Document:

ofix-ex102_72.htm

Exhibit 10.2

ORTHOFIX MEDICAL INC.

CHANGE IN CONTROL AND SEVERANCE AGREEMENT

This AGREEMENT (the “Agreement”) is made and entered into as of September 11, 2020 (the “Effective Date”), by and between Orthofix Medical Inc., a Delaware corporation (together with its direct and indirect subsidiaries, the “Company”), and Paul Gonsalves (the “Executive”).

RECITALS

WHEREAS, the Executive is expected to make significant contributions to the profitability, growth and financial strength of the Company;

WHEREAS, the Company believes that it is important to provide the Executive with severance benefits upon certain terminations of employment to provide the Executive with enhanced financial security and incentive and encouragement to remain with the Company; 

WHEREAS, the Company recognizes that the possibility of a Change in Control (as hereinafter defined) and the uncertainty that it would cause could result in the departure or distraction of the Executive, to the detriment of the Company and its stockholders; and

WHEREAS, the Company desires to encourage the continued employment of the Executive by the Company and wants assurance that it shall have the continued dedication, loyalty and service of, and the availability of objective advice and counsel from, the Executive notwithstanding the possibility, threat or occurrence of a Change in Control.

NOW, THEREFORE, in consideration of the mutual covenants and promises contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:

1.Definitions.  As used in this Agreement, the following terms have the following meanings which are equally applicable to both the singular and plural forms of the terms defined:

(a)“2012 LTIP” shall mean the Company’s 2012 Long-Term Incentive Plan, as amended from time-to-time (including after the Effective Date).

(b)“Board” shall mean the Board of Directors of the Company.

(c)“Cause” shall mean (i) willful and intentional commission by the Executive of one or more material acts of (A) fraud, misappropriation or embezzlement related to the business or property of the Company or (B) moral turpitude; (ii) conviction for, or guilty plea to, or plea of nolo contendere to, a felony; or (iii) fraud or willful misconduct committed by the Executive that caused or otherwise materially contributed to the requirement for an accounting restatement of the Company’s financial statements due to noncompliance with any financial reporting requirement (other than a restatement due to a change in accounting rules). No act or omission shall be deemed willful, intentional or material for purposes of this definition if taken or omitted to be taken by 

 

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Executive in a good faith belief that such act or omission to act was in the best interests of the Company or if done at the express direction of the Board or the board of directors or principal executive officer of any acquirer of the Company.

(d) “Change in Control” shall mean the occurrence of any of the following events:

(i)the acquisition by any individual, entity or group (within the meaning of Section 13(d)(3) or 14(d)(2) of the Exchange Act) of beneficial ownership (within the meaning of Rule 13d-3 promulgated under the Exchange Act), in any individual transaction or series of related transactions, of 50% or more of either (A) the then outstanding shares of common stock of Parent (the “Outstanding Common Stock”) or (B) the combined voting power of the then outstanding voting securities of Parent entitled to vote generally in the election of directors (the “Outstanding Voting Securities”); excluding, however, the following:  (1) any acquisition directly from Parent, other than an acquisition by virtue of the exercise of a conversion privilege unless the security being so converted was itself acquired directly from Parent; (2) any acquisition by Parent; (3) any acquisition by any employee benefit plan (or related trust) sponsored or maintained by Parent or any entity controlled by Parent; or (4) any acquisition pursuant to a transaction which complies with clauses (A), (B) and (C) of subsection (iii) of this definition of Change in Control;

(ii)a change in the composition of the Board such that the individuals who as of the Effective Date constitute the Board (the “Incumbent Board”) cease for any reason to constitute at least a majority of the Board; provided, however, for purposes of this paragraph, that any individual who becomes a member of the Board subsequent to the Effective Date, whose appointment, election, or nomination for election by Parent’s shareholders was approved by a vote of at least a majority of those individuals who are members of the Board and who were also members of the Incumbent Board (or deemed to be such pursuant to this proviso) shall be considered as though such individual were a member of the Incumbent Board; but provided further that any such individual whose initial assumption of office occurs as a result of either an actual or threatened election contest (as such terms are used in Rule 14a-11 of Regulation 14A promulgated under the Exchange Act) or other actual or threatened solicitation of proxies or consents by or on behalf of a Person other than the Board shall not be so considered as a member of the Incumbent Board;

(iii)consummation of a reorganization, merger, consolidation or other business combination or the sale or other disposition of all or substantially all of the assets of Parent (including assets that are shares held by Parent in its subsidiaries) (any such transaction, a “Business Combination”); expressly excluding, however, any such Business Combination pursuant to which all of the following conditions are met:  (A) all or substantially all of the Person(s) who are the beneficial owners of the Outstanding Common Stock and Outstanding Voting Securities, respectively, immediately prior to such Business Combination will beneficially own, directly or indirectly, more than 50% of, respectively, the outstanding shares of common stock, and the combined voting power of the outstanding voting securities entitled to vote generally in the election of directors, as the case may be, of the entity resulting from such Business Combination (including, without limitation, an entity which as a result of such transaction owns 

 

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Parent or all or substantially all of Parent’s assets either directly or through one or more subsidiaries) in substantially the same proportions as their ownership, immediately prior to such Business Combination, of the Outstanding Common Stock and Outstanding Voting Securities, as the case may be, (B) no Person (other than Parent, any employee benefit plan (or related trust) of Parent or such entity resulting from such Business Combination) will beneficially own, directly or indirectly, 50% or more of, respectively, the outstanding shares of common stock of the entity resulting from such Business Combination or the combined voting power of the outstanding voting securities of such entity entitled to vote generally in the election of directors except to the extent that such ownership existed prior to the Business Combination, and (C) individuals who were members of the Incumbent Board will constitute at least a majority of the members of the board of directors of the entity resulting from such Business Combination;

(iv)the approval by the shareholders of Parent of a complete liquidation or dissolution of Parent;

(v)the Company shall sell or dispose of, in a single transaction or series of related transactions, business operations that generated two-thirds of the consolidated revenues of the Company (determined on the basis of Company’s four most recently completed fiscal quarters for which reports have been filed under the Exchange Act) and such disposal shall not be exempted pursuant to clause (iii) of this definition of Change in Control; 

(vi)Parent files a report or proxy statement with the Securities and Exchange Commission pursuant to the Exchange Act disclosing in response to Form 8-K or Schedule 14A (or any successor schedule, form or report or item therein) that a change in control of Parent has or may have occurred or will or may occur in the future pursuant to any then-existing agreement or transaction; notwithstanding the foregoing, unless determined in a specific case by a majority vote of the Board, a “Change in Control” shall not be deemed to have occurred solely because:  (A) an entity in which Parent directly or indirectly beneficially owns 50% or more of the voting securities, or any Parent-sponsored employee stock ownership plan, or any other employee plan of the Company, either files or becomes obligated to file a report or a proxy statement under or in response to Schedule 13D, Schedule 14D-1, Form 8-K or Schedule 14A (or any successor schedule, form or report or item therein) under the Exchange Act, disclosing beneficial ownership by form or report or item therein, disclosing beneficial ownership by it of shares of stock of Parent, or because Parent reports that a change in control of Parent has or may have occurred or will or may occur in the future by reason of such beneficial ownership or (B) any Company‐sponsored employee stock ownership plan, or any other employee plan of the Company, either files or becomes obligated to file a report or a proxy statement under or in response to Schedule 13D, Schedule 14D-1, Form 8-K or Schedule 14A (or any successor schedule, form or report or item therein) under the Exchange Act, disclosing beneficial ownership by form or report or item therein, disclosing beneficial ownership by it of shares of stock of Parent, or because Parent reports that a change in control of Parent has or may have occurred or will or may occur in the future by reason of such beneficial ownership; or

(vii)any other transaction or series of related transactions occur that have substantially the effect of the transactions specified in any of the preceding clauses in this 

 

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definition.

Notwithstanding this definition of “Change in Control,” the Board, in its sole discretion, may determine that a Change in Control has occurred for purposes of this Agreement, even if the events giving rise to such Change in Control are not expressly described in the above definition.

(e)“CiC Date” shall mean the date on which a Change in Control occurs.

(f)“CiC Period” shall mean the twenty four (24)-month period commencing on the CiC Date; provided, however, if the Company terminates the Executive’s employment with the Company prior to the CiC Date but on or after a Potential CiC Date, and it is reasonably demonstrated that the Executive’s (i) employment was terminated at the request of an unaffiliated third party who has taken steps reasonably calculated to effect a Change in Control or (ii) termination of employment otherwise arose in connection with or in anticipation of the Change in Control, then the “CiC Period” shall mean the twenty four (24)-month period beginning on the date immediately prior to the date of the Executive’s termination of employment with the Company.

(g) “CiC Period Good Reason” shall mean the occurrence of any of the following without the written consent of the Executive: (i) a requirement that the Executive work principally from a location that is more than thirty (30) miles from his or her current principal place of employment, (ii) any reduction in the Executive’s Total Compensation, (iii) any material breach of this Agreement or any other material agreement with the Executive by the Company or any successor entity, or (iv) any diminution in the Executive’s employment position, authority, duties, responsibilities or line of reporting structure, or the assignment to the Executive of any duties materially inconsistent with the Executive’s position and title immediately prior to consummation of the Change in Control (including, for example, if the Executive was the Chief Financial Officer of the Company immediately prior to consummation of a Change in Control and is not the Chief Financial Officer of the Company immediately following consummation of the Change in Control, then a diminution in the Executive’s responsibilities will have occurred), in each case excluding for this purpose an isolated, insubstantial and inadvertent action taken in good faith and which is promptly remedied by employer.  The Executive shall only have CiC Period Good Reason if (A) the Executive has provided notice of termination to the Company of any of the foregoing conditions within ninety (90) days of the initial existence of the condition, (B) the Company does not cure such condition within thirty (30) days following receipt of such notice of termination, and (C) if such condition is not cured within such thirty (30) day period, the Executive actually terminates employment within sixty (60) days after the notice of termination.  The Executive’s mental or physical incapacity following the occurrence of an event described above in clauses (i), (ii), (iii) or (iv) shall not affect the Executive’s ability to terminate employment for CiC Period Good Reason, and the Executive’s death following delivery of a notice of termination for CiC Period Good Reason shall not affect the Executive’s estate’s entitlement to the severance benefits provided hereunder upon a termination of employment for CiC Period Good Reason.

(h)“Compensation Committee” shall mean the Compensation Committee of the Board. 

 

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(i) “Disability” as used in this Agreement shall have the meaning given that term by any disability insurance the Company carries at the time of termination that would apply to the Executive. Otherwise, the term “Disability” shall mean the inability of the Executive to perform each of the essential duties of the Executive’s position by reason of a medically determinable physical or mental impairment which is potentially permanent in character or which can be expected to last for a continuous period of not less than twelve (12) months. Any dispute as to whether or not the Executive has a “Disability” for purposes of this Agreement shall be resolved by a physician reasonably satisfactory to the Board and the Executive (or his legal representative, if applicable). If the Board and the Executive (or his legal representative, if applicable) are unable to agree on a physician, then each shall select one physician and those two physicians shall pick a third physician and the determination of such third physician shall be binding on the parties.  

(j)“Exchange Act” shall mean the Securities Exchange Act of 1934, as amended.

(k)“Good Reason” shall mean: (i) during a CiC Period, CiC Period Good Reason; and (ii) during a Non-CiC Period, Non-CiC Period Good Reason. 

(l)“Non-CiC Period” shall mean any period of time that is not a CiC Period. 

(m)“Non-CiC Period Good Reason” shall mean the occurrence of any of the following without the written consent of the Executive: (i) a requirement that the Executive work principally from a location that is more than fifty (50) miles from his or her current principal place of employment, (ii) any 10% or greater reduction in the sum of the Executive’s base salary and target bonus opportunity, (iii) any 20% or greater reduction in the grant date fair value of equity-based compensation annually awarded to the Executive (other than reductions that are made substantially pro rata to other executives of the Company), or (iv) any material breach of this Agreement or any other material agreement with the Executive by the Company or any successor entity. The Executive shall only have Non-CiC Period Good Reason if (A) the Executive has provided notice of termination to the Company of any of the foregoing conditions within ninety (90) days of the initial existence of the condition, (B) the Company does not cure such condition within thirty (30) days following receipt of such notice of termination, and (C) if such condition is not cured within such thirty (30) day period, the Executive actually terminates employment within sixty (60) days after the notice of termination.  The Executive’s mental or physical incapacity following the occurrence of an event described above in clauses (i), (ii), (iii), or (iv) shall not affect the Executive’s ability to terminate employment for Non-CiC Period Good Reason, and the Executive’s death following delivery of a notice of termination for Non-CiC Period Good Reason shall not affect the Executive’s estate’s entitlement to the severance benefits provided hereunder upon a termination of employment for Non-CiC Period Good Reason.

(n)“Parent” shall mean Orthofix Medical Inc. and its successors.

 

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(o)“Person” shall include individuals or entities such as corporations, partnerships, companies, firms, business organizations or enterprises, and governmental or quasi-governmental bodies. 

(p)“Potential CiC Date” shall mean the earliest to occur of: (i) the date on which Parent executes an agreement or letter of intent, the consummation of the transactions described in which would result in the occurrence of a Change in Control or (ii) the date on which the Board approves a transaction or series of transactions, the consummation of which would result in a Change in Control; provided, however, that such date shall become null and void when, in the opinion of the Board, Parent or the respective third party has abandoned or terminated such transaction or series of transactions without consummation. 

(q)“Qualified Retirement” shall mean a retirement from Service by the Executive in which, at the time of such retirement, the sum of the Executive’s age and aggregate 12-month completed periods of Service (whether or not such completed 12-month periods are consecutive), in each case without giving credit for any partial years, equals or exceeds 75.

(r)“Service” shall have the meaning ascribed to such term in the 2012 LTIP.

(s)“Total Compensation” shall mean aggregate of base salary, target bonus opportunity, employee benefits (retirement plan, welfare plans, and fringe benefits), and grant date fair value of equity-based compensation, but excluding for the avoidance of doubt any reductions caused by the failure to achieve performance targets) taken as a whole.

2.Term of Agreement.  The term of this Agreement (the “Term”) shall commence on the Effective Date and shall continue in effect until the earlier of (i) the parties’ satisfaction of their respective obligations under this Agreement or (ii) the execution of a written agreement between the Company and the Executive terminating this Agreement. 

3.Certain Terminations of Employment During a Non-CiC Period.  If, during a Non-CiC Period, the Executive’s employment with the Company terminates as a result of death, the Executive terminates his or her employment as a result of Disability or for Non-CiC Period Good Reason, or the Company terminates the Executive’s employment without Cause, the Company shall pay or provide to the Executive (i) the Executive’s annual base salary due through the Executive’s date of termination, (ii) any amounts or benefits owing to the Executive as of the Executive’s date of termination under the then applicable benefit plans of the Company, at the time such amounts or benefits are due (including any accrued vacation payable), (iii) any amounts owing to the Executive for reimbursement of expenses properly incurred by the Executive prior to the Executive’s date of termination, which shall be subject to and paid in accordance with the Company’s expense reimbursement policy, (iv) if, for the calendar year prior to the Executive’s termination, Executive has achieved performance goals such that Executive has earned a bonus under any annual cash incentive program of the Company (an “Annual Cash Incentive Program”) and such Annual Cash Incentive Program bonus with respect to such prior calendar year has not yet been determined and/or paid, the amount of such bonus, payable at the same time as payments are made to other participants under such Annual Cash Incentive Program, and (v) a pro rata 

 

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amount of any Annual Cash Incentive Program bonus, if any, with respect to the year of termination (based on the number of days the Executive was employed by the Company during such year of termination) based on the achievement of applicable performance goals for such year, payable during the following year at the same time as payments are made to other participants under such Annual Cash Incentive Program (collectively, the “Accrued Amounts”).  Subject to the Executive’s compliance with the restrictive covenants in Section 9 hereof and the Executive’s execution and non-revocation of the release described in Section 5 hereof, the Company shall also pay to the Executive, in a cash lump sum within ten (10) days following the Release Effective Date (as defined below), an amount equal to one (1.0) times the sum of (A) the Executive’s annual base salary in effect as of the Executive’s date of termination (without giving effect to any reduction of base salary that has occurred within the 12-month period preceding such date of termination), (B) the Executive’s current annual target cash bonus amount under the Annual Cash Incentive Program (without giving effect to any reduction of such annual target amount that has occurred within the 12-month period preceding such date of termination and (C) $12,500 to be used by the Executive for outplacement services (such sum, the “Severance Amount”).  Notwithstanding the foregoing, if the Severance Amount could be paid to the Executive during the subsequent taxable year of the Executive rather than the Executive’s taxable year in which the Executive’s date of termination occurs based on when the Executive executes and delivers the release described in Section 5 hereof to the Company, then, to the extent that the Severance Amount constitutes nonqualified deferred compensation subject to Section 409A of Internal Revenue Code of 1986, as amended (the “Code”), the Severance Amount shall not be paid earlier than the first business day of the later of such taxable years.  In addition, subject to the Executive’s compliance with the restrictive covenants in Section 9 hereof and the Executive’s execution and non-revocation of the release described in Section 5 hereof, the Company shall reimburse the Executive on a monthly basis for the Executive’s monthly premium payments for health care coverage under the Consolidated Omnibus Budget Reconciliation Act of 1985 (“COBRA”) for the Executive and the Executive’s eligible dependents for a period of twelve (12) months, provided that the Executive and, if applicable, the Executive’s eligible dependents are currently enrolled in the applicable plan(s) of the Company at the time of the Executive’s termination and that the Executive timely elects to continue the Executive’s coverage under COBRA; provided, however, that the Company’s obligation to reimburse the Executive for such premiums shall cease on the date the Executive is no longer eligible to receive COBRA coverage.  The Executive must advise the Company as soon as the Executive becomes eligible for health care coverage from a third party (e.g., spouse’s employer, the Executive’s subsequent employer, or any other party with a relationship with the Executive).

4.Termination of Employment During a CiC Period.  If, during a CiC Period, the Executive’s employment with the Company terminates as a result of death, the Executive terminates his or her employment as a result of Disability or for CiC Period Good Reason, or the Company terminates the Executive’s employment without Cause, the Company shall: (A) pay or provide to the Executive the Accrued Amounts, and (B) subject to the Executive’s compliance with the restrictive covenants in Section 9 hereof and the Executive’s execution and non-revocation of the release described in Section 5 hereof, (i) pay to the Executive, in a cash lump sum within ten (10) days following the Release Effective Date, an amount equal to one and one-half (1.5) times the sum of (A) the Executive’s annual base salary in effect as of the Executive’s 

 

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date of termination (without giving effect to any reduction of base salary that has occurred within the 12-month period preceding such date of termination), (B) the Executive’s current annual target cash bonus amount under the Annual Cash Incentive Program (without giving effect to any reduction of such annual target amount that has occurred within the 12-month period preceding such date of termination and (C) $12,500 to be used by the Executive for outplacement services (such sum, the “CiC Severance Amount”); provided, however, that if the CiC Severance Amount could be paid to the Executive during the subsequent taxable year of the Executive rather than the Executive’s taxable year in which the Executive’s date of termination occurs based on when the Executive executes and delivers the release described in Section 5 hereof to the Company, then, to the extent that the CiC Severance Amount constitutes nonqualified deferred compensation subject to Section 409A of the Code, the CiC Severance Amount shall not be paid earlier than the first business day of the later of such taxable years; and (ii) reimburse the Executive on a monthly basis for the Executive’s monthly premium payments for health care coverage under COBRA for the Executive and the Executive’s eligible dependents for a period of twelve (12) months, provided that the Executive and, if applicable, the Executive’s eligible dependents are currently enrolled in the applicable plan(s) of the Company at the time of the Executive’s termination and that the Executive timely elects to continue the Executive’s coverage under COBRA; provided, however, that the Company’s obligation to reimburse the Executive for such premiums shall cease on the date the Executive is no longer eligible to receive COBRA coverage.  The Executive must advise the Company as soon as the Executive becomes eligible for health care coverage from a third party (e.g., spouse’s employer, the Executive’s subsequent employer, or any other party with a relationship with the Executive).   

5.Payments Contingent Upon Release Agreement.  As a condition to receiving the Severance Amount or the CiC Severance Amount, as applicable, and the reimbursement of COBRA premiums pursuant to Sections 3 or 4 hereof, the Executive will execute a release of claims substantially in the form of the release attached hereto as Exhibit A (the “Release”).  Within ten (10) business days of the Executive’s date of termination, the Company shall deliver to the Executive the Release for the Executive to execute.  The Executive will forfeit all rights to receive the Severance Amount or the CiC Severance Amount, as applicable, and the reimbursement of COBRA premiums pursuant to Sections 3 or 4 hereof unless, within forty-five (45) days of delivery of the Release by the Company to the Executive, the Executive executes and delivers the Release to the Company and such Release has become irrevocable by virtue of the expiration of the revocation period specified therein without the Release having been revoked (the first such date, the “Release Effective Date”).  The Company’s obligation to pay the Severance Amount or the CiC Severance Amount, as applicable, or to reimburse COBRA premiums pursuant to Sections 3 or 4 hereof, is subject to the occurrence of the Release Effective Date, and if the Release Effective Date does not occur, then the Company shall have no obligation to make such payments or reimbursements.  Any reimbursements of COBRA premiums pursuant to Sections 3 or 4 hereof that would otherwise have become due prior to the Release Effective Date shall be paid in a cash lump sum within ten (10) days following the Release Effective Date; provided, that if any reimbursements of COBRA premiums pursuant to Sections 3 or 4 hereof could be paid to the Executive during a different taxable year of the Executive than the Executive’s taxable year in which the Executive’s date of termination occurs based on when the Executive executes and delivers the Release to the Company, then, to the extent that the reimbursements constitute 

 

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nonqualified deferred compensation subject to Section 409A of the Code, the reimbursement amounts shall not be paid earlier than the first business day of the later of such taxable years.  In the event the Executive breaches one or more of the restrictive covenants set forth in Section 9 hereof, the Executive shall forfeit the Executive’s right to receive the Severance Amount or the CiC Severance Amount, as applicable, and the reimbursement of COBRA premiums pursuant to Sections 3 or 4 hereof, and, to the extent such amounts have been paid to the Executive, shall repay to the Company the after-tax amount of any such previously paid amounts.  

6.Time-Based Stock Options and Time-Based Restricted Stock Vesting and Exercisability.  The provisions set forth in Sections 6(a), (b), (c) and (e) below shall apply with respect to (a) all time-based vesting stock options of the Company (“Time-Based Stock Options” or “Options”) granted to the Executive before or after the date of this Agreement, and (b) all time-based vesting shares of restricted stock of the Company (“Time-Based Restricted Stock” or “TBRS”) granted to the Executive before or after the date of this Agreement.  The provisions set forth in Section 6(d) below only shall apply with respect to all Time-Based Stock Options and Time-Based Restricted Stock granted during or after the 2016 calendar year.  Such provisions shall supersede and override any conflicting provisions set forth in applicable award agreements of the Company governing applicable grants, and shall be incorporated by reference into the terms of such award agreements. 

(a)Termination with or without Cause; Certain Voluntary Terminations. If, prior to vesting, the Executive’s Service is terminated for any reason other than (i) death, (ii) Disability, (iii) a Qualified Retirement occurring no less than six (6) months after the grant date of the Option (the “Grant Date”) or (iv) a circumstance providing for accelerated vesting pursuant Section 6(d) hereof, the unvested portion of the applicable Option or TBRS shall be cancelled and revert back to the Company as of the date of such termination of Service, and the Executive shall have no further right or interest therein unless the Compensation Committee in its sole discretion shall determine otherwise.  In such event, the Executive shall have the right, subject to the other terms and conditions set forth in this Agreement and the applicable plan, to exercise such Option, to the extent it has vested as of the date of such termination of Service, at any time within three (3) months after the date of such termination of Service, subject to the earlier expiration of the Option on the ten (10)-year anniversary of grant or such other term as is provided in the applicable equity award agreement otherwise governing such grant (the “Expiration Date”).  To the extent the vested portion of the Option is not exercised within such three (3)-month period, such Option shall be cancelled and revert back to the Company, and the Executive or any permitted transferee pursuant to the terms of the applicable award agreement shall have no further right or interest therein.

(b)Termination of Service for Death or Disability. If the Executive’s Service terminates by reason of death or Disability, as of the date of such termination of Service (i) the unvested portion of any Option shall automatically vest and become immediately exercisable in full and (ii) any TBRS shall automatically vest in full.  The full portion of any unexercised Option shall remain exercisable by the Executive (or any person entitled to do so) at any time within eighteen (18) months after the date of such termination of Service, subject to the earlier expiration of such Option on the Expiration Date. To the extent such Option is not exercised within such  period, such Option shall be cancelled and revert back to the Company, and the Executive or any 

 

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permitted transferee pursuant to the terms of the applicable award agreement, as applicable, shall have no further right or interest therein.

(c)Termination of Service for Certain Qualified Retirements. If the Executive’s Service terminates by reason of a Qualified Retirement occurring no less than six (6) months after the Grant Date but prior to the second anniversary of the Grant Date, any Option shall automatically vest and become immediately exercisable, and any TBRS shall be considered vested, as of the date of such termination of Service with respect to the aggregate number of shares of common stock of Parent as to which such Option or TBRS, as applicable, would have been vested as of such second anniversary of the Grant Date.  If the Executive’s Service terminates by reason of a Qualified Retirement after the second anniversary of the Grant Date but before the third anniversary of the Grant Date, any Option shall automatically vest and become immediately exercisable, and any TBRS shall be considered vested, as of the date of such termination of Service with respect to the aggregate number of shares of common stock of Parent as to which such Option or TBRS, as applicable, would have been vested as of such third anniversary of the Grant Date.  If the Executive’s Service is terminated by reason of a Qualified Retirement after the third anniversary of the Grant Date but before the fourth anniversary of the Grant Date, any Option shall automatically vest and become immediately exercisable, and any TBRS shall be considered vested, in full as of the date of such termination of Service.  In each of the circumstances described in the preceding three sentences, the applicable Option shall remain exercisable by the Executive (or any person entitled to do so) at any time within eighteen (18) months after the date of such termination of Service, subject to the earlier expiration of the Option on the Expiration Date.  To the extent such Option is not exercised within such eighteen (18)-month period, the Option shall be cancelled and revert back to the Company and the Executive or any permitted transferee pursuant to the terms of the applicable award agreement, as applicable, shall have no further right or interest therein.

(d)Certain Additional Change in Control Circumstances. In the event that any Option is assumed or continued, or substituted for new common stock options or another equity-based award of a successor entity, or parent or subsidiary thereof (with appropriate adjustments as to the number of shares and option exercise prices), or any unvested portion of the TBRS is assumed or continued, or substituted for new restricted common stock or another equity-based award of a successor entity, or parent or subsidiary thereof (with appropriate adjustments as to the number of shares), in each case upon the consummation of any Change in Control, and the employment of the Executive with the Company is terminated by the Company without Cause or by the Executive for CiC Period Good Reason, in each case during a CiC Period, (i) such Option shall be fully vested and may be exercised in full, to the extent applicable, beginning on the date of such termination and for the twenty-four (24)-month period immediately following such termination (subject to the earlier expiration of the Option on the Expiration Date) or for such longer period as the Compensation Committee shall determine and (ii) the unvested portion of such TBRS shall be fully vested. (Nothing in the preceding sentence shall limit or alter the Executive’s rights under Section 6(c) hereof in the event that the Executive instead terminates his or her Service by reason of a Qualified Termination.) In the event that a Change in Control occurs in which outstanding Options and/or shares of TBRS are not being assumed, continued or substituted (as contemplated by the preceding sentence), any Option and the unvested portion of 

 

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any TBRS shall be treated in accordance with the default rules applicable under Section 17.3 of the 2012 LTIP (or if made pursuant to a successor long-term incentive plan or inducement plan, the default rules contained in such plan).  

(e)Definition of Qualified Retirement.  The term Qualified Retirement as used in any award agreement with respect to Options or TBRS shall, notwithstanding any definition of such phrase in an award agreement, be defined as set forth in this Agreement. 

(f)Survival.  All of the provisions in this Section 6 shall survive any expiration or termination of this Agreement for any reason (unless such termination is as a result of a future novation of such provisions entered into by each of the parties).  

7.Section 280G.  In the event that any of the severance payments and other benefits provided by this Agreement or otherwise payable to Executive (a) constitute “parachute payments” within the meaning of Section 280G of the Code, and (b) but for this Section 7, would be subject to the excise tax imposed by Section 4999 of the Code (“Excise Tax”), then Executive’s severance payments and benefits under this Agreement or otherwise shall be payable either in full or in such lesser amount which would result in no portion of such severance payments or benefits being subject to the Excise Tax, whichever of the foregoing amounts, taking into account the applicable federal, state and local income and employment taxes and the Excise Tax, results in the receipt by Executive, on an after-tax basis, of the greatest amount of severance payments and benefits under this Agreement or otherwise, notwithstanding that all or some portion of such severance payments or benefits may be taxable under Section 4999 of the Code.  Any reduction in the severance payments and benefits required by this Section 7 shall be made in the following order: (i) reduction of cash payments; (ii) reduction of accelerated vesting of equity awards other than stock options; (iii) reduction of accelerated vesting of stock options; and (iv) reduction of other benefits paid or provided to Executive.  The calculations and establishment of assumptions in this Section 7 will be performed by a professional tax firm engaged by the Company as of the day prior to the CiC Date.  If the tax firm so engaged by the Company is serving as accountant or auditor for the acquiring company, the Company shall appoint a nationally recognized tax firm to make the determinations required by this Section 7.  The Company shall bear all expenses with respect to the determinations by such firm required to be made by this Section 7.  The Company and Executive shall furnish such tax firm such information and documents as the tax firm may reasonably request in order to make its required determination.  The tax firm will provide its calculations, together with detailed supporting documentation, to the Company and Executive as soon as practicable following its engagement.  Any good faith determinations of the tax firm made hereunder shall be final, binding and conclusive upon the Company and Executive.  However, the Executive shall have the final authority to make any good faith determination(s) associated with the assumptions used by the tax firm in providing its calculations, and such good faith determination by the Executive shall be binding on the Company.  As a result of the uncertainty in the application of Sections 409A, 280G or 4999 of the Code at the time of the initial determination by the professional tax firm described in this Section 7, it is possible that the Internal Revenue Service (the “IRS”) or other agency will claim that an Excise Tax greater than that amount, if any, determined by such professional firm for the purposes of this Section 7 is due (the “Additional Excise Tax”).  Executive shall notify the Company in writing of any claim by the IRS 

 

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or other agency that, if successful, would require payment of Additional Excise Tax.  Executive and the Company shall each reasonably cooperate with the other in connection with any administrative or judicial proceedings concerning the existence or amount of liability for Excise Tax with respect to payments made or due to Executive.  The Company shall pay all reasonable fees, expenses and penalties of Executive relating to a claim by the IRS or other agency.  In the event it is finally determined that a further reduction would have been required under this Section 7 to place Executive in a better after-tax position, Executive shall repay the Company such amount within 30 days thereof in order to effect such result.

8.Section 409A. 

(a)For purposes of Section 409A of the Code (“Section 409A”) (i) each “payment” (as defined by Section 409A) made under this Agreement shall be considered a “separate payment,” and (ii) payments shall be deemed exempt from the definition of deferred compensation under Section 409A to the fullest extent possible under (x) the “short-term deferral” exemption of Treasury Regulation § 1.409A-1(b)(4), and (y) with respect to amounts paid as separation pay (as defined under Treasury Regulation § 1.409A-1(m)) no later than the second calendar year following the calendar year containing the Executive’s “separation from service” (as defined for purposes of Section 409A), the “two years/two-times” separation pay exemption of Treasury Regulation § 1.409A-1(b)(9)(iii), which exemptions are hereby incorporated by reference.  

(b)Any payments otherwise payable under this Agreement shall not commence until the Executive has a “separation from service” (as defined in Section 409A).  

(c)If the Executive is a “specified employee” as defined in Section 409A (and as applied according to procedures of the Company and its affiliates) as of the Executive’s separation from service, to the extent any payment under this Agreement constitutes deferred compensation (after taking into account any applicable exemptions from Section 409A) that is payable upon a separation from service, and to the extent required in order to avoid the imposition of an excise tax under Section 409A, no payments due under this Agreement may be made until the earlier of:  (1) the date of the Executive’s death and (2) the first day of the seventh month following the Executive’s separation from service, provided, however, that any payments delayed during this six-month period shall be paid in the aggregate in a lump sum on the first day of the seventh month following the Executive’s separation from service (or upon the date of the Executive’s death, if earlier).

(d)Any expense reimbursements or in kind benefits under this Agreement that constitute deferred compensation within the meaning of Section 409A shall be made or provided in accordance with the requirements of Section 409A, including, without limitation, that: (i) the expenses eligible for reimbursement or the amount of in-kind benefits provided in one taxable year shall not affect the expenses eligible for reimbursement or the amount of in-kind benefits provided in any other taxable year; (ii) the reimbursement of an eligible expense shall be made no later than the end of the year after the year in which such expense was incurred; and (iii) the right to 

 

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reimbursement or in-kind benefits shall not be subject to liquidation or exchange for another benefit.

(e)If this Agreement fails to meet the requirements of Section 409A, neither the Company nor any of its affiliates shall have any liability for any tax, penalty or interest imposed on the Executive by Section 409A, and the Executive shall have no recourse against the Company or any of its affiliates for payment of any such tax, penalty, or interest imposed by Section 409A.

9.Restrictive Covenants.  

(a)Non-Disparagement.  The Executive agrees that the Company’s reputation and goodwill in the marketplace is of utmost importance and value to the Company.  The Executive further agrees that during and after the term of the Executive’s employment with the Company, the Executive will not make, publish or cause to be published any public or private statement or comments disparaging or defaming the Company, its subsidiaries or affiliates, or any of their respective stockholders, partners, members, directors, managers, officers and employees.  The Executive acknowledges and agrees that this prohibition extends to statements, written or verbal, made to anyone, including but not limited to, the news media, competitors, vendors, and employees (past and present).  The Executive further understands and agrees that this Section 9(a) is a material provision of this Agreement and that any breach of this Section 9(a) shall be a material breach of this Agreement, and that the Company would be irreparably harmed by violation of this provision.  This prohibition does not preclude the Executive from providing truthful testimony if compelled by law.

(b)Cooperation.  The Executive agrees that after the Executive’s date of termination, the Executive shall make the Executive available at reasonable times, intervals and places for interviews, consultations, internal investigations and/or testimony during which the Executive shall provide to the Company, or its designated attorneys or agents, any and all information known to the Executive regarding or relating to the Company or the Executive’s activities on behalf of the Company pertaining to the subject matter on which the Executive’s cooperation is sought.  The Executive agrees to remain involved for so long as any such matters shall be pending.  

(c)Non-Disclosure.

(i)During the course of the Executive’s employment with the Company, before and after the execution of this Agreement, and as consideration for the restrictive covenants entered into by the Executive herein, the Executive has received and will continue to receive some or all of the Company’s various Trade Secrets (as defined under applicable law) and confidential or proprietary information, which includes the following whether in physical or electronic form: (1) data and compilations of data related to, Business Opportunities (as defined below), (2) computer software, hardware, network and internet technology utilized, modified or enhanced by the Company or by the Executive in furtherance of the Executive’s duties with the Company; (3) compilations of data concerning Company products, services, customers, and end users including but not limited to compilations concerning projected sales, new project timelines, 

 

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inventory reports, sales, and cost and expense reports; (4) compilations of information about the Company’s employees and independent contracting consultants; (5) the Company’s financial information, including, without limitation, amounts charged to customers and amounts charged to the Company by its vendors, suppliers, and service providers; (6) proposals submitted to the Company’s customers, potential customers, wholesalers, distributors, vendors, suppliers and service providers; (7) the Company’s marketing strategies and compilations of marketing data; (8) compilations of data or information concerning, and communications and agreements with, vendors, suppliers and licensors to the Company and other sources of technology, products, services or components used in the Company’s business; (9) the Company’s research and development records and data; and (10) any summary, extract or analysis of such information together with information that has been received or disclosed to the Company by any third party as to which the Company has an obligation to treat as confidential (collectively, “Confidential Information”). “Business Opportunities” shall mean all ideas, concepts or information received or developed (in whatever form) by the Executive concerning any business, transaction or potential transaction that constitutes or may constitute an opportunity for the Company to earn a fee or income, specifically including those relationships that were initiated, nourished or developed at the Company’s expense. Confidential Information does not include data or information: (1) which has been voluntarily disclosed to the public by the Company, except where such public disclosure has been made by the Executive without authorization from the Company; (2) which has been independently developed and disclosed by others; or (3) which has otherwise entered the public domain through lawful means.

(ii)All Confidential Information, Trade Secrets, and all physical and electronic embodiments thereof are confidential and are and will remain the sole and exclusive property of the Company. During and after the term of the Executive’s employment with the Company, the Executive agrees that the Executive shall protect any such Confidential Information and Trade Secrets and shall not, except in connection with the performance of the Executive’s remaining duties for the Company, use, disclose or otherwise copy, reproduce, distribute or otherwise disseminate any such Confidential Information or Trade Secrets, or any physical or electronic embodiments thereof, to any third party; provided, however, that the Executive may make disclosures required by a valid order or subpoena issued by a court or administrative agency of competent jurisdiction, in which event the Executive will promptly notify the Company of such order or subpoena to provide the Company an opportunity to protect its interests.  Without limiting the generality of the foregoing, the Executive agrees that after the Executive’s termination of employment with the Company, the Executive shall not disclose to any third party any transaction or potential transaction that was under active consideration by the Company on or during the six (6) month period prior to the Executive’s date of termination from the Company.  The Executive further agrees that if the Executive is ever subpoenaed or otherwise required by law to provide any statement or other assistance to a party to a dispute or litigation with the Company, other than the Company, then the Executive shall provide written notice of the circumstances requiring such statement or other assistance, including where applicable a copy of the subpoena or other legal writ, in such a manner and at such a time that allows the Company to timely respond.  Nothing herein shall prevent the Executive from cooperating with co-defendants in litigation or with inquiry in a government investigation without a need to obtain prior consent or approval from the Company; provided, however, the Executive shall provide prompt notice of any voluntary giving 

 

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of oral or written statements to such parties, and provide to the Company a copy of any written statement so given or a summary of any oral statement provided.

(iii)Upon request by the Company and, in any event, upon termination of the Executive’s employment with the Company for any reason, the Executive will promptly deliver to the Company (within twenty-four (24) hours) all property belonging to the Company, including but without limitation, all Confidential Information, Trade Secrets and all electronic and physical embodiments thereof, all Company files, customer lists, management reports, memoranda, research, Company forms, financial data and reports and other documents (including but not limited to all such data and documents in electronic form) supplied to or created by the Executive in connection with the Executive’s employment with the Company (including all copies of the foregoing) in the Executive’s possession or control, and all of the Company’s equipment and other materials in the Executive’s possession or control. The Executive agrees to allow the Company, at its request, to verify return of Company property and documents and information and/or permanent deletion of the same, through inspection of personal computers, personal storage media, third party websites, third party e-mail systems, personal digital assistant devices, cell phones and/or social networking sites on which Company information was stored during the Executive’s employment with the Company.

(iv)Nothing contained herein shall be in derogation or a limitation of the rights of the Company to enforce its rights or the Executive’s duties under the applicable law relating to Trade Secrets.

(v)Notwithstanding anything to the contrary contain herein, the parties hereto acknowledge that pursuant to 18 USC § 1833(b), the Executive may not be held liable under any criminal or civil federal or state trade secret law for disclosure of a trade secret: (i) made in confidence to a government official, either directly or indirectly, or to an attorney, solely for the purpose of reporting or investigating a suspected violation of law or (ii) in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal.  Additionally, the parties hereto acknowledge that if the Executive sues the Company for retaliation based on the reporting of a suspected violation of law, the Executive may disclose a trade secret to the Executive’s attorney and use the trade secret information in the court proceeding, so long as any document containing the trade secret is filed under seal and the Executive does not disclose the trade secret except pursuant to court order.

(d)Innovations.  

(i)The Executive hereby assigns, transfers and conveys to Orthofix Inc. and its successors and assigns any and all inventions, processes, procedures, systems, discoveries, designs, configurations, technology, works of authorship, trade secrets and improvements (whether or not they are made, conceived or reduced to practice during working hours or using the Company’s data or facilities) (collectively, “Innovations”) which the Executive makes, conceives, reduces to practice or otherwise acquires during any period of his/her employment by the Company (either solely or jointly with others), and which are related to the Company’s present or planned business, the Company’s services or products, and any and all 

 

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patents, copyrights, trademarks, trade names and applications therefor, in the United States and elsewhere, relating thereto.  The Innovations shall be the sole property of Orthofix Inc. and shall at all times be held by the Executive in a fiduciary capacity for the sole benefit of Orthofix Inc.

(ii) All such Innovations that consist of works of authorship capable of protection under copyright laws shall be prepared by the Executive as works made for hire, with the understanding that Orthofix Inc. shall own all of the exclusive rights to such works of authorship under the United States copyright law and all international copyright conventions and foreign laws.  The foregoing notwithstanding, to the extent that any such Innovation is not deemed a work made for hire, the Executive hereby assigns to Orthofix Inc. such Innovation and any and all patents, copyrights, trademarks, trade names and applications therefor, in the United States and elsewhere, relating thereto.

(iii)The Executive shall maintain adequate and current written records of all such Innovations, which shall be available to and remain the sole property of Orthofix Inc. at all times.  The Executive shall promptly disclose to the Company all such Innovations and shall assist the Company in obtaining and enforcing for its own benefit patents and copyright registrations on and in respect of such Innovations in all countries in all ways that the Company may request, to secure and enjoy the full benefits and advantages of such Innovations.  The Executive understands that his/her obligations under this section shall continue after the termination of the Executive’s employment by the Company.

(e)Non-Solicitation.  The Executive agrees that during the course of the Executive’s employment with the Company and for a period of twelve (12) months following the termination of the Executive’s employment with the Company for any reason, with or without Cause, whether upon the initiative of either the Executive or the Company, the Executive will not, on behalf of the Executive or any other individual, corporation, partnership, limited liability company, association, trust or any other entity or organization (including a government or political subdivision or an agency or instrumentality thereof), directly or by assisting others, solicit, induce, persuade or encourage, or attempt to solicit, induce, persuade or encourage, any individual employed by the Company, with whom the Executive has worked, to terminate such employee’s position with the Company, whether or not such employee is a full-time or temporary employee of the Company and whether or not such employment is pursuant to a written agreement, for a determined period, or at will. The provisions of this Section 9(e) shall only apply to the Executive’s solicitation or attempted solicitation of those individuals employed by the Company at the time of solicitation or attempted solicitation. 

(f)Non-Competition.  Without the prior written consent of the Board (which may be withheld in the Board’s sole discretion), so long as the Executive is an employee of the Company and for a period of twelve (12) months thereafter, the Executive agrees that the Executive shall not anywhere in the Prohibited Area, for the Executive’s own account or the benefit of any other, engage or participate in or assist or otherwise be connected with a Competing Business.  For the avoidance of doubt, the Executive understands that this Section 9(f) prohibits the Executive from acting for himself or as an officer, employee, manager, operator, principal, owner, partner, shareholder, advisor, consultant of, or lender to, any individual or other Person that is engaged or 

 

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participates in or carries out a Competing Business or is actively planning or preparing to enter into a Competing Business.  The parties agree that such prohibition shall not apply to the Executive’s passive ownership of not more than 5% of a publicly-traded company.  For purposes of the foregoing, (i) “Competing Business” shall mean any business or activity that (i) competes with the Company and involves (ii) (A) the same or substantially similar types of products or services (individually or collectively) manufactured, marketed or sold by the Company after the Effective Date or (B) products or services so similar in nature to that of the Company’s (or that the Company will soon thereafter offer) that they would be reasonably likely to displace substantial business opportunities or customers of the Company, and (ii) “Prohibited Area” shall mean North America, South America and Europe, which Prohibited Area the parties have agreed to as a result of the fact that those are the geographic areas in which the Company conducts a preponderance of its business and in which the Executive provides substantive services to the benefit of the Company. 

(g)Acknowledgements.  The Executive acknowledges that the Company is in the business of providing reconstructive, regenerative and trauma-related products used in various orthopedic and spine procedures worldwide and that the Company makes substantial investments and has established substantial goodwill associated with its business, supplier relationships and marketing programs throughout the United States.  The Executive therefore acknowledges and agrees that it is fair and reasonable for the Company to take steps to protect its Confidential Information, Trade Secrets, goodwill, business relationships, employees, economic advantages, and/or other legitimate business interests from the risk of misappropriation of or harm to its Confidential Information, Trade Secrets, goodwill, business relationships, employees, economic advantages, and/or other legitimate business interests.  The Executive acknowledges that any limitations as to time and scope of activity to be restrained are reasonable and do not impose a greater restraint than is necessary to protect Company’s Confidential Information, Trade Secrets, good will, business relationships, employees, economic advantages, and/or other legitimate business interests, and will not prevent the Executive from earning a livelihood.

(h)Survival of Covenants.  The provisions and restrictive covenants in this Section 9 shall survive the expiration or termination of this Agreement for any reason.  The Executive agrees not to challenge the enforceability or scope of the provisions and restrictive covenants in this Section 9.  The Executive further agrees to notify all future persons or businesses, with which the Executive becomes affiliated or employed by, of the provisions and restrictions set forth in this Section 9, prior to the commencement of any such affiliation or employment.  If any of the provisions in this Section 9 are construed to be invalid or unenforceable in any respect, the parties agree that the same may be modified as the court may direct to make such provisions and covenants reasonable, and such modification shall not affect the remainder of such provision, and such provisions shall be given the maximum possible effect and the modified agreement shall be fully enforceable.

(i)Injunctive Relief. The Executive acknowledges that if the Executive breaches or threatens to breach any of the provisions of this Agreement, the Executive’s actions will cause irreparable harm and damage to the Company which cannot be compensated by damages alone. Accordingly, if the Executive breaches or threatens to breach any of the provisions of this 

 

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Agreement, the Company shall be entitled to injunctive relief, in addition to any other rights or remedies the Company may have. The Executive hereby waives the requirement for a bond by the Company as a condition to seeking injunctive relief.  The existence of any claim or cause of action by the Executive against the Company, whether predicated on this Agreement or otherwise, shall not constitute a defense to the enforcement by the Company of the Executive’s agreements under this Agreement.

10.Entire Agreement.  This Agreement supersedes any and all other agreements, either oral or in writing, between the parties hereto with respect to severance payments and benefits, and contains all of the agreements between the parties with respect to severance payments and benefits.

11.Miscellaneous.  

(a)Except for injunctive relief as set forth herein, the parties agree that any dispute or controversy arising under or in connection with this Agreement shall be resolved exclusively and finally by binding arbitration in Lewisville, Texas, before a single arbitrator, with such arbitration to be conducted in accordance with the rules of the American Arbitration Association’s Commercial Arbitration Rules then in effect.  Judgment on the arbitrator’s award may be entered by any court having jurisdiction.  The Company shall be responsible for its own attorneys’ fees, costs and expenses and shall pay to the Executive an amount equal to all reasonable attorneys’ and related fees, costs and expenses incurred by the Executive in connection with such arbitration and entry of judgment, but only if the arbitrator determines that the Executive prevailed on a material issue of the arbitration.  If there is any dispute between the Company and the Executive as to the payment of such fees and expenses, the arbitrator shall resolve such dispute, which resolution shall also be final and binding on the parties, and as to such dispute only, the burden of proof shall be on the Company.

(b)This Agreement shall be governed, construed and interpreted in accordance with the laws of the State of Texas (without regard to any provision of that State’s rules on the conflicts of law that might make applicable the law of a jurisdiction other than that of the State of Texas). Subject to Section 11(a) hereof, all actions or proceedings for injunctive relief arising out of this Agreement shall exclusively be heard and determined in state or federal courts in the State of Texas having appropriate jurisdiction for Collin County, Texas.  The parties expressly consent to the exclusive jurisdiction of such courts in any such action or proceeding and waive any objection to venue therein and any defense of forum non conveniens.

(c)This Agreement may be executed in any number of counterparts, each of which, when executed by both parties to this Agreement shall be deemed to be an original, and all of which counterparts together shall constitute one and the same instrument.  

(d)The failure of either party hereto to enforce any right under this Agreement shall not be construed to be a waiver of that right, or of damages caused thereby, or of any other rights under this Agreement.  

 

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(e)This Agreement may not be amended or modified otherwise than by a written agreement executed by the parties hereto or their respective successors and legal representatives. 

(f)This Agreement shall inure to the benefit of and be binding upon the Company and its successors and assigns.  This Agreement shall bind any successor of or to the Company, its assets or its businesses (whether direct or indirect, by purchase, merger, consolidation or otherwise), in the same manner and to the same extent that the Company would be obligated under this Agreement if no succession had taken place.  In the case of any transaction in which a successor would not by the foregoing provision or by operation of law be bound by this Agreement, the Company shall require such successor expressly and unconditionally to assume and agree to perform the Company’s obligations under this Agreement, in the same manner and to the same extent that the Company would be required to perform if no such succession had taken place.  All rights under this Agreement are personal to the Executive and, without the prior written consent of the Company, shall not be assignable by the Executive otherwise than by shall or the laws of descent and distribution.  This Agreement shall inure to the benefit of and be enforceable in the event of the Executive’s death or disability by the Executive’s legal representatives, heirs and legatees.

(g)The Executive and the Company acknowledge that the employment of the Executive by the Company is “at will” and may be terminated by either the Executive or the Company at any time.  Nothing contained in the Agreement shall affect such rights to terminate, provided, however, that nothing in this Section 11(g) shall prevent the Executive from receiving any amounts payable pursuant to Sections 3 or 4 hereof in the event of a termination described in such Sections.

(h)Notwithstanding anything in this Agreement to the contrary, in no event shall anything in this Agreement (whether in Section 9 or otherwise) be interpreted to limit or restrict the Executive’s right or ability to provide whistleblower information to the Securities and Exchange Commission regarding violations of the federal securities laws pursuant to Section 21F of the Exchange Act.

(i)Any provision in this Agreement which is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective only to the extent of such prohibition or unenforceability without invalidating or affecting the remaining provisions hereof, and any such prohibition or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction.

(j)Notices and all other communications contemplated by this Agreement shall be in writing and shall be deemed to have been duly given when personally delivered or when mailed by U.S. registered or certified mail, return receipt requested and postage prepaid or when sent by express U.S. mail or overnight delivery through a national delivery service (or an international delivery service in the case of an address outside the U.S.) with signature required.  Notice to the Company shall be directed to the attention of the General Counsel of the Company 

 

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at the address of the Company’s headquarters, and notice to the Executive shall be directed to the Executive at the Executive’s most recent personal residence on file with the Company.

(k)The Company shall deduct from the amounts payable to the Executive pursuant to this Agreement all required withholding amounts and deductions, including but not limited to federal, state and local withholding amounts in accordance all applicable laws and regulations and deductions authorized by the Executive.  The Executive shall be solely responsible for and shall pay all taxes associated with the amounts payable under this Agreement.  

 

 

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IN WITNESS WHEREOF, each of the undersigned has executed this Agreement as of the date first above written.

	
	
ORTHOFIX MEDICAL INC.

 

By:  /s/ Jon Serbousek

        Jon Serbousek

        President and Chief Executive Officer

	
 

EXECUTIVE

 

/s/ Paul Gonsalves

Paul Gonsalves

 

 

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EXHIBIT A

Release

 

You, for yourself, your spouse and your agents, successors, heirs, executors, administrators and assigns, hereby irrevocably and unconditionally forever release and discharge Orthofix Medical Inc., a Delaware corporation, and its direct and indirect subsidiaries (all such entities, collectively, the “Company”), its parents, divisions and affiliates and its and their current and former owners, directors, officers, stockholders, insurers, benefit plans, representatives, agents and employees, and each of their predecessors, successors, and assigns (collectively, the “Releasees”), from any and all actual or potential claims or liabilities of any kind or nature, including, but not limited to, any claims arising out of or related to your employment and separation from employment with the Company and any services that you provided to the Company; any claims for salary, commissions, bonuses, other severance pay, vacation pay, allowances or other compensation, or for any benefits under the Employee Retirement Income Security Act of 1974 (“ERISA”) (except for vested ERISA benefits); any claims for discrimination, harassment or retaliation of any kind or based upon any legally protected classification or activity; any claims under Title VII of the Civil Rights Acts of 1964, the Civil Rights Act of 1866 and 1964, as amended, 42 U.S.C. § 1981, the Age Discrimination in Employment Act, the Older Workers Benefit Protection Act, the Americans with Disabilities Act, 42 U.S.C. §1981, 42 U.S.C. § 1983, the Family Medical Leave Act and any similar state law, the Fair Credit Reporting Act and any similar state law, the Fair Credit Reporting Act, 15 U.S.C. § 1681, et seq., the Worker Adjustment and Retraining Notification Act, 29 U.S.C. § 2101, et seq., the Equal Pay Act and any similar state law, as well as any amendments to any such laws; any claims for any violation of any federal or state constitutions or executive orders; any claims for wrongful or constructive discharge, violation of public policy, breach of contract or promise (oral, written, express or implied), personal injury not covered by workers’ compensation benefits, misrepresentation, negligence, fraud, estoppel, defamation, infliction of emotional distress, contribution and any claims under any other federal, state or local law, including those not specifically listed in this Release, that you, your heirs, executors, administrators, successors, and assigns now have, ever had or may hereafter have, whether known or unknown, suspected or unsuspected, up to and including the date of your execution of this Release.

 

For the purpose of implementing a full and complete release and discharge of the Releasees as set forth above, you acknowledge that this Release is intended to include in its effect, without limitation, all claims known or unknown that you have or may have against the Releasees which arise out of or relate to your employment, including but not limited to compensation, performance or termination of employment with the Company, except for, and notwithstanding anything in this Release to the contrary, claims which cannot be released solely by private agreement.  This Release also excludes any claims relating to any right you may have to payments pursuant to Sections 3 or 4 of the Change in Control and Severance Agreement, entered into as of September 11, 2020, by and between the Company and me, any claim for workers’ compensation benefits and any rights you may have to indemnification or directors’ and officers’ liability insurance under the Company’s articles of association, certificates of incorporation or bylaws, any indemnification agreement to which you are a party or beneficiary or applicable law, as a result of having served 

 

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as an officer, director or employee of the Company or any of its affiliates.  You further acknowledge and agree that you have received all leave, compensation and reinstatement benefits to which you were entitled through the date of your execution of this Release, and that you were not subjected to any improper treatment, conduct or actions as a result of a request for leave, compensation or reinstatement.

 

You affirm, by signing this Release, that you have not suffered any unreported injury or illness arising from your employment, and that you have not filed, with any federal, state, or local court or agency, any actions or charges against the Releasees relating to or arising out of your employment with or separation from the Company.  You further agree that while this Release does not preclude you from filing a charge with the National Labor Relations Board (“NLRB”), the Equal Employment Opportunity Commission (“EEOC”), or a similar federal, state or local agency, or from participating in any investigation or proceeding with them, you do waive your right to personally recover monies or reinstatement as a result of any complaint or charge filed against the  Company with the NLRB, EEOC, or any federal, state or local court or agency.

 

You understand that the claims released in this Release do not include claims by you for: (1) unemployment insurance; (2) worker’s compensation benefits; (3) state disability compensation; (4) previously vested benefits under any Company-sponsored benefits plan; and (5) any other rights that cannot by law be released by private agreement.

 

You acknowledge:

 

	
 
	
(a)
	
That you were provided forty-five (45) full days during which to consider whether to sign this Release.  If you have signed this Agreement prior to the expiration of the forty-five (45)-day period, you have voluntarily elected to forego the remainder of that period. 

 

	
 
	
(b)
	
That you have carefully read and fully understand all of the terms of this Release.

 

	
 
	
(c)
	
That you understand that by signing this Release, you are waiving your rights under the Age Discrimination in Employment Act, as amended by the Older Workers Benefit Protection Act, 29 U.S.C. § 621, et seq., and that you are not waiving any rights arising after the date that this Release is signed.

 

	
 
	
(d)
	
That you have been given an opportunity and have been advised to consult with anyone you choose, including an attorney, about this Release.

 

	
 
	
(e)
	
That you understand fully the terms and effect of this Release and know of no claim that has not been released by this Release.  And, you further acknowledge that you are not aware of, or that you have fully disclosed to the Company, any matters for which you are responsible or which has come to your attention as an employee of the Company that might give rise to, evidence, or support any claim of illegal conduct, regulatory violation, unlawful discrimination, or other cause of action against the Company.

 

Change in Control and Severance Agreement—Paul Gonsalves

Effective Date:  September 11, 2020Page 23

   

   

 

 

	
 
	
(f)
	
That you have made full and truthful disclosures to the Company’s compliance department regarding any misconduct (including any violations of federal securities laws) relating to the Company or its subsidiaries of which you are aware, and that you understand that notwithstanding anything herein or in any other agreement to the contrary, in no event shall you be prohibited or limited from my right to provide truthful information to or otherwise assist U.S. governmental authorities in any investigation regarding the Company (whether pursuant to Section 21F of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise), and in the event of such assistance, nothing herein or in any other agreement shall be deemed to conflict with my right to receive any award payable pursuant to Section 21F of the Exchange Act.

 

	
 
	
(g)
	
That these terms are final and binding on you.

 

	
 
	
(h)
	
That you have signed this Release voluntarily, and not in reliance on any representations or statements made to you by any employee or officer of the Company or any of its subsidiaries.

 

	
 
	
(i)
	
That you have seven (7) days following your execution of this Release to revoke it in writing, and that this Release is not effective or enforceable until after this seven (7) day period has expired without revocation.  If you wish to revoke this Release after signing it, you must provide written notice of your decision to revoke this Release to the Company, to the attention of the General Counsel of the Company at the address of the Company’s headquarters, by no later than 11:59 p.m. on the seventh calendar day after the date on which you have signed this Release. 

 

 

PLEASE READ CAREFULLY.  THIS RELEASE INCLUDES A RELEASE OF ALL KNOWN AND UNKNOWN CLAIMS.

 

ACKNOWLEDGED AND AGREED

 

 

____________________________________________________

Paul GonsalvesDate

 

 

 

Change in Control and Severance Agreement—Paul Gonsalves

Effective Date:  September 11, 2020Page 24Exhibit 10.1
EXECUTION VERSION
CONFIDENTIAL
​
Certain identified information has been excluded from the exhibit because it is both (i) not material and (ii) would likely cause competitive harm to the Company, if publicly disclosed. Double asterisks denote omissions.
​
​
​
​
​
​
LICENSE AGREEMENT
BY AND BETWEEN
OCULAR THERAPEUTIX, INC.
AND
AFFAMED THERAPEUTICS LIMITED
​
​
​
​

​

CONFIDENTIAL
TABLE OF CONTENTS
​
	

	

	

	ARTICLE I DEFINITIONS
	1

	ARTICLE II LICENSES; EXCLUSIVITY
	16

	Section 2.01
	Grant of Licenses.‌

	16

	Section 2.02
	Rights to Sublicense or Subcontract‌

	16

	Section 2.03
	No Other Rights and Retained Rights‌

	17

	Section 2.04
	Knowledge Transfer‌

	17

	Section 2.05
	Product Data and Regulatory Documents‌

	18

	Section 2.06
	In-License Agreements‌

	18

	Section 2.07
	Exclusivity‌

	19

	Section 2.08
	Exports and Resale‌

	20

	ARTICLE III GOVERNANCE
	21

	Section 3.01
	General‌

	21

	Section 3.02
	Membership.‌

	23

	Section 3.03
	Meetings‌

	24

	Section 3.04
	JC Decision Making‌

	24

	Section 3.05
	Executive Officers; Disputes‌

	24

	Section 3.06
	Final Decision-Making Authority‌

	25

	Section 3.07
	Limitations on Decision-Making‌

	25

	Section 3.08
	Scope of Governance‌

	26

	Section 3.09
	Alliance Managers‌

	26

	ARTICLE IV DEVELOPMENT
	26

	Section 4.01
	Development in the Field in the Territory‌

	26

	Section 4.02
	Development Costs‌

	27

	Section 4.03
	Development Reports‌

	28

	Section 4.04
	Records‌

	29

	Section 4.05
	Development and Commercialization in South Korea‌

	29

	ARTICLE V REGULATORY
	29

	Section 5.01
	Regulatory Filings‌

	29

	Section 5.02
	In-Market Release; Secondary Packaging‌

	30

	ARTICLE VI COMMERCIALIZATION
	31

i

​

	Section 6.01
	General‌

	31

	Section 6.02
	Promotional Materials‌

	31

	Section 6.03
	Commercialization Reports‌

	31

	Section 6.04
	Commercialization Efforts‌

	31

	Section 6.05
	Standards of Conduct‌

	31

	Section 6.06
	Trademarks; Use of Names‌

	32

	ARTICLE VII MANUFACTURE AND SUPPLY
	32

	Section 7.01
	Supply‌

	32

	Section 7.02
	Serialization‌

	32

	Section 7.03
	Ocular Supply Chain Security Requirements.‌

	33

	ARTICLE VIII PAYMENTS
	33

	Section 8.01
	Upfront Payment‌

	33

	Section 8.02
	Clinical Development Milestone and Clinical Development Support Payments‌

	34

	Section 8.03
	Commercial Milestone Payments‌

	35

	Section 8.04
	Royalties‌

	35

	Section 8.05
	Product Royalty Reduction‌

	36

	Section 8.06
	Royalty Payments and Reports‌

	37

	Section 8.07
	Recordkeeping‌

	37

	Section 8.08
	Currency Conversion‌

	38

	Section 8.09
	Methods of Payment‌

	38

	Section 8.10
	Taxes‌

	38

	Section 8.11
	Late Payments‌

	40

	ARTICLE IX INTELLECTUAL PROPERTY
	40

	Section 9.01
	Ownership‌

	40

	Section 9.02
	Prosecution of Patent Rights‌

	41

	Section 9.03
	Enforcement and Defense‌

	41

	Section 9.04
	Defense of Third Party Infringement and Misappropriation Claims‌

	43

	ARTICLE X DATA SECURITY AND ADVERSE DRUG EVENTS AND REPORTS
	44

	Section 10.01
	Data Security‌

	44

	Section 10.02
	Complaints‌

	44

	Section 10.03
	Adverse Drug Events‌

	45

ii

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	Section 10.04
	No Admissions by Licensee in Response to Product Complaints that May Be Adverse to Ocular‌

	45

	ARTICLE XI REPRESENTATIONS, WARRANTIES, AND COVENANTS
	45

	Section 11.01
	Mutual Representations and Warranties‌

	45

	Section 11.02
	Mutual Covenants‌

	46

	Section 11.03
	Additional Ocular Warranties‌

	46

	Section 11.04
	Additional Licensee Warranties and Covenants‌

	47

	Section 11.05
	Anti-Corruption‌

	48

	Section 11.06
	Exportation of Data‌

	50

	Section 11.07
	Disclaimer‌

	50

	Section 11.08
	Limitation of Liability‌

	50

	ARTICLE XII CONFIDENTIALITY
	51

	Section 12.01
	Generally‌

	51

	Section 12.02
	Exceptions‌

	51

	Section 12.03
	Permitted Disclosures‌

	52

	Section 12.04
	Publicity‌

	52

	Section 12.05
	Publications‌

	53

	Section 12.06
	Injunctive Relief‌

	53

	ARTICLE XIII INDEMNIFICATION
	53

	Section 13.01
	Indemnification by Ocular‌

	53

	Section 13.02
	Indemnification by Licensee‌

	54

	Section 13.03
	Procedure‌

	54

	Section 13.04
	Insurance‌

	54

	ARTICLE XIV TERM AND TERMINATION
	55

	Section 14.01
	Term‌

	55

	Section 14.02
	Termination for Breach‌

	55

	Section 14.03
	Termination for Bankruptcy and Rights in Bankruptcy‌

	55

	Section 14.04
	Termination on Ocular’s Change in Control‌

	56

	Section 14.05
	Termination at Will by Licensee‌

	56

	Section 14.06
	Effect of Termination‌

	56

	Section 14.07
	Survival; Accrued Rights‌

	58

	ARTICLE XV DISPUTE RESOLUTION; GOVERNING LAW
	58

	Section 15.01
	Arbitration‌

	58

iii

​

	Section 15.02
	Choice of Law‌

	60

	Section 15.03
	Language‌

	60

	ARTICLE XVI ASSIGNMENT AND ACQUISITIONS
	60

	Section 16.01
	Assignment‌

	60

	Section 16.02
	Acquisitions‌

	60

	ARTICLE XVII MISCELLANEOUS
	61

	Section 17.01
	Force Majeure‌

	61

	Section 17.02
	Entire Agreement‌

	61

	Section 17.03
	Severability‌

	61

	Section 17.04
	Notices‌

	61

	Section 17.05
	Agency‌

	62

	Section 17.06
	No Waiver‌

	62

	Section 17.07
	Cumulative Remedies‌

	63

	Section 17.08
	Third Party Beneficiary Rights‌

	63

	Section 17.09
	Performance by Affiliates, Sublicensees or Subcontractors‌

	63

	Section 17.10
	Counterparts‌

	63

​
LIST OF EXHIBITS
Exhibit A – List of Ocular Patent Rights Existing as of the Effective Date
Exhibit B – Initial Development Outline
Exhibit C – Trademark License Agreement
Exhibit D – Form of Annual Compliance Certification
​
​
​

iv

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LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this “Agreement”) is made and entered into as of October 29, 2020, (“Effective Date”) between Ocular Therapeutix, Inc., a corporation organized and existing under the laws of Delaware with a principal place of business at 24 Crosby Drive Bedford, MA  01730 (“Ocular”), and AffaMed Therapeutics Limited a Corporation duly organized and existing under the laws of Hong Kong, with a principal place of business at Room 3306-3307, Two Exchange Square, 8 Connaught, Hong Kong (“Licensee”).
Ocular and Licensee may be referred to herein individually as a “Party” and collectively as the “Parties”.
RECITALS
WHEREAS, Ocular is the owner of, or otherwise controls, the Ocular Technology in the Territory (each as defined below);
WHEREAS, Ocular has expertise in the development of biopharmaceutical products and desires to further Develop and Manufacture the Licensed Products to enable Licensee’s Commercialization thereof (each as defined below);
WHEREAS, Licensee has commercial capabilities in the Territory, and is interested in obtaining an exclusive license to Develop and Commercialize the Licensed Products in the Territory; and
WHEREAS, the Parties desire to collaborate to Develop and Commercialize the Licensed Products in the Territory;
NOW THEREFORE, the Parties agree as follows:
ARTICLE I
​
DEFINITIONS
Section 1.01"AC" means allergic conjunctivitis.
Section 1.02“Accounting Standards” means, United States Generally Accepted Accounting Principles or International Financial Reporting Standards, as applicable, in each case, consistently applied.
Section 1.03“Affiliate” means, with respect to an entity, any corporation or other business entity controlled by, controlling, or under common control with such entity, with “control” meaning (a) direct or indirect beneficial ownership of at least fifty percent (50%) of the voting stock of, or at least a fifty percent (50%) interest in the income of, the applicable entity (or such lesser percentage that is the maximum allowed to be owned by a foreign entity in a particular jurisdiction and is sufficient to grant the holder of such voting stock or interest the 

1

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power to direct the management and policies of such entity) or (b) possession, directly or indirectly, of the power to direct the management and policies of an entity, whether through ownership of voting securities, by contract relating to voting rights or corporate governance or otherwise.  Notwithstanding the foregoing, CBC Group and its portfolio companies shall not be deemed Affiliates of Licensee.
Section 1.04“API” means active pharmaceutical ingredient.
Section 1.05“Arising IP” means any invention (whether patentable or not) conceived, reduced to practice, authored, created or developed (a) solely by or on behalf of a Party or any of its Affiliates or (b) jointly by or on behalf of the Parties or any of their Affiliates in the course of its activities under this Agreement during the Term (“Joint Arising IP”).
Section 1.06“Arising Patent Rights” means Patent Rights claiming Arising IP.
Section 1.07“Arising Product IP” means any Arising IP that specifically relates to any Licensed Product, including any method of use therefor and is not generally applicable to compounds and products. Arising Product IP includes the Licensee Product Data.
Section 1.08“Arising Product Patent Rights” means Patent Rights claiming Arising Product IP.
Section 1.09“Business Day” means a day other than (a) a Saturday or a Sunday or (b) a day on which banking institutions in Boston, Massachusetts, or in Beijing, China are authorized or required by Law to remain closed.
Section 1.10“Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
Section 1.11“Calendar Year” means the respective periods of twelve (12) months commencing on January 1 and ending on December 31.
Section 1.12“Change in Control” means, as to a Party, the (i) consolidation or merger of such Party with or into any person or entity as a result of which the beneficial owners of the outstanding voting securities or other ownership interests of such Party immediately prior to such transaction have beneficial ownership of fifty percent (50%) or less of the outstanding voting securities or other ownership interests of such surviving person or entity immediately following such transaction, or (ii) sale, transfer or other disposition of all or substantially all of the assets of such Party related to this Agreement, or (iii) acquisition by any person or entity, or group of persons or entities acting in concert, of beneficial ownership of fifty percent (50%) percent or more of the outstanding voting securities or other ownership interests of such Party or the power, directly or indirectly, to elect a majority of the members of such Party’s board of directors or similar governing body, or (iv) acquisition by any person or entity, or group of persons or entities acting in concert, of the power to direct the management or policies of such Party.

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Section 1.13“Clinical Trial” means any clinical study involving the administration of a product to a human subject for the purpose of evaluating the safety, efficacy, performance or other characteristic of such product.
Section 1.14“Commercialization” or “Commercialize” means, with respect to a pharmaceutical product, any and all activities directed to the marketing, promotion, importation, distribution, pricing, Reimbursement Approval, offering for sale, or sale of such pharmaceutical product, and interacting with Regulatory Authorities regarding the foregoing.  Commercialization shall exclude Manufacturing.
Section 1.15“Commercially Reasonable Efforts” means, with respect to the performing Party under this Agreement, the carrying out of obligations of such Party in a diligent, expeditious and sustained manner with efforts and resources that are consistent with the efforts and resources typically used by biopharmaceutical companies of similar size and resources as such Party in the exercise of its commercially reasonable business practices with respect to the Development, Manufacture or Commercialization of products (as applicable) that are wholly owned by such biopharmaceutical companies and having market potential, profit potential and strategic value and of a stage in Development or product life comparable to that of Licensed Product(s), including reasonably necessary personnel, based on conditions then prevailing and taking into account issues of safety and efficacy, product profile, difficulty in Developing such Licensed Product, competitiveness of alternative Third Party products in the marketplace, the patent or other proprietary position of such Licensed Product, the regulatory structure involved and the potential profitability of such Licensed Product, as applicable.
Section 1.16“Competing Product” means: (a) for DEXTENZA, any product that is directly competitive with DEXTENZA, including any biopharmaceutical product intended for the same indications in the Field as DEXTENZA; and (b) for OTX-TIC, any product that is administered as a intracameral insert, is intended for the same indication in the Field as OTX-TIC, is directed to the same biological target as OTX-TIC and has the same mechanism of action as OTX-TIC.
Section 1.17“Confidential Information” means, subject to Section 12.02(a)-(d), Know-How and any technical, scientific, trade, research, manufacturing, business, financial, marketing, product, supplier, intellectual property or other information that may be disclosed by one Party or any of its Affiliates to the other Party or any of its Affiliates, regardless of whether such information is specifically designated as confidential and regardless of whether such information is in written, oral, electronic, or other form.  Notwithstanding the foregoing, subject to Section 12.02(a)-(d), all information that (a) was disclosed prior to the Effective Date by or on behalf of either Party or any of its Affiliates under, and subject to, the Mutual Confidentiality and Non-Disclosure Agreement between the Parties with an effective date of [**] (“Confidentiality Agreement”) and (b) is “Confidential Information” as defined in the Confidentiality Agreement, shall be deemed “Confidential Information” hereunder.
Section 1.18“Controlled” means, subject to Section 2.06 and Section 16.02, with respect to a Party, any Know-How, Patent Right, Regulatory Documents or other intellectual property right, that such Party or any of its Affiliates has the ability (other than pursuant to a 

3

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license granted to such Party under this Agreement) to grant to the other Party a license or sublicense to, or other right with respect to, such Know-How, Patent Right, Regulatory Documents or other intellectual property right without violating the terms of any pre-existing agreement with any Third Party.
Section 1.19“Cover”, “Covering” or “Covered” means, with respect to a product, composition, technology, process or method and a Patent Right, that, in the absence of ownership of, or a license granted under, a claim in such Patent Right, the manufacture, use, offer for sale, sale or importation of such product or composition or the practice of such technology, process or method would infringe such claim (or, in the case of a claim of a pending patent application, would infringe such claim if it were to issue as a claim of an issued patent).
Section 1.20“Development” means formulation, pre-clinical and clinical development activities, including (i) Clinical Trials of such pharmaceutical compound or product and (ii) preparation, submission, review, and development of data or information for the purpose of submission to a Regulatory Authority to obtain authorization to conduct clinical trials or obtain Regulatory Approval of such pharmaceutical product.  Development shall include Clinical Trials initiated following receipt of Regulatory Approval, but shall exclude Manufacturing and Commercialization.
Section 1.21“Development Plan” means the plan setting out activities to be undertaken in Developing the Licensed Products in the Field in the Territory, together with estimated timelines for such activities, including the proposed clinical trials, registry studies and regulatory plans, as well as outlining the key elements involved in obtaining Regulatory Approval of the Licensed Products in the Field in the Territory, as may be amended from time to time in accordance with Section 4.01, which plan shall include in reasonable detail (a) Development activities reasonably anticipated to be undertaken by the Ocular Entities with respect to the Licensed Products in the Field in the Territory, (b) Development activities required to be undertaken by the Licensee Entities, (c) the endpoints for all clinical trials contemplated by such plan, and (d) regulatory activities and interactions anticipated to be conducted by the Ocular Entities in support of Regulatory Approval of the Licensed Products in the Field in the Territory, including planned Regulatory Filings to be submitted in connection with such approvals.
Section 1.22“DEXTENZA” means an ophthalmic insert containing 0.4 mg of dexamethasone for intracanalicular use in the treatment of ocular inflammation and pain following ophthalmic surgery and the treatment of allergic conjunctivitis.
Section 1.23“Dollars” or “$” means the legal tender of the United States.
Section 1.24“Drug Approval Application” means a New Drug Application as defined in the FD&C Act, or an equivalent application filed with any Regulatory Authority in any country other than the United States.
Section 1.25“Existing In-License Agreement” means the [**] Agreement between [**] and Ocular dated [**].

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Section 1.26“FDA” means the U.S. Food and Drug Administration or any successor agency thereto.
Section 1.27“FD&C Act” means the U.S. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time.
Section 1.28“Field” means, (a) with respect to DEXTENZA, post-operative / cataract surgery and allergic conjunctivitis; and (b) with respect to OTX-TIC, open angle glaucoma and ocular hypertension.
Section 1.29“First Commercial Sale” means, with respect to a product in a Jurisdiction, the first sale for end use or consumption of such product in such Jurisdiction in an arms’ length transaction to a Third Party following receipt of applicable Regulatory Approval of such product in such Jurisdiction.  Sales for test marketing or clinical trial purposes shall not constitute a First Commercial Sale.
Section 1.30“Functional Sublicensee” means a Third Party distributor or distribution service provider in any Jurisdiction in the Territory that (a) is not a Sublicensee and (b) makes any upfront, royalty, or other payments (other than or in addition to payments for supply of Licensee Products) to Licensee or any of its Affiliates or Sublicensees with respect to any Licensee Product or performs material Commercialization activities beyond the mere distribution of Licensed Products.
Section 1.31“Generic Product” means, as to a Licensed Product, any pharmaceutical product that (a) contains the same active pharmaceutical ingredient as such Licensed Product; (b) is sold by a Third Party that is not a licensee or Sublicensee of Licensee or any of its Affiliates and that has not otherwise been authorized by Licensee or any of its Affiliates, under a Regulatory Approval granted by a Regulatory Authority to such Third Party pursuant to an abbreviated Regulatory Approval process that is based upon or relies upon the Regulatory Approval granted by such Regulatory Authority for the Licensed Product; and (c) is lawfully substitutable for the Licensed Product.
Section 1.32“Global Brand Strategy” means the global brand strategy that determines, among other aspects, product positioning, market access strategies, messaging strategies, trademark layout and logos, all as determined by Ocular for Licensed Products and updated from time to time and provided to Licensee.
Section 1.33“Global Medical Affairs Strategy” means the global Medical Affairs strategy for Licensed Products, as determined by Ocular and updated from time to time and provided to Licensee.
Section 1.34“Global Study” means any clinical trial for any Licensed Product that (a) is conducted, in whole or in part, by any Ocular Entity and (b) is designed to be sufficient to support Regulatory Approval by the FDA or the EMA, at a minimum.

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Section 1.35“Good Clinical Practices” or “GCP” means the then-current good clinical practice standards, practices, and procedures promulgated or endorsed by any applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time to time.
Section 1.36“Good Laboratory Practices” or “GLP” means the then-current good laboratory practice standards, practices, and procedures promulgated or endorsed by any applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time to time.
Section 1.37“Good Manufacturing Practices” or “GMP” means the then-current good manufacturing practice standards, practices, and procedures promulgated or endorsed by any applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time to time.
Section 1.38“Good Pharmacovigilance Practices” or “GVP” means the then-current good pharmacovigilance practice standards, practices, and procedures promulgated or endorsed by any applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time to time.
Section 1.39“Governmental Authority” means any federal, national, multinational, state, provincial, country, city or local government or any court, arbitrational tribunal, administrative agency or commission or government authority acting under the authority of any federal, national, multinational, state, provincial, country, city or local government.
Section 1.40“IND” means an Investigational New Drug application for submission to the FDA or any equivalent counterpart application in any country other than the United States (including, e.g., a clinical trial application in Mainland China), including all supplements and amendments thereto.
Section 1.41“Indication” means the intended use of a product for the treatment, control, mitigation, prevention or cure of a distinct recognized human disease or condition, or of a manifestation of a recognized human disease or condition, or for the relief of symptoms associated with a recognized human disease or condition.
Section 1.42“Initial Development Outline” means the initial outline of the development strategy for the Licensed Product in the Territory attached hereto as Exhibit B.
Section 1.43“In-License Agreement” means any agreement between Ocular or any of its Affiliates, on the one hand, and one or more Third Parties, on the other hand, entered into prior to or after the Effective Date pursuant to which Ocular acquires Control of any Know-How or Patent Right that Covers the Development, Manufacture or Commercialization of any Licensed Product in the Field in the Territory, that Licensee has accepted as an In-License Agreement under Section 2.06, including the Existing In-License Agreement.

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Section 1.44“Joint Global Study” means a Global Study which includes clinical sites in the Territory and is designed to be sufficient to support Regulatory Approval in Greater China, for which Licensee elects to participate pursuant to Section 4.01(c) and is responsible for paying a portion of costs as set forth in Section 4.02(b).
Section 1.45“Jurisdiction” means each of the following: Mainland China, Taiwan, Hong Kong, Macau (“collectively, “Greater China”), South Korea, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore, Thailand and Vietnam.
Section 1.46“Know-How” means inventions (whether patentable or not), discoveries, trade secrets, technology, information, Regulatory Documents, formulae, practices, methods, knowledge, know-how, processes, procedures, experience, results and test data (including physical, chemical, biological, toxicological, pharmacological, clinical, veterinary, analytical and quality control data), dosage regimens, control assays, product specifications, manufacturing, and marketing, pricing, distribution cost and sales data and descriptions; but excluding Patent Rights.
Section 1.47“Law” means any law, statute, rule, regulation, order, judgment, standard or ordinance of any Governmental Authority.
Section 1.48“Licensed Product” means each of (a) DEXTENZA in the form of dexamethasone formulated in an intracanalicular insert, and (b) OTX-TIC in the form of a sustained release travoprost intracameral insert. For clarity, any other Ocular products are not Licensed Products.
Section 1.49“Licensee Entity” means, as applicable, (a) Licensee, (b) any of Licensee’s Affiliates or (c) any Sublicensee or Subcontractor of Licensee with respect to any Licensed Product.
Section 1.50“Licensee Know-How” means all Know-How that is: (a) Controlled as of the Effective Date or during the Term by Licensee or any of its Affiliates; and (b) necessary for the Development, Manufacture or Commercialization of any Licensed Product; and (c) incorporated or generated by Licensee in the Development or Commercialization of the Licensed Product; but excluding all Arising Product IP assigned by Licensee to Ocular pursuant to Section 9.01(c).
Section 1.51“Licensee Patent Rights” means all Patent Rights that: (a) are Controlled as of the Effective Date or during the Term by Licensee or any of its Affiliates; and (b) Cover any Licensed Product or their respective Development, Manufacture or Commercialization; and (c) are incorporated or generated by Licensee in the Development or Commercialization of the Licensed Product; but excluding Arising Product Patent Rights assigned to Licensee pursuant to Section 9.01(c).
Section 1.52“Licensee Sole Arising Patent Rights” means Patent Rights claiming Arising Product IP conceived, reduced to practice, authored, created or developed solely by or on behalf of Licensee or any of its Affiliates.

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Section 1.53“Licensee Technology” means Licensee Know-How and Licensee Patent Rights.
Section 1.54“Local Study” means any Territory-specific registrational studies that are conducted by a Licensee Entity or, to the extent set forth in Section 4.01(b), by an Ocular Entity, in the Territory with respect to the Licensed Product; but excluding all Global Studies.
Section 1.55“Mainland China” means China excluding Taiwan, Hong Kong and Macau.
Section 1.56“Manufacture” or “Manufacturing” means, as applicable, all activities associated with the production, manufacture, process of formulating, processing, filling, finishing, packaging, labeling, shipping, importing or storage of pharmaceutical compounds or materials, including process development, process validation, stability testing, manufacturing scale-up, pre-clinical, clinical and commercial manufacture and analytical development, product characterization, quality assurance and quality control development, testing and release.
Section 1.57“Medical Affairs” means matters relating to information services; publication, scientific and medical affairs; advisory and collaborative activities with opinion leaders and professional societies including medical education, symposia and other medical programs and communications; but excluding other Development activities.
Section 1.58“NDA” means a New Drug Application (as more fully described in 21 C.F.R. 314.50 et seq. or its successor regulation) and all amendments and supplements thereto filed with the FDA, or any equivalent filing in a country or jurisdiction other than the United States.
Section 1.59“Net Sales” means the amount received for the sale of a particular Licensed Product to a Third Party (other than a Licensee Entity) by Licensee or any of its Affiliates, Sublicensees or Functional Sublicensees for consideration, reduced by the following amounts to the extent such items are customary under industry practices and to the extent such amounts are included in the gross sales price, all as calculated in accordance with Accounting Standards, consistently applied:
(a)discounts (including trade, quantity and cash discounts) actually allowed, cash and non-cash coupons, retroactive price reductions, and charge-back payments and rebates granted to any Third Party (including to governmental authorities, purchasers, reimbursers, customers, distributors, wholesalers, and group purchasing and managed care organizations or entities (and other similar entities and institutions));
(b)credits or allowances, if any, on account of price adjustments, recalls, claims, damaged goods, rejections or returns of items previously sold (including Licensed Product returned in connection with recalls or withdrawals) and amounts written off by reason of uncollectible debt; provided that, if the debt is thereafter paid, the corresponding amount shall be added to the Net Sales of the period during which it is paid;

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(c)rebates (or their equivalent), chargebacks and retroactive price adjustments and any other similar allowances granted by a Licensee Entity (including to governmental authorities, purchasers, reimbursers, customers, distributors, wholesalers, and group purchasing and managed care organizations and entities (and other equivalent entities and institutions)) which effectively reduce the selling price or gross sales of the Licensed Product;
(d)insurance, customs charges, freight, postage, shipping, handling, and other transportation costs incurred by a Licensee Entity in shipping Licensed Product to a Third Party; and
(e)to the extent separately stated on purchase orders, invoices or other documents of sale, any sales or use tax, value added tax, goods and services tax, or similar tax, levied directly on the sale of a Licensed Product, that are paid to the taxing authority by or on behalf of a Licensee Entity, but excluding any taxes paid on the income from such sales.
If non-monetary consideration is received by a Licensee Entity for any Licensed Product in the relevant Jurisdiction, Net Sales will be calculated based on the average price charged for such Licensed Product, as applicable, during the preceding royalty period, or in the absence of such sales, the fair market value of the Licensed Product, as applicable, as determined by the Parties in good faith. Notwithstanding the foregoing, Net Sales shall not be imputed to transfers of Licensed Products, as applicable, for use in clinical trials, non-clinical development activities or other development activities with respect to Licensed Products by or on behalf of the Parties, for bona fide charitable purposes or for compassionate use or for Licensed Product samples, if no monetary consideration is received for such transfers.
Section 1.60“NMPA” means the National Medical Product Administration of China (formerly known as the China Food and Drug Administration), including its divisions and the Center for Drug Evaluation, and local counterparts thereto, and any successor agency or authority thereto having substantially the same function.
Section 1.61“Ocular Entity” means, as applicable, (a) Ocular, (b) any of Ocular’s Affiliates or (c) any direct or indirect licensee, sublicensee or contractor of Ocular with respect to any Licensed Product.
Section 1.62“Ocular Know-How” means all Know-How that is both (a) Controlled as of the Effective Date or during the Term by Ocular or any of its Affiliates and (b) necessary or reasonably useful for the Development, Manufacture or Commercialization of any Licensed Product in the Field in the Territory.
Section 1.63“Ocular Patent Rights” means all Patent Rights that both (a) are Controlled as of the Effective Date or during the Term by Ocular or any of its Affiliates in the Territory, and (b) Cover any Licensed Product, or its Development, Manufacture or Commercialization, in the Field in the Territory.  Ocular Patent Rights as of the Effective Date include those listed in Exhibit A.

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Section 1.64“Ocular Regulatory Documents” means Regulatory Documents Controlled by Ocular or any of its Affiliates as of the Effective Date or at any time during the Term that relate to a Licensed Product.
Section 1.65“Ocular Technology” means Ocular Know-How and Ocular Patent Rights, including Arising IP assigned to Ocular by Licensee pursuant to Section 9.01(c).
Section 1.66“OTX-TIC” means a bioresorbable intracameral implant containing micronized travoprost that is injected into the anterior chamber of the eye for the treatment of glaucoma.
Section 1.67“Patent Rights” means (a) all patents and patent applications (including provisional applications) in any country or jurisdiction, and (b) any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like.
Section 1.68“Phase 1 Clinical Trial” means a Clinical Trial, or the relevant portion of such trial, of a product in patients in or for any Jurisdiction that would satisfy the requirements of applicable Laws for such Jurisdiction in which such Clinical Trial is conducted, such as 21 C.F.R. § 312.21(a), relating to Clinical Trials conducted in the United States, or any successor regulation thereto or foreign equivalents.
Section 1.69“Phase 2 Clinical Trial” means a Clinical Trial, or the relevant portion of such trial, conducted in patients with a product in or for any Jurisdiction that would satisfy the requirements of applicable Laws of the country in which such Clinical Trial is conducted, such as 21 C.F.R. § 312.21(b), relating to Clinical Trials conducted in the United States, or any successor regulation thereto or foreign equivalents.
Section 1.70“Phase 3 Clinical Trial” means a Clinical Trial, or the relevant portion of such trial, in or for any Jurisdiction that would satisfy the requirements of applicable Laws of the country in which such Clinical Trial is conducted, such as 21 C.F.R. § 312.21(c), relating to Clinical Trials conducted in the United States, or any successor regulation thereto or foreign equivalents.
Section 1.71"POAG and OHT" means primary open angle glaucoma and ocular hypertension.
Section 1.72"POPI" means post-operative pain and inflammation.
Section 1.73“Product Materials” means tangible Licensed Products.
Section 1.74“Regulatory Approval” means, with respect to a particular regulatory jurisdiction, any approval, product or establishment license, registration or authorization of any Governmental Authority (other than any Reimbursement Approval) necessary for the commercial sale of a pharmaceutical product in such regulatory jurisdiction.

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Section 1.75“Regulatory Authority” means, in a particular country or jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or jurisdiction, including (a) in the United States, the FDA and any other applicable Governmental Authority in the United States having jurisdiction over pharmaceutical products, (b) in the European Union, the European Medicines Agency (“EMA”), (c) in Mainland China, the NMPA and (d) any other applicable Governmental Authority in the Territory having jurisdiction over pharmaceutical products.
Section 1.76“Regulatory Documents” means all (a) applications (including all INDs and Drug Approval Applications), 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 regulatory drug lists, advertising and promotion documents, adverse event files and complaint files; and (c) preclinical, clinical and other data results, analyses, publications, and reports contained or referred to in any of the foregoing; in each case ((a), (b) and (c)) relating to a Licensed Product. For the avoidance of doubt, Regulatory Documents include Regulatory Approvals and Regulatory Filings.
Section 1.77“Regulatory Exclusivity” means, with respect to any Jurisdiction, an additional market protection, other than patent protection, granted by a Regulatory Authority in such Jurisdiction which confers an exclusive Commercialization period during which Licensee Entities have the exclusive right to market and sell the Licensed Product in such Jurisdiction through a regulatory exclusivity right (e.g., new drug entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity, or any applicable data exclusivity).
Section 1.78“Regulatory Filings” means all applications, filings, dossiers and the like submitted to a Regulatory Authority for the purpose of Developing, Manufacturing or Commercializing a product, including obtaining Regulatory Approval from that Regulatory Authority.  Regulatory Filings include all INDs, Drug Approval Applications and other Regulatory Approval and Reimbursement Approval applications.
Section 1.79“Reimbursement Approval” means an approval, agreement, determination, or other decision by any applicable Regulatory Authority or other Governmental Authority that establishes prices at which a pharmaceutical product may be priced, or will be reimbursed by the Regulatory Authorities or other applicable Governmental Authorities, in a particular country or jurisdiction.
Section 1.80“Safety Data Exchange Agreement” means that agreement between the Parties regarding receipt, investigation and reporting of product complaints, adverse events, product recalls, and any other information related to the safety of the Licensed Products as set forth in Section 10.03.

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Section 1.81“Secondary Packaging” means grouped or display packaging of the Licensed Products for use in sales of multiple Licensed Product units, as distinguished from the primary packaging of Licensed Products units provided by Ocular to Licensee under the Supply Agreement.
Section 1.82“Serialization” means a combination of systems and procedures that records the history of the chain of custody of the Finished Drug Product from Licensee Entity to the point the Finished Drug Product is dispensed.
Section 1.83“Subcontractor” means a Third Party contractor engaged by a Party or its Affiliates to conduct certain activities of such Party under this Agreement on a fee-for-service basis, including (a) contract research organizations, (b) contract manufacturers, and (c) distributors and distribution service providers.
Section 1.84“Sublicensee” means any Third Party to whom Licensee or any of its Affiliates or any Sublicensee grants a license or sublicense of Licensee’s rights under Section 2.01(a)(ii), excluding all Subcontractors.
Section 1.85“Supply Price” means: (a) for clinical supply, Ocular’s cost of goods for the applicable Licensed Products; and (b) for commercial supply, [**] percent ([**]%) of Ocular’s cost of goods for the applicable Licensed Products, provided that, in the case of commercial supply, the Supply Price shall not exceed (i) in the case of DEXTENZA, the greater of [**] percent ([**]%) of the Net Sales for DEXTENZA or Ocular’s cost of goods therefor and (ii) in the case of OTX-TIC, the greater of [**] percent ([**]%) of the Net Sales for OTX-TIC or Ocular’s cost of goods therefor.
Section 1.86“Tax” means any present or future taxes, levies, imposts, duties, tariffs, charges, assessments or fees of any nature imposed by a Governmental Authority in the exercise of its taxing power (including interest, penalties and additions thereto), including value-added tax or any similar tax (including but not limited to sales, use, or goods and services tax) (“VAT”) and withholding tax.
Section 1.87“Territory” means any Jurisdiction, or, collectively, all Jurisdictions, as the context requires.
Section 1.88“Third Party” means any person or entity other than the Parties and their respective Affiliates.
Section 1.89“Trade Control Laws” shall refer to U.S. laws which prohibit or limit export, distribution or sales of goods from the United States and their re-export from other countries into certain countries, referred to as Sanctioned Countries. More specifically and for purpose of performing the Agreement, Trade Control Laws shall refer to the U.S. Export Administration Regulations and the economic sanctions, rules and regulations implemented under statutory authority or President’s Executive Orders and administered by the U.S. Treasury Department’s OFAC.

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Section 1.90“Trademark” means any trademark, trade name, service mark, service name, brand, domain name, trade dress, logo, slogan or other indicia of origin or ownership, including the goodwill and activities associated with each of the foregoing.
Section 1.91“U.S.” or “United States” means the United States of America, including its districts, territories and possessions.
Section 1.92“Valid Claim” means (a) an issued and unexpired claim of any Patent Right that has not been rejected, revoked or held unenforceable, unpatentable or invalid by a decision of a court or other Governmental Authority of competent jurisdiction, which is not appealable or has not been appealed within the time allowed for appeal, and which has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise or (b) a claim of a pending patent application that is being actively prosecuted and that remains pending not later than [**] following the filing of the earliest patent application from which such claim derives priority and that has not been cancelled, withdrawn from consideration, abandoned, disclaimed, finally rejected or expired without the possibility of appeal or refiling.
Section 1.93“Wholly Owned Subsidiary” means any Affiliate who is a subsidiary of a Party and one hundred percent (100%) of whose capital stock is at the applicable time owned by such Party and/or one or more Wholly Owned Subsidiaries of such Party.
Section 1.94
	Additional Defined Terms 
	Section 

	AAA
	Section 15.01

	Achieved Milestone
	Section 8.02(a)

	Arising IP
	Section 9.01(c)

	Acquired Party
	Section 16.02

	Acquirer
	Section 16.02

	Agreement
	Preamble

	Alliance Manager
	Section 3.09

	Annual Net Sales
	Section 8.04

	Arbitration Request
	Section 15.01(a)

	Bankrupt Party
	Section 14.03(a)

	Breaching Party
	Section 14.02

	Breach Notice
	Section 14.02

	CMC
	Section 2.04(a)

	CRO
	Section 3.01(c)

	Committee
	Section 3.01(b)

	Confidentiality Agreement
	Section 1.17

	Current Ocular Information
	Section 2.04(b)

	Deductible VAT
	Section 8.10(b)(i)

	Distributor
	Section 3.01(c)

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	Additional Defined Terms 
	Section 

	Effective Date
	Preamble

	EMA
	Section 1.75

	Event of Bankruptcy
	Section 14.03(a)

	Executive Officer
	Section 3.05

	Existing Acquirer Affiliates
	Section 16.02

	FCPA
	Section 11.05(b)(i)

	Government Official
	Section 11.05(a)(A)

	Greater China
	Section 1.45

	ICH
	Section 10.02

	[**]
	Section 1.25

	Indemnified Party
	Section 13.03

	Indemnifying Party
	Section 13.03

	Infringement Activity
	Section 9.03

	In-Market Release
	Section 5.02(a)

	JC
	Section 3.01(a)

	Joint Arising IP
	Section 1.05

	Licensee
	Preamble

	Licensee Directed Challenge Defense
	Section 9.03(d)

	Licensee Indemnitees
	Section 13.01

	Licensee Product Data
	Section 2.05(a)

	Losses
	Section 13.01

	Marketing Materials
	Exhibit C, Section 1.03(a)

	Non-Breaching Party
	Section 14.02

	Ocular
	Preamble

	Ocular Indemnitees
	Section 13.02

	Ocular Product Data
	Section 2.04(b)

	Ocular Prosecuted Patent Rights
	Section 9.02(b)

	Ocular Trademarks
	Exhibit C, Section 2.01(a)

	Ocular Web Presence
	Exhibit C, Section 2.01(b)

	Ocular Works
	Exhibit C, Section 2.02(c)

	Other Covered Party
	Section 11.05(a)(B)

	Other Party
	Section 14.03(a)

	Party or Parties
	Preamble

	Public Statement
	Section 12.04

	Qualifying Generic Competition 
	Section 8.05(a)

	Recipient
	Section 12.02

	Regulatory Budget
	Section 4.02(a)

	Representatives
	Section 12.01

	Royalty Term
	Section 8.04(b)

	Rules
	Section 15.01

	Severed Clause
	Section 17.03

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	Additional Defined Terms 
	Section 

	Supply Agreement
	Section 7.01

	Term
	Section 14.01

	Third Party Challenge
	Section 9.03(c)

	TTM Period
	Section 8.03

	VAT
	Section 1.86

​
Section 1.95Interpretation.  (a) Whenever any provision of this Agreement uses the word “including,” “include,” “includes,” or “e.g.,” such word shall be deemed to mean “including without limitation” and “including but not limited to”; (b) “herein,” “hereby,” “hereunder,” “hereof” and other equivalent words shall refer to this Agreement in its entirety and not solely to the particular portion of this Agreement in which any such word is used; (c) a capitalized term not defined herein but reflecting a different part of speech from that of a capitalized term which is defined herein shall be interpreted in a correlative manner; (d) wherever used herein, any pronoun or pronouns shall be deemed to include both the singular and plural and to cover all genders; (e) the recitals set forth at the start of this Agreement, along with the schedules and the exhibits to this Agreement, and the terms and conditions incorporated in such recitals and schedules and exhibits, shall be deemed integral parts of this Agreement and all references in this Agreement to this Agreement shall encompass such recitals and schedules and exhibits and the terms and conditions incorporated in such recitals and schedules and exhibits; provided that, in the event of any conflict between the terms and conditions of the body of this Agreement and any terms and conditions set forth in the recitals, schedules or exhibits, the terms of the body of this Agreement shall control; (f) in the event of any conflict between the terms and conditions of this Agreement and any terms and conditions that may be set forth on any order, invoice, verbal agreement or otherwise, the terms and conditions of this Agreement shall govern; (g) this Agreement shall be construed as if both Parties drafted it jointly, and shall not be construed against either Party as principal drafter; (h) unless otherwise provided, all references to Sections, Articles and Schedules in this Agreement are to Sections, Articles and Schedules of and to this Agreement; (i) any reference to any Law shall mean such Law as in effect as of the relevant time, including all rules and regulations thereunder and any successor Law in effect as of the relevant time, and including the then-current amendments thereto; (j) wherever used, the word “shall” and the word “will” are each understood to be imperative or mandatory in nature and are interchangeable with one another; (k) references to a particular person or entity include such person’s or entity’s successors and assigns to the extent not prohibited by this Agreement; (l) references to Ocular’s knowledge shall be taken to refer to the knowledge of Ocular’s senior management team as of the Effective Date; (m) the captions and table of contents used herein are inserted for convenience of reference only and shall not be construed to create obligations, benefits or limitations; and (n) the word “or” shall be inclusive and not exclusive (i.e., “and/or”);.

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ARTICLE II
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LICENSES; EXCLUSIVITY
Section 2.01Grant of Licenses.
(a)Subject to the terms and conditions of this Agreement, Ocular hereby grants to Licensee (i) a non-exclusive, royalty-free, non-sublicensable license under the Ocular Technology to use Licensed Products for activities required of Licensee under the Development Plan; and (ii) an exclusive (including as to Ocular and its Affiliates), royalty-bearing, sublicensable (solely in accordance with Section 2.02), non-transferable (except in accordance with Section 16.01) license under the Ocular Technology to use, sell, offer for sale, import, have imported, Commercialize and have Commercialized Licensed Products in the Field in the Territory in accordance with this Agreement.  Ocular shall not, either by itself or through any of its Affiliates (excluding products of Ocular’s Acquirers and Existing Acquirer Affiliates that were not Ocular products prior to the applicable Ocular Change in Control), (sub)licensees or contractors, Develop or Commercialize any Licensed Product outside the Field in the Territory, or Develop or Commercialize any product containing the same API (either alone or in combination with any other ingredient) and administered into the anterior chamber of the eye in the Territory, without first obtaining Licensee’s prior written consent and granting Licensee the first right to do so.
(b)Subject to the terms and conditions of this Agreement, Licensee hereby grants to Ocular (i) an exclusive (including as to Licensee and its Affiliates), royalty-free, fully-paid-up, transferable, sublicensable, perpetual, irrevocable license under the Licensee Technology and its interest in the Joint Arising IP to Develop, Manufacture and Commercialize the Licensed Products outside the Territory; and (ii) from and after any early termination of this Agreement, an exclusive (including with regard to Licensee and its Affiliates), royalty-free, fully-paid-up, transferable, sublicensable, perpetual, irrevocable license under the Licensee Technology and its interest in the Joint Arising IP to Develop, Manufacture and Commercialize the Licensed Products in the Territory.
Section 2.02Rights to Sublicense or Subcontract.  Licensee may not sublicense to any Third Party any of the rights granted to Licensee by Ocular under Section 2.01(a) except with Ocular’s prior written consent, provided that, upon Ocular’s receipt of [**] consent in accordance with the Existing In-License Agreement, and subject to (i) compliance with and performance of any further actions required under Section 2.2 of the Existing In-License Agreement; and (ii) Licensee’s compliance with Section 2.06, including with respect to the Existing In-License Agreement, or as otherwise directed by [**], Licensee may grant sublicenses to its Affiliates (after written notice to Ocular) under the license granted by Ocular to Licensee in Section 2.01(a)(ii). Notwithstanding the foregoing, in the event that Ocular is unable to obtain [**] consent in accordance with the foregoing sentence for Licensee’s grant of a sublicense of any of the rights granted to Licensee by Ocular under Section 2.01(a) to its Affiliate, Ocular shall upon Licensee’s written request grant a sublicense of the applicable rights directly to such Affiliate in accordance with the Existing In-License Agreement and this Agreement, provided that, for clarity, any 

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sublicense to a Third Party who is not Licensee’s Affiliate shall remain subject to Ocular’s prior written consent. Licensee shall have the right to engage Subcontractors for its activities under this Agreement.  Licensee shall ensure that all Licensee Entities comply with all applicable provisions of this Agreement and shall remain responsible for the acts or omissions of all Licensee Entities with respect to this Agreement as if such acts or omissions were taken by Licensee hereunder.
Section 2.03No Other Rights and Retained Rights.  Nothing in this Agreement shall be interpreted to grant a Party any rights under any Patent Rights or Know-How Controlled by the other Party that are not expressly granted herein, whether by implication, estoppel or otherwise, and, notwithstanding the foregoing provisions of Section 2.01, neither Party grants any right or license in this Agreement to the other Party under Patent Rights or Know-How Controlled by the first Party with respect to APIs or drug products other than the Licensed Product.  Any rights not expressly granted to a Party by the other Party under this Agreement are hereby retained by such other Party.
Section 2.04Knowledge Transfer.
(a)Within [**] after the Effective Date, the Parties shall mutually agree on a technology transfer plan pursuant to which Ocular will make available to Licensee all material information then Controlled by the Ocular Entities and reasonably necessary or reasonably useful for Licensee’s Development or Commercialization of the Licensed Products in the Field in the Territory.  Provided that such technology transfer plan is completed and agreed within the foregoing [**], Ocular shall make available to Licensee the agreed information within [**] after the conclusion of such initial [**] period. Notwithstanding the foregoing, the foregoing information made available to Licensee shall not include any chemistry, manufacturing, and controls (“CMC”) information unless otherwise agreed by the Parties in connection with regulatory activities mutually agreed by the Parties to be undertaken by Licensee pursuant to Section 5.01(d).
(b)Throughout the Term, on a periodic basis, Ocular shall make available to Licensee (i) Current Ocular Information (as assessed periodically), to the extent not previously provided to Licensee; and (ii) copies of certain Ocular Regulatory Documents, clinical and preclinical data, safety and pharmacovigilance data, in each case that are Controlled by Ocular (collectively, the “Ocular Product Data”) to the extent such Ocular Product Data is necessary or reasonably useful for any Licensee Entity to Develop or Commercialize any Licensed Product in the Field in the Territory in accordance with this Agreement. Notwithstanding the foregoing, the foregoing information made available to Licensee shall not include any CMC information unless otherwise agreed by the Parties in connection with regulatory activities mutually agreed by the Parties to be undertaken by Licensee pursuant to pursuant to Section 5.01(d). Each information transfer under this Section 2.04(b) shall include such information Controlled by the Ocular Entities and necessary or reasonably useful for (a) subject to the foregoing limitation as to CMC information, Licensee’s permitted or obligated Development activities as reasonably contemplated by this Agreement and the then-current Development Plan; and (b) Licensee’s 

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regulatory (solely to the extent mutually agreed pursuant to Section 5.01(d)) and Commercialization activities as reasonably contemplated by this Agreement, taking into consideration the stage of the collaboration and different Development stages of DEXTENZA and OTX-TIC (“Current Ocular Information”).
(c)Any knowledge transfer by Ocular pursuant to this Section 2.04 shall be at no additional cost to Licensee, except that Licensee shall reimburse Ocular for any reasonable out-of-pocket costs directly incurred by Ocular with respect to such transfer within [**] of its receipt of an invoice from Ocular for such costs. All direct costs and ongoing support beyond those set forth in this Section 2.04 shall be charged to Licensee at the then-applicable industry rate.
Section 2.05Product Data and Regulatory Documents.
(a)Throughout the Term, to the extent applicable (for example, if generated in the course of a Licensee Entity’s designated and permitted activities under the Development Plan or in the course of a Licensee Entity’s permitted Commercialization of the Licensed Products in the Field in the Territory), on a periodic basis not less than [**] or more frequently as requested by Ocular, Licensee shall make available to Ocular all Licensee clinical and preclinical data, efficacy, safety and pharmacovigilance data in each case that are Controlled by Licensee or any of its Affiliates (collectively, the “Licensee Product Data”) to the extent such Licensee Product Data is necessary or reasonably useful for any Ocular Entity to (i) Develop any Ocular product, including any Licensed Product; or (ii) Commercialize any Licensed Product outside the Territory, in each case ((i) and (ii)) in accordance with this Agreement. In accordance with Section 15.03, Licensee shall provide Licensee Product Data to Ocular in English.  Upon Ocular’s request, Licensee shall provide Licensee Product Data to an independent translator designated by Ocular for localized translation at Ocular’s cost and expense.  Ocular shall reimburse Licensee for any reasonable out-of-pocket costs incurred by Licensee in fulfilling its obligations under this Section 2.05(a).
Section 2.06In-License Agreements.
(a)Subject to Section 16.02, in the event that Ocular or any of its Affiliates enters into an agreement with a Third Party after the Effective Date that Ocular determines is necessary or reasonably useful for the Development or Commercialization of any Licensed Product in the Field in the Territory, then Ocular will promptly provide Licensee with notice and a copy of the applicable Third Party agreement.  Within [**] following receipt of such notice, Licensee will decide, in its sole discretion, whether to accept the applicable Third Party agreement as an In-License Agreement, and provide notice of such decision to Ocular.  If Licensee accepts such In-License Agreement, Licensee shall pay royalties for sales of the Licensed Product by any Licensee Entity in the Territory in accordance with such In-License Agreement and the pro rata share of any other license consideration (such as upfront license fees and milestone payments) associated with such In-License Agreement to the extent that such consideration is attributed or allocated by the operation of the terms of such In-License Agreement to any Licensee Entity’s activities in the Field in the Territory under this Agreement.  In the event that 

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Licensee declines to accept such Third Party agreement as an In-License Agreement, then (i) such Third Party agreement shall not be deemed to be an “In-License Agreement” hereunder and (ii) any rights granted to Ocular under such Third Party agreement will not be deemed to be “Controlled” by Ocular or licensed to Licensee under this Agreement.  In the event that Licensee accepts such Third Party agreement as an In-License Agreement, such Third Party agreement will thereafter be included within the definition of “In-License Agreement,” and any rights granted to Ocular under such In-License Agreement will be deemed to be “Controlled” by Ocular and sublicensed to Licensee pursuant to the terms of this Agreement.
(b)Subject to Section 16.02, Licensee acknowledges and agrees that certain of the rights, licenses and sublicenses granted by Ocular to Licensee in this Agreement (including any sublicense rights) are subject to the terms of each In-License Agreement and the rights granted to the Third Party counterparties thereunder, the scope of the licenses granted to Ocular or any applicable Affiliate thereunder and the rights retained by such Third Party counterparties and any other Third Parties (including Governmental Authorities) set forth therein.  Licensee shall, and shall ensure that each Licensee Entity shall, perform and take such actions to allow Ocular and its Affiliates to comply with their obligations under each In-License Agreement, to the extent applicable to Licensee’s rights or obligations under this Agreement.  Without limiting the foregoing, Licensee hereby agrees to be bound by all applicable terms and conditions of the Existing In-License Agreement. Without limiting the foregoing, each Licensee Entity shall prepare and deliver to Ocular, or assist Ocular in preparing, any additional reports required under any In-License Agreement, in each case reasonably sufficiently in advance to enable Ocular and its Affiliates to comply with their obligations thereunder.  Each Licensee Entity shall comply with all provisions of each In-License Agreement that are applicable to such Licensee Entity’s exercise of rights or performance of obligations under this Agreement.  To the extent there is a conflict between the terms of any In-License Agreement and any rights granted to, or obligations imposed upon, Licensee hereunder, the terms of the applicable In-License Agreement(s) shall control.  Any breach by any Licensee Entity of any provision of any In-License Agreement applicable to any of them pursuant to this Section 2.06 shall be deemed a material breach of this Agreement.  Notwithstanding the foregoing, Licensee shall not have any payment obligation under any Existing In-License Agreement resulting from Licensee’s practice of the sublicense granted to Licensee under Section 2.01(a) in accordance with this Agreement, and Ocular shall be solely responsible for fulfilling such payment obligations.  During the Term, Ocular shall not terminate any In-License Agreement, or amend or waive compliance under any In-License Agreement in a manner that would adversely affect Licensee’s right under such sublicense.
Section 2.07Exclusivity.
(a)During the Term, neither Licensee nor any of its Affiliates shall, itself or with or through any Third Party, without the prior written consent of Ocular, engage in Development, Manufacture or Commercialization of any Competing Product in the Territory.
(b)Licensee acknowledges and agrees that the exclusivity obligations set forth in this Section 2.07, including the duration and scope thereof, are intended, in part, to protect 

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the Parties’ trade secrets and other Confidential Information.  In the event that any arbitrator or court determines that the duration or scope of any such provision is unreasonable and that any such provision is to that extent unenforceable, Licensee agrees that such provision shall remain in full force and effect for the greatest time period and to the greatest scope that would not render it unenforceable.  The Parties intend that the provisions of this Section 2.07 shall be deemed to be a series of separate covenants, one for each and every product, Indication and Jurisdiction where such provision is intended to be effective.
(c)If, during the term of the exclusivity covenant in Section 2.07(a), Licensee or any of its Affiliates acquires or becomes an Affiliate of a Third Party (whether by way of a purchase of assets, merger, consolidation, Change in Control or otherwise) that is, at such time, Developing, Manufacturing or Commercializing a Competing Product in a manner that, if performed by Licensee or any of its Affiliates, would violate Section 2.07(a), then Licensee or its applicable Affiliate will, no later than [**] following the closing date of the relevant acquisition or other event, unless otherwise agreed by Ocular, notify Ocular in writing that Licensee or such Affiliate will:
(i)Divest, whether by license, divestiture of assets or otherwise, its interest in such Competing Product in the Territory to a Third Party, to the extent necessary to be in compliance with Section 2.07(a), provided that Licensee or its applicable Affiliate may retain an economic interest through such a license, divestiture of assets or other transaction as long as Licensee does not retain any other material rights as to such Competing Product in the Territory beyond a passive economic interest; or
(ii)terminate the Development, Manufacture and Commercialization of such Competing Product in the Territory, to the extent necessary to be in compliance with Section 2.07(a).
If Licensee or any of its Affiliates notifies Ocular in writing that it or its relevant Affiliate intends to divest such Competing Product as provided in Section 2.07(c)(i), or terminate the Development, Manufacture and Commercialization of the Competing Product in the Territory as provided in Section 2.07(c)(ii), then Licensee or its relevant Affiliate will effect such divestiture or termination within [**] after the date of the relevant acquisition or other event, subject to compliance with applicable Law, and will confirm to Ocular in writing when such divestiture or termination has been completed.  Licensee will keep Ocular reasonably informed of its and its Affiliates’ efforts and progress in effecting such divestiture or termination until it is completed.  Until such divestiture or termination occurs, Licensee shall keep its and its Affiliates’ activities with respect to such Competing Product separate from their activities with respect to the Licensed Products and shall continue to fully perform all of their obligations hereunder with respect to Licensed Products, including their applicable diligence obligations with respect to the Development and Commercialization of Licensed Products hereunder.
Section 2.08Exports and Resale. Each Licensee Entity will use Commercially Reasonable Efforts to monitor and prevent exports or resale of Licensed Products from inside the Territory for Development or Commercialization outside of the Territory using methods commonly used 

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in the industry for such purpose, and shall promptly inform Ocular of any such actual or suspected exports from the Territory, and the actions taken to prevent such exports.  If Licensee or any of its Affiliates or, to Licensee’s or any of its Affiliates’ knowledge, any other Licensee Entity receives a request or order to Develop, Manufacture or Commercialize any Licensed Product outside of the Territory, Licensee shall immediately notify Ocular thereof, shall not accept such request or order, and shall direct the relevant individual or entity to Ocular.  Each Ocular Entity will use Commercially Reasonable Efforts to monitor and prevent exports or resale of Licensed Products from outside the Territory for Development or Commercialization in the Territory using methods commonly used in the industry for such purpose, and shall promptly inform Licensee of any such actual or suspected exports into the Territory, and the actions taken to prevent such exports.  If Ocular or any of its Affiliates or, to Ocular’s or any of its Affiliates’ knowledge, any other Ocular Entity receives a request or order to Develop, Manufacture or Commercialize any Licensed Product in the Field in the Territory, Ocular shall immediately notify Licensee thereof, shall not accept such request or order, and shall direct the relevant individual or entity to Licensee.
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ARTICLE III
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GOVERNANCE
Section 3.01General.
(a)The Parties shall establish a Joint Committee (“JC”) to oversee and coordinate: (i) the Development of the Licensed Products in the Field in the Territory and (ii) the Commercialization of the Licensed Products in the Field in the Territory. The JC shall have decision-making authority with respect to the matters within its purview to the extent expressly provided herein, provided that after the completion of the activities in the Joint Development Plan, the JC shall only oversee and coordinate the Commercialization of the Licensed Products in the Field in the Territory.
(b)From time to time, the JC may establish one or more subcommittees or working groups to oversee particular projects or activities, as it deems necessary or advisable (each, a “Committee”).  Each Committee shall consist of such number of members as the JC determines is appropriate from time to time.  Such members shall be individuals with expertise and responsibilities in the relevant areas.  Each Committee shall discuss matters within the scope of such Committee’s oversight and shall report the outcome of the discussions of such Committee to the JC promptly after each meeting.  Following the receipt of the report from such Committee, the JC shall make any required decisions regarding matters set forth in such report.
(c)JC Responsibilities. Within [**] following the Effective Date, the Parties shall establish the JC.

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The JC shall oversee and coordinate the following Development Activities:
(i)review and approve the Development Plan and any proposed updates or amendments to the Development Plan, and propose revisions to the Development Plan in accordance with Section 4.01;
(ii)review and approve the Regulatory Budget and any proposed updates or amendments to the Regulatory Budget;
(iii)determine with respect to each Global Study and on an Indication-by-Indication basis whether to include clinical sites in the Territory in such Global Study and whether such Global Study shall be a Joint Global Study (but subject to Section 4.01(c));
(iv)discuss the clinical sites in the Territory, if any, to be included in each Local Study;
(v)approve the protocols for each Local Study and Joint Global Study;
(vi)determine the clinical sites in the Territory to be included in each Joint Global Study;
(vii)for each Joint Global Study, coordinate the operations of the Ocular Entities and Licensee Entities with respect to such Joint Global Study;
(viii)determine the contract research organizations (each, a “CRO”) in the Territory to be used for each Joint Global Study;
(ix)discuss the Ocular Entities’ regulatory strategy for the Licensed Products in the Territory based on the then-current Development Plan;
(x)provide a forum to share information with respect to the Development of the Licensed Products in the Field, including updates on progress and status of Local Studies and Joint Global Studies in the Territory and updates regarding interactions with Regulatory Authorities;
(xi)subject to Section 12.05, review and approve publications and publications plans as to the Development and Commercialization of Licensed Products in the Territory;
(xii)review and approve the Licensee Entities’ In-Market Release plans and Secondary Packaging as described in Section 5.02;
(xiii)discuss Third Party wholesalers or distributors (each, a “Distributor”) to be engaged by Licensee to market, distribute and sell each Licensed Product in the Territory;

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(xiv)discuss material updates with respect to Manufacturing Activities, including current and projected availability of Product Materials;
(xv)oversee, review, coordinate and provide strategic guidance on the Development of the Licensed Products in the Field in the Territory; and
(xvi)perform such other duties as are specifically assigned to the JC under this Agreement.
Beginning at least [**] prior to the anticipated filing of the first Drug Approval Application for a Licensed Product in the Territory, the JC shall oversee and coordinate the following Commercialization Activities:
(i)discuss Licensee’s proposed Commercialization activities;
(ii)ensure that the Licensee Entities’ Medical Affairs strategy for the Licensed Products in the Territory is in line with Ocular’s Global Medical Affairs Strategy;
(iii)discuss safety data exchange and pharmacovigilance matters relating to the Licensed Products in the Field in the Territory in accordance with the Safety Data Exchange Agreement;
(iv)discuss the Licensee Entities’ pricing strategy for the Licensed Products in the Territory;
(v)discuss Licensee Entities’ forecasted sales numbers for the next [**];
(vi)review and discuss any promotional or other materials for a Licensed Product proposed to be used by Licensee in the Territory in accordance with Section 6.02;
(vii)discuss each Party’s plans and strategies with respect to such Party’s presence at international congresses and conventions, relationships with key opinion leaders and other medical educational activities; and
(viii)perform such other duties as are specifically assigned to the JC under this Agreement.
Section 3.02Membership.  The JC shall be composed of an equal number of representatives from each of Ocular and Licensee, each of which representatives shall be of the seniority and experience appropriate for service on the JC in light of the functions, responsibilities and authority of the JC and the status of activities within the scope of the authority and responsibility of the JC.  Any representative from either Party may represent such Party on the JC.  Each Party may replace any of its representatives on the JC at any time with written notice to the other Party; provided that such replacement meets the standard described in the preceding 

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sentence.  Each Party’s representatives and any replacement of a representative shall be bound by obligations of confidentiality and non-use applicable to the other Party’s Confidential Information that are at least as stringent as those set forth in ARTICLE XII.  Each Party may invite a reasonable number of its or its Affiliate’s employees as required or useful to discuss the applicable agenda items.  The JC shall appoint a chairperson from among its members, with the first chairperson of being a representative of Ocular.  Each chairperson (whether initially appointed or any successor therefor) shall serve a term of one (1) year, at which time, the JC shall select a successor chairperson who is a representative of the Party other than the Party represented by the outgoing chairperson (e.g., the second chairperson of the JC shall be a representative of Licensee, the third chairperson of each of the JC shall be a representative of Ocular, etc.).  Within [**] following each JC meeting, the chairperson shall circulate to all JC members a draft of the minutes of such meeting.  The JC shall then approve, by mutual agreement, such minutes within [**] following circulation.  No chairperson of the JC shall have any greater authority than any other member of the JC.
Section 3.03Meetings.
(a)The JC shall hold an initial meeting within [**] after its formation or as otherwise agreed by the Parties.  Thereafter, unless the Parties otherwise agree, the JC will meet in person or by video or teleconference at least [**]. Unless otherwise agreed in writing by the Parties, any in-person meetings will be held at a mutually agreed location, and the JC shall make reasonable efforts to meet in person at least [**] to the extent reasonably practicable in light of travel, entertainment and business restrictions in light of the COVID-19 pandemic in existence as of the Effective Date and any applicable governmental responses thereto. Each Party shall be responsible for all of its own personnel and travel costs and expenses relating to participation in JC meetings.
(b)Ocular may upon reasonable notice include relevant representatives of Ocular licensees of the Licensed Product outside the Territory to attend any JC meeting as non-voting guest; provided that such additional representatives shall be bound by obligations of confidentiality and non-use applicable to the other Party’s Confidential Information that are at least as stringent as those set forth in ARTICLE XII.
Section 3.04JC Decision Making.  All decisions of the JC shall be made by unanimous vote, with each Party’s representatives collectively having one (1) vote, and shall be set forth in minutes approved by both Parties.  If the JC is unable to reach agreement on any matter within [**] after the matter is referred to it or first considered by it, such matter shall be referred to the Executive Officers for resolution in accordance with Section 3.05.
Section 3.05Executive Officers; Disputes.  Unless otherwise set forth in this Agreement, in the event of a dispute arising under this Agreement between the Parties, the Parties shall refer such dispute to the chief executive officer of each Party or such individual’s designee (each such individual, such Party’s “Executive Officer”), who shall attempt in good faith to resolve such dispute. Each Party shall promptly notify the other Party of its initial, or any change in its, Executive Officer.

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Section 3.06Final Decision-Making Authority.  If the Parties are unable to resolve a given dispute within the purview of the JC within [**] after referring such dispute to the Executive Officers pursuant to Section 3.05, then, subject to Section 3.07, Ocular’s Executive Officer shall have the deciding vote. Any decision made by Ocular’s Executive Officer in accordance with this Section 3.06 shall be deemed to be a decision of the JC.
Section 3.07Limitations on Decision-Making.
(a)Ocular shall not have the deciding vote on, and the JC shall have no decision-making authority regarding, any of the following matters:
(i)the imposition of any requirements on Licensee to undertake obligations beyond those for which it is responsible, or to forgo any of its rights, under this Agreement;
(ii)the imposition of any requirements that Licensee takes or declines to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of any Third Party;
(iii)the unilateral imposition on Licensee of obligations under the Development Plan, or the unilateral decision to add, delay or terminate any Local Trial, or the unilateral decision to deny the addition of any Local Trial proposed by Licensee so long as the proposed Local Trial is not reasonably expected to negatively and materially affect the Licensed Product outside the Territory;
(iv)the resolution of any dispute involving the breach or alleged breach of this Agreement;
(v)any decision that is expressly stated to require the mutual agreement (or similar language) of the JC or the Parties or the approval of the other Party (but not “approval” of the JC);
(vi)any matter described in Section 3.01(c) to the extent such matter is solely described as a matter to be discussed by the JC without any expressly stated JC approval right;
(vii)any matters that would excuse Ocular from any of its obligations under this Agreement; or
(viii)modifying the terms of this Agreement or taking any action to expand or narrow the responsibilities of the JC.
(b)In no event may Ocular unilaterally determine that it has fulfilled any obligations hereunder or that Licensee has breached any obligations hereunder.

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(c)In no event may Ocular unilaterally determine that the events required for the payment of milestone payments have occurred.
(d)For clarity, approval by the JC shall not be understood to mean approval by a Party.
Section 3.08Scope of Governance.  Notwithstanding the creation of each of the JC, each Party shall retain the rights, powers and discretion granted to it under this Agreement, and the JC shall not be delegated or vested with rights, powers or discretion unless such delegation or vesting is expressly provided herein, or the Parties expressly so agree in writing.  It is understood and agreed that issues to be formally decided by the JC are only those specific issues that are expressly provided in this Agreement to be decided by the JC.  For clarity, the JC shall not have any rights, powers or discretion to decide any matter not relating to the Development, Manufacturing or Commercialization of the Licensed Product in the Field and the Territory.
Section 3.09Alliance Managers.  Each of the Parties shall appoint a single individual to manage Development, Manufacturing and Commercialization obligations between the Parties under this Agreement (each, an “Alliance Manager”).  The role of the Alliance Manager is to act as a single point of contact between the Parties to ensure a successful relationship under this Agreement.  The Alliance Managers may attend any JC and Committee meetings.  Each Alliance Manager shall be a non-voting participant in the JC and such Committee meetings, unless s/he is also appointed a member of the JC; provided, however, that an Alliance Manager may bring any matter to the attention of the JC if such Alliance Manager reasonably believes that such matter warrants such attention.  Each Party may change its designated Alliance Manager at any time upon written notice to the other Party.  Any Alliance Manager may designate a substitute to temporarily perform the functions of that Alliance Manager by written notice to the other Party.  Each Party’s Alliance Manager and any substitute for an Alliance Manager shall be bound by obligations of confidentiality and non-use applicable to the other Party’s Confidential Information that are at least as stringent as those set forth in ARTICLE XII.  Each Alliance Manager will also: (a) plan and coordinate cooperative efforts and internal and external communications; and (b) facilitate the governance activities hereunder and the fulfillment of action items resulting from JC meetings.
ARTICLE IV
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DEVELOPMENT
Section 4.01Development in the Field in the Territory.
(a)The Initial Development Outline is attached to this Agreement as Exhibit B and as soon as reasonably practicable after the Effective Date or within [**], Ocular shall finalize the Development Plan and present it to the JC for approval.  The Development Plan shall be prepared based on and in accordance with the Initial Development Outline. The Development of Licensed Products in the Field in the Territory shall be governed by the Development Plan, and, except as set forth in this Section 4.01 or as otherwise agreed by the Parties in accordance with 

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Section 5.01(d), the Licensee Entities shall solely perform those Development activities allocated to Licensee under and in accordance with the Development Plan.  Each Development Plan shall provide for each Local Study or Joint Global Study to be conducted in the Territory and shall at least contain the Development activities set forth in the Initial Development Outline.  Each Development Plan shall reflect Licensee’s participation in the Joint Global Studies and Local Studies, if any.  The JC shall periodically review and update the Development Plan.  Each Party may submit to the JC from time to time proposed amendments to the Development Plan. The JC shall review and may approve such proposed amendments or any other proposed amendments that the JC may consider from time to time in its discretion and, upon any such approval by the JC, the Development Plan shall be amended accordingly.
(b)Each Joint Global Study conducted  in the Territory shall be conducted by or on behalf of Ocular or Licensee in accordance with the Development Plan and the study protocol approved by the JC. Each Local Study conducted in the Territory shall be conducted by or on behalf of Licensee in accordance with the Development Plan and the study protocol approved by the JC, provided, however, that Ocular may conduct Global Studies or Local Studies in the Territory without Licensee’s consent in the event that Licensee determines not to participate in such Global Studies or not to conduct such Local Studies (including pursuant to Section 4.01(c)). Subject to any activities expressly allocated to Licensee under the Development Plan, Ocular shall be responsible for implementation activities in the Territory as to each Joint Global Study as determined by the JC.  Each Joint Global Study shall be designed to enroll sufficient human subjects in the Territory to support the Regulatory Approval in Greater China.  Licensee shall be responsible for paying certain costs of activities with respect to each Joint Global Study and certain Local Studies in the Territory in accordance with Section 4.02(b).
(c)Licensee shall use Commercially Reasonable Efforts to execute and to perform, or cause to be performed, the activities assigned to it in the Development Plan.  Subject to Section 4.02(b), Licensee shall have the sole discretion to determine whether to participate in each Global Study or to conduct a Local Study by itself.
(d)To the extent supported by clinical results, unless otherwise agreed by the Parties, subject to Section 4.05, Ocular shall file for, and endeavor to obtain, or cause to be obtained, Regulatory Approval  for the Licensed Products in each Jurisdiction in the Territory, including by providing all necessary resources required to seek and maintain Regulatory Approval for the Licensed Products in each Jurisdiction in the Territory.
(e)If applicable, Licensee shall use Commercially Reasonable Efforts to obtain, or cause to be obtained Reimbursement Approval, for the Licensed Products in each Jurisdiction in the Territory, including by providing all necessary resources required to seek and maintain Reimbursement Approval for the Licensed Products in each Jurisdiction in the Territory.
Section 4.02Development Costs.
(a)Except as expressly provided in this Agreement or the Development Plan, (i) Ocular’s reasonable costs and expenses of seeking and maintaining Regulatory Approvals for 

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the Licensed Products in each Jurisdiction of the Territory shall be reimbursed by Licensee to Ocular in accordance with a plan and budget to be prepared by Ocular and approved in advance by mutual agreement of the JC (“Regulatory Budget”) (for clarity, Ocular shall not have the deciding vote regarding such Regulatory Budget); and (ii) each Party shall otherwise bear its own costs incurred in the performance of its obligations under this ARTICLE IV.  In the event that the Parties are unable to agree on the costs set forth in the Regulatory Budget, the Parties agree to select an independent third party with appropriate commercial and regulatory experience to determine the reasonableness of such costs.
(b)Notwithstanding anything to the contrary in Section 4.02(a), (A) for any Joint Global Study, Licensee shall bear [**] percent [**]% of the out-of-pocket global Development costs incurred for such Joint Global Study in accordance with a plan and budget presented to Licensee at the time Licensee elects to participate in such Joint Global Study; and (B) for any Local Study performed by Licensee in accordance with Section 4.01(c), Licensee shall bear all costs incurred by Licensee Entities and all out-of-pocket costs incurred by Ocular and its Affiliates. In the event that, pursuant to Licensee’s election under Section 4.01(c), (i) Licensee both determines not to participate in a Joint Global Study and does not elect to conduct a Local Study reasonably designed to support regulatory approval for the same Jurisdiction(s) in the Territory with respect to the same Licensed Product as the proposed Joint Global Study; and (ii) Ocular subsequently determines to conduct either a Global Study or a Local Study reasonably designed to support regulatory approval for such Jurisdictions in the Territory with respect to such Licensed Product, then Licensee may elect,  prior to Ocular conducting such Global Study or a Local Study, to bear the applicable costs set forth in this Section 4.02(b) as if such Global Study were a Joint Global Study or as if such Local Study were conducted by Licensee, as applicable.  In the event that Licensee does not elect to bear such costs in accordance with the prior sentence of this Section 4.02(b), notwithstanding anything to the contrary, Ocular shall have no obligation to provide any data (other than safety data) arising from such Global Study or Local Study to Licensee, including pursuant to Ocular’s obligations with respect to Ocular Product Data under Section 2.04(b), unless Licensee pays to Ocular the applicable costs set forth in this Section 4.02(b) plus [**] percent ([**]%) thereof. Except as set forth above, Licensee shall not be required to bear the costs of Global Studies.
(c)Within [**] following the end of each Calendar Quarter, Ocular shall invoice Licensee for the amounts set forth in Section 4.02(a) and Section 4.02(b).  Licensee shall pay all amounts payable under such invoice within [**] after the end of each Calendar Quarter.
Section 4.03Development Reports.  At least [**] in advance of the first meeting of the JC in each Calendar Year, (a) Licensee shall provide Ocular with a written report that summarizes the status of items to be performed by the Licensee Entities under the Development Plan in the year prior to such meeting of the JC, and at least [**] in advance of each other meeting of the JC in such Calendar Year, Licensee shall provide Ocular with a written report that updates the previous annual report or update provided to Ocular; and (b) Ocular shall provide Licensee with a written report that summarizes the Development of the Licensed Products in the Field in the Territory performed by the Ocular Entities in the year prior to such meeting of the JC, and at least 

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[**] in advance of each other meeting of the JC in such Calendar Year, Ocular shall provide Licensee with a written report that updates the previous annual report or update provided to Licensee.  The Ocular reports described in this Section 4.03 shall include the status of Regulatory Filings for Licensed Products in the Field in the Territory.  The reports to be submitted by Licensee under this Section 4.03 shall include any information that is reasonably necessary or useful for the Development or Commercialization of Licensed Products by Ocular Entities outside of the Territory.
Section 4.04Records.  The Licensee Entities shall maintain written or electronic records in sufficient detail, in a good scientific manner (in accordance with all applicable GLP, GMP, GVP and GCP promulgated or endorsed by any applicable Regulatory Authority in the Territory, or as otherwise specified in the Development Plan) and appropriate for regulatory and patent purposes, which are complete and accurate in all material respects and reflect all Development work assigned to and performed by the Licensee Entities under the Development Plan and results achieved.  Ocular shall have the right, upon reasonable advance notice, and no more than [**], to inspect and copy all such records.  Ocular shall have the right to use and reference all data and results generated by or on behalf of Licensee, its Affiliates or (sub)licensees in the course of Development of the Licensed Product, and Licensee hereby grants Ocular the right to reference any and all Regulatory Filings and Regulatory Approvals Controlled  by Licensee for the Licensed Product solely for Ocular to exercise its rights and fulfill its obligations under this Agreement and to exercise its retained rights outside the Territory.
Section 4.05Development and Commercialization in South Korea. Although South Korea is a Jurisdiction in the Territory, Licensee acknowledges and agrees that Ocular does not anticipate beginning to modify its manufacturing capabilities to meet South Korean Regulatory Approval requirements until [**]. Therefore, notwithstanding anything to the contrary, including Section 4.01(d), Section 5.01(a) and Section 7.01, (i) Ocular shall have no obligations with respect to the Development (including Regulatory Approvals) of any Licensed Product in South Korea until the completion of such manufacturing capability modifications; and (ii) Ocular’s subsequent Manufacturing obligations under this Agreement and the Supply Agreement shall be dependent upon Ocular’s completion of any such Development (including Regulatory Approvals) occurring after the completion of such manufacturing capability modifications.
ARTICLE V
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REGULATORY
Section 5.01Regulatory Filings.
(a)Subject to Section 4.01(a) and Section 4.05, Ocular shall have the responsibility to, prepare, obtain, and maintain all Regulatory Filings, Licensed Product labeling and Regulatory Approvals, and to conduct communications with the Regulatory Authorities in the Territory, for the Development of Licensed Products in the Field in the Territory undertaken by Ocular and the for the Commercialization of Licensed Products in the Field in the Territory undertaken by Licensee. Licensee shall be responsible for Ocular’s documented out-of-pocket 

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expenses incurred in connection with the foregoing. Ocular shall provide Licensee with an opportunity to review and comment on all such Regulatory Filings in the Territory and consider Licensee’s comments in good faith, provided, however, that Ocular shall be entitled to redact CMC information and such other information as it considers sensitive to its business. For clarity, Licensee shall be solely responsible for all costs and expenses related to the Parties’ participation in any such communications.
(b)All Regulatory Filings for Local Studies and Global Studies of Licensed Products in the Field in the Territory and corresponding applications for Regulatory Exclusivity shall be filed in the name of and shall be owned by Ocular. All Regulatory Filings and Regulatory Approvals in the Field in the Territory shall be at Licensee’s sole expense.
(c)Within [**] following the end of each Calendar Quarter, Ocular shall invoice Licensee for the amounts set forth in Section 5.01(a)  Licensee shall pay all amounts payable under such invoice within [**] after the end of each Calendar Quarter.
(d)The Parties may mutually agree that Licensee shall be the owner of certain Regulatory Filings or Regulatory Approvals for the Licensed Products in the Territory, in which case Ocular shall assign such ownership to Licensee subject to the Parties’ agreement on terms for Licensee’s conduct of such regulatory activities, including restrictions designed for the protection of CMC information and such other information as Ocular considers sensitive to its business.
Section 5.02In-Market Release; Secondary Packaging. As may be further detailed in the Supply Agreement:
(a)Subject to this Section 5.02(a), Licensee shall be responsible for all activities related to the release of the Licensed Products in each Jurisdiction in the Territory, and shall conduct all such activities required under applicable Laws in connection with the marketing, promotion and sale of the Licensed Products by the Licensee Entities in each Jurisdiction in the Territory, including labelling requirements (“In-Market Release”). Licensee’s plan for In-Market Release shall be subject to review and approval by the JC.  The Licensee Entities shall perform all In-Market Release activities (i) in compliance in all material respects with applicable Laws and (ii) in a manner that could not reasonably be expected to have a material adverse effect on the Development, Manufacture or Commercialization of the Licensed Product outside of the Territory.
(b)Licensee shall be responsible for all activities related to Secondary Packaging of the Licensed Products in each Jurisdiction in the Territory. The design and specification of all Secondary Packaging shall be subject to review and approval by the JC. The Licensee Entities shall design, manufacture, store and sell Licensed Products within such Secondary Packaging (i) in compliance in all material respects with applicable Laws and (ii) in a manner that could not reasonably be expected to have a material adverse effect on the Development, Manufacture or Commercialization of the Licensed Product outside of the Territory.

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ARTICLE VI
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COMMERCIALIZATION
Section 6.01General.  Under the oversight of the JC, Licensee (itself or through any of the Licensee Entities) shall have the sole right to Commercialize (including booking sales, establishing pricing and engaging in related interactions with Governmental Authorities in order to obtain listing on the central or provincial reimbursement list, warehousing, commercial distribution, order processing, invoicing and collection) the Licensed Products in the Field in the Territory at its sole expense.  Licensee shall keep the JC reasonably informed on its plans for the Commercialization of the Licensed Products in the Field in the Territory.  Licensee shall additionally promptly respond through the JC in reasonable detail to any follow-up questions or requests for additional information from Ocular with respect to its plans for the Commercialization of the Licensed Products in the Field in the Territory.
Section 6.02Promotional Materials.  Licensee shall ensure that all promotional materials for the Licensed Products in the Territory are consistent with the approved labeling for such Licensed Products and that such promotional materials comply in all respects with Law. Licensee shall share the promotional materials used in the Territory by any Licensee Entity in connection with the Licensed Products in the Territory with the JC on a regular basis, and the JC shall have the right to review and comment on (but for clarity shall not have the right to approve), which comments shall be considered in good faith by the Licensee Entities, any of the Licensee Entities’ promotional materials prior to their use in the Territory.
Section 6.03Commercialization Reports.  At least [**] prior to each meeting of the JC, for any meeting of the JC following the First Commercial Sale of any Licensed Product in the Field in the Territory, Licensee shall provide the JC with (a) a written report that summarizes Commercialization and Medical Affairs activities performed during the prior [**] period with respect to each Licensed Product in each Jurisdiction in the Territory, (b) detailed sales reports for each month of the prior [**] period of each Licensed Product in each Jurisdiction in the Territory, and (c) [**] sales forecasts for each Licensed Product in each Jurisdiction in the Territory for the next [**]. Licensee shall provide an update of such report at each JC meeting.
Section 6.04Commercialization Efforts.  At its sole cost and expense, Licensee shall use Commercially Reasonable Efforts to Commercialize Licensed Products in each Jurisdiction in the Territory.
Section 6.05Standards of Conduct.  The Licensee Entities shall perform all Commercialization activities with respect to Licensed Products in the Field in the Territory (a) in a professional and ethical business manner, and (b) in compliance in all material respects with applicable Laws.  Licensee shall ensure that the Medical Affairs strategy that each applicable Licensee Entity pursues for the Licensed Products in the Territory is in line with the Global Medical Affairs Strategy provided to Licensee reasonably in advance.

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Section 6.06Trademarks; Use of Names.    The Parties shall cooperate to choose a Trademark for use in the Territory, which may vary by Jurisdiction if agreed to by the Parties, and any such Trademark shall be owned by Ocular and subject to the terms of the trademark license set forth in Exhibit C.  Without limiting the terms of such trademark license or Section 5.02(b), each unique use of such Trademark on Secondary Packaging shall be subject to the prior approval of the JC by consensus. Except as expressly provided herein, or except as otherwise required by applicable Law or agreed by the Parties in advance in writing, neither Party shall have any right to use the other Party’s or the other Party’s Affiliates’, and Licensee shall not have any right to use any Ocular Entity’s, corporate names or logos in connection with any Commercialization of any Licensed Product.  At either Party’s option, each Licensed Product in the Territory shall be co-branded with the Ocular name and Ocular-designated corporate trademark, in a manner to be reasonably agreed by the Parties, which may include entering into a trademark license agreement in form and substance reasonably acceptable to Ocular.
ARTICLE VII
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MANUFACTURE AND SUPPLY
Section 7.01Supply.  The Parties will negotiate in good faith and enter into a supply agreement for clinical and commercial supply of Product Materials and a related quality agreement (collectively, the “Supply Agreement”), and such Supply Agreement shall be entered into at least [**] prior to the anticipated date of receipt of the first Regulatory Approval for the first Licensed Product in the Territory, or at such later date as may be mutually agreed in writing.  The Supply Agreement will be consistent with the terms set forth in this Section 7.01.  Subject to Section 4.05, from and after the execution of the Supply Agreement, and subject to the terms of the Supply Agreement, Ocular will use Commercially Reasonable Efforts, either itself or through Third Parties, to Manufacture and supply to Licensee Product Materials in quantities that are reasonably sufficient for the conduct of Development or Commercialization, as applicable, of Licensed Products in the Field in the Territory by the Licensee Entities.  For any Product Materials supplied by Ocular to Licensee pursuant to this Section 7.01 in the Field in the Territory, Licensee shall pay to Ocular the Supply Price for such Product Materials, payable within [**] after receipt of an invoice therefor after the acceptance of the Product Materials.  For clarity, nothing (including the exclusivity of the license granted Licensee under Section 2.01(a)) will prevent Ocular from manufacturing or having manufactured all or any portion of the Licensed Products in the Territory to supply Licensee’s use in the Territory or for Ocular’s use outside the Territory, and the Supply Agreement will contain customary provisions regarding acceptance, rejection, product release and warranty, inspection, supply failure remedy and backup supply, forecasting and ordering.
Section 7.02Serialization.  Licensee shall ensure that any distribution of Licensed Products by or on behalf of the Licensee Entities complies with any Serialization requirements required by applicable Law or reasonably requested by Ocular.  As between the Parties, Licensee 
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shall be responsible, at its cost and expense, with respect to any traceability issues or counterfeiting limitations required by applicable Laws or reasonably requested by Ocular with respect to the Commercialization of Licensed Products in the Territory.
Section 7.03Ocular Supply Chain Security Requirements.  Licensee commits to refrain from selling Licensed Product to unauthorized Third Parties or end users under Trade Control Laws such as any military and law enforcement parties of Sanctioned Countries, including but not limited to military hospitals.  Licensee shall perform this Agreement in the Territory in compliance with Trade Control Laws as defined herein and within the limits set forth by any applicable OFAC Authorization.  Licensee shall ensure that any Licensee Entity shall comply with Trade Control Laws and the scope of any applicable OFAC Authorization.  Licensee shall ensure that this duty to comply with such Trade Control Laws and the prohibitions or restrictions it involves will be reflected in the Supply Agreement. Licensee shall perform its contractual obligations in conformity with any restrictions which may be set forth by any applicable OFAC Authorization and the Trade Control Laws.  Such OFAC Authorization or Trade Control Laws may restrict the selling of Licensed Products to specific Third Parties as mentioned therein.  Licensee shall comply with such restrictions imposed by the OFAC Authorization to the extent they apply to Third Parties to which it sells Licensed Products pursuant to this Agreement.  While storing, handling or distributing the Licensed Product, Licensee Entities shall make all reasonable efforts to comply with Ocular supply chain security requirements, in order in particular to verify the security and integrity of the Licensed Products through all points of the supply chain. Licensee shall also ensure that any Subcontractors used by Licensee in the distribution of the Licensed Products are duly informed of such requirements and shall require that such Subcontractors comply with these requirements. Licensee expressly agrees it will not do anything under this Agreement or the Supply Agreement which could cause Ocular to be in breach of Trade Control Laws.  In the event that any Licensee Entity violates any Trade Control Law or the terms or conditions set by the OFAC Authorization to any Sanctioned Countries (or in the case of a Licensee Entity, the Licensee Entity commits such violation and Licensee fails to terminate its agreement with the Licensee Entity upon becoming aware of such violation), or breaches any provision in this Section 7.03, Ocular shall have the right to unilaterally terminate this Agreement pursuant to Section 14.02, except that the cure and dispute resolution period set forth therein shall not apply.
ARTICLE VIII
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PAYMENTS
Section 8.01Upfront Payment.  Within [**] after the Effective Date, Licensee shall pay Ocular the one-time, non-refundable, non-creditable upfront payments set forth below, by wire transfer.
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	​

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	DEXTENZA for POPI
	DEXTENZA  for AC
	OTX-TIC for POAG and OHT

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

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​

	​

	​

	​

	DEXTENZA for POPI
	DEXTENZA  for AC
	OTX-TIC for POAG and OHT

	​
	​
	​

	Total upfront payment:
	$12,000,000

​
Section 8.02Clinical Development Milestone and Clinical Development Support Payments.
(a)Licensee shall make the non-refundable, non-creditable milestone payments to Ocular set forth in the table below no later than [**] after the date on which Licensee receives an invoice from Ocular for each payment, and Ocular shall only have the right to issue such invoice after the achievement of such milestone event (if achieved by Ocular) or receiving written notification from Licensee that such milestone event has been achieved (if achieved by Licensee).  Licensee shall notify Ocular within [**] after the achievement of such milestone event.  The milestone payments set forth in the below table shall be payable only once under this Agreement, upon the first achievement of such milestone event, and Licensee’s total payment obligation under this Section 8.02(a) shall not exceed [**] dollars ($[**]). Notwithstanding the foregoing, if Licensee has not paid to Ocular a milestone payment for a particular Licensed Product/Indication combination set forth below, and a milestone event set forth in a subsequent row for such Licensed Product/Indication combination occurs (“Achieved Milestone”), then, upon the occurrence of such later milestone event, Licensee shall additionally pay to Ocular the prior milestone payment in conjunction with payment for the Achieved Milestone.
	DEXTENZA for POPI
	DEXTENZA for AC
	OTX-TIC for POAG and OHT

	Milestone Event
	Payment Amount
	Milestone Event
	Payment Amount
	Milestone Event
	Payment Amount

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

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

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

​
(b)Licensee shall make a non-refundable, non-creditable payment to Ocular in respect of support for the Phase 2 Clinical Trial of OTX-TIC for POAG and OHT of $[**] not later than [**] following enrollment of the first patient in such Phase 2 Clinical Trial.

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Section 8.03Commercial Milestone Payments.  Licensee shall pay to Ocular the following non-refundable and non-creditable amounts upon the first achievement of aggregate Net Sales of all Licensed Products in the Territory exceeding the minimum annual Net Sales thresholds set forth below for the trailing twelve (12) month period (starting on the first of each month) (“TTM Period”).  Licensee shall notify Ocular of the achievement of such milestone event within [**] after the date upon which such milestone is achieved, and shall pay Ocular the payment amount for each such milestone within [**] after the end of the Calendar Quarter in which such milestone was achieved:
	DEXTENZA
	OTX-TIC
	​

	TTM Period Net Sales Threshold
	Payment Amount
	TTM Period Net Sales Threshold
	Payment Amount
	​

	Equal to or greater than $[**]
	$[**]
	Equal to or greater than $[**]
	$[**]
	​

	Equal to or greater than $[**]
	$[**]
	Equal to or greater than $[**]
	$[**]
	​

	Equal to or greater than $[**]
	$[**]
	Equal to or greater than $[**]
	$[**]
	​

	Equal to or greater than $[**]
	$[**]
	Equal to or greater than $[**]
	$[**]
	​

​
Each milestone payment in this Section 8.03 shall be payable only once upon the first achievement of such milestone in a given TTM Period and no amounts shall be due for subsequent or repeated achievements of such milestone in subsequent TTM Period.  For clarity, the Net Sales of all Licensed Products in a TTM Period shall be aggregated for purposes of determining whether any milestone in the table above has been met.  If more than one of the milestones set forth in the table above are first achieved in a single TTM Period, then Licensee shall pay to Ocular in such TTM Period all of the payments corresponding to all of the milestones achieved in such TTM Period under this Section 8.03.  Licensee’s total payment obligation under this Section 8.03 shall not exceed [**] dollars ($[**]).
Section 8.04Royalties.
(a)Subject to the remainder of this Section 8.04, Licensee shall pay Ocular the following royalties on aggregate Net Sales in the Territory of the applicable Licensed Products designated in the column header, at an incremental royalty rate determined by aggregate annual Net Sales of all such applicable Licensed Products in each Calendar Year during the Term in the Territory (“Annual Net Sales”):

35

​

	​
	​
	​
	​
	​

	DEXTENZA
	OTX-TIC
	​

	Portion of Aggregate Annual Net Sales in the Territory
	Royalty
	Portion of Aggregate Annual Net Sales in the Territory
	Royalty
	​

	Up to $[**]
	[**]%
	Up to $[**]
	[**]%
	​

	$[**] up to and including $[**]
	[**]%
	$[**] up to and including $[**]
	[**]%
	​

	Greater than $[**]
	[**]%
	Greater than $[**]
	[**]%
	​

​
(b)Running royalties paid by Licensee under this Section 8.04 shall be paid on a Licensed Product-by-Licensed Product and Jurisdiction-by-Jurisdiction basis until the latest of (i) expiration of the last-to-expire Valid Claim in the Ocular Patent Rights or Arising Patent Rights that are not Licensee Sole Arising Product Patent Rights assigned to Ocular by Licensee under this Agreement, in each case that Covers the composition of matter, formulation, dosing, or use of the Licensed Product in the Jurisdiction of sale, or (ii) ten (10) years from the First Commercial Sale of such Licensed Product in the Field in such Jurisdiction, or (iii) the expiration of all Regulatory Exclusivity for such Licensed Product in such Jurisdiction (each, a “Royalty Term”).  Following the expiration of the Royalty Term with respect to a particular Licensed Product in the Field in a Jurisdiction, the licenses granted by Ocular to Licensee pursuant to Section 2.01(a) with respect to such Licensed Product in the Field in such Jurisdiction shall be perpetual, irrevocable, fully-paid and royalty-free, and freely sublicensable through multiple tiers and not subject to Section 2.02 and Net Sales of such Licensed Product shall no longer be included in the aggregate Net Sales calculation in Section 8.03 and Section 8.04(a).
Section 8.05Product Royalty Reduction.
(a)If, in a given Jurisdiction, one or more Generic Products becomes commercially available in such Jurisdiction and such Generic Product(s) achieve an aggregate quarterly unit market share in such Jurisdiction of [**]%) or more of the aggregate quarterly unit market share of such Generic Product(s) and the applicable Licensed Product in such Jurisdiction (based on data provided by IQVIA or, if such data is not available, such other reliable data source as agreed by the Parties (such agreement not to be unreasonably withheld)), as measured by unit volume in such Jurisdiction in such Calendar Quarter (“Qualifying Generic Competition”), then royalty payments due to Ocular by Licensee for Net Sales of such Licensed Product in such Jurisdiction shall be reduced by [**] percent ([**]%), and such reduction shall remain in place for the remainder of the applicable Royalty Term as to the applicable Licensed Product in the applicable Jurisdiction in the event that such Qualifying Generic Competition persists for [**] consecutive Calendar Quarters; otherwise, such reduction shall no longer apply beginning in any subsequent Calendar Quarter where such Qualifying Generic Competition no longer exists until and unless such Qualifying Generic Competition once again exists.

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(b)In the event that, after the Effective Date, (i) Licensee obtains a license under any Patent Rights or Know-How from any Third Party(ies) that is necessary in order to Commercialize a given Licensed Product in a given Jurisdiction in the Territory; or (ii) Licensee accepts any Third Party agreement of Ocular as In-License Agreement pursuant to Section 2.06(a) and pays any royalties to Ocular on Net Sales of a Licensed Product in the Territory and/or any pro rata share of any other licensing consideration associated with such In-License Agreement as described in Section 2.06(a), in accordance with such In-License Agreement, Licensee shall be permitted to deduct [**] percent ([**]%) of royalty payments and [**] percent ([**]%) of any such pro rata share of other licensing consideration, in each case as paid by Licensee to such Third Party or to Ocular for such license or sublicense, from the royalty payment otherwise owed to Ocular in accordance with Section 8.04 for the applicable Calendar Quarter.
(c)Notwithstanding the provisions of Section 8.05(a) and Section 8.05(b), in no event shall the total royalty rate reduction(s) allowable under Section 8.05(a) and Section 8.05(b) with respect to a Licensed Product in a Jurisdiction in a Calendar Quarter, alone or together, lead to a reduction of more than [**] percent ([**]%) of the applicable royalty rate determined in accordance with Section 8.04. If any amount that Licensee is entitled to deduct from the royalty payments due to Ocular under Section 8.05(a) or Section 8.05(b) with respect to a Licensed Product is not fully offset against such royalty amounts as a result of the preceding sentence, such amount may be carried forward and applied to future periods until fully exhausted.
Section 8.06Royalty Payments and Reports.
(a)On a Jurisdiction-by-Jurisdiction basis, until the expiration of the Royalty Term with respect to such Licensed Product in such Jurisdiction, Licensee agrees to provide quarterly written reports to Ocular within [**] after the end of each Calendar Quarter, covering all Net Sales of such Licensed Product in such Jurisdiction by any Licensee Entity, each such written report stating for the period in question the amount of gross sales and Net Sales of each Licensed Product in each Jurisdiction in the Territory during the applicable Calendar Quarter (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 Calendar Quarter.
(b)Licensee shall make the royalty payments due hereunder within [**] after the end of each Calendar Quarter.
Section 8.07Recordkeeping.
(a)Each Licensee Entity shall keep full, clear and accurate records of any Licensed Product that is made, used or sold under this Agreement and of any costs borne by such Licensee Entity for any Joint Global Study, in accordance with the Accounting Standards consistently applied, for a period of at least [**] after the end of the Calendar Year to which the records relate, setting forth the sales of any Licensed Product in sufficient detail to enable royalties and other amounts payable to Ocular hereunder to be determined.  Licensee, for itself and on behalf of each Licensee Entity, further agrees to permit its books and records to be 

37

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examined by an independent accounting firm selected by Ocular and reasonably acceptable to Licensee no more than once per Calendar Year, to verify any reports and payments delivered under this Agreement during the [**] most recently-ended Calendar Years, upon reasonable notice (which shall be no less than [**] prior notice) and during regular business hours and subject to a reasonable confidentiality agreement. The Parties shall reconcile any underpayment or overpayment within [**] after the accounting firm delivers the results of any audit.  Such examination is to be made at the expense of Ocular, except in the event that the results of the audit reveal an underpayment by Licensee of [**] percent ([**]%) or more during the period being audited, in which case reasonable audit fees for such examination shall be paid by Licensee.
(b)Ocular shall keep full, clear and accurate records of costs of performance of the out-of-pocket costs for which Licensee is responsible to reimburse Ocular hereunder, in accordance with Accounting Standards consistently applied, for a period of at least [**] after the end of the Calendar Year to which the records relate, in sufficient detail to enable Licensee’s payment obligations.  Ocular further agrees to permit its books and records to be examined by an independent accounting firm selected by Licensee and reasonably acceptable to Ocular no more than once per Calendar Year, to verify any invoices delivered in connection with such payment obligations during the [**] most recently-ended Calendar Years, upon reasonable notice (which shall be no less than [**] prior notice) and during regular business hours and subject to a reasonable confidentiality agreement.  The Parties shall reconcile any underpayment or overpayment within [**] after the accounting firm delivers the results of any audit.  Such examination is to be made at the expense of Licensee, except in the event that the results of the audit reveal an overcharging by Ocular of [**] percent ([**]%) or more during the period being audited, in which case reasonable audit fees for such examination shall be paid by Ocular.
Section 8.08Currency Conversion.  Wherever it is necessary to convert currencies for Net Sales invoiced in a currency other than the Dollar, such conversion shall be made into Dollars at the conversion rate existing in the United States (as reported in the Wall Street Journal) on the last working day of the applicable Calendar Quarter or, if such rate is unavailable, a substitute therefor reasonably selected by Ocular.  All payments due to Ocular under this Agreement shall be made without deduction of exchange, collection or other charges.  Once the amount of Net Sales paid to Ocular in respect of a particular Calendar Quarter has been converted into Dollars, such amount of Dollars shall be used for the purpose of calculating the total amount of Net Sales during the Calendar Year that includes such Calendar Quarter.
Section 8.09Methods of Payment.  All payments due to Ocular under this Agreement shall be made in Dollars by wire or ACH transfer to a bank account of Ocular, or any Affiliate of Ocular, designated from time to time in writing by Ocular. Ocular may direct that all or any portion of any payment owed by Licensee to Ocular under this Agreement be paid to any Ocular Affiliate.
Section 8.10Taxes.
(a)Each Party shall be solely responsible for the payment of all taxes imposed by any taxing authority within the United States on such Party’s share of income arising from the 

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activities of such Party under this Agreement, provided that Licensee shall make all payments due to Ocular under this Agreement without any withholding of such taxes.  If any payment owed by Licensee to Ocular pursuant to this Agreement is subject to any deduction or withholding for taxes imposed by a taxing authority outside of the United States, then the full amount of any such tax required to be deducted and withheld on such payments will be duly deducted, withheld and timely paid over by Licensee on behalf of Ocular.  Any such payment payable under this Agreement with respect to which any such tax has been deducted or withheld pursuant to this Section 8.10 shall be increased as necessary to ensure that, after all required tax deductions and withholdings have been made (including with respect to any such increased amount), the net amount received by Ocular (free and clear of any tax required to be paid over by Licensee or with respect thereto to any non-United States governmental authority) shall be equal to the amount that would have been due to, and received by, Ocular under this Agreement had no such deduction or withholding been required or made.
(b)Notwithstanding anything to the contrary in this Agreement, this Section 8.10(b) shall apply with respect to VAT or any similar tax. All payments by Licensee Entities shall be exclusive of VAT. If any VAT is required in respect of any payments made under this Agreement under applicable Laws, except as provided below, each Licensee Entity shall pay VAT at the applicable rate in respect of any such payments in accordance with local Law whether such amounts are invoiced or not in respect of those payments. To the extent any VAT is due on any amounts payable by Licensee to Ocular:
(i)under Section 8.04 of this Agreement, if such VAT is not recoverable, not creditable, not exempt, or like neutral effect under applicable VAT rules, then (x) the applicable Licensee Entity may deduct such VAT up to [**]% (by way of example, VAT Example #1: [**]. Additionally, any VAT borne by a Licensee Entity for failure to comply with local VAT rules and procedures (such as failure to properly invoice VAT), shall not be an amount borne by Ocular; and
(ii)under any Section of this Agreement other than Section 8.04, pay such VAT to the appropriate Governmental Authority, and pay to Ocular the full amount due, without deduction.
The Parties will cooperate to provide Licensee Entity all documentation required to properly and timely pay VAT amounts described in this Section 8.10(b).  If the VAT originally paid or otherwise borne by Ocular is in whole or in part subsequently determined not to have been chargeable, or is fully creditable, eligible for offset, refund or recovery, or otherwise not borne by any Licensee Entity then all necessary steps will be taken by Licensee to obtain a refund of such undue VAT charge from the applicable Governmental Authority and any amount of VAT repaid by such Governmental Authority, or any amounts already offset or credited to Licensee’s account will be transferred to Ocular within [**] of such offset, credit, recovery, refund or receipt.  Each Party shall provide the other with reasonable assistance to enable the recovery, as permitted by law, of VAT or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such VAT.

39

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Section 8.11Late Payments.  Interest shall be payable by Licensee on any amounts payable to Ocular under this Agreement which are not paid by the due date for payment.  All interest shall accrue and be calculated on a daily basis (both before and after any judgment) at a rate per month equal to the lesser of (a) [**] percentage point above the then-current “prime rate” in effect published in The Wall Street Journal or (b) the maximum rate permissible under applicable Law, for the period from the due date for payment until the date of actual payment.  The payment of such interest shall not limit Ocular from exercising any other rights it may have as a consequence of the lateness of any payment.
ARTICLE IX
​
INTELLECTUAL PROPERTY
Section 9.01Ownership.
(a)Ownership of the Ocular Technology shall remain vested at all times in Ocular.
(b)Ownership of the Licensee Technology shall remain vested at all times in Licensee.
(c)Each Party shall promptly notify the other Party of any new Arising Product IP.  As between the Parties, any such Arising Product IP shall be owned by Ocular.  Licensee hereby assigns to Ocular all right, title and interest it or any Licensee Entities may have in or to any Arising Product IP.  Other than Arising Product IP, each Party shall solely own all Arising IP conceived, reduced to practice, authored, created or developed solely by or on behalf of such Party or any of its Affiliates in the course of its activities during the Term, and the Parties shall jointly own all Joint Arising IP, with each Party having an undivided half interest in and to such Joint Arising IP, with the right to practice and exploit such Joint Arising IP with no duty of accounting or seeking consent from the other Party, subject only to the applicable licenses granted under this Agreement.  All Arising Product IP and Arising IP otherwise owned by Ocular shall be included with the Ocular Technology, and included in the licenses granted to Licensee pursuant to Section 2.01.
(d)Licensee agrees to assist Ocular, or its designee, at Ocular’s expense, in every proper way in connection with securing, applying for, registering, perfecting and enforcing Ocular’s rights in the Arising IP in any and all countries, including the disclosure to Ocular of all pertinent information and data with respect to this Agreement, the execution of all applications, specifications, oaths, assignments and all other instruments which Ocular shall deem necessary in order to apply for and obtain such rights and in order to assign and convey to Ocular, its successors, assigns and nominees the sole and exclusive right, title and interest in and to the Arising IP.
(e)Each Party shall be solely responsible for payments due under applicable inventor remuneration laws in any Jurisdiction to each inventor as to any Patent Right described 

40

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in the foregoing Section 9.01(a)-(b) to which such Party is assigned an ownership interest by such inventor.
Section 9.02Prosecution of Patent Rights.  Subject to the terms of each In-License Agreement:
(a)Ocular shall have the first right, but not the obligation, to file, prosecute and maintain all Ocular Patent Rights and Arising Product Patent Rights, at Ocular’s sole cost and expense.
(b)Ocular shall consult with Licensee on the preparation, filing, prosecution and maintenance of all Ocular Patent Rights and Arising Product Patent Rights in the Territory (collectively, the “Ocular Prosecuted Patent Rights”), and shall take into consideration the commercial strategy of Licensee in the Territory.  Ocular shall furnish Licensee with copies of each material document that is relevant to such preparation, filing, prosecution and maintenance at least [**] prior (or such shorter period prior if it is not reasonably practicable to provide such copies [**] prior) to filing such document or making any payment due thereunder to allow for review and comment by Licensee and shall consider in good faith timely comments from Licensee thereon.  Ocular shall also furnish Licensee with copies of all final filings and responses made to any patent authority in the Territory with respect to the Ocular Prosecuted Patent Rights in a timely manner following submission thereof.
(c)Notwithstanding the foregoing, if Ocular elects not to, or is unable to, file, prosecute or maintain any Ocular Prosecuted Patent Rights in any Jurisdiction, Ocular shall give Licensee prompt notice thereof, and, in such cases, shall allow Licensee to prosecute or maintain such Ocular Prosecuted Patent Rights in such Jurisdiction, at Licensee’s cost and expense. Licensee may deduct up to [**] percent ([**]%) of such costs and expenses incurred by Licensee in with respect to the prosecution and maintenance of such Ocular Prosecuted Patent Rights in such Jurisdiction against royalties due to Ocular pursuant to Section 8.04, provided that any such deduction shall not reduce any applicable royalty payment to less than [**] percent ([**]%) of the amount that would otherwise be due and payable to Ocular pursuant to Section 8.04 in any Calendar Quarter.  If any amount that Licensee is entitled to deduct from the royalty payments due to Ocular under this Section 9.02(c) with respect to a Licensed Product is not fully offset against such royalty amounts as a result of the preceding sentence, such amount may be carried forward and applied to future periods until fully exhausted.
Section 9.03Enforcement and Defense.  If either Party becomes aware of any Third Party activity in the Territory, including any Development activity (whether or not an exemption from infringement liability for such Development activity is available under applicable Law), that infringes (or that is directed to the Development of a product that would infringe) an Ocular Prosecuted Patent Rights, then the Party becoming aware of such activity shall give prompt written notice to the other Party regarding such alleged infringement or misappropriation (collectively, “Infringement Activity”).
Subject to the terms of each In-License Agreement:

41

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(a)Licensee shall have the first right, but not the obligation, to attempt to resolve any Infringement Activity in the Territory by commercially appropriate steps at its own expense, including the filing of an infringement or misappropriation suit using counsel of its own choice.  If Licensee fails to resolve such Infringement Activity in the Territory or to initiate a suit with respect thereto by the date that is [**] before any deadline for taking action to avoid any loss of material enforcement rights or remedies, then Ocular shall have the right, but not the obligation, to attempt to resolve such Infringement Activity by commercially appropriate steps at its own expense, including the filing of an infringement or misappropriation suit using counsel of its own choice.
(b)Any amounts recovered by a Party as a result of an action pursuant to Section 9.03(a), whether by settlement or judgment, shall be allocated first to pay to each Third Party counterparty under any In-License Agreement any amounts owed to such Third Party counterparty with respect to such enforcement action and next to reimburse the Parties for all costs and expenses incurred in connection with such proceeding paid by the Parties and not otherwise recovered.  Any remaining amount shall be allocated as follows: (i) in the event that Licensee controls the applicable Infringement Activity in the Territory in accordance with Section 9.03(a), retained by Licensee but deemed Net Sales and subject to the royalty obligation to Ocular hereunder; (ii) in the event that Ocular controls the applicable Infringement Activity in the Territory in accordance with Section 9.03(a), [**] percent ([**]%) to Ocular and [**] percent ([**]%) to Licensee.
(c)If a Third Party asserts that an Ocular Prosecuted Patent Rights is invalid or unenforceable in the Territory (other than as part of its defense of the Infringement Activity set forth above) (a “Third Party Challenge”), then Ocular shall have the sole right and, but not the obligation, to defend against such assertion and, at Ocular’s request and expense, Licensee shall provide reasonable assistance in defending against such Third Party assertion.  Ocular shall (i) keep Licensee reasonably informed regarding such assertion and such defense (including by providing Licensee with drafts of each filing a reasonable period before the deadline for such filing and promptly providing Licensee with copies of all final filings and correspondence), (ii) consult with Licensee on such defense, and (iii) consider in good faith all comments from Licensee regarding such defense.  Licensee shall have the right to join as a party to such defense and participate with its own counsel at its sole expense; provided that Ocular shall retain control of such defense.
(d)Should Ocular decide that it is not, or is no longer, interested in defending a Third Party Challenge, it shall promptly (and in any event by the date that is [**] before any deadline for taking action to avoid any loss of material rights) provide Licensee written notice of this decision. In such event, Licensee may elect either of the following:
(i)Licensee may request that Ocular defend (or continue to defend) such Third Party Challenge at Licensee’s cost and expense (a “Licensee Directed Challenge Defense”) and Ocular shall exercise Commercially Reasonable Efforts as reasonably requested by Licensee to carry out such Licensee Directed Challenge Defense. Ocular shall invoice Licensee for 

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its costs and expenses incurred in relation to any Licensee Directed Challenge Defense, and Licensee shall pay such invoice within [**] of receipt thereof. Following a successful Licensee Directed Challenge Defense, Licensee may deduct any such costs and expenses incurred by Ocular and reimbursed by Licensee in defending such Licensee Directed Challenge Defense against royalties due to Ocular pursuant to Section 8.04, provided that any such deduction shall not reduce any applicable royalty payment to less than [**] percent ([**]%) of the amount that would otherwise be due and payable to Ocular pursuant to Section 8.04 in any Calendar Quarter. If any amount that Licensee is entitled to deduct from the royalty payments due to Ocular under this Section 9.03(d)(i) with respect to a Licensed Product is not fully offset against such royalty amounts as a result of the preceding sentence, such amount may be carried forward and applied to future periods until fully exhausted; or
(ii)Licensee may defend (or may take over the defense of) such Third Party Challenge at Licensee’s sole cost and expense and, at Licensee’s request and expense, Ocular shall provide reasonable assistance in defending against such Third Party challenge. Licensee shall (i) keep Ocular reasonably informed regarding such defense (including by providing Ocular with drafts of each filing a reasonable period before the deadline for such filing and promptly providing Ocular with copies of all final filings and correspondence), (ii) consult with Ocular on such defense, and (iii) consider in good faith all comments from Ocular regarding such defense.  For the avoidance of doubt, if Licensee elects to exercise its rights under this Section 9.03(d)(ii), then Licensee may not thereafter elect to exercise its rights under Section 9.03(d)(i).
(e)At the request of the enforcing or defending Party, the other Party shall, at the enforcing or defending Party’s cost and expense, provide reasonable assistance in any enforcement or defense action undertaken pursuant this Section 9.03 (including entering into a common interest agreement if reasonably deemed necessary by the enforcing or defending Party) and be joined as a party to the suit if necessary for the initiating or defending Party to bring or continue such suit.  The non-enforcing or non-defending Party shall always have the right to be represented by counsel of its own selection and its own expense in any suit or other action instituted by the other Party pursuant to this Section 9.03.
Section 9.04Defense of Third Party Infringement and Misappropriation Claims.  Subject to the terms of each In-License Agreement:
(a)If a Third Party asserts that a Patent Right or other right Controlled by it in the Territory is infringed or misappropriated by a Party’s activities under this Agreement or a Party becomes aware of a Patent Right or other right that might form the basis for such a claim, the Party first obtaining knowledge of such a claim or such potential claim shall immediately provide the other Party with notice thereof and the related facts in reasonable detail.  The Parties shall discuss what commercially appropriate steps, if any, to take to avoid infringement or misappropriation of said Third Party Patent Right or other right controlled by such Third Party in the Territory. If a Third Party asserts that a Patent Right or other right Controlled by it in the Territory is infringed or misappropriated by a Party’s activities under this Agreement, then, subject to any indemnification obligation from one Party to the other in respect of such 

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infringement or misappropriation (in which case, notwithstanding the remainder of this sentence, the indemnifying Party shall have the first right to control such defense in accordance with Section 13.03), such Party shall have the first right, but not the obligation, to defend against such assertion and, at such Party’s request and expense, the other Party will provide reasonable assistance in defending against such Third Party assertion.  Such Party shall keep the other Party reasonably informed regarding such assertion and such defense.
ARTICLE X
​
DATA SECURITY AND ADVERSE DRUG EVENTS AND REPORTS
Section 10.01Data Security.  During the Term, each Licensee Entity will maintain safety and facility procedures, data security procedures and other safeguards against the disclosure, destruction, loss, or alteration of Ocular’s information in its possession, all in accordance with the standards therefor consistent with customary industry standard.
Section 10.02Complaints. Each Party shall maintain a record of all non-medical and medical product-related complaints it receives with respect to any Licensed Product in accordance with the applicable Laws of each Jurisdiction where the Licensed Products are commercialized, to include validation, investigation and trending of all complaints, which investigation shall be conducted by a qualified Third Party if necessary to comply with regulatory requirements.  Each Party shall notify the other Party of any such complaint received by it in sufficient detail and in accordance with the timeframes and procedures for reporting established, and in any event in sufficient time to allow each Ocular Entity and each Licensee Entity to comply with any and all regulatory requirements imposed upon it, including in accordance with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) guidelines. Licensee shall investigate and respond to all such complaints in in any Jurisdiction in the Territory with respect to any Licensed Product as soon as reasonably practicable.  All such responses shall be made in accordance with the procedures established pursuant to ICH, FDA, EMA, NMPA and other applicable guidelines, and subject to such additional requirements as may be determined by the JC from time to time.  Licensee shall promptly provide Ocular a copy of any such response.
Section 10.03Adverse Drug Events.  Within [**] after the Effective Date, the Parties shall enter into the Safety Data Exchange Agreement.  Such Safety Data Exchange Agreement shall provide for the exchange by the Parties of any information of which a Party becomes aware concerning any adverse event experienced by a subject or patient being administered any Licensed Product, whether or not such adverse event is determined to be attributable to any Licensed Product, including any such information received by either Party from any Third Party (subject to receipt of any required consents from such Third Party).  It is understood that each Party and in the case of Ocular, the Ocular Entities, and in the case of Licensee, the Licensee Entities, shall have the right to disclose such information if such disclosure is reasonably necessary to comply with applicable Laws or requirements of any applicable Regulatory Authority.  Licensee shall be responsible for handling all such returns, suspensions and 

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withdrawals of each Licensed Product in the Territory at its sole expense, unless otherwise provided for in the Supply Agreement. The Safety Data Exchange Agreement will detail Licensee’s responsibilities relating to such recalls, suspensions and withdrawals.
Section 10.04No Admissions by Licensee in Response to Product Complaints that May Be Adverse to Ocular.  If Licensee (including any Licensee Entity) receives any complaint relating to the quality or condition of the Licensed Product or its packaging, or the Trademark or the Patents, from any Third Party, Licensee shall forthwith acknowledge receipt of such complaint but shall not make any admissions in respect thereof which could result in liability to Ocular (or any other Ocular Entity), through indemnification or otherwise, unless such admission is required by Applicable Law or under a court order.  Licensee shall notify Ocular in writing as soon as practicable to permit all applicable Ocular Entities to comply with all applicable Laws for any matter relating to the safety of the Licensed Product. Licensee shall offer reasonable cooperation to Ocular (and other Ocular Entities designated by Ocular) in investigating any complaint and the circumstances surrounding it and shall comply with Ocular’s standard operating procedures in respect of adverse events, product recall or other related matters, a copy which shall be provided to Licensee.
ARTICLE XI
​
REPRESENTATIONS, WARRANTIES, AND COVENANTS
Section 11.01Mutual Representations and Warranties.  Each of Licensee and Ocular hereby represents and warrants to the other Party as of the Effective Date that:
(a)it is a corporation or entity duly organized and validly existing under the Laws of the state, municipality, province, administrative division or other jurisdiction of its incorporation or formation;
(b)the execution, delivery and performance of this Agreement by it has been duly authorized by all requisite corporate action;
(c)it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder, and such performance does not conflict with or constitute a breach of any of its agreements with any Third Party;
(d)it has the right to grant the rights and licenses described in this Agreement;
(e)it has not made any commitment to any Third Party in conflict with the rights granted by it hereunder;
(f)to its knowledge, no consent, approval or agreement of any person or Governmental Authority is required to be obtained in connection with the execution and delivery of this Agreement; and

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(g)it has not been debarred by the FDA, is not the subject of a conviction described in Section 306 of the FD&C Act, and is not subject to any similar sanction of any other Governmental Authority outside of the U.S., and neither it nor any of its Affiliates has used, in any capacity, any person or entity who either has been debarred by the FDA, is the subject of a conviction described in Section 306 of the FD&C Act or is subject to any such similar sanction inside or outside of the U.S.
Section 11.02Mutual Covenants.  Each of Licensee and Ocular hereby covenants to the other Party that:
(a)it will not engage, in any capacity in connection with this Agreement or any ancillary agreement, any person or entity who either has been debarred by the FDA, is the subject of a conviction described in Section 306 of the FD&C Act or is subject to any such similar sanction inside or outside of the U.S., and such Party shall inform the other Party in writing promptly if such Party or any person or entity engaged by such Party who is performing services under this Agreement, or any ancillary agreements, is debarred or is the subject of a conviction described in Section 306 of the FD&C Act or any similar sanction inside or outside of the U.S., or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to such Party’s knowledge, is threatened, relating to the debarment or conviction of a Party, any of its Affiliates or any such person or entity performing services hereunder or thereunder;
(b)during the Term, it will not make any commitment to any Third Party in conflict with the rights granted by it hereunder; and
(c)it will comply, and will cause its Affiliates to comply, with all applicable Laws in performing its activities hereunder.
Section 11.03Additional Ocular Warranties.  Ocular hereby represents and warrants to Licensee as of the Effective Date that:
(a)to Ocular’s knowledge, Exhibit A contains a list of all Patent Rights that are Controlled by Ocular of any of its Affiliates as of the Effective Date and Cover the Development or Commercialization of the Licensed Products as they exist on the Effective Date in the Field in the Territory and Ocular and its Affiliates do not own and have not in-licensed any Know-How or Patents that Cover the Development or Commercialization of the Licensed Product that are not Controlled by Ocular or its Affiliates;
(b)Ocular is unaware of any challenge in the Territory to the validity or enforceability of any of the Ocular Patent Rights listed in Exhibit A;
(c)to Ocular’s knowledge and with respect to the Territory, there is no pending or threatened litigation, arbitration or investigation before any regulatory or administrative body of any country or jurisdiction (including any Governmental Authority), or pertaining to pending or threatened civil, economic, administrative or criminal litigation any country or jurisdiction (including letters asserting claims, complaints, answers, briefs, motion 

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papers, etc.) that would affect the ownership of assets or business regulation of Ocular or any of its Affiliates, or would negatively impact Ocular’s or any of its Affiliates’ business and operations, including litigation against such party’s management, group leaders, directors and scientists, pertaining to performance of such party’s obligations under this Agreement, or pertaining to the conduct of clinical research, including without limitation intellectual property rights;
(d)Ocular has provided Licensee with a redacted version of the Existing In-License Agreement in effect as of the Effective Date. Such redacted version is redacted only to remove confidential or competitively sensitive information not relevant to Licensee as a sublicensee thereunder. To Ocular’s knowledge, the Existing In-License Agreement is in full force and effect, and Ocular is not in breach of the Existing In-License Agreement; As of the Effective Date, except for the Existing In-License Agreement, there is no agreement between Ocular or its Affiliates and any Third Party pursuant to which Ocular or its Affiliates have obtained any right or license to the Licensed Products or any intellectual property rights related to the Licensed Products;
(e)During the Term of this Agreement, Ocular shall keep all In-License Agreements (including Existing In-License Agreement) in full force and effect and shall not terminate, amend, waive or otherwise modify (or consent to any of the foregoing) its rights under any In-License Agreement in any manner that materially diminishes the rights or licenses granted to Licensee hereunder, without Licensee’s express written consent;
(f)Ocular has not received written notice of any investigations, inquiries, actions or other proceedings pending before or threatened by any Regulatory Authority or other Governmental Authority with respect to the Licensed Products arising from any action or default by Ocular or any of its Affiliates or a Third Party acting on behalf Ocular in the discovery, Manufacture or Development of the Licensed Products; and
(g)Ocular has not received written notice from a Third Party claiming that the development, use, manufacture or sale of any Licensed Product would infringe or misappropriate any intellectual property rights of such Third Party.
Section 11.04Additional Licensee Warranties and Covenants.  Licensee hereby represents, warrants and covenants to Ocular that:
(a)Licensee has (or will have at the anticipated time of launch) the capability to Commercialize Licensed Products in the Territory as contemplated in this Agreement;
(b)each Licensee Entity (other than Licensee) and each Licensee Entity’s employees and permitted agents and contractors have executed agreements or have existing obligations under applicable Laws, or, upon their engagement by Licensee or any of its Affiliates, will execute such agreements, requiring automatic assignment to Licensee of all inventions (whether patentable or not) or other Know-how identified, discovered, authored, developed, conceived or reduced to practice during the course of and as the result of their association with Licensee or its Affiliates, and all intellectual property rights therein, and obligating the relevant 

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individual or entity to maintain as confidential Licensee’s Confidential Information related to the Licensed Product as well as Confidential Information of other parties (including Ocular and any Ocular Entity) which such individual or entity may receive, to the extent required to support Licensee’s obligations under this Agreement;
(c)to Licensee’s knowledge, there is no pending or threatened litigation, arbitration or investigation before any regulatory or administrative body of any country or jurisdiction (including any Governmental Authority), or pertaining to pending or threatened civil, economic, administrative or criminal litigation any country or jurisdiction (including letters asserting claims, complaints, answers, briefs, motion papers, etc.) that would affect the ownership of assets or business regulation of Licensee or any of its Affiliates, or would negatively impact Licensee’s or any of its Affiliates’ business and operations, including litigation against such party’s management, group leaders, directors and scientists, pertaining to performance of such party’s obligations under this Agreement, or pertaining to the conduct of clinical research, including without limitation intellectual property rights;
(d)neither Licensee nor any of its Affiliates are (i) state-owned, (ii) subject to any state-owned assets administrations or other authorities with respect to the registration of state-owned assets or (iii) under collective ownership;
(e)Licensee and its Affiliates have (i) passed all annual inspections by Governmental Authorities and (ii) paid all taxes imposed upon such party by any Governmental Authority as such taxes have become due, in each case ((i) and (ii)) since its inception;
(f)neither Licensee nor any of its Affiliates is, and, during the Term, neither Licensee nor any of its Affiliates will become, a relevant scientific research institution or higher level educational school under the Notice of the General Office of the State Council on Issuing the Measures for the Management of Scientific Data, Guo Ban Fa (2018) No. 17, as such Law exists as of the Effective Date; and
(g)the Development to be undertaken under this Agreement will not be funded by the government of Mainland China.
Section 11.05Anti-Corruption.
(a)Anti-Corruption Provisions.  Each Party represents and warrants to the other Party that such Party has not, directly or indirectly, offered, promised, paid, authorized or given, and each Party agrees that such Party will not, in the future, offer, promise, pay, authorize or give, money or anything of value, directly or indirectly, to any Government Official or Other Covered Party for the purpose, pertaining to this Agreement, of:  (i) influencing any act or decision of such Government Official or Other Covered Party; (ii) inducing such Government Official or Other Covered Party to do or omit to do an act in violation of a lawful duty; (iii) securing any improper advantage; or (iv) inducing such Government Official or Other Covered Party to influence the act or decision of a Governmental Authority, in order to obtain or retain business, or direct business to, any person or entity, in any way related to this Agreement.

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For purposes of this Agreement: (A) “Government Official” means any official, officer, employee or representative of: (1) any Governmental Authority; (2) any public international organization or any department or agency thereof; or (3) any company or other entity owned or controlled by any Governmental Authority; and (B) “Other Covered Party” means any political party or party official, or any candidate for political office.
(b)Anti-Corruption Compliance.
(i)In performing under this Agreement, each Party, on behalf of itself, its respective Affiliates and (in the case of Ocular) other Ocular Entities and (in the case of Licensee) other Licensee Entities, agrees to comply with all applicable anti-corruption Laws, including the Foreign Corrupt Practices Act of 1977, as amended from time to time (“FCPA”) and all anti-corruption Laws of the Territory.
(ii)Each Party represents and warrants to the other Party that such Party is not aware of any Government Official or Other Covered Party having any financial interest in the subject matter of this Agreement or in any way personally benefiting, directly or indirectly, from this Agreement.
(iii)No Party, nor any Affiliate of any Party (and (in the case of Ocular) no other Ocular Entity and (in the case of Licensee) no other Licensee Entity), shall give, offer, promise or pay any political contribution or charitable donation at the request of any Government Official or Other Covered Party that is in any way related to this Agreement or any related activity.
(iv)Licensee Entities shall in all cases, refrain from engaging in any activities or conduct which would cause any Ocular Entity to be in violation of the FCPA and any applicable anti-bribery laws. If any Licensee Entity proposes to provide any information, data or documentation to any governmental or regulatory authority in respect of the Licensed Product, it shall first obtain the prior written approval of Ocular, which will not be unreasonably withheld, or shall provide such information, data or documentation in accordance with Ocular’s written instructions, unless otherwise required by Law.
(v)Licensee agrees that it will, and will cause each of its directors, officers, employees, agents or other representatives who have any direct involvement with any of the management or operations of the business of Licensee under this Agreement, at the request of Ocular, and at least annually, provide Ocular with a certification in the form hereto attached and incorporated by reference as Exhibit D.
(vi)Licensee agrees that should it learn or have reason to know of: (i) any payment, offer, or agreement to make a payment to a foreign official or political party for the purpose of obtaining or retaining business or securing any improper advantage for Ocular under this Agreement or otherwise, or (ii) any other development during the Term that in any way makes inaccurate or incomplete the representations, warranties and certifications of Licensee hereunder given or made as of the date hereof or at any time during the Term, relating 

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to the FCPA, Licensee will immediately advise Ocular in writing of such knowledge or suspicion and the entire basis known to Licensee therefor.
(vii)Notwithstanding any other provisions contained in this Agreement, Licensee agrees that full disclosure of information relating to a possible violation of the FCPA or the existence and terms of this Agreement, including the compensation provisions hereof, may be made at any time and for any reason to the U.S. government and its agencies, and to whomsoever Ocular determines has a legitimate need to know.
(viii)In the event that a Party violates the FCPA, any anti-corruption Law of the Territory or any other applicable anti-corruption Law, or breaches any provision in this Section 11.05, the other Party shall have the right to unilaterally terminate this Agreement pursuant to Section 14.02, except that the cure period set forth therein shall not apply.
Section 11.06Exportation of Data.  Licensee shall ensure that the export of all Licensee Product Data that Licensee is required to provide to Ocular under this Agreement complies with all applicable Laws in the Territory and shall use Commercially Reasonable Efforts to obtain any approval of any Governmental Authority required, and to take all other steps required under applicable Laws, for such export. To the extent that export of any Licensee Product Data is prohibited by applicable Laws, the Parties will work together in good faith to endeavor to provide Ocular or its designee with rights and access to such Licensee Product Data as close to those described in the preceding sentence as is permitted by applicable Law.
Section 11.07Disclaimer.  EXCEPT AS EXPRESSLY SET FORTH HEREIN, THE INTELLECTUAL PROPERTY RIGHTS PROVIDED BY OCULAR TO LICENSEE HEREIN ARE PROVIDED “AS IS” AND WITHOUT WARRANTY.  EXCEPT AS EXPRESSLY SET FORTH HEREIN, EACH OF THE PARTIES EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OR ENFORCEABILITY OF THEIR RESPECTIVE INTELLECTUAL PROPERTY RIGHTS, AND NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
Section 11.08Limitation of Liability.  NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, EXEMPLARY, INDIRECT, CONSEQUENTIAL OR PUNITIVE DAMAGES OR DAMAGES FOR LOSS OF PROFIT OR LOST OPPORTUNITY IN CONNECTION WITH THIS AGREEMENT, ITS PERFORMANCE OR LACK OF PERFORMANCE HEREUNDER, OR ANY LICENSE GRANTED HEREUNDER.  THE FOREGOING SHALL NOT LIMIT (a) ANY INDEMNIFICATION OBLIGATIONS HEREUNDER OR (b) REMEDIES AVAILABLE TO EITHER PARTY WITH RESPECT TO A BREACH OF ARTICLE XII OR Section 2.07 OR FRAUD COMMITTED BY THE OTHER PARTY.

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ARTICLE XII
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CONFIDENTIALITY
Section 12.01Generally.  During the Term and for a period of [**] thereafter, each Party (a) shall maintain in confidence all Confidential Information of the other Party; (b) shall not use such Confidential Information for any purpose except to fulfill its obligations or exercise its rights under this Agreement; and (c) shall not disclose such Confidential Information to anyone other than those of its Affiliates, directors, investors, prospective investors, lenders, prospective lenders, acquirers, prospective acquirers, licensees, prospective licensees, sublicensees, prospective sublicensees, employees, consultants, financial or legal advisors, or other agents or contractors (collectively, “Representatives”) who are bound by written obligations of nondisclosure and non-use no less stringent than those set forth in this ARTICLE XII (except that the duration of confidentiality and non-use may be shorter but no less than [**], so long as such shorter duration does not apply to any Confidential Information comprising scientific trade secret information disclosed to such Representatives) and to whom such disclosure, under this Agreement, is necessary in connection with the fulfillment of such Party’s obligations or exercise of such Party’s rights under this Agreement or in connection with bona fide financing or acquisition activities.  Each Party shall (i) ensure that such Party’s Representatives who receive any of the other Party’s Confidential Information comply with the obligations set forth in this ARTICLE XII and (ii) be responsible for any breach of these obligations by any of its Representatives who receive any of the other Party’s Confidential Information.  Each Party shall notify the other Party promptly on discovery of any unauthorized use or disclosure of the other’s Confidential Information. Notwithstanding anything to the contrary in this ARTICLE XII, Ocular may disclose Licensee’s Confidential Information to each Third Party counterparty under any In-License Agreement as reasonably required to fulfill Ocular’s obligations under such In-License Agreement, and Licensee acknowledges and agrees that, with respect to any such Confidential Information, such Third Party counterparty(ies) shall only be bound by the confidentiality obligations set forth in the applicable In-License Agreement(s).  From and after the Effective Date, any “Confidential Information” (as defined in the Confidentiality Agreement) shall be deemed to be Confidential Information hereunder and subject to the terms of this Agreement.
Section 12.02Exceptions.  The obligations of confidentiality, non-disclosure, and non-use set forth in Section 12.01 shall not apply to, and “Confidential Information” shall exclude, any information to the extent the receiving Party (the “Recipient”) can demonstrate that such information:  (a) was in the public domain or publicly available at the time of disclosure to the Recipient or any of its Affiliates by the disclosing Party or any of its Affiliates pursuant to this Agreement, or thereafter entered the public domain or became publicly available, in each case other than as a result of any action of the Recipient, or any of its Representatives, in breach of this Agreement or the Confidentiality Agreement; (b) was rightfully known by the Recipient or any of its Affiliates (as shown by its written records) prior to the date of disclosure to the Recipient or any of its Affiliates by the disclosing Party or any of its Affiliates pursuant to this Agreement or the Confidentiality Agreement; (c) was received by the Recipient or any of its Affiliates on an unrestricted basis from a Third Party rightfully in possession of such information 

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and not under a duty of confidentiality to the disclosing Party or any of its Affiliates; or (d) was independently developed by or for the Recipient or any of its Affiliates without reference to or reliance on the Confidential Information of the other Party or any of its Affiliates (as demonstrated by written records).
Section 12.03Permitted Disclosures.
(a)Notwithstanding any other provision of this Agreement, Recipient’s (or its Affiliates’) disclosure of the other Party’s Confidential Information shall not be prohibited if such disclosure: (i) is in response to a valid order of a court or other Governmental Authority including the rules and regulations promulgated by the Securities and Exchange Commission (or similar foreign authority) or any other Governmental Authority or (ii) to patent offices in order to seek or obtain Patent Rights or to Regulatory Authorities in order to seek or obtain approval to conduct clinical trials or to gain Regulatory Approval with respect to the Licensed Products as contemplated by this Agreement; provided that such disclosure may be made only to the extent reasonably necessary to respond to such court or other Governmental Authority order to seek or obtain such Patent Rights or Regulatory Approvals and the Recipient (or its applicable Affiliate) shall use Commercially Reasonable Efforts to obtain confidential treatment of such information.  If a Recipient is required to disclose Confidential Information pursuant to this Section 12.03(a), prior to any disclosure the Recipient shall, to the extent legally permitted and practicable, provide the disclosing Party with prior written notice of such disclosure in order to permit the disclosing Party to seek a protective order or other confidential treatment of such disclosing Party’s Confidential Information.
(b)Each Party acknowledges that the other Party may be required by Law or by stock exchange rules to make public disclosures (including in filings with Government Authorities or stock exchanges) of the terms of this Agreement or certain material developments or material information generated under this Agreement.  Each Party agrees that the other Party may make such disclosures as required by Law or by stock exchange rules, provided that the Party seeking such disclosure first provides the other Party a copy of the proposed disclosure, except where prohibited by applicable Law, and provided further that (except to the extent that the Party seeking disclosure is required to disclose such information to comply with applicable Law and rules) if the other Party demonstrates to the reasonable satisfaction of the Party seeking disclosure, within [**] of such Party’s providing the copy (or such lesser period of time as required by applicable Law, and provided that the other Party will make reasonable efforts to accommodate a shorter timeframe if requested), that the public disclosure of previously undisclosed information will materially adversely affect the Development or Commercialization of the Licensed Product (including with respect to such Party’s intellectual property protection strategy), the Party seeking disclosure will remove from the disclosure such specific previously undisclosed information as the other Party shall reasonably request to be removed.
Section 12.04Publicity.  On or after the Effective Date, each Party may issue a press release announcing the existence of this Agreement at a time, and in a form, to be agreed by the Parties. Additionally, the Parties recognize that each Party may from time to time desire to issue 

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press releases and make other public statements or public disclosures (each, a “Public Statement”) in respect of this Agreement, including the Development or Commercialization of Licensed Products in the Territory.  If Licensee desires to make a Public Statement, it shall provide Ocular a copy of such Public Statement at least [**] prior to the date it desires to make such public disclosure. Licensee shall not issue a Public Statement without Ocular’s prior written approval, which advance approval shall not be unreasonably withheld, conditioned or delayed. Once any public statement or public disclosure has been approved by Ocular in accordance with the prior sentence, then Licensee may appropriately communicate information contained in such permitted statement or disclosure. Notwithstanding anything to the contrary in this Section 12.04, nothing in this Section 12.04 shall be deemed to limit either Party’s rights under Section 12.03.
Section 12.05Publications.  Except for disclosures permitted pursuant to Section 12.02, Section 12.03 or Section 12.04, if Licensee wishes to make a publication or public presentation with respect to its Commercialization of any Licensed Product in the Field in the Territory, Licensee shall deliver to Ocular a copy of the proposed written publication or presentation within [**] prior to submission for publication or presentation. Ocular shall have the right (a) to require modifications to the publication or presentation for patent or any other business reasons, and Licensee will remove all of Ocular’s Confidential Information if requested by Ocular and (b) to require a reasonable delay in publication or presentation in order to protect patentable information. If Ocular requests a delay, then Licensee shall delay submission or presentation for a period of [**] (or such shorter period as may be mutually agreed by the Parties) to enable Ocular to file patent applications protecting Ocular’ rights in such information. For clarity, Licensee shall not make any publication or public presentation (i) with respect to the Development or Manufacturing of the Licensed Products; or (ii) which includes any CMC data related to the Licensed Products, in each case without Ocular’s prior written consent, which Ocular may withhold in its sole discretion.
Section 12.06Injunctive Relief.  Each Party acknowledges and agrees that there may be no adequate remedy at law for any breach of its obligations under this ARTICLE XII, that any such breach may result in irreparable harm to the other Party and, therefore, that upon any such breach or any threat thereof, such other Party may seek appropriate equitable relief in addition to whatever remedies it might have at law, without the necessity of showing actual damages.
ARTICLE XIII
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INDEMNIFICATION
Section 13.01Indemnification by Ocular.  Ocular shall indemnify, hold harmless and defend Licensee and its Affiliates, and their respective directors, officers, consultants, agents, contractors and employees (the “Licensee Indemnitees”) from and against any and all Third Party suits, claims, actions, demands, liabilities, expenses, costs, damages, deficiencies, obligations or losses (including reasonable attorneys’ fees, court costs, witness fees, damages, judgments, fines and amounts paid in settlement) (“Losses”) to the extent that such Losses arise out of (a) any 

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breach of this Agreement by Ocular, (b) the Development, Manufacture (excluding Losses arising out of infringement of Third Party Patent Rights) or Commercialization of any Licensed Product by or on behalf of any Ocular Entity or (c) the gross negligence or willful misconduct of any Ocular Indemnitee.  Notwithstanding the foregoing, Ocular shall not have any obligation to indemnify the Licensee Indemnitees to the extent that the applicable Losses arise out of the scenarios set forth in Section 13.02(a), Section 13.02(b) or Section 13.02(c) below.
Section 13.02Indemnification by Licensee.  Licensee shall indemnify, hold harmless and defend Ocular and its Affiliates, and their respective directors, officers, consultants, agents, contractors and employees (the “Ocular Indemnitees”) from and against any and all Losses, to the extent that such Losses arise out of (a) any breach of this Agreement by Licensee, (b) the Development or Commercialization of any Licensed Product by or on behalf of any Licensee Entity or (c) the gross negligence or willful misconduct of any Licensee Indemnitee.  Notwithstanding the foregoing, Licensee shall not have any obligation to indemnify the Ocular Indemnitees to the extent that the applicable Losses arise out of the scenarios set forth in Section 13.01(a), Section 13.01(b) or Section 13.01(c) above.
Section 13.03Procedure.  In the event of a claim by a Third Party against a Licensee Indemnitee or Ocular Indemnitee entitled to indemnification under this Agreement (“Indemnified Party”), the Indemnified Party shall promptly notify the Party obligated to provide such indemnification (“Indemnifying Party”) in writing of the claim and the Indemnifying Party shall undertake and solely manage and control, at its sole expense, the defense of the claim and its settlement.  The Indemnified Party shall cooperate with the Indemnifying Party.  The Indemnified Party may, at its option and expense, be represented in any such action or proceeding by counsel of its choice.  The Indemnifying Party shall not be liable for any litigation costs or expenses incurred by the Indemnified Party without the Indemnifying Party’s written consent.  The Indemnifying Party shall not settle any such claim unless such settlement fully and unconditionally releases the Indemnified Party from all liability relating thereto and does not impose any obligations on the Indemnified Party, unless the Indemnified Party otherwise agrees in writing.  No Indemnified Party may settle any claim for which it is being indemnified under this Agreement without the Indemnifying Party’s prior written consent.
Section 13.04Insurance.  Licensee shall, at its own expense, obtain and maintain insurance with a reputable insurance carrier with respect to the Licensee Entities’ Development and Commercialization of Licensed Products in the Field in the Territory under this Agreement in such type and amount and subject to such deductibles and other limitations as biopharmaceutical companies in the Territory customarily maintain with respect to the Development and Commercialization of similar products.  Such insurance policy shall provide product liability coverage and broad form contractual liability coverage for Licensee’s indemnification obligations under this Agreement and shall name the Ocular Indemnitees as additional insureds.  Licensee shall provide a copy of such insurance policy to Ocular upon reasonable request by Ocular.  Licensee shall provide Ocular with written notice at least [**] prior to any cancellation, non-renewal or material change in such insurance.  If Licensee does not obtain replacement insurance providing comparable coverage within such [**] period, Ocular 

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shall have the right to terminate this Agreement effective at the end of such [**] period without notice or any additional waiting periods.  This Section 13.04 shall survive expiration or termination of this Agreement and last until [**] after the last sale of any Licensed Product in the Field in the Territory by any Licensee Entity.
ARTICLE XIV
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TERM AND TERMINATION
Section 14.01Term.  The term of this Agreement shall begin on the Effective Date and, unless earlier terminated in accordance with the terms of this ARTICLE XIV (Term and Termination), will expire upon the expiration of the last-to-expire Royalty Term (the “Term”).
Section 14.02Termination for Breach.  Subject to the terms and conditions of this Section 14.02 (Termination for Breach), a Party (the “Non-Breaching Party”) shall have the right, in addition to any other rights and remedies available to such Party at law or in equity, to terminate this Agreement in the event the other Party (the “Breaching Party”) is in material breach of its obligations under this Agreement.  The Non-Breaching Party shall first provide written notice to the Breaching Party, which notice shall identify with particularity the alleged breach (the “Breach Notice”).  With respect to material breaches of any payment provision hereunder, the Breaching Party shall have a period of [**] after such Breach Notice is provided to cure such breach.  With respect to all other breaches, the Breaching Party shall have a period of [**] after such Breach Notice is provided to cure such breach.  If such breach is not cured within the applicable period set forth above, the Non-Breaching Party may, at its election, terminate this Agreement upon written notice to the Breaching Party, provided that, in the event the Breaching Party disputes such allegation of breach, for so long as the Breaching Party continues to dispute such allegation in good faith, the termination shall not become effective unless and until such dispute is resolved in such Non-Breaching Party’s favor.  The waiver by either Party of any breach of any term or condition of this Agreement shall not be deemed a waiver as to any subsequent or similar breach.
Section 14.03Termination for Bankruptcy and Rights in Bankruptcy.
(a)To the extent permitted under applicable Law, if, at any time during the Term, an Event of Bankruptcy (as defined below) relating to either Party (the “Bankrupt Party”) occurs, the other Party (the “Other Party”) shall have, in addition to all other legal and equitable rights and remedies available to such Party, the option to terminate this Agreement upon [**] written notice to the Bankrupt Party. It is agreed and understood that, if the Other Party does not elect to terminate this Agreement upon the occurrence of an Event of Bankruptcy, except as may otherwise be agreed with the trustee or receiver appointed to manage the affairs of the Bankrupt Party, the Other Party shall continue to make all payments required of it under this Agreement as if the Event of Bankruptcy had not occurred, and the Bankrupt Party shall not have the right to terminate any license granted herein.  The term “Event of Bankruptcy” means:  (a) filing 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 the Bankrupt Party or of its assets or (b) being served 

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with an involuntary petition against the Bankrupt Party, filed in any insolvency proceeding, where such petition is not dismissed within [**] after the filing thereof.
(b)All rights and licenses granted under or pursuant to this Agreement by Licensee and Ocular 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 (i) 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 (ii) if not delivered under clause (i) 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.  The Parties acknowledge and agree that payments made under Section 8.02 (Clinical Development Milestone and Clinical Development Support Payments) or Section 8.03 (Commercial Milestone Payments) or pursuant to any Supply Agreement shall not (x) constitute royalties within the meaning of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction or (y) relate to licenses of intellectual property hereunder.
Section 14.04Termination on Ocular’s Change in Control. In the event of a Change in Control of Ocular or any global licensing agreement with a Third Party which includes any Jurisdiction, Ocular shall have the right to terminate this Agreement and redeem all rights licensed by Ocular to Licensee hereunder at a redemption price of, [**] percent ([**]%) of the upfront and milestone payments Licensee has actually paid to Ocular under Section 8.01, Section 8.02 and Section 8.03, plus any costs and expenses that have been incurred and accrued by Licensee. Such right shall be exercisable by Ocular within [**] after the closing of such Change in Control transaction upon [**] written notice to Licensee, and such redemption price shall be due and payable concurrent with such notice.
Section 14.05Termination at Will by Licensee. At any time after completion of the Phase 3 Clinical Trial for OTX-TIC, Licensee may terminate this Agreement for any or no reason upon giving three (3) months’ notice to Ocular.
Section 14.06Effect of Termination.
(a)In the event of any termination (but not expiration) of this Agreement, the following shall apply:

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(i)All license grants in this agreement from Ocular to Licensee shall immediately terminate;
(ii)Licensee shall cease using the Ocular Technology and return all inventory of the Product Materials to Ocular, together with all copies of the Ocular Know-How and other Confidential Information of Ocular in the possession or control of Licensee or any of its Representatives;
(iii)Licensee shall, at Ocular’s written request, to the extent feasible under applicable Law, promptly: (A) assign and transfer to Ocular all confidentiality and other agreements, and Arising IP solely relating to any Licensed Product, and solely to the extent in any Licensee Entity’s possession or control; (B) assign and transfer to Ocular all Regulatory Filings and Regulatory Approvals for the Licensed Product in the Territory Controlled by the Licensee Entities; (C) disclose to Ocular all documents embodying the foregoing that are in any Licensee Entity’s possession or control or that any Licensee Entity is able to obtain using reasonable efforts; and (D) provide to Ocular a copy of all Licensee Product Data then in the possession of Licensee and any other Licensee Entity;
(iv)At Ocular’s request, Licensee shall promptly take all action that may be reasonably required to transfer all customer lists, promotional materials and any other information it has generated for selling the Licensed Product in the Territory, as well as any remaining inventories of Licensed Product to Ocular or a Third Party designated by Ocular.  In addition, Licensee shall promptly transfer to Ocular or to the legal entity designated by Ocular all documents Controlled by Licensee relating to the Licensed Product and Licensee Regulatory Documents (including Regulatory Approvals) necessary for a smooth transition of the right of Licensee to sell Licensed Product back to Ocular; all rights granted by Ocular to Licensee (including to any Licensee Entity) under this Agreement shall revert to Ocular (and Licensee shall reasonably cooperate with Ocular (or its designated Ocular Entities) to take all necessary steps, at Ocular’s option, to cancel or transfer to Ocular all registrations made by Licensee, if any, of any Trademark associated with any Licensed Product;
(v)Licensee (including each Licensee Entity) shall cease forthwith the use of all samples, advertising and promotional literature, technical data, point of sale and other material relating to the Licensed Product and in the possession or under the control of Licensee, or any Licensee Entity and its sales representatives, and shall destroy them and certify such destruction to Ocular in writing.  Licensee shall also cease immediately the use of any Internet website relating to the Licensed Product as well as any Trademark associated with any Licensed Product;
(vi)Licensee hereby grants, and shall cause each Licensee Entity to grant, to Ocular an exclusive (even as to Licensee and each Licensee Entity), royalty-free, worldwide, sublicensable, transferable, perpetual, irrevocable, royalty-free license under Licensee Technology as set forth in Section 2.01(b);

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(vii)The rights to the Licensee Product Data granted to Ocular under Section 2.05(a) shall be deemed automatically revised to be worldwide;
(viii)The costs associated with the activities set forth in subsections (a)(ii), (a)(iii) and (a)(iv) of this Section 14.04 shall be borne by (A) Licensee, in the event of termination of this Agreement by Ocular pursuant to Section 14.02 or Section 14.03; (B) Ocular in the event of termination of this Agreement by Licensee pursuant to Section 14.02 or Section 14.03; (C) Ocular in the event of termination of this Agreement by Ocular pursuant to Section 14.04; and (D) Licensee in the event of termination of this Agreement by Licensee pursuant to Section 14.05; and
(ix)Notwithstanding any expiration or termination of this Agreement, the Safety Data Exchange Agreement (with respect to Licensee’s obligations thereunder) shall continue in accordance with its terms.
Section 14.07Survival; Accrued Rights.  The following articles and sections of this Agreement shall survive expiration or early termination for any reason: ARTICLE I, Section 2.01(b), Section 4.02 (solely with respect to applicable payment obligations accrued prior to termination or expiration), Section 5.01 (solely with respect to applicable payment obligations accrued prior to termination or expiration), ARTICLE VIII (solely with respect to applicable payment obligations accrued prior to termination or expiration), Section 9.01, Section 11.07, Section 11.08, ARTICLE XII, ARTICLE XIII, Section 14.03(b), Section 14.06, Section 14.07, ARTICLE XV, ARTICLE XVI and ARTICLE XVII.  In any event, expiration or termination of this Agreement shall not relieve either Party of any liability which accrued hereunder prior to the effective date of such expiration or termination nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement, nor prejudice either Party’s right to obtain performance of any obligation.
ARTICLE XV
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DISPUTE RESOLUTION; GOVERNING LAW
Section 15.01Arbitration.  Subject to Section 15.01(d), any disputes, claims or controversies in connection with this Agreement, including any questions regarding its formation, existence, validity, enforceability, performance, interpretation, breach or termination, that are not resolved in accordance with ARTICLE III and not subject to a Party’s final decision-making authority in accordance with ARTICLE III (except with regard to a dispute, claim or controversy with respect to which Party has final decision-making authority thereunder) shall be referred to and finally resolved by binding arbitration under the American Arbitration Association  (“AAA”) in accordance with its Commercial Arbitration Rules (the “Rules”), which 
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rules are deemed to be incorporated by reference into this Section 15.01, in the manner described below:
(a)Arbitration Request.  If a Party intends to begin an arbitration to resolve a dispute arising under this Agreement, such Party shall provide written notice (the “Arbitration Request”) to the other Party of such intention and the issues for resolution.  Any such dispute that is not to be resolved in accordance with Section 15.01(d) shall be resolved in accordance with Section 15.01(c), any such dispute that relates to validity or enforceability of a Patent Right shall be resolved in accordance with Section 15.01(d).
(b)Additional Issues.  Within [**] after the receipt of an Arbitration Request, the other Party may, by written notice, add additional issues for resolution.
(c)General Arbitration Procedure for Disputes.  The seat of arbitration will be in New York, New York unless other venue is agreed upon by Parties, and it will be conducted in the English language. The arbitrators may not decide based on equity. Unless agreed by the Parties to choose a single common arbitrator, the arbitration will be conducted by three (3) arbitrators, with one (1) appointed by each Party, according to the Rules. The two (2) arbitrators appointed by the Parties will by mutual agreement appoint the third arbitrator, who will preside over the arbitration. Any dispute or omission regarding the appointment of the arbitrators by the Parties, as well as the choice of the third arbitrator, will be resolved by the AAA. The arbitral award shall be final, definitive and binding on the Parties and their successors.  The Parties reserve the right to apply to a competent judicial court to obtain urgent remedies to protect rights before establishment of the arbitration panel, without such recourse being considered as a waiver of arbitration. Except as otherwise determined by the arbitrators, the Parties shall each bear half of the fees and expenses of the arbitrators and AAA, and each Party shall bear the costs and fees of its attorneys. Nothing in this Agreement shall be deemed as preventing either Party from seeking injunctive relief (or any other provisional remedy) from any court having jurisdiction over the Parties and the subject matter of the dispute as necessary to protect either Party’s name, Confidential Information, Know-How, intellectual property rights or any other proprietary right or otherwise to avoid irreparable harm.  If the issues in dispute involve scientific or technical matters, any arbitrators chosen hereunder shall have educational training or experience sufficient to demonstrate a reasonable level of knowledge in the field of biotechnology and pharmaceuticals.  Judgment on the award rendered by the arbitrator may be entered in any court having jurisdiction thereof.  The Parties intend that each award rendered by an Arbitrator hereunder shall be entitled to recognition and enforcement under the United Nations Convention on the Recognition and Enforcement of Arbitral Awards (New York, 1958).
(d)Intellectual Property Disputes.  Unless otherwise agreed by the Parties, a dispute between the Parties relating to the validity or enforceability of any Patent Right shall not be subject to arbitration and shall be submitted to a court or patent office of competent jurisdiction in the relevant country or jurisdiction in which such patent was issued or, if not issued, in which the underlying patent application was filed.

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Section 15.02Choice of Law.  This Agreement and all amendments, modifications, alterations, or supplements hereto, and the rights of the Parties hereunder, shall be construed under and governed by the Laws of the State of New York, exclusive of its conflicts of laws principles.
Section 15.03Language.  This Agreement has been prepared in the English language and the English language shall control its interpretation.  All consents, notices, reports and other written documents to be delivered or provided by a Party under this Agreement shall be in the English language, and in the event of any conflict between the provisions of any document and the English language translation thereof, the terms of the English language translation shall control.
ARTICLE XVI
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ASSIGNMENT AND ACQUISITIONS
Section 16.01Assignment.
(a)Neither this Agreement nor any of the rights, interests or obligations hereunder shall be assigned by either Party (and, for these purposes, a merger, sale of assets, operation of law or other transaction shall be deemed an assignment) without the prior written consent of the other Party.  Notwithstanding the foregoing, either Party may, without the other Party’s written consent, assign this Agreement and its rights and obligations hereunder in whole or in part to (i) an Affiliate of such Party or (ii) a Third Party that acquires, by or otherwise in connection with, a merger, sale of assets or otherwise, all or substantially all of the business of such Party to which the subject matter of this Agreement relates; provided that the assignee agrees in writing to assume all of such Party’s obligations under this Agreement. The assigning Party will remain responsible for the performance by its assignee of this Agreement or any obligations hereunder so assigned.
(b)The terms of this Agreement will be binding upon and will inure to the benefit of the successors, heirs, administrators and permitted assigns of the Parties.  Any purported assignment in violation of this Section 16.01 will be null and void ab initio.
Section 16.02Acquisitions.  Each Party agrees that, in the event that a Party (the “Acquired Party”) is acquired through a Change in Control by one or more persons or entities (collectively, the “Acquirer”), the Acquired Party shall be deemed not to “Control” for purposes of this Agreement, and the non-Acquired Party shall not obtain any rights or access under this Agreement to, any Know-How or Patent Rights owned by or licensed to such Acquirer, or any of such Acquirer’s Affiliates that were not Affiliates of the Acquired Party immediately prior to the consummation of such Change in Control (“Existing Acquirer Affiliates”), that were not already within Ocular Technology (if the Acquired Party is Ocular) or Licensee Technology (if the Acquired Party is Licensee) immediately prior to the consummation of such Change in Control.  Each Party shall notify the other Party promptly after any Change in Control of such Party.

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ARTICLE XVII
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MISCELLANEOUS
Section 17.01Force Majeure.  Subject to the terms of each In-License Agreement, If either Party shall be delayed, interrupted in or prevented from the performance of any obligation hereunder by reason of force majeure, which may include any act of God, fire, flood, earthquake, war (declared or undeclared), public disaster, act of terrorism, government action, strike or labor differences, in each case outside of such Party’s reasonable control, such Party shall not be liable to the other therefor, and the time for performance of such obligation shall be extended for a period equal to the duration of the force majeure event which occasioned the delay, interruption or prevention.  The Party invoking the force majeure rights of this Section 17.01 must notify the other Party by courier or overnight dispatch (e.g., Federal Express) within a period of [**] after both the first and last day of the force majeure event unless the force majeure event renders such notification impossible, in which case notification will be made as soon as possible.  If the delay resulting from the force majeure event exceeds [**], the other Party may terminate this Agreement immediately upon written notice to the Party invoking the force majeure rights of this Section 17.01.
Section 17.02Entire Agreement.  This Agreement, together with the exhibits and schedules attached hereto, constitutes the entire agreement between Ocular or any of its Affiliates, on the one hand, and Licensee or any of its Affiliates, on the other hand, with respect to the subject matter hereof, supersedes all prior understandings and writings between Ocular or any of its Affiliates, on the one hand, and Licensee or any of its Affiliates, on the other hand relating to such subject matter, including the Confidentiality Agreement, and, subject to Section 12.01, shall not be modified, amended or terminated, except by another agreement in writing executed by the Parties.
Section 17.03Severability.  If, under applicable Law, any provision of this Agreement is invalid or unenforceable, or otherwise directly or indirectly affects the validity of any other material provision of this Agreement (such invalid or unenforceable provision, a “Severed Clause”), it is mutually agreed that this Agreement shall endure except for the Severed Clause.  The Parties shall consult one another and use their reasonable efforts to agree upon a valid and enforceable provision that is a reasonable substitute for the Severed Clause in view of the intent of this Agreement.
Section 17.04Notices.  Any notice required or permitted to be given under this Agreement shall be in writing and shall be mailed by internationally recognized express delivery service, or sent by facsimile and confirmed by mailing, as follows (or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith):
If to Ocular:
General Counsel

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Ocular Therapeutix
24 Crosby Drive
Bedford, MA 01730
Attention:  General Counsel
Facsimile:  +1-781-275-7562
With a copy to (which shall not constitute notice for purposes of this Agreement):
WilmerHale LLP
60 State Street
Boston, Massachusetts 02109
Attention:  Steven D. Barrett, Esq.
Facsimile:  (617) 526-5000
If to Licensee:
Affamed Therapeutics Limited
Room 3306-3307
Two Exchange Square
8 Connaught
Hong Kong
With a copy to (which shall not constitute notice for purposes of this Agreement):
Cooley LLP
3175 Hanover Street
Palo Alto, California 94304-1130
Attn: Lila Hope, Esq.
Office: (650) 843-5735
Facsimile: (650) 849-7400
Any such notice shall be deemed to have been given (a) when delivered if personally delivered, (b) on receipt if sent by overnight courier or (c) on receipt if sent by mail.
Section 17.05Agency.  Neither Party is, nor will be deemed to be a partner, employee, agent or representative of the other Party for any purpose.  Each Party is an independent contractor of the other Party.  Neither Party shall have the authority to speak for, represent or obligate the other Party in any way without prior written authority from the other Party.
Section 17.06No Waiver.  Any omission or delay by either Party at any time to enforce any right or remedy reserved to it, or to require performance of any of the terms, covenants or provisions hereof, by the other Party, shall not constitute a waiver of such Party’s rights to the future enforcement of any of its rights under this Agreement.  Any waiver by a Party of a particular breach or default by the other Party shall not operate or be construed as a waiver of any subsequent breach or default by the other Party.

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Section 17.07Cumulative Remedies.  Except as may be expressly set forth herein, no remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law or in equity.
Section 17.08Third Party Beneficiary Rights.  This Agreement is not intended to and shall not be construed to give any Third Party any interest or rights (including any Third Party beneficiary rights) with respect to or in connection with any agreement or provision contained herein or contemplated hereby, other than (a) to the extent provided in Section 13.01, the Licensee Indemnitees and (b) to the extent provided in Section 13.02, the Ocular Indemnitees.
Section 17.09Performance by Affiliates, Sublicensees or Subcontractors.  To the extent that this Agreement imposes any obligation on any Licensee Entity, Licensee shall cause such Licensee Entity to perform such obligation.  Either Party may use one or more of its Affiliates to perform its obligations and duties hereunder; provided that such Party so notifies the other Party in writing and provided, further, that such Party shall remain liable hereunder for the prompt payment and performance of all of its obligations hereunder.
Section 17.10Counterparts.  This Agreement may be executed in counterparts, all of which taken together shall be regarded as one and the same instrument.
[Signature page follows]
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IN WITNESS WHEREOF, the Parties have executed this Agreement through their duly authorized representatives to be effective as of the Effective Date.
OCULAR THERAPEUTIX, INC.
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	By:
	/s/ Antony Mattessich
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	Name:
	Antony Mattessich
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	Title:
	President & Chief Executive Officer

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AFFAMED THERAPEUTICS LIMITED
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	​
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	By:
	/s/ Dr. Dayao Zhao
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	Name:
	Dr. Dayao Zhao
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	Title:
	Chief Executive Officer 

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