conducted by telephone, by video-conference, or in-person as determined by such Joint Committee.  In-person meetings of each Joint Committee, unless otherwise agreed, shall alternate between REGENX’s offices and PARTNER’s offices.  The co-chairpersons of the Joint Committees shall be responsible for calling meetings on no less than [****] notice unless exigent circumstances require shorter notice.  Each Party shall make all proposals for agenda items at least [****] in advance of the applicable meeting; provided that under exigent circumstances requiring input by a Joint Committee, a Party may provide its agenda items to the other Party within a shorter period of time in advance of the meeting or may propose that there not be a specific agenda for a particular meeting, so long as the other Party consents to such later addition of such agenda items or the absence of a specific agenda for such meeting (which consent shall not be unreasonably withheld, conditioned or delayed).  The co-chairpersons of each Joint Committee shall prepare and circulate for review and approval of the Parties’ minutes of each meeting within [****] after the meeting.  The Parties shall agree on the minutes of each meeting promptly, [****].  

7.4.2Procedural Rules.  Each Joint Committee shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement.  A quorum of each Joint Committee shall exist whenever there is present at a meeting [****] appointed by each Party.  Subject to a Party having final decision-making authority with respect to a matter, each Party shall have [****] with respect to any matters properly before each Joint Committee.  [****].  Subject to Section 7.4.3, each Joint Committee shall take action by consensus of the representatives present at a meeting at which a quorum exists, [****] or by a written resolution signed by [****] appointed by each Party.  Alliance Managers or other employees or consultants of a Party who are not representatives of the Parties on a Joint Committee may attend meetings of such Joint Committee; provided, however, that such attendees (a) shall not vote in such Joint Committee and (b) are bound by obligations of confidentiality and non-disclosure at least as protective of the other Party as those set forth in ARTICLE 10.  For clarity, each Party shall have the right to make operational, day-to-day decisions with respect to the performance of its activities under this Agreement.

7.4.3Dispute Resolution.  If a Joint Committee, after a period of [****], cannot, or does not, reach consensus on a matter that is expressly within its jurisdiction under this ARTICLE 7 (such consensus shall consist of [****] in mutual agreement), either Party may require that the dispute be submitted to the Senior Officers for resolution by providing written notice to the other Party formally requesting that the dispute be resolved by the Senior Officers and specifying the nature of the dispute.  If a dispute is referred to the Senior Officers, then the Senior Officers shall diligently and in good faith attempt to resolve the referred dispute within [****] after receiving written notification of such dispute or such longer period of time as the Senior Officers may agree in writing.  Any final decision mutually agreed to by the Senior Officers 

17

 

with respect to a dispute and set forth in writing shall be conclusive and binding on the Parties.  If the Senior Officers cannot resolve such dispute within such [****] or such other period as agreed by the Senior Officers, then subject to Section 7.4.4, such dispute will be resolved as follows: [****].

7.4.4Limitations on Authority.  Without limitation of the foregoing, the Parties hereby agree that Legal Disputes and matters explicitly reserved to the consent, approval or other decision-making authority of one or both Parties, as expressly provided in this Agreement, are outside the jurisdiction and authority of the Joint Committees, including [****].

7.4.5Alliance Managers.  Each Party shall appoint a person(s) who shall oversee contact between the Parties for all matters between meetings of the Joint Committees and shall have such other responsibilities as the Parties may agree in writing after the Effective Date, which person(s) may be replaced at any time by notice in writing to the other Party (each an “Alliance Manager”).  The Alliance Managers shall work together to manage and facilitate the communication between the Parties under this Agreement, including the resolution (in accordance with the terms of this Agreement) of issues between the Parties that arise in connection with this Agreement.  The Alliance Managers shall not have final decision-making authority with respect to any matter under this Agreement.

7.4.6Discontinuation; Disbandment; Annual Reports.  Subject to the remainder of this Section 7.4.6 or as otherwise expressly set forth in this Agreement, each Joint Committee shall continue to exist until the Parties mutually agree to disband the applicable Joint Committee.  Upon such mutual agreement (a) the applicable Joint Committee shall disband, have no further responsibilities or authority under this Agreement and will be considered dissolved by the Parties, (b) any requirement of a Party to provide Information or other materials to such Joint Committee shall be deemed a requirement to provide such Information or other materials to the other Party and, (c) with respect to any matter that is subject to the review or approval by such Joint Committee hereunder, after consultation with the other Party and taking the other Party’s comments, if any, into consideration in good faith, the Party with decision-making authority with respect to such matter as set forth in Section 7.4.3 shall have the right to decide such matter.  

ARTICLE 8
PAYMENTS AND RECORDS

8.1Upfront Payment.  Within [****] following the Effective Date, PARTNER shall pay REGENX a nonrefundable and non-creditable upfront amount equal to Three Hundred Seventy Million Dollars ($370,000,000).  

8.2Milestones.  

8.2.1Development and Regulatory Milestones.  In partial consideration of the obligations imposed on REGENX and rights granted to PARTNER hereunder and under the Penn Sublicense Agreement, PARTNER shall pay to REGENX the following one-time payments within [****] after the achievement of each of the following milestone events by or on behalf of the Parties, any of their Affiliates or any Sublicensee in activities under this Agreement during the Term with respect to the applicable Licensed Product for use in the Licensed 

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Field, which shall be nonrefundable, non-creditable and fully earned upon the achievement of the applicable milestone event: 

		
	
Milestone Event (nAMD)
	
Milestone Payment

	
[****]
	
[****]

	
[****]
	
[****]

	
[****]
	
[****]

	
[****]
	
[****]

 

		
	
Milestone Event (DR)
	
Milestone Payment

	
[****]
	
[****]

	
[****]
	
[****]

	
[****]
	
[****]

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[****]
	
[****]

 

		
	
Milestone Event (Additional Indication)
	
Milestone Payment

	
[****]
	
[****]

	
[****]
	
[****]

	
[****]
	
[****]

	
[****]
	
[****]

Each of the milestone payments set forth in the tables above will be payable one (1) time only (regardless of the number of Licensed Products or Indications with respect to which, or the number of times with respect to any Licensed Product or Indication, the specified milestone event occurs). 

8.2.2Commercial Milestones.  In partial consideration of the obligations imposed on REGENX and rights granted to PARTNER hereunder and under the Penn Sublicense Agreement, PARTNER shall pay to REGENX the following one-time payments after the achievement of the following milestone events by or on behalf of PARTNER, any of its Affiliates or any Sublicensees in activities under this Agreement during the Term, which shall be nonrefundable, non-creditable and fully earned upon such achievement of the applicable milestone event:

		
	
Milestone Event
	
Milestone Payment

	
(a) [****] Net Sales of any and all Licensed Products for use in the Licensed Field in the Royalty Territory exceed [****].
	
[****]

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Milestone Event
	
Milestone Payment

	
(b) [****] Net Sales of any and all Licensed Products for use in the Licensed Field in the Royalty Territory exceed [****].
	
[****]

	
(c) [****] Net Sales of any and all Licensed Products for use in the Licensed Field in the Royalty Territory exceed [****].
	
[****]

In the event that more than one (1) of the foregoing thresholds set forth in clauses (a) through (c) of this Section 8.2.2 is exceeded [****], PARTNER shall pay to REGENX a separate milestone payment with respect to each such threshold that is exceeded.  Each such milestone payment shall be due within [****] of the end of the [****] in which such milestone was achieved.  For clarity, no amounts will be due for subsequent or repeated achievements of a milestone event in the table above in this Section 8.2.2 for any Licensed Product or Products once such milestone event has already been achieved by any Licensed Product or Products.

8.2.3Determination that Milestones Have Occurred.  PARTNER shall notify REGENX promptly of the achievement of each of the events identified as a milestone in Section 8.2.1 or Section 8.2.2.  In the event that, notwithstanding the fact that PARTNER has not provided REGENX such a notice, REGENX believes that any such milestone has been achieved, it shall so notify PARTNER in writing, and the Parties will work in good faith to resolve such dispute in accordance with Section 14.5.

8.3Royalties.

8.3.1Royalty Rates.  Subject to Section 8.3.3, as further consideration of the obligations imposed on REGENX and rights granted to PARTNER hereunder and under the Penn Sublicense Agreement, commencing upon the First Commercial Sale of a Licensed Product for use in the Licensed Field in any country in the Royalty Territory, PARTNER shall pay to REGENX a royalty on Net Sales of each Licensed Product for use in the Licensed Field in the Royalty Territory during [****] in the Royalty Term for each such Licensed Product in the applicable country in the Royalty Territory, at the following rates:  

		
	
Aggregate Net Sales of Licensed Products in a [****]
	
Royalty Rate

	
For that portion of [****] Net Sales in the Royalty Territory in a [****] equal to or less than [****]
	
[****]

	
For that portion of [****] Net Sales in the Royalty Territory in a[****] greater than [****] but equal to or less than [****]
	
[****]

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Aggregate Net Sales of Licensed Products in a [****]
	
Royalty Rate

	
For that portion of [****] Net Sales in the Royalty Territory in a[****] greater than [****] but equal to or less than [****]
	
[****]

	
For that portion of [****] Net Sales in the Royalty Territory in a [****] greater than [****] 
	
[****]

 

8.3.2Royalty Term.  PARTNER shall have no obligation to pay any royalty with respect to Net Sales of a Licensed Product for use in the Licensed Field in any country in the Royalty Territory after the Royalty Term for such Licensed Product for use in the Licensed Field in such country has expired.  Upon termination of the Royalty Term with respect to a Licensed Product for use in the Licensed Field for a given country in the Royalty Territory, the license grants to PARTNER in Section 9.1 of this Agreement and in Section 2.2 (Sublicense Grant to PARTNER) of the Penn Sublicense Agreement with respect to such Licensed Product in such country shall become fully paid-up, perpetual and irrevocable in such country.

8.3.3Reductions.  Subject to Section 8.3.4, on a [****] and country-by-country basis, during the Royalty Term for a Licensed Product for use in the Licensed Field in a given country in the Royalty Territory, in the event that:

(a)there is no Valid Claim within the Royalty-Bearing Patents that Covers such Licensed Product in a given country in the Royalty Territory during a given [****], then the royalty rates set forth in Section 8.3.1 with respect to such Licensed Product in such country in the Royalty Territory during such [****] shall be reduced by [****]; 

(b)there is (i) a sale of one or more Biosimilar Products with respect to a Licensed Product in a given country in the Royalty Territory and (ii) (x) a decrease in revenue of [****] then the royalty rates set forth in Section 8.3.1 with respect to such Licensed Product in such country in the Royalty Territory shall be reduced by [****] for the remainder of the Royalty Term for such Licensed Product in such country; and 

(c)PARTNER obtains a license or otherwise acquires rights from any Third Party to any Patent or Information that is [****] to Exploit such Licensed Product in a country in the Royalty Territory [****], PARTNER shall be entitled to deduct from [****] payable hereunder in a given [****] with respect to such Licensed Product in such country [****] of the payments (including any upfront payments, milestone payments and royalties) paid to such Third Party during such [****], solely to the extent that such payments are directly attributable or otherwise reasonably allocable to the Exploitation of such Licensed Product in such country (“Third Party Payments”).

8.3.4Maximum Amount of Royalty Reduction.  In no event shall the amounts payable to REGENX under Section 8.3.1 for a Licensed Product be reduced by more than [****] of what would otherwise be due by operation of Section 8.3.1 for a Licensed Product 

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without regard to Section 8.3.3.  [****].

8.3.5Royalty Payments and Reports.  PARTNER (a) shall provide REGENX, no later than [****] after the end of each [****], with a preliminary, good faith estimate of all amounts payable to REGENX pursuant to Section 8.3.1 at the end of such [****] and (b) shall calculate all amounts payable to REGENX pursuant to Section 8.3.1 at the end of each [****], which amounts shall be converted to Dollars, in accordance with Section 8.6.  PARTNER shall provide REGENX, no later than [****] after the end of each [****], with a statement specifying, on a country-by-country basis, [****], in each case attributable to a Licensed Product for use in each Indication of the Licensed Field in each country in the Royalty Territory during the applicable [****] (including such amounts expressed in local currency and as converted to Dollars) and a calculation of the amount of royalty payment due on such Net Sales for such [****].  PARTNER shall pay to REGENX the royalty amounts due with respect to a given [****] within [****] after the end of such [****].  Without limitation of the generality of the foregoing, PARTNER shall require its Affiliates and Sublicensees to account for their Net Sales and to provide such reports with respect thereto, as if such sales were made by PARTNER. 

8.4United States Profit and Loss Share.  Each Party will receive its respective portion of the United States Profit and Loss Share set forth in Schedule 8.4 determined on a [****] basis and without regard to whether there is a net profit or net loss with respect to any Licensed Product for use in the Licensed Field in the United States for such [****].  

8.5Calculation and Payment of US Net Sales, Allowable US Expenses and Allowable Development Expenses Share. 

8.5.1Reports.  Each Party shall prepare and deliver to the other Party the applicable periodic reports specified below: 

(a)no later than [****] after the end of each [****] during which a Party performs any activities with respect to which Allowable Development Expenses or Allowable US Expenses are incurred by such Party, or during which a Party Manufactures or has Manufactured Commercial Supply, each Party shall provide to the other Party a preliminary non-binding written report summarizing the material Development or Commercialization activities undertaken by such Party under this Agreement during such [****], together with a preliminary, non-binding good faith estimate of (i) Allowable US Expenses and Reimbursable Development Expenses incurred by such Party during such [****] and (ii) US Net Sales;

(b)within [****] after the end of each [****] during which a Party performs any activities with respect to which Reimbursable Development Expenses or Allowable US Expenses are incurred by such Party, each Party shall provide to the other Party a written report summarizing the material Development or Commercialization activities undertaken by such Party under this Agreement during such [****], together with a statement of Allowable US Expenses and Reimbursable Development Expenses incurred by such Party during such [****];

(c)within [****] after the end of each [****] commencing with the [****] in which the First Commercial Sale of any Licensed Product for use in the Licensed Field occurs in the United States, PARTNER shall provide to REGENX a written report setting 

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forth [****]; 

(d)within [****] after the end of each [****], PARTNER shall provide to REGENX a written report setting forth [****]. In the event that, based on PARTNER’s audited financials for such [****], any adjustments or reconciliations with respect for amounts reported in prior  [****] are recognized in such [****], PARTNER shall notify REGENX without undue delay and any reconciliation payments shall be addressed in the [****] in which they are identified;

(e)within [****] after the end of each [****] for which a report is provided pursuant to Section 8.5.1(a) or Section 8.5.1(c), (i) the Parties shall prepare a written report combining the information reported by each Party pursuant to this Section 8.5.1 and showing the calculation of any payments to be made by the Parties for such [****] (including showing the sharing of (x) total Reimbursable Development Expenses, (y) total Allowable US Expenses of the Parties and (z) US Net Sales) and, if applicable, providing for the netting of such payments and (ii) the Party to whom payment is owed under such report in accordance with Section 8.5.2 shall provide an invoice to the other Party consistent with such agreed upon report.  

8.5.2Payments.  Within [****] following issuance of the invoice delivered by the owed Party pursuant to Section 8.5.1(e), the Parties shall make such payments to one another in accordance with Section 8.6 as may be necessary to achieve the sharing of Reimbursable Development Expenses in accordance with Section 3.3 and the sharing of US Net Sales and Allowable US Expenses with respect to Licensed Products for use in the Licensed Field in the United States provided for in Section 8.4. In the event that, based on a Party’s [****], any adjustments or reconciliations with respect to amounts reported in prior [****] are recognized in such [****], the relevant Party shall notify the other Party without undue delay and then the Parties shall make reconciling payments to one another no later than [****] after the end of the [****] in which such adjustments or reconciliations were recognized, if and as necessary to ensure that each Party receives for such [****] its share of US Net Sales and bears its share of Allowable US Expenses in accordance with Section 8.4 and bears its share of Reimbursable Development Expenses in accordance with Section 3.3.  

8.5.3General Principles.  In no event shall the same costs and expenses be included more than once in calculating the reconciliation of Net Sales, Allowable US Expenses and Reimbursable Development Expenses, collectively, with respect to any [****], even if such costs and expenses could be applied to either reconciliation of Allowable US Expenses, Net Sales or Reimbursable Development Expenses. 

8.5.4FTE Records and Calculations.  Each Party shall record and account for FTE efforts that are included in Reimbursable Development Expenses and Allowable US Expenses in accordance with this Agreement and in the same manner as used for other products developed by such Party.  Each Party shall report such FTE effort to the JDC, JCC or JMC, as applicable, if requested (such request not to be more than on a [****] basis).  

8.6Mode of Payment; Offsets.  All payments to either Party under this Agreement shall be made by deposit of Dollars in the requisite amount to such bank account as the receiving Party may from time to time designate by notice to the paying Party.  For the purpose 

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of calculating any sums due under, or otherwise reimbursable pursuant to, this Agreement (including the calculation of Net Sales expressed in currencies other than Dollars), a Party shall convert any amount expressed in a foreign currency into Dollar equivalents using its, its Affiliate’s or Sublicensee’s standard conversion methodology consistent with Accounting Standards. Each Party shall have the right to offset any payment that is owed by the other Party but not paid against any payments owed by the first Party pursuant to Section 8.5.2, if any, under this Agreement.  

8.7Reimbursement.  For all costs for which a Party (the “Owing Party”) is obligated to reimburse the other Party (the “Owed Party”) pursuant to this Agreement for which no specific provision is made hereunder for such payment, the Owed Party shall send to the Owing Party an invoice for such amount within [****] of the last day of a [****] during which Owed Party determines that such amount is payable by the Owing Party, which invoice shall include a reference to the section of this Agreement under which the Owed Party is requesting reimbursement or payment and be accompanied by reasonable documentation of the incurrence or accrual of the costs to be reimbursed.  Payment with respect to each such invoice shall be due within [****] after receipt by the Owing Party thereof and shall be made in accordance with Section 8.6; provided, however, that if the Owing Party in good faith disputes any portion of any such invoice, it shall pay the undisputed portion and shall provide the Owed Party with written notice of the disputed portion and its reasons therefor, and the Owing Party shall not be obligated to pay such disputed portion unless and until such dispute is resolved in favor of the Owed Party.  The Parties shall use good faith efforts to resolve any such disputes promptly.

8.8Finance Working Group.  With respect to the financial reporting activities between the Parties, the JDC will establish a finance working group (the “Finance Working Group”) to provide support for review and discussion by the JDC of Budgets pursuant to Section 7.1.2 and by the JMC pursuant to Section 7.3.3 and coordinate the activities and reporting by the Parties as set forth in Section 8.5 through Section 8.7 and to assist the JCC in its responsibilities with respect to the review and resolution of financial matters.  In particular, the Finance Working Group will:

8.8.1facilitate the creation of each Budget pursuant to the Development Plan and the Commercialization Plans; 

8.8.2reconcile financial and accounting matters between the Parties;

8.8.3initiate and execute an effective and efficient revenue and cost-sharing process (cross-charges);

8.8.4review and recommend for the Parties’ consideration modifications to the FTE Rate and tracking of FTE Costs;

8.8.5cooperate to ensure that all Budgets for a [****] (or any other given period) can be interpreted for the purposes of both Parties’ internal financial and audit reporting requirements, including each Party’s fiscal year reporting;

8.8.6implement a series of reporting requirements for actual and forecasted financial information, available at times to be agreed by the Parties through the Finance Working Group;

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8.8.7monitor the Budget, expense and revenue reporting requirements between the Parties related to Licensed Products to ensure that each Party is able to comply with its respective internal financial and audit reporting requirements and, as appropriate, recommending to the JCC, JDC or JMC, as applicable, for approval, changes to the reporting requirements under this Agreement; and

8.8.8undertake such other tasks as may be necessary or desirable with respect to the calculation, implementation and reporting for United States Profit and Loss Share.  

8.9Taxes. 

8.9.1General.  Any amounts due to be paid to a Party (the “Recipient”) hereunder (each, a “Payment”) shall be paid free and clear of any and all taxes (which, for clarity, shall be the responsibility of the paying Party (the “Payor”)), except for any withholding taxes required by Applicable Law.  Except as provided in this Section 8.9, Recipient shall be solely responsible for paying any and all taxes (other than withholding taxes required by Applicable Law to be deducted from Payments and remitted by Payor) levied on account of, or measured in whole or in part by reference to, any Payments it receives.  Payor shall deduct or withhold from the Payments any taxes that it is required by Applicable Law to deduct or withhold.  Notwithstanding the foregoing, if Recipient is entitled under any applicable tax treaty to a reduction of rate of, or the elimination of, applicable withholding tax, it may deliver to Payor or the appropriate Governmental Authority (with the assistance of Payor to the extent that this is reasonably required and is requested in writing) the prescribed forms necessary to reduce the applicable rate of withholding or to relieve Payor of its obligation to withhold such tax and Payor shall apply the reduced rate of withholding or dispense with withholding, as the case may be; provided that Payor has received evidence of Recipient’s delivery of all applicable forms (and, if necessary, its receipt of appropriate governmental authorization) at least [****] prior to the time that the Payments are due.  If, in accordance with the foregoing, Payor withholds any amount, it shall pay to Recipient the balance when due, make timely payment to the proper taxing authority of the withheld amount and send to Recipient proof of such payment within [****] following such payment.  In the event that a government authority retroactively determines that a payment made by Payor to Recipient pursuant to this Agreement should have been subject to withholding or similar (or to additional withholding or similar) taxes, and Payor remits such withholding or similar taxes to the government authority, including any interest and penalties that may be imposed thereon (together with the tax paid, the “Amount”), Payor will have the right (a) to offset the Amount against future payment obligations of Payor under this Agreement, (b) to invoice Recipient for the Amount (which shall be payable by Recipient within [****] of its receipt of such invoice) or (c) to pursue reimbursement of the Amount by any other available remedy.

8.9.2Gross Up.  If either Party assigns this Agreement to an Affiliate or Third Party (the “Assigning Party”), sublicenses any rights granted to it hereunder or undergoes a Change of Control and, as a result of such assignment, sublicense or Change of Control, Payments made hereunder are subject to additional withholding tax, the Assigning Party shall be responsible for the resulting additional withholding taxes; provided, however, that if the non-Assigning Party derives a tax benefit (including through the use of foreign tax credit) determined on a with and without basis as a result of such additional withholding, then such non-Assigning Party shall promptly reimburse Assigning Party for the amount of such benefit; provided, further, 

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that the non-Assigning Party shall take all commercially reasonable actions necessary to obtain any tax benefit (including through the use of foreign tax credit) with respect to such additional withholding taxes and to defend such benefit in a tax audit; provided, further, that the amount of additional withholding tax shall be determined by taking into account the reduction in the rate of, or the elimination of, the withholding tax pursuant to a tax treaty to which the non-Assigning Party would be entitled had it claimed such benefit under the tax treaty.  For purposes hereof, “tax benefit” shall mean any refund or credit of taxes to be paid or reduction in the amount of taxes which otherwise would be owed by the non-Assigning Party, as applicable, in each case computed at the highest marginal tax rates applicable to non-Assigning Party.

8.9.3Value Added Tax.  Notwithstanding anything contained in Section 8.9.1 or Section 8.9.2, this Section 8.9.3 shall apply with respect to value added tax (“VAT”).  All Payments are exclusive of VAT.  If any VAT is chargeable in respect of any Payments, Payor shall pay VAT at the applicable rate in respect of any such Payments following the receipt of a VAT invoice in the appropriate form issued by Recipient in respect of those Payments, such VAT to be payable on the later of the due date of the payment of the Payments to which such VAT relates and [****] after the receipt by Payor of the applicable invoice relating to that VAT payment, but Payor shall not reduce any Payment for the payment of VAT.  If the VAT originally paid or otherwise borne by Payor are in whole or in part subsequently determined not to have been chargeable, all necessary steps will be taken by Recipient to receive a refund of the undue VAT from the applicable Governmental Authority or other fiscal authority and any amount of undue VAT repaid by such authority to Recipient will be transferred to Payor within [****] of receipt.

8.10Interest on Late Payments.  If any payment due to either Party under this Agreement is not paid when due, then such paying Party shall pay interest thereon (before and after any judgment) at an annual rate (but with interest accruing on a daily basis) of [****] (or the maximum allowed by Applicable Law, if less), such interest to run from the date on which payment of such sum became due until payment thereof in full together with such interest. 

8.11Financial Records.  Without limitation of Section 8.5.1, each Party shall, and shall cause its Affiliates and require its and their Sublicensees to, keep complete and accurate financial books and records pertaining to the Development, Process Development, Manufacture and Commercialization of a Licensed Product hereunder, including books and records of [****], in sufficient detail to calculate and verify all amounts payable hereunder.  Such books and records shall be retained by such Party and its Affiliates (and with respect to PARTNER, its Sublicensees) until the later of (a) [****] after the end of the period to which such books and records pertain, (b) [****] after the submission of any financial report to which such books and record pertain required to be made to the other Party under this Agreement or to a Third Party Licensor under an applicable Third Party License Agreement, (c) the expiration of the applicable tax statute of limitations (or any extensions thereof) and (d) for such period as may be required by Applicable Law.

8.12Audit.  At the request of the other Party, the GSK Licensor or the Penn Licensor, each Party shall, and shall cause its Affiliates to (and in the case of PARTNER, shall require its Sublicensees to), permit an independent public accounting firm of nationally recognized standing designated by the other Party and reasonably acceptable to the audited Party, [****], to audit the books and records maintained pursuant to Section 8.11 to ensure the accuracy of all 

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reports and payments made hereunder.  Such examinations may not (a) be conducted for any [****], (b) be conducted more than once in any [****] period (unless a previous audit during such [****] period revealed an underpayment with respect to such period) or (c) be repeated for any [****].  The accounting firm shall disclose to the auditing Party only whether the reports are correct or not, and the specific details concerning any discrepancies.  No other information shall be shared.  Except as provided below, the cost of this audit shall be borne by the auditing Party, unless the audit reveals a variance of more than [****] from the reported amounts or [****], in which case the audited Party shall bear the cost of the audit.  Unless disputed pursuant to Section 8.13 below, if such audit concludes that (x) additional amounts were owed by the audited Party, the audited Party shall pay the additional amounts, with interest from the date originally due as provided in Section 8.10, or (y) excess payments were made by the audited Party, the auditing Party shall reimburse such excess payments, in either case ((x) or (y)), within [****] after the date on which such audit is completed by the auditing Party.  

8.13Audit Dispute.  In the event of a dispute with respect to any audit under Section 8.12, REGENX and PARTNER shall work in good faith to resolve the disagreement.  If the Parties are unable to reach a mutually acceptable resolution of any such dispute within [****], the dispute shall be submitted for resolution to a certified public accounting firm jointly selected by each Party’s certified public accountants or to such other Person as the Parties shall mutually agree (the “Auditor”).  The decision of the Auditor shall be final and the costs of such arbitration as well as the initial audit shall be borne between the Parties in such manner as the Auditor shall determine.  Not later than [****] after such decision and in accordance with such decision, the audited Party shall pay the additional amounts, with interest from the date originally due as provided in Section 8.10, or the auditing Party shall reimburse the excess payments, as applicable.

ARTICLE 9
LICENSES; INTELLECTUAL PROPERTY

9.1License Grant to PARTNER.  Subject to the terms and conditions of this Agreement, including Section 9.2, REGENX hereby grants to PARTNER an exclusive, sublicensable, with the right to sublicense through multiple tiers (pursuant to Section 9.4), non-transferable (except as provided in Section 14.3), royalty-bearing, worldwide license or sublicense (as applicable) under REGENX Technology and Joint Technology to Exploit Licensed Compounds and Licensed Products solely for use in the Licensed Field in the Territory. 

9.2[****].  Except for the rights and licenses specified in Section 9.1, no license or other rights are granted to PARTNER under this Agreement under any REGENX Technology or other intellectual property of REGENX, excluding the Penn Patents, whether by implication, estoppel, or otherwise and whether such intellectual property is subordinate, dominant, or otherwise useful for the practice of the REGENX Technology as licensed under Section 9.1.  Notwithstanding anything to the contrary in this Agreement, but subject to ARTICLE 6, REGENX may use and permit others to use, and PARTNER shall not be granted the right under this Agreement to use or to grant others the right to use, the REGENX Technology for any research, Development, Commercialization, Manufacturing or other purposes, or otherwise practice the REGENX Technology, outside of the Licensed Field.  [****]

9.3Government Rights.  PARTNER acknowledges that the United States government retains certain rights in certain GSK Patents funded in whole or part under any contract, grant, or similar agreement with a federal agency.  Any rights granted in this Agreement, including 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.

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9.4Sublicensing

9.4.1The license granted pursuant to Section 9.1 is sublicensable by PARTNER to any of its Affiliates or Third Parties; provided that any such sublicense must comply with the provisions of this Section 9.4 (including Section 9.4.2).

9.4.2The right to sublicense granted to PARTNER under this Agreement is subject to the following conditions:

(a)PARTNER may only grant sublicenses pursuant to a written sublicense agreement with the Sublicensee.  Any further sublicenses granted by any Sublicensees (to the extent permitted hereunder) must comply with the provisions of this Section 9.4 (including this Section 9.4.2) to the same extent as if PARTNER granted such sublicense directly.

(b)In each sublicense agreement, the Sublicensee must be required to comply with the applicable provisions of this Agreement, to the same extent as PARTNER has agreed.

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

(d)Within [****] after entering into a sublicense or an amendment thereof, [****].

(e)PARTNER’s execution of a sublicense agreement will not relieve PARTNER of any of its obligations under this Agreement except to the extent such Sublicensee satisfies such obligations on behalf of PARTNER.  Notwithstanding the exception in the foregoing sentence, PARTNER is and shall remain [****] to REGENX for all of PARTNER’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 PARTNER, and, PARTNER will be deemed to be in breach of this Agreement, as applicable, as a result of such act or omission.

9.5License Grant to REGENX

9.5.1Subject to the terms and conditions of this Agreement, PARTNER hereby grants to REGENX and its Affiliates a non-exclusive, sublicensable, royalty-free, worldwide license or sublicense (as applicable) under the PARTNER Patents and the PARTNER Know-How solely for purposes of performing REGENX’s obligations under this Agreement.

9.5.2PARTNER hereby grants to REGENX a non-exclusive, worldwide, royalty-free, transferable, sublicensable (solely to the extent necessary to satisfy its obligations under the GSK Agreement), irrevocable, perpetual license to use any [****]; provided that REGENX shall solely be permitted to exercise this license to the extent necessary to satisfy its obligations under the GSK Agreement. 

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9.6Section 365(n) of the Bankruptcy Code

9.6.1Applicability of 11 U.S.C. § 365(n).  All intellectual property granted or licensed under or pursuant to this Agreement, including all rights and licenses to use improvements or enhancements developed during the Term, are intended to be, and shall otherwise be deemed to be, for purposes of the Bankruptcy Code or any analogous provisions in any other country or jurisdiction, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code.  The Parties agree that the licensee of such intellectual property under this Agreement shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code, including Section 365(n) of the Bankruptcy Code, or any analogous provisions in any other country or jurisdiction.  All of the rights granted to either Party under this Agreement shall be deemed to exist immediately before the occurrence of any bankruptcy case in which the other Party is the debtor.

9.6.2Rights of non-Debtor Party in Bankruptcy.  If a bankruptcy proceeding is commenced by or against either Party under the Bankruptcy Code or any analogous provisions in any other country or jurisdiction, the non-debtor Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any intellectual property and all embodiments of such intellectual property, which, if not already in the non-debtor Party’s possession, shall be delivered to the non-debtor Party within [****] of such request; provided that the debtor Party is excused from its obligation to deliver the intellectual property to the extent the debtor Party continues to perform all of its obligations under this Agreement and the Agreement has not been rejected pursuant to the Bankruptcy Code or any analogous provision in any other country or jurisdiction.  

9.7Obligations Under Third Party Agreements.  PARTNER acknowledges that certain REGENX Technology is or will be licensed to REGENX pursuant to the applicable Third Party License Agreements (the “Sublicensed IP”) and will be sublicensed to PARTNER hereunder.  [****].  Notwithstanding any provision in this Agreement to the contrary, REGENX shall be solely responsible for all payments that may be due and payable by REGENX to any Third Party, including the REGENX Licensors, under any Third Party Agreements. 

9.8Ownership and Disclosure of Intellectual Property

. 

9.8.1Ownership of Technology.  As between the Parties, (a) REGENX shall solely own and retain all right, title and interest in and to any and all REGENX Collaboration Know-How and REGENX Collaboration Patents, (b) subject to Section 9.8.3, PARTNER shall solely own and retain all right, title and interest in and to any and all PARTNER Collaboration Know-How and PARTNER Collaboration Patents, and (c) each Party shall solely own and retain all other Information, inventions, Patents and other intellectual property rights that are owned or otherwise Controlled (other than pursuant to the license grants in this Agreement) by such Party or its Affiliates or its or their respective (sub)licensees or Sublicensees, as applicable, 

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outside of this Agreement.  

9.8.2Ownership of Joint Patents and Joint Know-How.  Subject to Section 9.8.3, as between the Parties, each of REGENX and PARTNER shall own an equal, undivided interest in and to any and all Joint Know-How and Joint Patents.  In the event that any issues, objections or rejections arise concerning obviousness-type double patenting in the United States involving the Joint Patents, the Parties shall reasonably cooperate with each other to resolve or take any action necessary to overcome any such issues, objections or rejections.  

9.8.3Ownership of REGENX NAV Platform Patents and REGENX NAV Platform Know-How.  As between the Parties, REGENX shall solely own and retain all right, title and interest in and to any and all REGENX NAV Platform Patents and REGENX NAV Platform Know-How. 

9.8.4United States Law.  The determination of inventorship and whether Information and other inventions are conceived, created, discovered, developed or otherwise made by or on behalf of a Party or its Affiliates and its and their respective (sub)licensees and Sublicensees, as applicable, for the purpose of allocating proprietary rights (including Patent, copyright or other intellectual property rights) therein, shall, for purposes of this Agreement, be made in accordance with the United States patent law and other Applicable Law in the United States irrespective of where such conception, creation, discovery, development or making occurs.  In case of a dispute between the Parties with respect to inventorship that cannot be resolved within [****], the Parties shall, within [****] after the expiration of such [****] period, jointly select a patent attorney registered before the United States Patent and Trademark Office to resolve such matter.  Within [****] after selection of such patent attorney, the Parties will submit such dispute to such patent attorney for resolution of the inventorship thereof under United States patent law and cooperate to facilitate his or her determination thereof.  Notwithstanding the foregoing, the Parties shall during the pendency of such claim proceed to file such Patents, with PARTNER having the right on an interim basis to make such filing until the patent attorney’s decision is rendered.  The decision of such patent attorney with respect to inventorship will be treated as final with respect to the Parties, and his or her decision shall be used for determining the Parties’ respective rights to file, prosecute, maintain and enforce Patents under this ARTICLE 9.  The Parties will share equally the expenses of engaging such patent attorney.  For clarity, the decision of such patent attorney will not be binding with respect to Third Party challenges in court to the inventorship of a given Patent or with respect to the Parties’ response to court challenges to the inventorship of such Patent.

9.8.5Assignment. 

(a)Each Party shall, and does hereby, assign, and shall cause its Affiliates and its and their respective (sub)licensees and Sublicensees, as applicable, to so assign, to the other Party, without additional compensation, such right, title and interest in and to any Information and other inventions as well as any intellectual property rights with respect thereto, as is necessary to fully effect, as applicable, (i) the sole ownership provided for in Section 9.8.3, (ii) the joint ownership provided for in Section 9.8.2, and (iii) any such ownership provided for in Section 9.8.1 if and as applicable; provided that clause (iii) shall not apply to (sub)licensees or Sublicensees except for subcontractors as set forth in Section 9.8.5(b). 

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(b)Each Party shall cause all Persons who perform any activities under this Agreement, including any and all Development activities (including regulatory activities), Manufacturing activities, and Commercialization activities, for, or on behalf of, such Party under this Agreement, or who conceive, create, discover, develop or otherwise make any Information or other inventions by or on behalf of either Party or its Affiliates and its and their respective (sub)licensees and Sublicensees, as applicable, under this Agreement to assign (or if such Party is unable to cause such Person to assign despite such Party using commercially reasonable efforts to negotiate such assignment, then be under an obligation to assign, or, if such Party is unable to cause such Person to agree to such assignment obligation despite such Party using commercially reasonable efforts to negotiate such assignment obligation, then to grant an exclusive license with the right to sublicense through multiple tiers) their rights in any Collaboration Know-How developed or invented by such Person to such Party, except where Applicable Law requires otherwise and except in the case of governmental, not-for-profit and public institutions that have standard policies against such an assignment (in which case, a suitable license or right to obtain such a license shall be obtained).

9.8.6Disclosure.

(a)PARTNER shall provide prompt notice to REGENX, and shall cause its Affiliates and its and their respective (sub)licensees and Sublicensees, as applicable, to so notify, [****].  

(b)PARTNER shall promptly disclose to REGENX in writing, and shall cause its Affiliates and its and their respective (sub)licensees and Sublicensees, as applicable, to so disclose, [****].

(c)Each Party shall promptly disclose to the other Party in writing and shall cause its Affiliates and its and their respective (sub)licensees or Sublicensees, as applicable, to so disclose, the creation, discovery, development, conception, reduction to practice, or otherwise making (each as applicable) of any Collaboration Know-How or Collaboration Patents.

9.8.7Ownership of Product Trademarks.  Subject to Section 13.4.2, as between the Parties, PARTNER shall own all right, title and interest to the Product Trademarks in the Territory. 

9.8.8Ownership of Corporate Names.  As between the Parties, (a) REGENX shall retain all right, title and interest in and to its Corporate Names and (b) PARTNER shall retain all right, title and interest in and to its Corporate Names.

9.8.9REGENX-Penn Jointly Owned Patents.  Notwithstanding anything to the contrary in this Agreement, ARTICLE 5 of the Penn Sublicense Agreement, and not Sections 9.9 through 9.12 of this Agreement, shall govern prosecution, infringement, invalidity or unenforceability defenses or actions of any REGENX Patent that is co-owned by REGENX or its Affiliates, on one hand, and Penn, on the other hand.

9.9Prosecution

9.9.1.

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9.9.1REGENX Prosecution Rights.  As between the Parties, and subject to Section 9.9.3, REGENX shall have the first right, but not the obligation, to Prosecute the REGENX NAV Platform Patents and the GSK Patents.  REGENX shall (a) provide PARTNER with a reasonable opportunity to review and provide comments in connection with such Prosecution, (b) keep PARTNER reasonably informed as to all material developments with respect to such Prosecution, and (c) consider in good faith PARTNER’s comments with respect to such Prosecution.  Notwithstanding the foregoing, if REGENX determines in its sole discretion to abandon or not maintain in any country or jurisdiction of the Territory any Patent subject to Prosecution under this Section 9.9.1, to the extent available and allowable under the applicable Third Party License Agreements, REGENX will provide PARTNER with timely prior written notice of such determination and PARTNER, upon written notice to REGENX, will thereafter have the right, but not the obligation, at its sole discretion [****], to Prosecute such Patent, and PARTNER will thereafter be the “Prosecuting Party” with respect to such Patent for all purposes under this Agreement.

9.9.2PARTNER Prosecution Rights.  As between the Parties, and subject to Section 9.9.3, PARTNER shall have (i) the sole right, but not the obligation, to Prosecute the PARTNER Patents including the PARTNER Collaboration Patents, and (ii) the first right, but not the obligation to Prosecute the REGENX Patents (excluding REGENX NAV Platform Patents and GSK Patents) and Joint Patents.  PARTNER shall (a) provide REGENX with a reasonable opportunity to review and provide comments in connection with the Prosecution of such Patents, and (b) keep REGENX reasonably informed as to all material developments with respect to such Patents and, (c) consider in good faith REGENX’s comments with respect to such Prosecution.  Notwithstanding the foregoing, if PARTNER determines in its sole discretion to abandon or not maintain in any country or jurisdiction of the Territory any such REGENX Patent or Joint Patent, PARTNER will provide REGENX with timely prior written notice of such determination and REGENX, upon written notice to PARTNER, will thereafter have the right, but not the obligation, at its sole discretion [****], to Prosecute such Patent, and REGENX will thereafter be the “Prosecuting Party” with respect to such Patent for all purposes under this Agreement.

9.9.3Third Party Control of Prosecution.  Notwithstanding anything to the contrary herein, the rights and obligations under this Section 9.9 are subject to the rights of the REGENX Licensors other than Penn and the limitations imposed on REGENX, its Affiliates and its and their respective sublicensees that are set forth in the Third Party License Agreements other than the Penn Agreement; provided that if such Third Party License Agreements provide REGENX with an option or right to Prosecute a REGENX Patent under certain conditions, REGENX, if it determines in its sole discretion that exercise of such option or right would be reasonably necessary to effectively manage prosecution of such REGENX Patent, will use good faith efforts to exercise such option or obtain such right so as to allow PARTNER to Prosecute such REGENX Patent pursuant to Section 9.9.2.  

9.9.4Cooperation.  [****].  The non-Prosecuting Party shall, and shall cause its Affiliates and its and their respective (sub)licensees or Sublicensees, as applicable, to, assist and cooperate with the Prosecuting Party, as the Prosecuting Party may reasonably request from time to time, in the Prosecution of Patents under this Section 9.9 in the Territory, including that the non-Prosecuting Party shall, and shall ensure that its Affiliates and its and their sublicensees or Sublicensees, as applicable, (a) offer comments, if any, promptly, (b) provide 

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access to relevant documents and other evidence and make its employees available at reasonable business hours, and (c) execute all such documents and instruments and perform such acts as may be reasonably necessary in order to permit the Prosecuting Party to conduct any such Prosecution; provided, however, that neither Party shall be required to provide legally privileged information unless and until procedures reasonably acceptable to such Party are in place to protect such privilege; [****]. 

9.9.5Patent Listings.  In connection with a Licensed Product, PARTNER shall have the sole right to determine and make all listings or filings with Regulatory Authorities or patent agencies in the Territory with respect to REGENX Patents, PARTNER Patents, and Joint Patents, including as required or allowed in the United States, in the FDA’s Orange Book or Purple Book, or under other international equivalents.  REGENX shall (a) provide to PARTNER all Information, including a correct and complete list of REGENX Patents covering the Licensed Product or otherwise necessary or reasonably useful to enable PARTNER to make such listing or filings with Regulatory Authorities or patent agencies in the Territory with respect to such Patents, and (b) cooperate with PARTNER in connection therewith, including using commercially reasonable efforts to make any submission deadlines, in each case ((a) and (b)), to the extent required or permitted by Applicable Law. 

9.9.6Patent Term Extension and Supplementary Protection Certificate.  With respect to a Licensed Product, and subject to Section 9.9.3, PARTNER shall be responsible for making decisions regarding patent term extensions, including supplementary protection certificates, pediatric exclusivity, and any other extensions that are now or become available in the future, wherever applicable, for REGENX Patents, PARTNER Patents, and any Joint Patents, in any country or other jurisdiction.  PARTNER shall have the sole responsibility of applying for, and REGENX shall have no right to apply for, any extension (including patent term extension, supplementary protection certificate, and pediatric exclusivity) with respect to any Patents in the Territory in connection with the Licensed Product.  PARTNER shall keep REGENX fully informed of its efforts to obtain such extension.  REGENX shall provide prompt and reasonable assistance as reasonably requested by PARTNER and as required under any Applicable Law to obtain any such extension.  [****].

9.9.7Joint Research Agreements.  The Parties acknowledge and agree that this Agreement is, collectively, a “joint research agreement” as defined in 35 U.S.C. 100(h). 

9.10Infringement Actions Against Third Parties. 

9.10.1Notice.  Each Party shall notify the other Party promptly of any alleged or threatened Infringement of any REGENX Patent, PARTNER Patent or Joint Patent in the Licensed Field in the Territory that may come to such Party’s attention.  However, neither Party is under any obligation to search for potential infringers.

9.10.2PARTNER Sole Right.  As between REGENX and PARTNER, PARTNER shall have the sole right, but not the obligation, to prosecute any Infringement with respect to any PARTNER Patent in the Licensed Field in the Territory, as well as any infringement of any PARTNER Patent with respect to a product that is biosimilar to or competes against a 

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Licensed Product in the Licensed Field in the Territory, and PARTNER shall retain control of the prosecution of such claim, suit or proceeding.  In the event PARTNER prosecutes any such Infringement, REGENX shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel [****]; provided that PARTNER shall retain control of the prosecution of such claim, suit, or proceeding.  Subject to Section 9.10.3(b), REGENX shall not assert any Patent in such claim, suit or proceeding, or against the same potential or actual infringer in connection with the same product in a different claim, suit, or proceeding, in each case without PARTNER’s prior written consent.

9.10.3PARTNER First Right. 

(a)As between REGENX and PARTNER, but subject to Section 9.10.6, PARTNER shall have the first right, but not the obligation, to prosecute any Infringement in the Licensed Field in the Territory of any REGENX Patent that is not a GSK Patent, any Collaboration Patent that is not a REGENX NAV Platform Patent, and any Joint Patent. In the event PARTNER prosecutes any such Infringement, REGENX shall have the right to join as a party to such claim, suit or proceeding in the Licensed Field in the Territory and participate with its own counsel [****].

(b)If PARTNER either (i) declines to prosecute an Infringement of any of the Patents set forth in (a) above, (ii) fails to take action with respect to such Infringement within [****] following the first notice provided above with respect to such Infringement, or (iii) if [****] before the deadline, if any, set forth in Applicable Law, PARTNER fails to take action in connection with such Infringement, whichever of the events described in clauses (i)-(iii) come first, then REGENX has the right, but not the obligation, to prosecute such Infringement. In the event REGENX prosecutes such Infringement, PARTNER shall have the right to join as a party to such claim, suit or proceeding in the Territory and participate with its own counsel [****].

(c)[****]. 

(d)PARTNER shall have the first right to make decisions regarding the Opt Out or Opt-In under the Article 83(4) of the Agreement on a Unified Patent Court between the participating Member States of the European Union (2013/C 175/01), with respect to any of the Patents set forth in Section 9.10.3(a), and pay all fees and make all submissions associated with such decisions.  REGENX shall assist PARTNER in such submissions [****], including providing all necessary documents and making all necessary submissions as a Patent owner where applicable.  If REGENX controls the prosecution of an Infringement of any of the Patents set forth in Section 9.10.3(a) above, then REGENX shall have the right to make such decision [****].

(e)Notwithstanding anything to the contrary in this Section 9.10.3, as between the Parties, PARTNER has the first right, but not the obligation, to control the defense of a claim or counterclaim, arising from and related to the prosecution of an Infringement of any of the Patents set forth in Section 9.10.3(a), that challenges the scope, validity, title, or enforceability of any of the Patents set forth in Section 9.10.3(a) above.  If PARTNER either (i) declines to defend such challenge of any of the Patents set forth in Section 9.10.3(a) above, (ii) fails to take action with respect to such challenge within [****] following the first notice 

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provided above with respect to such challenge, or (iii) if [****] before the deadline, if any, set forth in Applicable Law, PARTNER fails to take action in connection with such challenge, whichever of the events described in clauses (i)-(iii) come first, then REGENX has the right, but not the obligation, to defend such challenge [****]. In the event REGENX defends such challenge, PARTNER shall have the right to join as a party to such action, suit or proceeding in the Territory and participate with its own counsel [****].

9.10.4REGENX Sole Right. 

(a)As between REGENX and PARTNER, but subject to Section 9.10.6, REGENX shall have the sole right, but not the obligation, to prosecute any Infringement in the Licensed Field in the Territory of any REGENX Patent that is a GSK Patent, or any REGENX NAV Platform Patent.  In the event REGENX prosecutes any such Infringement, PARTNER shall have the right to join as a party to such claim, suit or proceeding in the Licensed Field in the Territory and participate with its own counsel [****].

(b)[****]. 

(c)REGENX shall have the sole right to make decisions regarding the Opt Out or Opt-In under the Article 83(4) of the Agreement on a Unified Patent Court between the participating Member States of the European Union (2013/C 175/01), with respect to any of the Patents set forth in Section 9.10.4(a), and pay all fees and make all submissions associated with such decisions.  PARTNER shall assist REGENX in such submissions [****], including providing all necessary documents and making all necessary submissions as a Patent owner where applicable.  

(d)Notwithstanding anything to the contrary in this Section 9.10.4, as between the Parties, REGENX has the sole right, but not the obligation, to control the defense of a claim or counterclaim, arising from and related to the prosecution of an Infringement of any of the Patents set forth in Section 9.10.4(a), that challenges the scope, validity, title, or enforceability of any of the Patents set forth in Section 9.10.4(a) above.  

9.10.5Expenses and Recovery.  [****].

9.10.6Third Party Control of Enforcement.  Notwithstanding anything to the contrary herein, the rights and obligations under this Section 9.10 are subject to [****].  

9.10.7Cooperation.  For purposes of this Section 9.10, the Party prosecuting any infringement with respect to a Patent shall be the “Enforcing Party.”  The Parties will cooperate fully in any infringement action pursuant to this Section 9.10, including by making the inventors, applicable records and documents (including laboratory notebooks) with respect to the relevant Patents enforceable under this Section 9.10 and available to the Enforcing Party at the Enforcing Party’s request.  With respect to an action controlled by the applicable Enforcing Party, the other Party shall, and shall cause its Affiliates to, assist and cooperate with the Enforcing Party, as the Enforcing Party may reasonably request from time to time, in connection with its activities set forth in this Section 9.10, including where necessary, furnishing a power of attorney solely for such purpose or joining in, or being named as a necessary party to, such action, providing access 

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to relevant documents and other evidence and making its employees available at reasonable business hours; [****]. In connection with any activities with respect to an Infringement action prosecuted by the applicable Enforcing Party pursuant to this Section 9.10, the Enforcing Party shall (a) consult with the other Party as to the strategy for the prosecution of such claim, suit or proceeding, (b) consider in good faith any comments from the other Party with respect thereto and (c) keep the other Party reasonably informed of any material steps taken and provide copies of all material documents filed, in connection with such action.

9.10.8Right to Settle.  Unless otherwise set forth herein, the Enforcing Party shall have the right to settle such claim; provided that neither Party shall have the right to settle any Infringement litigation (including related defensive claims and counterclaims) under this Section 9.10 with respect to any Patent [****]. Furthermore, the Enforcing Party shall not settle or compromise any claim or Infringement litigation (including related defensive claims and counterclaims) under this Section 9.10 with respect to any Patent [****].

9.10.9Biosimilar Competition.  (i) Subject to this Section 9.10, including Sections 9.10.2, 9.10.3, 9.10.4 and 9.10.6, PARTNER shall have the right, but not the obligation, to prosecute, manage and settle any litigation with respect to Biosimilar Products in the Licensed Field and the Territory and any proceedings associated therewith, in connection with any Patents, including any invalidity, unpatentability or unenforceability challenges, oppositions and post-grant proceedings in connection therewith.  If either Party receives a notice or a copy of an application submitted to the FDA or its foreign counterpart for a Biosimilar Product (a “Biosimilar Application”) for which a Licensed Product is a “reference product” as such term is used in Section 351(i)(4) of the PHSA, or an equivalent under its foreign counterpart, whether or not such notice or copy is provided under any Applicable Laws, or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for Regulatory Approval, such Party shall, within [****], notify the other Party and provide the other Party with copies of such notice or communication to the extent permitted by Applicable Law.  PARTNER shall carry out any such rights and responsibilities of the “reference product sponsor,” as defined in Section 351(l)(1)(A) of the PHSA, for purposes of such Biosimilar Application, provided that PARTNER’s rights to bring an action for patent Infringement under Section 351(l)(6) of the PHSA based on any REGENX Patents, Collaboration Patents or Joint Patents are subject to REGENX’s applicable sole or first rights to bring an action for patent Infringement under Sections 9.10.3 and 9.10.4, and to the rights of the applicable REGENX Licensors and the limitations imposed on REGENX, its Affiliates and its and their respective sublicensees that are set forth in the applicable Third Party License Agreements.  The Parties shall cooperate seeking to obtain access to the Biosimilar Application and related confidential information, including in accordance with Section 351(l)(1)(B)(iii) of the PHSA, if applicable.  If permitted pursuant to Applicable Law, upon one Party’s request, the other Party shall assist the requesting Party in identifying and listing any and all relevant Patents pursuant to Section 351(l)(1)(3)(A) or Section 351(l)(7) of the PHSA, in preparing, pursuant to section 351(l)(3)(C) of the PHSA, a detailed statement regarding the reference product sponsor’s opinion that any such Patent will be infringed and a response to the statement by the filer of the Biosimilar Application concerning validity and enforceability, in negotiating with the filer of the Biosimilar Application pursuant to Section 351(l)(4) of the PHSA, and in selecting Patents enforceable under this Section 9.10 for and conducting litigation pursuant to Section 351(l)(5), Section 351(l)(6), and Section 351(l)(9) of the PHSA, to the extent applicable, and shall cooperate with the requesting Party in responding to relevant communications with 

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respect to such lists and statements from the filer of the Biosimilar Application.  The Parties shall cooperate and assist each other in seeking an injunction against any commercial marketing by the filer of a Biosimilar Application as permitted pursuant to Section 351(l)(8)(B) of the PHSA or in filing an action for infringement against the filer of such Biosimilar Application.

9.11Defense of Infringement Claims.  In the event PARTNER or REGENX becomes aware that PARTNER’s or any of its Affiliates’ or any Sublicensees’ Exploitation of the Licensed Product in the Licensed Field is the subject of a claim for patent infringement by a Third Party, that Party shall promptly notify the other Party, [****].  Unless the Party against whom a Third Party infringement claim is filed seeks indemnification for such claim covered pursuant to ARTICLE 12, subject to compliance with the provisions of this Section 9.11, the alleged infringing Party shall have the sole right, but not the obligation, to defend and control the defense of any such claim, suit or proceeding.  Without limitation of the foregoing, if the alleged infringing Party finds it necessary or desirable to join the other Party as a party to any such action, the other Party shall execute all papers and perform such acts as shall be reasonably required.  Each Party shall keep the other Party reasonably informed of all material developments in connection with any such claim, suit, or proceeding.  [****].  Notwithstanding anything to the contrary herein, the rights and obligations under this Section 9.11 are subject to the rights of the applicable REGENX Licensors and the limitations imposed on REGENX, its Affiliates and its and their respective sublicensees that are set forth in the applicable Third Party License Agreements and the alleged infringing Party shall not settle or compromise any claim for patent infringement (including related defensive claims and counterclaims) under this Section 9.11 with respect to any Patent [****].

9.12Invalidity or Unenforceability Defenses or Actions.  

9.12.1Notice.  Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity, unpatentability or unenforceability of any of the REGENX Patents, PARTNER Patents, or Joint Patents by a Third Party, in each case in the Territory and of which such Party becomes aware.  Notwithstanding anything to the contrary herein, the rights and obligations under this Section 9.12 are subject to the rights of the applicable REGENX Licensors and the limitations imposed on REGENX, its Affiliates and its and their respective sublicensees that are set forth in the applicable Third Party License Agreements.

9.12.2Defense of Patents.  Subject to the terms and conditions of this Agreement, the Prosecuting Party shall have the first right, but not the obligation, to defend and control the defense of the validity, patentability and enforceability of the Patents being Prosecuted by such Prosecuting Party under this Section 9.12 in the Territory.  The non-Prosecuting Party may participate in any such claim, suit, or proceeding in the Territory with counsel of its choice at its own expense; provided that the Prosecuting Party shall retain control of the defense in such claim, suit, or proceeding.  If the Prosecuting Party elects not to defend or control the defense of such Patent (other than a PARTNER Patent) in a claim, suit or proceeding brought in the Territory, or otherwise fails to initiate and maintain the defense of any such claim, suit, or proceeding, then the non-Prosecuting Party may become the controlling Party and conduct and control the defense of any such claim, suit, or proceeding. 

9.12.3Cooperation.  Each Party shall assist and cooperate with the other Party as such other Party may reasonably request from time to time in connection with its 

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activities set forth in this Section 9.12, including by being joined as a necessary party in such claim, suit or proceeding, providing access to relevant documents and other evidence, and making its employees available at reasonable business hours.  In connection with any such defense or claim or counterclaim, the controlling Party shall consider in good faith any comments from the other Party and shall keep the other Party reasonably informed of any material steps taken.  Subject to the other terms and conditions of this Agreement, the controlling Party shall have the right to settle such claim, suit or proceeding under this Section 9.12, provided that the controlling Party shall not settle any such claim, suit or proceeding in a manner that imposes any out-of-pocket costs or liability on, or involves any admission by, the other Party, without the express written consent of such other Party.  Furthermore, the controlling Party shall not settle or compromise any such claim, suit or proceeding under this Section 9.12 with respect to any Patent in a manner that imposes any obligations or other restrictions on an applicable REGENX Licensor, or that has a material adverse effect on the validity, scope of patent claims, or enforceability of any of the GSK Patents, or grants any rights to the GSK Patents, other than any permitted sublicenses, without the applicable REGENX Licensor’s prior written permission as set forth in the applicable Third Party License Agreements. [****]. 

9.13Third Party Patent Rights.  If in the reasonable opinion of either Party, a license under any Patent or other intellectual property right of a Third Party in any country in the Territory is necessary or reasonably useful to Exploit the Licensed Product for use in the Licensed Field in the Territory in accordance with this Agreement (such right, a “Third Party Patent Right”), then the Parties shall meet and discuss the strategy for obtaining such Third Party Patent Right.   The Parties shall negotiate in good faith to reach agreement with respect to such strategy.  If no agreement has been reached after [****] following commencement of such discussions, then [****].  If either Party determines not to enter into such an agreement under the foregoing clauses (a) or (b), then it shall promptly notify the other Party thereof, and the other Party shall thereafter have the right to enter into such an agreement.  Each Party shall ensure that any such license entered into under this Section 9.13 shall be freely sublicensable to the other Party and its Affiliates to enable such other Party and its Affiliates to fully exercise its rights and perform its obligations under this Agreement and shall promptly provide the other Party with a copy of any Third Party agreement entered into under this Section 9.13 with redactions permitted to the extent not reasonably necessary for the other Party to understand its obligations under such agreement or such agreement’s relevance to this Agreement.  If the grant of a sublicense under a Third Party agreement entered into by either Party under this Section 9.13 would result in the other Party having any different or additional obligations or being subject to any additional terms as a result of being a sublicensee under such agreement, the other Party shall have [****] after receipt of a copy of such agreement to notify the Party that entered into the Third Party agreement as to whether it accepts such sublicensed rights.  Notwithstanding anything to the contrary in this Agreement, unless and until the other Party notifies the Party that entered into the Third Party agreement within such [****] period that it wishes to receive a sublicense under the Third Party agreement entered into under this Section 9.13, Information and Patents licensed by the Party that entered into the Third Party agreement from a Third Party will not be deemed “Controlled” by the Party that entered into the Third Party agreement or its Affiliates under this Agreement and the other Party shall not be granted any rights, or have any obligations, under such Third Party agreement. [****].  If in the reasonable opinion of PARTNER, a Third Party Patent Right may relate to the Exploitation of a Licensed Product by PARTNER or its Affiliates, then PARTNER or its Affiliates shall have the sole right, but not the obligation, to challenge the patentability, 

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validity or enforceability of such Patent in any court of competent jurisdiction or before any supra-national, federal, national, regional, state, provincial and local governmental body of competent jurisdiction including the United States Patent and Trademark Office and the European Patent Office. REGENX shall not challenge the patentability, validity or enforceability of such Patent in any court or governmental body without PARTNER’s prior written consent, provided, however, that notwithstanding the foregoing, REGENX will not be prevented from challenging the patentability, validity or enforceability of any such Third Party Patent Right to the extent unrelated to the Licensed Product and the Indications in the Licensed Field.  REGENX shall assist and cooperate with PARTNER as PARTNER may reasonably request from time to time in connection with the activities set forth in this Section 9.13.  

9.14International Nonproprietary Name.  As between the Parties, PARTNER shall have the sole right and responsibility to select the International Nonproprietary Name or other name or identifier for any Licensed Product.  PARTNER shall have the sole right and responsibility to apply for submission to the World Health Organization for the International Nonproprietary Name, and submission to the United States Adopted Names Council for the United States Adopted Name.

9.15Product Trademarks.  PARTNER shall be responsible for the registration, prosecution, and maintenance of the Product Trademarks using counsel of its own choice.  PARTNER shall have the sole right and responsibility to take such action as PARTNER reasonably deems necessary against a Third Party based on any alleged, threatened or actual infringement, dilution, misappropriation or other violation of or unfair trade practices or any other like offense relating to, the Product Trademarks by a Third Party using counsel of its own choice.  PARTNER shall have the sole right and responsibility to defend against and settle any alleged, threatened or actual claim by a Third Party that the use or registration of the Product Trademarks in the Territory infringes, dilutes, misappropriates or otherwise violates any Trademark or other right of that Third Party or constitutes unfair trade practices or any other like offense or any other claims as may be brought by a Third Party against a Party in connection with the use of the Product Trademarks with respect to the Licensed Product for use in the Licensed Field in the Territory using counsel of its choice.  [****].

9.16[****]

ARTICLE 10
CONFIDENTIALITY AND NON-DISCLOSURE

10.1Confidentiality Obligations.  At all times during the Term and for a period of [****] following termination or expiration hereof in its entirety, each Party shall, and shall cause its officers, directors, employees and agents to, keep confidential and not publish or otherwise disclose to a Third Party and not use, directly or indirectly, for any purpose, any Confidential Information furnished or otherwise made known to it, directly or indirectly, by the other Party, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement or the Penn Sublicense Agreement. “Confidential Information” means any confidential and proprietary technical, business or other information provided by or on behalf of one Party to the other Party in connection with this Agreement or the Penn Sublicense Agreement, whether prior to, on or after the Effective Date, including the terms of this Agreement or the Penn Sublicense 

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Agreement (subject to Section 10.2.4 and Section 10.4), confidential and proprietary information relating to any Licensed Product (including the Regulatory Documentation), any Development or Commercialization of any Licensed Product, any confidential and proprietary Information with respect thereto developed by or on behalf of the disclosing Party or its Affiliates (including PARTNER Know-How and REGENX Know-How, as applicable) or the confidential and proprietary scientific, regulatory or business affairs or other activities of either Party.  Notwithstanding the foregoing, (a) Joint Know-How and the terms of this Agreement shall be deemed to be the Confidential Information of both Parties and both Parties shall be deemed to be the receiving Party and the disclosing Party with respect thereto, (b) any Information solely relating to Licensed Products (including the Regulatory Documentation) or the Exploitation thereof ([****]) (“Product Information”) shall be deemed to be the Confidential Information of both Parties and both Parties shall be deemed to be the receiving Party and the disclosing Party with respect thereto and (c) [****] (and REGENX shall be deemed to be the disclosing Party and PARTNER shall be deemed the receiving Party with respect thereto).  Notwithstanding the foregoing, Confidential Information shall not include any information that:

10.1.1is or becomes part of the public domain by public use, publication, general knowledge or the like through no breach of this Agreement or the Penn Sublicense Agreement by the receiving Party;

10.1.2can be demonstrated by documentation or other competent proof to have been in the receiving Party’s possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; provided that the foregoing exception shall not apply with respect to Product Information, Joint Know-How or REGENX NAV Platform Know-How, in each case, generated by the receiving Party with respect thereto as set forth in Section 10.1;

10.1.3is subsequently received by the receiving Party from a Third Party who is not bound by any obligation of confidentiality with respect to such information;

10.1.4has been published by a Third Party or otherwise enters the public domain through no fault of the receiving Party in breach of this Agreement or the Penn Sublicense Agreement; or

10.1.5can be demonstrated by documentation or other competent evidence to have been independently developed by or for the receiving Party without reference to the disclosing Party’s Confidential Information; provided that the foregoing exception shall not apply with respect to Product Information, Joint Know-How or REGENX NAV Platform Know-How, in each case, generated by the receiving Party with respect thereto as set forth in Section 10.1.

Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party.  Further, Confidential Information shall not be considered in the public domain or in the possession of the receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the receiving Party unless the 

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combination of these elements and its principles are in the public domain or in the possession of the receiving Party.

10.2Permitted Disclosures.  Each Party may disclose Confidential Information to the extent that such disclosure is:

10.2.1made in response to a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial and local governmental or regulatory body of competent jurisdiction or, if in the reasonable opinion of the receiving Party’s legal counsel, such disclosure is otherwise required by Applicable Law, including by reason of filing with securities regulators; provided, however, except with respect to securities filings (which are addressed in Section 10.4 below), that as promptly as reasonably practicable and to the extent not prohibited by Applicable Law or judicial or administrative process, the receiving Party shall first have given notice to the disclosing Party and given the disclosing Party a reasonable opportunity to quash such order or to obtain a protective order or confidential treatment requiring that the Confidential Information and documents that are the subject of such order be held in confidence by such court or agency or, if disclosed, be used only for the purposes for which the order was issued; and provided, further, that the Confidential Information disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order;

10.2.2made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with the conduct of a Clinical Trial or any filing, application or request for Regulatory Approval; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information to the extent practicable and consistent with Applicable Law;

10.2.3made by or on behalf of the receiving Party to a patent authority as may be reasonably necessary or useful for purposes of Prosecuting or enforcing a Patent under and in accordance with this Agreement or the Penn Sublicense Agreement; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available; 

10.2.4made by or on behalf of the receiving Party to [****]; provided, however, that such persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the receiving Party pursuant to this ARTICLE 10 (with a duration of confidentiality and non-use obligations as appropriate that is no less than [****] from the date of disclosure); or

10.2.5to allow the receiving Party to exercise its rights or perform its obligations hereunder, provided that such disclosure is covered by terms of confidentiality and non-use at least as restrictive as those set forth herein. 

10.3Use of Name.  

10.3.1General.  Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo or Trademark of the other Party or any of its Affiliates or any of its or their (sub)licensees (or Sublicensees) (or any abbreviation or adaptation 

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thereof) in any publication, press release, marketing and Promotional Material or other form of publicity without the prior written approval of such other Party in each instance.  The restrictions imposed by this Section 10.3 shall not prohibit (a) either Party from making any disclosure identifying the other Party to the extent required in connection with its exercise of its rights or obligations under this Agreement or the Penn Sublicense Agreement and (b) either Party from making any disclosure identifying the other Party that is required by Applicable Law or the rules of a stock exchange on which the securities of the disclosing Party are listed (or to which an application for listing has been submitted).

10.3.2REGENX Names.  PARTNER, its Affiliates and all of their respective employees and agents must not use the name, seal, logo, trademark, or service mark (or any adaptation thereof) of REGENX or the GSK Licensor in any way without the prior written consent of REGENX; provided, however, that PARTNER may acknowledge the existence and general nature of this Agreement and the Penn Sublicense Agreement, subject to ARTICLE 10.

10.3.3PARTNER Names.  REGENX, its Affiliates and all of their respective employees and agents must not use PARTNER’s name, seal, logo, trademark, or service mark (or any adaptation thereof) in any way without the prior written consent of PARTNER; provided, however that REGENX may acknowledge the existence and general nature of this Agreement and the Penn Sublicense Agreement, subject to ARTICLE 10.

10.4Public Announcements.  The Parties have agreed upon the content of one (1) or more press releases which shall be issued substantially in the form(s) attached hereto as Schedule 10.4, the release of which the Parties shall coordinate in order to accomplish such release promptly upon execution of this Agreement.  Neither Party shall issue any other public announcement, press release or other public disclosure regarding this Agreement, the Penn Sublicense Agreement or their respective subject matters without the other Party’s prior written consent, such consent not to be unreasonably withheld, conditioned or delayed, except for any such disclosure that is, in the opinion of the disclosing Party’s counsel, required by Applicable Law or the rules of a stock exchange on which the securities of the disclosing Party are listed (or to which an application for listing has been submitted).  In the event a Party is, in the opinion of its counsel, required by Applicable Law or the rules of a stock exchange on which its securities are listed (or to which an application for listing has been submitted) to make such a public disclosure, such Party shall submit the proposed disclosure in writing to the other Party as far in advance as reasonably practicable (and in no event less than [****] prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon.  In addition, in the event REGENX is, in the opinion of its counsel, required by Applicable Law or the rules of a stock exchange on which its securities are listed (or to which an application for listing has been submitted) to publicly file this Agreement or the Penn Sublicense Agreement, REGENX shall submit its proposed redactions to this Agreement or the Penn Sublicense Agreement, as applicable, in writing to PARTNER as far in advance as reasonably practicable (and in no event less than [****] prior to the anticipated date of disclosure) so as to provide a reasonable opportunity to comment thereon.  REGENX shall incorporate all comments of PARTNER with respect thereto except to the extent inconsistent with Applicable Law, and shall use reasonable efforts to obtain confidential treatment for the terms of this Agreement or the Penn Sublicense Agreement, as applicable, so redacted.  Neither Party shall be required to seek the permission of the other Party to repeat any information regarding the terms of this Agreement, the Penn Sublicense Agreement or any amendment hereto 

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or thereto that has already been publicly disclosed by such Party or by the other Party, in accordance with this Section 10.4; provided that such information remains accurate as of such time and provided the context and form of such disclosure are the same as the previously approved context and form. 

10.5Publications.  

10.5.1Generally.  With respect to the activities under the Development Plan that are not (a) Global Clinical Trials or (b) Development activities solely intended to support Regulatory Approval in any jurisdiction(s) outside the United States, a Party (a “Publishing Party”) will, prior to publishing, publicly presenting or otherwise publicly disclosing any paper, publication, oral presentation, abstract, poster, manuscript or other presentation relating to the results of any such Development activities, provide the other Party (a “Reviewing Party”) an opportunity to review such publication to determine whether such publication contains the Confidential Information of the Reviewing Party.  The Publishing Party will deliver to the Reviewing Party a copy of any such proposed publication or an outline of the proposed oral disclosure at least [****] prior to submission for publication or presentation for review by the Reviewing Party.  The Reviewing Party will have the right, in its sole discretion, to: (i) require the removal of its Confidential Information from any such publication by the Publishing Party; or (ii) request a reasonable delay in publication or presentation in order to protect patentable information.  If the Reviewing Party requests such a delay, the Publishing Party will delay submission or presentation for a period of [****] after its provision of the copy of the proposed publication to enable the filing of one (1) or more patent applications protecting the Reviewing Party’s rights in such information.  In addition, the Publishing Party shall give due regard to comments furnished by the Reviewing Party and such comments shall not be unreasonably rejected.  For all Independent Studies, Global Clinical Trials and Development activities solely intended to support Regulatory Approval in any jurisdiction(s) outside the United States, any proposed publication (whether written, electronic, oral or otherwise) by PARTNER or any of its Affiliates related to activities under this Agreement or the Licensed Products will be at the sole discretion of PARTNER. 

10.5.2Referral to Disclosed Results.  Notwithstanding anything to the contrary herein, each Party has the right to publish (through press releases, scientific journals, or otherwise) and refer to any clinical, regulatory, or research results related to a Licensed Product that have been publicly disclosed by either Party, including referring to the other Party by name as a licensee or licensor, as applicable, of such Publishing Party, which publication or referral by such Party shall not require the prior consent of the other Party.

10.6Return of Confidential Information.  Upon the effective date of the expiration or termination of this Agreement for any reason, either Party may request in writing and the non-requesting Party shall either, with respect to Confidential Information to which such non-requesting Party does not retain rights under the surviving provisions of this Agreement, at the requesting Party’s election, (a) promptly destroy all copies of such Confidential Information in the possession or control of the non-requesting Party and confirm such destruction in writing to the requesting Party or (b) promptly deliver to the requesting Party, at the non-requesting Party’s sole cost and expense, all copies of such Confidential Information in the possession or control of the non-requesting Party.  Notwithstanding the foregoing, the non-requesting Party shall be permitted 

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to retain such Confidential Information (x) to the extent necessary or useful for purposes of performing any continuing obligations or exercising any ongoing rights hereunder and, in any event, a single copy of such Confidential Information for archival purposes and (y) any computer records or files containing such Confidential Information that have been created solely by such non-requesting Party’s automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such non-requesting Party’s standard archiving and back-up procedures, but not for any other uses or purposes.  All Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in Section 10.1.

ARTICLE 11
REPRESENTATIONS, WARRANTIES AND COVENANTS

11.1Mutual Representations and Warranties.  REGENX and PARTNER each represents and warrants to the other, as of the Execution Date, and covenants, that:

11.1.1it is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization and has all requisite power and authority, corporate or otherwise, to execute, deliver and perform this Agreement;

11.1.2the execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby and thereby have been duly authorized by all necessary corporate action and do not violate:  (a) such Party’s charter documents, bylaws or other organizational documents; (b) any agreement, instrument or contractual obligation to which such Party is bound; (c) any requirement of any Applicable Law, subject to compliance with the HSR Act as set forth herein; or (d) any order, writ, judgment, injunction, decree, determination or award of any court or Governmental Authority presently in effect applicable to such Party, subject to compliance with the HSR Act as set forth herein;

11.1.3Subject to ARTICLE 2, this Agreement is a legal, valid and binding obligation of such Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance and general principles of equity (whether enforceability is considered a proceeding at law or equity); and

11.1.4it is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent with the terms of this Agreement or that would impede the diligent and complete fulfillment of its obligations hereunder and thereunder.

11.2Additional Representations and Warranties of REGENX.  REGENX further represents and warrants to PARTNER, as of the Execution Date, that: 

(a)all REGENX Existing Patents are set forth on Schedule 1.188.  All REGENX Existing Patents are subsisting and to the knowledge of REGENX are not invalid or unenforceable in whole or in part, and, except as set forth on Schedule 1.188, REGENX solely owns all right, title and interest in the REGENX Existing Patents.  REGENX has the right to grant the licenses and sublicenses specified herein; 

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(b)except as otherwise disclosed in Schedule 11.2(b): (i)  there are no claims, judgments, or settlements against, or amounts with respect thereto, owed by REGENX or any of its Affiliates relating to the Regulatory Documentation, the REGENX Existing Patents, or the REGENX Know-How; (ii) REGENX has not received any written claim or demand alleging that (A) the REGENX Existing Patents, or the REGENX Know-How are invalid or unenforceable or (B) the Development, Manufacture or Commercialization of a Licensed Compound or Licensed Product for use in the Licensed Field as contemplated herein will violate, infringe, misappropriate or otherwise conflict or interfere with any Patent or other intellectual property or proprietary right owned by any Third Party; 

(c)to the Knowledge of REGENX, no Third Party has any rights, interest, or claim in or to such REGENX Existing Patents in the Licensed Field that are inconsistent with those granted to PARTNER under this Agreement;

(d)to the Knowledge of REGENX, no Person is in a material way infringing or threatening to infringe or misappropriating or threatening to misappropriate the REGENX Existing Patents, the REGENX Know-How, or the Regulatory Documentation;

(e)to the Knowledge of REGENX, REGENX has the right to use all Information, and Patents necessary to conduct the Development activities allocated to REGENX under the Development Plan and to Manufacture any Licensed Compounds and Licensed Products as contemplated herein;

(f)to the Knowledge of REGENX (but, with respect to Patents or other intellectual property or proprietary right in any jurisdiction outside of the US, [****], without any further duty of inquiry), the Development, Manufacture and Commercialization of the Licensed Compounds and Licensed Products (for clarity, including the use of the Delivery System identified in the Development Plan as of the Execution Date in the administration thereof) as contemplated herein would not infringe any Patent (with the exception of invalid claims of a Patent) or other intellectual property or proprietary right of any Person; 

(g)to the Knowledge of REGENX, the conception, development, and reduction to practice of the Regulatory Documentation, the REGENX Existing Patents and REGENX Know-How existing as of the Execution Date have not constituted or involved the misappropriation of trade secrets or other rights or property of any Person;

(h)the REGENX Existing Patents Prosecuted by REGENX and, to the Knowledge of REGENX, all other REGENX Existing Patents, are being diligently prosecuted in the respective patent offices in the Territory in accordance with Applicable Law.  The REGENX Existing Patents have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment;

(i)to the Knowledge of REGENX, each of the REGENX Existing Patents and Penn Patents properly identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such REGENX Existing Patent and Penn Patent is issued or such application is pending;

(j)with respect to the REGENX Existing Patents Prosecuted by REGENX and, to the Knowledge of REGENX, all other REGENX Existing Patents, true, materially complete, and correct copies of:  (i) the file wrapper and other documents and materials relating to the prosecution, defense, maintenance, validity, and enforceability of the REGENX Existing Patents; (ii) all Regulatory Documentation existing as of the Execution Date; and (iii) all material adverse information with respect to the safety and efficacy of the Licensed Compounds and Licensed Products known to REGENX, in each case ((i) through (iii)) that have been requested by PARTNER have been provided or made available to PARTNER prior to the Execution Date;

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(k)to the Knowledge of REGENX, REGENX and its Affiliates have generated, prepared, maintained, and retained all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with good laboratory and clinical practice and Applicable Law, and all such information is true, complete and correct and what it purports to be;

(l)the REGENX Existing Patents and Penn Patents represent all the Patents that REGENX or its Affiliates own, Control or otherwise have rights to as of the Execution Date that Cover the Exploitation of a Licensed Compound or Licensed Product for use in the Licensed Field in the manner contemplated as of the Execution Date, the REGENX Know-How as of the Execution Date represents all the Information that REGENX or its Affiliates own, Control or otherwise has rights to as of the Execution Date that relate to the Exploitation of a Licensed Compound or Licensed Product for use in the Licensed Field in the manner contemplated as of the Execution Date and REGENX solely owns the REGENX Know-How existing as of the Execution Date;

(m)to the Knowledge of REGENX, neither REGENX nor any of its Affiliates, nor any of its or their respective officers, employees, or agents has made an untrue statement of material fact or fraudulent statement to the FDA or any other Regulatory Authority with respect to the Development of the Licensed Products, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority with respect to the Development of the Licensed Compounds or Licensed Products, or committed an act, made a statement, or failed to make a statement with respect to the Development of the Licensed Compounds or Licensed Products that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any analogous laws or policies in the Territory;

(n)to the Knowledge of REGENX, REGENX and its Affiliates have conducted, and their respective contractors and consultants have conducted, all Development of the Licensed Compounds and Licensed Products that they have conducted prior to the Execution Date in material compliance with good laboratory and clinical practice and Applicable Law.  REGENX has conducted, and has caused its contractors and consultants to conduct, any and all pre-clinical and Clinical Trials related to the Licensed Products in material compliance with good laboratory and clinical practice and Applicable Law.  REGENX and its Affiliates have employed Persons with appropriate education, knowledge and experience to conduct and to oversee the conduct of the pre-clinical and Clinical Trials with respect to the Licensed Compounds and Licensed Products;

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(o)Except with respect to the certain GSK Patents described in Section 9.3 and to the Knowledge of REGENX, the inventions claimed or covered by the REGENX Existing Patents (i) were not conceived, discovered, developed, or otherwise made in connection with any research activities funded, in whole or in part, by the federal government of the United States or any agency thereof, (ii) are not a “subject invention” as that term is described in 35 U.S.C. Section 201(f), and (iii) are not otherwise subject to the provisions of the Bayh-Dole Act;

(p)(i) REGENX has implemented confidentiality policies that are materially consistent with industry standards, and (ii) to the Knowledge of REGENX, no material breach of such confidentiality has been committed by any Third Party;

(q)REGENX has made available to PARTNER all Regulatory Documentation requested by PARTNER related to the Licensed Products;

(r)all Third Party License Agreements are listed on Schedule 11.2(r);

(s)(i) the licenses to REGENX in the Third Party Agreements are in full force and effect and by their terms and the Third Party License Agreements are sublicensable to PARTNER as contemplated by this Agreement and the Penn Sublicense Agreement, (ii) REGENX is not in breach under any such Third Party Agreements, nor, to REGENX’s Knowledge, is any counterparty thereto, (iii) REGENX has not received any written notice of breach under any such Third Party Agreements from the counterparty thereto, and (iv) to REGENX’s Knowledge, no facts or circumstances exist that would reasonably be expected to give rise to any such challenge, violation or breach. The rights and obligations of the Parties hereunder are fully consistent with and are not limited in any material respect to such Third Party Agreements;

(t)no provision of any Third Party License Agreement conflicts with PARTNER’s rights, as set forth in Section 9.4 of this Agreement, to grant further sublicenses of the applicable REGENX Technology in compliance with the terms for such permitted further sublicensing under this Agreement, the Penn Sublicense Agreement, and the Third Party License Agreements, as applicable, and through multiple tiers;

(u)there is no Information licensed to REGENX under the Penn Agreement that, to the Knowledge of REGENX, is necessary or reasonably useful for the performance of PARTNER’s obligations, Exploitation of any Licensed Compound or Licensed Product for use in the Licensed Field or exercise of PARTNER’s rights hereunder;

(v)the Processing of Personal Data by REGENX (including, without limitation, any transfer of Personal Data across national borders) in connection with the Licensed Compounds and Licensed Products is and has been in material compliance with Data Security and Privacy Laws in all countries and jurisdictions in the Territory, all privacy related consents and notices that apply to the Licensed Compounds or Licensed Products, and the requirements of any contract or codes of conduct to which REGENX is a party (“Privacy and Security Obligations”).  To the Knowledge of REGENX, REGENX has provided all necessary privacy notices related to research participants and has an appropriate legal basis under Data 

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Security and Privacy Laws to Process all Personal Data in connection with the Licensed Compounds and Licensed Products.  REGENX has developed, implemented and maintains a compliance program, policies and procedures, and training programs to ensure ongoing compliance with the Privacy and Security Obligations.  REGENX has commercially reasonable physical, technical, organizational and administrative security measures and policies in place to protect all Personal Data collected by it or on its behalf from and against unauthorized Processing.  REGENX is and has complied in all material respects with all Privacy and Security Obligations relating to Data Breach reporting and notification obligations;

(w)in the last [****], REGENX has not received written notice of any alleged material violation from a Regulatory Authority or other Third Party of any Privacy and Security Obligations.  To the Knowledge of REGENX, REGENX is not under investigation by any Regulatory Authority for a violation of Data Security and Privacy Laws;

(x)REGENX has disclosed all material adverse events relating to the safety and efficacy of the Licensed Compounds and Licensed Products of which REGENX or any of its Affiliates has any Knowledge as of the Execution Date;

(y)the execution and delivery of this Agreement and the other agreements and instruments contemplated hereby complies with the Privacy and Security Obligations; and

(z)Without limiting any other representation or warranty made by REGENX under this Agreement, to the Knowledge of REGENX, there are no facts or circumstances that exist as of the Execution Date that would reasonably be expected to have an adverse effect in any material respect on the Exploitation of the Licensed Compound or Licensed Product as contemplated under this Agreement that have not been disclosed to PARTNER, including via the [****] data room established by or on behalf of REGENX (or any subfolders thereof) on or prior to the [****] prior to the Execution Date.

11.3Additional Representation and Warranty of PARTNER.  PARTNER has or has access to financial resources sufficient to meet PARTNER’s payment obligations under Section 8.1 and Section 8.2.1 of this Agreement when such obligations become due.

11.4DISCLAIMER OF WARRANTIES.  EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH HEREIN AND IN THE PENN SUBLICENSE AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR ORAL OR EXPRESS OR IMPLIED, INCLUDING ANY CONDITIONS AND WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.

11.5REGENX Covenants.  REGENX hereby covenants to PARTNER as follows: 

11.5.1REGENX will not assign, transfer, convey or grant any license or other rights to its rights, title and interests in or to the REGENX Patents, Penn Patents or 

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REGENX Know-How (or agree to do any of the foregoing) in any way that would conflict with any of the rights or licenses granted to PARTNER under this Agreement;

11.5.2REGENX will not, and will cause its Affiliates not to incur or permit to exist, with respect to any REGENX Patents, Penn Patents or REGENX Know-How, any lien, encumbrance, charge, security interest, mortgage, liability, or other restriction (including in connection with any indebtedness) that would conflict with any of the rights or licenses granted to PARTNER under this Agreement;

11.5.3REGENX will not (a) amend, modify or terminate any Third Party Agreement, (b) breach any such Third Party Agreement or otherwise take or omit any action under any such Third Party Agreement, (c) exercise, waive, release, or assign any rights or claims under any such Third Party Agreement or (d) enter into another agreement with respect to any Penn Patent or GSK Patent (including any rights or obligations related to any sublicensed rights), in each case ((a) through (d)), in a manner that would adversely affect PARTNER’s rights or impose any additional obligations on PARTNER hereunder, or under the Penn Sublicense Agreement, Clinical Supply Agreement or Commercial Supply Agreement, without first obtaining PARTNER’s written consent;

11.5.4if REGENX or its Affiliate receives notice of an alleged breach or default by REGENX or its Affiliate under any Third Party Agreement or any notice asserting a Third Party’s right to (a) terminate such Third Party Agreement or (b) diminish the scope or exclusivity of the licenses granted to REGENX or its Affiliate under any such Third Party Agreement in any way that would conflict with any of the rights or licenses granted to PARTNER under this Agreement or would otherwise adversely affect PARTNER’s rights or impose any additional obligations on PARTNER hereunder, then REGENX will promptly, but in no event less than [****] thereafter, provide written notice thereof to PARTNER; and

11.5.5REGENX will comply with the terms set forth on Schedule 11.5.5.

11.6Mutual Covenants.  Each Party hereby covenants to the other Party that it will, and will ensure that its Affiliates and subcontractors will, obtain written agreements from any and all Persons involved in or performing any Development activities by or on behalf of such Party hereunder that assign, to the extent legally permissible, (or exclusively license, with a right to grant sublicenses) such Person’s rights, title and interests in and to any Information or other intellectual property rights developed or invented in the performance of such activities that specifically relate to the Licensed Compounds, Licensed Products or their use, Manufacture or sale to such Party prior to any such Person performing such activities.

11.7Anti-Bribery and Anti-Corruption Compliance. [****]

11.8Debarment.  [****]

(a)A “Debarred Individual” is an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from providing services in any capacity to a Person that has an approved or pending drug or biological product application.

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(b)A “Debarred Entity” is a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or affiliate of a Debarred Entity.

(c)An “Excluded Individual” or “Excluded Entity” is (A) an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal health care programs such as Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the U.S. Department of Health and Human Services, or (B) is an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration (GSA).

(d)A “Convicted Individual” or “Convicted Entity” is an individual or entity, as applicable, who has been convicted of a criminal offense that falls within the ambit of 21 U.S.C. §335a (a) or 42 U.S.C. §1320a - 7(a), but has not yet been excluded, debarred, suspended or otherwise declared ineligible.

(e)“FDA’s Disqualified/Restricted List” is the list of clinical investigators restricted from receiving investigational drugs, biologics, or devices if the FDA has determined that the investigators have repeatedly or deliberately failed to comply with regulatory requirements for studies or have submitted false Information to the study sponsor or the FDA.

11.9Data Privacy and Security.

11.9.1Covenants.  For all Personal Data collected, Processed, hosted, or transmitted in performance by the Parties of this Agreement, including, but not limited to, in connection with the conduct of the Development activities and Clinical Trials, each Party shall: 

(a)comply at all times with the Data Security and Privacy Laws; 

(b)to the extent permitted by Applicable Law, notify the other Party, as soon as practicable and in any event prior to making the relevant disclosure, if it is obliged to make a disclosure of the Personal Data under Applicable Law;

(c)make timely notification to, and obtain any necessary authorizations from, any applicable Regulatory Authority where required under applicable Data Security and Privacy Laws of its collection and other Processing of Personal Data in order to comply with its obligations under this Agreement;

(d)at all times, act in a manner such that it is not subject to any prohibition or restriction that (i) prevents or restricts it from disclosing or transferring the Personal Data to the other Party, as required under this Agreement; or (ii) prevents or restricts either Party from Processing the Personal Data as envisaged under this Agreement. If either Party becomes aware of any circumstances that it believes, acting reasonably, may give rise to such a prohibition or restriction, it shall promptly notify the other Party of the same and take all reasonable steps, to ensure that it does not impact its performance of its obligations under this Section 11.9.1;

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(e)ensure that all fair Processing or required notices or informed consent have been obtained and are maintained and are sufficient in scope, and that each Party has an appropriate legal basis under Data Security and Privacy Laws, sufficient in scope to enable the other Party to Process the Personal Data as required in order to comply with its obligation under this Agreement to obtain the benefit of its rights and to fulfil its obligations under this Agreement (including the transfer of all applicable Personal Data), in each case, in accordance with the Data Security and Privacy Laws;

(f)implement and maintain reasonable administrative, technical, and physical safeguards designed to (i) maintain the security and confidentiality of the Personal Data; (ii) protect against reasonably anticipated threats or hazards to the security or integrity of the Personal Data; and (iii) protect against unauthorized access to or use of Personal Data; 

(g)notify the other Party promptly, and in any event within [****] of receipt of (i) any correspondence from a data protection regulator in relation to the Processing of Personal Data related to this Agreement, or (ii) a request or notice from a data subject exercising his rights under the Data Security and Privacy Laws, including to access, rectify or delete his Personal Data in relation to the Personal Data Processed under this Agreement; and

(h)refrain from taking actions related to the Processing of the Personal Data that would be reasonably likely to damage or impair the other Party’s reputation.

11.9.2Data Agreements.  At the reasonable request of either Party, the Parties shall cooperate to enter into any necessary joint controller agreements or controller-processor agreements with respect to such Personal Data as necessary to comply with Applicable Law, including the cross-border transfer of Personal Data requirements set forth in the Data Security and Privacy Laws.

11.9.3Security Breach Notification.  Each Party shall notify the other Party by email to [****] or [****], as applicable, immediately, and in any event no later than [****], upon learning of any actual or suspected misappropriation or unauthorized access to, or disclosure or use of the Personal Data collected, Processed, hosted, or transmitted by a Party related to the performance of this Agreement, including the conduct of the Development Plan (a “Data Breach”).  Each Party shall promptly investigate each Data Breach that it becomes aware of or has reason to suspect may have occurred and, in the case of an actual Data Breach, shall, at the other Party’s request, provide reasonable levels of access and information to the other Party in connection with any independent investigation that such Party may desire to conduct with respect to such Data Breach.  Each Party shall cooperate with the other Party in identifying any reasonable steps that should be implemented to limit, stop or otherwise remedy any actual or suspected Data Breach.  Such Party shall perform all remediation efforts required by Data Security and Privacy Laws, and shall be responsible for all liabilities, costs, and expenses associated with the Data Breach.  Neither Party shall make any statements or notifications about the Data Breach to any affected individual, a Regulatory Authority, the public, or any Third Party without the other Party’s prior written approval.

ARTICLE 12
INDEMNITY

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12.1Indemnification of REGENX.  PARTNER shall indemnify REGENX, its Affiliates, and its and their respective directors, officers, employees and agents (collectively, “REGENX Indemnitees”) and defend and save each of them harmless, from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) (collectively, “Losses”) to which any REGENX Indemnitee becomes subject as a result of any and all suits, investigations, claims or demands of Third Parties (collectively, “Third Party Claims”) arising from or occurring as a result of: [****], except, [****], for those Losses for which REGENX has an obligation to indemnify PARTNER pursuant to Section 12.2 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability.  

12.2Indemnification of PARTNER.  REGENX shall indemnify PARTNER, its Affiliates, and its and their respective directors, officers, employees and agents (collectively, “PARTNER Indemnitees”) and defend and save each of them harmless, from and against any and all Losses to which any PARTNER Indemnitee becomes subject as a result of any and all Third Party Claims arising from or occurring as a result of: [****], except, [****], for those Losses for which PARTNER has an obligation to indemnify REGENX pursuant to Section 12.1 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for the Losses. 

12.3Certain Losses.  [****].  If either Party learns of any Third Party Claim with respect to Losses covered by this Section 12.3, such Party shall provide the other Party with prompt written notice thereof.  The Parties shall confer with respect to how to respond to such Third Party Claim and how to handle such Third Party Claim in an efficient manner.  In the absence of such an agreement, each Party shall have the right to take such action as it deems appropriate.

12.4Indemnification Procedures.

12.4.1Notice of Claim.  All indemnification claims in respect of a REGENX Indemnitee or PARTNER Indemnitee shall be made solely by REGENX or PARTNER, respectively (the “Indemnified Party”).  The Indemnified Party shall give the indemnifying Party prompt written notice (an “Indemnification Claim Notice”) of any Losses or discovery of fact upon which such Indemnified Party intends to base a request for indemnification under this ARTICLE 12, but in no event shall the indemnifying Party be liable for any Losses that result from any delay in providing such notice.  Each Indemnification Claim Notice must contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss is known at such time).  The Indemnified Party shall furnish promptly to the indemnifying Party copies of all papers and official documents received in respect of any Losses and Third Party Claims.

12.4.2Control of Defense.  The indemnifying Party shall have the right to assume the defense of any Third Party Claim by giving written notice to the Indemnified Party within [****] after the indemnifying Party’s receipt of an Indemnification Claim Notice.  The assumption of the defense of a Third Party Claim by the indemnifying Party shall not be construed as an acknowledgment that the indemnifying Party is liable to indemnify the Indemnified Party in respect of the Third Party Claim, nor shall it constitute a waiver by the 

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indemnifying Party of any defenses it may assert against the Indemnified Party’s claim for indemnification.  Upon assuming the defense of a Third Party Claim, the indemnifying Party may appoint as lead counsel in the defense of the Third Party Claim any legal counsel selected by the indemnifying Party; provided that it obtains the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld, conditioned or delayed).  In the event that the indemnifying Party assumes the defense of a Third Party Claim, the Indemnified Party shall immediately deliver to the indemnifying Party all original notices and documents (including court papers) received by the Indemnified Party in connection with the Third Party Claim.  Should the indemnifying Party assume the defense of a Third Party Claim, except as provided in Section 12.4.3, the indemnifying Party shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party in connection with the analysis, defense or settlement of the Third Party Claim unless specifically requested in writing by the indemnifying Party.  In the event that it is ultimately determined that the indemnifying Party is not obligated to indemnify, defend or hold harmless the Indemnified Party from and against the Third Party Claim, the Indemnified Party shall reimburse the indemnifying Party for any and all reasonable and verifiable costs and expenses (including attorneys’ fees and costs of suit) and any Losses incurred by the indemnifying Party in accordance with this ARTICLE 12 in its defense of the Third Party Claim.

12.4.3Right to Participate in Defense.  Any Indemnified Party shall be entitled to participate in the defense of such Third Party Claim and to employ counsel of its choice for such purpose; provided, however, that such employment shall be at the Indemnified Party’s sole cost and expense unless (a) the employment thereof has been specifically authorized in writing by the indemnifying Party (in which case, the defense shall be controlled as provided in Section 12.4.2), (b) the indemnifying Party has failed to assume the defense and employ counsel in accordance with Section 12.4.2 (in which case the Indemnified Party shall control the defense) or (c) the interests of the indemnitee and the indemnifying Party with respect to such Third Party Claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under Applicable Law, ethical rules or equitable principles (in which case, the Indemnified Party shall control its defense).

12.4.4Settlement.  With respect to any Losses relating solely to the payment of money damages in connection with a Third Party Claim and that shall not result in the applicable indemnitee(s) becoming subject to injunctive or other relief or otherwise adversely affecting the business of the Indemnified Party in any manner and as to which the indemnifying Party shall have acknowledged in writing the obligation to indemnify the applicable indemnitee hereunder, the indemnifying Party shall have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, on such terms as the indemnifying Party, in its sole discretion, shall deem appropriate.  With respect to all other Losses in connection with Third Party Claims, where the indemnifying Party has assumed the defense of the Third Party Claim in accordance with Section 12.4.2, the indemnifying Party shall have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss; provided that it obtains the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld, conditioned or delayed).  If the indemnifying Party does not assume and conduct the defense of a Third Party Claim as provided above, the Indemnified Party may defend against such Third Party Claim; provided that the Indemnified Party shall not settle any Third Party Claim without the prior written consent of the indemnifying Party (which consent shall not be 

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unreasonably withheld, conditioned or delayed).

12.4.5Cooperation.  Regardless of whether the indemnifying Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall and shall cause each indemnitee to, cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith.  Such cooperation shall include access during normal business hours afforded to the indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Third Party Claim and making indemnitees and other employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder and the indemnifying Party shall reimburse the Indemnified Party for all its, its Affiliates’ and its and their (sub)licensees’ or their respective directors’, officers’, employees’ and agents’, as applicable, reasonable and verifiable out-of-pocket expenses in connection therewith.

12.4.6Expenses.  Except as provided above, the costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party and its Affiliates and its and their (sub)licensees and their respective directors, officers, employees and agents, as applicable, in connection with any claim shall be reimbursed on a [****] basis by the indemnifying Party, without prejudice to the indemnifying Party’s right to contest the Indemnified Party’s right to indemnification and subject to refund in the event the indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party.

12.5Special, Indirect and Other Losses.  EXCEPT (a) IN THE EVENT THE WILLFUL MISCONDUCT OR FRAUD OF A PARTY OR OF A PARTY’S BREACH OF ITS OBLIGATIONS UNDER ARTICLE 10 OR ARTICLE 6, (b) AS PROVIDED UNDER SECTION 14.10, OR (c) TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS ARTICLE 12, (x) NEITHER PARTY NOR ANY OF ITS AFFILIATES OR (SUB)LICENSEES SHALL BE LIABLE IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY SPECIAL OR PUNITIVE DAMAGES OR FOR LOSS OF PROFITS SUFFERED BY THE OTHER PARTY, AND (y) NEITHER THE GSK LICENSOR OR THE PENN LICENSOR SHALL BE LIABLE TO PARTNER, PARTNER’S SUCCESSORS OR ASSIGNS, ANY SUBLICENSEES, OR ANY THIRD PARTY WITH RESPECT TO ANY CLAIM ARISING FROM USE OF THE REGENX TECHNOLOGY OR PENN PATENTS, LICENSED PRODUCTS, AND ANY OR ALL RIGHTS LICENSED UNDER THIS AGREEMENT OR THE PENN SUBLICENSE AGREEMENT FOR THE DEVELOPMENT, TESTING, MANUFACTURE, USE, SALE, COMMERCIALIZATION OR OTHER EXPLOITATION OF LICENSED PRODUCTS.

12.6Insurance.  Each Party shall obtain and carry in full force and effect the minimum insurance requirements set forth herein from an insurance company properly licensed to provide the required insurance.  Such insurance (a) shall be primary insurance with respect to each Party’s own participation under this Agreement, (b) shall be issued by a recognized insurer rated by A.M. Bests [****] (or its equivalent) or better and (c) shall list PARTNER as an additional insured under the General Liability policy.  The types of insurance and minimum limits are set 

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forth below:

(a)Required Coverages.  Each Party shall at all times maintain in force any insurance policy that is required by any Applicable Law and at all times remain fully compliant with any such Applicable Law.

(b)Clinical Trials Insurance.  Effective at least [****] prior to the launch of any Clinical Trial, each Party shall maintain in force Clinical Trial insurance, with a minimum limit of [****] in the aggregate to be maintained in force throughout the life of any such Clinical Trials, such insurance to be effected, maintained and documented to the other Party in compliance with this Agreement and in compliance with any and all local requirements in any territory in which such trials are conducted.

(c)Product Liability Insurance.  Effective at least [****] prior to First Commercial Sale of Licensed Product, each Party shall maintain in force product liability insurance with a minimum limit of [****] in the aggregate.

Certificates of insurance evidencing compliance with the above requirements in this Section 12.6 shall be provided upon request.  The insurance policies shall be under an occurrence form, but if only a claims-made form is available, then the Parties shall continue to maintain such insurance after the expiration or termination of this Agreement for a period of [****] following termination or expiration of this Agreement in its entirety.  Notwithstanding the above, PARTNER shall have the right to self-insure any of the insurance requirements under this Agreement.

ARTICLE 13
TERM AND TERMINATION

13.1Term and Expiration.  Subject to ARTICLE 2, this Agreement shall commence on the Effective Date and, unless earlier terminated in accordance herewith, shall continue in force and effect on a country-by-country basis until (a) in the case of the United States, the later of (i) the one hundred twentieth (120th) day following the completion of any Calendar Quarter in which (A) neither Party nor any of its Affiliates or its or their sublicensees has conducted any Exploitation of a Licensed Compound or Licensed Product in the Licensed Field in the United States, (B) neither Party nor any of its Affiliates or its or their sublicensees incurred any Reimbursable Development Expenses or Allowable US Expenses in connection with the Development, Commercialization or Exploitation of Licensed Compounds or Licensed Products in the Licensed Field in the United States and (C) there is no Development Plan or Commercialization Plan in effect, provided that clauses (A) and (C) both remain true on such one hundred twentieth (120th) day, and (ii) the date on which there is no Royalty-Bearing Patent with respect to any Licensed Product in the United States; and (b) in the case of any country in the Royalty Territory, the date the Royalty Term for a Licensed Product for use in the Licensed Field has expired in such country (the “Term”).

13.2Termination.

13.2.1Termination for Patent Challenge.  In the event that PARTNER or any of its Affiliates voluntarily commences any Challenge of [****], REGENX shall have the right to immediately terminate this Agreement [****] upon written notice to 

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PARTNER.  For the purposes of this Section 13.2.1, “Challenge” shall mean, with respect to a Patent, a challenge to the validity or enforceability of such Patent; provided that Challenge shall not include arguments, or any other statements or allegations, made by or on behalf of PARTNER or its Affiliate that: (a) distinguish the inventions claimed in Patents owned or controlled by PARTNER or its Affiliate from those claimed in such Patent (as applicable) (i) in the ordinary course of ex parte prosecution of such patents or patent applications owned or controlled by PARTNER or its Affiliate, including any reissue or reexamination patents or patent applications, or (ii) in inter partes, post grant review proceedings, oppositions, nullity proceedings, reissue proceedings, reexamination proceedings, and other similar proceedings before the U.S. Patent & Trademark Office or other agency or tribunal in any jurisdiction, or in any arbitration or litigation, wherein such patents or patent applications owned or controlled by PARTNER or its Affiliate have been challenged by Penn, REGENX or REGENX’s Affiliates; (b) are made in connection with a response to a claim or allegation that PARTNER or its Affiliate or any of their respective direct or indirect customers infringes or may infringe any Patents controlled or enforceable by Penn, REGENX, its Affiliates, or any of their respective successors or assigns or (c) relate to the inventorship of inventions claimed in a patent or patent application or as to whether a patent or patent application should or does claim priority to another patent. 

13.2.2Material Breach.  

(a)Breach Notice.  If either Party (the “Non-Breaching Party”) believes that the other Party (the “Breaching Party”) is in Material Breach, then in addition to any other right and remedy the Non-Breaching Party may have, the Non-Breaching Party may deliver notice of such Material Breach to the Breaching Party that specifies the breach and its claim of right to terminate (the “Termination Notice”).  With regard to any Material Breach by PARTNER that constitutes a material breach under the GSK Agreement, PARTNER shall have [****] (the “GSK Notice Period”) following the receipt of such Termination Notice to cure such Material Breach.  With regard to any Material Breach by PARTNER that constitutes a material breach under the Penn Agreement, PARTNER shall have [****] (the “Penn Notice Period”) following the receipt of such Termination Notice to cure such Material Breach.  With regard to any other Material Breach by either Party, the Breaching Party shall have [****] (the “Notice Period”) following the receipt of such Termination Notice to cure such Material Breach, provided that for all Material Breaches other than a payment breach, if such breach cannot be reasonably cured during such [****] period but is capable of cure within [****], then the Breaching Party may submit to the Non-Breaching Party a reasonable cure plan to remedy such Material Breach that is reasonably acceptable to the Non-Breaching Party, and upon such submission, the applicable cure period will automatically be extended for so long as the Breaching Party continues to use commercially reasonable efforts to cure such Material Breach in accordance with such cure plan, but for no more than [****] from receipt of such Termination Notice (subject to the dispute resolution procedures set forth in Section 13.2.2(b) below).  [****].  If the Breaching Party is REGENX and REGENX fails to cure such Material Breach within the applicable cure period set forth above, then, as applicable and subject to Section 13.2.2(b) below, PARTNER may terminate this Agreement and the Penn Sublicense Agreement in their entirety effective on written notice thereof to REGENX.  [****].

(b)Disputes Regarding Material Breach.  In each case other than with regard to a sublicense granted by REGENX to PARTNER under the Penn Agreement or 

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the GSK Agreement, the Breaching Party may dispute occurrence of such Material Breach, and in such case the Breaching Party shall give written notice of such dispute no later than [****] after its receipt of the Termination Notice and the issue of whether the Non-Breaching Party may properly terminate this Agreement on expiration of the applicable cure period will be resolved in accordance with Section 14.5. If as a result of such dispute resolution process, it is determined that the Breaching Party committed a Material Breach and the Breaching Party does not cure such Material Breach within (i) [****] in the case of a failure to make a payment set forth in this Agreement or (ii) [****] in the case of any other Material Breach, as applicable, after the date of such determination, (the “Additional Cure Period”), then such termination will be effective as of the expiration of the Additional Cure Period.  Except for [****], this Agreement will remain in full force and effect during the pendency of any such dispute resolution proceeding and the cure periods set forth in this Section 13.2.2, and any Additional Cure Period, in each case, will be tolled during any such dispute resolution proceeding, such proceeding will not suspend any obligations of either Party hereunder, and each Party will use reasonable efforts to mitigate any damage.  If as a result of such dispute resolution proceeding it is determined that the Breaching Party did not commit such Material Breach (or such Material Breach was cured in accordance with this Section 13.2.2), then no termination will be effective, and this Agreement will continue in full force and effect. With regard to any sublicense granted by REGENX to PARTNER under the Penn Agreement or the GSK Agreement, [****].  The issue of whether the Non-Breaching Party may properly terminate this Agreement on expiration of the applicable cure period will be resolved in accordance with Section 14.5, [****].

(c)Invocation of Termination for Material Breach.  Notwithstanding the foregoing, the Parties agree that termination pursuant to this Section 13.2.2 is a remedy to be invoked only if the breach cannot be adequately remedied through a combination of specific performance and the payment of money damages.

(d)Limitation on Diligence Breach Termination.  Notwithstanding anything to the contrary in this Agreement, in the event a breach by PARTNER of its diligence obligations in [****] the US [****] under Section 3.1.1 or Section 4.3 is determined to constitute a Material Breach and such Material Breach remains uncured in the applicable time period set forth in this Section 13.2.2, REGENX shall be entitled to terminate this Agreement and the Penn Sublicense Agreement solely with respect to the applicable country or countries [****], and this Agreement and the Penn Sublicense Agreement will remain in full force and effect with respect to all other countries in the Territory.  

13.2.3Termination for Convenience.  PARTNER may terminate this Agreement in its entirety at any time after the Effective Date upon [****] prior written notice to REGENX thereof. 

13.2.4Termination for Safety Reasons.  PARTNER may terminate this Agreement in its entirety effective immediately upon written notice to REGENX in the event that PARTNER in good faith believes that it is not advisable for PARTNER to continue to Develop or Commercialize the Licensed Products as a result of a Safety Issue; provided that prior to delivery of such written notice, the Senior Officers shall meet and discuss the alleged Safety Issue in good faith for not less than [****].

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13.2.5Termination for Insolvency.  In the event that either Party (a) files for protection under bankruptcy or insolvency laws, (b) makes an assignment for the benefit of creditors, (c) appoints or suffers appointment of a receiver or trustee over substantially all of its property that is not discharged within [****] after such filing, (d) proposes a written agreement of composition or extension of its debts, (e) proposes or is a party to any dissolution or liquidation, (f) files a petition under any bankruptcy or insolvency act or has any such petition filed against that is not discharged within [****] of the filing thereof or (g) admits in writing its inability generally to meet its obligations as they fall due in the general course, then the other Party may terminate this Agreement and the Penn Sublicense Agreement in their entireties effective immediately upon written notice to such Party.

13.2.6[****]

13.3Rights in Bankruptcy.  All rights and licenses granted under or pursuant to this Agreement by PARTNER or REGENX are and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code.  The Parties agree that the Parties, as licensees of such rights under this Agreement, shall retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction.  The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against either Party under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, the Party hereto that is not a Party to such proceeding shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, which, if not already in the non-subject Party’s possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon the non-subject Party’s written request therefor, unless the Party subject to such proceeding elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under clause (a) above, following the rejection of this Agreement by or on behalf of the Party subject to such proceeding upon written request therefor by the non-subject Party.  

13.4Consequences of Termination.  

13.4.1General.  In the event of a termination of this Agreement pursuant to Section 13.2 (but, for clarity, not a termination of rights sublicensed under the GSK Agreement as described in Section 13.2.6) and subject to the proviso at the end of this Section 13.4.1:

(a)subject to clause (c) below, all of the applicable rights and licenses granted by REGENX to PARTNER hereunder and under the Penn Sublicense Agreement shall immediately terminate; provided that PARTNER and its Affiliates shall have the right to continue to sell their existing inventories of Licensed Product for use in the Licensed Field for a period of not more than [****] after the effective date of the termination of this Agreement or the Penn Sublicense Agreement; provided, further, that, at the end of such [****] period, any remaining inventories of Licensed Product may be purchased by REGENX at a price equal to PARTNER’s Cost of Goods for such Licensed Products;

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(b)the terms of Section 10.6 shall apply; 

(c)upon the request of any Sublicensee, REGENX will enter into a direct license from REGENX to such Sublicensee on the same terms as this Agreement and, as applicable, the Penn Sublicense Agreement, taking into account any difference in license scope, territory, and duration of sublicense grant (each a “New License Agreement”), provided that such Sublicensee is not at the time of such termination in breach of its sublicense agreement.  Under any such New License Agreement between REGENX and such former Sublicensee, such Sublicensee will be required to pay to REGENX the same amounts in consideration for such direct grant as REGENX would have received from PARTNER pursuant to this Agreement and, as applicable, the Penn Sublicense Agreement on account of such Sublicensee’s Exploitation of Licensed Products had this Agreement and the Penn Sublicense Agreement not been terminated.  Under such New License Agreement, REGENX will not be bound by any grant of rights broader than, and will not be required to perform any obligation other than those rights and obligations contained in this Agreement and the Penn Sublicense Agreement and all applicable rights of REGENX set forth in this Agreement and the Penn Sublicense Agreement shall be included in such New License Agreement.  Notwithstanding the foregoing, REGENX will not be obligated to enter into a New License Agreement with a Sublicensee unless such Sublicensee notifies REGENX within [****] after the termination of this Agreement and the Penn Sublicense Agreement that it wishes to enter into a New License Agreement.  All sublicenses granted by PARTNER to its Sublicensees not requested to be converted into a New License Agreement within such [****] period shall terminate; and 

(d)for the avoidance of doubt, all licenses granted by PARTNER to REGENX under this Agreement with regard to the Licensed Back Improvements shall survive any termination of this Agreement; and

(e)PARTNER shall pay all monies then owed to REGENX under this Agreement within [****] of the date of such termination; 

provided that, if termination of this Agreement and the Penn Sublicense Agreement is solely with respect to a country or countries as described in Section 13.2.2(d), then (x) the provisions of this Section 13.4.1 shall only apply with respect to such country or countries; provided, further, that, in all other cases, the provisions of this Section 13.4.1 shall apply with respect to all Terminated Products and all countries and (y) all licenses and other rights granted by REGENX to PARTNER under this Agreement and the Penn Sublicense Agreement shall (i) automatically be deemed to be amended to exclude the right to market, promote, detail, distribute, import, sell, offer for sale, or seek any Regulatory Approval for, such Terminated Product in such terminated country or countries, and (ii) otherwise survive and continue in effect in such terminated country or countries solely for purposes of supporting the Exploitation of the Licensed Compound and Licensed Product in the Licensed Field in the rest of the Territory.

13.4.2Termination by PARTNER for Convenience or by REGENX Due to PARTNER’s Patent Challenge, Material Breach or Insolvency.  Subject to the rights granted to a Sublicensee who is a party to a New License Agreement and the proviso at the end of this Section 13.4.2, in the event of a termination of this Agreement and the Penn Sublicense Agreement by REGENX pursuant to Section 13.2.1, Section 13.2.2 or Section 13.2.5, 

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or by PARTNER pursuant to Section 13.2.3:

(a)[****]; 

(b)On a country-by-country and Terminated Product-by-Terminated Product basis, REGENX will pay to PARTNER a royalty on Net Sales of Terminated Products in the Territory of [****].  For the purposes of this Section 13.4.2, the definitions of “Net Sales” and the terms set forth in Section 8.3 and Sections 8.5 through 8.13 shall apply mutatis mutandis to the calculation, payment, recording and auditing of REGENX’s obligations to make payments under this Section 13.4.2 as they apply to PARTNER under such Sections and, solely for such purpose, each reference in each such Section (and any related definitions) to (i) PARTNER will be deemed a reference to REGENX and (ii) REGENX will be deemed to be a reference to PARTNER. The obligation of REGENX to make any royalty payments with respect to any Terminated Product under this Section 13.4.2 shall terminate on a Terminated Product-by-Terminated Product and country-by-country basis, upon the expiration of the last-to-expire Valid Claim within the [****] that claims (i) the composition of matter of such Terminated Product in such country or (ii) methods of use for the treatment of all Indications for which such Terminated Product has received Regulatory Approval in such country with respect to the specific mode of administration (e.g., subretinal or suprachoroidal) of such Terminated Product;

(c)to the extent not already provided to REGENX under this Agreement, PARTNER shall use reasonable efforts to transfer to REGENX copies of any Information to the extent relating to a Terminated Product (including Product Information relating to such Licensed Product which became a Terminated Product) or included within the [****] and shall use reasonable efforts to provide to REGENX access and rights to Exploit any preclinical and clinical data, safety data and all other supporting data, including pharmacology and biology data, and Product Information, customer lists and customer contact information, in PARTNER’s or its Affiliates’ Control to the extent necessary for REGENX to continue the Development or Commercialization, as applicable, of Terminated Products for use in the Licensed Field; 

(d)PARTNER shall and hereby does, and shall cause its Affiliates to, when and as requested by REGENX, assign to REGENX or is designee all of its right, title and interest in and to (i) each Product Trademark and the goodwill associated therewith and (ii) all Regulatory Documentation (including any Regulatory Approvals, filings and dossiers) solely and specifically related to any Terminated Product then Controlled by PARTNER or any of its Affiliates; provided that if any such Regulatory Documentation or Regulatory Approval is not immediately transferable in a country, PARTNER shall (A) grant REGENX or its designee a right of reference or use to any such Regulatory Documentation or Regulatory Approvals and use reasonable efforts to provide REGENX or its designee with all other benefits of such Regulatory Documentation or Regulatory Approval, as applicable, and (B) provide REGENX or its designee with such assistance and cooperation as necessary or reasonably requested by REGENX to timely transfer such Regulatory Documentation or Regulatory Approval, as applicable, to REGENX or its designee (including sign, and cause its Affiliates to sign, any instruments reasonably requested by REGENX in order to effect the above) or, at REGENX’s option, to enable REGENX to obtain a substitute for such Regulatory Documentation or Regulatory Approval, as applicable, without disruption to REGENX’s Exploitation of a Terminated Product, including, if requested by REGENX at its sole discretion, by appointing REGENX or its designee as the exclusive distributor 

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of a Terminated Product in the Territory and grant REGENX the right to appoint sub-distributors, until such time as all Regulatory Approvals in the Territory with respect to a Terminated Product have been transferred to REGENX or its designee thereto, but not to exceed [****] after the effective date of termination;

(e)unless expressly prohibited by any Regulatory Authority, at REGENX’s written request, PARTNER shall and hereby does, and shall cause its Affiliates to, (i) transfer control to REGENX of any or all Clinical Trials for a Terminated Product being conducted by or on behalf of PARTNER or its Affiliates as of the effective date of termination or (ii) if such transfer is expressly prohibited by the applicable Regulatory Authority, [****], following the effective date of termination; provided that REGENX shall not have any obligation to continue any Clinical Trial unless required by Applicable Law; 

(f)at REGENX’s written request, PARTNER shall, and shall cause its Affiliates and require its and their Sublicensees to, assign to REGENX all Terminated Product Agreements, unless, with respect to any such Terminated Product Agreement, such Terminated Product Agreement expressly prohibits such assignment, in which case PARTNER (or such Affiliate, as applicable) shall cooperate with REGENX in all reasonable respects to secure the consent of the applicable Third Party to such assignment; and

(g)at REGENX’s written request, if REGENX is not supplying Commercial Supply as of the date of such termination and the applicable Terminated Product Agreement(s) related to the supply of Terminated Product have not been assigned to REGENX under Section 13.4.2(f), PARTNER shall use reasonable efforts to supply to REGENX any unsold or unused inventory [****] at PARTNER’s actual, fully-burdened cost (excluding costs for general overhead, communications, operating supplies or other equipment) to Manufacture a Terminated Product until the earlier of [****]; 

(h)provided that, if termination of this Agreement and the Penn Sublicense Agreement is solely with respect to a country or countries as described in Section 13.2.2(d), then the provisions of this Section 13.4.2 shall only apply with respect to the Terminated Products in such country or countries; provided, further that, in all other cases of a termination of this Agreement and the Penn Sublicense Agreement by REGENX pursuant to Section 13.2.1, Section 13.2.2 or Section 13.2.5, or by PARTNER pursuant to Section 13.2.3, the provisions of this Section 13.4.2 shall apply with respect to all Terminated Products and all countries.

13.5Remedies.  Except as otherwise expressly provided herein, termination of this Agreement and the Penn Sublicense Agreement in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity.

13.6Alternative Remedy in Lieu of Termination.  If PARTNER has the right to terminate this Agreement pursuant to Section 13.2.2 or Section 13.2.5, then in lieu of terminating this Agreement PARTNER may, in its sole discretion, exercise an alternative remedy as follows:

13.6.1PARTNER may retain all of its licenses and other rights granted under this Agreement and the Penn Sublicense Agreement, subject to all of its payment and other obligations, and, except that (a) [****] effective from and after the delivery of the applicable notice 

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of breach, and (b) PARTNER’s obligations under Section 3.1 and Section 4.3 will terminate, [****];  

13.6.2PARTNER will have the right to conduct any activities allocated to REGENX under the Development Plan or the Commercialization Plan, and all activities under such plan will be deemed to be allocated to PARTNER for the purposes of this Agreement;

13.6.3PARTNER will have the right to assume all obligations allocated to REGENX under this Agreement, the Clinical Supply Agreement or the Commercial Supply Agreement with respect to the Manufacture and supply of Clinical Supply or Commercial Supply;

13.6.4Upon PARTNER’s written request, REGENX shall, at its expense, (a) transfer to PARTNER or any such designee all REGENX Know-How that is necessary or reasonably useful to conduct the activities set forth in Section 13.6.2 or 13.6.3 above so as to enable PARTNER to conduct such activities, and (b) provide such support as may be necessary or reasonably useful to PARTNER or any of its Affiliates or subcontractors to conduct the activities set forth in Section 13.6.2 or 13.6.3;

13.6.5[****]; and

13.6.6any Confidential Information of PARTNER provided to REGENX pursuant to this Agreement will be promptly returned to PARTNER or destroyed.

For the avoidance of doubt, except as set forth in this Section 13.6, if PARTNER exercises the alternative remedy set forth above in this Section 13.6, then all rights and obligations of both Parties under this Agreement and the Penn Sublicense Agreement will continue unaffected, unless and until this Agreement and the Penn Sublicense Agreement are subsequently terminated by either Party pursuant to this ARTICLE 13.

13.7Assumption of Development and Manufacturing Activities Following Termination of Third Party License Agreements.  Without limiting any other remedy of PARTNER under this Agreement (including Section 13.6) or Applicable Law, if any Third Party Licensor terminates its respective Third Party License Agreement with REGENX, and such termination is through no fault of PARTNER or any of its Affiliates or Sublicensees (including any termination for any failure by REGENX to pay any amounts due thereunder), then in addition to any other remedies available to PARTNER at law or in equity, PARTNER may, by written notice to REGENX, elect to continue this Agreement and the Penn Sublicense Agreement as modified by Section 13.6, in which case, effective as of the date PARTNER delivers such notice of such election to PARTNER: 

13.7.1PARTNER will have the right to conduct any activities allocated to REGENX under the Development Plan or the Commercialization Plan, and all activities under such plan will be deemed to be allocated to PARTNER for the purposes of this Agreement with PARTNER having final decision-making authority at the Joint Committees for such activities but with the cost sharing allocation for such activities remaining the same as prior to PARTNER’s assumption of such activities;

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13.7.2PARTNER will have the right to assume all obligations allocated to REGENX under this Agreement, the Clinical Supply Agreement or the Commercial Supply Agreement with respect to the Manufacture and supply of Clinical Supply or Commercial Supply;

13.7.3Upon PARTNER’s written request, REGENX shall, at its own expense (a) transfer to PARTNER or any such designee all REGENX Know-How that is necessary or reasonably useful to conduct the activities set forth in Section 13.7.1 or 13.7.2 above so as to enable PARTNER to conduct such activities, and (b) provide such support as may be necessary or reasonably useful to PARTNER or any of its Affiliates or subcontractors to conduct the activities set forth in Section 13.7.1 or 13.7.2; and

13.7.4[****].

13.8Accrued Rights; Surviving Obligations.  Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration.  Such termination or expiration shall not relieve a Party from obligations that are expressly indicated to survive the termination or expiration of this Agreement.  Without limitation of the foregoing, Sections 3.4.1 (with respect to, and for the duration, that Development Records are required to be maintained following the effective date of termination or expiration of this Agreement), 3.7 (with respect to Licensed Product under this Agreement), 4.4.1 (with respect to, and for the duration, that Commercialization records are required to be maintained following the effective date of termination or expiration of this Agreement), 8.2-8.7 (only to the extent related to an obligation arising (or activities conducted) prior to the effective date of termination or expiration of this Agreement), 8.9, 8.10, 8.11 (for the specified duration set forth therein), 8.12 (for the specified duration set forth therein), 8.13, 9.5.2, 9.7 (with respect to PARTNER’s obligations, solely to the extent that the [****] expressly extend beyond the effective date of termination or expiration), 9.8, 10.1 (for the specified duration set forth therein), 10.2, 10.6, 11.5 (except for Section 11.5.5 and solely in the event of an expiration of this Agreement to the extent any relevant licenses under REGENX Know-How continue to be granted to PARTNER), 13.3-13.7 and this Section 13.8, ARTICLE 12 and ARTICLE 14, and Schedule 1 (only to the extent such defined terms are used in the surviving provisions) of this Agreement shall survive the termination or expiration of this Agreement for any reason.

ARTICLE 14
MISCELLANEOUS

14.1Force Majeure.  Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement (other than an obligation to make payments) when such failure or delay is caused by or results from events beyond the reasonable control of the non-performing Party, including fires, floods, earthquakes, hurricanes, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not), terrorist acts, insurrections, riots, civil commotion, strikes (whether involving the workforce of the non-performing Party or of any other Person), acts of God or acts, omissions or delays in acting by any Governmental Authority (except to the extent such delay results from the breach by the non-performing Party or any of its Affiliates of any term or condition of this Agreement).  [****].  The 

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non-performing Party shall notify the other Party of such force majeure within [****] after such occurrence by giving written notice to the other Party stating the nature of the event, its anticipated duration and any action being taken to avoid or minimize its effect.  The suspension of performance shall be of no greater scope and no longer duration than is necessary and the non-performing Party shall use commercially reasonable efforts to remedy its inability to perform. 

14.2Export Control.  This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on the Parties from time to time.  Each Party agrees that it will not export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other Governmental Authority in accordance with Applicable Law.

14.3Assignment.  Neither Party may assign its rights or, except as provided in Section 3.5, Section 4.6, [****], delegate its obligations under this Agreement, whether by operation of law or otherwise, in whole or in part without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed, except that each Party shall have the right, without such consent, (a) to perform any or all of its obligations and exercise any or all of its rights under this Agreement through any of its Affiliates, and (b) assign any or all of its rights and delegate any or all of its obligations hereunder to any of its Affiliates or to any successor in interest (whether by merger, acquisition, asset purchase or otherwise) to all or substantially all of the business to which this Agreement relates; provided that such Party shall provide written notice to the other Party within [****] after such assignment or delegation.  Any permitted successor of a Party or any permitted assignee of all of a Party’s rights, in each case except for an Affiliate, under this Agreement that has also assumed all of such Party’s obligations hereunder in writing shall, upon any such succession or assignment and assumption, be deemed to be a party to this Agreement as though named herein in substitution for the Assigning Party, whereupon the Assigning Party shall cease to be a party to this Agreement and shall cease to have any rights or obligations under this Agreement.  All validly assigned rights of a Party shall inure to the benefit of and be enforceable by, and all validly delegated obligations of such Party shall be binding on and be enforceable against, the permitted successors and assigns of such Party.  Any attempted assignment or delegation in violation of this Section 14.3 shall be void and of no effect.

14.4Severability.  If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future law and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (d) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties.  To the fullest extent permitted by Applicable Law, each Party hereby waives any provision of law that would render any provision hereof illegal, invalid or unenforceable in any respect.

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14.5Dispute Resolution.

14.5.1General.  Except as provided in Section 8.13 or Section 14.10, if a dispute arises in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a “Dispute”), then such Dispute shall be resolved pursuant to this Section 14.5.  Any Dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue.  Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties.  If the Senior Officers are not able to agree on the resolution of any such issue within [****] (or such other period of time as mutually agreed by the Senior Officers) after such issue was first referred to them, then, subject to Section 14.5.5, either Party may, by written notice to the other Party, elect to initiate an alternative dispute resolution (“ADR”) proceeding pursuant to the procedures set forth in Section 14.5.2 for purposes of having the matter settled.

14.5.2ADR.  Any ADR proceeding under this Agreement shall take place pursuant to the procedures set forth in Schedule 14.5.2.

14.5.3Adverse Ruling.  Any determination pursuant to this Section 14.5 that a Party is in Material Breach shall specify a (nonexclusive) set of actions to be taken to cure such Material Breach, if feasible.

14.5.4Interim Relief and Tolling.  Notwithstanding anything herein to the contrary, nothing in this Section 14.5 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute following the ADR procedures set forth in Section 14.5.2, if necessary to protect the interests of such Party.  This Section shall be specifically enforceable.

14.5.5Intellectual Property Disputes.  In the event that a Dispute arises with respect to the validity, patentability, or enforceability of any Patent, and such Dispute cannot be resolved in accordance with Section 14.5.1, unless otherwise agreed by the Parties in writing, such Dispute shall not be submitted to an ADR proceeding in accordance with Section 14.5.2 and instead, either Party may initiate litigation or proceeding in a court or governmental agency of competent jurisdiction, notwithstanding Section 14.6, in any country or other jurisdiction in which such rights apply.

14.6Governing Law, Jurisdiction and Service.

14.6.1Governing Law.  This Agreement shall be governed by and construed in accordance with the laws of the State of New York, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction.  The Parties agree to exclude the application to this Agreement of the United Nations Convention on Contracts for the International Sale of Goods.  

14.6.2Jurisdiction.  Subject to Section 14.5 and Section 14.10, the Parties hereby irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of the State of New York for any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement and agree not to commence any action, suit or proceeding (other than appeals therefrom) related thereto except in such courts.  The Parties irrevocably and 

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unconditionally waive their right to a jury trial.

14.6.3Venue.  The Parties further hereby irrevocably and unconditionally waive any objection to the laying of venue of any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this Agreement in the courts of the State of New York and hereby further irrevocably and unconditionally waive and agree not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum.

14.6.4Service.  Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 14.7.2 shall be effective service of process for any action, suit or proceeding brought against it under this Agreement in any such court.  

14.7Notices.

14.7.1Notice Requirements.  Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if delivered by hand or sent by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 14.7.2 or to such other address as the Party to whom notice is to be given may have provided to the other Party in accordance with this Section 14.7.1.  Such notice shall be deemed to have been given as of the date delivered by hand or on the [****] (at the place of delivery) after deposit with an internationally recognized overnight delivery service.  This Section 14.7.1 is not intended to govern the day-to-day business communications necessary between the Parties in performing their obligations under the terms of this Agreement.

14.7.2Address for Notice.

If to PARTNER, to:

AbbVie Global Enterprises Ltd.

 4th floor, Washington House

16 Church Street

Hamilton HM 11

Bermuda

 

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with a copy (which shall not constitute notice) to:

AbbVie Inc.

1 North Waukegan Road

North Chicago, Illinois 60064

United States

Attention: General Counsel

 

Ropes & Gray LLP

800 Boylston Street, Prudential Tower

Boston, MA 02199

United States

Attention: Amanda F. Austin

 

If to REGENX, to:

REGENXBIO Inc.

9804 Medical Center Drive

Rockville, MD 20850

United States

Attention: Chief Executive Officer

with a copy (which shall not constitute notice) to:

REGENXBIO Inc.

9804 Medical Center Drive

Rockville, MD 20850

United States

Attention: Chief Legal Officer

 

14.8Entire Agreement; Amendments.  This Agreement, together with the Penn Sublicense Agreement and the Schedules attached hereto and thereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises and representations, whether written or oral, with respect thereto are superseded hereby.  Each Party confirms that it is not relying on any representations or warranties of the other Party except as specifically set forth in this Agreement, the Penn Sublicense Agreement and the Schedules attached hereto and thereto.  No amendment, modification, release or discharge shall be binding on the Parties unless in writing and duly executed by authorized representatives of both Parties.  All Schedules to this Agreement are expressly and hereby incorporated by reference into this Agreement and all references to the “Agreement” (whether in the body of the Agreement or the Schedules hereto), shall refer to the body of this Agreement and all Schedules hereto collectively.

14.9English Language.  This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language.  Any translation into any other language shall not be an official version thereof and in the event of any conflict in interpretation between the English version and such translation, the English version shall control.

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14.10Equitable Relief.  Each Party acknowledges and agrees that the restrictions set forth in ARTICLE 6 and ARTICLE 10 of this Agreement are reasonable and necessary to protect the legitimate interests of the other Party and that such other Party would not have entered into this Agreement in the absence of such restrictions and that any breach or threatened breach of any provision of such Articles may result in irreparable injury to such other Party for which there will be no adequate remedy at law.  Nothing in this Section 14.10 is intended or should be construed, to limit either Party’s right to equitable relief or any other remedy for a breach of any other provision of this Agreement.

14.11Waiver and Non-Exclusion of Remedies.  Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition.  The waiver by either Party hereto of any right hereunder or of the failure to perform or of a breach by the other Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise.  The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth herein.

14.12No Benefit to Third Parties.  Except as provided in ARTICLE 12, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns and they shall not be construed as conferring any rights on any other Persons.

14.13Further Assurances.  Each Party shall duly execute and deliver or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be reasonably necessary to carry out the intent and purposes of this Agreement.

14.14Relationship of the Parties.  It is expressly agreed that REGENX, on the one hand and PARTNER, on the other hand, are not Affiliates, shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency, including for all tax purposes.  Neither REGENX, on the one hand, nor PARTNER, on the other hand, shall have the authority to make any statements, representations or commitments of any kind, or to take any action, that will be binding on the other, without the prior written consent of the other Party to do so.  All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such first Party.

14.15References.  Unless otherwise specified, (a) references in this Agreement to any Article, Section or Schedule shall mean references to such Article, Section or Schedule of this Agreement, (b) references in any Section to any clause are references to such clause of such Section and (c) references to any agreement, instrument or other document in this Agreement refer to such agreement, instrument or other document as originally executed or, if subsequently amended, replaced or supplemented from time to time, as so amended, replaced or supplemented and in effect at the relevant time of reference thereto.

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14.16Construction.  Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word “or” is used in the inclusive sense (and/or).  Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days.  The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement.  The term “including,” “include,” or “includes” as used herein shall mean including, without limitation of the generality of any description preceding such term.  The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against either Party hereto.

14.17Counterparts.  This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.  This Agreement may be executed by PDF format via email or other electronically transmitted signatures and such signatures shall be deemed to bind each Party hereto as if they were original signatures.

[SIGNATURE PAGE FOLLOWS.]

 

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THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the date first written above.

 

		
	
ABBVIE GLOBAL ENTERPRISES LTD. 
	
REGENXBIO INC.

	
 

By: /s/ Jonathan C. Clipper

Name: Jonathan C. Clipper

Title: Director
	
 

By: /s/ Kenneth Mills

Name: Kenneth Mills

Title: President & CEO

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[Signature Page to Collaboration and License Agreement]

 

 

 

 

 

Schedule 1
Definitions

1.1.“AAV8” means (a) the recombinant adeno-associated virus serotype 8 vector with the specified sequence set forth in GenBank [****] and (b) any recombinant adeno-associated virus derivatives of such serotype 8 vector that are Covered by the claims of the REGENX Patents or Penn Patents.

1.2.“Accounting Standards” means, with respect to a Party, that such Party shall maintain records and books of accounts in accordance with United States Generally Accepted Accounting Principles.

1.3. “Additional Cure Period” shall have the meaning set forth in Section 13.2.2.

1.4.“Additional Indication” means a disease in humans treated by in vivo gene therapy using any Licensed Compound or Licensed Product in the field of ophthalmology via administration to the eye, excluding DR and nAMD.

1.5.“ADR” shall have the meaning set forth in Section 14.5.1.

1.6.“Affiliate” means, with respect to a Person, any other Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such first Person for so long as such other Person controls, is controlled by or is under common control with such first Person.  For purposes of this definition, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” means: (a) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance or otherwise; or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity).  

1.7.“Agreement” has the meaning set forth in the preamble hereto.

1.8.“Alliance Manager” has the meaning set forth in Section 7.4.5.

1.9.“Allowable Development Expenses” means, with respect to a Party, the following expenses determined in accordance with the Accounting Standards that are incurred by such Party and are directly attributable or reasonably allocable to the Development of a Licensed Product for use in the Licensed Field in accordance with the Development Plan.  Except in the case of Development costs incurred in accordance with clause (g) below, Development costs shall be limited to Development activities that are specifically identified or otherwise referenced in the Development Plan; provided that such costs shall be included in Allowable Development Expenses only to the extent less than or equal to the amounts set forth in the applicable Development Plan and related Budget for such Development activities.  Subject to the foregoing, Allowable 

 

 

Development Expenses shall include such costs in connection with the following activities, as applicable:

[****].  The components of Allowable Development Expenses shall be calculated in accordance with the applicable definition thereof and the applicable terms of this Agreement.  [****].  If any cost or expense is directly attributable and reasonably allocable to more than one (1) category under “Allowable Development Expenses” such cost or expense shall only be counted as an Allowable Development Expense with respect to one (1) such category. 

1.10.“Allowable Overruns” means, with respect to any Allowable Development Expenses, any amounts incurred by or on behalf of a Party in the performance of activities allocated to such Party under the Development Plan in a given [****] that (a) are not attributable to any breach of this Agreement, and (b) are in excess of the aggregate amount budgeted in the Development Plan for such Party in such [****] (i) by an amount not to exceed [****] or (ii) that are otherwise approved [****] (in the case of Allowable Development Expenses).

1.11.“Allowable US Expenses” means, with respect to a Party and a particular period of time during the Term, the following expenses (x) that are incurred by such Party during such period and are directly attributable and reasonably allocable to the Commercialization of a Licensed Product for use in the Licensed Field in the United States and (y) with respect to clauses (a) through (h), solely to the extent provided for in and consistent with the applicable Commercialization Plan and the related Budget:  

[****].  The components of Allowable US Expenses shall be calculated in accordance with the applicable definition thereof and the applicable terms of this Agreement.  [****].  If any cost or expense is directly attributable and reasonably allocable to more than one (1) category under “Allowable US Expenses” such cost or expense shall only be counted as an Allowable US Expense with respect to one (1) such category. 

1.12.“Amount” has the meaning set forth in Section 8.9.1.

1.13.“Anti-Corruption Laws” means the U.S. Foreign Corrupt Practices Act, as amended, the UK Bribery Act 2010, as amended, and any other applicable anti-corruption laws and laws for the prevention of fraud, racketeering, money laundering or terrorism.

1.14.“Applicable Law” means applicable laws, rules, regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, and generally acceptable industry codes, including the PhRMA Code, that may be in effect from time to time, including the FFDCA and the Anti-Corruption Laws.

1.15.“Assigning Party” has the meaning set forth in Section 8.9.2.

1.16.“Auditor” has the meaning set forth in Section 8.13.

1.17.“Bayh-Dole Act” means the Patent and Trademark Law Amendments Act of 1980, as amended, codified at 35 U.S.C. §§ 200-212, as amended, as well as any regulations promulgated pursuant thereto, including in 37 C.F.R. Part 401.

 

 

1.18.“Biosimilar Application” has the meaning set forth in Section 9.10.9. 

1.19.“Biosimilar Product” means, with respect to a Licensed Product for use in a particular Indication in the Licensed Field in a particular country in the Territory, any pharmaceutical product that is claimed to be biosimilar to or interchangeable with such Licensed Product (including a product that is the subject of an application submitted under Section 351(k) of the PHSA in the United States or under Article 10(4) of Directive 2001/83/EC in the European Union or any member state thereof, in each case citing such Licensed Product as the reference product). 

1.20.“BLA” means (a) a Biologics License Application submitted to the FDA pursuant to 21 CFR § 601.2 (or an successor regulation thereto) or a New Drug Application filed with the FDA as described in 21 C.F.R. § 314., (b) any equivalent of a United States BLA in other countries or regulatory jurisdictions, as applicable, and (c) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.

1.21.“Board of Directors” has the meaning set forth in the definition of Change of Control.

1.22. “Breaching Party” has the meaning set forth in Section 13.2.2.

1.23.“Budget” means, as the context requires, the total budgeted costs and expenses for (a) Development, (b) Manufacturing or (c) Commercialization, in each case as agreed by the Parties and as attached to, as applicable, the Development Plan or the Commercialization Plan, which Budget (i) shall define the amount of funds to be paid by each Party as well as the allocation and use of such funds and (ii) may be amended from time to time through the JDC (in the case of the Budget for the Development Plan) or JCC (in the case of the Budget for the Commercialization Plan).

1.24.“Business Day” means a day other than a Saturday or Sunday or a day on which banking institutions in Chicago, Illinois or New York, New York are permitted or required to be closed.

1.25.“Calendar Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1 and October 1, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1 or October 1 after the Effective Date and the last Calendar Quarter shall end on the last day of the Term.

1.26.“Calendar Year” means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term shall commence on January 1 of the year in which the Term ends and end on the last day of the Term.

1.27.“Change of Control” with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Effective Date:  

 

 

1.27.1.any “person” or “group” (as such terms are defined below) (a) is or becomes the “beneficial owner” (as defined below, except that a “person” or “group” shall be deemed to have “beneficial ownership” of all shares of capital stock or other equity interests if such person or group has the right to acquire, whether such right is exercisable immediately or only after the passage of time), directly or indirectly, shares of capital stock or other interests (including partnership interests) of such Party then outstanding and normally entitled (without regard to the occurrence of any contingency) to vote in the election of the directors, managers or similar supervisory positions (“Voting Stock”) of such Party representing fifty percent (50%) or more of the total voting power of all outstanding classes of Voting Stock of such Party or (b) has the power, directly or indirectly, to elect a majority of the members of the Party’s board of directors or similar governing body (“Board of Directors”);

1.27.2.such Party enters into a merger, consolidation or similar transaction with another Person (whether or not such Party is the surviving entity) and as a result of such merger, consolidation or similar transaction (a) the members of the Board of Directors of such Party immediately prior to such transaction constitute less than a majority of the members of the Board of Directors of such Party or such surviving Person immediately following such transaction or (b) the Persons that beneficially owned, directly or indirectly, the shares of Voting Stock of such Party immediately prior to such transaction cease to beneficially own, directly or indirectly, shares of Voting Stock of such Party representing at least a majority of the total voting power of all outstanding classes of Voting Stock of the surviving Person in substantially the same proportions as their ownership of Voting Stock of such Party immediately prior to such transaction;

1.27.3.such Party sells or transfers to any Third Party, in one or more related transactions, properties or assets representing all or substantially all of such Party’s consolidated total assets to which this Agreement relates; or

1.27.4.the holders of capital stock of such Party approve a plan or proposal for the liquidation or dissolution of such Party.  

For the purpose of this definition of Change of Control: (a) “person” and “group” have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934 and the term “group” includes any group acting for the purpose of acquiring, holding or disposing of securities within the meaning of Rule 13d-5(b)(1) under the aforesaid Act; (b) a “beneficial owner” shall be determined in accordance with Rule 13d-3 under the aforesaid Act; and (c) the terms “beneficially owned” and “beneficially own” shall have meanings correlative to that of “beneficial owner.”

1.28.[****]

1.29.[****]

1.30.“Clinical Quality Agreement” has the meaning set forth in Section 5.1.2.

1.31.“Clinical Supply” has the meaning set forth in Section 5.1.1.

1.32.“Clinical Supply Agreement” has the meaning set forth in Section 5.1.2.

 

 

1.33.“Clinical Trial” means, with respect to a therapeutic, a human clinical trial of such therapeutic intended to determine safety and efficacy in the target patient population, including the trials referred to in 21 C.F.R. §312.21, as amended. 

1.34.“CMC Data” means the chemistry, manufacturing and controls data for a Licensed Product required by Applicable Law to be included or referenced in, or that otherwise supports, an IND or application for Regulatory Approval.

1.35.“Collaboration Know-How” means any Information that is (a) not generally known and (b) developed or invented during the Term by or on behalf of a Party or any of its Affiliates, either alone or jointly, in the performance of any activities relating to the Exploitation of any Licensed Compound or Licensed Product under this Agreement.

1.36.“Collaboration Patents” means any Patent that (a) has a priority date after the Effective Date and (b) claims an invention made during the Term by or on behalf of a Party or any of its Affiliates, either alone or jointly, in the performance of any activities relating to the Exploitation of any Licensed Compound or Licensed Product under this Agreement.

1.37.“Combination Product” means a Licensed Product that is comprised of or contains a Licensed Compound as an active ingredient together with one (1) or more other active ingredients and is sold either as a fixed dose/unit or as separate doses/units as one (1) product.

1.38.“Commercial Quality Agreement” has the meaning set forth in Section 5.2.2(a).

1.39.“Commercial Sale” means, with respect to a Licensed Product for use in the Licensed Field, a bona fide sale, use, lease, transfer or other disposition for value of a Licensed Product for use in the Licensed Field by PARTNER, its Affiliates or any Sublicensees to a Third Party.  Sales between or among PARTNER and its Affiliates or any Sublicensees shall not be deemed a “Commercial Sale”, except where such Affiliates or Sublicensees are end users, but “Commercial Sales” shall include the subsequent final sales to Third Parties by such Affiliates or Sublicensees.

1.40.“Commercial Supply” has the meaning set forth in Section 5.2.1(a)

1.41.“Commercial Supply Agreement” has the meaning set forth in Section 5.2.2(a).

1.42.“Commercialization” means any and all activities related to the preparation for sale of, offering for sale of or sale of a product or service, including activities related to marketing, using, selling, offering to sell, final (commercial and secondary) packaging and labeling (both in and outside of the United States), promoting, warehousing, distributing, having imported, importing, exporting, having exported or other commercialization of such product or service, and interacting with Regulatory Authorities or other Governmental Authorities regarding any of the foregoing, but excluding Development and Process Development.  When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization and “Commercialized” has a corresponding meaning.

 

 

1.43.“Commercialization Plan” has the meaning set forth in Section 4.2.2.

1.44.“Commercially Reasonable Efforts” [****].

1.45.“Competing Activities” has the meaning set forth in Section 6.1.

1.46.“Competing Products” has the meaning set forth in Section 6.1.

1.47.“Competition Laws” means any antitrust or competition related Applicable Laws intended to prevent market distortion caused by anti-competitive practices on the part of businesses, including the HSR Act.

1.48.“Confidential Information” has the meaning set forth in Section 10.1.

1.49.“Control” means, subject to Section 9.13, with respect to any item of Information, Regulatory Documentation, material, Patent or other intellectual property right, possession of the right, whether directly or indirectly and whether by ownership, license or otherwise (other than by operation of the license and other grants in this Agreement and the Penn Sublicense Agreement), to grant a license, sublicense or other right (including the right to reference Regulatory Documentation) to or under such Information, Regulatory Documentation, material, Patent or other intellectual property right as provided for herein without violating the terms of any agreement with any Third Party or Applicable Law.  Notwithstanding any provision set forth in this Agreement to the contrary, a Person will not be deemed to “Control” any Information, Regulatory Documentation, material, Patent or other intellectual property right that is owned or in-licensed by any Third Party that becomes an Affiliate of such Person after the Effective Date as a result of a Change of Control of such Person or any Third Party that obtains an assignment of this Agreement in accordance with Section 14.3 unless (a) prior to the consummation of such Change of Control or assignment, such acquired (or assigning) Person or any of its Affiliates also Controlled such Information, Regulatory Documentation, material, Patent or other intellectual property rights owned or in-licensed by such Third Party, (b) any such Information, Regulatory Documentation, material, Patent or other intellectual property rights owned or in-licensed by such Third Party was generated by employees or consultants of such Third Party in the performance of activities under this Agreement after such Change of Control or assignment or (c) the Information, Regulatory Documentation, material, Patent or other intellectual property rights owned or in-licensed by such Third Party were not used in the performance of activities under this Agreement prior to the consummation of such Change of Control or assignment, but after the consummation of such Change of Control or assignment, such acquired (or assigning) Person or any of its Affiliates uses any such Information, Regulatory Documentation, material, Patent or other intellectual property rights in the performance of activities under this Agreement.

1.50. “Corporate Names” means (a) with respect to REGENX, the Trademarks, names and logos identified on Schedule 1.50(a) and such other Trademarks, names and logos as REGENX may designate in writing from time to time, and (b) with respect to PARTNER, the Trademarks, names and logos identified on Schedule 1.50(b) and such other Trademarks, names and logos as PARTNER may designate in writing from time to time.

1.51.“Cost of Goods” means, with respect to a product: 

 

 

1.51.1.to the extent such product is Manufactured by a Third Party for a Party, [****] 

1.51.2.to the extent such product is Manufactured directly by a Party or any of its Affiliates, [****].

1.52.“Cover” means, with respect to any particular subject matter at issue and any relevant Patent or individual claim in such Patent, as applicable, that the Development, Manufacture, Commercialization, use, sale, offer for sale, importation, or other Exploitation of such subject matter would, but for ownership of or a license under such Patent or such individual claim, infringe such Patent or such individual claim.

1.53.“Data Breach” has the meaning set forth in Section 11.9.3.

1.54.“Data Security and Privacy Laws” means all Applicable Laws relating to the privacy, Processing and security of Personal Data.

1.55. “Delivery System” means any delivery system meant to assist in the administration of a Licensed Compound or Licensed Product in the Licensed Field.

1.56.“Detail” means, with respect to a Licensed Product for use in the Licensed Field in the United States, a direct contact between a sales representative and a physician or other medical professional licensed to prescribe drugs, during which a detail is made to such person, in each case as measured by each Party’s internal recording of such activity in accordance with the Commercialization Plan; provided that such meeting is consistent with and in accordance with the requirements of Applicable Law and this Agreement.  When used as a verb, “Detail” means to engage in a Detail.

1.57.“Development” means all activities related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, Clinical Trials, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of INDs and BLAs, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval, excluding Process Development (other than Process Development included by way of reference to Manufacturing in support in Clinical Trials).  When used as a verb, “Develop” means to engage in Development.

1.58.“Development Plan” means, with respect to a Licensed Product for use in the Licensed Field, the written plan for conducting Development activities with respect to a Licensed Product for use in the Licensed Field as further described in Section 3.2.

1.59.“Development Records” has the meaning set forth in Section 3.4.1. 

1.60.“Dispute” has the meaning set forth in Section 14.5.1.

1.61.[****].

 

 

1.62.“Distribution Costs” means, to the extent not included in a Party’s Cost of Goods for a Licensed Product for use in the Licensed Field for sale or distribution in the United States, or a Permitted Deduction, the FTE Costs (charged in accordance with Section 8.5.4), and the direct Out-of-Pocket Costs recorded as an expense by a Party or any of its Affiliates after the Effective Date, during the Term pursuant to this Agreement (as agreed to by the Parties from time to time) that are directly attributable and reasonably allocable to the following activities for the commercial distribution of a Licensed Product for use in the Licensed Field to a Third Party in the United States: [****].

1.63.“DOJ” means the United States Department of Justice, or any successor United States governmental agency performing similar functions.

1.64.“Dollars” or “$” means United States Dollars.

1.65.“Domain Antibody” [****].

1.66.“DR” means diabetic retinopathy without diabetic macular edema.

1.67.“DR Suprachoroidal Treatment” means the treatment of DR in humans by in vivo gene therapy using any Licensed Compound or Licensed Product delivered suprachoroidally.

1.68.“Effective Date” has the meaning set forth in Section 2.1. 

1.69. “EMA” means the European Medicines Agency and any successor agency thereto in the European Union with responsibilities comparable to those of the European Medicines Agency.

1.70.“Enforcing Party” has the meaning set forth in Section 9.10.7.

1.71.“European Union” or “EU” means the economic, scientific and political organization of member states as it may be constituted from time to time and for the purposes of this Agreement shall include the United Kingdom (“UK”).

1.72. “Excess Commercialization Expenses” has the meaning set forth in Section 4.5.2.

1.73.“Excess Development Expenses” has the meaning set forth in Section 3.3.2.

1.74.“Execution Date” has the meaning set forth in the preamble hereto. 

1.75.[****].

1.76.“Existing Inventory” has the meaning set forth in Section 5.1.1. 

1.77.“Exploit” means to make, have made, import, use, sell or offer for sale, including to research, Develop, have Developed, Commercialize, have Commercialized, register, 

 

 

Manufacture, have Manufactured, hold or keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market or have sold or otherwise dispose of.  “Exploitation” means the act of Exploiting a compound, product or process.

1.78.“FDA” means the United States Food and Drug Administration and any successor agency thereto in the United States with responsibilities comparable to those of the United States Food and Drug Administration.

1.79. “FFDCA” means the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).

1.80.“Finance Working Group” has the meaning set forth in Section 8.8.

1.81.“First Commercial Sale” means, with respect to a Licensed Product for use in a particular Indication in the Licensed Field and a country, the first Commercial Sale of such Licensed Product in such country after Regulatory Approval for such Licensed Product has been obtained in such country.  Sales prior to receipt of Regulatory Approval for a Licensed Product for use in a particular Indication in the Licensed Field, such as so-called “treatment IND sales,” “named patient sales,” and “compassionate use sales,” shall not be construed as a First Commercial Sale.

1.82.“FTC” means the United States Federal Trade Commission, or any successor United States governmental agency performing similar functions.

1.83.“FTE” means the equivalent of the work of one (1) employee full time for one (1) Calendar Year (consisting of at least a total of [****]) of work directly related to the Development, Commercialization or Manufacturing of a Licensed Product for use in the Licensed Field.  No additional payment shall be made with respect to any person who works more than [****] and any person who devotes less than [****] (or such other number as may be agreed by the Parties, as applicable) shall be treated as an FTE on a pro rata basis based upon the actual number of hours worked divided by [****].

1.84.“FTE Costs” means, with respect to a Party for any period, the applicable FTE Rate multiplied by the applicable number of FTEs of such Party performing Development, Commercialization or Manufacturing activities during such period in accordance with the Development Plan and applicable Commercialization Plan, including the Budget therefor.

1.85.“FTE Rate” means [****], which represents the fully burdened rate for such FTE and includes all Included FTE Costs and Expenses for such FTE.  [****].

1.86.“Global Clinical Trial” means any Clinical Trial that is intended to support a Regulatory Approval for a Licensed Product in the Licensed Field both in the United States and in any other country in the Territory.

1.87.“Global Commercialization Strategy” has the meaning set forth in Section 4.2.1.

 

 

1.88.“GMP” means current good manufacturing practices as specified in 21 C.F.R. Parts 11, 210 and 211, ICH Guideline Q7A, or equivalent laws, rules or regulations of an applicable Regulatory Authority at the time of manufacture.

1.89.“Governmental Authority” means any supranational, national, state, municipal, local or foreign government, any court, tribunal, arbitrator, administrative agency, commission or other governmental official, authority or instrumentality, in each case whether domestic or foreign, any stock exchange or similar self-regulatory organization or any quasi-governmental or private body exercising any regulatory, taxing or other governmental or quasi-governmental authority.

1.90.“GSK Agreement” means that certain License Agreement entered into between REGENX 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 in accordance with this Agreement.

1.91.“GSK Licensor” means SmithKline Beecham Corporation (or any assignee or successor thereto under the GSK Agreement), if any REGENX Patents are sublicensed pursuant the GSK Agreement.

1.92.“GSK Notice Period” has the meaning set forth in Section 13.2.2.

1.93.“GSK Patents” means any REGENX Existing Patents that are licensed to REGENX pursuant to the GSK Agreement.

1.94.“HSR Act” means the Hart-Scott Rodino Antitrust Improvements Act of 1976, as amended.

1.95.“Included FTE Costs and Expenses” means the sum of all costs and expenses for the employee performing any Development, Commercialization or Manufacturing, as applicable, activities hereunder, including [****] to the extent required for the performance of the applicable Development, Commercialization or Manufacturing activities. 

1.96.“IND” means an application filed with a Regulatory Authority for authorization to commence Clinical Trials, including (a) an Investigational New Drug Application as defined in the FFDCA or any successor application or procedure filed with the FDA, (b) any equivalent of a United States IND in other countries or regulatory jurisdictions, (e.g., clinical trial application (CTA)) and (c) all supplements, amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing.

1.97.“Indemnification Claim Notice” has the meaning set forth in Section 12.4.1.

1.98.“Indemnified Party” has the meaning set forth in Section 12.4.1.

1.99.[****]

1.100.[****]

 

 

1.101.“Indication” means any disease in humans, including (a) nAMD, (b) DR, and (c) any Additional Indication.

1.102.“Information” means all technical, scientific and other know-how and information, inventions, trade secrets, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including: biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols, assays and biological methodology, in each case (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed.

1.103.“Infringement” means any infringement of a REGENX Patent, Penn Patent, Joint Patent or PARTNER Patent related to the Development, Commercialization, Manufacture, having Manufactured or other Exploitation of a Licensed Compound or Licensed Product in the Licensed Field in the Territory.

1.104.“Initial Registration Enabling Trial Milestone Events” means each of the following milestone events, as further described in Section 8.2.1: (a) [****] patient dosed with a Licensed Product in the first Registration Enabling Trial for nAMD Suprachoroidal Treatment; and (b) [****] patient dosed with a Licensed Product in the first Registration Enabling Trial for DR Suprachoroidal Treatment.

1.105.“Initiation” means, with respect to a Clinical Trial, the [****] dosing of the [****] human subject with a Licensed Product in such Clinical Trial.

1.106.“Invoiced Sales” has the meaning set forth in the definition of “Net Sales.”

1.107.“Joint Commercialization Committee” or “JCC” has the meaning set forth in Section 7.2. 

1.108.“Joint Committees” means each of the Joint Development Committee, Joint Commercialization Committee, and Joint Manufacturing Committee. 

1.109.“Joint Development Committee” or “JDC” has the meaning set forth in Section 7.1. 

1.110.“Joint Know-How” means any and all Collaboration Know-How developed or invented jointly by or on behalf of REGENX or any of its Affiliates on the one hand, and PARTNER or any of its Affiliates on the other hand, but excluding REGENX NAV Platform Know-How.

1.111.“Joint Manufacturing Committee” or “JMC” has the meaning set forth in Section 7.3.

 

 

1.112.“Joint Patents” means any Collaboration Patents that claim inventions made jointly by or on behalf of REGENX or any of its Affiliates on one hand, and PARTNER or any of its Affiliates on the other hand, but excluding REGENX NAV Platform Patents.

1.113.“Joint Technology” means the Joint Know-How and Joint Patents. 

1.114.“Knowledge” means with respect to REGENX, [****] of its [****], or any personnel holding positions equivalent to such job titles.

1.115.“Lead Regulatory Party” means, with respect to a particular Regulatory Approval, the Party responsible for the day-to-day implementation and operational management for the preparation, obtaining and maintenance of such Regulatory Approval and all Regulatory Documentation relating thereto.

1.116.“Legal Dispute” means (a) any dispute, controversy or claim related to compliance with this Agreement or the validity, breach, termination or interpretation of this Agreement, (b) any dispute, controversy or claim with respect to any intellectual property (including trade secrets, Patents and copyrights) that is subject to resolution pursuant to ARTICLE 9, and (c) any disputed matters specifically identified as a “Legal Dispute” hereunder.

1.117. “Licensed Back Improvements” means any [****]. For clarity, Licensed Back Improvements shall not include any Information or Patents directed to a Licensed Compound or Licensed Product, or Exploitation thereof.

1.118.“Licensed Compound” means (a) RGX-314, and (b) any AAV8 vector encoding for a modified form of the RGX-314 transgene coding sequence. 

1.119.“Licensed Field” means all human and non-human diagnostic, prophylactic, and therapeutic uses.

1.120.“Licensed Product” means (a) any product that contains, alone or in combination with one or more other active ingredients, any Licensed Compound as an active ingredient, in any and all forms, presentations, dosages, and formulations or (b) any service with respect to the administration of any Licensed Compound to patients.

1.121.“Losses” has the meaning set forth in Section 12.1.

1.122.[****].

1.123.“Manufacture” and “Manufacturing” means all activities related to the production, making, manufacture, processing, filling, finishing, packaging, labeling, shipping and holding of a product or any intermediate thereof, including process development (including, with respect to Licensed Products for use in the Licensed Field, Process Development), process qualification and validation, scale-up, pre-clinical, clinical and commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control, excluding final (commercial and secondary) packaging and labeling. 

 

 

1.124.“Manufacturing Information” means all Information with respect to the Manufacture of a Licensed Compound or Licensed Product for use in the Licensed Field, including [****] the CMC Data.

1.125.[****]

1.126.[****]

1.127.“Marketing Authorization” means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of a Licensed Product for use in the Licensed Field in a country or regulatory jurisdiction.

1.128.“Material Breach” means a breach of this Agreement or the Penn Sublicense Agreement that is material to the rights and obligations of the Parties and the transactions contemplated by this Agreement and the Penn Sublicense Agreement, taken as a whole.

1.129.“Medical Affairs Activities” means, with respect to the United States, the coordination of medical information requests and field based medical scientific liaisons with respect to a Licensed Product for use in the Licensed Field in the United States, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Product for use in the Licensed Field.

1.130.“Medical Affairs Costs” means those FTE Costs (charged in accordance with Section 8.5.4 and the direct Out-of-Pocket Costs) incurred by a Party or any of its Affiliates in accordance with Accounting Standards after the Effective Date, during the Term pursuant to this Agreement that are directly attributable and reasonably allocable to Medical Affairs Activities with respect to a Licensed Product for use in the Licensed Field in the United States.

1.131.“Modified Party” has the meaning set forth in Section 6.3.

1.132.“Mono Product” has the meaning set forth in the definition of “Net Sales.”

1.133.“nAMD” means neovascular age-related macular degeneration.

1.134.“nAMD Subretinal Treatment” means the treatment of nAMD in humans by in vivo gene therapy using any Licensed Compound or Licensed Product delivered subretinally.

1.135.“nAMD Suprachoroidal Treatment” means the treatment of nAMD in humans by in vivo gene therapy using any Licensed Compound or Licensed Product delivered suprachoroidally.

1.136.“Net Sales” means, with respect to a Licensed Product for use in the Licensed Field for any period, the total amount billed or invoiced on Commercial Sales of such Licensed Product in the Licensed Field (including fees for services within the definition of “Licensed Product”) during such period by PARTNER, its Affiliates or any Sublicensees (each, a “Selling Party”) to Third Parties, in bona fide arm’s length transactions, less the following 

 

 

deductions, in each case in accordance with the standard internal policies and procedures of the applicable Selling Party, which must be in accordance with Accounting Standards, related specifically to the Licensed Product (“Invoiced Sales”) and actually allowed and taken by such Third Parties and not otherwise recovered by or reimbursed to PARTNER, its Affiliates, or Sublicensees:

[****] (each deduction specified in (a) – (i) a “Permitted Deduction”).

[****].  

In the event a Licensed Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows:  

(i)If the Selling Party separately sells in such country or other jurisdiction, (A) a product containing as its sole active ingredient a Licensed Compound contained in such Combination Product (the “Mono Product”) and (B) products containing as their sole active ingredients the other active ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by [****]. 

(ii)If the Selling Party separately sells in such country or other jurisdiction the Mono Product but does not separately sell in such country or other jurisdiction products containing as their sole active ingredients the other active ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by [****].

(iii)If the Selling Party does not separately sell in such country or other jurisdiction the Mono Product but do separately sell products containing as their sole active ingredients the other active ingredients contained in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by [****].

If the Selling Party does not separately sell in such country or other jurisdiction both the Mono Product and the other active ingredient or ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be determined by [****].

1.137.“New License Agreement” has the meaning set forth in Section 13.4.1.

1.138.[****]

1.139.[****]

1.140.[****]

1.141.“Non-Breaching Party” has the meaning set forth in Section 13.2.2(a).

1.142.“Non-Shared Development Activities” means any Development activities conducted under this Agreement in which REGENX is solely responsible for the Reimbursable Development Expenses therefor, as further described in Schedule 3.3.  [****].

 

 

1.143.“Notice Period” shall have the meaning set forth in Section 13.2.2.

1.144.“Opt-In” means opting into the jurisdiction of Unified Patent Court, such as through withdrawal under Article 83(4) of the Agreement on a Unified Patent Court between the participating Member States of the European Union (2013/C 175/01) of the Opt-Out of a Patent. 

1.145.“Opt-Out” means opting out of the jurisdiction of Unified Patent Court, such as the opt-out of a Patent right from the exclusive competence of the Unified Patent Court under Article 83(3) of the Agreement on a Unified Patent Court between the participating Member States of the European Union (2013/C 175/01). 

1.146.“Out-of-Pocket Costs” means costs and expenses paid to Third Parties (or payable to Third Parties and accrued in accordance with the Accounting Standards consistently applied) by PARTNER (or its Affiliate) or REGENX (or its Affiliate) directly incurred in, to the extent reasonably allocable to, the conduct of any applicable activities under this Agreement; [****]. 

1.147.“Owed Party” has the meaning set forth in Section 8.7. 

1.148.“Owing Party” has the meaning set forth in Section 8.7.

1.149.“PARTNER” has the meaning set forth in the preamble hereto.

1.150.“PARTNER Collaboration Know-How” means any Collaboration Know-How developed or invented solely by or on behalf of PARTNER or any of its Affiliates, but excluding any REGENX NAV Platform Know-How.

1.151.“PARTNER Collaboration Patents” means any Collaboration Patent that claims an invention made solely by or on behalf of PARTNER or any of its Affiliates, but excluding any REGENX NAV Platform Patents.

1.152.“PARTNER Indemnitees” has the meaning set forth in Section 12.2.

1.153.“PARTNER Know-How” means all Information that is Controlled by PARTNER or any of its Affiliates as of the Execution Date or at any time during the Term that is necessary for the performance of REGENX’s obligations hereunder, but excluding (a) any Information to the extent published in PARTNER Patents or Joint Patents or otherwise generally known or (b) any Joint Know-How.  PARTNER Know-How includes PARTNER Collaboration Know-How but excludes REGENX NAV Platform Know-How.

1.154.“PARTNER Patents” means any Patents Controlled by PARTNER or any of its Affiliates as of the Execution Date or at any time during the Term that are necessary (or, with respect to patent applications, would be necessary if such patent applications were to issue as patents) for the performance of REGENX’s obligations under this Agreement, but excluding any Joint Patents.  PARTNER Patents include PARTNER Collaboration Patents but exclude REGENX NAV Platform Patents.  

 

 

1.155.[****].

1.156.“Party” and “Parties” have the meaning set forth in the preamble hereto.

1.157.“Patents” and “Patent” means: (a) all national, regional and international patents and patent applications, including provisional patent applications; (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications; (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents, innovation patents and design patents and certificates of invention; (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b) and (c)); and (e) any similar rights, including so-called pipeline protection or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any of such foregoing patent applications and patents.

1.158.“Payment” has the meaning set forth in Section 8.9.1.

1.159.“Payor” has the meaning set forth in Section 8.9.1.

1.160.“Penn Agreement” means that certain License Agreement entered into between REGENX 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, by that certain Third Amendment to License Agreement effective on April 29, 2016, by that certain Fourth Amendment to License Agreement effective on April 4, 2019, by that certain Fifth Amendment to the License Agreement effective on September 11, 2020, and as further amended from time to time in accordance with this Agreement. 

1.161.“Penn Licensor” or “Penn” means The Trustees of the University of Pennsylvania (or any successor thereto under the Penn Agreement) if any Penn Patents are sublicensed pursuant to the Penn Agreement. 

1.162.“Penn Notice Period” has the meaning set forth in Section 13.2.2.

1.163.“Penn Patents” means any Patents that are licensed to REGENX pursuant to the Penn Agreement and which are set forth on Schedule 1.163 (Penn Patents), and any re-examination certificates thereof, and their foreign counterparts and extensions, continuations, divisionals, continuations-in-part, continuing, and re-issue applications; provided, however, that with respect to a Penn Patent that is jointly owned by REGENX or its Affiliate, on one hand, and Penn, on the other hand, only Penn’s interest in such Patent shall be a “Penn Patent” and, for clarity, REGENX’s interest in such Patent shall be a “REGENX Patent,” subject to Section 9.8.9.

1.164.“Penn Sublicense Agreement” has the meaning set forth in the recitals.

 

 

1.165.“Permitted Deduction” has the meaning set forth in the definition of “Net Sales.”

1.166.“Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.

1.167.“Personal Data” means (a) all information identifying, or in combination with other information, identifiable to an individual, including pseudonymized (key-coded) clinical data containing such information; and (b) any other information that is governed, regulated or protected by one or more Data Security and Privacy Laws.

1.168.“PhRMA Code” means the PhRMA Code on Interactions with Healthcare Professionals.

1.169.“PHSA” means the Public Health Service Act as set forth at 42 U.S.C. Chapter 6A, as may be amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).

1.170.“Privacy and Security Obligations” has the meaning set forth in Section 11.2(v).

1.171.“Process Development” means, with respect to a product, all process development, process improvements, manufacturing scale-up, qualification and validation and quality assurance/quality control with respect to such product.

1.172.“Processing” (or its conjugates) means any operation or set of operations that is performed upon Personal Data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alternation, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, blocking, erasure or destruction.

1.173.“Product Information” has the meaning set forth in Section 10.1.

1.174.“Product Labeling” means, with respect to a Licensed Product for use in a particular Indication in the Licensed Field in a country in the Territory, (a) the Regulatory Authority‐approved full prescribing information for such Licensed Product in such country, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country. 

1.175.“Product Patent” means any (a) REGENX Patent, (b) Penn Patent, (c) PARTNER Patent or (d) Joint Patent, in each case (a)-(d), that claims a Licensed Compound or a Licensed Product, or the Exploitation thereof.

 

 

1.176.“Product Trademarks” means the Trademark(s) used or to be used by PARTNER or its Affiliates or its or their Sublicensees for the Commercialization of a Licensed Product for use in the Licensed Field in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (excluding, in any event, any Corporate Names and any Trademarks that consist of or include any corporate name or corporate logo of the Parties or their Affiliates or its or their (sub)licensees (or Sublicensees)).  

1.177.“Product Warranty” means, with respect to a Licensed Product at a specified time, that such Licensed Product at such time is (a) in conformity with the applicable specifications for such Licensed Product as mutually agreed upon by the Parties; (b) Manufactured in conformance with GMP, all other Applicable Law, this Agreement and the relevant Quality Agreement (as applicable); (c) Manufactured in facilities that are in compliance with Applicable Law at the time of such Manufacture (including applicable inspection requirements of FDA and other Regulatory Authorities); (d) not adulterated or misbranded under the FFDCA, and similar provisions of the laws of other countries as to which any Regulatory Approval has been granted or such Licensed Product will be used; and (e) able to be introduced into interstate commerce pursuant to the FFDCA, and similar provisions of the laws of other countries as to which any Regulatory Approval has been granted or such Licensed Product will be used.

1.178.“Promotion” means, with respect to a Licensed Product for use in the Licensed Field, Detailing, activities with respect to product sampling, detail aids, coupons, discount cards, journal advertising, direct mail programs, direct-to-consumer advertising, convention exhibits and other forms of marketing, advertising, public relations and other similar promotional activities undertaken by a Party with respect to a Licensed Product for use in the Licensed Field.  When used as a verb, “Promote” means to engage in Promotion. 

1.179.“Promotional Materials” means, with respect to a Licensed Product for use in a particular Indication in the Licensed Field and country in which such Licensed Product is or will be sold, promotional, advertising, communication and educational materials relating to such Licensed Product for use in connection with the marketing, Promotion and sale of such Licensed Product in such country, and the content thereof, and shall include promotional literature, product support materials and promotional giveaways. 

1.180.“Prosecute” or “Prosecution” means preparation, filing, and prosecuting Patent applications and maintaining Patents, including any reexaminations, reissues, oppositions, post-grant review, inter partes review, interferences, and applications for extension of Patent term (including but not limited to, applications for Patent term extension, supplementary protection certificate, and patent supplementary protection).

1.181.“Prosecuting Party” means the Party controlling Prosecution of a Patent under this Agreement.

1.182.“Publishing Party” has the meaning set forth in Section 10.5.1.

1.183.“Recipient” has the meaning set forth in Section 8.9.1.

1.184.“REGENX” has the meaning set forth in the preamble hereto.

 

 

1.185.“REGENX Collaboration Know-How” means any Collaboration Know-How developed or invented solely by or on behalf of REGENX or any of its Affiliates.

1.186.“REGENX Collaboration Patents” means any Collaboration Patent that claims any REGENX Collaboration Know-How.

1.187.“REGENX Competitor” [****].

1.188.“REGENX Existing Patents” means (a) any REGENX Patents existing as of the Execution Date, which are set forth on Schedule 1.188, and (b) any re-examination certificates thereof, and their foreign counterparts and extensions, continuations, divisionals, continuations-in-part, continuing, and re-issue applications.

1.189.“REGENX Indemnitees” has the meaning set forth in Section 12.1.

1.190.“REGENX Know-How” means all Information Controlled by REGENX or any of its Affiliates as of the Execution Date or at any time during the Term that is necessary or reasonably useful for the performance of PARTNER’s obligations, Exploitation of any Licensed Compound or Licensed Product for use in the Licensed Field or exercise of PARTNER’s rights hereunder, but excluding (a) any Information to the extent published in REGENX Patents, Penn Patents or Joint Patents or otherwise generally known or (b) any Joint Know-How.  REGENX Know-How includes REGENX Collaboration Know-How.

1.191.“REGENX Licensors” means, as applicable, the GSK Licensor, the Penn Licensor, or any other Third Party Licensor under any Third Party License Agreement to which REGENX or its Affiliates is a Party. 

1.192.“REGENX NAV Platform” means the REGENX proprietary gene delivery platform that utilizes recombinant AAV8 for gene therapy applications.  For clarity, REGENX NAV Platform shall not include any Licensed Compound, Licensed Product or Exploitation in each case thereof. 

1.193.“REGENX NAV Platform Know-How” means any Collaboration Know-How that solely and specifically relates to the REGENX NAV Platform (including the process for Manufacture of any products generated using the REGENX NAV Platform), but excluding any Information that is directed to a Licensed Compound or Licensed Product for use in the Licensed Field or the Exploitation thereof. 

1.194.“REGENX NAV Platform Patents” means any Collaboration Patents that solely and specifically claim inventions directed to the REGENX NAV Platform Know-How, but excluding any Collaboration Patents that claim any Licensed Compound or Licensed Product, or the Exploitation thereof.

1.195.“REGENX Patents” means any Patents Controlled by REGENX or any of its Affiliates as of the Execution Date or at any time during the Term that (a) Cover REGENX Know-How (without regard to the exclusion with respect to REGENX Patents in clause (a) thereof), or (b) are necessary or reasonably useful (or, with respect to patent applications, would be necessary or reasonably useful if such patent applications were to issue as Patents) for the 

 

 

performance of PARTNER’s obligations, Exploitation of any Licensed Compound or Licensed Product for use in the Licensed Field or exercise of PARTNER’s rights hereunder, but, in each case ((a) and (b)), excluding any Penn Patents and Joint Patents.  REGENX Patents include REGENX Collaboration Patents.

1.196. “REGENX Technology” means the REGENX Patents and the REGENX Know-How.

1.197.“Registration Enabling Trial” means, with respect to a Licensed Product for use in a particular Indication in the Licensed Field in a given country in the Territory, a Clinical Trial for such Licensed Product for which the applicable Regulatory Authority in such country has provided guidance that the design of such Clinical Trial and results of such Clinical Trial, together with prior data and information concerning such Licensed Product, (a) are sufficient to establish that such Licensed Product is safe and effective for its intended use, and (b) forms the primary basis (alone or with one (1) or more additional Registration Enabling Trials) of an effectiveness claim in support of Regulatory Approval for such Licensed Product, regardless of whether such Clinical Trial is referred to as a Phase 2, Phase 2b or Phase 3 clinical trial.  If a Clinical Trial of a Licensed Product does not meet the definition of a Registration Enabling Trial as of the date it is Initiated but later meets the definition of a Registration Enabling Trial, then for the purposes of Section 8.2, such Clinical Trial shall be deemed to be a Registration Enabling Trial as of the date the applicable Regulatory Authority accepts the submission of the BLA in which such Clinical Trial forms the primary basis of an effectiveness claim in support of Regulatory Approval for such Licensed Product.

1.198.“Regulatory Approval” means, with respect to a country in the Territory, any and all approvals (including BLAs), licenses, registrations or authorizations of any Regulatory Authority necessary to commercially distribute, sell or market a Licensed Product for use in the Licensed Field in such country, including, where applicable, (a) pricing or reimbursement approval in such country, (b) pre- and post-approval Marketing Authorizations (including any prerequisite Manufacturing approval or authorization related thereto) and (c) labeling approval.

1.199.“Regulatory Authority” means any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other Governmental Authorities regulating or otherwise exercising authority with respect to the Exploitation of a Licensed Product for use in the Licensed Field in the Territory, including the FDA and the EMA.

1.200.“Regulatory Documentation” means: all (a) applications (including all INDs and BLAs), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; and (c) clinical and other data contained or relied upon in any of the foregoing; in each case ((a), (b) and (c)), relating to a Licensed Compound or Licensed Product for use in the Licensed Field.  Regulatory Documentation includes, for clarity, documentation relating to a Delivery System used in the administration of a Licensed Compound or Licensed 

 

 

Product for use in the Licensed Field and any information received or authorized by a Third Party in support of applications for Licensed Product Regulatory Approvals.

1.201.“Regulatory Exclusivity Period” means, with respect to a Licensed Product for use in a particular Indication in the Licensed Field in any country in the Territory, any period of data, market or other regulatory exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that confers exclusive marketing rights with respect to such Licensed Product in such country and prevents another Person from marketing such Licensed Product without the prior written consent of the BLA-holder. 

1.202.“Reimbursable Development Expenses” has the meaning set forth in Section 3.3.1.

1.203. [****].

1.204.“Reviewing Party” has the meaning set forth in Section 10.5.1.

1.205.“RGX-314” means the AAV8 vector containing a gene encoding for an antibody fragment that is designed to bind VEGF as described in [****].

1.206.“Royalty Term” means, on a country-by-country and Licensed Product-by-Licensed Product basis, the period beginning on the date of the First Commercial Sale of a Licensed Product in a particular country and ending on the latest to occur of: (a) the expiration of the last-to-expire Valid Claim within the REGENX Patents, Penn Patents or Joint Patents that claims (i) the composition of matter of such Licensed Product in such country or (ii) methods of use for the treatment of all Indications for which such Licensed Product has received Regulatory Approval in such country with respect to the specific mode of administration (e.g., subretinal or suprachoroidal) of such Licensed Product (collectively, the “Royalty-Bearing Patents”); (b) the expiration of Regulatory Exclusivity Period in such country for such Licensed Product in the Licensed Field; and (c) (x) if such country is in the European Union, the twelfth (12th) anniversary of the First Commercial Sale of such Licensed Product in the Licensed Field in such country or (y) if such country is outside the European Union, the tenth (10th) anniversary of the First Commercial Sale of such Licensed Product in the Licensed Field in such country. 

1.207.“Royalty Territory” means, with respect to a Licensed Product for use in the Licensed Field, the Territory excluding the United States.

1.208.“Royalty-Bearing Patents” has the meaning set forth in the definition of “Royalty Term.”

1.209.“Safety Issue” means, with respect to a Licensed Product, any clinical hold or mandatory marketing withdrawal imposed by a Regulatory Authority in the United States, the European Union [****], in each case, relating to a significant safety concern or serious adverse event that is clinically relevant to the benefit risk assessment for the Licensed Product which, in the case of a clinical hold, is not lifted within [****] of the notice of such hold.

 

 

1.210.“Sales and Marketing Costs” means those FTE Costs (charged in accordance with Section 8.5.4) and the direct Out-of-Pocket Costs recorded as an expense by a Party or any of its Affiliates in accordance with Accounting Standards, after the Effective Date and during the Term pursuant to this Agreement that are compliant with Applicable Law and, in each case, are directly attributable and reasonably allocable to the following sales and marketing activities for a Licensed Product for use in the Licensed Field in the United States: [****]

Sales and Marketing Costs shall include costs of such activities that are incurred at any time after the Effective Date and during the Term of this Agreement (including prior to Regulatory Approval of a Licensed Product for use in the Licensed Field in the United States); provided that such costs shall be included in “Sales and Marketing Costs” for a Licensed Product for use in the Licensed Field in the United States solely to the extent provided for in and consistent with the applicable Commercialization Plan. If any cost or expense is directly attributable and reasonably allocable to more than one (1) category under “Sales and Marketing Costs” such cost or expense shall only be counted as a Sales and Marketing Cost with respect to one (1) such category.  

1.211.“Selling Party” has the meaning set forth in Section 1.136.

1.212.“Senior Officer” means, (a) with respect to REGENX, its [****] and (b) with respect to PARTNER, its [****].

1.213.“Shared Development Activities” means any Development activities set forth in the Development Plan in which the Parties are each sharing a portion of the Reimbursable Development Expenses therefor, as further described in Schedule 3.3.  [****].  

1.214.“Sublicensed IP” has the meaning set forth in Section 9.7.

1.215.“Sublicensee” means (a) any Third Party or Affiliate to whom PARTNER grants a sublicense of some or all of the rights granted to PARTNER under this Agreement as permitted herein or the Penn Sublicense Agreement as permitted therein; and (b) any other Third Party or Affiliate to whom a Sublicensee described in clause (a) has granted further sublicenses as permitted in this Agreement, but excluding, in each case ((a) and (b)), any [****].

1.216.[****].

1.217.[****]

1.218.“Term” has the meaning set forth in Section 13.1.

1.219.“Terminated Product Agreement” means, with respect to a Terminated Product for use in the Licensed Field, any agreement entered into by and between PARTNER or any of its Affiliates, on the one hand and one (1) or more Third Parties, on the other hand, that pertains solely to the Terminated Products and is necessary or reasonably useful for the Exploitation of such Terminated Product in the Territory.

1.220.“Terminated Products” means all Licensed Products that are Mono Products and are being Developed or Commercialized under this Agreement as of the effective 

 

 

date of termination of this Agreement, in the form and formulation in which such Licensed Products exist as of such effective date of termination.

1.221.“Termination Notice” has the meaning set forth in Section 13.2.2.

1.222.“Territory” means, subject to Section 13.2.2(d), the entire world.

1.223.“Third Party” means any Person other than REGENX, PARTNER and their respective Affiliates.

1.224.“Third Party Agreement” means, as applicable, any Third Party License Agreement [****].

1.225.“Third Party Claims” has the meaning set forth in Section 12.1.

1.226.“Third Party License Agreement” means, as applicable, the GSK Agreement, the Penn Agreement, or any agreement with a Third Party (a “Third Party Licensor”) that a Party enters into in accordance with Section 9.13 (except to the extent that PARTNER does not take a sublicense under such agreement as described under Section 9.13), as such agreement is amended from time to time in accordance with this Agreement.

1.227.“Third Party Licensor” has the meaning set forth in the definition of “Third Party License Agreement.”

1.228.“Third Party Patent Right” has the meaning set forth in Section 9.13.

1.229.“Third Party Payments” has the meaning set forth in Section 8.3.3(c).

1.230.[****]

1.231.“Trademark” means any word, name, symbol, color, shape, designation or any combination thereof, including any trademark, service mark, trade name, brand name, sub-brand name, trade dress, product configuration rights, program name, delivery form name, certification mark, collective mark, logo, tagline, slogan, design or business symbol, that functions as an identifier of source, origin or quality, whether or not registered, and all statutory and common law rights therein and all registrations and applications therefor, together with all goodwill associated with, or symbolized by, any of the foregoing.

1.232.“United States” or “U.S.” means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico).

1.233.“United States Profit and Loss Share” means the allocation of profits and losses for the sale of a Licensed Product for use in the Licensed Field in the United States set forth in Section 8.4.

1.234.“US Net Sales” means all Net Sales with respect to Licensed Products for use in the Licensed Field in the United States.

 

 

1.235.“Valid Claim” means (a) 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 REGENX Patents, the Penn Patents, the PARTNER Patents, or the Joint Patents that has not lapsed, been abandoned, canceled, dedicated to the public, disclaimed, revoked, or held unenforceable, unpatentable 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 or (b) a claim of a pending Patent application included within the REGENX Patents, the Penn Patents, the PARTNER Patents or the Joint Patents, filed and Prosecuted in good faith and no more than [****] have elapsed from its earliest priority date.  For clarity, a holding is a non-appealable decision or an appealable decision from which no appeal was taken within the time allowed for such appeal, or is a holding from which no appeal (other than a petition to the United States Supreme Court for a writ of certiorari or a similar appeal the consideration of which is subject to the discretion of the higher court) can be or has been taken.

1.236.“VAT” has the meaning set forth in Section 8.9.3.

1.237. “VEGF” means vascular endothelial growth factor.

1.238. “Voting Stock” has the meaning set forth in the definition of “Change of Control.”

 

 

 

Schedule 8.4

United States Profit and Loss Share

 

REGENX’s portion of the United States Profit and Loss Share shall be one-half of an amount which is calculated as all US Net Sales less all Allowable US Expenses.

PARTNER’s portion of the United States Profit and Loss Share shall be one-half of an amount which is calculated as all US Net Sales less all Allowable US Expenses.tcon-ex101_290.htm

Exhibit 10.1

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE TRACON PHARMACEUTICALS, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO TRACON PHARMACEUTICALS, INC. IF PUBLICLY DISCLOSED.

 

 

COLLABORATIVE DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

 

This Collaborative Development and Commercialization Agreement (the “Agreement”) is entered into on October 8, 2021 (the “Effective Date”) between Tracon Pharmaceuticals, Inc., a Delaware corporation, with its principal place of business at 4350 La Jolla Village Drive, Suite 800, San Diego, CA, USA (“Tracon”), Eucure (Beijing) Biopharma Co., Ltd., a company organized and existing under the laws of the People’s Republic of China and having its registered address at 23F, Tower 3, China Central Place, No.77, Jian Guo Road, Chaoyang District, Beijing, China (“Eucure”), and, solely with respect to Section 13.15, Eucure’s controlling Affiliate Biocytogen Pharmaceuticals (Beijing) Co., Ltd., a company organized and existing under the laws of the People’s Republic of China and having its registered address at No.12, Baoshen South Street, Daxing Bio-Medicine Industry Park, 102600 Daxing District, Beijing, China (“Parent”). Eucure and Tracon are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”  

RECITALS 

Whereas, Eucure has developed and possesses the rights to a YH001 , and wishes to collaborate with Tracon with respect to the clinical development and commercialization of such monoclonal antibody;

Whereas, Tracon is a biopharmaceutical company engaged in the research, development and future commercialization of pharmaceutical products, including novel targeted therapeutics for oncology applications; and

Whereas, the Parties wish to conduct the development and clinical trials for this antibody, and the Parties agree to share the economic interest in resulting product, all on the terms and conditions set forth herein. 

Now Therefore, in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

Article 1
Definitions

As used in this Agreement, the following initially capitalized terms, whether used in the singular or plural form, shall have the meanings set forth in this Article 1. 

1.

 

 

1.1“Accounting Standards” means U.S. generally accepted accounting principles, the People's Republic of China generally accepted accounting principles, or International Financial Reporting Standards, as consistently applied.

1.2 “Affiliate” means, with respect to a Party, any corporation, firm, partnership or other entity, which directly or indirectly controls or is controlled by or is under common control with such Party. For the purpose of this definition, “control” (including, with correlative meaning, the terms “controlled by” and “under the common control”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of such entity, whether by the ownership of more than fifty percent (50%) of the voting stock of such entity, by contract or otherwise.

1.3“Agreement” has the meaning set forth in the preamble.

1.4“Antibody” means Eucure’s proprietary YH001 [***], as further described in the Patents listed in Exhibit A.

1.5“Applicable Laws” means the applicable provisions of any and all national, supranational, regional, state and local laws, treaties, statutes, rules, regulations, administrative codes, guidance, ordinances, judgments, decrees, directives, injunctions, orders, permits (including Regulatory Approvals) of or from any court, arbitration panel, Regulatory Authority, governmental agency, stock exchange (including the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited, as amended, supplemented or otherwise modified from time to time), or any authority having jurisdiction over or related to subject item or subject person, including GLP, GCP, GMP, the FCPA, Export Control Laws and other laws, in each case as applicable.

1.6“BLA” means a biologics license application for Regulatory Approval of a biologic product. 

1.7“Business Day” means any day that is not a Saturday, a Sunday or other day on which banks are required or authorized by Applicable Laws to be closed in San Diego, California or Beijing, China.

1.8“Calendar Quarter” means each successive period of three (3) consecutive calendar months ending on March 31, June 30, September 30, or December 31.

1.9“Calendar Year” means each successive period of twelve (12) consecutive calendar months ending on December 31. 

1.10“Change of Control” means, with respect to a Party: (a) the sale of all or substantially all of such Party’s (or any of its controlling Affiliates’) assets or business relating to the subject matter of this Agreement; (b) a merger, reorganization or consolidation involving such Party (or a controlling Affiliate thereof) in which the voting securities of such Party (or such controlling Affiliate, as applicable) outstanding immediately prior thereto cease to represent at

2.

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

 

 

least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger, reorganization or consolidation; or (c) the acquisition by a person or entity of more than fifty percent (50%) of the voting equity securities or management control of such Party (or a controlling Affiliate thereof) as a result of a single transaction or a series of related transactions.

1.11“Clinical Supply and Quality Agreement” has the meaning set forth in Section 4.3(a).

1.12“CMO” means a contract manufacturing organization.

1.13“CMO Supply Agreement” means a contract manufacturing and services agreement between Eucure and CMO for the supply of Collaborative Product.

1.14“Collaborative Product” means any pharmaceutical composition or preparation comprising Antibody; provided, however, Collaborative Product excludes (i) compositions comprising bi-specific or multi-specific antibodies targeting both the same target as Antibody and other different target(s); and (ii) co-formulations of Antibody in a fixed dose combination with one or more other active ingredient(s) having an independent therapeutic effect.  

1.15“Collaborative Product IP” means any and all intellectual property rights, including Patents, copyrights, trademarks and Know-How, that are (a) Controlled by Eucure or any of its Affiliates as of the Effective Date or at any time during the Term and (b) (i) claim or cover a Collaborative Product, or (ii) are necessary or useful for the Development, manufacture, marketing, promotion, distribution, use, sale, import or other exploitation of a Collaborative Product. For clarity, Collaborative Product IP includes any and all intellectual property rights that are Controlled by Eucure or any of its Affiliates within the Development IP.

1.16“Collaborative Products License” has the meaning set forth in Section 3.1.

1.17“Collaborative Territory” means the United States, Canada, Mexico and each of their dependent territories. 

1.18“Commercialize”, “Commercialized” or “Commercialization” means any and all activities effective to market, promote, advertise, sell, offer for sale, have sold or otherwise dispose of, transport, distribute, import or export, branding, preparation for the launch and medical education regarding a Collaborative Product, and interacting with Regulatory Authorities in connection with any of the foregoing after all Regulatory Approvals have been obtained in the applicable country or region. 

1.19“Commercially Reasonable Efforts” means, with respect to the efforts to be expended by a Party pertaining to a particular objective, the objective, reasonable, diligent, good faith efforts to accomplish such objective in an active and ongoing program as a similarly situated (with respect to size, stage of development, and assets) biotechnology or pharmaceutical company, as the case may be. Such efforts shall be substantially no less than the efforts and resources commonly used by such Party (or a similarly situated biotechnology or pharmaceutical company 

3.

 

 

 

for pharmaceutical or biological products, as applicable) to accomplish a similar objective under similar circumstances exercising reasonable business judgment, taking into account the following factors to the extent applicable: stage of development, mechanism of action, efficacy and safety issues, characteristics of competitive products in or anticipated to be in the marketplace, process development, scale-up or manufacturing, Third Party intellectual property rights, actual or anticipated Regulatory Authority approved labeling, the nature and extent of market exclusivity (including patent coverage and regulatory exclusivity), cost and likelihood of obtaining Regulatory Approval, and projected or actual economic return; provided that, with respect to Tracon’s obligation to Develop and Commercialize Products, Commercially Reasonable Efforts shall be no less than the efforts expended by Tracon in connection with its other high priority projects. Commercially Reasonable Efforts shall be determined on a market-by-market and Indication-by-Indication basis for a particular Collaborative Product, and it is anticipated that the level of effort may be different for different markets, and may change over time, reflecting changes in the status of each such Collaborative Product and the market(s) involved. 

1.20“Competing Product” shall mean any monospecific pharmaceutical product other than the Collaborative Product that contains anti-CTLA-4 monoclonal antibody, whether sold alone or in combination with other products. For clarity, Competing Product shall not include (a) bi-specific or multi-specific agents or oncolytic viruses that have multiple targets and are additionally specific to a target other than CTLA-4, or (b) the specific combination therapy comprising the anti-CTLA-4 monoclonal antibody known as ipilimumab (YERVOY®) that is proprietary to Bristol-Myers Squibb and the anti-PD-L1 antibody known as envafolimab that is proprietary to Tracon, for which Tracon is conducting a Phase 2 Study (NCT No. NCT04480502).

1.21“Competing Program” has the meaning set forth in Section 3.7(a).

1.22“Completion” means, with respect to a clinical trial, the locking of the database that contains the data collected from such clinical trial in a manner consistent with industry standards to enable final data analysis and reporting.

1.23“Confidential Information” means, with respect to a Party, all know-how, data and other information of a financial, commercial, business, operational or technical nature of such Party that is: (a) disclosed by or on behalf of such Party or any of its Affiliates or otherwise made available to the other Party or any of its Affiliates, whether made available orally, in writing or in electronic form; or (b) learned by the other Party pursuant to this Agreement. Notwithstanding anything contained herein to the contrary, (i) the terms of this Agreement shall be deemed to be the Confidential Information of both Parties (and both Parties shall be deemed to be the Receiving Party with respect thereto) and (ii) all Development IP and Development Data shall be deemed to be the Confidential Information of the Party that owns such Development IP and Development Data (and the owning Party shall be deemed to be the Disclosing Party and the non-owning Party shall be deemed to be the Receiving Party with respect thereto).

1.24“Control” or “Controlled” means, with respect to an item of Know-How, Patent or other intellectual property rights, the ability and authority of a Party or its Affiliates, whether 

4.

 

 

 

arising by ownership, possession, or pursuant to a license or sublicense (other than by operation of the license and other rights granted in this Agreement) or a right to acquire (by option or otherwise), to grant licenses, sublicenses, or other rights to the other Party under or to such item of Know-How, Patent or other intellectual property rights as provided for in this Agreement, without breaching the terms of any agreement between such Party and any Third Party. 

1.25“Cost of Goods” or “COGS” means the per unit cost for clinical or commercial supply of Collaborative Product as determined by Eucure’s Accounting Standards, as consistently applied. If the Collaborative Product is manufactured by a CMO, the COGS shall be the per unit amount paid to the CMO for the manufacture and supply of the Collaborative Product. 

1.26“CTLA-4” means cytotoxic T-lymphocyte-associated protein 4.

1.27“Develop”, “Developed” or “Development” means all activities that relate to the development of a Collaborative Product for use in the Field or that are necessary or useful to obtain or maintain Regulatory Approval for such Collaborative Product, including all non-clinical studies and clinical trials of such Collaborative Product, technology transfer, manufacture process development and manufacture (with respect to Eucure only; for clarity, Development activities conducted by Tracon shall not include any manufacture process development or manufacture activity), labelling, packaging and distribution of such Collaborative Product for use in clinical trials (including placebos and comparators), statistical analyses, and the preparation and submission of regulatory materials and other regulatory activities related to such Collaborative Product. 

1.28“Development Activities” means all Development activities performed by or on behalf of either or both Parties pursuant to this Agreement.

1.29“Development Costs” means all costs incurred by or on behalf of either Party or its Affiliates that are reasonably allocable in accordance with such Parties’ Accounting Standard, as consistently applied, to the Development of a Collaborative Product in the Field in the Collaborative Territory as delineated herein, which for clarity may include costs for conducting clinical trials in the United Kingdom and European Union as determined by the JSC. 

1.30“Development Data” means all data generated by or on behalf of Tracon or its Affiliates in the course of, and as a result of, the performance of the Development Activities and directly relating to the Development of a Collaborative Product in the Field in the Collaborative Territory, including data related to all non-clinical studies and clinical trials of such Collaborative Product, which for clarity may include data from clinical trials in the United Kingdom and European Union as determined by the JSC, technology transfer, manufacture process development, manufacture and distribution of such Collaborative Product for use in clinical trials (including placebos and comparators), statistical analyses, and the preparation and submission of regulatory materials and other regulatory activities related to such Collaborative Product. 

1.31“Development IP” means any and all inventions, other than Development Data, that are specific to Collaborative Product or its use and are generated in connection with the 

5.

 

 

 

Development of the Collaborative Product in the Field in the Collaborative Territory by or on behalf of Tracon or its Affiliates during the Term, and any and all intellectual property rights therein (including Patents, copyrights, trademarks and Know-How). 

1.32“Development Plan” has the meaning set forth in Section 4.1. 

1.33“Disclosing Party” has the meaning set forth in Section 9.1.

1.34“Divest” or “Divestiture” means, with respect to a Competing Program, the sale or transfer of rights to such Competing Program, including all technology, intellectual property, and other assets relating solely thereto, by a Party or its Affiliate to a Third Party in an arm’s-length transaction, such that neither such Party nor any of its Affiliates has any right or obligation to engage in any Development, Commercialization, management, governance or decision-making activities in connection with such Competing Program. 

1.35“Effective Date” has the meaning set forth in the preamble.

1.36“Eucure” has the meaning set forth in the preamble.

1.37“Eucure Combination Therapy” means a combination therapy comprising the administration of two products: (a) a Collaborative Product for intravenous or subcutaneous administration and (b) an other product (other than a Collaborative Product) comprising at least one (1) other compound, molecule, product or product candidate (that is not the Antibody) consisting of one or more of Eucure’s proprietary pipeline compounds, and any other necessary treatment agents. 

1.38“Eucure Indemnitees” has the meaning set forth in Section 8.1.

1.39“Eucure BLA Submission” has the meaning set forth in Section 3.6(c).

1.40“Eucure Study Report” has the meaning set forth in Section 3.6(c).

1.41“Eucure Territory” means all territories of the world other than the Collaborative Territory.

1.42“European Union” means the economic, scientific and political organization of European Union member states as it may be constituted from time to time, specifically including any territory that was a European Union member state as of the Effective Date, whether or not such territory is a participating member as of the applicable time.

1.43“Export Control Laws” means all applicable U.S. laws and regulations relating to (a) sanctions and embargoes imposed by the Office of Foreign Assets Control of the U.S. Department of Treasury or (b) the export or re-export of commodities, technologies, or services, including the Export Administration Act of 1979, 24 U.S.C. §§ 2401-2420, the International Emergency Economic Powers Act, 50 U.S.C. §§ 1701-1706, the Trading with the Enemy Act, 50 

6.

 

 

 

U.S.C. §§ 1 et. seq., the Arms Export Control Act, 22 U.S.C. §§ 2778 and 2779, and the International Boycott Provisions of Section 999 of the U.S. Internal Revenue Code of 1986 (as amended).

1.44“FCPA” means the U.S. Foreign Corrupt Practices Act (15 U.S.C. Section 78dd-1, et. seq.), as amended.

1.45“FDA” means the U.S. Food and Drug Administration, or any successor Regulatory Authority thereto in the U.S. having substantially the same function. 

1.46“Field” means human therapeutic applications of the Collaborative Product administered by intravenous or subcutaneous means for (a) sarcoma, (b) microsatellite stable colorectal cancer (“mssCRC”), (c) renal cell carcinoma (“RCC”), and (d) K-ras positive non-small cell lung cancer (“K-ras NSCLC”), subject to any substitution or addition of Indications pursuant to Section 3.6 or otherwise mutually agreed upon by the Parties; provided, however, in the event that Tracon exercises the Tracon Option, the Field shall thereafter be the Development and Commercialization of all human and veterinary therapeutic applications of the Collaborative Product administered by intravenous or subcutaneous means for all Indications. 

1.47“First Commercial Sale” means the first sale by Tracon or its Affiliate for value for end use or consumption of such Collaborative Product in a country in the Collaborative Territory after the governing Regulatory Authority of such country has granted Regulatory Approval of such Collaborative Product. For clarity, any sale of a Collaborative Product prior to receipt of Regulatory Approval, such as compassionate use, named patient use, clinical trial purposes or other similar uses will not constitute a First Commercial Sale.

1.48“GLP” means the Good Laboratory Practices standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable regulatory standards promulgated by NMPA or other Regulatory Authority applicable to the Collaborative Territory, as may be updated from time to time, including applicable quality guidelines promulgated under the ICH..

1.49“GCP” means the Good Clinical Practices officially published by the Medicinal Health Regulatory Authority, European Medicines Agency (and any successor agency), the FDA and the ICH that may be in effect from time to time and are applicable to the Development of Collaborative Product. 

1.50“GMP” means those laws and regulations applicable in the U.S., United Kingdom, and European Union, relating to the manufacture of medicinal products for human use, including, without limitation, current good manufacturing practices as specified in the ICH guidelines, including without limitation, ICH Q7A “ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”, US Federal Food Drug and Cosmetic Act at 21 C.F.R. (Chapters 210, 211, 600 and 610) and the Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356/EEC that may be in effect from time to time and are applicable to the Development or manufacture of Collaborative Product. 

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1.51“HKEx” means the Stock Exchange of Hong Kong Limited.

1.52“ICC” has the meaning set forth in Section 12.3(a).

1.53“ICH” means the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

1.54“IND” means an investigational new drug application, clinical trial application, clinical trial exemption, or similar application or submission filed with or submitted to a Regulatory Authority in a jurisdiction that is necessary to commence human clinical trials in such jurisdiction, including any such application filed with the FDA pursuant to 21 C.F.R. Part 312. 

1.55“Indication” means a separate and distinct disease, disorder or condition: (a) which the Collaborative Product is intended to treat or prevent, as evidenced by the protocol for a clinical trial of the Collaborative Product or by the proposed Collaborative Product labeling in a Regulatory Approval application filed with a Regulatory Authority for the Collaborative Product, or (b) which is contained in the Collaborative Product’s labeling approved by a Regulatory Authority as part of the Regulatory Approval for the Collaborative Product. The Parties agree that: (i) any genetically defined cancer (e.g., where an explicit genetic mutation is the basis for enrollment in a clinical trial) is a separate Indication from other cancers lacking such genetic characteristic; (ii) the treatment or prevention of the same disease, disorder or condition in different populations (e.g., adult and pediatric or treatment of naïve and relapsed/refractory) shall not be treated as separate Indications; and (iii) with respect to any cancer type, the treatment of different stages within such cancer type based on the size or extent of the primary tumor and whether or not cancer has spread in the body (e.g., different stages in the TNM cancer staging system) shall not be treated as separate Indications.

1.56“Infringement” has the meaning set forth in Section 10.4.

1.57“Initiate” or “Initiation” means, with respect to a clinical trial, the first dosing in the first patient in such clinical trial.

1.58“Joint Development Committee” or “JDC” has the meaning set forth in Section 2.2(a).

1.59“Joint Steering Committee” or “JSC” has the meaning set forth in Section 2.1(a).

1.60“Know-How” means tangible and intangible information, techniques, technology, practices, trade secrets, inventions (whether patentable or not), processes, formulations, compounds, products, biological materials, cell lines (it being understood that any rights to use “Know-How” include the rights to use such cell lines), samples of assay components, media, designs, formulas, ideas, programs, software models, algorithms, developments, experimental works, protocols, methods, knowledge, know-how, skill, experience, test data and results (including pharmacological, toxicological and non-clinical and clinical data and results), 

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compilations of data, other works of analytical and quality control data, results, descriptions, compositions of matter, regulatory submissions, minutes, correspondence and strategy.

1.61“Losses” has the meaning set forth in Section 8.1.

1.62“Net Sales” shall mean the gross amounts invoiced for sales or other dispositions of a Collaborative Product by Tracon or any of its Affiliates (each, a “Selling Party”) to Third Parties, less deductions actually incurred, allowed, paid, accrued or otherwise reasonably allocated to such Collaborative Product by the Selling Party in accordance with the Selling Party’s Accounting Standards, as consistently applied, for:

(a)trade, cash and quantity discounts or rebates actually allowed or taken;

(b)credits or allowances given or made for rejection of or return of previously sold Collaborative Products or for retroactive price reductions and billing errors or for stocking allowances;

(c)governmental and other rebates (or credits or other equivalents thereof) granted to managed health care organizations, commercial insurance companies, pharmacy benefit managers (or equivalents thereof), distributors, national, state/provincial, local, and other governments, their agencies and purchasers, and reimbursors, or to trade customers;

(d)costs of freight, insurance, and other transportation charges directly related to the distribution of Collaborative Products, to the extent included in gross invoiced sales prices; and

(e)taxes, duties or other governmental charges (including any tax such as a value added or similar tax or government charge other than an income tax) levied on or measured by the billing amount for Collaborative Products, as adjusted for rebates and refunds.

In no event shall any particular amount, identified above, be deducted more than once in calculating Net Sales (i.e., no “double counting” of reductions). Sales of a Collaborative Product between a Party and its Affiliates for resale shall be excluded from the computation of Net Sales, provided that the subsequent resale of such Collaborative Product to a Third Party are included in the computation of Net Sales. Sale, disposal or use of such Collaborative Product for development or charitable purposes, such as clinical trials, compassionate use, named patient use, or indigent patient programs, without consideration, shall not be deemed a sale hereunder.

1.63“Parent” has the meaning set forth in the preamble.

1.64“Party” or “Parties” has the meaning set forth in the preamble.

1.65“Patents” means (a) patents, re-examinations, reissues, renewals, extensions and term restorations, and foreign counterparts of any of the foregoing, (b) pending applications for patents, including provisional applications, continuations, continuations-in-part, requests for 

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continued examination, divisional and substitute applications, including inventors’ certificates of any of the foregoing, and (c) foreign counterparts of any of the foregoing.

1.66“Phase 1 Study” means a human clinical trial in the U.S. that would satisfy the requirements for a Phase 1 study as defined in 21 CFR § 312.21(a) (or any amended or successor regulations), or its substantial equivalence if such clinical trial is conducted outside the U.S. 

1.67“Phase 2 Study” means a human clinical trial in the U.S. that would satisfy the requirements for a Phase 2 study as defined in 21 CFR § 312.21(b) (or any amended or successor regulations), or its substantial equivalence if such clinical trial is conducted outside the U.S. 

1.68“Phase 3 Study” means a human clinical trial in the U.S. that would satisfy the requirements for a Phase 3 study as defined in 21 CFR § 312.21(c) (or any amended or successor regulations), or its substantial equivalence if such clinical trial is conducted outside the U.S. 

1.69“Pivotal Trial” means: (a) a Phase 3 Study; or (b) any other human clinical trial that the applicable Regulatory Authority has agreed, whether before first dosing of the first patient in such trial (e.g., pursuant to a special protocol assessment agreement with the FDA) or after first dosing of the first patient in such trial (e.g., based on an interim data analysis), is sufficient to form the primary basis of an efficacy claim in an application for Regulatory Approval, regardless of whether the sponsor of such trial characterizes or refers to such trial as a “Phase 3,” “Phase 2b” or “Phase 2b/3” trial (or otherwise) in the applicable protocol, on clinicaltrials.gov, or in any other context. If a human clinical trial does not constitute a Pivotal Trial at the time of first dosing of the first patient in such trial, but is later determined by the applicable Regulatory Authority to be sufficient to form the primary basis of an efficacy claim in an application for Regulatory Approval, then, for purposes of this Agreement, “Initiation” of such Pivotal Trial shall be deemed to have occurred on the date of such determination by the applicable Regulatory Authority. 

1.70“Quality Agreement” has the meaning set forth in Section 4.3(b).

1.71“Receiving Party” has the meaning set forth in Section 9.1.

1.72“Regulatory Approval” means, with respect to a particular country or regulatory jurisdiction, all approvals (including any legally required pricing approvals) that are necessary for the commercial sale of a Collaborative Product in such country or regulatory jurisdiction. 

1.73“Regulatory Authority” means any country, federal, supranational, state or local regulatory agency, department, bureau or other governmental or regulatory authority having the administrative authority to regulate the development or marketing of pharmaceutical products in any country or other jurisdiction, including the FDA.

1.74“Representatives” has the meaning set forth in Section 9.1.

1.75“Royalty Term” has the meaning set forth in Section 6.1(d).

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1.76“SDEA” has the meaning set forth in Section 4.5(a).

1.77“SEC” has the meaning set forth in Section 9.3(b).

1.78“SFC” means Securities and Futures Commission of Hong Kong.

1.79“Successful Launch Milestone” has the meaning set forth in Section 6.1(c).

1.80“Term” has the meaning set forth in Section 11.1.

1.81“Third Party” means any person or entity other than a Party or an Affiliate of a Party.

1.82“Third Party Claim” has the meaning set forth in Section 8.1.

1.83“Tracon” has the meaning set forth in the preamble.

1.84“Tracon Delay” shall mean a delay in performance of any Development activity by or on behalf of Tracon that is subject to Tracon’s sole decision-making authority and control in violation of the terms and conditions of this Agreement. For clarity, the decision by the JSC to postpone or not to Initiate a clinical trial proposed in the Development Plan due to a change in the competitive landscape will not constitute a Tracon Delay.

1.85“Tracon Indemnitees” has the meaning set forth in Section 8.2.

1.86“Tracon IP” means any and all intellectual property rights, including Patents, copyrights, trademarks and Know-How that are (a) Controlled by Tracon or any of its Affiliates before the Effective Date, (b) developed or acquired by Tracon or any of its Affiliates independent of its performance of the Development Activities, and are not related to Collaborative Product.

1.87“Tracon Option” has the meaning set forth in Section 3.6(c).

1.88“U.S.” shall mean the United States of America and its territories and possessions.

1.89“Wind-Down Activities” has the meaning set forth in Section 11.5(c)(iv). 

Article 2
Governance

2.1Joint Steering Committee. 

(a)Establishment. The Parties hereby establish a joint steering committee (the “Joint Steering Committee” or the “JSC”) to oversee and coordinate the Development Activities and Commercialization of the Collaborative Products in the Collaborative Territory, and to encourage and facilitate the ongoing cooperation and communication between the Parties regarding matters related to such activities. 

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(b)Membership. The JSC shall consist of six (6) members total, with three (3) appointed by Eucure and three (3) appointed by Tracon, each of whom shall have appropriate technical credentials, experience, knowledge, and authority within such Party’s organization. Within [***] following the Effective Date, each Party shall designate its initial members to serve on the JSC. Each Party may replace its representatives on the JSC by written notice to the other Party. The Parties shall alternate, on a meeting by meeting basis, in appointing one (1) of their representatives on the JSC to act as the chairperson of the JSC for the meeting. The chairperson shall prepare and circulate agendas prior to each JSC meeting and subsequently, promptly provide to the Parties reasonably detailed drafts of the minutes of each such meeting. The Parties shall promptly discuss any comments on such minutes and finalize the minutes no later than [***] prior to the date of the next JSC meeting. The JSC members of each Party shall, where practical to do so, supply to the JSC members of the other Party copies of materials to be presented at a meeting at least [***] hours in advance of such meeting.

(c)Responsibilities. In particular, the JSC shall: 

(i)Review and approve the Development Plan for Development of Collaborative Product in the Field in the Collaborative Territory, and semi-annual updates to such Development Plan, including either Party’s proposal to substitute or add Indications to be pursued within the Field under the Development Plan pursuant to Section 3.6 and Section 4.1(b);

(ii)Monitor progress of the Development Plan for the Development of Collaborative Product in the Field in the Collaborative Territory, review relevant Development Data and timely share information on progress of such Development with the Parties;

(iii)Review and approve the selection of the CMO for Collaborative Product, if applicable, and monitor the establishment, qualification, compliance, and maintenance of the manufacturing facilities and processes for purposes of pre-clinical (if applicable), clinical, and commercial supply of Collaborative Product; provided that the Parties agree that Mabplex International Ltd. is approved as the CMO as of the Effective Date;

(iv)Review and approve proposals by Tracon for the conduct of clinical trials of a Collaborative Product in the Field at clinical sites in the Collaborative Territory;

(v)Review the Development Plan for Development of Collaborative Product in the Field in the Collaborative Territory, and coordinate the Parties’ activities with respect to the Commercialization of Collaborative Products in the Field in the Collaborative Territory; 

(vi)Review and approve proposals by Tracon to expand the Field to include additional Indications pursuant to Section 3.6;

(vii)Review and approve proposals by Eucure for additional clinical trials involving Collaborative Product beyond those in the then current Development Plan pursuant to Section 4.1(b);

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(viii)Serve as a forum for the discussion of any safety, scientific or technical concerns regarding the Development, manufacture or Commercialization of Collaborative Products;

(ix)Review quarterly reports provided by Tracon with respect to the planning for and progress of Commercialization activities for Collaborative Products in the Collaborative Territory pursuant to Section 5.1;

(x)Delegate any functions of the JSC to the JDC pursuant to the consensus of the JSC; and

(xi)Perform such other appropriate activities and functions and making such other appropriate decisions as agreed by the Parties in writing. 

(d)JSC Meetings. The JSC shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than once every quarter. Meetings of the JSC may be held in person, or by audio or video teleconference, provided that meetings shall be in person only be mutual agreement of the Parties. JSC meetings shall be chaired by a JSC representative of the Parties on an alternating basis and, if in-person, held at locations selected on an alternating basis by the Parties, with the first in-person JSC meeting to be chaired by a Eucure representative and held at a location to be selected by Eucure. In person meetings shall provide the opportunity for some, but not all, of a Party’s members to attend remotely by audio or video teleconference. Each Party shall be responsible for all of its own expenses in connection with participating in the JSC meetings. Each Party may from time to time invite a reasonable number of its representatives, who are not members of the JSC, to attend meetings in a non-voting capacity; provided that such participants are bound by confidentiality and non-use obligations consistent with the terms of this Agreement; and provided further that each Party shall provide reasonable prior written notice to the other Party if it has invited any Third Party (including any consultant) to attend such a meeting and the attendance of such Third Party shall be subject to the consent of the other Party. 

(e)Decision-Making. 

(i)All decisions of the JSC shall be made by unanimous vote, with each Party’s representatives collectively having one (1) vote. No vote of the JSC may be taken unless at least one of each Party’s representatives is present for the vote. Each Party shall be responsible for ensuring that, at all times, its representatives on the JSC act reasonably and in good faith in carrying out their respective responsibilities hereunder. 

(ii)If the JSC cannot reach consensus with regard to any matter within its authority within [***] after such matter has been brought to the JSC’s attention, such matter shall be referred to the Chief Executive Officer of each Party, who shall promptly meet and attempt in good faith to resolve such issue within [***] from the date upon which such matter is referred to them. In the event that such Chief Executive Officers are unable to resolve such issue within [***] of the issue being referred to them, then (i) with respect to all matters solely relating to Development and Commercialization of the Collaborative Product in the Field in the Collaborative 

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Territory, Tracon shall have the deciding vote; (ii) with respect to all matters solely relating to manufacture of the Collaborative Product, Eucure shall have the deciding vote; and (iii) with respect to all other matters properly before the JSC and not reserved for consensus of the Parties, Eucure shall have the deciding vote; provided, however, that, in each case (i)-(iii), (A) Tracon may not use such deciding vote to (x) disadvantage the Development and Commercialization of Collaborative Product in the Eucure Territory in comparison with its development and commercialization in the Field in the Collaborative Territory, (y) determine whether or not to approve the substitution or addition of an Indication pursuant to Section 3.6, or (z) determine whether or not a Tracon Delay has occurred under Section 4.1(d); and (B) Eucure may not use such deciding vote to disadvantage the Development and Commercialization of Collaborative Product in the Field in the Collaborative Territory in comparison with its development and commercialization by Eucure in the Eucure Territory. In all cases where a Party exercises its right to cast a deciding vote to resolve an impasse before the JSC, such Party shall give good faith consideration to the other Party’s position, and make reasonable efforts to take such Party’s position into account, in making such decision.

(f)Limitations of JSC Authority. The JSC shall only have the powers expressly assigned to it in this Article 2 and elsewhere in this Agreement, and shall not have the authority to: (i) modify or amend the terms and conditions of this Agreement; or (ii) decide any such issue in a manner that would conflict with the express terms and conditions of this Agreement.

2.2Joint Development Committee.

(a)General. Within [***] of the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or the “JDC”) to oversee (i) the execution of the Development Plan, (ii) the progress towards obtaining Regulatory Approvals for the Collaborative Product, (iii) the sharing of information regarding proposed clinical trial sites in the Collaborative Territory, and (iv) such other Development related activities delegated to it by the JSC. Each Party shall appoint three (3) representatives to the JDC, each of whom shall be an officer or employee of the applicable Party having sufficient knowledge regarding Development of the Collaborative Products. 

(b)Meetings. While the Parties are developing and conducting Clinical Trials for Collaborative Product in the Collaborative Territory, the JDC shall meet at least once per Calendar Quarter. The Parties shall endeavor to schedule meetings of the JDC at least [***] in advance.

(c) Decisions. All decisions of the JDC on matters for which it has responsibility shall be made unanimously, with each Party’s representatives on the JDC collectively having one vote. In the event that the JDC is unable to reach a unanimous decision within [***] after it has met and attempted to reach such decision, then either Party may, by written notice to the other Party, have such issue submitted to the JSC for resolution in accordance with Section 2.1(e). 

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LICENSE GRANT

3.1License Grant to Tracon. Subject to the terms and conditions of this Agreement, Eucure hereby grants an exclusive (even with respect to Eucure and its Affiliates), nontransferable, license to Tracon under the Collaborative Product IP and its rights in the Development IP for the Development and Commercialization of the Collaborative Products in the Field in the Collaborative Territory (the “Collaborative Products License”). The Collaborative Products License shall include a non-exclusive right to have the Collaborative Product manufactured and supplied pursuant to Sections 4.3 and 5.2, but Tracon shall not itself have the right to manufacture Collaborative Product.  For clarity, the licenses granted to Tracon under this Section 3.1 shall not include any rights to any molecule, other than the Antibody, that is proprietary to Eucure, its Affiliates or its (sub)licensees. 

3.2Sublicensing Rights. The Collaborative Products License shall not be sublicensable by Tracon except with the prior written consent of Eucure, in Eucure’s sole discretion. In the event the Parties agree to an arrangement whereby Tracon sub-licenses any rights under the Collaborative Products License to a Third Party Licensee in the Field in the Collaborative Territory, the Parties shall use good faith efforts to negotiate the sharing of all proceeds from such sublicense grant, on the basis of each Party’s investment in the discovery and Development of Collaborative Product.

3.3License Grant to Eucure. Tracon hereby grants to Eucure an irrevocable, perpetual, royalty-free, exclusive license, with the right to grant sublicenses, under its rights in all Development Data and Development IP to develop, register, sell, offer to sell, have sold, market and distribute the Collaborative Product in the Eucure Territory or outside the Field in the Collaborative Territory (provided that in the event that the scope of the Field changes, the scope of this license outside the Field shall adjust accordingly), and to make and have made the Collaborative Product anywhere in the world. Upon any expiration or termination of the Agreement (other than by Tracon pursuant to Section 11.2 or Section 11.4), Tracon shall grant Eucure an irrevocable, perpetual, royalty-free, non-exclusive license with the right to grant sublicenses under its rights in all Development Data and Development IP to develop, register, sell, offer to sell, have sold, market and distribute the Collaborative Product in the Collaborative Territory. 

3.4No Implied Licenses; Negative Covenants; Retained Rights. Except as expressly provided in this Agreement, neither Party shall be deemed to have granted to the other Party (by implication, estoppel or otherwise) any right, title, license or other interest in or with respect to any intellectual property rights or other information owned by or licensed to such Party or its Affiliates. Eucure hereby covenants that, during the Term, it and its Affiliates shall not engage in (or permit a Third Party to engage in) the Development or Commercialization of a Collaborative Product in the Field in the Collaborative Territory, except the Parties hereby agree as follows: (a) Eucure shall have the right to Develop any Eucure Combination Therapy in the Field in the Collaborative Territory; (b) Eucure shall have the right to Commercialize in the Collaborative Territory any component of the Eucure Combination Therapy other than Collaborative Product, and (c) Eucure shall have the right to conduct clinical trials of Collaborative Product in the Field in the Collaborative Territory as permitted under Section 4.1(b). Notwithstanding the exclusive

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license granted by Eucure to Tracon under Section 3.1, Eucure retains the rights under the Collaborative Product IP to directly or indirectly perform its obligations under this Agreement. For clarity, Eucure retains all rights under the Collaborative Product IP outside the scope of the licenses granted to Tracon under Section 3.1. Tracon hereby covenants that it shall not, nor shall it cause or permit any Affiliate or sublicensee to, use or practice, directly or indirectly, any Collaborative Product IP for any purposes other than those expressly permitted by this Agreement.  

3.5Tracon’s Rights to Develop in the United Kingdom and European Union. Tracon may from time to time request for the rights to the conduct of a clinical trial in the United Kingdom and European Union for the sole purpose of supporting the Development of Collaborative Products in the Field in the Collaborative Territory. Upon Eucure’s receipt of such proposal, the Parties will engage in good faith discussion of such request. Subject to Eucure’s grant of its written consent, which Eucure may withhold in its sole discretion, Tracon shall be permitted to Develop Collaborative Product in the United Kingdom and European Union solely through the conduct of such requested trial. Absent written consent from Eucure, Tracon shall have no right to conduct Development of Collaborative Product in the Eucure Territory. For clarity, the Collaborative Products License shall not include the right to Commercialize or seek Regulatory Approval of Collaborative Products in the Eucure Territory.

3.6Modification or Expansion of Field. 

(a)Modification. So long as Tracon is in compliance with and has not breached any of the terms under this Agreement (including without limitations its diligence obligations pursuant to Section 4.1(d)), Tracon shall have the right to propose to substitute an existing Indication in the Field with a new Indication with notice to the JSC and an explanation of Tracon’s view of its assessment of the relevant clinical and commercial competitive landscape for such proposed substitute Indication. Upon the approval in writing by Eucure, in its sole discretion, of such proposal by Tracon, the Field shall include such substitute Indication and the replaced Indication shall no longer be part of the Field. Notwithstanding the foregoing, Eucure agrees that the potential Indications listed in Schedule 3.6(a) are pre-approved by Eucure for substitution as an Indication in the Field under this Section 3.6.  In connection with any permitted substitution of Indications in the Field, Tracon shall amend the Development Plan to implement such change. 

(b)Expansion. Tracon may propose to the JSC to expand the Field to include additional Indications (beyond the Indications as of the Effective Date or any substitutes as permitted in Section 3.6(a)), including proposed amendments to the Development Plan to support such additional Indications. The JSC shall review and determine whether or not to approve such proposal, provided that Eucure’s JSC representatives shall not unreasonably withhold such approval, and upon such approval, the Field shall be amended to reflect such addition of Indications.

(c)Tracon Option. Eucure shall promptly notify Tracon (x) upon the completion (delivery of the final study report) of Eucure’s multiregional clinical trial (“MRCT”) Phase 2 Study of YH001 and toripalimab to treat non-small cell lung cancer (NSCLC) and HCC (Hepatocellular carcinoma) (the “Eucure Study Report”), (y) of any plans of Eucure, its Affiliates, its sublicensees or permittees for the submission of a BLA in the U.S. with respect to Collaborative Product and/or Eucure Combination Therapy (a “Eucure BLA Submission”) [***] 

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prior to such submission, and (z) the occurrence of any such Eucure BLA Submission. Subject to Eucure’s prior written approval (which shall be given in writing or deemed denied within [***] of written notice of Tracon’s intent to exercise the option), Tracon shall have the option, exercisable upon written notice to Eucure at any time during the period commencing on the [***] anniversary of the Effective Date and ending [***] after the earlier of (i) delivery to Tracon of the Eucure Study Report, or (ii) Eucure’s notice to Tracon of a Eucure BLA Submission, to expand the Field to include the Development and Commercialization of all human and veterinary therapeutic applications of the Collaborative Product administered by intravenous or subcutaneous means for all Indications (the “Tracon Option”) effective upon Tracon’s payment to Eucure of an option exercise fee of [***] dollars ($[***]), which payment shall be made concurrently with the delivery of the option exercise notice.  If Tracon exercises the Tracon Option before the delivery of the Eucure Study Report, Eucure nonetheless shall retain the right to complete the corresponding MRCT Phase 2 Study at the clinical sites in the Collaborative Territory and shall deliver the Eucure Study Report to Tracon upon its completion. 

3.7Exclusivity. 

(a)Subject to Section 3.4(a) during the Term, each Party shall not, and shall cause its Affiliates not to, directly or indirectly, (i) Develop, manufacture or Commercialize, or (ii) authorize (by license or otherwise) any Third Party to Develop, manufacture or Commercialize, any Competing Product in the Field in the Collaborative Territory (a “Competing Program”). For clarity, it shall not be a violation of the requirements of this Section 3.7 for a Party to Develop, manufacture or Commercialize a product other than an anti-CTLA-4 antibody where the label for such product directs that it be co-administered with a Third Party’s commercially available Competing Product, so long as such Party does not package such Competing Product with such product or otherwise Commercialize such Competing Product.

(b)In the event of (i) a Third Party becomes an Affiliate of such Party as a result of a transaction that does not result in a Change of Control of such Party, and (ii) as of the closing date of such transaction, such Third Party is engaged in the conduct of a Competing Program, then, within [***] after such closing date, such Affiliate shall either: (A) Divest the Competing Program to a Third Party, or (B) discontinue the Competing Program. Prior to such Divestiture or discontinuation during such [***] period, such Affiliate may conduct Competing Program activities without breaching the obligations of Section (a); provided that (x) such activities are conducted independently of the activities pursuant to this Agreement and do not use any Collaborative Product IP, Development Data, Development IP or Tracon IP, and (y) such Party shall, and shall cause its Affiliates to, (A) segregate such Competing Program from the Development, manufacture, Commercialization and other exploitation of Collaborative Product under this Agreement, and (B) establish reasonable firewalls to prevent disclosure of non-public plans or non-public information relating to the Collaborative Product or any Confidential Information of the other Party to any personnel of such Party or its Affiliates who are conducting the Competing Program. 

(c)In the event that (i) a Third Party becomes an Affiliate of such Party as a result of a Change of Control of such Party, and (ii) as of the closing date of such Change of Control, such Third Party is engaged in the conduct of a Competing Program, then such new Affiliate may continue to conduct such Competing Program activities without breaching the

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obligations of Section 3.7(a); provided that (x) such activities are conducted independently of the activities pursuant to this Agreement and do not use any Collaborative Product IP, Development Data, Development IP or Tracon IP, and (y) such Party shall, and shall cause its Affiliates to, (A) segregate such Competing Program from the Development, manufacture, Commercialization and other exploitation of Collaborative Products under this Agreement, and (B) establish reasonable firewalls to prevent disclosure of non-public plans or non-public information relating to the Collaborative Product or any Confidential Information of the other Party to any personnel of such Party or its Affiliates who are conducting the Competing Program. 

Article 4
Development; REGULATORY

4.1Development in the Collaborative Territory. 

(a)Overview; Development Plan. As between the Parties and subject to Eucure’s fulfillment of its obligations under Section 4.1(c) and Section 4.3, Tracon shall be solely responsible for Development of the Collaborative Product in the Field in the Collaborative Territory, at its sole cost and expense in accordance with a detailed written plan attached hereto as Schedule 4.1(a) (the “Development Plan”); provided, further, notwithstanding anything herein to the contrary Tracon shall not be obligated to commence a clinical trial of Collaborative Product unless the supply for the completion of such clinical trial has been delivered to Tracon or the necessary quantity has been manufactured and allocated for delivery to Tracon. The Development Plan (including any amendments or updates thereto) shall include a reasonably detailed plan setting forth the Development activities to be conducted by or on behalf of Tracon in support of obtaining Regulatory Approval for the Collaborative Product for each of the Indications in the Field in the Collaborative Territory, and shall at a minimum include the following information: (i) tumor type and stage of therapy; (ii) single agent and combinations dosed, control arms, and randomization; (iii) proposed dose and dosing intervals, including dose modifications and therapy for adverse events (including immune related adverse events); (iv) estimated number of patients (in each arm); (v) inclusion and exclusion criteria, such as age, labs, co-morbidities, or previous therapies; (vi) primary and secondary endpoints, including a brief description of how such endpoints will be measured and evaluated; and (vii) the clinical trials to be conducted during the time period covered by such plan, and a budget and a timeline for such clinical trials. The JSC shall review each Development Plan and updates as appropriate no less than once per Calendar Quarter, and the JDC shall oversee and facilitate cooperation and information transfer between the Parties in conducting the activities set forth in the Development Plan.

(b)Eucure Proposals for Additional Clinical Trials. During the Term, Eucure may propose to the JSC that certain additional clinical trials for Collaborative Product for intravenous or subcutaneous administration and involving either Indications or combinations not then included in the Development Plan be pursued under this Agreement. If the JSC approves such proposal, the JSC shall amend the Development Plan (and, if necessary, the Field pursuant to Section 3.6) to include Development of Collaborative Product with respect to such Indications, combinations and proposed clinical trials. If the JSC declines to approve a proposal for additional clinical trials by Eucure pursuant to this Section 4.1(b) for reasons other than reasonable concerns for patient safety, Eucure shall have the right to pursue such proposed clinical trial for Collaborative Product in the Collaborative Territory at its expense; provided that Eucure shall keep

18.

 

 

the JSC reasonably informed at each JSC meeting of its plans for, progress of, and the results of such clinical trials.  

(c)Technology Transfer; Assistance. Promptly following the Effective Date, Eucure shall provide to the JSC and Tracon, at Eucure’s expense, any information Controlled by Eucure that is necessary or reasonably useful for the Development and Commercialization of Collaborative Product in the Field in the Collaborative Territory (including without limitation all INDs filed anywhere in the world with respect to Collaborative Product, all human clinical trial results related to Collaborative Product’s effectiveness in the Field or safety, and all existing IND-enabling final reports and all CMC information that is (x) needed to file a BLA for the Collaborative Product in the Field in the Collaborative Territory and (y) Controlled by Eucure or a Third Party contracted by Eucure), pursuant to a technology transfer plan mutually agreed by the Parties. All information will be provided in English. Eucure shall permit Tracon a right to reference any IND or BLA filed by or on behalf of Eucure with respect to Collaborative Product (or for any co-formulation of Antibody with other products, but solely as it relates to Antibody) for the sole purpose of supporting Tracon’s IND or BLA for Collaborative Product in the Field in the Collaborative Territory. Eucure shall provide Tracon with reasonable assistance for the conduct, at Tracon’s cost and expense, of all IND-enabling and BLA-enabling Development activities for Collaborative Product in the Field in the Collaborative Territory, including, without limitation, transferring to Tracon the pharmacodynamic, pharmacokinetic, immunogenicity, and other bioanalytical assay, methods, and final reports for human plasma sample analysis through all phases of Development and all stability testing and non-clinical bridging studies.  

(d)Diligence. Tracon shall use Commercially Reasonable Efforts to Develop Collaborative Products in the Field in the Territory. Without limiting the generality of the foregoing, Tracon shall (i) Initiate a clinical trial for Collaborative Product consistent with the Development Plan within [***] following the later of (A) FDA clearance of the applicable IND and (B) receipt of adequate clinical supply of Collaborative Product at the mutually agreed supply depot pursuant to Section 4.3, and (ii) Initiate clinical trials for Collaborative Product for at least three (3) Indications in the Field before the [***] anniversary of the Completion of Tracon’s first clinical trial for a Collaborative Product under the Development Plan. If Tracon fails to meet the clinical milestones in either (i) or (ii) of the foregoing, the JSC shall determine whether such failure is a result of a Tracon Delay. If the JSC determines that Tracon’s failure to meet the clinical milestones in either (i) or (ii) of the foregoing is due to a Tracon Delay, or does not otherwise reach consensus with respect to a mitigation plan for such failure, such failure shall be deemed a material breach of this Agreement by Tracon for which Eucure may terminate this Agreement pursuant to Section 11.2  If the JSC determines that Tracon’s failure to meet the clinical milestones in either (i) or (ii) of the foregoing is not due to a Tracon Delay, the deadlines set forth in this Section 4.1(d) shall be extended by a reasonable time period; provided that Tracon shall continue to use Commercially Reasonable Efforts to achieve the clinical milestones in either (i) or (ii) of the foregoing as soon as practicable. 

(e)Performance Standards. Each party shall perform its activities under the Development Plan in accordance with the terms and conditions of this Agreement and Applicable 

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Laws, including GCP and GMP to the extent applicable. If there is any conflict between performance in accordance with Applicable Laws and this Agreement, performance in accordance with Applicable Laws shall prevail.

(f)Eucure Development in the Collaborative Territory.  Promptly following Tracon’s exercise of the Tracon Option, (i) Eucure shall assign to Tracon all regulatory filings for Collaborative Product in the Field (as expanded pursuant to Tracon’s exercise of the Tracon Option) within the Collaborative Territory (except to the extent necessary for Eucure to complete the MRCT Phase 2 Study as contemplated under Section 3.6(c)), (ii) Eucure shall provide Tracon with complete access and right of reference to all data generated by or on behalf of Eucure or its Affiliates in the course of, and as a result of, the Development of Collaborative Product in the Field (as expanded pursuant to exercise of Tracon Option) in the Collaborative Territory, including data related to all non-clinical studies and clinical trials of Collaborative Product in the Field (as expanded pursuant to exercise of Tracon Option) in the Collaborative Territory and related activities concerning manufacture process development, manufacture and distribution of such Collaborative Product for use in clinical trials in the Field (including placebos and comparators), statistical analyses, and the preparation and submission of regulatory materials and other regulatory activities related to such Collaborative Product in the Field, and (iii) Eucure shall permit Tracon to access all other data in the possession or control of Eucure related to Collaborative Product in the Field in support of Tracon’s Development and Commercialization of Collaborative Product in the Field in the Collaborative Territory.  For clarity, the data in (ii) and (iii) shall be deemed Collaborative Product IP and licensed to Tracon as part of the Collaborative Product License. 

4.2Development in the Eucure Territory. As between the Parties, Eucure shall have the sole right but not the obligation to Develop Collaborative Product in the Eucure Territory, at its sole cost and expense. Eucure shall have the right to access, use and reference all Development Data generated by or on behalf of Tracon or its Affiliates for the Collaborative Product in support of such Development activities in the Eucure Territory. Eucure shall keep Tracon and the JSC reasonably informed regarding the status of all Development Activities for Collaborative Products in the Field in the Eucure Territory. 

4.3Clinical Supply. 

(a)As between the Parties, Eucure, itself or through its designees, shall be solely responsible for manufacturing and supplying to Tracon, consistent with the requirements of this Section 4.3, all amounts of Collaborative Product necessary for Tracon to perform all pre-clinical and clinical studies for its Development of Collaborative Products, pursuant to a written clinical supply and quality agreement, which shall be separately negotiated and agreed in good faith by the Parties within [***] after the Effective Date (the “Clinical Supply and Quality Agreement”). The price for all Collaborative Product supplied by Eucure to Tracon for Development Activities for Collaborative Product shall be [***] percent ([***]%) of Eucure’s COGS for such Collaborative Product, and the Clinical Supply and Quality Agreement will include the terms set forth on Exhibit B. Eucure acknowledges and agrees that Tracon’s performance of the Development Activities is conditioned upon and subject to Eucure’s supply of Collaborative Product in compliance with the terms and conditions of this Agreement and the Clinical Supply

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and Quality Agreement. While Eucure supplies Collaborative Product for purposes of Development of Collaborative Product both in the Collaborative Territory as well as the Eucure Territory, the requirements for Development in the Field in the Collaborative Territory shall be given equal treatment with respect to requirements for use outside of the Field and/or Collaborative Territory in the event of a shortage or interruption of supply. In all events, Eucure shall not discontinue supplying Collaborative Product to Tracon under the terms of this Agreement so long as Eucure supplies Collaborative Product for any use or to any party. Notwithstanding anything herein to the contrary, until such time as Tracon exercises the Tracon Option with Eucure’s approval, Eucure shall bear the cost of the pre-clinical and clinical supply of Collaborative Product to Tracon at the depot in China designated by Tracon pursuant to this Section 4.3. 

(b)Eucure shall enter into a CMO Supply Agreement consistent with the terms of this Agreement. The Parties agree that the CMO shall initially be Mabplex International Ltd. which shall manufacture Collaborative Product in China. Eucure shall be responsible for the cost of packaging and shipment of Collaborative Product to a depot in China designated by Tracon in its discretion, and Tracon shall be responsible for, at its cost, the shipment (including export and import) of the Collaborative Product from such China depot to any U.S. depot and to clinical trial sites. The Parties will work together to manage exportation and importation of the Collaborative Product in accordance with importation laws of the U.S., China and other countries as applicable. Eucure shall use Commercially Reasonable Efforts to ensure that the CMO has adequate capabilities and necessary controls in place for the production, testing, and release of cGMP compliant and quality Collaborative Products necessary for all Development Activities and experience in supporting the submission of IND and BLA applications to the FDA with respect to the chemistry-manufacturing-controls activities sections of such IND and BLA applications. With respect to a CMO Supply Agreement with the CMO for Collaborative Product, the supply price in such agreement shall be the COGS for Collaborative Product supplied and charged from such CMO; provided that such price shall not be greater than the price charged by the same CMO to Eucure or its partners in China for supply of Collaborative Product that are manufactured in the same facility in the same period of time. Eucure shall annually provide Tracon with documentation providing the basis for establishment of COGS with respect to clinical supply of Collaborative Product. Eucure shall use Commercially Reasonable Efforts to cause the CMO to supply to Tracon the necessary documentation and information for the chemistry-manufacturing-controls activities section of the IND and BLA and all correspondence with the FDA and other Regulatory Authorities relevant to the supply of Collaborative Products. Tracon shall have conventional inspection and audit rights (which inspection and audit shall be conducted at Tracon’s own cost and expense) with respect to the manufacture and supply of Collaborative Products conducted by CMO including the right to participate in all FDA inspections concerning Collaborative Products, as a partner or consultant of Eucure to the extent legally able to do so. The Clinical Supply and Quality Agreements shall provide for the supply of Tracon’s requirements for Collaborative Product through the completion of all clinical trials and upon Commercialization of Collaborative Product in the Collaborative Territory. Eucure and Tracon shall enter into a quality agreement with the CMO concerning the manufacture and supply of Collaborative Product (such agreement a “Quality Agreement”). Tracon shall have the right to review and approve the Quality Agreement and provide input to Eucure on its terms. Eucure and Tracon shall use Commercially Reasonable Efforts to negotiate the terms and any necessary amendment to the Quality Agreement to include Tracon’s input, provide terms that are satisfactory to Tracon, and meet Tracon’s needs with respect to interactions with the FDA. Tracon shall have the right to review (at Tracon’s own cost and

21.

 

 

 

expense) all source documents that are relevant to Collaborative Product (including master and executed batch records, specifications, and product stability plan/data in English) and to request and participate as a partner or consultant of Eucure in quality audits of the CMO no more than [***], and in inspections by all Regulatory Authorities, with respect to records, processes and facilities relevant to Collaborative Product. In the event that Tracon requests more than [***] audit in a given [***], Eucure shall use Commercially Reasonable Efforts to implement such audit in coordination with the CMO, and Tracon agrees to bear the expense of such additional audit.

4.4Regulatory. 

(a)Regulatory Filings. As between the Parties, subject to this Section 4.4(a), Tracon shall be responsible for, at its sole cost and expense, preparing, translating and filing all regulatory materials, and obtaining and maintaining Regulatory Approvals, for the Collaborative Products in the Field in the Collaborative Territory, in compliance with all Applicable Laws. Prior to filing any regulatory materials that incorporates any CMC information for the Collaborative Products, Tracon shall submit a draft of such regulatory materials to Eucure for review and comment, and reasonably incorporate any of Eucure’s comments with respect to such CMC information. Tracon shall have the right to cross-reference Eucure’s IND for the Collaborative Product in the U.S. in support of Tracon’s Development and Commercialization of Collaborative Product for intravenous or subcutaneous administration in the Field in the Collaborative Territory. Eucure shall have the right, but not the obligation, to review and comment on all regulatory filings for any Collaborative Products to any Regulatory Authority in the Collaborative Territory, and Tracon shall reasonably incorporate any such comments in such regulatory filings prior to filing thereof and shall promptly provide copies of any regulatory filings (including all updates thereof) to Eucure. The Parties shall reasonably cooperate with each other in all material respects with respect to such regulatory submissions. Eucure and its Affiliates, licensees and sublicensee in the Eucure Territory or outside the Field in the Collaborative Territory shall have the right to cross-reference the regulatory filings and Regulatory Approvals of the Collaborative Product in the Collaborative Territory to support the Development and Commercialization of the Collaborative Product in the Eucure Territory or outside the Field in the Collaborative Territory.  

(b)Interactions with Regulatory Authorities. As between the Parties, subject to this Section 4.4(b), Tracon shall be responsible for, at its sole cost and expense, responding to inquiries and correspondence from the applicable Regulatory Authorities with respect to Collaborative Product in the Field in the Collaborative Territory. Eucure (or its designee) shall have a right to participate (and Tracon may otherwise request Eucure to participate) in meetings with the Regulatory Authorities if it is reasonably likely that there would be discussions on the agenda about the Collaborative Product beyond the scope of Tracon’s Development of the Collaborative Product the Collaborative Territory (e.g., CMC matters, clinical data generated by Eucure). Following each substantive communication (whether by phone or in person) with a Regulatory Authority with respect to the Collaborative Product in the Field in the Collaborative Territory, Tracon shall prepare a record of such meeting in accordance with its standard business practices (e.g., written minutes) and provide to Eucure a copy of such record.

(c)Product Recalls. In the event that any Regulatory Authority issues or requests a recall or takes similar action in connection with a Collaborative Product, or in the event a Party reasonably believes that an event, incident or circumstance has occurred impacting product

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data, quality, safety, or efficacy that may result in the need for a voluntary or mandatory recall, market withdrawal or other corrective action regarding a Collaborative Product, such Party shall promptly so advise the other Party by telephone or email. Tracon shall decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it shall be required) or to take other corrective action in the Field in any country of the Collaborative Territory and the manner in which any such recall, market withdrawal or corrective action shall be conducted; provided that, Tracon shall (i) give prompt and due consideration to any report by Eucure of any failure of Collaborative Product supplied by or on behalf of Eucure to Tracon to comply with any quality standard set forth in the Clinical Supply and Quality Agreement (or other supply agreement or quality agreement between the Parties); (ii) notify Eucure prior to making any public disclosure of the recall, market withdrawal or corrective action; and (iii) shall keep Eucure regularly informed regarding any such recall, market withdrawal or corrective action. Tracon shall be solely responsible for all costs incurred in connection with any such recall, market withdrawal or corrective action for a Collaborative Product in the Field in the Collaborative Territory, provided that to the extent the recall is a result of the failure of any Collaborative Product supplied by or on behalf of Eucure to Tracon to comply with any quality standard set forth in the Clinical Supply and Quality Agreement (or other supply agreement or quality agreement between the Parties), the costs of the recall shall be borne by Eucure (except to the extent that such costs are exacerbated due to delay or inaction by Tracon after such failure to comply has been reported or become known to Tracon). Eucure shall decide and have control of whether to conduct a recall or market withdrawal (except in the event of a recall or market withdrawal mandated by a Regulatory Authority, in which case it shall be required) or to take other corrective action in the Eucure Territory and the manner in which any such recall, market withdrawal or corrective action shall be conducted; provided that Eucure shall notify Tracon prior to making any public disclosure of the recall, market withdrawal or corrective action and shall keep Tracon regularly informed regarding any such recall, market withdrawal or corrective action. Eucure shall be solely responsible for all costs incurred in connection with any such recall, market withdrawal or corrective action for a Collaborative Product in the Eucure Territory.

(d)Power of Attorney.  Eucure hereby irrevocably designates and appoints Tracon and its duly authorized officers and agents as Eucure’s agent and attorney-in-fact to act for and in Eucure’s behalf to execute, deliver, and file any and all letters granting rights of reference to Eucure BLAs with the same legal force and effect as if executed by Eucure if and solely to the extent that Tracon is unable for any reason to secure Eucure’s signature on any such letters granting rights of reference that Eucure is required to execute and deliver pursuant to Sections 4.1 or 4.4 above. 

4.5Safety Data Exchange. 

(a)Prior to the initiation of the first clinical trial of Collaborative Product by Tracon, the Parties shall negotiate in good faith and enter into a Safety Data Exchange Agreement (“SDEA”) for the Collaborative Product, with customary terms and conditions consistent with industry standard practices for the Development of the Collaborative Product. With respect to clinical trials being carried out by or on behalf of Tracon and with respect to clinical trials being carried out by or on behalf of Eucure in the Eucure Territory, each Party agrees pursuant to this Agreement, during the Term hereof, to establish and abide by safety data exchange procedures for

23.

 

 

 

individual case safety reports (ICSRs) and safety aggregate reports and any other safety information required, to support each other to meet the regulatory authority requirements in its respective Territory. All such exchanges will be in English. The ICSRs exchange timeline will be set up as following: fatal/ life-threatening serious adverse experiences (SAEs) will be exchanged within [***] of date of awareness; non-fatal/life-threatening SAEs will be exchanged within [***] of date of awareness. The exchange timeline for other safety reports will be also clearly defined in the SDEA. Above terms, which used herein, shall have the meaning as defined in the ICH E2A, B, C, D, E, F and their interpretation in applicable local legislation in both Parties’ territories. 

(b)Further, no later than [***] before the anticipated launch date of any Collaborative Product in the Collaborative Territory, the Parties shall enter into a separate SDEA, with customary terms and conditions consistent with industry standard practices for the Commercialization of the Collaborative Product. Each SDEA shall include mutually acceptable guidelines and procedures for the receipt, investigation, recording, communication, and exchange of adverse event reports between the Parties, pregnancy reports, and any other information concerning the safety of the Collaborative Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations under Applicable Laws. Furthermore, such agreed procedure shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory reporting safety reporting requirement, in which case local reporting requirement shall prevail.

Article 5
COMMERCIALIZATION

5.1Commercialization in the Collaborative Territory. As between the Parties, Tracon shall be solely responsible for the Commercialization of Collaborative Products in the Field in the Collaborative Territory. Upon procurement of Regulatory Approval of the Collaborative Product for an Indication in the Field in any country in the Collaborative Territory, Tracon shall use Commercially Reasonable Efforts to Commercialize the Collaborative Product for such Indication in the Field in such country. Tracon shall book all sales of Collaborative Products in the Field in the Collaborative Territory during the Term. No less than [***] prior to the anticipated First Commercial Sale of the Collaborative Product in the Field in the Collaborative Territory and each anniversary of the First Commercial Sale thereafter, Tracon shall provide Eucure with a written report that summarizes, in reasonable detail, the Commercialization activities performed during such time period. Additionally, Tracon shall report to the JSC on a quarterly basis regarding its planning for and the progress of Commercialization activities with respect to the Collaborative Product in the Field in the Collaborative Territory. 

5.2Commercial Supply. 

As between the Parties, Eucure, itself or through its designees, will be solely responsible for Manufacturing Collaborative Product for all commercial uses in the Collaborative Territory. Eucure shall use Commercially Reasonable Efforts to supply, or cause to be supplied, to Tracon all amounts of Collaborative Product necessary for Tracon to Commercialize Collaborative Product in the Field in the Collaborative Territory, at Eucure’s COGS for such Collaborative 

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Product plus a [***] percent ([***]%) markup. No later than [***] prior to the anticipated First Commercial Sale of the Collaborative Product in the Field in the Collaborative Territory, the Parties shall negotiate in good faith and enter into a written commercial supply and quality agreement, which will be consistent with the terms of this Agreement and include customary terms and conditions consistent with industry standard practices for such a commercial supply arrangement. 

(a)Eucure shall enter into CMO Supply Agreements with one or more CMOs for the supply of Collaborative Product in quantities sufficient for the Commercialization of Collaborative Product in the Field in the Collaborative Territory, which arrangements shall be on terms reasonably acceptable to Tracon. Eucure shall be responsible for the shipment of Collaborative Product to a Tracon designated depot in the U.S.; The Parties will work together to manage importation of the Collaborative Product in accordance with importation laws of the U.S., China and other countries as applicable. For clarity, upon Eucure’s entry into a CMO Supply Agreement with a CMO for Collaborative Product, the COGS for Collaborative Product shall be the supply price in such agreement; provided that such COGS amount shall not be greater than the price charged by same CMO to Eucure or its partners in China for supply of Collaborative Product that are manufactured in the same facility in the same time period. Eucure shall annually provide Tracon with documentation providing the basis for establishment of COGS with respect to commercial supply of Collaborative Product. Within [***] of commercial launch of Collaborative Product in the Field in the Collaborative Territory, Eucure shall use Commercially Reasonable Efforts to establish a second source of commercial supply of such Collaborative Product by entering into a second CMO Supply Agreement with a CMO on terms that are reasonably acceptable to Tracon. In the event that the CMO supplies Collaborative Product for purposes of Commercialization of Collaborative Product in both the Collaborative Territory and the Eucure Territory, the requirements for Commercialization in the Collaborative Territory shall be given equal treatment with respect to requirements for use outside of the Field and/or in the Eucure Territory in the event of a shortage or interruption of supply.

(b)Substitute Supply. In the event of an uncured material breach of Eucure’s obligation to supply Collaborative Product as required under this Agreement (or any failure to supply at least [***] ([***]%) of the aggregate amount of firm orders for Collaborative Product placed by Tracon in accordance with its binding forecast during a [***] period, the details of which will be set forth in the commercial supply agreement between the Parties as contemplated in this Section 5.2), (i) Tracon shall have the right to enter into a direct supply agreement with a CMO of its choosing for the supply of all of its requirements for the Development and Commercialization of Collaborative Product, and (ii) Eucure shall provide to such CMO, at Eucure’s expense, any information Controlled by Eucure that is necessary or reasonably useful to enable such CMO to manufacture Collaborative Product. 

5.3Pricing. As between the Parties, Tracon shall have the sole right to make all decisions regarding the pricing of the Collaborative Product in the Field in the Collaborative Territory; provided that, if Tracon sells the Collaborative Product in a “bundle” with one or more other products or services at a discount to the purchaser, then Tracon shall not disproportionately or unreasonably discount such Collaborative Product relative to the other products or services composing such bundle. As between the Parties, Eucure shall have the sole right to make all 

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decisions regarding the pricing of the Collaborative Product in the Eucure Territory. Notwithstanding anything in this Agreement express or implied to the contrary, Eucure shall not have any right to direct, control, or approve Tracon’s decisions regarding the pricing of Collaborative Products for the Collaborative Territory. Tracon shall inform Eucure of the results of any pricing approval and update thereof, through the JSC, provided that the provision to Eucure of such information shall be for informational purposes only. 

5.4No Diversion.

(a)Tracon shall not, and shall ensure that its Affiliates do not, either directly or indirectly, promote, market, distribute for sale, import for sale, sell or have sold the Collaborative Product, including via internet or mail order, into countries of the Eucure Territory. As to such countries of the Eucure Territory (which are exclusively reserved for Eucure), Tracon shall not, and shall ensure that its Affiliates do not: (i) establish or maintain any branch, warehouse or distribution facility for sale of the Collaborative Product in such countries, (ii) engage in any advertising or promotional activities relating to the Collaborative Product that are directed primarily to customers or other purchasers of the Collaborative Product located in such countries, (iii) solicit orders for the Collaborative Product from any prospective purchaser located in such countries, or (iv) sell or distribute for sale the Collaborative Product to any person in the Collaborative Territory who intends to sell or has in the past sold the Collaborative Product in such countries. If Tracon receives any order for the Collaborative Product from a prospective purchaser located in a country in the Eucure Territory, Tracon shall immediately refer that order to Eucure and Tracon will not accept any such orders. Tracon shall not deliver or tender for sale (or cause to be so delivered or tendered) the Collaborative Product into a country in the Eucure Territory. Tracon shall not, and shall ensure that its Affiliates do not, restrict or impede in any manner Eucure’s exercise of its retained exclusive rights in the Collaborative Product in the Eucure Territory.

(b)Eucure shall not, and shall ensure that its Affiliates and sub-licensees do not, either directly or indirectly, promote, market, distribute for sale, import for sale, sell or have sold the Collaborative Product in the Field, including via internet or mail order, into countries within the Collaborative Territory. As to such countries within the Collaborative Territory, Eucure shall not, and shall ensure that its Affiliates and sub-licensees do not: (i) establish or maintain any branch, warehouse or distribution facility for sale of the Collaborative Product in the Field in such countries, (ii) engage in any advertising or promotional activities relating to the Collaborative Product in the Field that are directed primarily to customers or other purchasers of the Collaborative Product located in such countries, (iii) solicit orders for the Collaborative Product in the Field from any prospective purchaser located in such countries, or (iv) sell or distribute for sale the Collaborative Product to any person in the Eucure Territory who intends to sell or has in the past sold the Collaborative Product in the Field in such countries within the Collaborative Territory. If Eucure receives any order for the Collaborative Product in the Field from a prospective purchaser located in a country within the Collaborative Territory, Eucure shall immediately refer that order to Tracon and Eucure shall not accept any such orders. Eucure shall not deliver or tender for sale (or cause to be so delivered or tendered) the Collaborative Product in the Field into a country within the Collaborative Territory. Eucure shall not, and shall ensure that its Affiliates 

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and sub-licensees do not, restrict or impede in any manner Tracon’s exercise of its exclusive rights in the Collaborative Product in the Field within the Collaborative Territory.

Article 6
Financial provisions

6.1Royalties. 

(a)Royalty Rate. Subject to the remainder of this Section 6.1, on a country-by-country basis, during the Royalty Term, Tracon shall pay a royalty to Eucure on Net Sales of Collaborative Product in the Collaborative Territory, as calculated by multiplying the Net Sales amount with the applicable royalty rate set forth in the table below. 

			
	
Calendar Year Net Sales Threshold 
	
Royalty rate through the end of the first full Calendar Year following First Commercial Sale of Collaborative Product in the Collaborative Territory
	
Royalty rate for all periods after the first full Calendar Year of following First Commercial Sale of Collaborative Product in the Collaborative Territory

	
Up to $[***]
	
[***]%
	
[***]%

	
Above $[***] and up to $[***]
	
[***]%
	
[***]%

	
Above $[***] and up to $[***]
	
[***]%
	
[***]%

	
Above $[***]
	
[***]%
	
[***]%

 

(b)Royalty Payments and Reports. The royalty set forth in this Section 6.1 shall be payable within [***] following the end of each Calendar Quarter. No later than the end of such [***] period, Tracon shall provide to Eucure a report summarizing the amount of Net Sales of Collaborative Product sold in the Field, on a country-by-country basis, in the Collaborative Territory and the amount of royalty owed with respect to such Net Sales for such Calendar Quarter. 

(c)Successful Launch Milestone. If the total Net Sales for Collaborative Product in the Collaborative Territory in the first full Calendar Year following First Commercial Sale exceeds [***] dollars ($[***]) (“Successful Launch Milestone”), Tracon shall indicate the achievement of such Successful Launch Milestone in the applicable royalty report for the Calendar Quarter in which such Successful Launch Milestone is achieved, and concurrently make a one-time payment of [***] dollars ($[***]) to Eucure. If the Successful Launch Milestone is not met with respect to such first Calendar Year following First Commercial Sale, Tracon shall have no payment obligation with respect to this Section 6.1(c).

(d)Royalty Term. Royalties under this Section 6.1 shall be payable, on a country-by country basis, starting from the First Commercial Sale of the Collaborative Product in such country and until the latest of (i) expiration of the last to expire of the Patents within the Collaborative Product IP covering the Collaborative Product or its use in the Field in such country, (ii) expiration of marketing or regulatory exclusivity for the Collaborative Product in such country, 

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and (iii) ten years from First Commercial Sale of such Collaborative Product in such country in the Collaborative Territory (the “Royalty Term”).

6.2Currency; Exchange Rate. All payments to be made under this Agreement shall be made in US Dollars by bank wire transfer in immediately available funds to a bank account designated by written notice from the receiving Party. When conversion of payments from any foreign currency is required, such conversion shall be at an exchange rate equal to the weighted average of the rates of exchange for the currency of the country from which such payments are payable as published by The Wall Street Journal, Western U.S. Edition during the quarter for which a payment is due. The payment of such interest shall not limit the Party entitled to payment from exercising any other rights it may have as a consequence of the lateness of any payment.

6.3Late Payments. If a Party does not receive payment of any sum due to it on or before the due date therefor, simple interest shall thereafter accrue on the sum due to such Party from the due date until the date of payment at a per-annum rate of prime reported in The Wall Street Journal, Western U.S. Edition on the due date of the payment plus [***] percent ([***]%) per annum, or the maximum rate allowable by Applicable Laws, whichever is less. 

6.4Financial Records; Audit. 

(a)Tracon shall keep, and require its Affiliates, to keep, reasonably detailed, fair and true books of accounts and records for the purpose of determining the amounts payable to Eucure pursuant to this Agreement. Eucure shall keep, and require the CMO, to keep, reasonably detailed, fair and true books of accounts and records for the purpose of determining the amounts of COGS for Collaborative Product. In each case, such books and records shall be kept for at least [***] following the end of the year to which they pertain. 

(b)Tracon shall allow an independent certified public accountant selected by Eucure and reasonably acceptable to Tracon to audit its records for such year to verify the accuracy of any financial report furnished by Tracon and any amounts to be paid under this Agreement for the preceding [***]. Such audits may be exercised during normal business hours and no more frequently than once per calendar year upon reasonable prior written notice to Tracon. The cost of such any audit shall be borne by Eucure, unless the audit discloses an underpayment by Tracon of more than [***] percent ([***]%) of the amount of payments due under this Agreement for the period under audit, in which case, Tracon shall bear the cost of such audit. 

(c)Eucure shall allow an independent certified public accountant selected by Tracon and reasonably acceptable to Eucure to audit its records to verify the accuracy of COGS as stated by Eucure for the preceding [***]. Such audits may be exercised during normal business hours and no more frequently than [***] per [***] upon reasonable prior written notice to Eucure. The cost of such any audit shall be borne by Tracon, unless the audit discloses an overpayment by Tracon of more than [***] percent ([***]%) of the amount of payments due under this Agreement for the period under audit, in which case, Eucure shall bear the cost of such audit.

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(d)Any amounts shown to be owed but unpaid, or overpaid and in need of refund, by Tracon shall be paid or refunded (as the case may be) within [***] after the accountant’s report, plus interest (as set forth in Section 6.3) from the original due date on any amounts underpaid (but interest shall not apply to overpayments). In the event that any audit of COGS establishes that the COGS charged by Eucure for Collaborative Product exceeded the actual COGS, Eucure shall refund Tracon the excess amount charged for Collaborative Product within [***] after the accountant’s report, plus interest (as set forth in Section 6.3) from the date of Tracon’s overpayment for such Collaborative Product. 

6.5Tax. 

(a)Taxes on Income. Each Party shall be solely responsible for the payment of all taxes imposed on its share of income, including any payments received, as contemplated in this Agreement. 

(b)Tax Cooperation. The Parties agree to cooperate with one another and use reasonable efforts to take all such action as shall avoid or reduce tax withholding or similar obligations in respect of any payments made by a Party to the other Party under this Agreement and take advantage of any applicable double taxation agreement or treaty. Eucure shall deliver to Tracon an Internal Revenue Service Form W-8BEN-E claiming the benefits of the income tax convention between the United States and The People’s Republic of China within [***] after the Effective Date.

(c)Payment of Tax. To the extent a Party is required by Applicable Laws to deduct and withhold taxes on any payment to the other Party, the paying Party shall pay the amounts of such taxes to the proper tax authority in a timely manner and promptly transmit to the other Party an official tax certificate or other evidence of such withholding sufficient to enable such other Party to claim such payment of taxes.  

Article 7
Representations, Warranties and covenants

7.1Mutual Representations and Warranties. Each Party hereby represents, warrants, to the other Party that, as of the Effective Date:

(a)Corporate Existence and Power. It is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including, without limitation, the right to grant the licenses granted by it hereunder.

(b)Authority and Binding Agreement. (i) It has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and

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delivery of the Agreement and the performance of its obligations hereunder; and (iii) the Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms.

(c)No Conflict. It is not a party to any agreement that would materially prevent it from granting the rights granted to the other Party under this Agreement or performing its obligations under the Agreement.

7.2Additional Representations and Warranties of Eucure. Eucure represents and warrants to Tracon that, as of the Effective Date:

(a)Eucure (i) has the right to grant the Collaborative Products License that it purports to grant in Section 3.1 and all other rights granted to Tracon herein; (ii) has not granted and will not grant any right to any Third Party that would conflict with or adversely affect such Collaborative Products License or rights; and (iii) possesses all necessary rights in intellectual property for the Development and Commercialization of Collaborative Product in the Collaborative Territory;

(b)neither Eucure nor any of its Affiliates has granted any license or right to obtain any license to any Third Party to the Collaborative Product IP in the Field in the Collaborative Territory; 

(c)there are no actual, pending, or to Eucure’s knowledge, alleged or threatened, adverse actions, suits, proceedings, or claims against Eucure (or facts providing the basis for such an action, suit, proceeding or claim) involving the Collaborative Product or the Collaborative Product IP, nor has Eucure received any written communication from any Third Party, including, without limitation, any Regulatory Authority or other government agency, threatening such action, suit or proceeding; 

(d)neither Eucure nor any of its Affiliates has filed any regulatory filing for the Collaborative Product in the Field in the Collaborative Territory except as identified in Schedule 7.2(d); 

(e)all tangible or recorded information and data provided by or on behalf of Eucure to Tracon related to the Collaborative Product is true, accurate and complete in all material respects, and Eucure has not failed to disclose, or failed to cause to be disclosed, any such information or data related to the Collaborative Product in its Control that would cause the information and data that has been disclosed to be misleading in any material respect;  

(f)Eucure is not debarred or disqualified under the United States Federal Food, Drug and Cosmetic Act or comparable Applicable Laws in the Territory, and it has not employed or used the services of any person who is debarred or disqualified in connection with activities relating to any pharmaceutical products; and

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(g)there are no legal claims, judgments or settlements against or owed by Eucure or any of its Affiliates, or pending or, to Eucure’s knowledge, threatened, legal claims or litigation, in each case, relating to antitrust, anti-competition, anti-bribery or corruption violations. 

7.3Additional Representations and Warranties of Tracon. Tracon represents, warrants, and covenants to Eucure that, as of the Effective Date:

(a)Tracon shall conduct the Development Activities performed by it pursuant to the Development Plan in a competent and professional manner and the personnel assigned to perform Development Activities rendered by Tracon under this Agreement shall be qualified and professionally capable of performing the Development Activities;  

(b)Tracon is not debarred or disqualified under the United States Federal Food, Drug and Cosmetic Act or comparable Applicable Laws in the Territory, and it has not employed or used the services of any person who is debarred or disqualified in connection with activities relating to any pharmaceutical products; and 

(c)there are no legal claims, judgments or settlements against or owed by Tracon or any of its Affiliates, or pending or, to Tracon’s knowledge, threatened, legal claims or litigation, in each case, relating to antitrust, anti-competition, anti-bribery or corruption violations. 

7.4Eucure Covenants. In addition to any covenants made by Eucure elsewhere in this Agreement, Eucure hereby covenants to Tracon as follows: 

(a)All Collaborative Product supplied to Tracon will meet approved specifications and be provided with a certificate of analysis indicating that drug substance and drug product meets specifications and has at least [***] of stability under refrigerated conditions, and that no Collaborative Product has been out of specification in ongoing stability testing.

(b)Eucure will not knowingly employ or use the services of any person who is debarred or disqualified in connection with activities relating to Development of Collaborative Product; and, in the event that Eucure becomes aware of the debarment or disqualification or threatened debarment or disqualification of any person providing services to Eucure with respect to any activities relating to the Collaborative Product, Eucure will immediately notify Tracon in writing and Eucure will cease employing, contracting with, or retaining any such person to perform any services relating to such Collaborative Product; 

(c)Eucure will not, in connection with the performance of its obligations under this Agreement, directly or indirectly through Third Parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to a public official or entity or other person for purpose of obtaining or retaining business for or with, or directing business to, any person, including Eucure, nor will Eucure directly or indirectly promise, offer or provide any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a public official or

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entity or any other person in connection with the performance of Eucure’s obligations under this Agreement;

(d)Eucure and its employees and contractors, in connection with the performance of Eucure’s obligations under this Agreement, shall not knowingly cause Tracon to be in violation of the FCPA, Export Control Laws, or any other Applicable Laws; 

(e)Eucure has a policy or practice in place against corruption and bribery and in connection with the performance of its obligations under this Agreement, Eucure shall comply and shall cause its and its Affiliates’ employees to comply with Eucure’s such policy or practice; and

(f)Eucure shall comply in all material aspects with all Applicable Laws in the course of performing its obligations and exercising its rights under this Agreement, and immediately notify Tracon if it has any information or suspicion that there may be a violation of the FCPA, Export Control Laws, or any other Applicable Laws in connection with the performance of its obligations under this Agreement.

7.5Tracon Covenants. In addition to any covenants made by Tracon elsewhere in this Agreement, Tracon hereby covenants to Eucure as follows: 

(a)Tracon will not knowingly employ or use the services of any person who is debarred or disqualified in connection with activities relating to the Collaborative Product; and in the event that Tracon becomes aware of the debarment or disqualification or threatened debarment or disqualification of any person providing services to Tracon with respect to any activities relating to the Collaborative Product; Tracon will immediately notify Eucure in writing and Tracon will cease employing, contracting with, or retaining any such person to perform any services relating to such Collaborative Product; 

(b)Tracon will not, in connection with the performance of its obligations under this Agreement, directly or indirectly through Third Parties, pay, promise or offer to pay, or authorize the payment of, any money or give any promise or offer to give, or authorize the giving of anything of value to a public official or entity or other person for purpose of obtaining or retaining business for or with, or directing business to, any person, including Tracon, nor will Tracon directly or indirectly promise, offer or provide any corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a public official or entity or any other person in connection with the performance of Tracon’s obligations under this Agreement;

(c)Tracon and its employees and contractors, in connection with the performance of Tracon’s obligations under this Agreement, shall not knowingly cause Eucure to be in violation of the FCPA, Export Control Laws, or any other Applicable Laws; 

(d)Tracon has a policy or practice in place against corruption and bribery and in connection with the performance of its obligations under this Agreement, Tracon shall comply 

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and shall cause its and its Affiliates’ employees to comply with Tracon’s such policy or practice; and

(e)Tracon shall comply in all material aspects with all Applicable Laws in the course of performing its obligations and exercising its rights under this Agreement, immediately notify Eucure if it has any information or suspicion that there may be a violation of the FCPA, Export Control Laws, or any other Applicable Laws in connection with the performance of its obligations under this Agreement. 

7.6Performance by Affiliates and Subcontractors. The Parties recognize that each Party may perform some or all of its obligations or exercise some or all of its rights under this Agreement through one or more Affiliates or subcontractors; provided, in each case, that (a) none of the other Party’s rights hereunder are diminished or otherwise adversely affected as a result of such delegation or subcontracting, and (b) each such Affiliate, subcontractor, licensee or sublicensee undertakes in writing obligations of confidentiality and non-use regarding Confidential Information and ownership of intellectual property rights which are substantially the same as those undertaken by the parties pursuant to Article 9; and provided, further, that such Party shall at all times be fully responsible for the performance and payment of such Affiliate, subcontractor, licensee or sublicensee.

7.7Disclaimer. EXCEPT AS EXPRESSLY STATED IN THIS ARTICLE 7, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, IS MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL SUCH REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED. Each Party understands that Collaborative Product is the subject of ongoing research and development and that neither Party can assure that the Collaborative Product can successfully complete clinical trials, nor that the Collaborative Product can be successfully Developed and Commercialized in the Field in the Territory. 

Article 8
Indemnification; limitation of liability

8.1Indemnification by Tracon. Tracon hereby agrees to defend, hold harmless and indemnify each of Eucure, its Affiliates and their agents, shareholders, directors, officers, employees and consultants, and the successors and assigns of any of the foregoing (the “Eucure Indemnitees”) from and against any and all liabilities, expenses and losses, including reasonable legal expenses and attorneys’ fees (collectively “Losses”), incurred by any Eucure Indemnitee as a result of any suits, claims, actions and demands brought by a Third Party (each, a “Third Party Claim”) arising directly or indirectly out of (a) any breach of any representations, warranties, covenants or agreements by Tracon under this Agreement, or (b) the negligence or willful misconduct of any Tracon Indemnitee, or (c) the research, development, manufacture, use, 

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handling, storage, sale or other disposition of the Collaborative Product by Tracon or its Affiliates, licensees or sublicensees; provided that, Tracon’s obligation to indemnify the Eucure Indemnitees pursuant to this Section 8.1 shall not apply to the extent that any such Losses arise from any activities for which Eucure is obligated to indemnify Tracon Indemnitees under Section 8.2. 

8.2Indemnification by Eucure. Eucure hereby agrees to defend, hold harmless and indemnify Tracon, its Affiliates and their agents, directors, officers, employees and consultants, and the successors and assigns of any of the foregoing (the “Tracon Indemnitees”) from and against any and all Losses incurred by any Tracon Indemnitee as a result of any Third Party Claims arising directly or indirectly out of (a) any breach of any representations, warranties, covenants or agreements by Eucure under this Agreement, (b) the negligence or willful misconduct of Eucure Indemnitees, or (c) the research, development, manufacture, use, handling, storage, sale or other disposition of the Collaborative Product by Eucure or its Affiliates, licensees or sublicensees; provided that, Eucure’s obligation to indemnify the Tracon Indemnitees pursuant to the foregoing sentence shall not apply to the extent that any such Losses arise from any activities for which Tracon is obligated to indemnify Eucure Indemnitees under Section 8.1. 

8.3Procedure. The indemnified Party shall provide the indemnifying Party with prompt notice of the claim giving rise to the indemnification obligation pursuant to this Article 8 and the exclusive ability to defend (with the reasonable cooperation of the indemnified Party) or settle any such claim; provided, however, that the indemnifying Party shall not enter into any settlement for damages other than monetary damages without the indemnified Party’s written consent, such consent not to be unreasonably withheld. The indemnified Party shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the indemnifying Party. If the Parties cannot agree as to the application of Sections 8.1 and 8.2 to any particular Third Party Claim, the Parties may conduct separate defenses of such Third Party Claim. Each Party reserves the right to claim indemnity from the other Party in accordance with Sections 8.1 and 8.2 above upon resolution of the underlying claim, notwithstanding the provisions of this Section 8.3 requiring the indemnified Party to tender to the indemnifying Party the exclusive ability to defend such claim or suit. The failure to deliver written notice to the indemnifying Party within a reasonable time after the commencement of any action with respect to a Third Party Claim shall only relieve the indemnifying Party of its indemnification obligations under this Article 8 if and to the extent the indemnifying Party is actually prejudiced thereby.

8.4Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES OR LOSS OF PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS ARTICLE 8 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 8.1 OR 8.2, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 9.

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8.5Insurance.  Each Party, at its own expense, shall maintain product liability and other appropriate insurance (or self-insure) in an amount consistent with sound business practice in the region(s) where the Party operates and reasonable in light of its obligations under this Agreement. Each Party shall provide a certificate of insurance (or evidence of self-insurance) evidencing such coverage to the other Party upon request. 

Article 9
Confidentiality

9.1Confidentiality. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, each Party (in such capacity, the “Receiving Party”) agrees that, for the Term and for a period of [***] thereafter, it shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement (which includes the exercise of any rights or the performance of any obligations hereunder) any Confidential Information of the other Party (in such capacity, the “Disclosing Party”). Pursuant to Section 10.1, Development Data should be deemed as Confidential Information of Eucure. The Receiving Party shall use at least the same standard of care as it uses to protect proprietary or confidential information of its own (but in no event less than reasonable care) to ensure that its, and its Affiliates’, employees, directors, officers, agents, consultants, advisors (including legal, accounting, or other professional advisors) and other representatives (collectively the “Representatives”) do not disclose or make any unauthorized use of the Confidential Information. The Receiving Party may disclose Confidential Information only to the Representatives on a need-to-know basis. The Receiving Party will have executed or shall execute appropriate written agreements with its Representatives sufficient to enable it to comply with all the provisions of this Agreement, or the Representatives shall be bound by written confidentiality obligations no less stringent as those obligations imposed on the Receiving Party under this Agreement, and Receiving Party shall be responsible for the acts and or omissions of such Representative with regards to or any breach of the confidentiality obligations herein by such Representatives. The Receiving Party shall promptly notify the Disclosing Party upon discovery of any unauthorized use or disclosure of the Disclosing Party’s Confidential Information and will cooperate with Disclosing Party in every reasonable way to help Disclosing Party regain possession of the Confidential Information and prevent its further unauthorized use or disclosure. The foregoing confidentiality and non-use obligations shall not apply to any portion of the Confidential Information that the Receiving Party can demonstrate by competent written proof:

(a)was already known to the Receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the Disclosing Party;

(b)was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party;

(c)became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the Receiving Party in breach of this Agreement;

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(d)is subsequently disclosed to the Receiving Party by a Third Party who has a legal right to make such disclosure; or

(e)is subsequently independently discovered or developed by the Receiving Party without the aid, application, or use of the Disclosing Party’s Confidential Information, as evidenced by a contemporaneous writing.

9.2Authorized Disclosure. Notwithstanding the obligations set forth in Section 9.1, the Receiving Party may disclose the Disclosing Party’s Confidential Information and the terms of this Agreement to the extent:

(a)such disclosure is reasonably necessary for (i) the Development, manufacture or Commercialization of the Collaborative Product, including obtaining and maintaining Regulatory Approval or patent protection, pursuant to the terms of this Agreement; or (ii) the prosecuting or defending litigation as contemplated by this Agreement; or 

(b)such disclosure is reasonably necessary: (i) to the Receiving Party’s directors, attorneys, independent accountants or financial advisors for the sole purpose of enabling such directors, attorneys, independent accountants or financial advisors to provide advice to the Receiving Party, provided that in each such case on the condition that such directors, attorneys, independent accountants and financial advisors are bound in writing by confidentiality and non-use obligations consistent with those contained in this Agreement; or (ii) to actual or potential investors, acquirers, licensors, licensees, collaborators or other business partners solely for the purpose of evaluating or carrying out an actual or potential investment, acquisition, license or collaboration; provided that in each such case on the condition that such disclosures are bound in writing by confidentiality and non-use obligations consistent with those contained in the Agreement; 

(c)such disclosure is required by Applicable Laws, including judicial or administrative process (such as vetting process of securities listing), and/or by competent securities regulators and stock exchanges, including but not limited to the SEC, the HKEx and the SFC. Confidential Information that is disclosed under this Section 9.2(c) shall remain otherwise subject to the confidentiality and non-use provisions of this Article 9, and the Party disclosing Confidential Information pursuant to Applicable Laws may disclose, but only to the extent so required, and shall take all steps reasonably necessary and practicable, including seeking of confidential treatment or a protective order, to ensure the continued confidential treatment of such Confidential Information. 

Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to Section 9.2(a)(ii) or Section 9.2(c), it will, except where impracticable, give reasonable advance written notice to the other Party of such disclosure to allow the other Party a reasonable opportunity to seek a protective order or equivalent and use efforts to secure confidential treatment of such information at least as diligent as such Party would use to protect its own confidential information, but in no event less than reasonable efforts. In any 

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event, the Parties agree to take all reasonable action to avoid disclosure of Confidential Information hereunder. Any disclosure under this Section 9.2 shall not relieve such Party of its obligations as the Receiving Party contained herein. 

9.3Public Announcements.

(a)Publicity. Subject to the rest of this Article 9, no Party shall use the name, trademark, trade name or logo of the other Party, its Affiliates or their respective employee(s) in any publicity, promotion, news release or disclosure relating to this Agreement or its subject matter, without the prior express written permission of the other Party, except as may be required by Applicable Laws. 

(b)Press Releases. As soon as practicable following the Effective Date, the Parties shall issue a joint press release announcing the execution of this Agreement in substantially the form attached hereto as Exhibit C. Except as required by Applicable Laws (including disclosure requirements of the U.S. Securities and Exchange Commission (“SEC”), the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited (“Listing Rules”) of HKEx, or any other stock exchange on which securities issued by a Party or its Affiliates are traded), neither Party shall make any other public announcement concerning this Agreement or the subject matter hereof without the prior written consent of the other, which shall not be unreasonably withheld or delayed; provided that each Party may make any public statement in response to questions by the press, analysts, investors or those attending industry conferences or financial analyst calls, or issue press releases, so long as any such public statement or press release is not inconsistent with prior public disclosures or public statements approved by the other Party pursuant to this Article 9 and which do not reveal non‐public information about the other Party. In the event of a required public announcement, to the extent practicable under the circumstances, the Party making such announcement shall provide the other Party with a copy of the proposed text of such announcement sufficiently in advance of the scheduled release to afford such other Party a reasonable opportunity to review and comment upon the proposed text. 

(c)Filing of this Agreement. The Parties shall coordinate in advance with each other in connection with the filing of this Agreement (including redaction of certain provisions of this Agreement) with the SEC, the HKEx or any other stock exchange or governmental agency on which securities issued by a Party or its Affiliate are traded, and each Party will use reasonable efforts to seek confidential treatment for the terms proposed to be redacted; provided that each Party will ultimately retain control over what information to disclose to the SEC, the HKEx,  or any other stock exchange or other governmental agency, as the case may be, and provided further that the Parties will use their reasonable efforts to file redacted versions with any governing bodies which are consistent with redacted versions previously filed with any other governing bodies. Other than such obligation, neither Party (nor its Affiliates) will be obligated to consult with or obtain approval from the other Party with respect to any filings to the SEC, the HKEx or any other stock exchange or other governmental agency.

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9.4Publication. At least [***] prior to a Party or any of its Affiliates, licensees or sublicensees, publishing, publicly presenting, and/or submitting for written or oral publication a manuscript, abstract or the like that includes any data or results generated from the Development of the Collaborative Product in the Field in the Collaborative Territory that has not been previously published, such Party shall provide to the other Party a draft copy thereof for its review and approval (unless such Party is required by Applicable Law to publish such Know-How sooner, in which case such Party shall provide such draft copy to the other Party as much in advance of such publication as possible). The publishing Party shall consider in good faith any comments provided by the other Party during such [***] period. The review period shall be extended for an additional [***] if a representative of the non-publishing Party can demonstrate a reasonable need for such extension including, but not limited to, the preparation and filing of patent applications. By mutual agreement of the Parties, this period may be further extended. In addition, the publishing Party shall, and shall cause its Affiliates, licensees or sublicensees, as applicable, at the other Party’s reasonable request, remove therefrom any Confidential Information of such other Party. The contribution of each Party shall be noted in all publications or presentations by acknowledgment or co-authorship, whichever is appropriate. 

9.5Prior Non-Disclosure Agreement. As of the Effective Date, the terms of this Article 9 shall supersede any prior non-disclosure, secrecy or confidentiality agreement between the Parties (or their Affiliates) dealing with the subject of this Agreement. Any information disclosed pursuant to any such prior agreement shall be deemed Confidential Information for purposes of this Agreement.

9.6Equitable Relief. Each Party acknowledges that a breach of this Article 9 cannot be reasonably or adequately compensated in damages in an action at law and that such a breach shall cause the other Party irreparable injury and damage. By reason thereof, each Party agrees that the other Party shall be entitled, in addition to any other remedies it may have under this Agreement or otherwise, to preliminary and permanent injunctive and other equitable relief to prevent or curtail any breach of the obligations relating to Confidential Information set forth herein. 

Article 10
Intellectual Property

10.1Ownership. As between the Parties, and subject to the licenses granted under this Agreement, (a) Eucure is the sole owner of all rights, title and interest in and to the Collaborative Product IP (other than Development IP), (b) Tracon is the sole owner of all rights, title and interest in and to the Tracon IP, (c) Eucure and Tracon shall jointly own all rights, title and interest in and to the Development IP and Development Data. Upon generation of Development Data or the conception or reduction to practice of any Development IP by a Party, such Party shall promptly notify the other Party thereof. Each of Tracon and Eucure agree and hereby irrevocably transfer and assign to the other sufficient rights to vest joint ownership in the Development Data and Development IP. Each Party shall perform and, if necessary, obligate its personnel to perform any and all other reasonable acts necessary to assist the other Party in obtaining, maintaining, 

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implementing, securing and perfecting such any and all rights hereof, including but not limited to executing the necessary documents by such Party and/or its personnel. 

10.2Prosecution and Maintenance. 

(a)Collaborative Product IP. Eucure shall be solely responsible for, and shall have the sole rights in relation to, the preparation, filing, prosecution and maintenance of any Patents and other intellectual property rights within the Collaborative Product IP (other than Development IP), at its sole cost and expense. 

(b)Development IP. The Parties shall collaborate with respect to the prosecution and maintenance of any Patents within the Development IP. The prosecuting Party shall inform the non-prosecuting Party as to the material correspondence received from the applicable patent office in the course of prosecution and maintenance of any Patents within the Development IP reasonably prior to any deadline or action with any patent office, shall furnish to the non-prosecuting Party copies of the draft responses reasonably in advance of such deadline, and shall reasonably take into account the non-prosecuting Party’s comments. The prosecuting Party shall keep the non-prosecuting Party reasonably informed of progress with regard to the prosecution and maintenance of any Patents within the Development IP and shall provide to the non-prosecuting Party copies of all material patent office submissions within a reasonable amount of time following submission thereof by the prosecuting Party. In the event that the prosecuting Party desires to abandon or cease the prosecution or maintenance of any Patents within the Development IP in any country in the Territory, or decides not to file any Patents within the Development IP in any country in the Territory, the prosecuting Party shall provide reasonable prior written notice to the non-prosecuting Party of such intention to abandon or not to file (which notice shall, to the extent possible, be given no later than [***] prior to the next deadline for any action that must be taken with respect to any such Patent within the Development IP in the relevant patent office). In such case, upon written notice to the prosecuting Party from the non-prosecuting Party, the non-prosecuting Party may elect to file or continue the prosecution and maintenance of any such Patent in the applicable country, at its sole cost and expense and by counsel of its own choice. 

(c)Cooperation of the Parties. Each Party agrees to cooperate fully in the prosecution and maintenance of the Patents within the Development IP pursuant to Section 10.2(b). The non-prosecuting Party shall provide reasonable cooperation in the prosecution and maintenance of such Patents at the prosecuting Patent’s sole cost and expense, including but not limited to: (i) executing all papers and instruments, or requiring its employees or contractors, to execute such papers and instruments, so as to enable the prosecuting Party to apply for and to prosecute patent applications in any country as permitted by Section 10.2(b), and (ii) promptly informing the other Party of any matters coming to such Party’s attention that may materially adversely affect the prosecution and maintenance of any such patent applications.

10.3Defense of Third Party Claims. In the event that any Third Party asserts that the Commercialization of Collaborative Product in the Collaborative Territory infringes any Third 

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Party intellectual property rights, the Party first having notice of the assertion shall promptly notify the other Party and the Parties promptly meet to consider the claim or assertion and the appropriate course of action, including entering into an “identity of interest agreement” wherein such Parties agree to their shared mutual interest in the outcome of such potential dispute, as appropriate. The Parties shall discuss and agree on how best to mitigate or control the defense of any such claim or assertion; provided that, if either Party or any of its Affiliates have been individually named as a defendant in such claim or assertion, the other Party shall be allowed to join in such action, at its own expense. The Parties shall keep each other informed of the status of and of their respective activities regarding any claim or assertion under this Section 10.3; provided, however, that no settlement or consent judgment or other voluntary final disposition of a suit under this Section 10.3 may be undertaken by a Party without the consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed. 

10.4Infringement by Third Parties. In the event either Party becomes aware of any Third Party infringement of the Collaborative Product IP in the Field in the Collaborative Territory (an “Infringement”), such Party shall promptly notify the other Party and the Parties shall confer in good faith regarding strategy for abating such infringement in view of its potential effect upon the Commercialization of Collaborative Products in the Field in the Collaborative Territory. As between the Parties, Tracon shall have the first right to bring an action for infringement of the Collaborative Product IP in the Field in the Collaborative Territory, at its sole cost and expense, and any recovery realized as a result of any such action or proceeding, whether by way of settlement or otherwise, shall first be used to reimburse the Parties for their costs in connection with such enforcement action and the balance shall be treated as Net Sales. Eucure shall have the right (but not the obligation), at its own expense, to participate in any such Infringement action and to be represented in any such suit, proceeding, or action by counsel of its own choice. If Tracon does not elect to bring an enforcement action against such Infringement or does not bring such enforcement action within [***] after receiving notice of such Infringement, Eucure shall have the right but not the responsibility to bring an enforcement action against such Infringement, at its sole cost and expense, and any recovery shall first be used to reimburse the Parties for their costs in connection with such enforcement action and the balance shall retained by Eucure. Each Party shall cooperate at the enforcing Party’s expense with any enforcement action brought against an Infringement and, additionally, shall have the right to participate in such action with its own counsel at its own expense subject to the foregoing right of reimbursement from any recoveries from such action. 

Article 11
Term And Termination

11.1Term. This Agreement shall become effective on the Effective Date and, unless earlier terminated pursuant to this Article 11, shall remain in effect until the earlier of (a) the date that the Parties cease Development and Commercialization of all Collaborative Products in the Field in the Collaborative Territory pursuant to this Agreement; or (b) on a country-by-country basis, the expiration of the Royalty Term in such country of the Collaborative Territory (the 

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“Term”). In the event the Agreement expires in a country pursuant to this Section 11.1(b), the licenses granted herein shall become non-exclusive, perpetual and fully paid-up in such country. 

11.2Termination for Breach. Each Party shall have the right to terminate this Agreement in its entirety immediately upon written notice to the other Party, if the other Party materially breaches its obligations under this Agreement and, after receiving written notice identifying such material breach in reasonable detail, such breaching party fails to cure such material breach within sixty (60) days (or twenty-five (25) days with respect to any payment breach) from the date of such notice. Any right to terminate under this Section 11.2, other than with respect to any payment breach, shall be stayed and the cure period tolled in the event that, during any cure period, the Party alleged to have been in material breach shall have initiated dispute resolution in accordance with Article 12 with respect to the alleged breach, which stay and tolling shall continue until such dispute has been resolved in accordance with Article 12. 

11.3Termination for Convenience or Good Reason. 

(a)Either Party shall have the right to terminate this Agreement upon sixty (60) days advance written notice to the other Party if the terminating Party reasonably determines, based upon additional information that becomes available or an analysis of the existing information at any time, that the medical risk/benefit of Collaborative Product is so unfavorable that it would be incompatible with the welfare of patients to Develop or Commercialize or to continue to Develop or Commercialize Collaborative Product. Prior to any such termination, the terminating Party shall comply with such internal review and management approval processes as it would normally follow in connection with the termination of the development and commercialization of its own products for safety reasons and shall present and discuss the findings of such internal review for approval by the JSC.

(b)If Eucure does not grant prior approval for Tracon’s exercise of the Tracon Option under Section 3.6(c), then Tracon shall have the right, in its discretion, to terminate this Agreement for convenience upon thirty (30) days written notice to Eucure during the ninety (90) days period after Eucure denies approval for the exercise of the Tracon Option; provided, further that if such notice of termination is given within twelve (12) months of the Effective Date, (x) Eucure shall reimburse Tracon for all costs and expenses incurred by Tracon in the course of performing the Development Activities, and (y) notwithstanding the provisions of Sections 11.5(c)(iii) and (iv), Eucure shall bear the cost of the Wind-Down Activities and Eucure shall reimburse Tracon for its costs and expenses incurred to provide all cooperation and assistance requested or required by Eucure pursuant to Section 11.5(c)(iii). 

11.4Termination for Bankruptcy. Each Party shall have the right to terminate this Agreement in its entirety immediately upon written notice to the other Party, if the other Party shall file in any court or agency pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of such other Party or of substantially all of its assets, or if such other Party proposes a written agreement of composition or extension of substantially all of its debts, or if such other Party shall be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed within ninety (90) days after the

41.

 

 

 

filing thereof, or if such other Party shall propose or be a party to any dissolution or liquidation, or if such other Party shall make an assignment of substantially all of its assets for the benefit of creditors. 

11.5Effect of Termination.

(a)In the event of any termination of the Agreement other than by Tracon pursuant to Section 11.2 or 11.4, the Collaborative Products License shall terminate. 

(b)In the event of a termination of the Agreement by Tracon pursuant to Section 11.2 or 11.4, the Collaborative Products License shall continue in the Field and in the Collaborative Territory, provided that (i) such license shall remain exclusive during the Royalty Term and non-exclusive thereafter; (ii) Tracon shall have the right to have the Collaborative Product manufactured for its Development and Commercialization requirements in the Field and in the Collaborative Territory; and (iii) in addition to those provisions of the Agreement that survive pursuant to Section 11.6, during the Royalty Term, Articles 6, and 10, and Sections 3.1, 3.2, 3.4, 3.7, 4.1(a), 4.1(c), 4.1(e), 4.1(f), 4.4, 4.5, 5.1(except for the second and last sentences thereof), 5.3, 5.4, 7.5, and 7.6, shall additionally survive such termination; (iv) Section 2.1 shall survive solely with respect to the information sharing function of the JSC which shall no longer have a decision-making or approval role; and (v) the Collaborative Product License shall terminate if Tracon materially breaches any provision that so survives (including its obligations to make payment under Article 6) and fails to cure such breach within sixty (60) days after receipt of a notice of such breach from Eucure. 

(c)In the event of termination pursuant to Section 11.3, by mutual agreement of the Parties, or by Eucure pursuant to Section 11.2 or 11.4, the following terms shall apply:

(i)Development Data. Tracon shall, within a period of [***] following the effective date of such termination, provide Eucure access to, and transfer to Eucure, all Development Data for Collaborative Product in its possession as of the effective date of such termination. 

(ii)Regulatory Filings.  Tracon shall promptly transfer and assign to Eucure all regulatory filings (including Regulatory Approval) for the Collaborative Product in the Field in the Collaborative Territory that are held by Tracon or its Affiliates. Upon Eucure’s request, Tracon shall provide Eucure with reasonable assistance and cooperation regarding any inquiries and correspondence with Regulatory Authorities relating to the Collaborative Product in the Field in the Collaborative Territory. 

(iii)Transition to Eucure. Upon Eucure’s request, Tracon shall and shall cause its Affiliate to reasonably cooperate with Eucure to facilitate the orderly transition of the Development (including any ongoing clinical trials) and Commercialization of the Collaborative Product in the Field in the Collaborative Territory to Eucure, including (1) assigning or terminating as appropriate, upon request of Eucure (and subject to any necessary Third Party 

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consent), any agreements or arrangements with Third Party vendors (including distributors) to Develop, promote, distribute, sell or otherwise Commercialize the Collaborative Product; (2) to the extent that Tracon or its Affiliate is performing any activities described above in (1), reasonably cooperating with Eucure to transfer such activities to Eucure or its designee, and continuing to perform such activities on Eucure’s behalf for a reasonable time after termination until such transfer is completed.  Eucure shall reimburse Tracon for the cost and expense incurred to provide all such cooperation and assistance requested or required by Eucure pursuant to this Section 11.5(c)(iii), unless the Agreement is terminated by Tracon pursuant to Section 11.3 or by Eucure pursuant to Section 11.2 or 11.4, in which case Tracon shall bear its costs to provide such cooperation and assistance.  

(iv)Wind-Down Activities. Tracon, in consultation with Eucure, will promptly wind-down any of Tracon’s ongoing Development and Commercialization activities (including any clinical studies) for Collaborative Product that Eucure does not request transition to Eucure under clause (iii) above in an orderly manner consistent with accepted pharmaceutical industry norms and ethical practices (“Wind-Down Activities”). If the Agreement is terminated pursuant to Section 11.3, the cost and expense of the Wind-Down Activities shall be borne by the terminating Party.  If the Agreement is terminated by the mutual agreement of the Parties, the Parties shall share equally the costs and expenses of the Wind-Down Activities or as otherwise mutually agreed. If the Agreement is terminated by Eucure pursuant to Section 11.2 or 11.4, Tracon shall bear the costs and expenses of the Wind-Down Activities, absent mutual agreement to the contrary.  

11.6Survival. Expiration or termination of this Agreement shall not relieve either Party of any obligation or liability accruing prior to such expiration or termination, nor shall expiration or any termination of this Agreement preclude either Party from pursuing all rights and remedies it may have under this Agreement, at law or in equity, with respect to breach of this Agreement. Without limiting the foregoing, the following provisions, including the Parties’ rights and obligations thereunder, shall survive any expiration or termination of this Agreement: Articles 1, 8, 9, 12, and 13 and Sections 3.3, 6.4, 7.7, 10.1, 11.5, and 11.6 and those which, by their nature, are intended to survive. 

Article 12
Dispute Resolution 

12.1Disputes. The Parties recognize that disputes as to certain matters may from time to time arise during the Term which relate to either Party’s rights or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Article 12 to resolve any controversy or claim arising out of, relating to or in connection with any provision of this Agreement, if and when a dispute arises under this Agreement.

43.

 

 

 

12.2Internal Resolution. With respect to all disputes arising between the Parties under this Agreement, including, without limitation, any alleged breach under this Agreement or any issue relating to the interpretation or application of this Agreement or any failure of the parties toreach consensus where consensus is required under the Agreement, if the Parties are unable to resolve such dispute within [***] after such dispute is first identified by either Party in writing to the other, the Parties shall refer such dispute to the Chief Executive Officers of the Parties for attempted resolution by good faith negotiations within [***] after such notice is received. 

12.3Binding Arbitration. 

(a)Claims. If the Chief Executive Officers of the Parties are not able to resolve any disputed matter within [***] and either Party wishes to pursue the matter, each such dispute, controversy or claim shall be finally resolved by binding arbitration before a panel of three neutral experts with relevant industry experience, and judgment on the arbitration award may be entered in any court having jurisdiction thereof. The arbitration proceeding shall be administered by the International Court of Arbitration of the International Chamber of Commerce (the “ICC”) in accordance with its then existing arbitration rules or procedures regarding commercial or business disputes, and the panel of arbitrators shall be selected in accordance with such rules. The arbitration and all associated discovery proceedings and communications shall be conducted in English, and the arbitration shall be held in New York, NY. Except to the extent necessary to confirm an award or as may be required by law, neither a Party nor an arbitrator may disclose the existence, content, or results of arbitration without the prior written consent of both Parties.

(b)Arbitrators’ Award. The arbitrators shall, within [***] after the conclusion of the arbitration hearing, issue a written award and statement of decision describing the essential findings and conclusions on which the award is based, including the calculation of any damages awarded. The arbitrators shall not be authorized to award any damages expressly excluded pursuant to Section 8.4. The decision or award rendered by the arbitrators shall be final and non-appealable, and judgment may be entered upon it in any court of competent jurisdiction. Either Party may apply for interim injunctive relief with the arbitrators until the arbitration award is rendered or the controversy is otherwise resolved. 

(c)Costs. Each Party shall bear its own attorney’s fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the arbitrators; provided, however, that the arbitrators shall be authorized to determine whether a Party is the prevailing party, and if so, to award to that prevailing party reimbursement for any or all of its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), or the fees and costs of the tribunal and the arbitrators. 

(d)Court Actions. Nothing contained in this Agreement shall deny either Party the right to seek, upon good cause, injunctive or other equitable relief from a court of competent jurisdiction in the context of an emergency or prospective irreparable harm, and such an action 

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may be filed and maintained notwithstanding any ongoing dispute resolution discussions or arbitration proceedings. 

Article 13
Miscellaneous

13.1Entire Agreement; Amendment. This Agreement, including the Exhibits attached hereto, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto with respect to the subject matter hereof and supersedes, as of the Effective Date, all prior agreements and understandings between the Parties with respect to the subject matter hereof. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth herein and therein. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.

13.2Force Majeure. Each Party shall be excused from the performance of its obligations under this Agreement, other than obligations to make payments when due, to the extent that such performance is prevented by force majeure and the nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse shall be continued so long as the condition constituting force majeure continues, the nonperforming Party takes reasonable efforts to remove the condition and provided that the nonperforming Party has not caused such condition to occur. For purposes of this Agreement, force majeure shall include conditions beyond the reasonable control of the nonperforming Party, including without limitation, an act of God or terrorism, involuntary compliance with any regulation, law or order of any government, war, civil commotion, epidemic or pandemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe. If a force majeure persists for more than [***], then the Parties will discuss in good faith the modification of the Parties’ obligations under this Agreement in order to mitigate the delays caused by such force majeure.

13.3Bankruptcy Code. All licenses and rights granted under this Agreement will be deemed licenses of rights to intellectual property for purposes of Section 365(n) of the United States Bankruptcy Code or any analogous provisions in any other country or jurisdiction and a licensee or sublicensee under this Agreement will retain and may fully exercise all of its rights and elections under the United States Bankruptcy Code or any analogous provisions in any other country or jurisdiction.

13.4Notices. Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement, and delivered either in person, by any method of mail (postage prepaid) requiring return receipt, or by reputable overnight courier or facsimile confirmed thereafter by any of the foregoing, to the Party to be notified at the address specified below or such other address as may be specified by such Party in writing in accordance with this Article 13. Notice shall be deemed to have been sufficiently given for all purposes upon the earliest 

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of (a) the date of actual receipt, if hand-delivered, or sent by facsimile with electronic confirmation of receipt, or a reputable courier service, or (b) [***] after mailing, if mailed by first class certified or registered airmail, postage prepaid, return receipt requested.

	
 
	
If to Tracon:  
	
TRACON Pharmaceuticals, Inc.

4350 La Jolla Village Dr., Suite 800

San Diego, CA 92121 USA

Attention: Chief Business Officer

Fax: +1 858-550-078

 

	
 
	
with a copy to:
	
Pillsbury Winthrop Shaw Pittman LLP
12255 El Camino Real, Suite 300

San Diego, CA 92130

United States
Attn:Richard L. Blaylock 

Email:  not permitted

 

	
 
	
If to Eucure:  
	
Eucure (Beijing) Biopharma Co., Ltd.
23F, Tower 3, China Central Place, No.77, Jian Guo Road Chaoyang District, Beijing, China

                                             Attention: Dr. Chaoshe Guo,  VP of Business Development

                                             Email: [***]

 

	
 
	
with a copy to:
	
Cooley LLP
4401 Eastgate Mall, San Diego, CA 92121, United States
Attn:James Lu 
Email:    [***]

 

13.5No Strict Construction; Headings. This Agreement has been prepared jointly and shall not be strictly construed against either Party. Ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision. The headings of each Article and Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section.

13.6Assignment. Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other, except that a Party may make such an assignment without the other Party’s consent to an Affiliate or to a successor to substantially all of the business of such Party (whether by merger, sale of stock, sale of assets or other transaction) or as expressly permitted herein. Any permitted successor or assignee of rights or obligations hereunder shall, in writing to the other Party, expressly assume performance of such rights or obligations. Any permitted assignment shall be binding on the successors of the assigning Party. Any assignment or attempted assignment by either Party in violation of the foregoing shall be null, void and of no legal effect. 

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13.7Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

13.8No Third Party Beneficiaries. This Agreement is neither expressly nor impliedly made for the benefit of any party other than those executing it, except as expressly provided with respect to the Eucure Indemnitees and the Tracon Indemnitees. 

13.9Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is taken, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

13.10No Waiver. Any delay in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time.

13.11Independent Contractors. Each Party shall act solely as an independent contractor, and nothing in this Agreement shall be construed to give either Party the power or authority to act for, bind, or commit the other Party in any way. Nothing herein shall be construed to create the relationship of partners, principal and agent, or joint-venture partners between the Parties.

13.12Interpretations. In this Agreement, unless otherwise specified: 

(a)“includes” and “including” shall mean respectively includes and including without limitation;

(b)the word “or” means “and/or” unless the context dictates otherwise because the subject of the conjunction is mutually exclusive; 

(c)words denoting the singular shall include the plural and vice versa and words denoting any gender shall include all genders; 

(d)words such as “herein”, “hereof”, and “hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear; 

(e)all references to days, quarters and years in this Agreement shall mean calendar days, quarters and years, respectively, unless otherwise specified; and

(f)the Exhibits attached hereto form part of the operative provision of this Agreement and references to this Agreement shall include references to such Exhibits.

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13.13English Language. This Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this Agreement. To the extent this Agreement requires a Party to provide to the other Party information, correspondence, notice or other documentation, such Party shall provide such information, correspondence, notice or other documentation in the English language and also a copy of the original of such information, correspondence, notice or other documentation if such original is not in the English language.

13.14Governing Law. This Agreement and all disputes arising out of or related to this Agreement or any breach hereof shall be governed by and construed under the laws of State of New York, U.S., without giving effect to any choice of law principles that would require the application of the laws of a different jurisdiction.

13.15Guaranty. To induce Tracon to enter into this agreement, Parent hereby absolutely, unconditionally and irrevocably guarantees to Tracon the due and punctual observance, performance and discharge of the obligations of Eucure (payment and otherwise) under this Agreement. The provisions of Section 12 and 13 shall apply mutatis mutandis to this guarantee by Parent as if Parent were a Party. 

13.16Counterparts. This Agreement may be executed in one (1) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. 

 

48.

 

Confidential

 

In Witness Whereof, the Parties have executed this Collaborative Development and Commercialization Agreement in triplicate originals by their duly authorized officers as of the Effective Date.

		
	
 

Tracon Pharmaceuticals, Inc.

By:  /s/ Charles Theuer, M.D. Ph.D. 

Name:   CHARLES THEUER, M.D. Ph.D.

Title:            President and CEO

 

 
	
 

Eucure (Beijing) Biopharma Co., Ltd

By:  /s/ Yuelei Shen

Name:  Yuelei Shen

Title:  President and CEO                  

 

 

 

With respect to Section 13.15:

Biocytogen Pharmaceuticals (Beijing) Co., Ltd

By:  /s/ Yuelei Shen

Name:  Yuelei Shen

Title:   President and CEO                       

     

 

 

 

 

Exhibit A

 Patents describing Antibody

 

[***]

 

 

 

 

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

 

 

Exhibit B

 

Clinical Supply and Quality Agreement Terms

 

[***]

 

 

[***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED

 

 

Exhibit C

[Press Release]

 

TRACON Pharmaceuticals and Eucure Biopharma, a Subsidiary of Biocytogen, Announce Partnership for Development of Clinical Stage CTLA-4 Antibody YH001

 

YH001 is a potential best-in-class CTLA-4 antibody with enhanced ADCC and CDC effector functions  

 

YH001 is currently being dosed in multiple Phase 1 oncology trials sponsored by Eucure Biopharma in Australia and China 

 

TRACON intends to initiate a Phase 1 trial of YH001 in combination with envafolimab in soft tissue sarcoma as well as to study YH001 in multiple other selected tumor types 

 

 

San Diego, CA – October 11, 2021 – TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., announced today that it has entered into a collaborative partnership agreement with Eucure Biopharma, a subsidiary of Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen), and a China-based clinical stage biopharmaceutical company primarily focused on the research and development of biologics, for the development of YH001, a CTLA-4 antibody with enhanced ADCC and CDC effector functions, for development in multiple oncology indications, including soft tissue sarcoma, in North America.

 

Under the terms of the agreement, TRACON will be responsible for the clinical development and commercialization of YH001 in multiple oncology indications in North America, with the majority of the development activities expected to occur in the U.S. TRACON will bear the costs of clinical trials and Eucure Biopharma will supply YH001. TRACON will be responsible for commercializing YH001 in multiple oncology indications in North America and will owe Eucure Biopharma escalating double digit royalties on net sales. 

 

YH001 was developed to potently inhibit CTLA-4 binding to the CD80/CD86 receptors and deplete regulatory T cells through enhanced ADCC and CDC effector functions. YH001 demonstrated superior activity in vitro and in transgenic syngeneic tumor models compared to ipilimumab (Yervoy®), both as a single agent and when combined with a PD-(L)1 antibody. 

 

“We are focused on advancing a dual checkpoint inhibitor strategy focused on the PD-(L)1 and CTLA-4 pathways, that we expect to leverage in sarcoma by combining YH001 with envafolimab, our novel, single-domain PD-L1 antibody, in sarcoma. Going forward, we intend to use YH001 rather than Yervoy in our future dual checkpoint inhibition trials in sarcoma, which we anticipate will result in meaningful cost savings from not needing to purchase Yervoy at retail prices.” said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. “Moreover, we expect to study YH001 in other solid tumors in combination with PD-(L)1 antibodies, including in patients who have progressed on prior PD-(L)1 treatment.”  

 

“We believe that this collaboration with TRACON has potential to provide cancer patients in the United States with  a best-in-class CTLA-4 checkpoint inhibitor. YH001 was optimized using Biocytogen’s discovery labs and proprietary transgenic mouse models to inhibit CTLA-4 binding and to deplete regulatory cells. 

 

 

In our ongoing Phase 1 clinical trials, YH001 has been tolerable as a single agent and in combination with the PD-1 antibody toripalimab,” said Dr. Yuelei Shen, CEO of Biocytogen and Eucure Biopharma.

 

About YH001

 

YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 is being dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756). In July 2021, the U.S. Food and Drug Administration (FDA) approved the Investigational New Drug application to initiate multiple phase II clinical trials for YH001 in the United States.

 

About Envafolimab

 

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, as well as in a Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines. Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. In the Phase 2 MSI-H/dMMR advanced solid tumor trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of KEYNOTE-164.

About TRACON

 

TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, product development platform. The Company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads U.S. regulatory and clinical development and shares in the cost and risk of clinical development and leads U.S. commercialization. In these partnerships TRACON believes it can serve as a solution for companies without clinical and 

 

 

commercial capabilities in the U.S. To learn more about TRACON and its product pipeline, visit TRACON's website at www.traconpharma.com.

 

 

About Eucure Biopharma

 

Eucure Biopharma, a subsidiary of Biocytogen, is a China based innovative biotechnology company with global vision, specializing in developing innovative antibody drugs with independent intellectual property rights. Relying on a strong clinical development team with extensive experience, the company has established a product pipeline for more than 10 targets. At present, three products have received clinical trial approvals in the US and China including that two products have obtained the phase II clinical approval from the FDA and have initiated the global phase II clinical trial, two products have entered the phase I clinical trial in China, four products have entered Phase I clinical stages in Australia. These lay a solid foundation for the development of Eucure Biopharma. As a wholly owned subsidiary of Biocytogen, Eucure Biopharma is focused on clinical development. Biocytogen is an international biotechnology company driven by innovative technology and committed to becoming the global birthplace of new drugs, with a mission to focus on technological innovation, continuously produce new drugs, and safeguard human health. For more information, please visit www.eucure.com.

 

About Biocytogen

 

Biocytogen Pharmaceuticals (Beijing) Co., Ltd. is a global biotech company that drives the research and development of new drugs with innovative technologies. The company is committed to becoming a global headstream of new drugs and bringing the benefits to patients around the world as its mission. Based on the fully human antibody RenMabTM and RenLiteTM mice for fully human antibodies production with robust humoral responses, highly diverse antibody repertoire and superior affinity, Biocytogen has integrated its platforms in single-cell antibody discovery, gene editing, large-scale animal model supply, and screening to form a new approach to streamline the entire drug development process. Biocytogen actively promotes the independent and cooperative development of new drugs. For more, please visit http://en.biocytogen.com.cn/

 

 

Forward-Looking Statements

 

Statements made in this press release regarding matters that are not historical facts are “forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding TRACON's and Eucure’s plans to further develop YH001, potential benefits of the collaboration between TRACON and Eucure, expectations regarding the timing, design and scope of clinical trials, potential payments and activities under the collaboration with Eucure, expected development milestones, and potential benefits of YH001 and TRACON’s product candidates. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; whether TRACON or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all; the impact of the COVID-19 pandemic; the fact that future preclinical studies and clinical trials may not be successful or otherwise consistent with results from prior studies; the fact that the collaboration agreement with Eucure Biopharma is subject to early termination; potential changes in regulatory requirements in the United States and foreign countries; 

 

 

TRACON’s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing; and other risks described in TRACON’s filings with the Securities and Exchange Commission under the heading “Risk Factors”. All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

 

 

		
	
TRACON Contacts:
	
 

	
 
	
 

	
Company Contact:
	
Investor Contact:

	
Mark Wiggins
	
Brian Ritchie

	
Chief Business Officer
	
LifeSci Advisors LLC

	
(858) 251-3492
	
(212) 915-2578

	
mwiggins@traconpharma.com
	
britchie@lifesciadvisors.com 

 

		
	
Biocytogen and Eucure Biopharma Contacts:

	
 
	
 

	
Company Contact:
	
Investor Contact:

	
Chaoshe Guo
	
Yongliang Wang

	
Vice President, Business Development and Licensing
	
Deputy General Manager

	
Biocytogen Pharmaceuticals (Beijing) Co., Ltd.
	
Biocytogen Pharmaceuticals (Beijing) Co., Ltd.

	
Chaoshe.guo@bbctg.com.cn
	
Yongliang.wang@bbctg.com.cn

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Schedule 3.6(a)

 

Pre-approved Substitute Indications

 

bladder cancer

endometrial cancer

melanoma

 

 

 

 

 

Schedule 4.1(a)

 

Development Plan

 

 

 

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