Document:

Exhibit 10.17

 

EMPLOYMENT AGREEMENT

 

THIS EMPLOYMENT AGREEMENT (the “Agreement”), dated as of December 16, 2016, is made and entered into by and between TELA Bio, Inc., a Delaware corporation (the “Company”), and E. Skott Greenhalgh, PhD. (the “Executive”).

 

WHEREAS, the Parties desire to continue the employment of Executive with the Company, on the terms and conditions set forth herein; and

 

WHEREAS, in connection with the execution and delivery of this Agreement, the Executive is also reaffirming the terms and conditions of, and his agreement with, the Confidential Information, Non-Competition and Assignment Agreement (as defined in Section 6) entered into by and between the Company and the Executive as of January 21, 2013 upon the commencement of the Executive’s employment with the Company.

 

NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein and intending to be bound hereby, the parties agree as follows:

 

1.                                      Duration of Agreement.  This Agreement is effective on the date set forth above and has no specific expiration date.  Unless terminated or amended in writing by the parties, this Agreement will govern the Executive’s continued employment by the Company until that employment ceases in accordance with Section 5 hereof.

 

2.                                      Position; Duties.  The Executive has been promoted from Vice President - Engineering to the position of the Company’s Chief Technology Officer, reporting directly to the Company’s Chief Executive Officer.  In such position, the Executive shall perform such duties and shall have such authority consistent with such position as may be assigned to him from time to time by the Company’s Board of Directors (the “Board”) and the Company’s Chief Executive Officer, including, but not limited to, the responsibility and authority for and having authority over the Product Research and Development and Manufacturing functions of the Company.  The Executive shall devote his best efforts and all of his business time and services to the Company and its Affiliates.  The Executive may, with the Consent of the Company’s Chief Executive Officer, engage in a limited number of other business activities related to his involvement in specific unrelated medical device development projects so long as those activities do not competitive with the Company’s development focus and as long as such activities do not interfere with his responsibilities with the Company, such interference to be determined solely by the Company’s Chief Executive Officer.  The Executive, may, without the consent of the Company’s Chief Executive Officer, the Executive may engage in charitable or public service, so long as such activities do not interfere with the Executive’s performance of his duties and obligations hereunder.

 

3.                                      Place of Performance.  The Executive may perform his services hereunder at, among other locations, the principal executive offices of the Company, the Executive’s home office and/or during business related travel.

 

 

4.                                      Compensation.

 

4.1                               Base Salary/Bonus Opportunity/Stock Options.  The Executive’s annual salary will be $250,000 (the “Base Salary”).  The Company shall pay the Base Salary, less such withholdings and deductions as required by applicable law, to the Executive in accordance with the Company’s usual payroll practices as in effect from time to time.  The Base Salary shall be reviewed on an annual basis by the Board and may adjusted from time to time by the Board; provided, however, that any decrease in the Base Salary shall be made only if the Company contemporaneously decreases the salaries of all senior executives and vice presidents of the Company and the Executive’s Base Salary is decreased by a percentage that is not greater than the percentage by which the salaries of such other senior executives and vice presidents are decreased.

 

You will retain the stock options previously awarded to you in the amount of 861,373 shares of the Company’s Common Stock, and they shall remain subject to the current Equity Compensation Plan.

 

4.2                               Employee Benefits.  The Executive will be eligible to participate in the employee benefit plans, policies or arrangements maintained by the Company for its senior executive employees generally, subject to the terms and conditions of such plans, policies or arrangements; provided, however, that this Agreement will not limit the Company’s ability to amend, modify or terminate such plans, policies or arrangements at any time for any reason.

 

4.3                               Paid Time Off.  Subject to the terms and conditions of the Company’s policy, as may be amended from time to time, the Executive will be eligible for four (4) weeks of paid time off each calendar year, four (4) floating holidays and five (5) paid sick leave days.

 

4.4                               Reimbursement of Expenses.  The Company will pay or reimburse the Executive for all reasonable business expenses incurred or paid by the Executive in the performance of his duties and responsibilities for the Company in accordance with the business expense reimbursement policies of the Company, as may be amended from time to time.

 

5.                                      Termination; Severance.  The Executive’s employment hereunder shall terminate (i) on the date not less than 30 days following written notice from the Company that Executive’s employment with the Company has been or will be terminated, (ii) on the date not less than 30 days following written notice from the Executive that he is resigning from the Company, (iii) on the date of his death or (iv) on the date of his Disability, as reasonably determined by the Company.  Upon cessation of his employment for any reason, unless otherwise consented to in writing by the Board, the Executive shall resign immediately from any and all officer, director and other positions he then holds with the Company and/or its Affiliates.  Upon any cessation of his employment with the Company, the Executive shall be entitled only to such compensation and benefits as described in this Section 5, with the understanding that the period between the date of the written notice and the date of actual termination will count towards the agreed upon period during which the executive will receive severance.

 

5.1                               Termination without Cause or upon Good Reason.  If the Executive’s employment by the Company ceases due to a termination by the Company without Cause (as

 

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defined below) or a termination by the Executive for Good Reason (as defined below), the Company shall:

 

5.1.1                      pay to the Executive (i) all accrued and unpaid Base Salary through the date of such cessation of employment at the time such Base Salary would otherwise be paid according to the Company’s usual payroll practices, and (ii) any bonus that the Company’s Compensation Committee has approved and has determined is payable to the Executive;

 

5.1.2                      pay to the Executive monthly severance payments equal to one- twelfth (1/12) of the Executive’s then current Base Salary for a period equal to nine (9) months (the “Severance Period”); and

 

5.1.3                      provide to the Executive a continuation of health, dental and vision insurance during the Severance Period and, to the extent that the continuation of such insurance coverage is not permitted under the Company’s insurance policies, then payment to the Executive of the monthly cost to obtain equivalent insurance coverage under the Consolidated Omnibus Budget Reconciliation Act (“COBRA”) or otherwise.

 

5.1.4                      Except as otherwise provided in this Section 5.1, all compensation and benefits will cease at the time of the Executive’s cessation of employment and the Company will have no further liability or obligation by reason of such cessation of employment.  The payments and benefits described in this Section 5.1 are in lieu of, and not in addition to, any other severance arrangement maintained by the Company.  Notwithstanding any provision of this Agreement, the payments described in Section 5.1.2 are conditioned on: (a) the Executive’s execution and delivery to the Company and the expiration of all applicable statutory revocation periods, by the 60lh day following the effective date of his cessation of employment, of a general release of claims against the Company and its Affiliates in form and substance satisfactory to the Company (the “Release”); (b) the Executive’s continued compliance with the provisions of the Confidential Information, Non-Competition and Assignment Agreement (as defined below); and (c) the Company being financially solvent at the time any such severance payment becomes due, and further provided that that the payment of any such severance amounts would not cause the Company to become insolvent.  For purposes of this Agreement, the Company shall be considered financially solvent if the Company’s then current assets exceed its then current liabilities and the Company is able to pay its debts as they become due.  Subject to Section 5.4 below, the benefits described in Section 5.1.2 and 5.1.3 will be paid as soon as administratively practicable after the Release becomes irrevocable, provided that if the 60 day period described above begins in one taxable year and ends in a second taxable year such payments or benefits shall not commence until the second taxable year.

 

5.2                               Other Terminations.  If the Executive’s employment with the Company ceases for any reason other than as described in Section 5.1 above (including but not limited to (a) termination by the Company for Cause, (b) resignation by the Executive without Good Reason, (c) termination as a result of the Executive’s Disability, or (d) the Executive’s death), then the Company’s obligation to the Executive will be limited solely to the payment of accrued and unpaid Base Salary and any bonus as described in Section 5.1.1 through the date of such cessation of employment.  All compensation and benefits will cease at the time of such cessation

 

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of employment and, except as otherwise provided by COBRA, the Company will have no further liability or obligation by reason of such termination.  The foregoing will not be construed to limit the Executive’s right to payment or reimbursement for claims incurred prior to the date of such termination under any insurance contract funding an employee benefit plan, policy or arrangement of the Company in accordance with the terms of such insurance contract.

 

5.3                               Compliance with Section 409A.  Notwithstanding anything to the contrary in this Agreement, no portion of the benefits or payments to be made under Section 5.1.2 hereof will be payable until the Executive has a “separation from service” from the Company within the meaning of Section 409A of the Code.  In addition, to the extent compliance with the requirements of Treas. Reg. § 1.409A-3(i)(2) (or any successor provision) is necessary to avoid the application of an additional tax under Section 409A of the Code to payments due to the Executive upon or following his “separation from service”, then notwithstanding any other provision of this Agreement (or any otherwise applicable plan, policy, agreement or arrangement), any such payments that are otherwise due within six months following the Executive’s “separation from service” (taking into account the preceding sentence of this paragraph) will be deferred without interest and paid to the Executive in a lump sum immediately following such six month period.  This paragraph should not be construed to prevent the application of Treas. Reg. § 1.409A-l(b)(9)(iii) (or any successor provision) to amounts payable hereunder.  For purposes of the application of Section 409A of the Code, each payment in a series of payments will be deemed a separate payment.

 

6.                                      Restrictive Covenants.  The Executive acknowledges and agrees to abide by the terms of, and agrees that his employment by the Company is contingent upon his compliance with the Confidential Information, Non-Competition and Assignment Agreement attached hereto as Exhibit A and which the Executive previously executed and delivered to the Company (the “Confidential Information, Non-Competition and Assignment Agreement”).  By execution and delivery of this Agreement, the Executive reaffirms his obligations under the Confidential Information, Non-Competition and Assignment Agreement.  The Executive acknowledges that the terms of the Confidential Information, Non-Competition and Assignment Agreement shall continue to remain in full-force and effect following the cessation of the Executive’s employment with the Company for any reason.

 

7.                                      Certain Definitions.  For purposes of this Agreement:

 

7.1                               “Affiliate” means, with respect to any specified Person, any other Person that directly or indirectly, through one or more intermediaries, Controls, is Controlled by, or is under common Control with, such specified Person, provided that, in any event, any business in which the Company has any direct ownership interest shall be treated as an Affiliate of the Company.

 

7.2                               “Cause” means (i) indictment, commission of, or the entry of a plea of guilty or no contest to, (A) a felony or (B) any crime (other than a felony) that causes the Company or its Affiliates public disgrace or disrepute, or adversely affects the Company’s or its Affiliates’ operations or financial performance or the relationship the Company has with its Affiliates, customers and suppliers; (ii) commission of an act of gross negligence, willful misconduct, fraud, embezzlement, theft or material dishonesty with respect to the Company or

 

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any of its Affiliates; (iii) a breach of the Executive’s fiduciary duty of loyalty to the Company or any of its Affiliates; (iv) alcohol abuse or use of controlled substances (other than prescription drugs taken in accordance with a physician’s prescription); (v) material breach of any agreement with the Company or any of its Affiliates, including this Agreement and the Confidential Information, Non-Competition and Assignment Agreement; (vi) a material breach of any Company policy regarding employment practices; or (vii) refusal to perform the lawful directives of the Board, if not cured within 30 days following receipt by the Executive from the Company of written notice thereof.

 

7.3                               “Change of Control” means (a) any sale, lease, exclusive license or other transfer of all or substantially all of the assets of the Corporation and its Subsidiaries taken as a whole by means of a single transaction or series of related transactions, except where such sale, lease, exclusive license or other transfer is to a wholly owned Subsidiary of the Corporation, or (b) any transaction or series of transactions involving the Corporation, or its securities, whether by consolidation, merger, purchase of shares of capital stock or other reorganization or combination or otherwise, in which the holders of the Corporation’s outstanding shares of capital stock immediately prior to such transaction or series of related transactions own, immediately after such transaction or series of related transactions, securities representing fifty percent (50%) or less of the voting power of the entity surviving such transaction or series of related transactions or the entity whose securities are issued pursuant to such transaction or series of related transactions.

 

7.4                               “Code” means the Internal Revenue Code of 1986, as amended.

 

7.5                               “Control” (including, with correlative meanings, the terms “Controlled by” and “under common Control with”), as used with respect to any Person, means the direct or indirect possession of the power to direct or cause the direction of the management or policies of such Person, whether through the ownership of voting securities, by contract or otherwise.

 

7.6                               “Disability” means a condition entitling the Executive to benefits under the Company’s long term disability plan, policy or arrangement; provided, however, that if no such plan, policy or arrangement is then maintained by the Company and applicable to the Executive, “Disability” will mean the Executive’s inability to perform the essential duties of his position due to a mental or physical condition (other than alcohol or substance abuse), with or without a reasonable accommodation.  Termination as a result of a Disability will not be construed as a termination by the Company “without Cause.”

 

7.7                               “Good Reason” means one or more of the following: (i) a material reduction in the Executive’s title, duties, authority or responsibilities, provided that a material reduction of the Executive’s title, duties, authority or responsibilities hereunder shall be deemed not to have occurred if, following a Change of Control, (A) if the Company remains a separate entity, Executive is the most senior executive directly responsible for the Research, Development and Manufacturing functions of the Company, or (B) if the Company does not remain a separate entity, Executive is the most senior executive directly responsible for the Research, Development and Manufacturing functions of the acquiring entity that are comprised of the former business of the Company; (ii) a material breach of this Agreement by the Company; or (iii) a material reduction in aggregate compensation paid by the Company to the Executive that is not in

 

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accordance with Section 4.1 and to which the Executive has not provided written consent.  The notice by the Executive of the condition constituting Good Reason under this Agreement shall be provided to the Company in writing within ninety (90) days of the initial existence of the condition constituting Good Reason and the Company shall then have thirty (30) days after receipt of such written notice to remedy the condition.

 

7.8                               “Person” means any individual, firm, corporation, partnership, limited liability company, trust, joint venture, association, governmental entity, unincorporated entity or other entity.

 

8.                                      Miscellaneous.

 

8.1                               Cooperation.  The Executive further agrees that, subject to reimbursement of his reasonable expenses, he will cooperate fully with the Company and its counsel with respect to any matter (including litigation, investigations, or governmental proceedings) in which the Executive was in any way involved during his employment with the Company.  The Executive shall render such cooperation in a timely manner on reasonable notice from the Company, so long as the Company exercises commercially reasonable efforts to schedule and limit its need for the Executive’s cooperation under this paragraph so as not to interfere with the Executive’s other personal and professional commitments.

 

8.2                               Section 409A.

 

8.2.1                      Notwithstanding anything herein to the contrary or otherwise, except to the extent any expense, reimbursement or in-kind benefit provided to the Executive does not constitute a “deferral of compensation” within the meaning of Section 409A of the Code, and its implementing regulations and guidance, (i) the amount of expenses eligible for reimbursement or in-kind benefits provided to the Executive during any calendar year will not affect the amount of expenses eligible for reimbursement or in-kind benefits provided to the Executive in any other calendar year, (ii) the reimbursements for expenses for which the Executive is entitled to be reimbursed shall be made on or before the last day of the calendar year following the calendar year in which the applicable expense is incurred and (iii) the right to payment or reimbursement or in-kind benefits hereunder may not be liquidated or exchanged for any other benefit.

 

8.2.2                      Anything to the contrary herein notwithstanding, all benefits or payments provided by the Company to the Executive that would be deemed to constitute “nonqualified deferred compensation” within the meaning of Section 409A of the Code are intended to comply with Section 409A of the Code.  Notwithstanding anything in this Agreement to the contrary, distributions may only be made under this Agreement upon an event and in a manner permitted by Section 409A of the Code or an applicable exemption.

 

8.3                               Section 280G.

 

8.3.1                      Notwithstanding any other provision of this Agreement, if any payment or benefit due under this Agreement, together with all other payments and benefits that the Executive receives or is entitled to receive from the Company or any of its subsidiaries, Affiliates or related entities, will constitute an “excess parachute payment” (as that term is

 

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defined in Section 280G(b)(l) of the Code and related regulations), such payments and benefits will be limited to the minimum extent necessary to ensure that no portion thereof will fail to be tax-deductible to the Company or its Affiliates by reason of Section 280G of the Code.  If a reduction to the payments or benefits otherwise payable under this Agreement is required pursuant to this Section 8.3, such reduction shall occur to the payments or benefits in the order that results in the greatest economic present value of all payments actually made to the Executive.

 

8.3.2                      Notwithstanding the foregoing and provided that no securities of the Company, any member of its affiliated group (within the meaning of Section 1504 of the Code) and any entity possessing a direct or indirect ownership interest in the Company which interest constitutes more than 1/3 of such entity’s gross fair market value (as described in Treasury Regulation Section 1.280G-1, Q&A 6) are then publicly traded, to the extent that any payments and/or benefits provided to the Executive from the Company or any of its subsidiaries, Affiliates or related entities, will constitute an “excess parachute payment” (as that term is defined in Section 280G(b)(l) of the Code and related regulations) without regard to the application of Section 8.3.1, the Company agrees to submit such payments and/or benefits for approval by the holders of more than 75% of the voting power of the outstanding equity securities of the Company in a manner intended to comply with Section 280G(b)(5)(B) of the Code and regulations thereunder.  The Executive acknowledges that to the extent any such payment and/or benefits are submitted to the Company’s equity holders for approval pursuant to the preceding sentence, the Company’s equity holders have no obligation to approve such payments and/or benefits (or portions thereof) and that if such approval is not timely obtained in a manner that satisfies Section 280G(b)(5)(B) of the Code and regulations thereunder, such payments or benefits (to the extent necessary to avoid the Company’s loss of deduction pursuant to Section 280G of the Code) will be reduced in accordance with Section 8.3.1 hereof.

 

8.4                               Other Agreements.  The Executive represents and warrants to the Company that there are no restrictions, agreements, including but not limited to confidentiality, non-compete, invention assignment, or consulting agreements, or understandings whatsoever to which he is a party that would prevent or make unlawful his execution of this Agreement, that would be inconsistent or in conflict with this Agreement or the Executive’s obligations hereunder, or that would otherwise prevent, limit or impair the performance by the Executive of his duties under this Agreement

 

8.5                               Successors and Assigns.  The Company may assign this Agreement to any Affiliate or to any successor to its assets and business by means of liquidation, dissolution, merger, sale of assets or otherwise.  Upon such assignment, the rights and obligations of the Company hereunder shall become the rights and obligations of such Affiliate or successor.  For avoidance of doubt, a termination of the Executive’s employment by the Company in connection with a permitted assignment of the Company’s rights and obligations under this Agreement is not a termination “without Cause” so long as the assignee offers employment to the Executive substantially on the terms herein specified (without regard to whether the Executive accepts employment with the assignee).  The rights and duties of the Executive hereunder are personal to Executive and may not be assigned by him.

 

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8.6                               Governing Law and Enforcement.  This Agreement will be governed by and construed in accordance with the laws of the Commonwealth of Pennsylvania, without regard to the principles of conflicts of laws.  Any legal proceeding arising out of or relating to this Agreement will be instituted in a state or federal court in the Commonwealth of Pennsylvania, and the Executive and the Company hereby consent to the personal and exclusive jurisdiction of such court(s) and hereby waive any objection(s) that they may have to personal jurisdiction, the laying of venue of any such proceeding and any claim or defense of inconvenient forum.

 

8.7                               Waivers.  The waiver by either party of any right hereunder or of any breach by the other party will not be deemed a waiver of any other right hereunder or of any other breach by the other party.  No waiver will be deemed to have occurred unless set forth in writing.  No waiver will constitute a continuing waiver unless specifically stated, and any waiver will operate only as to the specific term or condition waived.

 

8.8                               Severability.  Whenever possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law.  However, if any provision of this Agreement is held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability will not affect any other provision, and this Agreement will be reformed, construed and enforced as though the invalid, illegal or unenforceable provision had never been herein contained.

 

8.9                               Survival.  This Agreement will survive the cessation of the Executive’s employment to the extent necessary to fulfill the purposes and intent of this Agreement.

 

8.10                        Notices.  Any notice or communication required or permitted under this Agreement will be made in writing and (a) sent by reputable overnight courier, (b) mailed by overnight U.S. express mail, return receipt requested or (c) sent by telefax.  Any notice or communication to the Executive will be sent to the address contained in his personnel file.  Any notice or communication to the Company will be sent to the Company’s principal executive offices, to the attention of the Board.  Notwithstanding the foregoing, either party may change the address for notices or communications hereunder by providing written notice to the other in the manner specified in this paragraph.

 

8.11                        Withholding.  All payments (or transfers of property) to the Executive will be subject to tax withholding to the extent required by applicable law.

 

8.12                        Section Headings.  The headings of sections and paragraphs of this Agreement are inserted for convenience only and will not in any way affect the meaning or construction of any provision of this Agreement.

 

8.13                        Counterparts; Facsimile.  This Agreement may be executed in multiple counterparts (including by facsimile signature), each of which will be deemed to be an original, but all of which together will constitute but one and the same instrument.

 

8.14                        Entire Agreement; Amendments.  This Agreement, including Exhibit A, contains the entire agreement and understanding of the parties hereto relating to the subject matter hereof, and supersedes all prior discussions, agreements and understandings of every

 

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nature relating to that subject matter.  This Agreement may not be changed or modified, except by an agreement in writing signed by each of the parties hereto.  This Agreement supersedes the Original Agreement.

 

IN WITNESS WHEREOF, the Company has caused this Agreement to be executed by its duly authorized officer, and the Executive has executed this Agreement in each case on the date first above written.

 

 

	
 
    	
TELA Bio, Inc.
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
/s/ Antony Koblish
    
	
 
    	
 
    	
Name: Antony Koblish
    
	
 
    	
 
    	
Title: Chief Executive Officer
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
/s/ E. Skott Greenhalgh, PhD
    
	
 
    	
E. Skott Greenhalgh, PhD
    

 

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EXHIBIT A

 

Confidential Information, Non-Competition and Assignment Agreement

 

A-1

 

CONFIDENTIAL INFORMATION,

 

NON-COMPETITION AND ASSIGNMENT AGREEMENT

 

In consideration of my employment by TELA Bio, Inc. (the “Company”) and for other valuable consideration the sufficiency of which is hereby acknowledged, intending to be legally bound, I agree to the following:

 

1.                                      Definitions.

 

(a)                                 “Agreement” means this Confidential Information, Non-Competition and Assignment Agreement, as may be amended from time to time.

 

(b)                                 “Affiliate” means, with respect to any specified Person, any other Person that directly or indirectly, through one or more intermediaries, Controls, is Controlled by, or is under common Control with, such specified Person, provided that, in any event, any business in which the Company has any direct ownership interest shall be treated as an Affiliate of the Company.

 

(c)                                  “Business” means any medical technology company engaged in the field of soft tissue reconstruction through the application of animal or human derived extracellular matrices, synthetic meshes / sheets / gels, or other tissues, and located in the United States, Canada or Mexico, or elsewhere in the world where the Company does business or has license rights to do business, or has actively negotiated to acquire license rights to do business within the one year period immediately preceding the cessation of my employment with the Company or Company Group.

 

(d)                                 “Customer” shall mean those Persons for whom or which the Company Group performed services or to whom or which the Company Group sold, distributed or licensed its products during the twelve (12) months preceding the cessation of my employment with the Company for any reason, and any Persons who participated in conducting preclinical or clinical studies sponsored by the Company Group.

 

(e)                                  “Company Group” means, collectively and individually, the Company and each of its Affiliates.

 

(f)                                   “Control” (including, with correlative meanings, the terms “Controlled by” and “under common Control with”), as used with respect to any Person, means the direct or indirect possession of the power to direct or cause the direction of the management or policies of such Person, whether through the ownership of voting securities, by contract or otherwise.

 

(g)                                  “Person” means any individual, firm, corporation, partnership, limited liability company, trust, joint venture, association, governmental entity, unincorporated entity or other entity.

 

 

TELA Bio, Inc.

E. Skott Greenhalgh, Ph.D.

CONFIDENTIAL INFORMATION,

NON-COMPETITION AND ASSIGNMENT AGREEMENT

 

(h)                                 “Prospective Customer” shall mean Persons whose business was solicited by the Company Group at any time during the twelve (12) months preceding the date on which my employment with the Company Group ceases for any reason.

 

(i)                                     “Restricted Non-Compete Period” means the one (1) year period immediately following the cessation of my employment with the Company Group for any reason.

 

(j)                                    “Restricted Non-Solicit Period” means the one (1) year period immediately following the cessation of my employment with the Company Group for any reason.

 

2.                                      Confidential Information.

 

(a)                                 Company Information.  I agree that at all times during the time I am an employee, consultant, officer and/or director of the Company and at all times thereafter to hold in strictest confidence and not to use or disclose, except for the benefit of the Company Group, any Confidential Information of the Company Group.  After my service with the Company has terminated, regardless of the reason for the termination and regardless of whether terminated by the Company or me, I will not use, publish, divulge, communicate, share, provide access to or otherwise disclose any Confidential Information.  I understand that “Confidential Information” means any Company Group proprietary or confidential information, technical data, trade secrets or know-how, including, but not limited to, research, product plans and developments, prototypes, products, services, customer lists and customers, prospective customers and contacts, proposals, customer purchasing practices, prices and pricing methodology, cost information, terms and conditions of business relationships with customers, customer research and other needs, markets, software, developments, inventions, processes, formulas, technology, designs, drawings, engineering, distribution and sales methods and systems, sales and profit figures, finances, personnel information including, information regarding compensation, skills, training, promotions, and duties, as well as reports and other business information that I learn of, obtain, or that is disclosed to me relating to the Company Group at any time prior to or during the course of my service to the Company, either directly or indirectly, in writing, orally or by review or inspection of documents or other tangible property.  However, Confidential Information does not include any of the foregoing items which has been made generally available to the public and become publicly known through no wrongful act of mine or any other Person owing a duty of confidentiality to the Company Group.  Either during my service to the Company or after my service has terminated, regardless of the reason and regardless of whether terminated by the Company or me, in the event I receive a request or demand, orally, in writing, electronically or otherwise, for the disclosure or production of Confidential Information, I must notify immediately the Chairman of the Board of the Company by calling him/her at his/her Company telephone number.  Regardless of whether I am successful in reaching the Chairman of the Board of the Company by telephone, I also must notify him/her immediately in writing, via certified mail, at the Company’s corporate headquarters, or at such other telephone number and/or address as provided by the Company from time to time for such purpose.  A copy of the request or demand as well as all documents potentially responsive to the request or demand shall be included with the written notification.  I will wait a minimum often (10) days (or the maximum time permitted by such legal process, if less) after sending the letter before making a disclosure

 

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or production to give the Company Group time to determine whether the disclosure or production involves Confidential Information, in which event the Company Group may seek to prohibit and/or restrict the production and/or disclosure and/or to obtain a protective order with regard thereto.  If the request or demand is in conjunction with judicial, administrative, arbitration or other adversarial proceedings, copies of all correspondence regarding the request or demand shall be included with the information sent to the Company’s Chairman of the Board.

 

(b)                                 Former Employer Information.  I agree that I will not, while I am an employee, consultant, officer and/or director of the Company or the Company Group, improperly use or disclose any proprietary information or trade secrets of any former or concurrent employer or other Person, if any, with whom I have an agreement or duty to keep such information or secrets confidential, if any, and that I will not use, disclose or bring onto the premises of the Company any unpublished document or proprietary information belonging to any such employer or Person unless consented to in writing by such employer or Person.

 

(c)                                  Third Party Information.  I recognize that the Company Group has received and in the future will receive from third parties (including customers of the Company Group) their confidential or proprietary information subject to a duty on the Company Group’s part to maintain the confidentiality of such information and to use it only for certain limited purposes.  I agree to hold all such confidential or proprietary information in the strictest confidence and not to disclose it to any Person or to use it except as necessary in carrying out my work for the Company, consistent with the Company Group’s agreement with such third party.

 

3.                                      Inventions.

 

(a)                                 Inventions Retained and Licensed.  I have attached hereto, as Attachment A. a list describing all inventions, original works of authorship, developments, improvements, and trade secrets which were made by me prior to becoming an employee, consultant, officer and/or director of the Company (collectively referred to as “Prior Inventions”), which are owned by me alone or jointly with others, which relate to the Company Group’s business, proposed business, products or research and development, and which are not assigned to the Company Group hereunder; or, if no such list is attached, I represent that there are no such Prior Inventions.  If, in the course of my service with the Company, I incorporate into a Company Group product, process or machine a Prior Invention owned by me or in which I have an interest, the Company, or its designee, is hereby granted and shall have a nonexclusive, royalty-free, irrevocable, perpetual, worldwide, assignable, transferable, and sublicenseable license to make, have made, modify, use and sell such Prior Invention as part of or in connection with such product, process or machine.

 

(b)                                 Assignment of Inventions.  I agree that I will promptly make full written disclosure to the Company, will hold in trust for the sole right and benefit of the Company, and hereby assign to the Company, or its designee, all my right, title, and interest in and to any and all inventions, original works of authorship, developments, concepts, improvements or any trade secrets which relate in any manner to the Company Group’s business or proposed business, whether or not patentable or registrable under patent, copyright or similar laws, which I may

 

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solely or jointly conceive or develop or reduce to practice (or may have conceived or developed or reduced to practice) or cause (or may have caused) to be conceived or developed or reduced to practice, at any time prior to the date of this Agreement until I am no longer an employee, consultant, officer and/or director of the Company (collectively referred to as “Inventions”). including any and all intellectual property rights inherent in the Inventions and appurtenant thereto including, without limitation, all patent rights, copyrights, trademark rights and trade secret rights (collectively referred to as “Intellectual Property Rights”).  I further acknowledge that all original works of authorship which are made by me (solely or jointly with others) within the scope of my service or duties as an employee, consultant, officer and/or director and which are protectable by copyright are “works made for hire,” as that term is defined in the United States Copyright Act.

 

(c)                                  Maintenance of Records.  I agree to keep and maintain adequate and current records of all Inventions.  The records will be in the form of notes, sketches, drawings, and any other format that may be specified by the Company.  The records will be available to the Company at all times, and Company, or its designee, shall retain all right, title, and interest in and to the same.

 

(d)                                 Patent and Copyright Registrations.  I agree to assist the Company, or its designee, at the Company’s expense, in every proper way to secure the Company Group’s rights in the Inventions and any Intellectual Property Rights related thereto in any and all countries, including the disclosure to the Company of all pertinent information and data with respect thereto, the execution of all applications, specifications, oaths, assignments and all other instruments which the Company shall deem necessary in order to apply for and obtain such rights and in order to assign and convey to the Company, or its designee, the sole and exclusive right, title and interest in and to such Inventions and any Intellectual Property Rights relating thereto.  I further agree that my obligation to execute or cause to be executed, when it is in my power to do so, any such instrument or papers’ shall continue after the termination of this Agreement.  If the Company is unable because of my mental or physical incapacity or for any other reason to secure my signature to apply for or to pursue any application for any United States or foreign Intellectual Property Right covering Inventions assigned to the Company, or its designee, as above, then I hereby irrevocably designate and appoint the Company and its duly authorized officers and agents as my agent and attorney in fact, to act for and in my behalf and stead to execute and file any such applications and to do all other lawfully permitted acts to further the prosecution and issuance of letters patent, or copyright, trademark or other registrations thereon with the same legal force and effect as if executed by me.

 

(e)                                  Post-Employment Disclosure Obligations.  I shall also promptly disclose in writing to the Company all discoveries, developments, designs, ideas, improvements, inventions, formulas, processes, techniques, know-how, and data (whether or not patentable or registrable under copyright or similar statutes) that relate to business of the Company Group and that are made, conceived or reduced to practice by me (either alone or jointly with others) within twelve (12) months after termination of my employment.  I acknowledge and agree that all of the foregoing items that are based on the Company’s Confidential Information hereunder - or which were, in fact, made, conceived or reduced to practice during my employment by the Company

 

4

 

Group- shall constitute Inventions subject to assignment under this Section 3. My disclosure hereunder shall be narrowly tailored to comply with the restrictions of any commercially reasonable non-disclosure agreement signed by me that is meant to protect the trade secrets and confidentiality of a subsequent employer.

 

(f)                                   Exceptions to Assignment Obligations.   The Company and I agree that the assignment obligations under this Section 3 shall not apply to inventions, and I shall not be obligated to assign to the Company any Inventions, that were developed entirely on my own time without using the Company’s equipment, supplies, facilities or trade secret information, unless such inventions either: (i) relate directly to the Company Group’s Business or the Company’s actual or demonstrably anticipated research, or (ii) result from any work performed by me for the Company Group.  By signing this Agreement, I acknowledge that I have received written notice of these express exceptions from the assignment obligations hereunder.

 

4.                                      Non-Competition; Non-Solicitation.

 

(a)                                 Non-Solicitation.  During my service with the Company and for the Restricted Non-Solicit Period, I shall not, directly or indirectly, for my own benefit or for the benefit of any third party, in any capacity (as a principal, shareholder, partner, director, officer, agent, executive, consultant, contractor, employee, lender or otherwise):

 

(i)                                     induce, solicit, recruit or attempt to persuade any Person to terminate such Person’s employment or other relationship with the Company Group or not to establish an employment or other relationship with the Company Group, whether or not such Person is or would be an employee, consultant, contractor, officer and/or director, whether or not such relationship is or would be pursuant to a written or oral agreement and whether or not such relationship is for a specific period of time or is at-will;

 

(ii)                                  employ or establish a business relationship with (or attempt to employ or establish a business relationship with), or encourage or assist any Person to employ or establish a business relationship with, any individual who was an employee, consultant, contractor, officer or director of the Company Group during the twelve month period preceding the first day of the Restricted Non-Solicit Period;

 

(iii)                               (A) direct or engage in any act which may interfere with or adversely affect, alter or change the relationship (contractual or otherwise) of the Company Group with any Person that is a Customer, Prospective Customer, vendor, supplier or contractor of the Company Group, or (B) otherwise induce or attempt to induce any such Person to cease doing business, reduce or otherwise limit its business with the Company Group; or

 

(iv)                              solicit business from any Customer or Prospective Customer, or do business with any Customer or Prospective Customer of the Company Group, involving the Business.

 

5

 

(b)                                 Non-Competition.  During my service with the Company and for the Restricted Non-Compete Period, on the condition that the Company is not in breach of its obligation to make severance payments to me under the Employment Agreement with the Company, I shall not, directly or indirectly, for my own benefit or for the benefit of any third party, in any capacity (as a principal, shareholder, partner, director, officer, agent, executive, consultant, contractor, employee, lender or otherwise), engage or participate in, or be financially interested in, (i) any Person involved in the Business (as defined in Section 1(c) hereof) anywhere in the world, including but not limited to, those Persons set forth on Attachment B (provided, however, that nothing contained in this Section 4(b) shall prevent me from holding for passive investment of less than two percent (2%) of any class of equity securities of a company whose securities are publicly traded on a national securities exchange or in a national market system) or (ii) any business that uses or relies on any Confidential Information.

 

5.                                      Returning Company Documents and Property.  I agree that, upon termination of my service with Company, for any reason, I will deliver to the Company, or its designee, and will not keep in my possession or deliver to anyone else, any and all records, data, notes, reports, information, proposals, lists, correspondence, emails, specifications, drawings, blueprints, sketches, materials, other documents, or reproductions or copies (including but not limited to on computer discs or drives) of any aforementioned items either developed by me pursuant to my service with the Company or otherwise relating to the business of the Company Group, retaining neither copies nor excerpts thereof.  I also agree that, at such time, or earlier upon request, I will deliver to the Company Group, or its designee, all Company Group property in my possession, including cell phones, computers, computer discs, drives and other equipment or devices, and that if I fail to do so the Company may withhold from my compensation the replacement cost of Company Group property I have not returned.

 

6.                                      Relief.

 

(a)                                 I acknowledge and agree that (i) the covenants set forth in Sections 2, 3, 4 and 5. of this Agreement are reasonable and necessary in order to protect the legitimate interests of the Company Group and I am receiving adequate consideration hereunder; (ii) the Company Group will not have any adequate remedy at law if I violate the terms hereof or fail to perform any of my obligations under Sections 2, 3, 4 or 5 of this Agreement; and (iii) the Company Group shall have the right, in addition to any other rights it may have under applicable law, to obtain from any court of competent jurisdiction preliminary and permanent injunctive relief to restrain any breach or threatened breach of, or otherwise to specifically enforce any such covenant or any of the other obligations under Sections 2, 3, 4 or 5 of this Agreement (and I hereby waive any right to require any bond or security in connection therewith), as well as to obtain damages and an equitable accounting of all earnings, profits and other benefits arising from such violation, which rights shall be cumulative and in addition to any other rights or remedies to which the Company Group may be entitled.

 

(b)                                 If the period of time or scope of any restriction set forth in Sections 2, 3, 4 or 5of this Agreement should be adjudged unreasonable in any proceeding, then the period of time shall be reduced by such number of months or the scope of the restriction shall be modified, or both,

 

6

 

by a court of competent jurisdiction so that such restrictions may be enforceable for such time and in the manner to the fullest extent adjudged to be reasonable.  If I violate any of the restrictions contained in subparagraph (a) above, then the restrictive period shall not run in my favor from the time of the commencement of any such violation until such time as such violation shall be cured by me.

 

(c)                                  I acknowledge and agree that if I breach any of the provisions of this Agreement, the Company will have the right and remedy to require me to account for and pay over to the Company or its designee, all compensation, profits, monies, accruals, increments or other benefits I derive or receive as a result of such breach.  This right and remedy will be in addition to, and not in lieu of, any other rights and remedies available to the Company Group under law or in equity.

 

(d)                                 I acknowledge that I have the right to request a waiver from the Company with regard to any of the restrictions contained in Sections 2, 3, 4 or 5 of this Agreement by providing a written notice of such request to the Company’s Chief Executive Officer or Vice President and General Counsel.  Upon receipt of such written notice, the Company’s Chief Executive Officer or Vice President and General Counsel shall consider such request and make reasonable efforts to respond to Executive within 15 business days of such notice as to whether the Company, in its sole discretion, shall agree to waive any of such restrictions.  If the Company’s Chief Executive Officer or Vice President and General Counsel fails to respond to Executive’s written notice within such 15 business day period, such failure shall be deemed a denial of the request.

 

7.                                      Nondisparagement.  I acknowledge and agree that I will not, whether in writing or orally, malign, denigrate or disparage the Company Group or any of their respective predecessors or successors, or any of the current or former directors, officers, employees, shareholders, partners, members, agents or representatives of any of the foregoing, with respect to any of their respective past or present activities, or otherwise publish (whether in writing or orally) statements that tend to portray any of the aforementioned parties in an unfavorable light. Disclosure of information I am required to disclose pursuant to any applicable law, court order, subpoena, compulsory process of law or governmental decree shall not constitute a violation or breach of this Section 7; provided that I deliver written notice of such required disclosure to the Company or its designee promptly before making such disclosure if such notice is not prohibited by applicable law, court order, subpoena, compulsory process of law or governmental decree. Similarly, the directors and senior executives of the Company Group will not, and the Company shall use reasonable and good faith efforts to cause its other employees not to, whether in writing or orally, malign, denigrate or disparage me with respect to any of my past or present activities, or otherwise publish (whether in writing or orally) statements that tend to portray me in an unfavorable light.

 

8.                                      Relatives, Affiliates, Etc.  I acknowledge and agree that I will not hire or otherwise engage to provide products or services to the Company (as an employee, consultant, supplier, vendor, or otherwise) any Person that is my Affiliate or any Person that is my familial relative by marriage or by birth (including adoption) without disclosure to and the consent of the Company.

 

7

 

9.                                      General Provisions.

 

(a)                                 Governing Law and Forum.  This Agreement shall be governed by and interpreted in accordance with the laws of the Commonwealth of Pennsylvania, without giving effect to any conflict of laws provisions.  Any court action instituted by me or on my behalf relating in any way to this Agreement shall be filed exclusively in federal or state court, respectively in the Commonwealth of Pennsylvania, and I consent to the jurisdiction and venue of these courts in any action instituted by the Company against me.  I hereby waive, to the fullest extent permitted by applicable law, any right I may have to a trial by jury in respect of any suit, action or proceeding arising out of or relating to this Agreement.

 

(b)                                 Severability.  If any provision of this Agreement or application thereof to anyone or under any circumstances is adjudicated to be invalid or unenforceable by an arbitrator or court of competent jurisdiction, such invalidity or unenforceability shall not affect any other provision or application of this Agreement which can be given effect without the invalid or unenforceable provision or application and shall not invalidate or render unenforceable such provision or application in any other jurisdiction.

 

(c)                                  Successors and Assigns.  This Agreement will be binding upon my heirs, executors, administrators and other legal representatives and may be assigned by the Company and its successors to any Person, including, but not limited to, any successor or parent of the Company or any member of the Company Group.  The Company also may assign this Agreement in connection with any sale or merger (whether a sale or merger of stock or assets or otherwise) of the Company or the business of the Company.  I expressly consent to the assignment of the restrictions and requirements set form in this Agreement to any new owner of the Company’s business or purchaser of the Company.  I may not assign, pledge, or encumber my interest in this Agreement, or any part thereof, without the written consent of the Company.

 

(d)                                 Survival.  The obligations contained in this Agreement shall survive the termination of my employment or other relationship with the Company.

 

10.                               Disclosure of Agreement.  I agree to disclose the existence and terms of this Agreement to any employer or other service recipient that I may render services to or for during the 12 month period immediately following termination of my service with the Company.  I further acknowledge and agree that if I breach Sections 2, 3, 4 or 5 of this Agreement in any respect, the restrictions contained in those Sections will be extended for a period equal to the period that I was in breach.

 

11.                               Acknowledgement.  I acknowledge and agree that (a) I have had the opportunity to consult with independent counsel of my own choice concerning this Agreement and have been advised to do so by the Company, (b) I have read and understand the Agreement, am fully aware of its legal effect, and have entered into it freely based on my own judgment, (c) the duration and scope of this Agreement are reasonable and necessary to protect the Company Group’s customer relationships, trade secrets, proprietary information and other legitimate business interests, (d) the Company would not employ me or engage my services or otherwise compensate me unless I

 

8

 

agree to be bound by the provisions of this Agreement, and (e) I have not relied on any agreements or representations, express or implied, that are not set forth expressly in this Agreement.

 

12.                               Entire Agreement.  This Agreement sets forth the entire agreement and understanding between the Company and me with respect to the subject matter hereof, and merge and supersedes all prior agreements, understandings and/or discussions between us with regard to the matters addressed herein.  No modification of or amendment to this Agreement, nor any waiver of any rights under this agreement, will be effective unless in writing signed by the Company and me.  Any subsequent change or changes in the terms and conditions of my relationship with the Company, including, but not limited to, my duties or compensation, will not affect the validity or scope of this Agreement.

 

	
Date:
    	
1/21/13
    	
 
    	
/s/ E. Skott Greenhalgh, PhD
    
	
 
    	
 
    	
 
    	
By: E. Skott Greenhalgh, Ph.D.
    
	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    
	
Date:
    	
21 Jan 2013
    	
 
    	
/s/ Antony Koblish
    
	
 
    	
 
    	
 
    	
By: Antony Koblish
    
	
 
    	
 
    	
 
    	
President and Chief Executive Officer
    
	
 
    	
 
    	
 
    	
TELA Bio, Inc.
    

 

9

 

	
 
    	
 
    	
 
    	
NONE
    
	
 
    	
 
    	
 
    	
Skott Greenhalgh
    
	
 
    	
 
    	
 
    	
/s/ E. Skott Greenhalgh, PhD
    
	
 
    	
 
    	
 
    	
1/21/13
    

 

ATTACHMENT A — PRIOR INVENTIONS

 

	
Patent Number
    	
 
    	
Patent Title
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    

 

10

 

ATTACHMENT B - COMPETITORS

 

Kinetic Concepts Inc. (KCI)

Ethicon

Bard

Davol

 

11Exhibit 10.18

 

Execution version

 

 

CREDIT AGREEMENT

 

dated as of November 16, 2018

 

by and between

 

TELA BIO, INC.,

 

as the Borrower,

and

 

ORBIMED ROYALTY OPPORTUNITIES II, LP,

 

as the Lender

 

 

 

TABLE OF CONTENTS

 

	
 
    	
 
    	
Page
    
	
 
    	
 
    	
 
    
	
ARTICLE I   DEFINITIONS AND ACCOUNTING TERMS
    	
1
    
	
 
    	
 
    
	
SECTION 1.1
    	
Defined Terms
    	
1
    
	
SECTION 1.2
    	
Use of Defined Terms
    	
21
    
	
SECTION 1.3
    	
Cross-References
    	
21
    
	
SECTION 1.4
    	
Accounting and   Financial Determinations
    	
21
    
	
 
    	
 
    	
 
    
	
ARTICLE II   COMMITMENT AND BORROWING PROCEDURES
    	
21
    
	
 
    	
 
    
	
SECTION 2.1
    	
Commitment
    	
21
    
	
SECTION 2.2
    	
Borrowing Procedure
    	
21
    
	
SECTION 2.3
    	
Funding
    	
22
    
	
SECTION 2.4
    	
Reduction of the   Commitment Amounts
    	
22
    
	
 
    	
 
    	
 
    
	
ARTICLE III   REPAYMENTS, PREPAYMENTS, INTEREST AND FEES
    	
22
    
	
 
    	
 
    
	
SECTION 3.1
    	
Repayments and   Prepayments; Application
    	
22
    
	
SECTION 3.2
    	
Repayments and   Prepayments
    	
22
    
	
SECTION 3.3
    	
Application
    	
23
    
	
SECTION 3.4
    	
Interest Rate
    	
23
    
	
SECTION 3.5
    	
Default Rate
    	
23
    
	
SECTION 3.6
    	
Payment Dates
    	
23
    
	
SECTION 3.7
    	
Repayment Premium
    	
23
    
	
SECTION 3.8
    	
Exit Fee
    	
23
    
	
SECTION 3.9
    	
Administration Fee
    	
24
    
	
 
    	
 
    	
 
    
	
ARTICLE IV   LIBO RATE AND OTHER PROVISIONS
    	
24
    
	
 
    	
 
    
	
SECTION 4.1
    	
Increased Costs, Etc.
    	
24
    
	
SECTION 4.2
    	
Increased Capital Costs
    	
24
    
	
SECTION 4.3
    	
Taxes
    	
25
    
	
SECTION 4.4
    	
Payments, Computations;   Proceeds of Collateral, Etc.
    	
26
    
	
SECTION 4.5
    	
Setoff
    	
26
    
	
SECTION 4.6
    	
LIBO Rate Not   Determinable
    	
27
    
	
 
    	
 
    	
 
    
	
ARTICLE V   CONDITIONS TO MAKING THE LOANS
    	
27
    
	
 
    	
 
    
	
SECTION 5.1
    	
Credit Extensions
    	
27
    
	
SECTION 5.2
    	
Secretary’s Certificate,   Etc.
    	
28
    
	
SECTION 5.3
    	
Closing Date   Certificate
    	
28
    
	
SECTION 5.4
    	
Payment of Outstanding   Indebtedness, Etc.
    	
28
    
	
SECTION 5.5
    	
Delivery of Note
    	
29
    
	
SECTION 5.6
    	
Financial Information,   Etc.
    	
29
    
	
SECTION 5.7
    	
Compliance Certificate
    	
29
    
	
SECTION 5.8
    	
Solvency, Etc.
    	
29
    
	
SECTION 5.9
    	
Guarantee
    	
29
    

 

i

 

	
SECTION 5.10
    	
Security Agreements
    	
29
    
	
SECTION 5.11
    	
Intellectual Property   Security Agreements
    	
30
    
	
SECTION 5.12
    	
Opinions of Counsel
    	
31
    
	
SECTION 5.13
    	
Insurance
    	
31
    
	
SECTION 5.14
    	
Closing Fees, Expenses,   Etc.
    	
31
    
	
SECTION 5.15
    	
Anti-Terrorism Laws
    	
31
    
	
SECTION 5.16
    	
Satisfactory Legal Form
    	
31
    
	
SECTION 5.17
    	
Revenue Base
    	
31
    
	
SECTION 5.18
    	
Disclosure Schedules
    	
31
    
	
 
    	
 
    	
 
    
	
ARTICLE VI   REPRESENTATIONS AND WARRANTIES
    	
31
    
	
 
    	
 
    
	
SECTION 6.1
    	
Organization, Etc.
    	
31
    
	
SECTION 6.2
    	
Due Authorization,   Non-Contravention, Etc.
    	
32
    
	
SECTION 6.3
    	
Government Approval,   Regulation, Etc.
    	
32
    
	
SECTION 6.4
    	
Validity, Etc.
    	
32
    
	
SECTION 6.5
    	
Financial Information
    	
32
    
	
SECTION 6.6
    	
No Material Adverse   Change
    	
32
    
	
SECTION 6.7
    	
Litigation, Labor   Matters and Environmental Matters
    	
33
    
	
SECTION 6.8
    	
Subsidiaries
    	
33
    
	
SECTION 6.9
    	
Ownership of Properties
    	
33
    
	
SECTION 6.10
    	
Taxes
    	
33
    
	
SECTION 6.11
    	
Benefit Plans, Etc.
    	
34
    
	
SECTION 6.12
    	
Accuracy of Information
    	
34
    
	
SECTION 6.13
    	
Regulations U and X
    	
34
    
	
SECTION 6.14
    	
Solvency
    	
34
    
	
SECTION 6.15
    	
Intellectual Property
    	
35
    
	
SECTION 6.16
    	
Material Agreements and   Key Contracts
    	
36
    
	
SECTION 6.17
    	
Permits
    	
37
    
	
SECTION 6.18
    	
Regulatory Matters
    	
37
    
	
SECTION 6.19
    	
Transactions with   Affiliates
    	
40
    
	
SECTION 6.20
    	
Investment Company Act
    	
41
    
	
SECTION 6.21
    	
OFAC
    	
41
    
	
SECTION 6.22
    	
Deposit and   Disbursement Accounts
    	
41
    
	
SECTION 6.23
    	
LifeCell Payments
    	
41
    
	
 
    	
 
    	
 
    
	
ARTICLE VII   AFFIRMATIVE COVENANTS
    	
41
    
	
 
    	
 
    
	
SECTION 7.1
    	
Financial Information,   Reports, Notices, Etc.
    	
42
    
	
SECTION 7.2
    	
Maintenance of   Existence; Compliance with Contracts, Laws, Etc.
    	
45
    
	
SECTION 7.3
    	
Maintenance of   Properties
    	
45
    
	
SECTION 7.4
    	
Insurance
    	
45
    
	
SECTION 7.5
    	
Books and Records
    	
46
    
	
SECTION 7.6
    	
Environmental Law Covenant
    	
46
    
	
SECTION 7.7
    	
Use of Proceeds
    	
46
    
	
SECTION 7.8
    	
Future Guarantors,   Security, Etc.
    	
46
    
	
SECTION 7.9
    	
Obtaining of Permits,   Etc.
    	
47
    

 

ii

 

	
SECTION 7.10
    	
Permits
    	
47
    
	
SECTION 7.11
    	
Maintenance of   Regulatory Authorizations, Contracts, Intellectual Property, Etc.
    	
47
    
	
SECTION 7.12
    	
Inbound Licenses
    	
49
    
	
SECTION 7.13
    	
Cash Management
    	
49
    
	
SECTION 7.14
    	
LifeCell Payments
    	
50
    
	
 
    	
 
    	
 
    
	
ARTICLE VIII   NEGATIVE COVENANTS
    	
50
    
	
 
    	
 
    
	
SECTION 8.1
    	
Business Activities
    	
50
    
	
SECTION 8.2
    	
Indebtedness
    	
50
    
	
SECTION 8.3
    	
Liens
    	
51
    
	
SECTION 8.4
    	
Minimum Liquidity
    	
53
    
	
SECTION 8.5
    	
Investments
    	
53
    
	
SECTION 8.6
    	
Restricted Payments,   Etc.
    	
54
    
	
SECTION 8.7
    	
Consolidation, Merger;   Permitted Acquisitions, Etc.
    	
54
    
	
SECTION 8.8
    	
Permitted Dispositions
    	
55
    
	
SECTION 8.9
    	
Modification of Certain   Agreements
    	
55
    
	
SECTION 8.10
    	
Transactions with   Affiliates
    	
56
    
	
SECTION 8.11
    	
Restrictive Agreements,   Etc.
    	
56
    
	
SECTION 8.12
    	
Sale and Leaseback
    	
56
    
	
SECTION 8.13
    	
Product Agreements
    	
56
    
	
SECTION 8.14
    	
Change in Name,   Location or Executive Office or Executive Management; Change in Fiscal Year
    	
57
    
	
SECTION 8.15
    	
Benefit Plans and   Agreements
    	
57
    
	
 
    	
 
    	
 
    
	
ARTICLE IX   EVENTS OF DEFAULT
    	
57
    
	
 
    	
 
    
	
SECTION 9.1
    	
Listing of Events of   Default
    	
57
    
	
SECTION 9.2
    	
Action if Bankruptcy
    	
60
    
	
SECTION 9.3
    	
Action if Other Event   of Default
    	
61
    
	
 
    	
 
    	
 
    
	
ARTICLE X   MISCELLANEOUS PROVISIONS
    	
61
    
	
 
    	
 
    
	
SECTION 10.1
    	
Waivers, Amendments,   Etc.
    	
61
    
	
SECTION 10.2
    	
Notices; Time
    	
61
    
	
SECTION 10.3
    	
Payment of Costs and   Expenses
    	
61
    
	
SECTION 10.4
    	
Indemnification
    	
62
    
	
SECTION 10.5
    	
Survival
    	
62
    
	
SECTION 10.6
    	
Severability
    	
63
    
	
SECTION 10.7
    	
Headings
    	
63
    
	
SECTION 10.8
    	
Execution in   Counterparts, Effectiveness, Etc.
    	
63
    
	
SECTION 10.9
    	
Governing Law; Entire   Agreement
    	
63
    
	
SECTION 10.10
    	
Successors and Assigns
    	
63
    
	
SECTION 10.11
    	
Other Transactions
    	
63
    
	
SECTION 10.12
    	
Forum Selection and   Consent to Jurisdiction
    	
64
    
	
SECTION 10.13
    	
Waiver of Jury Trial
    	
64
    
	
SECTION 10.14
    	
Confidentiality
    	
65
    
	
SECTION 10.15
    	
Exceptions to   Confidentiality
    	
65
    

 

iii

 

	
SCHEDULES:
    	
 
    
	
 
    	
 
    
	
Schedule 6.5
    	
Financial Information
    
	
 
    	
 
    
	
Schedule 6.7(a)
    	
Litigation
    
	
 
    	
 
    
	
Schedule 6.8
    	
Existing Subsidiaries 
    
	
 
    	
 
    
	
Schedule 6.15(a)
    	
Intellectual Property
    
	
 
    	
 
    
	
Schedule 6.15(d)
    	
Breaches under Intellectual Property Licenses 
    
	
 
    	
 
    
	
Schedule 6.15(e)
    	
Infringement Notices
    
	
 
    	
 
    
	
Schedule 6.16(a)
    	
Material Agreements
    
	
 
    	
 
    
	
Schedule 6.18(b)
    	
Product Regulatory Compliance
    
	
 
    	
 
    
	
Schedule 6.19
    	
Transactions with Affiliates Schedule
    
	
 
    	
 
    
	
Schedule 6.22
    	
Deposit and Disbursement Accounts
    
	
 
    	
 
    
	
Schedule 7.2(b)
    	
Compliance with Contracts Schedule
    
	
 
    	
 
    
	
Schedule 7.7
    	
Use of Proceeds
    
	
 
    	
 
    
	
Schedule 8.2(b)
    	
Indebtedness to be Paid
    
	
 
    	
 
    
	
Schedule 8.2(c)
    	
Existing Indebtedness
    
	
 
    	
 
    
	
Schedule 8.3(c)
    	
Existing Liens
    
	
 
    	
 
    
	
Schedule 8.5(a)
    	
Investments
    
	
 
    	
 
    
	
Schedule 8.8
    	
Permitted Dispositions
    
	
 
    	
 
    
	
Schedule 8.9
    	
Modification of Certain Agreements
    
	
 
    	
 
    
	
Schedule 8.10
    	
Transactions with Affiliates Schedule
    
	
 
    	
 
    
	
Schedule 10.2
    	
Notice Information
    

 

	
EXHIBITS:
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Exhibit A
    	
-
    	
Form of Promissory Note
    
	
Exhibit B
    	
-
    	
Form of Loan Request
    
	
Exhibit C
    	
-
    	
Form of Compliance Certificate
    

 

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Exhibit D
    	
-
    	
Form of Guarantee
    
	
Exhibit E
    	
-
    	
Form of Security Agreement
    

 

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CREDIT AGREEMENT

 

THIS CREDIT AGREEMENT dated as of November 16, 2018 (as amended, supplemented or otherwise modified from time to time, this “Agreement”), is by and between TELA BIO, INC., a Delaware corporation (the “Borrower”) and ORBIMED ROYALTY OPPORTUNITIES II, LP, a Delaware limited partnership (together with its Affiliates, successors, transferees and assignees, the “Lender”). The Borrower and the Lender are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

 

W I T N E S S E T H:

 

WHEREAS, the Borrower has requested that the Lender provide a senior term loan facility to the Borrower in an aggregate principal amount of $35,000,000 (with $30,000,000 available on the Closing Date and $5,000,000 available on or prior to December 31, 2019, subject to the terms and conditions set forth herein); and

 

WHEREAS, the Lender is willing, on the terms and subject to the conditions hereinafter set forth, to extend the Commitment and make the Loans to the Borrower;

 

NOW, THEREFORE, the parties hereto agree as follows.

 

ARTICLE I

 

DEFINITIONS AND ACCOUNTING TERMS

 

SECTION 1.1 Defined Terms. The following terms (whether or not underscored) when used in this Agreement, including its preamble and recitals, shall, except where the context otherwise requires, have the following meanings (such meanings to be equally applicable to the singular and plural forms thereof):

 

“Affiliate” of any Person means any other Person which, directly or indirectly, Controls, is Controlled by or is under common Control with such Person. “Control” (and its correlatives) by any Person means (a) the power of such Person, directly or indirectly, (i) to vote 10% or more of the Voting Securities (determined on a fully diluted basis) of another Person or (ii) to direct or cause the direction of the management and policies of such other Person (whether by contract or otherwise), or (b) ownership by such Person of 10% or more of the Capital Securities of another Person.

 

“Agreement” is defined in the preamble. “Applicable Margin” means 7.75%.

 

“Aroa” means Aroa Biosurgery Limited, a privately held New Zealand company.

 

“Aroa Umbrella Agreement” means that certain Second Amended and Restated License, Product Development and Supply Umbrella Agreement, made as of July 16, 2015, by and between the Borrower and Aroa, as amended effective November 26, 2015.

 

 

“Authorized Officer” means, relative to the Borrower, its President and Chief Executive Officer and its Vice President of Finance and Treasurer, and relative to any of the Subsidiaries, its equivalent officers or managers (as applicable), in each case whose signatures and incumbency shall have been certified to the Lender pursuant to Section 5.2.

 

“Benefit Plan” means any employee benefit plan, as defined in section 3(3) of ERISA, that either: (a) is a “multiemployer plan,” as defined in section 3(37) of ERISA, (b) is subject to section 412 of the Code, section 302 of ERISA or Title IV of ERISA, or (c) provides welfare benefits to terminated employees, other than to the extent required by section 4980B(f) of the Code and the corresponding provisions of ERISA.

 

“Borrower” is defined in the preamble.

 

“Business Day” means any day which is neither a Saturday or Sunday nor a legal holiday on which banks are authorized or required to be closed in New York, New York.

 

“Capital Securities” means, with respect to any Person, all shares of, interests or participations in, or other equivalents in respect of (in each case however designated, whether voting or non-voting), of such Person’s capital stock, whether now outstanding or issued after the Closing Date.

 

“Capitalized Lease Liabilities” means, with respect to any Person, all monetary obligations of such Person and its Subsidiaries under any leasing or similar arrangement which have been (or, in accordance with GAAP, should be) classified as capitalized leases (or a finance lease upon adoption by such Person of ASU No. 2016-02, Leases (Topic 842)), and for purposes of each Loan Document the amount of such obligations shall be the capitalized amount thereof, determined in accordance with GAAP, and the stated maturity thereof shall be the date of the last payment of rent or any other amount due under such lease prior to the first date upon which such lease may be terminated by the lessee without payment of a premium or a penalty.

 

“Cash Equivalent Investment” means, at any time:

 

(a)                                any direct obligation of (or unconditionally guaranteed by) the United States (or any agency or political subdivision thereof, to the extent such obligations are supported by the full faith and credit of the United States) maturing not more than one year after such time;

 

(b)                                commercial paper or notes maturing not more than one year from the date of purchase, which is issued by a corporation (other than an Affiliate of the Borrower or any of its Subsidiaries) or any Government Sponsored Enterprise, in each case that is organized under the Laws of any state of the United States or of the District of Columbia and rated A-1 or higher by S&P or P-1 or higher by Moody’s, or A or higher by S&P or A2 or higher by Moody’s; or

 

(c)                                  any certificate of deposit, demand or time deposit or bankers acceptance, maturing not more than 180 days after its date of issuance, which is issued by or placed with any bank or trust company organized under the Laws of the United States (or any state thereof) and which has (i) a credit rating of A2 or higher

 

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from Moody’s or A or higher from S&P and (ii) a combined capital and surplus greater than $500,000,000; or

 

(d)                                 investments in money market mutual funds at least 95% of the assets of which are comprised of securities of the types described in clauses (a) through (c) of this definition.

 

“Casualty Event” means the damage, destruction or condemnation, as the case may be, of property of any Person or any of its Subsidiaries.

 

“cGCP” means the then current Good Clinical Practices that establish the national and international ethical and scientific quality standards for designing, conducting, recording and reporting clinical trials that are promulgated or endorsed for the United States by the FDA (including through ICH E6 and 21 CFR Parts 50, 54, 56 and 312) and for outside the United States by comparable Governmental Authorities.

 

“Change in Control” means and shall be deemed to have occurred if: (a) any “person” or “group” (within the meaning of Rule 13d-5 of the Exchange Act), other than OrbiMed Private Investments IV, LP and its Affiliates, shall acquire or own, directly or indirectly, beneficially or of record, determined on a fully diluted basis, more than 40% of the Voting Securities of the Borrower; (b) a majority of the seats (other than vacant seats) on the board of directors (or equivalent) of the Borrower shall at any time be occupied by persons who were not approved by a majority of the board of directors of the Borrower; or (c) the Borrower shall cease to directly own, beneficially and of record, 100% of the issued and outstanding Capital Securities of the Subsidiaries; provided that the occurrence of a Qualified IPO, in and of itself, shall not be deemed a Change in Control.

 

“Change in Law” means the occurrence, after the date of this Agreement, of any of the following: (a) the adoption or taking effect of any Law, rule, regulation or treaty; (b) any change in any Law, rule, regulation or treaty or in the administration, interpretation, implementation or application thereof by any Governmental Authority; or (c) the making or issuance of any request, rule, guideline or directive (whether or not having the force of law) by any Governmental Authority; provided that, notwithstanding anything herein to the contrary, (i) the Dodd-Frank Wall Street Reform and Consumer Protection Act and all requests, rules, guidelines or directives thereunder or issued in connection therewith and (ii) all requests, rules, guidelines or directives promulgated by the Bank for International Settlements, the Basel Committee on Banking Supervision (or any successor or similar authority) or the United States or foreign regulatory authorities, in each case pursuant to Basel III, shall in each case be deemed to be a “Change in Law,” regardless of the date enacted, adopted or issued.

 

“CLIA” means the Clinical Laboratory Improvement Amendments of 1988, as amended together with any rule, regulation, interpretation, guidance document, policy, judgment lawfully issued or promulgated thereunder by CMS (or any predecessor entity).

 

“Closing Date” means the date of the making of the Initial Loan hereunder, which in no event shall be later than November 16, 2018.

 

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“Closing Date Certificate” means a closing date certificate executed and delivered by an Authorized Officer of the Borrower in form and substance satisfactory to the Lender.

 

“CMS” means the U.S. Center for Medicare and Medicaid Services.

 

“Code” means the Internal Revenue Code of 1986, and the regulations thereunder, in each case as amended from time to time.

 

“Commitment” means the Lender’s obligation (if any) to make Loans hereunder. “Commitment Amount” means the Initial Commitment Amount plus the Delayed Draw  Commitment Amount.

 

“Compliance Certificate” means a certificate duly completed and executed by an Authorized Officer of the Borrower, substantially in the form of Exhibit C hereto, together with such changes thereto as the Lender may from time to time request for the purpose of monitoring the Borrower’s compliance with the financial covenants contained herein.

 

“Confidential Information” means any and all information or material (whether written or oral, or in electronic or other form) that, at any time before, on or after the Closing Date, has been or is provided or communicated to the Receiving Party by or on behalf of the Disclosing Party pursuant to this Agreement or in connection with the transactions contemplated hereby, and shall include the existence and terms of this Agreement.

 

“Contingent Liability” means any agreement, undertaking or arrangement by which any Person guarantees, endorses or otherwise becomes or is contingently liable upon (by direct or indirect agreement, contingent or otherwise, to provide funds for payment, to supply funds to, or otherwise to invest in, a debtor, or otherwise to assure a creditor against loss) the Indebtedness of any other Person (other than by endorsements of instruments in the course of collection), or guarantees the payment of dividends or other distributions upon the Capital Securities of any other Person. The amount of any Person’s obligation under any Contingent Liability shall (subject to any limitation set forth therein) be deemed to be the outstanding amount of the debt, obligation or other liability guaranteed thereby.

 

“Control” is defined within the definition of “Affiliate.” “Controlled Account” is defined in Section 7.13(a).

 

“Copyrights” means all copyrights, whether statutory or common law, and all exclusive and nonexclusive licenses from third parties or rights to use copyrights owned by such third parties, along with any and all (a) renewals, revisions, extensions, derivative works,  enhancements, modifications, updates and new releases thereof, (b) income, royalties, damages, claims and payments now and hereafter due and/or payable with respect thereto, including damages and payments for past, present or future Infringements thereof, (c) rights to sue for past, present and future Infringements thereof, and (d) foreign copyrights and any other rights corresponding thereto throughout the world.

 

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“Copyright Security Agreement” means any Copyright Security Agreement executed and delivered by the Borrower or any of the Subsidiaries in substantially the form of Exhibit C to the Security Agreement, as amended, supplemented, amended and restated or otherwise modified from time to time.

 

“Credit Agreement Termination Date” means the date on which all Obligations have been paid in full in cash and the Commitment shall have terminated.

 

“Default” means any Event of Default or any condition, occurrence or event which, after notice or lapse of time or both, would constitute an Event of Default.

 

“Delayed Draw Closing Date” means the date of the making of the Delayed Draw Loan hereunder, which in no event shall be later than December 31, 2019.

 

“Delayed Draw Commitment Amount” means $5,000,000.

 

“Delayed Draw Commitment Termination Date” means the earliest to occur of (a) the Delayed Draw Closing Date (immediately after the making of the Delayed Draw Loan on such date), (b) December 31, 2019, and (c) November 16, 2018, if the Initial Loan shall not have been made hereunder prior to such date.

 

“Delayed Draw Loan” is defined in Section 2.1.

 

“Designated Jurisdiction” means any country or territory to the extent that such country or territory is the subject of any Sanction.

 

“Device” means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is (a) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (b) intended to affect the structure or any function of the body of man or other animals; and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

 

“Disclosing Party” means the Party disclosing Confidential Information.

 

“Disposition” (or words of similar import such as “Dispose”) means any sale, transfer, lease, license, contribution or other conveyance (including by way of merger) of, or the granting of options, warrants or other rights to, any of the Borrower’s or the Subsidiaries’ assets (including accounts receivable and Capital Securities of Subsidiaries) to any other Person (other than to the Borrower or any of the Guarantors) in a single transaction or series of transactions.

 

“Disqualified Capital Securities” shall mean any Capital Securities that, by their terms (or by the terms of any security or other Capital Securities into which they are convertible or for which they are exchangeable) or upon the happening of any event or condition, (a) mature or are mandatorily redeemable (other than solely for Qualified Capital Securities), pursuant to a sinking fund obligation or otherwise (except as a result of a Change in Control or asset sale so long as

 

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any rights of the holders thereof upon the occurrence of a Change in Control or asset sale event shall be subject to the prior repayment in full of the Loans and all other Obligations that are accrued and payable and the termination of the Commitment), (b) are redeemable at the option of the holder thereof (other than solely for Qualified Capital Securities) (except as a result of a Change in Control or asset sale so long as any rights of the holders thereof upon the occurrence of a Change in Control or asset sale event shall be subject to the prior repayment in full of the Loans and all other Obligations that are accrued and payable and the termination of the Commitment), in whole or in part, (c) provide for the scheduled payment of dividends in cash or (d) are or become convertible into or exchangeable for Indebtedness or any other Capital Securities that would constitute Disqualified Capital Securities, in each case of clauses (a) through (d), prior to the date that is 181 days after the Maturity Date; provided that if such  Capital Securities are issued pursuant to a plan for the benefit of employees of the Borrower or any of its Subsidiaries, or by any such plan to such employees, such Capital Securities shall not constitute Disqualified Capital Securities solely because they may be required to be repurchased by the Borrower or its Subsidiaries in order to satisfy applicable statutory or regulatory obligations.

 

“Division/Series Transaction” means, with respect to any Person that is a limited liability company organized under the Laws of the State of Delaware, that any such Person (a) divides into two or more Persons (whether or not the original Person survives such division) or (b) creates, or reorganizes into, one or more series, in each case, as contemplated under the Laws of the State of Delaware.

 

“Endoform Development Agreement #1” means the Development Agreement between the Borrower and Aroa, dated as of July 16, 2015, as amended effective November 26, 2015.

 

“Environmental Laws” means all federal, state, local or international laws, statutes, rules, regulations, codes, directives, treaties, requirements, ordinances, orders, decrees, judgments, injunctions, notices or binding agreements issued, promulgated or entered into by any Governmental Authority, relating in any way to the environment, natural resources, Hazardous Material or health and safety matters.

 

“Environmental Liability” means any liability, loss, claim, suit, action, investigation, proceeding, damage, commitment or obligation, contingent or otherwise (including any liability for damages, costs of environmental remediation, fines, penalties or indemnities), of or affecting the Borrower or any Subsidiary directly or indirectly arising from, in connection with or based upon (a) any Environmental Law or Environmental Permit, (b) the generation, use, handling,  transportation, storage, treatment, recycling, presence, disposal, Release or threatened Release of, or exposure to, any Hazardous Materials, or (c) any contract, agreement, penalty, order, decree, settlement, injunction or other arrangement (including operation of Law) pursuant to which liability is assumed, entered into, inherited or imposed with respect to any of the foregoing.

 

“Environmental Permit” is defined in Section 6.7(c).

 

“ERISA” means the Employee Retirement Income Security Act of 1974, as amended from time to time.

 

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“ERISA Affiliate” means, as applied to any Person, (a) any corporation that is a member of a controlled group of corporations within the meaning of section 414(b) of the Code of which that Person is a member, (b) any trade or business (whether or not incorporated) that is a member of a group of trades or businesses under common control within the meaning of section 414(c) of the Code of which that Person is a member, or (c) any member of an affiliated service group within the meaning of section 414(m) or 414(o) of the Code of which that Person, any corporation described in clause (a) above or any trade or business described in clause (b) above is a member.

 

“Event of Default” is defined in Section 9.1.

 

“Exchange Act” means the Securities Exchange Act of 1934, as amended. “Excluded Accounts” is defined in Section 7.13(a).

 

“Excluded Foreign Subsidiary” means each Subsidiary of the Borrower that is neither (a) a Material Subsidiary nor (b) organized under the laws of the United States, a state, territory or jurisdiction thereof, or the District of Columbia.

 

“Exit Fee” is defined in Section 3.8.

 

“FATCA” means Sections 1471 through 1474 of the Code, as of the Closing Date (or any amended or successor version that is substantively comparable and not materially more onerous to comply with), any current or future regulations or official interpretations thereof and any agreements entered into pursuant to Section 1471(b)(1) of the Code.

 

“FDA” means the U.S. Food and Drug Administration and any successor entity.

 

“FD&C Act” means the U.S. Food, Drug, and Cosmetic Act (or any successor thereto), as amended from time to time, and the rules, regulations, guidelines, guidance documents and compliance policy guides issued or promulgated thereunder.

 

“Fiscal Quarter” means a quarter ending on the last day of March, June, September or December.

 

“Fiscal Year” means any period of twelve consecutive calendar months ending on December 31; references to a Fiscal Year with a number corresponding to any calendar year  (e.g., the “2017 Fiscal Year”) refer to the Fiscal Year ending on December 31 of such calendar year.

 

“Foreign Lender” means a Lender that is organized under the laws of a jurisdiction outside of the United States.

 

“F.R.S. Board” means the Board of Governors of the Federal Reserve System or any successor thereto.

 

“FTC Act” means the Federal Trade Commission Act, as amended.

 

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“GAAP” means generally accepted accounting principles in the United States.

 

“Government Sponsored Enterprise” means any private enterprise corporation chartered by the federal government of the United States to provide public financial services.

 

“Governmental Authority” means any national, supranational, federal, state, county, provincial, local, municipal, territorial or other government or political subdivision thereof, whether domestic or foreign, and any agency, authority, commission, ministry, instrumentality, regulatory body, court, tribunal, arbitrator, central bank or other Person exercising executive, legislative, judicial, taxing, regulatory or administrative powers or functions of or pertaining to any such government.

 

“Guarantee” means the guarantee executed and delivered by an Authorized Officer of each Material Subsidiary, substantially in the form of Exhibit D hereto, as amended, supplemented, amended and restated or otherwise modified from time to time.

 

“Guarantor” means any Person that signs a Guarantee, which shall include all Material Subsidiaries.

 

“Hazardous Material” means any material, substance, chemical, mixture or waste which is capable of damaging or causing harm to any living organism, the environment or natural resources, including all explosive, special, hazardous, polluting, toxic, industrial, dangerous, biohazardous, medical, infectious or radioactive substances, materials or wastes, noise, odor,  electricity or heat, and including petroleum or petroleum products, byproducts or distillates, asbestos or asbestos-containing materials, urea formaldehyde, polychlorinated biphenyls, radon gas, ozone-depleting substances, greenhouse gases, and all other substances or wastes of any nature regulated pursuant to any Environmental Law or as to which any Governmental Authority requires investigation, reporting or remedial action.

 

“Headcount” is defined in Section 7.1(a).

 

“Hedging Obligations” means, with respect to any Person, all liabilities of such Person under currency exchange agreements, interest rate swap agreements, interest rate cap agreements and interest rate collar agreements, and all other agreements or arrangements designed to protect such Person against fluctuations in interest rates or currency exchange rates.

 

“herein,” “hereof,” “hereto,” “hereunder” and similar terms contained in any Loan Document refer to such Loan Document as a whole and not to any particular Section, paragraph or provision of such Loan Document.

 

“IDE” mean an Investigational Device Exemption, as defined in the FD&C Act or any successor application or procedure filed with the FDA.

 

“Impermissible Qualification” means any qualification or exception to the opinion or certification of any independent public accountant as to any financial statement of the Borrower which (a) is of a “going concern” or similar nature other than any such qualification that is based solely on a determination that the Borrower may not have sufficient cash or other available resources to run the business, (b) relates to the limited scope of examination of matters relevant

 

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to such financial statement, or (c) relates to the treatment or classification of any item in such financial statement and which, as a condition to its removal, would require an adjustment to such item the effect of which would be to cause the Borrower to be in Default, but excluding any  emphasis of matter paragraph similar in all material respects to the emphasis of matter paragraph included by the Borrower’s independent public accountant in their opinion on the Borrower’s financial statements in respect of the Fiscal Year ended December 31, 2017.

 

“including” and “include” means including without limiting the generality of any description preceding such term, and, for purposes of each Loan Document, the Parties agree that the rule of ejusdem generis shall not be applicable to limit a general statement, which is followed by or referable to an enumeration of specific matters, to matters similar to the matters specifically mentioned.

 

“IND” means an Investigational Drug Application, as defined in the FD&C Act or any successor application or procedure filed with the FDA.

 

“Indebtedness” of any Person means:

 

(a)                                 all obligations of such Person for borrowed money or advances and all obligations of such Person evidenced by bonds, debentures, notes or similar instruments;

 

(b)                                 all obligations, contingent or otherwise, relative to the face amount of all letters of credit, whether or not drawn, and banker’s acceptances issued for the account of such Person;

 

(c)                                  all Capitalized Lease Liabilities of such Person and all obligations of such Person arising under Synthetic Leases;

 

(d)                                 net Hedging Obligations of such Person;

 

(e)                                  all obligations of such Person in respect of Disqualified Capital Securities;

 

(f)                                   whether or not so included as liabilities in accordance with GAAP, all obligations of such Person to pay the deferred purchase price of property or services (excluding trade accounts payable in the ordinary course of business which are not overdue for a period of more than 90 days or, if overdue for more than 90 days, as to which a dispute exists and adequate reserves in conformity with GAAP have been established on the books of such Person), and indebtedness secured by (or for which the holder of such indebtedness has an existing right, contingent or otherwise, to be secured by) a Lien on property owned or being acquired by such Person (including indebtedness arising under conditional sales or other title retention agreements), whether or not such indebtedness shall have been assumed by such Person or is limited in recourse; and

 

(g)                                  all Contingent Liabilities of such Person in respect of any of the foregoing.

 

The Indebtedness of any Person shall include the Indebtedness of any other Person (including any partnership in which such Person is a general partner) to the extent such Person is liable therefor as a result of such Person’s ownership interest in or other relationship with such Person,

 

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except to the extent the terms of such Indebtedness provide that such Person is not liable therefor.

 

“Indemnified Liabilities” is defined in Section 10.4. “Indemnified Parties” is defined in Section 10.4.

 

“Infringement” and “Infringes” mean the misappropriation or other violation of know- how, trade secrets, confidential information, or Intellectual Property.

 

“Initial Commitment Amount” means $30,000,000.

 

“Initial Commitment Termination Date” means the earliest to occur of (a) the Closing Date (immediately after the making of the Initial Loan on such date), and (b) November 16, 2018, if the Initial Loan shall not have been made hereunder prior to such date.

 

“Initial Loan” is defined in Section 2.1.

 

“Intellectual Property” means all: (a) Patents, all patent applications and invention disclosure documents of any type, registrations and renewals, reissues, reexaminations and patent rights in any lawful form thereof; (b) Trademarks; (c) Copyrights and other works of authorship (registered or unregistered), and all applications, registrations and renewals therefor; (d) Product Agreements; (e) computer software, databases, data and documentation; (f) trade secrets and confidential business information, whether patentable or unpatentable and whether or not  reduced to practice, know-how, inventions, manufacturing processes and techniques, research and development information, data and other information included in or supporting Regulatory Authorizations; (g) financial, marketing and business data, pricing and cost information, business, finance and marketing plans, customer and prospective customer lists and information, and supplier and prospective supplier lists and information; (h) other intellectual property or similar proprietary rights; (i) copies and tangible embodiments of any of the foregoing (in whatever form or medium); and (j) any and all improvements to any of the foregoing which is owned, assigned to or could by contract be owned or assigned to the Borrower, its Subsidiaries or their respective agents.

 

“Interest Period” means: (a) initially, the period beginning on (and including) the date on which the Initial Loan is made hereunder pursuant to Section 2.3 and ending on (and including) the last day of the calendar month in which the Loan was made; and (b) thereafter, the period beginning on (and including) the first day of each succeeding calendar month and ending on the earlier of (and including) (i) the last day of such calendar month and (ii) the Maturity Date.

 

“Investigational Application” means an application, including an application filed with a Regulatory Agency, for authorization to commence human clinical studies or distribute an investigational product, including (a) an IND, (b) an IDE, (c) an abbreviated IDE as specified in FDA regulations in 21 C.F.R. § 812.2(b), (d) any equivalent of a United States IND or IDE in other countries or regulatory jurisdictions, (e) all amendments, variations, extensions and renewals thereof that may be filed with respect to the foregoing and (f) all related documents and correspondence thereto, including documents and correspondence with Institutional Review Boards (IRBs).

 

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“Investment” means, relative to any Person, (a) any loan, advance or extension of credit made by such Person to any other Person, including the purchase by such Person of any bonds, notes, debentures or other debt securities of any other Person, (b) Contingent Liabilities in favor of any other Person, and (c) any Capital Securities held by such Person in any other Person. The amount of any Investment shall be the original principal or capital amount thereof less all returns of principal or equity thereon and shall, if made by the transfer or exchange of property other than cash, be deemed to have been made in an original principal or capital amount equal to the fair market value of such property at the time of such Investment.

 

“Key Contracts” means: (a) the Aroa Umbrella Agreement; (b) the Endoform Development Agreement #1; (c) the Development Agreement for Endoform® Contoured Reconstructive Template, effective as of September 21, 2017 (including its separate Product Exhibit no. 2 of even date), between the Borrower and Aroa, as amended effective June 1, 2018; (d) the Development Agreement for Endoform® Reconstructive Template Large, effective as of May 31, 2018, between the Borrower and Aroa; each of the foregoing in clauses (a) through (d) as amended, supplemented or otherwise modified from time to time; and (e) any other existing or future material contract, agreement, arrangement, obligation or undertaking, between the Borrower or any of the Subsidiaries, on one hand, and Aroa or any of its Affiliates, on the other hand.

 

“Key Permits” means all Permits relating to the Products, which Permits are material to the business of the Borrower and its Subsidiaries, taken as a whole.

 

“knowledge” of the Borrower means the actual knowledge of any officer of the Borrower or any Subsidiary.

 

“Laws” is defined in Section 6.18(a). “Lender” is defined in the preamble.

 

“LIBO Rate” means the one-month London Interbank Offered Rate for deposits in U.S. Dollars at approximately 11:00 a.m. (London, England time), quoted by the Lender from the appropriate Bloomberg or Telerate page selected by the Lender (or any successor thereto or similar source determined by the Lender from time to time), which shall be that one-month London Interbank Offered Rate for deposits in U.S. Dollars in effect two Business Days prior to the last Business Day of the relevant calendar month, adjusted for any reserve requirement and any subsequent costs arising from a change in governmental regulation, such rate to be rounded up to the nearest 1/16 of 1% and such rate to be reset quarterly as of the first Business Day of each calendar month; provided that if the LIBO Rate shall be less than 1.00%, such rate shall be deemed to be 1.00% for the purposes of this Agreement. If the Initial Loan is advanced other than on the first Business Day of a calendar month, the initial LIBO Rate shall be that one-month London Interbank Offered Rate for deposits in U.S. Dollars in effect two Business Days prior to the date of the Initial Loan, which rate shall be in effect until (and including) the last Business Day of the calendar month next ending. The Lender’s internal records of applicable interest rates shall be determinative in the absence of manifest error.

 

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“Lien” means any security interest, mortgage, pledge, hypothecation, assignment, deposit arrangement, encumbrance, lien (statutory or otherwise), charge against or interest in property, or other priority or preferential arrangement of any kind or nature whatsoever, to secure payment of a debt or performance of an obligation.

 

“LifeCell Agreement” means that certain Settlement and Release Agreement, made as of November 18, 2016, between LifeCell Corporation, the Borrower, Mr. Antony Koblish and Dr. Maarten Persenaire.

 

“Liquidity” means, at any time, an amount equal to the sum of unrestricted consolidated cash-on-hand and Cash Equivalent Investments of the Borrower, to the extent held in a Controlled Account located in the United States.

 

“Loan Documents” means, collectively, this Agreement, any Notes, the Security Agreement, each other agreement pursuant to which the Lender is granted a Lien to secure the Obligations (including any mortgages or other documents entered into pursuant to Section 7.8), the Guarantee, and each other agreement, certificate, document or instrument delivered in connection with any Loan Document, whether or not specifically mentioned herein or therein.

 

“Loan Request” means a Loan request and certificate duly executed by an Authorized Officer of the Borrower substantially in the form of Exhibit B hereto.

 

“Loans” means the Initial Loan and the Delayed Draw Loan.

 

“Material Adverse Effect” means a material adverse effect on (a) the business, condition (financial or otherwise), operations or properties of the Borrower or of the Borrower and the Subsidiaries taken as a whole, (b) the rights and remedies of the Lender under any Loan Document or (c) the ability of the Borrower or any Subsidiary to perform its material Obligations under any Loan Document.

 

“Material Agreements” means: (a) each contract or agreement to which the Borrower or any Subsidiary is a party involving aggregate payments of more than $250,000, whether such payments are being made by the Borrower or any Subsidiary to a non-Affiliated Person, or by a non-Affiliated Person to the Borrower or any Subsidiary; and (b) all other contracts or agreements, individually or in the aggregate, material to the business, operations, assets, prospects, conditions (financial or otherwise), performance or liabilities of the Borrower or any Subsidiary.

 

“Material Subsidiary” means each Subsidiary which: (a) is organized under the laws of the United States, any state thereof, or the District of Columbia; (b) holds right, title or interest in any Intellectual Property; (c) holds or maintains any material Regulatory Authorization, whether now in effect or hereafter issued by any Regulatory Agency, including any Key Permits received from the FDA and any CE mark; (d) conducts business operations other than commercial sales  (e) is party to any Material Agreement (other than leases of real property) other than any Material Agreement between such Subsidiary and the Borrower or another Subsidiary; (f) is party to any Key Contract; (g) has, together with its Subsidiaries, assets with a book value or fair market value exceeding $500,000 in the aggregate; provided that, if at any time the aggregate book value or the aggregate fair market value of the assets attributable to all Subsidiaries that are

 

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not Material Subsidiaries exceeds $1,000,000, the Borrower (or in the event the Borrower has failed to do so within five days, the Lender) shall designate sufficient Subsidiaries as “Material Subsidiaries” to eliminate such excess, and such designated Subsidiaries shall for all purposes of this Agreement constitute “Material Subsidiaries”; (h) has cash or and Cash Equivalent Investments exceeding $200,000 individually; provided that, if at any time the aggregate amount of cash and Cash Equivalent Investments attributable to all Subsidiaries that are not Material Subsidiaries exceeds $400,000, the Borrower (or in the event the Borrower has failed to do so within five days, the Lender) shall designate sufficient Subsidiaries as “Material Subsidiaries” to eliminate such excess, and such designated Subsidiaries shall for all purposes of this Agreement constitute “Material Subsidiaries”; or (i) as of the most recent Fiscal Quarter of the Borrower, for the period of four consecutive Fiscal Quarters then ended for which financial statements have been delivered pursuant to Section 7.1(b) or 7.1(c) (or, if prior to the date of the delivery of the first financial statements to be delivered pursuant to Section 7.1(b) or 7.1(c), the most recent  financial statements referred to in Section 5.6), contributed greater than 10% of the Revenue Base for such period; provided that, if at any time the aggregate portion of the Revenue Base attributable to all Subsidiaries that are not Material Subsidiaries exceeds 10% of the Revenue Base for any such period, the Borrower (or in the event the Borrower has failed to do so within five days, the Lender) shall designate sufficient Subsidiaries as “Material Subsidiaries” to eliminate such excess, and such designated Subsidiaries shall for all purposes of this Agreement constitute “Material Subsidiaries.”

 

“Maturity Date” means November 16, 2023.

 

“Moody’s” means Moody’s Investors Service, Inc., and any successor thereto.

 

“Net Asset Sales Proceeds” means, with respect to a Disposition (other than Dispositions of inventory permitted by Section 8.8(a)) after the Closing Date by the Borrower or any Subsidiary to any Person of any assets of the Borrower or its Subsidiaries, the excess of gross cash proceeds received by the Borrower or any Subsidiary from such Disposition over all reasonable and customary costs and expenses, and including Taxes payable by the recipient of such proceeds, incurred in connection with such Disposition which have not been paid to Affiliates of the Borrower in connection therewith.

 

“Net Casualty Proceeds” means, with respect to any Casualty Event, the amount of any insurance proceeds or condemnation awards received by the Borrower or any of the Subsidiaries in connection with such Casualty Event (other than proceeds that are used to repair or replace the assets subject to such Casualty Event within 180 days of receipt of such proceeds with respect to such Casualty Event with like or similar assets of substantially equal or better value and utility)  in excess of $500,000, individually or in the aggregate, through the Termination Date (in each case net of all reasonable and customary collection expenses thereof), but excluding any proceeds or awards required to be paid to a creditor (other than the Lender) which holds a first priority Lien permitted by Section 8.3(f) on the property which is the subject of such Casualty Event.

 

“Net Revenue” means net revenue from commercial sales of Products by the Borrower and its Subsidiaries, as determined in accordance with GAAP. Net Revenue shall be determined

 

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in a manner consistent with the methodologies, practices and procedures used in developing the Borrower’s audited financial statements.

 

“Non-Excluded Taxes” means any Taxes other than (a) Taxes imposed on or measured by a Person’s net income, and franchise Taxes with respect to the Lender imposed by any Governmental Authority under the Laws of which the Lender is organized or in which it maintains its applicable lending office, (b) branch profits Taxes imposed by the United States or any similar Tax imposed by any other jurisdiction described in clause (a) above, and (c) (i) any withholding Tax that is imposed by the United States on amounts payable to a Foreign Lender at the time such Foreign Lender first becomes a party to this Agreement (or designates a new lending office), except to the extent that such Foreign Lender (or its assignor, if any) was entitled, at the time of designation of a new lending office (or assignment), to receive additional amounts from the Borrower with respect to such withholding Tax pursuant to Section 4.3(a) or (ii) any U.S. federal withholding Taxes or other amounts imposed or payable under FATCA.

 

“Note” means a promissory note of the Borrower payable to the Lender, in the form of Exhibit A hereto (as such promissory note may be amended, endorsed or otherwise modified from time to time), evidencing the aggregate Indebtedness of the Borrower to the Lender resulting from the outstanding amount of the Loans, and also means all other promissory notes accepted from time to time in substitution therefor or renewal thereof.

 

“Obligations” means all obligations (monetary or otherwise, whether absolute or contingent, matured or unmatured) of the Borrower and each Subsidiary arising under or in connection with a Loan Document and the principal of and premium, if any, and interest (including interest accruing during the pendency of any proceeding of the type described in Section 9.1(h), whether or not allowed in such proceeding) on the Loans.

 

“OFAC” means the Office of Foreign Assets Control of the United States Department of the Treasury.

 

“Organic Document” means, relative to the Borrower or any Subsidiary, its certificate of incorporation, by-laws, certificate of partnership, partnership agreement, certificate of formation, limited liability agreement, operating agreement and all shareholder agreements, voting trusts and similar arrangements applicable to the Borrower’s or any Subsidiary’s Capital Securities.

 

“Other Administrative Proceeding” means any administrative proceeding relating to a dispute involving a patent office or other relevant intellectual property registry which relates to validity, opposition, revocation, ownership or enforceability of the relevant Intellectual Property.

 

“Other Taxes” means any and all stamp, documentary or similar Taxes, or any other excise or property Taxes or similar levies that arise on account of any payment made or required to be made under any Loan Document or from the execution, delivery, registration, recording or enforcement of any Loan Document (excluding, for the avoidance of doubt, Taxes described in clauses (a), (b) or (c) of the definition of Non-Excluded Taxes).

 

“OviTex” means the surgical mesh implant product manufactured, distributed, offered for sale or sold under the OviTex brand or any successor product integrating biologic materials derived from ovine rumen with synthetic materials in an embroidered construction, as a surgical

 

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mesh to reinforce and/or repair soft tissue where weakness exists, which indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.

 

“Party” and “Parties” have the meanings set forth in the preamble.

 

“Patent” means any patent, any type of patent application or invention disclosure, including all divisions, continuations, continuations in-part, provisionals, continued prosecution applications, substitutions, reissues, reexaminations, inter partes review, post-grant review by or any other type of proceeding involving patents and patent applications before any patent office or other Governmental Authority, renewals, extensions, adjustments, restorations, supplemental protection certificates and patent rights in any form and other additions in connection therewith, whether in or related to the United States or any foreign country or other jurisdiction.

 

“Patent Security Agreement” means any Patent Security Agreement executed and delivered by the Borrower or any of the Subsidiaries in substantially the form of Exhibit A to the Security Agreement, as amended, supplemented, amended and restated or otherwise modified from time to time.

 

“Permits” means all permits, licenses, registrations, certificates, orders, approvals, clearances, authorizations, consents, waivers, franchises, variances and similar rights issued by or obtained from any Governmental Authority or any other Person, including those relating to Environmental Laws and Regulatory Authorizations.

 

“Permitted Acquisition” means the purchase or other acquisition of all of the Capital Securities (other than qualifying directors shares) in, or all or substantially all of the property of, or all or substantially all of any business or division of, any Person (other than any joint venture owned by another Person that is purchased or acquired) that, upon the consummation thereof, will be wholly owned directly by the Borrower or one or more of its wholly owned Subsidiaries (including as a result of a merger or consolidation); provided that, with respect to each Permitted Acquisition:

 

(a)           any such newly-created or acquired Subsidiary shall comply with the requirements of Section 7.8 and the Lender shall have received (or shall receive in connection with the closing of such acquisition) a first priority perfected security interest, subject only to Liens permitted under Section 8.3, in the property (including equity interests) acquired with respect to the entity acquired;

 

(b)                                 the lines of business of the Person to be (or the property of which is to be) so purchased or otherwise acquired shall be permitted pursuant to Section 8.1;

 

(c)                                  in the case of a purchase or other acquisition of the Capital Securities of another Person, the board of directors (or other comparable governing body) and, if required under applicable Law, the stockholders or equity holders, of such other Person shall have duly approved such purchase or other acquisition;

 

(d)                                 the total cash and non-cash consideration paid by or on behalf of the Borrower and its Subsidiaries for any such purchase or other acquisition, when

 

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aggregated with the consideration paid by or on behalf of the Borrower and its Subsidiaries for all other Permitted Acquisitions after the Closing Date shall not exceed the aggregate amount of $500,000 in any Fiscal Year and an aggregate cumulative amount of $1,000,000;

 

(e)                                  immediately before and after giving effect to any such purchase or other acquisition, no Default or Event of Default, shall exist or result therefrom; and

 

(f)                                   the Borrower shall have delivered to the Lender, at least 10 Business Days prior to the date on which any such purchase or other acquisition is to be consummated, a written notice describing such transaction, and thereafter, if requested by the Lender for any such transaction involving consideration in excess of $250,000, (i) historical financial statements of or related to the Person or assets to be acquired, (ii) twelve month projections for such Person or assets to be acquired and for the Borrower after giving effect to such transaction, and (iii) material documentation and other information relating to such transaction and reasonably requested by the Lender.

 

“Permitted Subordinated Indebtedness” means Indebtedness incurred after the Closing Date by the Borrower or the Subsidiaries that is (a) subordinated to the Obligations and all other Indebtedness owing from the Borrower or the Subsidiaries to the Lender pursuant to a written subordination agreement satisfactory to the Lender in its sole discretion and (b) in an amount and on terms approved by the Lender in its sole discretion.

 

“Person” means any natural person, corporation, limited liability company, partnership, joint venture, association, trust or unincorporated organization, Governmental Authority or any other legal entity, whether acting in an individual, fiduciary or other capacity.

 

“Prime Rate” means (a) the rate of interest last quoted by The Wall Street Journal as the “Prime Rate” in the U.S. or, if The Wall Street Journal ceases to quote such rate, the per annum interest rate published by the F.R.S. Board in Federal Reserve Statistical Release H.15 (519)  (Selected Interest Rates) as the “bank prime loan” rate or, if such rate is no longer quoted therein, any similar rate quoted therein (as determined by the Lender) or any similar release by the F.R.S. Board (as determined by the Lender) minus (b) 1.00%; provided that if the Prime Rate shall be less than 1.00%, such rate shall be deemed to be 1.00% for the purposes of this Agreement.

 

“Privacy Laws” means all applicable security and privacy standards regarding protected health information under (a) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder and (b) any applicable state privacy Laws.

 

“Product” means (a) OviTex, (b) Restella and (c) any current or future service or product (including software products and services) researched, designed, developed, manufactured, licensed, marketed, sold, performed, distributed or otherwise commercialized by the Borrower or any of its Subsidiaries, including any such product in development or which may be developed.

 

“Product Agreement” means each agreement, license, document, instrument, interest (equity or otherwise) or the like under which one or more parties grants or receives any right, title or interest with respect to any Product Development and Commercialization Activities in

 

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respect of one or more Products specified therein or to exclude third parties from engaging in, or otherwise restricting any right, title or interest as to any Product Development and Commercialization Activities with respect thereto, including each contract or agreement with suppliers, manufacturers, distributors, clinical research organizations, hospitals, group purchasing organizations, wholesalers, pharmacies or any other Person related to any such entity.

 

“Product Development and Commercialization Activities” means, with respect to any Product, any combination of research, development, manufacture, import, use, sale, importation, storage, labeling, marketing, promotion, supply, distribution, testing, packaging, purchasing or other commercialization activities, receipt of payment in respect of any of the foregoing, or like activities the purpose of which is to commercially exploit such Product.

 

“Publicly Reporting Company” means an issuer generally subject to the public reporting requirements of the Exchange Act.

 

“Purchase Money Indebtedness” means Indebtedness: (a) consisting of the deferred purchase price for equipment incurred in connection with the acquisition of such equipment, where the amount of such Indebtedness does not exceed the greater of (i) the cost of the equipment being financed and (ii) the fair market value of such equipment; and (b) incurred to finance such acquisition by the Borrower or a Subsidiary of such equipment.

 

“QSR” means quality systems regulation requirements related to the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management for the manufacturing of medical devices, as set forth in 21 CFR Part 820.

 

“Qualified Capital Securities” shall mean any Capital Securities that are not Disqualified Capital Securities.

 

“Qualified IPO” means an underwritten initial public offering of the Capital Securities of the Borrower which generates cash proceeds of at least $25,000,000 and results in a listing of the Borrower’s Capital Securities on a public securities exchange.

 

“Receiving Party” means the Party receiving Confidential Information. “Recipients” is defined in Section 10.14.

 

“Regulatory Agencies” means any Governmental Authority that is concerned with the use, control, safety, efficacy, reliability, manufacturing, testing, marketing, distribution, sale or other Product Development and Commercialization Activities relating to any Product of the Borrower or any of the Subsidiaries, including CMS, FDA, and all similar agencies in other jurisdictions, and includes Standard Bodies.

 

“Regulatory Authorizations” means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, listings, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies necessary for the testing, manufacture, development, distribution, use, storage, import, export, transport, promotion, marketing, sale or other commercialization of any Product in any country or jurisdiction,

 

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including any Investigational Application, IDE, premarket approval application (PMA), premarket notification submission (510(k)), and humanitarian device exemption (HDE).

 

“Related Parties” means the stockholders, members, partners, directors, officers, employees, agents, trustees, administrators, managers, advisors and representatives of the Borrower and the Subsidiaries.

 

“Release” means any releasing, disposing, discharging, injecting, spilling, leaking, leaching, pumping, pouring, dumping, depositing, emitting, escaping, emptying, seeping, dispersal, migrating or placing, including movement through, into or upon the environment or any natural or man-made structure.

 

“Repayment Premium” means a premium of:

 

(a)                                 ten percent (10.00%) of the principal amount of any prepayment or repayment of the Borrower on the applicable Loan, if such prepayment or repayment is made or required to be made (i) with respect to the Initial Loan, on or prior to the second anniversary of the Closing Date and (ii) with respect to the Delayed Draw Loan, on or prior to the second anniversary of the Delayed Draw Closing Date;

 

(b)                                 five percent (5.00%) of the principal amount of any prepayment or repayment of the Borrower on the applicable Loan, if such prepayment or repayment is not required to be made prior to, and is made or required to be made after (i) with respect to the Initial Loan, the second anniversary of the Closing Date, but on or prior to the third anniversary of the Closing Date and (ii) with respect to the Delayed Draw Loan, the second anniversary of the Delayed Draw Closing Date, but on or prior to the third anniversary of the Delayed Draw Closing Date;

 

(c)                                  two and one-half percent (2.50%) of the principal amount of any prepayment or repayment of the Borrower on the applicable Loan, if such prepayment or repayment is not required to be made prior to, and is made or required to be made after (i) with respect to the Initial Loan, the third anniversary of the Closing Date, but on or prior to the fourth anniversary of the Closing Date and (ii) with respect to the Delayed Draw Loan, the third anniversary of the Delayed Draw Closing Date, but on or prior to the fourth anniversary of the Delayed Draw Closing Date; or

 

(d)                                 zero percent (0%) of the principal amount of any prepayment or repayment of the Borrower on the applicable Loan, if such prepayment or repayment is not required to be made on or prior to, and is made or required to be made after (i) with respect to the Initial Loan, the fourth anniversary of the Closing Date and (ii) with respect to the Delayed Draw Loan, the fourth anniversary of the Delayed Draw Closing Date.

 

“Restella” means the surgical mesh implant product manufactured, distributed, offered for sale or sold under the Restella brand or any successor product integrating biologic materials derived from ovine rumen with synthetic materials in an embroidered construction, for use in plastic and breast reconstruction procedures requiring improved permeability and controlled stretch while allowing for expansion where needed.

 

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“Restricted Payment” means (a) the declaration or payment of any dividend on, or the making of any payment or distribution on account of, or setting apart assets for a sinking or other analogous fund for the purchase, redemption, defeasance, retirement or other acquisition of, any class of Capital Securities of the Borrower or any Subsidiary or any warrants, options or other right or obligation to purchase or acquire any such Capital Securities, whether now or hereafter outstanding, or (b) the making of any other distribution in respect of such Capital Securities, in each case either directly or indirectly, whether in cash, property or obligations of the Borrower or any Subsidiary or otherwise.

 

“Revenue Base” means, with respect to any period, the Net Revenues of all Products for such period.

 

“S&P” means Standard & Poor’s Financial Services LLC, a division of The McGraw- Hill Companies, Inc., and any successor thereto.

 

“Sanctions” means any international economic sanction administered or enforced by the United States government (including OFAC), the United Nations Security Council, the European Union, Her Majesty’s Treasury or other relevant sanctions authority.

 

“SEC” means the U.S. Securities and Exchange Commission.

 

“Security Agreement” means the Pledge and Security Agreement executed and delivered by each of the parties thereto, substantially in the form of Exhibit E hereto, as amended, supplemented, amended and restated or otherwise modified from time to time.

 

“Solvent” means, with respect to any Person on a particular date, that on such date (a) the fair value of the property of such Person is greater than the total amount of liabilities, including contingent liabilities, of such Person, (b) the present fair saleable value of the assets of such Person is not less than the amount that will be required to pay the probable liability of such Person on its debts as they become absolute and matured, (c) such Person does not intend to, and does not believe that it will, incur debts or liabilities beyond its ability to pay as such debts and liabilities mature, (d) such Person is not engaged in a business or a transaction, and is not about to engage in a business or a transaction, for which the property of such Person would constitute an unreasonably small capital and (e) such Person has not executed this Agreement or any other Loan Document, or made any transfer or incurred any obligations hereunder or thereunder, with actual intent to hinder, delay or defraud either present or future creditors. The amount of Contingent Liabilities at any time shall be computed as the amount that, in light of all the facts and circumstances existing at such time, can reasonably be expected to become an actual or matured liability.

 

“Standard Bodies” means any of the organizations that create, sponsor or maintain safety, quality or other standards, including ISO, ANSI, CEN and SCC and the like.

 

“Subsidiary” means, with respect to any Person, any other Person of which more than 50% of the outstanding Voting Securities of such other Person (irrespective of whether at the time Capital Securities of any other class or classes of such other Person shall or might have voting power upon the occurrence of any contingency) is at the time directly or indirectly owned or controlled by such Person, by such Person and one or more other Subsidiaries of such Person,

 

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or by one or more other Subsidiaries of such Person. Unless the context otherwise specifically requires, the term “Subsidiary” shall be a reference to a Subsidiary of Borrower.

 

“Synthetic Lease” means, as applied to any Person, any lease (including leases that may be terminated by the lessee at any time) of any property (whether real, personal or mixed) (a) that is not a capital lease in accordance with GAAP and (b) in respect of which the lessee retains or obtains ownership of the property so leased for federal income Tax purposes, other than any such lease under which that Person is the lessor.

 

“Taxes” means all income, stamp or other taxes, duties, levies, imposts, charges, assessments, fees, deductions or withholdings, now or hereafter imposed, levied, collected, withheld or assessed by any Governmental Authority, and all interest, additions to tax, penalties or similar liabilities with respect thereto.

 

“Termination Date” means the date on which all Obligations have been paid in full in cash and the Commitment shall have terminated.

 

“Third Party” means any Person other than the Borrower or any of its Subsidiaries.

 

“Trademark” means any trademark, whether registered or not, service mark, trade name, logo, symbol, trade dress, trade style, domain name, corporate name, company name, fictitious business name, certification mark, collective mark or other business identifier or indicator of source or origin, and all applications, registrations and renewals therefor, together with all of the goodwill associated therewith.

 

“Trademark Security Agreement” means any Trademark Security Agreement executed and delivered by the Borrower or any of the Subsidiaries substantially in the form of Exhibit B to any Security Agreement, as amended, supplemented, amended and restated or otherwise modified from time to time.

 

“UCC” means the Uniform Commercial Code as in effect from time to time in the State of New York; provided that, if, with respect to any financing statement or by reason of any provisions of Law, the perfection or the effect of perfection or non-perfection of the security interests granted to the Lender pursuant to the applicable Loan Document is governed by the Uniform Commercial Code as in effect in a jurisdiction of the United States other than New York, then “UCC” means the Uniform Commercial Code as in effect from time to time in such other jurisdiction for purposes of the provisions of each Loan Document and any financing statement relating to such perfection or effect of perfection or non-perfection.

 

“United States” or “U.S.” means the United States of America, its fifty states, its territories and jurisdictions, and the District of Columbia.

 

“Voting Securities” means, with respect to any Person, Capital Securities of any class or kind ordinarily having the power to vote for the election of directors, managers or other voting members of the governing body of such Person.

 

“wholly owned Subsidiary” means any direct or indirect Subsidiaries of Borrower, all of the outstanding Capital Securities of which (other than any director’s qualifying shares or

 

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investments by foreign nationals mandated by applicable Laws) is owned directly or indirectly by Borrower.

 

SECTION 1.2 Use of Defined Terms. Unless otherwise defined or the context otherwise requires, terms for which meanings are provided in this Agreement shall have such meanings when used in each other Loan Document and the schedules attached hereto.

 

SECTION 1.3 Cross-References. Unless otherwise specified, references in a Loan Document to any Article or Section are references to such Article or Section of such Loan Document, and references in any Article, Section or definition to any clause are references to such clause of such Article, Section or definition.

 

SECTION 1.4 Accounting and Financial Determinations. Unless otherwise specified, all accounting terms used in each Loan Document shall be interpreted, and all accounting determinations and computations thereunder (including under Section 8.4 and the definitions used in such calculations) shall be made, in accordance with GAAP, as in effect from time to time; provided that, if either the Borrower or the Lender requests an amendment to any provision hereof to eliminate the effect of any change occurring after the date hereof in GAAP or the application thereof on the operation of such provision, regardless of whether any such notice is given before or after such change in GAAP or the application thereof, then such provision shall be interpreted on the basis of GAAP in effect and applied immediately before such change shall have become effective until such request shall have been withdrawn or such provision amended in accordance herewith. Unless otherwise expressly provided, all financial covenants and defined financial terms shall be computed on a consolidated basis for the Borrower and the Subsidiaries, in each case without duplication.

 

ARTICLE II

COMMITMENT AND BORROWING PROCEDURES

 

SECTION 2.1 Commitment. On the terms and subject to the conditions of this Agreement, the Lender agrees to make a term loan (the “Initial Loan”) to the Borrower on the Closing Date in an amount equal to (but not less than) the Initial Commitment Amount. On the terms and subject to the conditions of this Agreement, the Lender agrees to make a term loan (the “Delayed Draw Loan”) to the Borrower on the Delayed Draw Closing Date in an amount equal to (but not less than) the Delayed Draw Commitment Amount. No amounts paid or prepaid with respect to the Loans may be reborrowed.

 

SECTION 2.2 Borrowing Procedure. The Borrower may irrevocably request that the Initial Loan be made by delivering to the Lender a Loan Request on or before 10:00 a.m. on a Business Day at least three Business Days prior to the proposed Closing Date. The Borrower may irrevocably request that the Delayed Draw Loan be made by delivering to the Lender a Loan Request on or

 

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before 10:00 a.m. on a Business Day at least three Business Days prior to the proposed Delayed Draw Closing Date.

 

SECTION 2.3 Funding. After receipt of the Loan Request for the Initial Loan, the Lender shall, on the Closing Date and subject to the terms and conditions hereof, make the requested proceeds of the Initial Loan available to the Borrower by wire transfer to the account the Borrower shall have specified in its Loan Request. After receipt of the Loan Request for the Delayed Draw Loan, the Lender shall, on the Delayed Draw Closing Date and subject to the terms and conditions hereof, make the requested proceeds of the Delayed Draw Loan available to the Borrower by wire transfer to the account the Borrower shall have specified in its Loan Request.

 

SECTION 2.4 Reduction of the Commitment Amounts. The Initial Commitment Amount shall automatically and permanently be reduced to zero on the Initial Commitment Termination Date. The Delayed Draw Commitment Amount shall automatically and permanently be reduced to zero on the Delayed Draw Commitment Termination Date.

 

ARTICLE III

REPAYMENTS, PREPAYMENTS, INTEREST AND FEES

 

SECTION 3.1 Repayments and Prepayments; Application. The Borrower agrees that the Loans, and any fees or interest accrued or accruing thereon, shall be repaid and prepaid solely in U.S. dollars pursuant to the terms of this Article III.

 

SECTION 3.2 Repayments and Prepayments. The Borrower shall repay in full the unpaid principal amount of the Loans on the Maturity Date. Prior thereto, payments and prepayments of the Loans shall be made as set forth below.

 

(a)                                The Borrower shall have the right, with at least three Business Days’ notice to the Lender, at any time and from time to time to prepay any unpaid principal amount of the Loans, in whole or in part.

 

(b)                                Within three Business Days of receipt by the Borrower or any Subsidiary of any (i) Net Casualty Proceeds or (ii) Net Asset Sales Proceeds, the Borrower shall notify the Lender thereof. If requested by the Lender, the Borrower shall within three Business Days of such request make a mandatory prepayment of the Loans, in an amount equal to 100% of such Net Casualty Proceeds or Net Asset Sales Proceeds, as the case may be (or such lesser amount as the Lender may specify on the date of such request), to be applied as set forth in Section 3.3.

 

(c)                                 The Borrower shall repay the Loans in full immediately upon any acceleration of the Maturity Date thereof pursuant to Section 9.2 or Section 9.3, unless, pursuant to Section 9.3, only a portion of the Loans is so accelerated (in which case the portion so accelerated shall be so repaid).

 

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SECTION 3.3 Application. Except as provided in Section 4.4(b), amounts repaid or prepaid in respect of the outstanding principal amount of the Loans pursuant to clauses (b) or (c) of Section 3.2 shall be applied pro rata to the Initial Loan and Delayed Draw Loan.

 

SECTION 3.4 Interest Rate. During any applicable Interest Period, the Loans shall accrue interest during such Interest Period at a rate per annum equal to the sum of (a) the Applicable Margin plus (b) the higher of (A) the LIBO Rate for such Interest Period and (B) 2.00%. The interest rate shall be recalculated and, if necessary, adjusted for each Interest Period, in each case pursuant to the terms hereof.

 

SECTION 3.5 Default Rate. At all times commencing upon the date any Event of Default occurs, and continuing until such Event of Default is no longer continuing, the Applicable Margin shall be increased by 3.00% per annum.

 

SECTION 3.6 Payment Dates. Interest accrued on the Loans shall be payable in cash, without duplication:

 

(a)                                on the Maturity Date therefor;

 

(b)                                on the date of any payment or prepayment, in whole or in part, of principal outstanding on such Loan on the principal amount so paid or prepaid;

 

(c)                                 on the last day of each calendar month; provided that if such day is not a Business Day, then such payment shall be made on the next succeeding Business Day; and

 

(d)                                on that portion of the Loans that is accelerated pursuant to Section 9.2 or Section 9.3, immediately upon such acceleration.

 

Interest accrued on the Loans or other monetary Obligations after the date such amount is due and payable (whether on the Maturity Date, upon acceleration or otherwise) shall be payable upon demand.

 

SECTION 3.7 Repayment Premium. Upon the prepayment or repayment of all or any portion of any Loans (or upon the date any such prepayment or repayment is required to be paid), whether pursuant to Section 9.2 or Section 9.3, or otherwise (but excluding any required repayment of Loans with Net Casualty Proceeds pursuant to Section 3.2(b)(i)), the Borrower shall pay to the Lender, in cash, on the date on which such prepayment or repayment is paid or required to be paid, as the case may be, in addition to the other Obligations (including the Exit Fee) so prepaid, repaid or required to be prepaid or repaid, the Repayment Premium that is applicable on such date with respect to the portion of each Loan so prepaid, repaid or required to be prepaid or repaid.

 

SECTION 3.8 Exit Fee. Upon the prepayment or repayment of all or any portion of any Loans (or upon the date any such prepayment or repayment is

 

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required to be paid), whether on the Maturity Date, or pursuant to Section 9.2 or Section 9.3, or otherwise, the Borrower shall pay to the Lender, in cash, on the date on which such prepayment or repayment is paid or required to be paid, as the case may be, in addition to the other Obligations (including the Repayment Premium, if any) so prepaid, repaid or required to be prepaid or repaid, a fee (the “Exit Fee”) in an amount equal to ten percent (10.00%) of the principal amount of the Loans prepaid, repaid or required to be prepaid or repaid, as the case may be, on such date.

 

SECTION 3.9 Administration Fee. The Borrower shall pay to the Lender, in cash, an administration fee in the amount of $10,000, on the last day of each Fiscal Quarter prior to the Termination Date; provided that if such day is not a Business Day, then such payment shall be made on the next succeeding Business Day.

 

ARTICLE IV

LIBO RATE AND OTHER PROVISIONS

 

SECTION 4.1 Increased Costs, Etc. The Borrower agrees to reimburse the Lender for any increase in the cost to the Lender of, or any reduction in the amount of any sum receivable by the Lender in respect of, the Lender’s Commitment and the making, continuation or maintaining of the Loans hereunder that may arise in connection with any Change in Law, except for such changes with respect to increased capital costs and Taxes which are governed by Section 4.2 and Section 4.3, respectively. The Lender shall notify the Borrower in writing of the occurrence of any such event, stating the reasons therefor and the additional amount required fully to compensate the Lender for such increased cost or reduced amount. Such additional amounts shall be payable by the Borrower directly to the Lender within five days of its receipt of such notice, and such notice shall, in the absence of manifest error, be conclusive and binding on the Borrower.

 

SECTION 4.2 Increased Capital Costs. If any Change in Law affects or would affect the amount of capital required or expected to be maintained by the Lender or any Person controlling the Lender, and the Lender determines (in good faith but in its sole and absolute discretion) that the rate of return on its or such controlling Person’s capital as a consequence of the Commitment or the Loans made by it hereunder is reduced to a level below that which the Lender or such controlling Person could have achieved but for the occurrence of any such circumstance, then upon notice from time to time by the Lender to the Borrower, the Borrower shall within five days following receipt of such notice pay directly to the Lender additional amounts sufficient to compensate the Lender or such controlling Person for such reduction in rate of return. A statement of the Lender as to any such additional amount or amounts shall, in the absence of manifest error, be conclusive and binding on the Borrower. In determining such amount, the Lender may use any method of averaging and attribution that it (in its sole and absolute discretion) shall deem applicable.

 

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SECTION 4.3 Taxes. The Borrower covenants and agrees as follows with respect to Taxes:

 

(a)                                Any and all payments by the Borrower or any Subsidiary under each Loan Document shall be made without setoff, counterclaim or other defense, and free and clear of, and without deduction or withholding for or on account of, any Taxes. In the event that any Taxes are imposed and required to be deducted or withheld from any payment required to be made by the Borrower or any of the Subsidiaries to or on behalf of the Lender under any Loan Document, then:

 

(i)                                     if such Taxes are Non-Excluded Taxes, the amount of such payment shall be increased as may be necessary so that such payment is made, after withholding or deduction for or on account of such Taxes, in an amount that is not less than the amount provided for in such Loan Document; and

 

(ii)                                  the Borrower or such Subsidiary shall deduct or withhold the full amount of such Taxes from such payment (as increased pursuant to clause (a)(i)) and shall pay such amount to the Governmental Authority imposing such Taxes in accordance with applicable Law.

 

(b)                                In addition, the Borrower or the applicable Subsidiary shall pay all Other Taxes imposed to the relevant Governmental Authority imposing such Other Taxes in accordance with applicable Law.

 

(c)                                 As promptly as practicable after the payment of any Taxes or Other Taxes required to be paid by the Borrower under Section 4.3(a) or (b), and in any event within 45 days of any such payment being due, the Borrower shall furnish to the Lender a copy of an official receipt (or a certified copy thereof) evidencing the payment of such Taxes or Other Taxes.

 

(d)                                The Borrower shall indemnify the Lender for any Non-Excluded Taxes and Other Taxes levied, imposed or assessed on (and whether or not paid directly by) the Lender whether or not such Non-Excluded Taxes or Other Taxes are correctly or legally asserted by the relevant Governmental Authority. Promptly upon having knowledge that any such Non-Excluded Taxes or Other Taxes have been levied, imposed or assessed, and promptly upon notice thereof by the Lender, the Borrower shall pay such Non-Excluded Taxes or Other Taxes directly to the relevant Governmental Authority (provided that the Lender shall not be under any obligation to provide any such notice to the Borrower). In addition, the Borrower shall indemnify the Lender for any incremental Taxes that may become payable by the Lender as a result of any failure of the Borrower to pay any Taxes when due to the appropriate Governmental Authority or to deliver to the Lender, pursuant to clause (c), documentation evidencing the payment of Taxes or Other Taxes. With respect to indemnification for Non-Excluded Taxes and Other Taxes actually paid by the Lender or the indemnification provided in the immediately preceding sentence, such indemnification shall be made within 30 days after the date the Lender makes written demand therefor. The Borrower acknowledges that any payment made to the Lender

 

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or to any Governmental Authority in respect of the indemnification obligations of the Borrower provided in this clause (d) shall constitute a payment in respect of which the provisions of clause (a) and this clause (d) shall apply.

 

(e)                                 For purposes of sections 1272, 1273 and 1275 of the Code and the U.S. Department of Treasury regulations thereunder, the Loans are being issued with original issue discount. Requests for information regarding the original issue discount, issue date, yield to maturity, comparable yield and projected payment schedule on the Loans shall be directed to the Borrower, at the address of Borrower specified on Schedule 10.2.

 

SECTION 4.4 Payments, Computations; Proceeds of Collateral, Etc.

 

(a)                                Unless otherwise expressly provided in a Loan Document, all payments by the Borrower pursuant to each Loan Document shall be made without setoff, deduction or counterclaim not later than 11:00 a.m. on the date due in same day or immediately available funds to such account as the Lender shall specify from time to time by notice to the Borrower. Funds received after 11:00 a.m. on any day shall be deemed to have been received by the Lender on the next succeeding Business Day. All interest and fees shall be computed on the basis of the actual number of days (including the first day but excluding the last day) occurring during the period for which such interest or fee is payable over a year comprised of 360 days. Payments due on other than a Business Day shall be made on the next succeeding Business Day and such extension of time shall be included in computing interest and fees in connection with that payment.

 

(b)                                 All amounts received as a result of the exercise of remedies under the Loan Documents (including from the proceeds of collateral securing the Obligations) or under applicable Law shall be applied upon receipt to the Obligations as follows: (i) first, to the payment in full in cash of all interest (including interest accruing after the commencement of a proceeding in bankruptcy, insolvency or similar Law, whether or not permitted as a claim under such Law) and fees owing under the Loan Documents, and all costs and expenses owing to the Lender pursuant to the terms of the Loan Documents, until paid in full in cash, (ii) second, after payment in full in cash of the amounts specified in clause (b)(i), to the payment of the principal amount of the Loans then outstanding, (iii) third, after payment in full in cash of the amounts specified in clauses (b)(i) and (b)(ii), to the payment of all other Obligations owing to the Lender, and (iv) fourth, after payment in full in cash of the amounts specified in clauses (b)(i) through (b)(iii), and following the Termination Date, to the Borrower or any other Person lawfully entitled to receive such surplus.

 

SECTION 4.5 Setoff. The Lender shall, upon the occurrence and during the continuance of any Default described in clauses (i) through (iv) of Section 9.1(h) or, upon the occurrence and during the continuance of any other Event of Default, have the right to appropriate and apply to the payment of the Obligations owing to it (whether or not then due), and (as security for such Obligations) the Borrower hereby grants to the Lender a continuing security interest in, any and all

 

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balances, credits, deposits, accounts or moneys of the Borrower then or thereafter maintained with or on behalf of the Lender. The Lender agrees promptly to notify the Borrower after any such appropriation and application made by the Lender; provided that the failure to give such notice shall not affect the validity of such setoff and application. The rights of the Lender under this Section 4.5 are in addition to other rights and remedies (including other rights of setoff under applicable Law or otherwise) which the Lender may have.

 

SECTION 4.6 LIBO Rate Not Determinable.

 

(a)                                If prior to the commencement of any Interest Period for a Loan, the Lender determines (which determination shall be conclusive absent manifest error) that adequate and reasonable means do not exist for ascertaining the LIBO Rate for such Interest Period, then the Lender shall give notice thereof to the Borrower as promptly as practicable and, until the Lender notifies the Borrower that the circumstances giving rise to such notice no longer exist, (i) the Loans shall bear interest calculated pursuant to Section 3.4 but using the Prime Rate instead of the LIBO Rate and (ii) the continuation of any outstanding Loan or the extension of a new Loan hereunder shall be made with interest calculated pursuant to Section 3.4 but using the Prime Rate instead of the LIBO Rate.

 

(b)                                If at any time the Lender determines (which determination shall be conclusive absent manifest error) that (i) the circumstances set forth in Section 4.6(a) have arisen and such circumstances are unlikely to be temporary or (ii) the circumstances set forth in Section 4.6(a) have not arisen but the supervisor for the administrator of the LIBO Rate has made a public statement identifying a specific date after which the LIBO Rate shall no longer be used for determining interest rates for loans, then the Lender shall establish an alternate rate of interest to that based on the LIBO Rate that gives due consideration to the then-prevailing market convention for determining a rate of interest for loans in the United States at such time, and the Lender and the Borrower shall enter into an amendment to this Agreement to reflect such alternate rate of interest and such other related changes as the Lender may determine to be appropriate. Until an alternate rate of interest shall be determined in accordance with this Section 4.6(b) (but, in the case of the circumstances described in clause (ii) of the first sentence of this Section 4.6(b), only to the extent the LIBO Rate for such Interest Period is not available or published at such time on a current basis), Section 4.6(a) shall be applicable.

 

ARTICLE V

CONDITIONS TO MAKING THE LOANS

 

SECTION 5.1 Credit Extensions. The obligation of the Lender to make the Initial Loan shall be subject to the execution and delivery of this Agreement by the Parties, the delivery of a Loan Request as requested pursuant to Section 2.3, and the satisfaction of each of the conditions precedent set forth below in this Article (other than Sections 5.17 and 5.18). The obligation of the Lender to make the Delayed Draw Loan shall be subject to the prior making of the Initial Loan,

 

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the delivery of a Loan Request as requested pursuant to Section 2.3, and the satisfaction of each of the conditions precedent set forth below in Sections 5.3, 5.8, 5.17 and 5.18.

 

SECTION 5.2 Secretary’s Certificate, Etc. The Lender shall have received from the Borrower and each Subsidiary party to a Loan Document, (i) a copy of a good standing certificate, dated a date reasonably close to the Closing Date, for each such Person and (ii) a certificate, dated as of the Closing Date, duly executed and delivered by such Person’s Secretary or Assistant Secretary, managing member or general partner, as applicable, as to:

 

(a)                                resolutions of each such Person’s board of directors (or other managing body, in the case of other than a corporation) and any other corporate resolutions required by applicable Law or pursuant to such Person’s Organic Documents, each of which shall be then in full force and effect, authorizing the execution, delivery and performance of each Loan Document to be executed by such Person and the transactions contemplated hereby and thereby;

 

(b)                                the incumbency and signatures of those of its officers, managers, managing member or general partner, as applicable, authorized to act with respect to each Loan Document to be executed by such Person; and

 

(c)                                 each Organic Document of such Person being in full force and effect, and attaching copies thereof;

 

upon which certificates the Lender may conclusively rely until it shall have received a further certificate of the Secretary, Assistant Secretary, managing member or general partner, as applicable, of any such Person canceling or amending the prior certificate of such Person.

 

SECTION 5.3 Closing Date Certificate. The Lender shall have received a Closing Date Certificate, dated as of the Closing Date or Delayed Draw Closing Date, as the case may be, and duly executed and delivered by an Authorized Officer of the Borrower, in which certificate the Borrower shall certify that the statements made therein shall be deemed to be true and correct representations and warranties of the Borrower as of such date and, at the time such certificate is delivered, such statements shall in fact be true and correct, and such statements shall include that (a) the representations and warranties set forth in each Loan Document shall, in each case, be true and correct in all material respects (other than any representations and warranties that are qualified by materiality or Material Adverse Effect, which shall be true and correct in all respects), (b) no Default shall have then occurred and be continuing, or would result from the Loan to be advanced on the Closing Date or Delayed Draw Closing Date, as the case may be, and (c) all of the applicable conditions set forth in this Article V have been satisfied in all material respects.

 

SECTION 5.4 Payment of Outstanding Indebtedness, Etc. All Indebtedness identified in Schedule 8.2(b), together with all interest, all

 

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prepayment premiums and all other amounts due and payable with respect thereto, shall have been paid in full from the proceeds of the Loan and the commitments in respect of such Indebtedness shall have been terminated, and all Liens securing payment of any such Indebtedness shall have been released and the Lender shall have received all Uniform Commercial Code Form UCC-3 termination statements or other instruments (including customary payoff letters) as may be suitable or appropriate in connection therewith.

 

SECTION 5.5 Delivery of Note. The Lender shall have received a Note duly executed and delivered by an Authorized Officer of the Borrower.

 

SECTION 5.6 Financial Information, Etc. The Lender shall have received:

 

(a)                                audited consolidated financial statements of the Borrower and the Subsidiaries for each of the fiscal years ended December 31, 2015, December 31, 2016, and December 31, 2017;

 

(b)                                unaudited consolidated balance sheets of the Borrower and the Subsidiaries for each Fiscal Quarter ended after December 31, 2016, together with the related consolidated statement of operations, shareholder’s equity and cash flows for the twelve months then ended; and

 

(c)                                 such other financial information as to the Borrower and the Subsidiaries and their respective businesses, assets and liabilities as the Lender may reasonably request.

 

SECTION 5.7 Compliance Certificate. The Lender shall have received an initial Compliance Certificate on a pro forma basis as if the Initial Loan had been made as of September 30, 2018 and as to such items therein as the Lender reasonably requests, dated the Closing Date, duly executed (and with all schedules thereto duly completed) and delivered by the chief financial or accounting Authorized Officer of the Borrower.

 

SECTION 5.8 Solvency, Etc. The Lender shall have received a solvency certificate duly executed and delivered by the chief financial or accounting Authorized Officer of the Borrower, dated as of the Closing Date or Delayed Draw Closing Date, as the case may be, in form and substance satisfactory to the Lender.

 

SECTION 5.9 Guarantee. In case there are any Material Subsidiaries as of the Closing Date, the Lender shall have received executed counterparts of the Guarantee, dated as of the date hereof, duly executed and delivered by each such Material Subsidiary.

 

SECTION 5.10 Security Agreements. The Lender shall have received executed counterparts of the Security Agreement, dated as of the date hereof, duly

 

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executed and delivered by the Borrower and each Material Subsidiary, together with:

 

(a)                                certificates (in the case of Capital Securities that are securities (as defined in the UCC)) evidencing (i) all of the issued and outstanding Capital Securities owned by the Borrower or any Guarantor in the Borrower and the Subsidiaries (other than any Excluded Foreign Subsidiary) and (ii) 65% of the issued and outstanding voting Capital Securities and 100% of the issued and outstanding non-voting Capital Securities owned by the Borrower or any Guarantor in any Excluded Foreign Subsidiary, which certificates in each case described in clauses (i) and (ii) shall be accompanied by undated instruments of transfer duly executed in blank, or, in the case of Capital Securities that are uncertificated securities (as defined in the UCC), confirmation and evidence satisfactory to the Lender that the security interest therein has been transferred to and perfected by the Lender in accordance with Articles 8 and 9 of the UCC and all laws otherwise applicable to the perfection of the pledge of such Capital Securities;

 

(b)                                 financing statements suitable in form for naming the Borrower and each Material Subsidiary as a debtor and the Lender as the secured party, or other similar instruments or documents to be filed under the UCC of all jurisdictions as may be necessary or, in the opinion of the Lender, desirable to perfect the security interests of the Lender pursuant to the Security Agreement;

 

(c)                                 UCC Form UCC-3 termination statements, if any, necessary to release all Liens and other rights of any Person (i) in any assets of the Borrower or any Subsidiary or (ii) securing any of the Indebtedness identified in Schedule 8.2(b), together with such other UCC Form UCC-3 termination statements as the Lender may reasonably request from the Borrower or any Subsidiary;

 

(d)                                landlord access agreements and bailee letters in form and substance satisfactory to the Lender from each landlord to the Borrower or any Material Subsidiary and each other Person that has possession of any Collateral (as defined in the Security Agreement); and

 

(e)                                 evidence that all deposit accounts, lockboxes, disbursement accounts, investment accounts or other similar accounts of the Borrower and each Material Subsidiary are Controlled Accounts (other than Excluded Accounts).

 

SECTION 5.11 Intellectual Property Security Agreements. In case the Collateral includes any Patents, any Copyrights or any Trademarks, the Lender shall have received, respectively, a Patent Security Agreement, a Copyright Security Agreement and a Trademark Security Agreement, as applicable, each dated as of the Closing Date, duly executed and delivered by the Borrower or any Subsidiary that, pursuant to the Security Agreement, is required to provide such intellectual property security agreements to the Lender.

 

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SECTION 5.12 Opinions of Counsel. The Lender shall have received opinions, dated the Closing Date and addressed to the Lender, from Duane Morris LLP, counsel to the Borrower and the Subsidiaries, in form and substance satisfactory to the Lender.

 

SECTION 5.13 Insurance. The Lender shall have received certified copies of the insurance policies (or binders in respect thereof), from one or more insurance companies satisfactory to the Lender, evidencing coverage required to be maintained pursuant to each Loan Document, with the Lender named as loss payee or additional insured, as applicable.

 

SECTION 5.14 Closing Fees, Expenses, Etc. The Lender shall have received for its own account all fees, costs and expenses due and payable pursuant to Section 10.3.

 

SECTION 5.15 Anti-Terrorism Laws. The Lender shall have received, as applicable, all documentation and other information required by bank regulatory authorities under applicable “know your customer” and anti-money laundering rules and regulations, including the U.S. Patriot Act.

 

SECTION 5.16 Satisfactory Legal Form. All documents executed or submitted pursuant hereto by or on behalf of the Borrower or any Subsidiary shall be satisfactory in form and substance to the Lender and its counsel, and the Lender and its counsel shall have received all information, approvals, resolutions, opinions, documents or instruments as the Lender or its counsel may reasonably request.

 

SECTION 5.17 Revenue Base. The Lender shall be satisfied that the Revenue Base for the six full calendar months immediately prior to the Delayed Draw Closing Date was at least $7,500,000.

 

SECTION 5.18 Disclosure Schedules. Immediately prior to the Delayed Draw Closing Date, the Borrower shall deliver to the Lender updates to Schedules 6.15(a), 6.16(a), 6.19 and 6.22, each such updated Schedule to be complete and accurate as of the Delayed Draw Closing Date.

 

ARTICLE VI

REPRESENTATIONS AND WARRANTIES

 

In order to induce the Lender to enter into this Agreement and to make the Loans hereunder, the Borrower represents and warrants on the Closing Date and on the Delayed Draw Closing Date, to the Lender as set forth in this Article VI.

 

SECTION 6.1 Organization, Etc. Each of the Borrower and each Subsidiary (a) is validly organized and existing and in good standing under the Laws of the jurisdiction of its incorporation or organization, is duly qualified to do business and is in good standing as a foreign entity in each jurisdiction where the nature of its business requires such qualification (unless the failure to so

 

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qualify as a foreign entity could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect), and (b) has full power and authority and holds all requisite governmental licenses, Permits and other approvals required (i) to enter into and perform its Obligations under each Loan Document to which it is a party, and (ii) to own and hold under lease its property and to conduct its business substantially as currently conducted by it.

 

SECTION 6.2 Due Authorization, Non-Contravention, Etc. The execution, delivery and performance by the Borrower and each Subsidiary of each Loan Document executed or to be executed by it are in each case within such Person’s corporate or organizational powers, have been duly authorized by all necessary corporate or organizational action, and do not:

 

(a)                                contravene (i) the Borrower’s or any Subsidiary’s Organic Documents, (ii) any court decree or order binding on or affecting the Borrower or any Subsidiary or (iii) any Law or regulation binding on or affecting the Borrower or any Subsidiary; or

 

(b)                                result in (i) or require the creation or imposition of any Lien on the Borrower’s or any Subsidiary’s properties (except as permitted by this Agreement) or (ii) a default under any Material Agreement.

 

SECTION 6.3 Government Approval, Regulation, Etc. No authorization, approval, clearance or other action by, and no notice to or filing with, any Governmental Authority or other Person (other than those that have been, or on the Closing Date will be, duly obtained or made and which are, or on the Closing Date will be, in full force and effect) is required for the due execution, delivery or performance by the Borrower or any Subsidiary of any Loan Document to which it is a party.

 

SECTION 6.4 Validity, Etc. Each Loan Document to which the Borrower or any Subsidiary is a party constitutes the legal, valid and binding obligations of such Person enforceable against such Person in accordance with its respective terms (except, in any case, as such enforceability may be limited by applicable bankruptcy, insolvency, reorganization or similar Laws affecting creditors’ rights generally and by principles of equity).

 

SECTION 6.5 Financial Information. Except as set forth on Schedule 6.5, the financial statements of the Borrower and the Subsidiaries furnished to the Lender pursuant to Sections 5.6 and 7.1 have been prepared in accordance with GAAP, consistently applied, and present fairly in all material respects the consolidated financial condition of the Persons covered thereby as at the dates thereof and the results of their operations for the periods then ended.

 

SECTION 6.6 No Material Adverse Change. There has been no material adverse change in the business, financial performance or condition, operations

 

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(including the results thereof), assets, properties or prospects of the Borrower or any Subsidiary since December 31, 2017.

 

SECTION 6.7 Litigation, Labor Matters and Environmental Matters.

 

(a)                                Except as described on Schedule 6.7(a), there are no actions, suits or proceedings by or before any arbitrator or Governmental Authority pending against or, to the knowledge of the Borrower, threatened, against or affecting the Borrower or any Subsidiary (i) as to which there is a reasonable likelihood of an adverse determination and that, if adversely determined, would reasonably be expected, individually or in the aggregate, to result in liabilities in excess of $250,000 or (ii) that would reasonably be likely to adversely affect this Agreement or the transactions contemplated hereby.

 

(b)                                There are no labor controversies pending against or, to the knowledge of the Borrower, threatened, against or affecting the Borrower or any Subsidiary (i) that would reasonably be expected, individually or in the aggregate, to result in liabilities in excess of $250,000 or (ii) that would reasonably be likely to adversely affect this Agreement or the transactions contemplated hereby.

 

(c)                                 Neither the Borrower nor any Subsidiary (i) has failed to comply with any Environmental Law or to obtain, maintain or comply with any Permit under or in connection with any Environmental Law (“Environmental Permit”), (ii) is or has been subject to any Environmental Liability, (iii) has received notice of any Environmental Liability, or (iv) knows of any basis for any Environmental Liability, in each case of clauses (i) through (iv) above, which would reasonably be expected to result in liabilities to the Borrower and the Subsidiaries, taken as a whole, in excess of $250,000.

 

SECTION 6.8 Subsidiaries. The Borrower has no Subsidiaries except those Subsidiaries that are identified in Schedule 6.8 (which Schedule also identifies the direct and indirect owners of the Capital Securities of such Subsidiaries) or which are permitted to have been organized or acquired after the Closing Date in accordance with Section 8.5 and Section 8.7.

 

SECTION 6.9 Ownership of Properties. The Borrower and each Subsidiary owns (a) in the case of owned real property, good and marketable fee title to, and (b) in the case of owned personal property, good and valid title to, or, in the case of leased real or personal property, valid and enforceable leasehold interests (as the case may be) in, all of its properties and assets, tangible and intangible, of any nature whatsoever, free and clear in each case of all Liens or claims, except for Liens permitted pursuant to Section 8.3.

 

SECTION 6.10 Taxes. The Borrower and each Subsidiary has filed all Tax returns and reports required by Law to have been filed by it and has paid all Taxes due and owing, except any such Taxes which are being diligently contested

 

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in good faith by appropriate proceedings and for which adequate reserves in accordance with GAAP have been set aside on its books.

 

SECTION 6.11 Benefit Plans, Etc. None of the Borrower or any of the Subsidiaries or any of their respective ERISA Affiliates sponsors, maintains, contributes to, is required to contribute to, or has any actual or potential liability with respect to, any Benefit Plan. None of the Borrower or any of the Subsidiaries is a party to any collective bargaining agreement, and none of the employees of the Borrower or any of the Subsidiaries are subject to any collective bargaining agreement with respect to their employment with the Borrower or any of the Subsidiaries. Each “employee benefit plan” as defined in section 3(3) of ERISA that provides retirement benefits, is sponsored by the Borrower or any of their ERISA Affiliates, and is intended to be Tax qualified under section 401 or 501 of the Code has a determination letter or opinion letter from the U.S. Internal Revenue Service on which it remains entitled to rely, and no assets of any such plan are invested in Capital Securities of the Borrower. Each employee benefit plan, program or arrangement sponsored, maintained, contributed to or required to be contributed to by the Borrower or any Subsidiary has complied, both in form and in operation, in all material respects with its terms and applicable Law. Each employee benefit plan as defined in section 3(3) of ERISA that provides medical, dental, vision, or long-term disability benefits and that is sponsored by the Borrower or any of its Subsidiaries or any of their ERISA Affiliates (or under which any of these entities has any actual or potential liability) is fully insured by a third party insurance company.

 

SECTION 6.12 Accuracy of Information. None of the information heretofore or contemporaneously furnished in writing to the Lender by or on behalf of the Borrower or any Subsidiary in connection with any Loan Document or any transaction contemplated hereby contains any untrue statement of a material fact, or omits to state any material fact necessary to make any information not misleading.

 

SECTION 6.13 Regulations U and X. None of the Borrower or any Subsidiary is engaged in the business of extending credit for the purpose of buying or carrying margin stock, and no proceeds of the Loans will be used to purchase or carry margin stock or otherwise for a purpose which violates, or would be inconsistent with, Regulation U or Regulation X of the F.R.S. Board. Terms for which meanings are provided in Regulation U and Regulation X of the F.R.S. Board, or any regulations substituted therefor, as from time to time in effect, are used in this Section 6.13 with such meanings.

 

SECTION 6.14 Solvency. The Borrower, individually, and the Borrower and its Subsidiaries taken as a whole, on a consolidated basis, both before and after giving effect to each of the Loans, are Solvent.

 

SECTION 6.15 Intellectual Property.

 

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(a)                                Schedule 6.15(a) sets forth a complete and accurate list as of the Closing Date or Delayed Draw Closing Date, as the case may be, of all (i) Patents, including any Patent applications and other items so defined as Patents, (ii) registered and material unregistered Trademarks (including domain names) and any pending registrations for Trademarks, (iii) any other registered Intellectual Property and (iv) any unregistered Intellectual Property that is material to the business of Borrower or any Subsidiary, in each case of clauses (i) through (iv) that are owned by or licensed to the Borrower or any of the Subsidiaries. For each item of Intellectual Property listed on Schedule 6.15(a), the Borrower has, where relevant, indicated (A) the countries in each case in which such item is registered, (B) the application numbers, (C) the registration or patent numbers, (D) with respect to the Patents, the expected expiration date of the issued Patents, (E) the owner of such item of Intellectual Property, (F) with respect to Intellectual Property owned by any Third Party, the agreement pursuant to which that Intellectual Property is licensed to the Borrower or any Subsidiary and (G) with respect to Intellectual Property licensed to any Third Party, the agreement pursuant to which that Intellectual Property is licensed by the Borrower or any Subsidiary.

 

(b)                                With respect to all Intellectual Property listed, or required to be listed, on Schedule 6.15(a):

 

(i)                                     the Borrower or a Subsidiary owns, has a valid license or rights in any other form to all rights associated with such Intellectual Property free and clear of any and all Liens, other than Liens permitted pursuant to Section 8.3, and all such Intellectual Property are in full force and effect, and have not expired, lapsed or been forfeited, cancelled or abandoned unless permitted hereunder;

 

(ii)                                  each of the Borrower and the Subsidiaries, as applicable, has taken commercially reasonable actions to maintain and protect such Intellectual Property and there are no unpaid maintenance or renewal fees payable by the Borrower or any of the Subsidiaries that are currently overdue for any of such registered Intellectual Property;

 

(iii)                               there is no actual or threatened (in writing or, to the knowledge of Borrower, orally) proceeding in any court, patent office, Governmental Authority, arbitral body or elsewhere challenging the validity or enforceability of any such Intellectual Property, none of the Borrower or any of the Subsidiaries is involved in any such proceeding with any Person and none of the Intellectual Property is the subject of any Other Administrative Proceeding;

 

(iv)                              to the knowledge of the Borrower, (A) such Intellectual Property is valid, enforceable and subsisting and (B) no event has occurred, and nothing has been done or omitted to have been done, that would affect the validity or enforceability of such Intellectual Property; and

 

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(v)                                 each of the Borrower and each Subsidiary, as applicable, is the sole and exclusive owner of all right, title and interest in and to all such Intellectual Property that is owned by it.

 

(c)                                 To the knowledge of the Borrower, no Third Party is committing any act of Infringement of any Intellectual Property listed, or required to be listed, on Schedule 6.15(a).

 

(d)                                With respect to each license agreement listed on Schedule 6.15(a), such license agreement (i) is in full force and effect and is binding upon and enforceable against the Borrower and the Subsidiaries party thereto and all other parties thereto in accordance with its terms, (ii) has not been amended or otherwise modified, except as set forth on Schedule 6.15(a), and (iii) except as set forth on Schedule 6.15(d), has not suffered a default or breach thereunder. None of the Borrower or any of the Subsidiaries has taken or omitted to take any action that would permit any other Person party to any such license agreement to have, and no such Person otherwise has, any defenses, counterclaims, termination rights or rights of setoff thereunder.

 

(e)                                 Except as set forth on Schedule 6.15(e), none of the Borrower or any of the Subsidiaries has received written notice from any Third Party alleging that the conduct of its business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that Third Party and, to the knowledge of the Borrower, the conduct of its business and the business of the Subsidiaries (including the development, manufacture, use, sale or other commercialization of any Product) does not Infringe any Intellectual Property of any Third Party.

 

(f)                                  The Borrower and the Subsidiaries have used commercially reasonable efforts and precautions to protect their respective commercially significant unregistered Intellectual Property.

 

SECTION 6.16 Material Agreements and Key Contracts.

 

(a)                                Set forth on Schedule 6.16(a) is a complete and accurate list as of the Closing Date or Delayed Draw Closing Date, as the case may be, of all Material Agreements and Key Contracts, in each case of the Borrower or any of the Subsidiaries. As of such dates, respectively, each such Material Agreement and each such Key Contract (i) is in full force and effect and is the legal, valid and binding obligation of the parties thereto, enforceable against the Borrower and the Subsidiaries party thereto and all other parties thereto in accordance with its terms, (ii) has not been amended or otherwise modified and (iii) has not suffered a default thereunder. As of such dates, respectively, (A) none of the Borrower or any of the Subsidiaries is in breach or in default in any material respect under any Material Agreement or Key Contract, nor has any of the Borrower or any of the Subsidiaries taken any action that would permit any other Person party to any Material Agreement or Key Contract to have, and no such Person otherwise has, any defenses,

 

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counterclaims, termination rights or rights of setoff thereunder and (B) to the knowledge of the Borrower, no such other Person party to such Material Agreement or Key Contract is in breach or in default thereunder.

 

(b)                                The Borrower has provided to the Lender full, complete and correct copies of the Key Contracts (including all exhibits and schedules thereto).

 

SECTION 6.17 Permits. The Borrower and the Subsidiaries have all Permits, including Environmental Permits, necessary or required for the ownership, operation and conduct of their business and the distribution of the Products, except for any failure to have any Permits which failure would not be reasonably expected to be material to the Borrower or any Subsidiary. All such Permits are validly held and there are no defaults thereunder.

 

SECTION 6.18 Regulatory Matters.

 

(a)                                The business of the Borrower and its Subsidiaries has been, and currently is, being conducted in compliance in all material respects with all applicable U.S. federal, state, provincial, territorial, local or foreign laws, statutes, ordinances, rules, regulations, guidances, judgments, orders, injunctions, decrees, arbitration awards and Key Permits issued by any Governmental Authority (collectively, “Laws”), including the FD&C Act and Privacy Laws and other similar state, provincial and foreign Laws. The Products were researched, developed, designed, distributed and validated solely by Borrower in compliance with all applicable Laws, including the FD&C Act, FTC Act, CLIA, Privacy Laws and state laws, and have been and continue to be performed, marketed, labeled, assembled, stored, packaged and conducted in compliance with all applicable Laws, including the FD&C Act, FTC Act, CLIA, Privacy Laws and state laws. All required and material notices, registrations and listings, supplemental applications or notifications, reports (including reports of adverse experiences) and other required and material filings and Regulatory Authorizations with respect to the Products have been filed with the FDA and all other applicable Governmental Authorities.

 

(b)                                To the Borrower’s knowledge, no investigation or prosecution by any Governmental Authority with respect to the Borrower or any Subsidiary has occurred, nor is any such action pending or threatened. None of the Borrower or any of the Subsidiaries has received any written communication from any Person (including any Governmental Authority) alleging any noncompliance with any Laws or any written communication from any Governmental Authority of any material issues regarding the quality or performance of any Product, and to the knowledge of the Borrower, there is no basis for any adverse regulatory action against the Borrower or any of the Subsidiaries with respect to any Product. Except as set forth on Schedule 6.18(b), there have been no product recalls, safety alerts, corrections, withdrawals, clinical holds, marketing suspensions, removals or the like conducted, undertaken or issued by any Person, whether or not at the request, demand or order of any Governmental Authority or otherwise, with respect to any Product, and there is no basis for the issuance of any such product recalls, safety alerts, corrections, withdrawals, clinical

 

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holds, marketing suspensions, removals, or the like by any Person with respect to any Products. None of the Borrower or any of the Subsidiaries has received any written notice of, and does not otherwise have knowledge of, any criminal, injunctive, seizure, detention or civil penalty actions that have at any time been commenced or threatened in writing by any Governmental Authority with respect to or in connection with any Product, or any consent decrees (including plea agreements) which relate to any Product, and, to the knowledge of the Borrower, there is no basis for the commencement for any criminal injunctive , seizure, detention or civil penalty actions by any Governmental Authority relating to any Product or for the issuance of any consent decrees.

 

(c)                                 The Borrower or its applicable Subsidiary, as the case may be, owns, free and clear of all Liens, except those permitted pursuant to Section 8.3, all Key Permits, including all authorizations under the FD&C Act, CLIA, and state laws, necessary for the research and development and commercialization of the Products and to carry on Borrower’s and each such Subsidiary’s respective business. All such Key Permits are valid, and in full force and effect and Borrower each such Subsidiary is in compliance in all material respects with all terms and conditions of such Key Permits and with all filing and maintenance requirements (including any fee requirements) thereof. None of the Borrower or any of the Subsidiaries has received any written notice that any Key Permits have been or are being revoked, withdrawn, suspended or challenged.

 

(d)                                The Borrower has made available to the Lender copies of all Key Permits and material correspondence submitted to or received from FDA, CMS, or other Governmental Authority (including minutes and official contact reports relating to any material communications with any Governmental Authority) in the Borrower’s possession or control. The Borrower has made available to the Lender all material adverse event reports and communications to or from the FDA (if any) and other relevant Governmental Authorities, including inspection reports, warning letters, untitled letters, and material reports, studies and other correspondence, other than opinions of counsel that are attorney-client privileged, with respect to regulatory matters relating to the Borrower and any Subsidiaries, the conduct of their business, the operation of any manufacturing facilities owned, leased or operated by the Borrower or any of the Subsidiaries, and the Products. There has been no material untrue statement of fact and no fraudulent statement made by the Borrower, any of the Subsidiaries, or any of their respective agents or representatives to the FDA, CMS, or any other Governmental Authority, and there has been no failure to disclose any material fact required to be disclosed to the FDA or any other Governmental Authority.

 

(e)                                 With respect to the Products, (i) all design, manufacturing, storage, distribution, packaging, labeling, sale, recordkeeping and other activities by the Borrower or any of its Subsidiaries and, to the knowledge of Borrower, their respective suppliers relating to the Products have been conducted, and are currently being conducted, in compliance in all material respects with the applicable requirements of the FD&C Act and other requirements of the FDA and all other

 

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Governmental Authorities, including the QSR, medical device reporting requirements, and adverse event reporting requirements, and (ii) none of the Borrower or any of its Subsidiaries, or, to the knowledge of the Borrower, any of their respective suppliers, has received written notice or threat of commencement of action by any Governmental Authority to withdraw its approval of or to enjoin production of any Product at any facility. No Product in the inventory of the Borrower or any of its Subsidiaries is adulterated or misbranded.

 

(f)                                  Neither Borrower nor any of its Subsidiaries owns, leases or operates any manufacturing facilities. To the knowledge of Borrower, the manufacturing facilities used by any supplier of the Borrower or any of its Subsidiaries in the production of any Product, are and have been operated in material compliance with QSRs and all other applicable Laws. The FDA has not issued any Form 483, warning letter, or untitled letter with respect to any such facility, or otherwise alleged any material non-compliance with QSRs, nor has any other Governmental Authority issued any similar notices or warning letters. All such facilities are operated in compliance in all material respects with other applicable federal, state and local Laws.

 

(g)                                 No right of the Borrower or any Subsidiary to receive reimbursements pursuant to any government program or private program has ever been terminated or otherwise adversely affected as a result of any investigation or enforcement action, whether by any Governmental Authority or other Third Party, and none of the Borrower or any Subsidiary has been the subject of any inspection, investigation, or audit, by any Governmental Authority for the purpose of any alleged improper activity.

 

(h)                                There is no arrangement relating to the Borrower or any of its Subsidiaries providing for any rebates, kickbacks or other forms of compensation that are unlawful to be paid to any Person in return for the referral of business or for the arrangement for recommendation of such referrals. All billings by the Borrower or any of its Subsidiaries for their respective services have been true and correct in all material respects and, to the Borrower’s knowledge, are in compliance in all material respects with all applicable Laws, including the Federal False Claims Act or any applicable state false claim or fraud Law.

 

(i)                                    None of the Borrower or any of its Subsidiaries or, to the Borrower’s knowledge, any individual who is an officer, director, manager, employee, stockholder, agent or managing agent of the Borrower or of any of its Subsidiaries has been convicted of, charged with or, to the Borrower’s knowledge, investigated for any federal or state health program-related offense or any other offense related to healthcare or been excluded or suspended from participation in any such program or, to the Borrower’s knowledge, within the past five years, has been convicted of, charged with or, to the Borrower’s knowledge, investigated for a violation of Laws related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, or obstruction of an investigation, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary

 

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responsibility, financial misconduct, or obstruction of an investigation. None of the Borrower or any of its Subsidiaries or, to the Borrower’s knowledge, any individual who is an officer, director, manager, employee, stockholder, agent or managing agent of the Borrower or of any of its Subsidiaries has been convicted of any crime or engaged in any conduct that has resulted or would reasonably be expected to result in a debarment or exclusion under (i) 21 U.S.C. Section 335a, (ii) Section 1128 of the Social Security Act or (iii) any similar applicable Law. No debarment proceedings or investigations in respect of the business of the Borrower or any of its Subsidiaries are pending or, to the Borrower’s knowledge, threatened against the Borrower or any of its Subsidiaries or any individual who is an officer, director, manager, employee, stockholder, agent or managing agent of the Borrower or of any of its Subsidiaries.

 

(j)                                   All studies, tests and trials conducted relating to each Product, by or on behalf of the Borrower and the Subsidiaries and, to the knowledge of the Borrower, their respective licensees, licensors and Third Party services providers and consultants, have been conducted, and are currently being conducted, in accordance with all applicable Laws, procedures and controls pursuant to, where applicable, QSRs and current good laboratory practices. All results of such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to the Lender as requested by it. To the extent necessary by applicable Law, the Borrower or its applicable Subsidiary has obtained all necessary and material Regulatory Authorizations, including an Investigational Application for the conduct of any clinical investigations conducted by or on behalf of the Borrower or such Subsidiary.

 

(k)                                To the Borrower’s knowledge, none of the clinical investigators in any study, test or trial conducted by or on behalf of the Borrower or any of its Subsidiaries has been or is disqualified or otherwise sanctioned by the FDA, the U.S. Department of Health and Human Services, or any other Governmental Authority and, to the Borrower’s knowledge, no such disqualification, or other sanction of any such clinical investigator is pending or threatened. None of the Borrower or any of its Subsidiaries has received any written or, to Borrower’s knowledge, oral communication from the FDA or any other Governmental Authority requiring or threatening the termination or suspension of any study, test or trial conducted by, or on behalf of, the Borrower or any of its Subsidiaries.

 

(l)                                    The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair the Borrower’s or any of the Subsidiaries’ ownership of or rights under (or the license or other right to use, as the case may be) any Regulatory Authorizations relating to any Product in any material manner.

 

SECTION 6.19 Transactions with Affiliates. Except as set forth on Schedule 6.19, none of the Borrower or any Subsidiary has entered into, renewed, extended or been a party to, any transaction (including the purchase, sale, lease, transfer or exchange of property or assets of any kind or the rendering of services

 

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of any kind) with any of its Affiliates during the three-year period immediately prior to the Closing Date.

 

SECTION 6.20 Investment Company Act. None of the Borrower or any Subsidiary is an “investment company” or is “controlled” by an “investment company,” as such terms are defined in, or subject to regulation under, the Investment Company Act of 1940, as amended.

 

SECTION 6.21 OFAC. None of the Borrower, any Subsidiary or, to the knowledge of the Borrower, any Related Party (a) is currently the subject of any Sanctions, (b) is located, organized or residing in any Designated Jurisdiction, or (c) is or has been (within the previous five years) engaged in any transaction with any Person who is now or was then the subject of Sanctions or who is located, organized or residing in any Designated Jurisdiction. No Loan, nor the proceeds from any Loan, has been or will be used, directly or indirectly, to lend, contribute or provide to, or has been or will be otherwise made available to fund, any activity or business in any Designated Jurisdiction or to fund any activity or business of any Person located, organized or residing in any Designated Jurisdiction or who is the subject of any Sanctions, or in any other manner that will result in any violation by any Person (including the Lender and its Affiliates) of Sanctions.

 

SECTION 6.22 Deposit and Disbursement Accounts. Set forth on Schedule 6.22 is a complete and accurate list as of the Closing Date or Delayed Draw Closing Date, as the case may be, of all banks and other financial institutions at which the Borrower or any Subsidiary maintains deposit accounts, lockboxes, disbursement accounts, investment accounts or other similar accounts. Schedule 6.22 correctly identifies the name, address and telephone number of each bank or financial institution, the name in which each such account is held, the type of each such account, and the complete account number for each such account, and each such account is a Controlled Account (other than Excluded Accounts) as required pursuant to Section 7.13(a).

 

SECTION 6.23 LifeCell Payments. The “Installment Payment” (as defined in the LifeCell Agreement) that was payable on October 30, 2018, in accordance with the terms of the LifeCell Agreement was paid in full prior to the date hereof, exclusively with the proceeds of the issuance of Capital Securities of the Borrower.

 

ARTICLE VII

AFFIRMATIVE COVENANTS

 

The Borrower covenants and agrees with the Lender that until the Termination Date has occurred, the Borrower will, and will cause the Subsidiaries to, perform or cause to be performed the obligations set forth below.

 

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SECTION 7.1 Financial Information, Reports, Notices, Etc. The Borrower will furnish the Lender copies of the following financial statements, reports, notices and information:

 

(a)                                 as soon as available and in any event within 30 days after the end of each calendar month, in each case with supporting detail and certified as complete and correct by the chief financial or accounting Authorized Officer of the Borrower (subject to normal year-end audit adjustments): (i) unaudited reports of (A) the Revenue Base, the unit sales for each Product and the net revenues for each Product, in each case for such calendar month and for the period commencing at the end of the previous Fiscal Year and ending with the end of such calendar month, and including in comparative form the figures for the corresponding calendar month in, and the year-to-date portion of, the immediately preceding Fiscal Year and (B) the Liquidity of the Borrower at the end of such calendar month and at the end of the corresponding calendar month in the preceding Fiscal Year, in comparative form; and (ii) a report of the number of employees and independent contractors of the Borrower and its Subsidiaries (the “Headcount”) at the end of such calendar month, the Headcount at the end of the immediately preceding calendar month, a calculation showing the change in the Headcount, if any, and, if applicable, a brief description of any material change in the Headcount;

 

(b)                                as soon as available and in any event within 45 days after the end of each Fiscal Quarter, an unaudited consolidated balance sheet of the Borrower and the Subsidiaries as of the end of such Fiscal Quarter and consolidated statements of income and cash flow of the Borrower and the Subsidiaries for such Fiscal Quarter and for the period commencing at the end of the previous Fiscal Year and ending with the end of such Fiscal Quarter, and including (in each case) in comparative form the figures for the corresponding Fiscal Quarter in, and the year-to-date portion of, the immediately preceding Fiscal Year, certified as complete and correct by the chief financial or accounting Authorized Officer of the Borrower (subject to normal year- end audit adjustments);

 

(c)                                 as soon as available and in any event within 180 days after the end of each Fiscal Year, a copy of the consolidated balance sheet of the Borrower and the Subsidiaries, and the related consolidated statements of income and cash flow of the Borrower and the Subsidiaries for such Fiscal Year, setting forth in comparative form the figures for the immediately preceding Fiscal Year, audited (without any Impermissible Qualification) by independent public accountants acceptable to the Lender, which shall include a statement that, in performing the examination necessary to deliver the audited financial statements of the Borrower, no knowledge was obtained by such independent public accountants of any Event of Default;

 

(d)                                concurrently with the delivery of the financial information pursuant to clauses (b) and (c), a Compliance Certificate, executed by the chief financial or accounting Authorized Officer of the Borrower, (i) showing compliance with the covenant set forth in Section 8.4, (ii) stating that no Default has occurred and is continuing (or, if a Default has occurred, specifying the details of such Default and

 

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the action that the Borrower or any of the Subsidiaries has taken or proposes to take with respect thereto), (iii) stating that no Subsidiary has been formed or acquired since the delivery of the last Compliance Certificate (or, if a Subsidiary has been formed or acquired since the delivery of the last Compliance Certificate, a statement that such Subsidiary has complied with Section 7.8) and (iv) stating that no real property has been acquired by the Borrower or any of the Subsidiaries since the delivery of the last Compliance Certificate (or, if any real property has been acquired since the delivery of the last Compliance Certificate, a statement that the Borrower has complied with Section 7.8 with respect to such real property);

 

(e)                                 as soon as possible and in any event within three days after the Borrower obtains knowledge of the occurrence of a Default, a statement of an Authorized Officer of the Borrower setting forth details of such Default and the action which the Borrower or any of the Subsidiaries has taken or proposes to take with respect thereto;

 

(f)                                   as soon as possible and in any event within three days after the Borrower obtains knowledge thereof, notice of the commencement of, or any material adverse development with respect to, any litigation, action, proceeding or labor controversy of the type and materiality described in Section 6.7; and, in each case in this Section 7.1(f), to the extent the Lender requests, copies of all documentation relating thereto;

 

(g)                                as soon as possible and in any event within three days after the Borrower obtains knowledge thereof, notice of any return, recovery, dispute or claim related to any Product or inventory that involves more than $250,000;

 

(h)                                as soon as possible and in any event within three days after the Borrower obtains knowledge thereof, notice of (i) any claim that the Borrower, any of the Subsidiaries or one of their ERISA Affiliates has actual or potential liability under a Benefit Plan, (ii) any effort to unionize the employees of the Borrower or any Subsidiary, or (iii) correspondence with the Internal Revenue Service regarding the qualification of a retirement plan under section 401(a) of the Code;

 

(i)                                    promptly after the sending or filing thereof, copies of all reports, notices, prospectuses and registration statements which the Borrower or any of the Subsidiaries files with the SEC or any national securities exchange, unless, so long as the Borrower or such Subsidiary, as the case may be, is a Publicly Reporting Company, copies of such reports, notices, prospectuses and registration statements are publicly available on the SEC’s EDGAR system within two Business Days of the sending or filing thereof;

 

(j)                                   so long as the Borrower is not a Publicly Reporting Company, concurrently with delivery thereof to the board of directors of the Borrower or any committees thereof, all notices and any materials delivered to the board of directors of the Borrower or any committees thereof in connection with a meeting of such board or committee, or with any action to be taken by written consent, including drafts of

 

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any material resolutions or actions proposed to be adopted by written consent; provided that the Borrower may withhold any such information and materials to the extent: (i) access thereto would adversely affect the attorney-client privilege between the Borrower and its counsel; or (ii) the Borrower’s board of directors, in the exercise of its fiduciary obligations and with the advice of counsel, determines that (A) it is in the best interest of the Borrower to do so because the Lender or any of its Affiliates has an interest in the subject matter under discussion or (B) doing so is necessary to discharge the directors’ fiduciary duties. In the event the Borrower withholds any such information or materials, the Borrower shall provide to the Lender a general description, which shall be true and correct in all material respects, of such withheld information;

 

(k)                                 promptly upon receipt thereof, copies of all “management letters” (or equivalent) submitted to the Borrower or any of the Subsidiaries by the independent public accountants referred to in clause (c) in connection with each audit made by such accountants;

 

(l)                                    (i) within 45 days after the end of each Fiscal Quarter, a report listing (A) all Material Agreements and Key Contracts entered into during such Fiscal Quarter, (B) all existing Material Agreements or Key Contracts amended or terminated during such Fiscal Quarter, (C) all Permits, including all Regulatory Authorizations, issued to the Borrower or any of the Subsidiaries during such Fiscal Quarter and (D) all notices and registrations filed by the Borrower or any Subsidiary during such Fiscal Quarter in each jurisdiction in which the Borrower or any of the Subsidiaries are required to obtain any Permit or Regulatory Authorization or to file any notice or registration, in order to design, manufacture, store, label, sell, promote, import or distribute any Product; and (ii) as soon as possible, and in any event within three days, after the Lender so requests, copies of any such Material Agreement, Key Contract, amendment or termination instrument, Permit, Regulatory Authorization, notice or registration, in each case as are listed in such report;

 

(m)                            as soon as possible and in any event within three days after receipt by, or delivery by, the Borrower, as the case may be, copies of any material written notice of material written correspondence relating to, or involving, any Key Contract, including any notice alleging breach or default under any Key Contract by any party thereto;

 

(n)                                as soon as available, but in any event not later than January 31 of each calendar year (or such later date to the extent that the Borrower’s board of directors elects to defer the approval thereof, but in any event no later than March 31 of each calendar year), the Borrower’s financial and sales projections and budget for such calendar year, with evidence of approval thereof by the Borrower’s board of directors; and

 

(o)                                such other financial and other information as the Lender may from time to time reasonably request (including information and reports in such detail as

 

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the Lender may request with respect to the terms of and information provided pursuant to the Compliance Certificate).

 

SECTION 7.2 Maintenance of Existence; Compliance with Contracts, Laws, Etc. Each of the Borrower and each Subsidiary will (a) preserve and maintain its legal existence (except as otherwise permitted by Section 8.7), (b) except as set forth on Schedule 7.2(b), perform in all material respects its obligations under all Material Agreements and Key Contracts, in each case to which the Borrower or any of the Subsidiaries is a party, and (c) comply in all material respects with all applicable Laws, rules, regulations and orders, including the payment (before the same become delinquent), of all Taxes, imposed upon the Borrower or any of the Subsidiaries or upon their property except to the extent being diligently contested in good faith by appropriate proceedings and for which adequate reserves in accordance with GAAP have been set aside on the books of the Borrower or any of the Subsidiaries, as applicable.

 

SECTION 7.3 Maintenance of Properties. Each of the Borrower and the Subsidiaries will maintain, preserve, protect and keep its and their respective properties in good repair, working order and condition (ordinary wear and tear excepted), and make necessary repairs, renewals and replacements so that the business carried on by the Borrower or any of the Subsidiaries may be properly conducted in all material respects at all times, unless the Borrower or any of the Subsidiaries determines in good faith that the continued maintenance of such property is no longer economically desirable, necessary or useful to the business of the Borrower or any of the Subsidiaries or the Disposition of such property is otherwise permitted by Section 8.7 or Section 8.8.

 

SECTION 7.4 Insurance. Each of the Borrower and each of the Subsidiaries will maintain:

 

(a)                                 insurance on its property with financially sound and reputable insurance companies against business interruption, loss and damage in at least the amounts (and with only those deductibles) customarily maintained, and against such risks as are typically insured against in the same general area, by Persons of comparable size engaged in the same or similar business as the Borrower and the Subsidiaries; and

 

(b)                                all worker’s compensation, employer’s liability insurance or similar insurance as may be required under the Laws of any state or jurisdiction in which it may be engaged in business.

 

Without limiting the foregoing, all insurance policies required pursuant to this Section 7.4 shall (i)        name the Lender as mortgagee and loss payee (in the case of property insurance) and additional insured (in the case of liability insurance), as applicable, and provide that no cancellation or modification as to the amount or scope of coverage of the policies will be made without the prior written consent of the Lender and (ii) be in addition to any requirements to maintain specific types of insurance contained in the other Loan Documents.

 

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SECTION 7.5 Books and Records. Each of the Borrower and each of the Subsidiaries will keep books and records in accordance with GAAP which accurately reflect all of its business affairs and transactions and will permit the Lender or any of its representatives, at reasonable times and intervals upon reasonable notice to the Borrower, to visit the Borrower’s or any of the Subsidiaries’ offices, to discuss the Borrower’s or any of the Subsidiaries’ financial or other matters with its officers and employees, and its independent public accountants and to examine (and photocopy extracts from) any of its books and records. The Borrower shall pay any fees of such independent public accountant incurred in connection with the Lender’s exercise of its rights pursuant to this Section 7.5.

 

SECTION 7.6 Environmental Law Covenant. Each of the Borrower and each of the Subsidiaries will (a) use and operate all of its and their businesses, facilities and properties in material compliance with all Environmental Laws, and keep and maintain all Environmental Permits and remain in compliance therewith in all material respects, and (b) promptly notify the Lender of, and provide the Lender with copies of all material claims, complaints, notices or inquiries relating to, any actual or alleged non-compliance with any Environmental Laws or Environmental Permits or any actual or alleged Environmental Liabilities. The Borrower and each of the Subsidiaries will promptly resolve, remedy and mitigate any such non-compliance or Environmental Liabilities, and shall keep the Lender informed as to the progress of same.

 

SECTION 7.7 Use of Proceeds. The Borrower will apply the proceeds of the Loan according to the sources and uses table in Schedule 7.7.

 

SECTION 7.8 Future Guarantors, Security, Etc. The Borrower and each Subsidiary will execute any documents, financing statements, agreements and instruments, and will take all further action that may be required under applicable Law, or that the Lender may reasonably request, in order to effectuate the transactions contemplated by the Loan Documents and in order to grant, preserve, protect and perfect the validity and first priority (subject to Liens permitted by Section 8.3) of the Liens created or intended to be created by the Loan Documents. The Borrower will (a) cause any subsequently acquired or organized Subsidiary that qualifies as a Material Subsidiary to, and (b) as promptly as practicable but in no event later than 15 days (or such later date as may be agreed upon by the Lender) after any Subsidiary qualifies independently as, or is designated by the Borrower or the Lender as, a Material Subsidiary, provide the Lender with written notice thereof and cause each such Subsidiary to, in each case of clauses (a) or (b), become a Guarantor and execute a supplement (in form and substance satisfactory to the Lender) to the Guarantee and each other applicable Loan Document in favor of the Lender and take such other actions as may be required or reasonably requested for the Lender to have a valid Lien with the priority intended to be created on and security interest in all of the assets of such Material Subsidiary, subject to no other Liens (other than Liens permitted by Section 8.3), in each case effective upon its acquisition or formation, or qualification or designation as a Material Subsidiary, as the case may be. The Borrower will

 

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promptly notify the Lender of any subsequently acquired ownership interest in real property by the Borrower or by any Subsidiary and will provide the Lender with a description of such real property, the acquisition date thereof and the purchase price therefor. In addition, from time to time, each of the Borrower and each of the Material Subsidiaries will, at its cost and expense, promptly secure the Obligations by pledging or creating, or causing to be pledged or created, perfected Liens with respect to such of its assets and properties as the Lender shall designate, it being agreed that it is the intent of the Parties that the Obligations shall be secured by, among other things, substantially all the assets of the Borrower and the Material Subsidiaries (including real property and personal property acquired subsequent to the Closing Date). Such Liens will be created under the Loan Documents in form and substance satisfactory to the Lender, and the Borrower and each of the Material Subsidiaries shall deliver or cause to be delivered to the Lender all such instruments and documents (including mortgages, legal opinions, title insurance policies and lien searches) as the Lender shall reasonably request to evidence compliance with this Section 7.8.

 

SECTION 7.9 Obtaining of Permits, Etc. With respect to each Product, each of the Borrower and each of the Subsidiaries will obtain, maintain and preserve, and take all necessary action to timely renew all Permits and accreditations which are necessary in the proper conduct of its business.

 

SECTION 7.10 Permits. The Borrower and each of the Subsidiaries shall maintain each material Permit, including each material Regulatory Authorization, from, or file any notice or registration in, each jurisdiction in which the Borrower or any of the Subsidiaries are required to obtain any Permit or Regulatory Authorization or to file any notice or registration, in order to design, store, label, sell, promote, import, distribute or, if applicable after the date hereof, manufacture, any Product.

 

SECTION 7.11 Maintenance of Regulatory Authorizations, Contracts, Intellectual Property, Etc.

 

(a)                                 With respect to the Products, each of the Borrower and each of the Subsidiaries will: (i) maintain in full force and effect all material Regulatory Authorizations, contract rights, authorizations or other rights necessary for the operations of its business; (ii) notify the Lender, promptly after learning thereof, of any product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like conducted, to be undertaken or issued, by the Borrower, any of the Subsidiaries or their respective suppliers whether or not at the request, demand or order of any Governmental Authority or otherwise with respect to any Product, or any basis for undertaking or issuing any such action or item; (iii) design, store, label, sell, promote, import, distribute and manufacture (or use reasonable best efforts to cause their respective suppliers to manufacture, as the case may be) all Products in compliance in all material respects with QSRs, the FD&C Act and other applicable Laws; (iv) conduct all studies, tests and trials relating to the Products in accordance with all cGCPs, and other applicable Laws; (v) operate (or use reasonable best efforts to cause their respective suppliers to operate, as the case may be) all manufacturing

 

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facilities in compliance in all material respects with QSRs and all other applicable Laws; (vi) maintain in full force and effect or pursue the prosecution of, as the case may be, and pay all costs and expenses relating to, all Intellectual Property owned or controlled by the Borrower or any of the Subsidiaries and all Material Agreements, except in the event that the Borrower determines in its reasonable commercial judgment not to do so, and all Key Contracts (other than the Endoform Development Agreement #1); (vii) notify the Lender, promptly after learning thereof, of any Infringement or other violation by any Person of its Intellectual Property and use commercially reasonable efforts to pursue any such Infringement or other violation except in any specific circumstances where both (A) the Borrower or any of the Subsidiaries are able to demonstrate that it is not commercially reasonable to do so and (B) where not doing so does not materially adversely affect any Product; (viii) use commercially reasonable efforts to pursue and maintain in full force and effect legal protection for, and protect against Infringement with respect to, all Intellectual Property, including Patents, developed or controlled by the Borrower or any of the Subsidiaries; and (ix) notify the Lender, promptly after the Borrower obtains knowledge thereof, of any claim by any Person that the conduct of the Borrower’s or any of the Subsidiaries’ or any of their respective suppliers’ business (including the development, manufacture, use, sale or other commercialization of any Product) Infringes any Intellectual Property of that Person and use commercially reasonable efforts to resolve such claim, except where the Borrower determines in its reasonable commercial judgment not to do so.

 

(b)                                 Each of the Borrower and its Subsidiaries will furnish to the Lender prompt written notice of the following, and, with respect to clauses (i) and (ii) below, copies of any notices from, or responses to, the FDA or other Governmental Authority:

 

(i)                                     any notice that the FDA or other Governmental Authority is limiting, suspending or revoking any Regulatory Authorization, changing the market classification or labeling of or otherwise materially restricting any Product, or considering any of the foregoing;

 

(ii)                                  the Borrower or any of its Subsidiaries, or to the Borrower’s knowledge any of its or their suppliers, becoming subject to any administrative or regulatory action, any FDA or any other Governmental Authority inspection or any non-routine inspection by any other Person, receipt of inspectional observations (e.g., on FDA Form 483), warning letter, untitled letter, or notice of violation letter, or any Product being seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing or import alert, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, suspension, import detention or refusal, or seizure of any Product, or if any of the foregoing are pending or threatened in writing or, to Borrower’s knowledge, orally, against the Borrower, any of its Subsidiaries or, to the Borrower’s knowledge, any of its or their suppliers, or if the Borrower, any of its Subsidiaries or, to the Borrower’s knowledge, any of its or their suppliers become subject to a consent decree; or

 

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(iii)                               copies of any written recommendation from any Governmental Authority or other regulatory body that the Borrower or any of its Subsidiaries, or any obligor to which the Borrower or any of its Subsidiaries provides services, should have its licensure, clearances, provider or supplier number, or accreditation suspended, revoked, or limited in any way, or any penalties or sanctions imposed.

 

SECTION 7.12 Inbound Licenses. Each of the Borrower and the Subsidiaries will, promptly after entering into or becoming bound by any inbound license or agreement (other than over-the-counter or “open-source” software that is commercially available to the public) in respect of any Intellectual Property: (a) provide written notice to the Lender of the material terms of such license or agreement with a description of its anticipated and projected impact on the Borrower’s and the Subsidiaries’ business and financial condition; and (b) take such commercially reasonable actions as the Lender may reasonably request to obtain the consent of, or waiver by, any Person whose consent or waiver is necessary for the Lender to be granted and perfect a valid security interest in such license or agreement and to fully exercise its rights under any of the Loan Documents in the event of a disposition or liquidation of the rights, assets or property that is the subject of such license or agreement.

 

SECTION 7.13 Cash Management. Each of the Borrower and the Material Subsidiaries will:

 

(a)                                 maintain a current and complete list of all accounts (of the type initially set forth on Schedule 6.22) and (other than (i) the account described in Section 8.3(m) and (ii) accounts exclusively used for payroll, payroll Taxes and other employee wage and benefit programs to or for the benefit of the Borrower’s or a Subsidiary’s employees, which shall in no event hold in the aggregate more than the amount reasonably expected to meet such payroll expenses for the following calendar month, including bonuses and other payments to be paid within the following calendar month (collectively, the “Excluded Accounts”)) promptly deliver any updates to such list to the Lender; execute and maintain an account control agreement for each such account (other than the Excluded Accounts), in form and substance reasonably acceptable to the Lender (each such account, a “Controlled Account”); and maintain each such Controlled Account as a cash collateral account, with all cash, checks and other similar items of payment in such account securing payment of the Obligations (and in which the Borrower and the Subsidiaries shall have granted a Lien to the Lender);

 

(b)                                deposit promptly after the date of receipt thereof in accordance with prudent business practices all cash, checks, drafts or other similar items of payment relating to or constituting payments made in respect of any and all accounts and other rights and interests into Controlled Accounts except to the extent permitted to be kept in Excluded Accounts; and

 

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(c)                                 at any time after the occurrence and during the continuance of an Event of Default, at the request of the Lender, promptly cause all payments constituting proceeds of accounts to be directed into lockbox accounts under agreements in form and substance satisfactory to the Lender.

 

SECTION 7.14 LifeCell Payments. The Borrower shall (a) pay when due each remaining “Installment Payment” (as defined in the LifeCell Agreement) payable in accordance with the terms of the LifeCell Agreement and (b) make such payments exclusively by using the proceeds of the issuance of Capital Securities of the Borrower after the date hereof.

 

ARTICLE VIII 
 NEGATIVE COVENANTS

 

The Borrower covenants and agrees with the Lender that until the Termination Date has occurred, the Borrower and the Subsidiaries will perform or cause to be performed the obligations set forth below.

 

SECTION 8.1 Business Activities. None of the Borrower or any of the Subsidiaries will engage in any business activity except those business activities engaged in on the date of this Agreement and activities reasonably incidental thereto.

 

SECTION 8.2 Indebtedness. None of the Borrower or any of the Subsidiaries will create, incur, assume or permit to exist any Indebtedness, other than:

 

(a)                                 Indebtedness in respect of the Obligations;

 

(b)                                until the Closing Date, Indebtedness that is to be repaid in full as further identified in Schedule 8.2(b);

 

(c)                                 Indebtedness existing as of the Closing Date which is identified in Schedule 8.2(c), and refinancing of such Indebtedness in a principal amount not in excess of that which is outstanding on the Closing Date (as such amount may have been reduced following the Closing Date);

 

(d)                                unsecured Indebtedness in respect of performance, surety or appeal bonds provided in the ordinary course of business in an aggregate amount at any time outstanding not to exceed $250,000;

 

(e)                                  Purchase Money Indebtedness and Capitalized Lease Liabilities in a principal amount not to exceed $500,000 in the aggregate outstanding at any time;

 

(f)                                   Permitted Subordinated Indebtedness;

 

(g)                                Indebtedness of any Guarantor or the Borrower owing to the Borrower or any Guarantor;

 

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(h)                                Indebtedness of any Subsidiaries that are not Guarantors owing to the Borrower or any Guarantors, in an aggregate amount at any time outstanding not to exceed $500,000;

 

(i)                                    Indebtedness incurred as a result of endorsing negotiable instruments received in the ordinary course of business;

 

(j)                                   so long as there exists no Event of Default both immediately before and immediately after giving effect to any such transaction, Indebtedness existing or arising under any Hedging Obligations; provided, however, that such obligations are (or were) entered into by the Borrower or the applicable Subsidiaries in the ordinary course of business for the sole purpose of directly mitigating risks associated with liabilities, commitments, investments, assets, or property held or reasonably anticipated by the Borrower, and not for purposes of speculation;

 

(k)                                Indebtedness not to exceed $500,000 in the aggregate at any time outstanding owed to any Person providing property, casualty, liability, or other insurance to the Borrower and the Subsidiaries, including to finance insurance premiums, so long as the amount of such Indebtedness is not in excess of the amount of the unpaid cost of, and shall be incurred only to defer the cost of, such insurance for the policy year in which such Indebtedness is incurred and such Indebtedness is outstanding only during such policy year;

 

(l)                                    unsecured Indebtedness of the Borrower consisting of (i) the “Installment Payments” (as defined in the LifeCell Agreement) payable in accordance with the terms of the LifeCell Agreement and (ii) the “Operational Milestone Payments” and “Revenue Milestone Payments” (each as defined in the Aroa Umbrella Agreement) payable in accordance with the terms of the Aroa Umbrella Agreement; provided that Borrower shall not make any payment in respect of any of the foregoing if an Event of Default has occurred and is continuing (or would result from the making of such payment); and

 

(m)                            other Indebtedness of the Borrower and the Subsidiaries in an aggregate amount at any time outstanding not to exceed $250,000;

 

provided that no Indebtedness otherwise permitted by clauses (c), (e), (f), (g), (h), (j) or (m) shall be assumed, created or otherwise incurred if a Default has occurred and is then continuing or would result therefrom.

 

SECTION 8.3 Liens. None of the Borrower or any of the Subsidiaries will create, incur, assume or permit to exist any Lien upon any of its property (including Capital Securities of any Person), revenues or assets, whether now owned or hereafter acquired, except:

 

(a)                                Liens securing payment of the Obligations;

 

(b)                                until the Closing Date, Liens securing payment of Indebtedness of the type described in Section 8.2(b);

 

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(c)                                 Liens existing as of the Closing Date and disclosed in Schedule 8.3(c) securing Indebtedness described in Section 8.2(c), and refinancings of such Indebtedness; provided that no such Lien shall encumber any additional property and the amount of Indebtedness secured by such Lien is not increased from that existing on the Closing Date (as such Indebtedness may have been reduced following the Closing Date);

 

(d)                                Liens securing payment of Permitted Subordinated Indebtedness that are (i) subordinate to the Liens securing payment of the Obligations and all other Indebtedness owing from the Borrower or the Subsidiaries to the Lender and (ii) subject to a written subordination agreement satisfactory to the Lender in its sole discretion;

 

(e)                                 Liens securing Indebtedness of the Borrower or the Subsidiaries permitted pursuant to Section 8.2(e); provided that (i) such Liens shall be created within 180 days of the acquisition of the assets financed with such Indebtedness and (ii) such Liens do not at any time encumber any property other than the property so financed;

 

(f)                                  Liens in favor of carriers, warehousemen, mechanics, materialmen and landlords granted in the ordinary course of business for amounts not overdue or being diligently contested in good faith by appropriate proceedings and for which adequate reserves in accordance with GAAP shall have been set aside on its books;

 

(g)                                 Liens incurred or deposits made in the ordinary course of business in connection with worker’s compensation, unemployment insurance or other forms of governmental insurance or benefits, or to secure performance of tenders, statutory obligations, bids, leases or other similar obligations (other than for borrowed money) entered into in the ordinary course of business or to secure obligations on surety and appeal bonds or performance bonds;

 

(h)                                judgment Liens in existence for less than 45 days after the entry thereof or with respect to which execution has been stayed or to the extent that the payment thereof in the aggregate is not more than $250,000 in excess of the applicable insurance coverage (subject to a customary deductible) maintained with responsible insurance companies, each of which do not otherwise result in an Event of Default under Section 9.1(f);

 

(i)                                    easements, rights-of-way, zoning restrictions, minor defects or irregularities in title and other similar encumbrances not interfering in any material respect with the value or use of the property to which such Lien is attached;

 

(j)                                   Liens for Taxes not at the time delinquent or thereafter payable without penalty or being diligently contested in good faith by appropriate proceedings and for which adequate reserves in accordance with GAAP shall have been set aside on its books;

 

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(k)                                licenses or sublicenses of Intellectual Property otherwise permitted under this Agreement or the other Loan Documents, and restrictions under licenses of Intellectual Property entered into in the ordinary course of business pursuant to which the Borrower is a licensee;

 

(l)                                    banker’s liens, rights of setoff and Liens in favor of financial institutions incurred in the ordinary course of business arising in connection with the Borrower’s or any Subsidiary’s deposit accounts or securities accounts held at such institutions to secure solely payment of fees and similar costs and expenses; provided that such accounts are maintained in compliance with Section 7.13(a); and

 

(m)                            Liens on no more than one collateral bank account securing any letter of credit in favor of the Borrower’s landlord under the lease for the Borrower’s corporate offices; provided that (i) such bank account is used exclusively for the purpose described in this Section 8.3(m) and (ii) the outstanding balance of such bank account shall not be more than $50,000 at any time.

 

The Lender agrees to execute and deliver such collateral subordination agreements and related documents as reasonably requested of it to confirm the priority of the Liens permitted pursuant to Section 8.3(e).

 

SECTION 8.4 Minimum Liquidity. The Liquidity of the Borrower shall not at any time be less than $2,000,000. The Borrower shall maintain an amount equal to the amount required under this Section 8.4, along with its other cash and Cash Equivalent Investments, in a Controlled Account as required pursuant to Section 7.13(a).

 

SECTION 8.5 Investments. None of the Borrower or any of the Subsidiaries will purchase, make, incur, assume or permit to exist any Investment in any other Person, except:

 

(a)                                Investments existing on the Closing Date and identified in Schedule 8.5(a);

 

(b)                                Cash Equivalent Investments;

 

(c)                                 Investments received in connection with the bankruptcy or reorganization of, or settlement of delinquent accounts and disputes with, customers and suppliers, in each case in the ordinary course of business;

 

(d)                                Investments consisting of any deferred portion of the sales price received by the Borrower or any of the Subsidiaries in connection with any Disposition permitted under Section 8.8;

 

(e)                                  Investments constituting (i) accounts receivable arising, (ii) trade debt granted, or (iii) deposits made, in each case of clauses (i) through (iii), in connection with the purchase price of goods or services, in each case in the ordinary course of business;

 

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(f)                                  Permitted Acquisitions;

 

(g)                                 Investments by the Borrower or any Guarantor in the Borrower or any Guarantor;

 

(h)                                Investments by the Borrower in any Subsidiary that is not a Guarantor, in an aggregate amount not to exceed $500,000 for all such Investments;

 

(i)                                    Investments consisting of the endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of business;

 

(j)                                   Investments consisting of (i) travel advances and employee relocation loans and other employee loans and advances in the ordinary course of business and (ii) loans to employees, officers or directors relating to the purchase of equity securities of the Borrower pursuant to employee stock purchase plans or agreements approved by the Borrower’s board of directors (or applicable committee thereof); provided that the aggregate of all such loans outstanding pursuant to this Section 8.5(j) may not exceed $250,000 at any time;

 

(k)                                Investments (including debt obligations) received in connection with the bankruptcy or reorganization of customers or suppliers and in settlement of delinquent obligations of, and other disputes with, customers or suppliers arising in the ordinary course of business;

 

(l)                                    Investments consisting of notes receivable of, or prepaid royalties and other credit extensions, to customers and suppliers who are not Affiliates, in the ordinary course of business, in an aggregate amount not to exceed $250,000; and

 

(m)                            other Investments in an aggregate amount not to exceed $250,000 over the term of this Agreement.

 

SECTION 8.6 Restricted Payments, Etc. None of the Borrower or any of the Subsidiaries will declare or make a Restricted Payment, or make any deposit for any Restricted Payment, other than (a) Restricted Payments made by the Borrower or any Subsidiary to the Borrower or any Guarantor and (b) as payment for the repurchase of Capital Securities of the Borrower from employees upon their termination of employment in the ordinary course of business, such payments pursuant to this clause (b) not to exceed an aggregate amount of $250,000 over the term of this Agreement.

 

SECTION 8.7 Consolidation, Merger; Permitted Acquisitions, Etc. None of the Borrower or any of the Subsidiaries will liquidate or dissolve, consolidate with, or merge into or with, any other Person, or purchase or otherwise acquire all or substantially all of the assets of any Person (or any division thereof), other than in connection with a Permitted Acquisition, except that, so long as no Event of Default has occurred and is continuing (or would occur), any Subsidiary may liquidate or dissolve voluntarily into, and may merge with and into, the Borrower or any Subsidiary; and provided that, in connection with any Permitted

 

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Acquisition, the Borrower or any Subsidiary may merge into or consolidate with any other Person or permit any other Person to merge into or consolidate with it, so long as (a) the Person surviving such merger with any Subsidiary shall be a direct or indirect wholly owned Subsidiary of the Borrower and, if qualifying as a Material Subsidiary, it shall be a Guarantor, and (b) in the case of any such merger to which the Borrower is a party, the Borrower is the surviving Person.

 

SECTION 8.8 Permitted Dispositions. None of the Borrower or any of the Subsidiaries will Dispose of any of its assets (including accounts receivable and Capital Securities of the Borrower or Subsidiaries) to any Person in one transaction or series of transactions unless such Disposition is:

 

(a)                                of inventory;

 

(b)                                 of obsolete, damaged, worn out or surplus property Disposed of in the ordinary course of business;

 

(c)                                  of property the continued maintenance of which the Borrower determines in good faith is no longer economically desirable, necessary or useful to the business of the Borrower or any of the Subsidiaries;

 

(d)                                 the abandonment or lapse of Intellectual Property that the Borrower determines in good faith is no longer useful in the conduct of the business of the Borrower or any of the Subsidiaries;

 

(e)                                  any sales, forgiveness or discounting, on a non-recourse basis and in the ordinary course of business, of past due accounts receivable in connection with the collection or compromise thereof or the settlement of delinquent accounts receivable or in connection with the bankruptcy or reorganization of suppliers or customers in accordance with the applicable terms of this Agreement;

 

(f)                                  permitted by Section 8.7; or

 

(g)                                 described on Schedule 8.8;

 

provided that no Dispositions shall be of any Key Contract or any rights thereunder, or any assets of the Borrower or any Subsidiary used or necessary thereunder.

 

SECTION 8.9 Modification of Certain Agreements. Except as described on Schedule 8.9, none of the Borrower or any of the Subsidiaries will consent to any amendment, supplement, waiver or other modification of, or enter into any forbearance from exercising any rights with respect to, the terms or provisions contained in (a) any Organic Documents, if the result would have an adverse effect on the rights or remedies of the Lender under this Agreement or any Loan Document, (b) any agreement governing any Permitted Subordinated Indebtedness, if the result would shorten the maturity date thereof or advance the date on which any cash payment is required to be made thereon or would otherwise change any terms thereof in a manner adverse to the Lender, or (c) any

 

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Key Contract, if the result could reasonably be expected to have an adverse effect in any material respect on the Lender. None of the Borrower or any of the Subsidiaries will (i) terminate or agree to the termination of any Key Contract for any reason, (ii) fail to enforce any of its rights under any Key Contract, or (ii) agree to any assignment or transfer of any Key Contract, or any rights or obligations thereunder, by any party thereto.

 

SECTION 8.10 Transactions with Affiliates. Except as set forth on Schedule 8.10, none of the Borrower or any of the Subsidiaries will enter into or cause or permit to exist any arrangement, transaction or contract (including for the purchase, lease or exchange of property or the rendering of services) with any of its Affiliates, unless such arrangement, transaction or contract (a) is on fair and reasonable terms no less favorable to the Borrower or any Subsidiary than it could obtain in an arm’s-length transaction with a Person that is not one of its Affiliates and (b) is of the kind which would be entered into by a prudent Person in its position with a Person that is not one of its Affiliates.

 

SECTION 8.11 Restrictive Agreements, Etc. None of the Borrower or any of the Subsidiaries will enter into any agreement prohibiting (a) the creation or assumption of any Lien upon its properties, revenues or assets, whether now owned or hereafter acquired, (b) the ability of the Borrower or any Subsidiary to amend or otherwise modify any Loan Document, or (c) the ability of the Borrower or any Subsidiary to make any payments, directly or indirectly, to the Borrower, including by way of dividends, advances, repayments of loans, reimbursements of management and other intercompany charges, expenses and accruals or other returns on investments. The foregoing prohibitions shall not apply to restrictions contained (i) in any Loan Document, or (ii) in the case of clause (a), in any agreement governing any Indebtedness permitted by Section 8.2(e) as to the assets financed with the proceeds of such Indebtedness.

 

SECTION 8.12 Sale and Leaseback. None of the Borrower or any of the Subsidiaries will directly or indirectly enter into any agreement or arrangement providing for the sale or transfer by it of any property (now owned or hereafter acquired) to a Person and the subsequent lease or rental of such property or other similar property from such Person.

 

SECTION 8.13 Product Agreements. None of the Borrower or any of the Subsidiaries will enter into any amendment with respect to any existing Product Agreement or enter into any new Product Agreement that contains (a) any provision that permits any counterparty other than the Borrower or any of the Subsidiaries to terminate such Product Agreement for any reason related to the insolvency or change of control of the Borrower or any of the Subsidiaries or assignment of such Product Agreement by the Borrower or any of the Subsidiaries, (b) any provision which restricts or penalizes a security interest in, or the assignment of, any Product Agreements, upon the sale, merger or other Disposition of all or a material portion of a Product to which such Product Agreement relates, or (c) any other provision that has or is likely to adversely

 

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affect, in any material respect, any Product to which such agreement relates or the Lender’s rights hereunder.

 

SECTION 8.14 Change in Name, Location or Executive Office or Executive Management; Change in Fiscal Year. None of the Borrower or any of the Subsidiaries will (a) change its legal name or any trade name used to identify it in the conduct of its business or ownership of its properties, (b) change its jurisdiction of organization or legal structure, (c) relocate its chief executive office, principal place of business or any office in which it maintains books or records relating to its business (including the establishment of any new office or facility) (d) change its federal taxpayer identification number or organizational number (or equivalent) without 30 days’ prior written notice to the Lender, (e) replace its chief executive officer or any future chief financial officer without written notification to the Lender within 30 days thereafter, (f) change its Fiscal Year or any of its Fiscal Quarters, or (g) enter into any Division/Series Transaction, or permit any of its Subsidiaries to enter into, any Division/Series Transaction (it being understood that none of the provisions in this Agreement nor any other Loan Document shall be deemed to permit any Division/Series Transaction).

 

SECTION 8.15 Benefit Plans and Agreements. None of the Borrower or any Subsidiary will (a) become the sponsor of, incur any responsibility to contribute to or otherwise incur actual or potential liability with respect to, any Benefit Plan, (b) allow any “employee benefit plan” as defined in section 3(3) of ERISA that provides retirement benefits, is sponsored by the Borrower, any Subsidiary or any of their ERISA Affiliates, and is intended to be Tax qualified under section 401 or 501 of the Code to cease to be Tax qualified, (c) allow the assets of any Tax qualified retirement plan to become invested in Capital Securities of the Borrower or any Subsidiary, (d) allow any employee benefit plan, program or arrangement sponsored, maintained, contributed to or required to be contributed to by the Borrower or any Subsidiary to fail to comply in all material respects with its terms and applicable Laws, or (e) allow any employee benefit plan as defined in section 3(3) of ERISA that provides medical, dental, vision, or long-term disability benefits and that is sponsored by the Borrower or any of its Subsidiaries or any of their ERISA Affiliates (or under which any of these Persons has any actual or potential liability), to cease to be fully insured by a third party insurance company. None of the Borrower or any of its Subsidiaries will enter into any employment, severance, change in control, independent contractor, or consulting agreements or grant any equity awards other than in the ordinary course of business and consistent with past practice.

 

ARTICLE IX

EVENTS OF DEFAULT

 

SECTION 9.1 Listing of Events of Default. Each of the following events or occurrences described in this Article IX shall constitute an “Event of Default”:

 

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(a)                                Non-Payment of Obligations.    The Borrower shall default in the payment or prepayment when due of (i) any principal of or interest on any Loan, or (ii) any fee described in Article III or any other monetary Obligation, and in the case of clause (ii) such default shall continue unremedied for a period of two Business Days after such amount was due.

 

(b)                                Breach of Warranty. Any representation or warranty made or deemed to be made by the Borrower or any of the Subsidiaries in any Loan Document (including any certificates delivered pursuant to Article V) is or shall be incorrect in any material respect when made or deemed to have been made.

 

(c)                                  Non-Performance of Certain Covenants and Obligations. The Borrower or any Subsidiary shall default in the due performance or observance of any of its obligations under Section 7.1, Section 7.7, Section 7.14 or Article VIII.

 

(d)                                Non-Performance of Other Covenants and Obligations. The Borrower or any Subsidiary shall default in the due performance and observance of any other covenant, obligation or agreement contained in any Loan Document executed by it, and such default shall continue unremedied for a period of 30 days after the earlier to occur of (i) notice thereof given to the Borrower by the Lender or (ii) the date on which the Borrower or any Subsidiary has knowledge of such default.

 

(e)                                 Default on Other Indebtedness. A default shall occur in the payment of any amount when due (subject to any applicable grace period), whether by acceleration or otherwise, of any principal or stated amount of, or interest or fees on, any Indebtedness of the Borrower or any of the Subsidiaries having a principal or stated amount, individually or in the aggregate, in excess of $250,000, or a default shall occur in the performance or observance of any obligation or condition with respect to such Indebtedness if the effect of such default is to accelerate the maturity of any such Indebtedness or such default shall continue unremedied for any applicable period of time sufficient to permit the holder or holders of such Indebtedness, or any trustee or agent for such holders, to cause or declare such Indebtedness to become due and payable or to require such Indebtedness to be prepaid, redeemed, purchased or defeased, or require an offer to purchase or defease such Indebtedness to be made, prior to its expressed maturity.

 

(f)                                  Judgments. Any judgment or order for the payment of money individually or in the aggregate in excess of $250,000 (exclusive of any amounts fully covered by insurance (less any applicable deductible) and as to which the insurer has acknowledged its responsibility to cover such judgment or order) shall be rendered against the Borrower or any of the Subsidiaries and such judgment shall not have been vacated or discharged or stayed or bonded pending appeal within 30 days after the entry thereof or enforcement proceedings shall have been commenced by any creditor upon such judgment or order.

 

(g)                                 Change in Control. Any Change in Control shall occur.

 

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(h)                                Bankruptcy, Insolvency, Etc. The Borrower or (except as permitted pursuant to Section 8.7) any of the Subsidiaries shall:

 

(i)                                     become insolvent or generally fail to pay, or admit in writing its inability or unwillingness generally to pay, debts as they become due;

 

(ii)                                  apply for, consent to, or acquiesce in the appointment of a trustee, receiver, sequestrator or other custodian for any substantial part of the property of any thereof, or make a general assignment for the benefit of creditors;

 

(iii)                               in the absence of such application, consent or acquiescence, permit or suffer to exist the appointment of a trustee, receiver, sequestrator or other custodian for a substantial part of the property of any thereof, and such trustee, receiver, sequestrator or other custodian shall not be discharged within 60 days; provided that the Borrower and each Subsidiary hereby expressly authorizes the Lender to appear in any court conducting any relevant proceeding during such 60-day period to preserve, protect and defend its rights under the Loan Documents;

 

(iv)                              permit or suffer to exist the commencement of any bankruptcy, reorganization, debt arrangement or other case or proceeding under any bankruptcy or insolvency law or any dissolution, winding up or liquidation proceeding, in respect thereof, and, if any such case or proceeding is not commenced by the Borrower or any Subsidiary, such case or proceeding shall be consented to or acquiesced in by the Borrower or such Subsidiary, as the case may be, or shall result in the entry of an order for relief or shall remain for 60 days undismissed; provided that the Borrower and each Subsidiary hereby expressly authorizes the Lender to appear in any court conducting any such case or proceeding during such 60-day period to preserve, protect and defend its rights under the Loan Documents; or

 

(v)                                 take any action authorizing, or in furtherance of, any of the foregoing.

 

(i)                                    Impairment of Security, Etc. Any Loan Document or any Lien granted thereunder shall (except in accordance with its terms), in whole or in part, terminate, cease to be effective or cease to be the legally valid, binding and enforceable obligation of the Borrower or any Subsidiary subject thereto; the Borrower, any Subsidiary or any other party shall, directly or indirectly, contest in any manner such effectiveness, validity, binding nature or enforceability; or, except as permitted under any Loan Document, any Lien securing any Obligation shall, in whole or in part, cease to be a perfected first priority Lien.

 

(j)                                   Key Permit Events. Any Key Permit or any of the Borrower’s or any Subsidiary’s material rights or interests thereunder is terminated or amended in any manner adverse to the Borrower or any Subsidiary in any material respect.

 

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(k)                                Material Adverse Change. Any circumstance occurs that has had or could reasonably be expected to have a Material Adverse Effect.

 

(l)                                     Key Person Event. If Antony Koblish ceases to be employed full time by the Borrower and actively working as its President and Chief Executive Officer, unless within 120 days after such Person ceases to be employed full time and actively working, the Borrower hires a replacement for such individual reasonably acceptable to the Lender.

 

(m)                            Regulatory Matters. If any of the following occurs: (i) the FDA, CMS or any other Governmental Authority (A) issues a letter or other communication asserting that any Product lacks a required Regulatory Authorization or (B) initiates enforcement action against, or issues a warning letter with respect to, the Borrower or any of the Subsidiaries, or any Product or the manufacturing facilities therefor, that in the case of either clause (A) or (B) causes the Borrower or such Subsidiary to discontinue marketing of or withdraw any Product, or causes a delay in the manufacture or offering of any Product, which discontinuance, withdrawal or delay could reasonably be expected to last for more than three months; (ii) a recall which could reasonably be expected to result in aggregate liability to the Borrower and the Subsidiaries in excess of $250,000; or (iii) the Borrower or any of the Subsidiaries enters into a settlement agreement with the FDA, CMS or any other Governmental Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions in excess of $250,000.

 

(n)                                Key Contracts. If any of the following occurs: (i) any material default or material breach by the Borrower or any of the Subsidiaries occurs and is continuing under any of the Key Contracts, which material default or material breach is not cured within any express grace period therein provided; (ii) any of the Key Contracts is terminated for any reason, other than (A) any expiration of such Key Contract in accordance with its own terms or (B) any termination of such Key Contract (other than the Aroa Umbrella Agreement or any Key Contract the termination of which would reasonably be expected to materially and adversely affect the Borrower’s ability to commercialize any Product then being commercialized) by the Borrower following the Borrower’s good faith determination that such termination is in the best interest of the Borrower and as long as the Borrower terminates such Key Contract in accordance with the applicable provisions thereof, and not as a result of any default or breach, or expected default or breach, by the Borrower or any Subsidiary thereunder; or (iii) any event occurs that would permit any other Person party to any Key Contract to have any termination right thereunder.

 

SECTION 9.2 Action if Bankruptcy. If any Event of Default described in clauses (i) through (iv) of Section 9.1(h) with respect to the Borrower shall occur, the Commitments (if not theretofore terminated) shall automatically terminate and the outstanding principal amount of the Loans and all other Obligations shall automatically be and become immediately due and payable, without notice or demand to any Person.

 

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SECTION 9.3 Action if Other Event of Default. If any Event of Default (other than any Event of Default described in clauses (i) through (iv) of Section 9.1(h)) shall occur for any reason, whether voluntary or involuntary, and be continuing, the Lender may, by notice to the Borrower declare all or any portion of the outstanding principal amount of the Loans and other Obligations to be due and payable and the Commitments (if not theretofore terminated) to be terminated, whereupon the full unpaid amount of the Loans and other Obligations which shall be so declared due and payable shall be and become immediately due and payable, without further notice, demand or presentment, and the Commitments shall terminate.

 

ARTICLE X

MISCELLANEOUS PROVISIONS

 

SECTION 10.1 Waivers, Amendments, Etc. The provisions of each Loan Document may from time to time be amended, modified or waived, if such amendment, modification or waiver is in writing and consented to by the Lender and the Borrower. No failure or delay on the part of the Lender in exercising any power or right under any Loan Document shall operate as a waiver thereof, nor shall any single or partial exercise of any such power or right preclude any other or further exercise thereof or the exercise of any other power or right. No notice to or demand on the Borrower or any of the Subsidiaries in any case shall entitle it or any of them to any notice or demand in similar or other circumstances. No waiver or approval by the Lender under any Loan Document shall, except as may be otherwise stated in such waiver or approval, be applicable to subsequent transactions. No waiver or approval hereunder shall require any similar or dissimilar waiver or approval thereafter to be granted hereunder.

 

SECTION 10.2 Notices; Time. All notices and other communications provided under any Loan Document shall be in writing or by facsimile and addressed, delivered or transmitted, if to the Borrower or the Lender, to the applicable Person at its address or facsimile number set forth on Schedule 10.2, or at such other address or facsimile number as may be designated by such Party in a notice to the other Parties. Any notice, if mailed and properly addressed with postage prepaid or if properly addressed and sent by pre-paid courier service, shall be deemed given when received; any notice, if transmitted by facsimile, shall be deemed given when the confirmation of transmission thereof is received by the transmitter. Unless otherwise indicated, all references to the time of a day in a Loan Document shall refer to New York City time.

 

SECTION 10.3 Payment of Costs and Expenses. The Borrower agrees to pay on demand all expenses of the Lender (including the fees and out-of-pocket expenses of Covington & Burling LLP, counsel to the Lender, and of local counsel, if any, which may be retained by or on behalf of the Lender) in connection with:

 

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(a)                                the negotiation, preparation, execution and delivery of each Loan Document, including schedules and exhibits, and any amendments, waivers, consents, supplements or other modifications to any Loan Document as may from time to time hereafter be required, whether or not the transactions contemplated hereby are consummated;

 

(b)                                the filing or recording of any Loan Document (including any financing statements) and all amendments, supplements, amendment and restatements and other modifications to any thereof, searches made following the Closing Date in jurisdictions where financing statements (or other documents evidencing Liens in favor of the Lender) have been recorded and any and all other documents or instruments of further assurance required to be filed or recorded by the terms of any Loan Document; and

 

(c)                                 the preparation and review of the form of any document or instrument relevant to any Loan Document.

 

The Borrower further agrees to pay, and to hold the Lender harmless from all liability for, any stamp or other Taxes which may be payable in connection with the execution or delivery of each Loan Document, the Loans or the issuance of the Note. The Borrower also agrees to reimburse the Lender upon demand for all reasonable out-of-pocket expenses (including reasonable attorneys’ fees and legal expenses of counsel to the Lender) incurred by the Lender in connection with (x) the negotiation of any restructuring or “work-out” with the Borrower, whether or not consummated, of any Obligations and (y) the enforcement of any Obligations.

 

SECTION 10.4 Indemnification. In consideration of the execution and delivery of this Agreement by the Lender, the Borrower hereby indemnifies, agrees to defend, exonerates and holds the Lender and each of its partners, members, officers, directors, managers, employees and agents (collectively, the “Indemnified Parties”) free and harmless from and against any and all actions, causes of action, suits, losses, costs, liabilities, obligations and damages, and expenses incurred in connection therewith (irrespective of whether any such Indemnified Party is a party to the action for which indemnification hereunder is sought), including reasonable attorneys’ and professionals’ fees and disbursements, whether incurred in connection with actions between the Parties or the Parties and third parties (collectively, the “Indemnified Liabilities”), including Indemnified Liabilities arising out of or relating to (a) the entering into and performance of any Loan Document by any of the Indemnified Parties (including any action brought by or on behalf of the Borrower as the result of any determination by the Lender pursuant to Article V not to fund any Loan), and (b) any Environmental Liability. If and to the extent that the foregoing indemnification may be unenforceable for any reason, the Borrower agrees to make the maximum contribution to the payment and satisfaction of each of the Indemnified Liabilities which is permissible under applicable Law.

 

SECTION 10.5 Survival. The obligations of the Borrower under Section 4.1, Section 4.2, Section 4.3, Section 10.3 and Section 10.4, shall in each case

 

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survive any assignment by the Lender and the occurrence of the Termination Date. The representations and warranties made by the Borrower in each Loan Document shall survive the execution and delivery of such Loan Document.

 

SECTION 10.6 Severability. Any provision of any Loan Document which is prohibited or unenforceable in any jurisdiction shall, as to such provision and such jurisdiction, be ineffective only to the extent of such prohibition or unenforceability without invalidating the remaining provisions of such Loan Document or affecting the validity or enforceability of such provision in any other jurisdiction.

 

SECTION 10.7 Headings. The various headings of each Loan Document are inserted for convenience only and shall not affect the meaning or interpretation of such Loan Document or any provisions thereof.

 

SECTION 10.8 Execution in Counterparts, Effectiveness, Etc.. This Agreement may be executed by the Parties in several counterparts, each of which shall be an original and all of which shall constitute together but one and the same agreement. This Agreement shall become effective when counterparts hereof executed on behalf of the Borrower and the Lender, shall have been received by the Lender. Delivery of an executed counterpart of a signature page to this Agreement by email (in “pdf,” “tiff” or similar format) or telecopy shall be effective as delivery of a manually executed counterpart of this Agreement.

 

SECTION 10.9 Governing Law; Entire Agreement. EACH LOAN DOCUMENT AND ANY CLAIMS, CONTROVERSY, DISPUTE OR CAUSE OF ACTION (WHETHER IN CONTRACT OR TORT OR OTHERWISE) BASED UPON, ARISING OUT OF OR RELATING TO THIS AGREEMENT OR ANY OTHER LOAN DOCUMENT CONTEMPLATED HEREBY AND THEREBY SHALL BE GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH, THE INTERNAL LAWS OF THE STATE OF NEW YORK (INCLUDING FOR SUCH PURPOSE SECTIONS 5-1401 AND 5-1402 OF THE GENERAL OBLIGATIONS LAW OF THE STATE OF NEW YORK) WITHOUT REGARD TO ANY CHOICE OR CONFLICT OF LAWS PROVISIONS OR RULES THAT WOULD REQUIRE THE APPLICATION OF THE LAWS OF ANY OTHER JURISDICTION. The Loan Documents constitute the entire understanding among the Parties with respect to the subject matter thereof and supersede any prior agreements, written or oral, with respect thereto.

 

SECTION 10.10 Successors and Assigns. This Agreement shall be binding upon and shall inure to the benefit of the Parties and their respective successors and assigns; provided that the Borrower may not assign or transfer its rights or obligations hereunder without the consent of the Lender.

 

SECTION 10.11 Other Transactions. Nothing contained herein shall preclude the Lender or any of its Affiliates from engaging in any transaction, in

 

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addition to those contemplated by the Loan Documents, with the Borrower or any of its Affiliates in which the Borrower or such Affiliate is not restricted hereby from engaging with any other Person.

 

SECTION 10.12 Forum Selection and Consent to Jurisdiction. ANY LITIGATION BASED HEREON, OR ARISING OUT OF, UNDER, OR IN CONNECTION WITH, ANY LOAN DOCUMENT, OR ANY COURSE OF CONDUCT, COURSE OF DEALING, STATEMENTS (WHETHER ORAL OR WRITTEN) OR ACTIONS OF THE LENDER OR THE BORROWER IN CONNECTION HEREWITH OR THEREWITH SHALL BE BROUGHT AND MAINTAINED IN THE COURTS OF THE BOROUGH OF MANHATTAN IN THE CITY OF NEW YORK IN THE STATE OF NEW YORK OR IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK; PROVIDED THAT ANY SUIT SEEKING ENFORCEMENT AGAINST ANY COLLATERAL OR OTHER PROPERTY MAY BE BROUGHT, AT THE LENDER’S OPTION, IN THE COURTS OF ANY JURISDICTION WHERE SUCH COLLATERAL OR OTHER PROPERTY MAY BE FOUND. THE BORROWER IRREVOCABLY CONSENTS TO THE SERVICE OF PROCESS BY REGISTERED MAIL, POSTAGE PREPAID, OR BY PERSONAL SERVICE WITHIN OR WITHOUT THE STATE OF NEW YORK AT THE ADDRESS FOR NOTICES SPECIFIED IN SECTION 10.2. THE BORROWER HEREBY EXPRESSLY AND IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW, ANY OBJECTION WHICH IT MAY HAVE OR HEREAFTER MAY HAVE TO THE LAYING OF VENUE OF ANY SUCH LITIGATION BROUGHT IN ANY SUCH COURT REFERRED TO ABOVE AND ANY CLAIM THAT ANY SUCH LITIGATION HAS BEEN BROUGHT IN AN INCONVENIENT FORUM. TO THE EXTENT THAT THE BORROWER HAS OR HEREAFTER MAY ACQUIRE ANY IMMUNITY FROM JURISDICTION OF ANY COURT OR FROM ANY LEGAL PROCESS (WHETHER THROUGH SERVICE OR NOTICE, ATTACHMENT PRIOR TO JUDGMENT, ATTACHMENT IN AID OF EXECUTION OR OTHERWISE) WITH RESPECT TO ITSELF OR ITS PROPERTY, THE BORROWER HEREBY IRREVOCABLY WAIVES TO THE FULLEST EXTENT PERMITTED BY LAW SUCH IMMUNITY IN RESPECT OF ITS OBLIGATIONS UNDER THE LOAN DOCUMENTS.

 

SECTION 10.13 Waiver of Jury Trial. THE LENDER AND THE BORROWER HEREBY KNOWINGLY, VOLUNTARILY AND INTENTIONALLY WAIVE TO THE FULLEST EXTENT PERMITTED BY LAW ANY RIGHTS THEY MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LITIGATION BASED HEREON, OR ARISING OUT OF, UNDER, OR IN CONNECTION WITH, EACH LOAN DOCUMENT, OR ANY COURSE OF CONDUCT, COURSE OF DEALING, STATEMENTS (WHETHER ORAL OR WRITTEN) OR ACTIONS OF THE LENDER OR THE BORROWER IN CONNECTION THEREWITH. THE BORROWER ACKNOWLEDGES AND AGREES THAT IT HAS RECEIVED FULL AND SUFFICIENT CONSIDERATION FOR THIS PROVISION (AND EACH

 

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OTHER PROVISION OF EACH OTHER LOAN DOCUMENT TO WHICH IT IS A PARTY) AND THAT THIS PROVISION IS A MATERIAL INDUCEMENT FOR THE LENDER ENTERING INTO THE LOAN DOCUMENTS.

 

SECTION 10.14 Confidential Information. Subject to the provisions of Section 10.15, at all times prior to the Credit Agreement Termination Date, the Receiving Party shall keep confidential and shall not publish or otherwise disclose any Confidential Information furnished to it by the Disclosing Party, except to those of the Receiving Party’s employees, advisors or consultants who have a need to know such information to assist such Party in the performance of such Party’s obligations or in the exercise of such Party’s rights hereunder and who are subject to reasonable obligations of confidentiality consistent with this Section 10.14 (collectively, “Recipients”). Notwithstanding anything to the contrary set forth herein: (a) the Lender may disclose this Agreement and the terms and conditions hereof and any information related hereto, to (i) its Affiliates, (ii) potential and actual assignees of any of the Lender’s rights hereunder and (iii) potential and actual investors in, or lenders to, the Lender (including, in each of the foregoing cases, such Person’s employees, advisors or consultants); provided that in each case, unless an Event of Default has occurred and is continuing, each such Recipient shall be subject to reasonable obligations of confidentiality; and (b)      upon receiving consent from the Lender, which consent shall not be unreasonably withheld, delayed or conditioned, the Borrower may disclose this Agreement and the terms and conditions hereof and information related hereto, to potential or actual permitted acquirers or assignees, collaborators and other licensees or sub-licensees, permitted subcontractors, investment bankers, investors, lenders (including, in each of the foregoing cases, such Person’s employees, advisors or consultants who have a need to receive and review such information); provided that in each case, each such Recipient shall be subject to reasonable obligations of confidentiality. In addition to the foregoing, the Receiving Party may disclose Confidential Information belonging to the Disclosing Party to the extent (and only to the extent) such disclosure is reasonably necessary in order to comply with applicable Laws (including any securities law or regulation or the rules of a securities exchange) and with judicial process, if in the reasonable opinion of the Receiving Party’s counsel, such disclosure is necessary for such compliance, provided that the Receiving Party (x) will only disclose those portions of the Confidential Information that are necessary or required to be so disclosed, and (y) to the extent legally permissible, will notify the Disclosing Party of the Receiving Party’s intent to make any disclosure pursuant thereto sufficiently prior to making such disclosure so as to allow the Disclosing Party time to take whatever action it may deem appropriate to protect the confidentiality of the information to be disclosed.

 

SECTION 10.15 Exceptions to Confidentiality. The Receiving Party’s obligations set forth in this Agreement shall not extend to any Confidential Information of the Disclosing Party:

 

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(a)                                that is or hereafter becomes part of the public domain (other than as a result of a disclosure by the Receiving Party or its Recipients in violation of this Agreement);

 

(b)                                that is received from a Third Party without restriction on disclosure and without, to the knowledge of the Receiving Party, breach of any agreement between such Third Party and the Disclosing Party;

 

(c)                                  that the Receiving Party can demonstrate by competent evidence was already in its possession without any limitation on disclosure prior to its receipt from the Disclosing Party;

 

(d)                                that is generally made available to Third Parties by the Disclosing Party without restriction on disclosure; or

 

(e)                                 that the Receiving Party can demonstrate by competent evidence was independently developed by the Receiving Party without use of or reference to the Confidential Information.

 

[Signature Page Follows]

 

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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their respective officers thereunto duly authorized as of the day and year first above written.

 

	
 
    	
TELA   BIO, INC.,
    
	
 
    	
as   the Borrower
    
	
 
    	
 
    	
 
    
	
 
    	
By:
    	
/s/   Francis M. Conway
    
	
 
    	
 
    	
Name:   Francis M. Conway
    
	
 
    	
 
    	
Title:   Vice President - Finance
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
ORBIMED   ROYALTY OPPORTUNITIES II, LP,
    
	
 
    	
as   the Lender
    
	
 
    	
 
    
	
 
    	
By   OrbiMed Advisors LLC,

its   investment manager
    
	
 
    	
 
    
	
 
    	
By:
    	
/s/   Sven H. Borho
    
	
 
    	
 
    	
Name:   Sven H. Borho
    
	
 
    	
 
    	
Title:   Member
    

 

Signature Page to Credit Agreement

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