Credit Agreement by and between the registrant and OrbiMed Royalty Opportunities II, LP, dated as of March 20, 2017
Exhibit 10.15
CREDIT AGREEMENT
dated as of March 20, 2017
by and between
AVEDRO, 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 | 22 | ||||
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 | 24 | ||||
SECTION 3.7 | Repayment Premium | 24 | ||||
ARTICLE IV LIBO RATE AND OTHER PROVISIONS | 24 | |||||
SECTION 4.1 | Increased Costs, Etc | 24 | ||||
SECTION 4.2 | Increased Capital Costs | 25 | ||||
SECTION 4.3 | Taxes | 25 | ||||
SECTION 4.4 | Payments, Computations; Proceeds of Collateral, Etc | 27 | ||||
SECTION 4.5 | Setoff | 28 | ||||
SECTION 4.6 | LIBO Rate Not Determinable | 28 | ||||
ARTICLE V CONDITIONS TO MAKING THE LOANS | 28 | |||||
SECTION 5.1 | Credit Extensions | 28 | ||||
SECTION 5.2 | Secretarys Certificate, Etc | 28 | ||||
SECTION 5.3 | Closing Date Certificate | 29 | ||||
SECTION 5.4 | Payment of Outstanding Indebtedness, Etc | 29 | ||||
SECTION 5.5 | Delivery of Note | 29 | ||||
SECTION 5.6 | Financial Information, Etc | 30 | ||||
SECTION 5.7 | Compliance Certificate | 30 | ||||
SECTION 5.8 | Solvency, Etc | 30 | ||||
SECTION 5.9 | Guarantee | 30 | ||||
SECTION 5.10 | Security Agreements | 30 | ||||
SECTION 5.11 | Intellectual Property Security Agreements | 31 |
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SECTION 5.12 | Warranty Agreement | 31 | ||||
SECTION 5.14 | Opinions of Counsel | 31 | ||||
SECTION 5.15 | Insurance | 31 | ||||
SECTION 5.16 | Closing Fees, Expenses, Etc | 32 | ||||
SECTION 5.17 | Anti-Terrorism Laws | 32 | ||||
SECTION 5.18 | Satisfactory Legal Form | 32 | ||||
SECTION 5.19 | Revenue Base | 32 | ||||
SECTION 5.20 | Disclosure Schedules | 32 | ||||
ARTICLE VI REPRESENTATIONS AND WARRANTIES | 32 | |||||
SECTION 6.1 | Organization, Etc | 32 | ||||
SECTION 6.2 | Due Authorization, Non-Contravention, Etc | 33 | ||||
SECTION 6.3 | Government Approval, Regulation, Etc | 33 | ||||
SECTION 6.4 | Validity, Etc | 33 | ||||
SECTION 6.5 | Financial Information | 33 | ||||
SECTION 6.6 | No Material Adverse Change | 33 | ||||
SECTION 6.7 | Litigation, Labor Matters and Environmental Matters | 34 | ||||
SECTION 6.8 | Subsidiaries | 34 | ||||
SECTION 6.9 | Ownership of Properties | 34 | ||||
SECTION 6.10 | Taxes | 34 | ||||
SECTION 6.11 | Benefit Plans, Etc | 35 | ||||
SECTION 6.12 | Accuracy of Information | 35 | ||||
SECTION 6.13 | Regulations U and X | 35 | ||||
SECTION 6.14 | Solvency | 35 | ||||
SECTION 6.15 | Intellectual Property | 35 | ||||
SECTION 6.16 | Material Agreements | 37 | ||||
SECTION 6.17 | Permits | 38 | ||||
SECTION 6.18 | Regulatory Matters | 38 | ||||
SECTION 6.19 | Transactions with Affiliates | 41 | ||||
SECTION 6.20 | Investment Company Act | 42 | ||||
SECTION 6.21 | OFAC | 42 | ||||
SECTION 6.22 | Deposit and Disbursement Accounts | 42 | ||||
ARTICLE VII AFFIRMATIVE COVENANTS | 42 | |||||
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 | ||||
SECTION 7.10 | Product Licenses | 47 |
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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 | Post-Closing Items | 50 | ||||
SECTION 7.15 | Quarterly Update Call; Board Materials | 50 | ||||
ARTICLE VIII NEGATIVE COVENANTS | 51 | |||||
SECTION 8.1 | Business Activities | 51 | ||||
SECTION 8.2 | Indebtedness | 51 | ||||
SECTION 8.3 | Liens | 52 | ||||
SECTION 8.5 | Investments | 54 | ||||
SECTION 8.6 | Restricted Payments, Etc | 55 | ||||
SECTION 8.7 | Consolidation, Merger; Permitted Acquisitions, Etc | 56 | ||||
SECTION 8.8 | Permitted Dispositions | 56 | ||||
SECTION 8.9 | Modification of Certain Agreements | 57 | ||||
SECTION 8.10 | Transactions with Affiliates | 57 | ||||
SECTION 8.11 | Restrictive Agreements, Etc | 57 | ||||
SECTION 8.12 | Sale and Leaseback | 58 | ||||
SECTION 8.13 | Product Agreements | 58 | ||||
SECTION 8.14 | Change in Name, Location or Executive Office or Executive Management; Change in Fiscal Year | 58 | ||||
SECTION 8.15 | Benefit Plans and Agreements | 58 | ||||
ARTICLE IX EVENTS OF DEFAULT | 59 | |||||
SECTION 9.1 | Listing of Events of Default | 59 | ||||
SECTION 9.2 | Action if Bankruptcy | 62 | ||||
SECTION 9.3 | Action if Other Event of Default | 62 | ||||
ARTICLE X MISCELLANEOUS PROVISIONS | 62 | |||||
SECTION 10.1 | Waivers, Amendments, Etc | 62 | ||||
SECTION 10.2 | Notices; Time | 62 | ||||
SECTION 10.3 | Payment of Costs and Expenses | 63 | ||||
SECTION 10.4 | Indemnification | 63 | ||||
SECTION 10.5 | Survival | 64 | ||||
SECTION 10.6 | Severability | 64 | ||||
SECTION 10.7 | Headings | 64 | ||||
SECTION 10.8 | Execution in Counterparts, Effectiveness, Etc | 64 | ||||
SECTION 10.9 | Governing Law; Entire Agreement | 64 | ||||
SECTION 10.10 | Successors and Assigns | 65 | ||||
SECTION 10.11 | Other Transactions | 65 | ||||
SECTION 10.12 | Forum Selection and Consent to Jurisdiction | 65 | ||||
SECTION 10.13 | Waiver of Jury Trial | 66 | ||||
SECTION 10.14 | Confidentiality | 66 | ||||
SECTION 10.15 | Exceptions to Confidentiality | 67 |
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SCHEDULES: | ||
Schedule 6.6 | Material Adverse Change | |
Schedule 6.7(a) | Litigation | |
Schedule 6.8 | Existing Subsidiaries | |
Schedule 6.10 | Taxes | |
Schedule 6.15(a) | Intellectual Property | |
Schedule 6.15(e) | Infringement Notices | |
Schedule 6.16 | Material Agreements | |
Schedule 6.19 | Transactions with Affiliates | |
Schedule 6.22 | Deposit and Disbursement Accounts | |
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 8.10 | Transactions with Affiliates | |
Schedule 10.2 | Notice Information |
EXHIBITS: | ||||
Exhibit A | - | Form of Promissory Note | ||
Exhibit B | - | Form of Loan Request | ||
Exhibit C | - | Form of Compliance Certificate | ||
Exhibit D | - | Form of Guarantee | ||
Exhibit E | - | Form of Security Agreement |
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CREDIT AGREEMENT
THIS CREDIT AGREEMENT dated as of March 20, 2017 (as amended, supplemented or otherwise modified from time to time, this Agreement), is by and between AVEDRO, 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 $30,000,000 (with $20,000,000 available at the Closing and $10,000,000 available on or prior to December 31, 2017, 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 the power of such Person, directly or indirectly, (i) to vote 15% or more of the Voting Securities 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).
Agreement is defined in the preamble.
Annual Revenues means consolidated revenue properly recognized under GAAP, applied in a manner consistent with past practice of the Borrower and the Subsidiaries, taken as a whole, for the last four Fiscal Quarters for which consolidated financial statements of the Borrower have been delivered pursuant to Section 7.1.
Applicable Margin means 10.00%.
Authorized Officer means, relative to the Borrower or any of the Subsidiaries, those of its officers, general partners or managing members (as applicable) 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: (i) is a multiemployer plan, as defined in section 3(37) of ERISA, (ii) is subject to section 412 of the Code, section 302 of ERISA or Title IV of ERISA, or (iii) 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.
Borrower Medical Devices means any Device researched, developed, marketed, manufactured, stored, distributed by or for the Borrower, including the KXL System.
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 Persons capital stock, and any warrants, options or other rights entitling the holder thereof to purchase or acquire any such capital stock, in each case 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, 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 maturing not more than one year from the date of issue, which is issued by a corporation (other than an Affiliate of the Borrower or any of its Subsidiaries) 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 Moodys; 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 (x) a credit rating of A2 or higher from Moodys or A or higher from S&P and (y) a combined capital and surplus greater than $500,000,000; or
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(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 Borrower 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.
cGMP means the then current good manufacturing practices and regulatory requirements for or concerning manufacturing practices for drugs, biologics and devices (including components thereof) that are promulgated or endorsed for the United States by the FDA (including through 21 CFR Parts 210, 211 and 820) and for outside the United States by comparable Governmental Authorities.
Change in Control means and shall be deemed to have occurred if (i) any person or group (within the meaning of Rule 13d-5 of the Exchange Act), other than OrbiMed Private Investments VI, LP and its Affiliates, shall own, directly or indirectly, beneficially or of record, determined on a fully diluted basis, more than 50% of the Voting Securities of the Borrower;
(ii) 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 neither (x) nominated by the board of directors of the Borrower nor (y) appointed by directors so nominated, or (iii) 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 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: (i) the adoption or taking effect of any Law, rule, regulation or treaty, (ii) any change in any Law, rule, regulation or treaty or in the administration, interpretation, implementation or application thereof by any Governmental Authority or (iii) 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, (x) the Dodd-Frank Wall Street Reform and Consumer Protection Act and all requests, rules, guidelines or directives thereunder or issued in connection therewith and (y) 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; and provided further that the implementation of, and compliance with, FATCA including any intergovernmental agreements established pursuant to FATCA shall not be deemed to be a Change in Law.
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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 March 20, 2017 .
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 Lenders 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 Borrowers 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 terms of this Agreement (but shall not include the existence 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 Persons obligation under any Contingent Liability shall (subject to any limitation set forth therein) be deemed to be the stated or determined amount of the outstanding debt, obligation or other liability guaranteed thereby, or if not stated or determinable, the maximum reasonably anticipated amount of such debt, obligation or other liability as determined by such Person in good faith; provided, however, that such amount shall not in any event exceed the maximum amount for which such Person may be liable under the applicable agreement, undertaking or arrangement.
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Control is defined within the definition of Affiliate.
Controlled Account is defined in Section 7.13.
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 (i) renewals, revisions, extensions, derivative works, enhancements, modifications, updates and new releases thereof, (ii) income, royalties, damages, claims and payments now and hereafter due and/or payable with respect thereto, including, without limitation, damages and payments for past, present or future infringements thereof, (iii) rights to sue for past, present and future infringements thereof, and (iv) foreign copyrights and any other rights corresponding thereto throughout the world.
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.
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, 2017.
Delayed Draw Commitment Amount means $10,000,000.
Delayed Draw Commitment Termination Date means the earliest to occur of (i) the Delayed Draw Closing Date (immediately after the making of the Delayed Draw Loan on such date), (ii) December 31, 2017, and (iii) March 20, 2017, 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 (i) 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 (ii) 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.
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Disposition (or similar words 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 Borrowers or the Subsidiaries assets (including accounts receivable and Capital Securities of Subsidiaries) to any other Person (other than to the Borrower or any of its Subsidiaries) in a single transaction or series of transactions; provided, that for the avoidance of doubt, (a) the issuance of its Capital Securities by the Borrower to its direct or indirect equity holders (including, without limitation, the issuance of Capital Securities pursuant to any employee, director or consultant (i.e. medical advisor) option program, benefit plan or compensation program), or (b) the issuance of its Capital Securities by a Subsidiary to the Borrower shall not, in either case, be deemed a Disposition.
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 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, prior to the date that is one hundred and eighty-one (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.
EMA means the European Medicines Agency or any successor entity.
Eligible Transferee means and includes a commercial bank, an insurance company, a finance company, a financial institution, any investment fund that invests in loans or any other accredited investor (as defined in Regulation D of the Securities Act) that is principally in the business of managing investments or holding assets for investment purposes; provided that, the following conditions are met: (1) for any entity (other than an Affiliate of the Original Lender) becoming a Lender after the Closing Date and prior to the Delayed Draw Commitment Termination Date, such entity shall have either (A) a rating of BBB or higher from Standard & Poors Rating Group or a rating of Baa2 or higher from Moodys Investors Service, Inc. at the date that it becomes a Lender or (B) has total assets in excess of $500,000,000 (including any unfunded capital commitments), and (2) for any entity (other than an Affiliate of the Original Lender) becoming a Lender after the Delayed Draw Commitment Termination Date, such entity
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shall have sufficient funds to acquire or purchase the assigned Loans from an assigning Lender; provided further that, notwithstanding the foregoing, Eligible Transferee shall not include (i) the Borrower or any of the Borrowers Affiliates or Subsidiaries or (ii) unless an Event of Default has occurred and is continuing, a direct competitor of the Borrower or any Subsidiary or any investment fund that principally invests in distressed debt.
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 applicable 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 (i) any Environmental Law or Environmental Permit, (ii) the generation, use, handling, transportation, storage, treatment, recycling, presence, disposal, Release or threatened Release of, or exposure to, any Hazardous Materials, or (iii) 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.
ERISA means the Employee Retirement Income Security Act of 1974, as amended from time to time.
ERISA Affiliate means, as applied to any Person, (i) 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, (ii) 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 (iii) 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 (i) above or any trade or business described in clause (ii) 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 Account is defined in Section 7.13.
FATCA means (a) 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, (b)
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any treaty, law, regulation or other official guidance enacted in any other jurisdiction, or relating to an intergovernmental agreement between the United States and any other jurisdiction with the purpose (in either case) of facilitating the implementation of (a) above, or (c) any agreement pursuant to the implementation of paragraphs (a) or (b) above with the United States Internal Revenue Service, the United States government or any governmental or taxation authority in the United States.
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 2012 Fiscal Year) refer to the Fiscal Year ending on December 31 of such calendar year.
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.
GAAP means generally accepted accounting principles in the United States.
Governmental Authority means any national, supranational, federal, state, county, provincial, local, municipal or other government or political subdivision thereof (including any Regulatory Agency), 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 Subsidiary, substantially in the form of Exhibit D hereto, as amended, supplemented, amended and restated or otherwise modified from time to time.
Guarantors means, collectively, the 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.
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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.
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 Investigational Drug Application (IND) as defined in the FD&C Act or any successor application or procedure filed with the FDA, (b) an Investigational Device Exemption (IDE) as defined in the FD&C Act or any successor application or procedure filed with the FDA, (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).
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 (i) which is of a going concern or similar nature other than any such qualification in any opinion that is based solely on a determination that the Borrower may not have sufficient cash or other available resources to run the business, (ii) which relates to the limited scope of examination of matters relevant to such financial statement, or (iii) which 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.
including and include means including without limiting the generality of any description preceding such term, and, for purposes of each Loan Document, the parties hereto 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.
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;
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(b) all obligations, contingent or otherwise, relative to the face amount of all letters of credit, whether or not drawn, and bankers 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 Persons ownership interest in or other relationship with such Person, 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, and/or Intellectual Property.
Initial Commitment Amount means $20,000,000.
Initial Commitment Termination Date means the earliest to occur of (i) the Closing Date (immediately after the making of the Initial Loan on such date), and (ii) March 20, 2017, 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 (i) Patents and all patent applications of any type, registrations and renewals, reissues, reexaminations and patent rights in any lawful form thereof;
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(ii) Trademarks and all applications, registrations and renewals thereof; (iii) Copyrights and other works of authorship (registered or unregistered), and all applications, registrations and renewals therefor; (iv) Product Agreements; (v) computer software, databases, data and documentation; (vi) 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; (vii) 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; (viii) other intellectual property or similar proprietary rights; (ix) copies and tangible embodiments of any of the foregoing (in whatever form or medium); and (x) 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 its 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 Fiscal Quarter in which the Loan was made, and (b) thereafter, the period beginning on (and including) the first day of each succeeding Fiscal Quarter and ending on the earlier of (and including) (x) the last day of such Fiscal Quarter and (y) the Maturity Date.
Investment means, relative to any Person, (i) 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, (ii) Contingent Liabilities in favor of any other Person, and (iii) 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 Permits means (i) all Permits necessary to sell the KXL System in the United States and (ii) all other Permits relating to the Products, the loss of which would reasonably be expected to have a Material Adverse Effect.
knowledge of the Borrower means the actual knowledge of the chief executive officer, chief financial officer, chief commercial officer, chief scientific officer, chief medical officer, chief legal officer and any other senior or executive officer of the Borrower, after due inquiry.
Laws is defined in Section 6.18.
Lender is defined in the preamble.
LIBO Rate means the three-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 three-month London Interbank Offered Rate for deposits in U.S. Dollars in effect two Business Days prior to
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the last Business Day of the relevant Fiscal Quarter, 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 Fiscal Quarter. If the Initial Loan is advanced other than on the first Business Day of a Fiscal Quarter, the initial LIBO Rate shall be that three-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 Fiscal Quarter next ending. The Lenders internal records of applicable interest rates shall be determinative in the absence of manifest error.
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.
Liquidity means, at any time, an amount determined for the Borrower equal to the sum of unrestricted (other than Liens securing the Obligations) 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, the Notes, the Security Agreement, each other agreement pursuant to which the Lender is granted a Lien to secure the Obligations (including any mortgages 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 (provided, that Loan Documents shall not include the Warrant Agreement or the Warrants).
Loan Parties means, collectively, the Borrower and the Guarantors.
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 (i) the business, financial condition, operations, performance or properties of the Borrower and its Subsidiaries taken as a whole, (ii) the rights and remedies of the Lender under any Loan Document or (iii) the ability of the Borrower or any Loan Party to perform its Obligations under any Loan Document.
Material Agreements means (i) each contract or agreement to which the Borrower or any Subsidiary is a party involving aggregate payments of more than the greater of (a) $500,000 in any Fiscal Year or (B) 5% of the Annual Revenues for the last four Fiscal Quarters, 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 (ii) all other contracts or agreements, individually or in the aggregate, material to the business, operations, assets, performance, liabilities or financial condition of the Borrower and its Subsidiaries taken as a whole; provided, however, that Material Agreements exclude all (x) licenses implied by the sale of a product; and (y) paid-up licenses for commonly available software programs under which Borrower or any Subsidiary is the licensee.
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Maturity Date means March 20, 2022.
Moodys means Moodys Investors Service, Inc.
Net Asset Sales Proceeds means, with respect to a Disposition (other than Dispositions permitted by Section 8.8(i) through (x) 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 in excess of $1,000,000 in the aggregate through the Termination Date received by the Borrower or any Subsidiary from such Disposition over all reasonable and customary costs, fees and expenses, 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 in excess of $1,000,000, 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 clause (f) of Section 8.3 on the property which is the subject of such Casualty Event.
Net Revenue means net sales, distribution income, service payments, license income, and other forms of consideration received by the Borrower and its Subsidiaries, as determined in accordance with GAAP. Net Revenue shall be determined in a manner consistent with the methodologies, practices and procedures used in developing the Borrowers audited financial statements.
Non-Excluded Taxes means in respect of the Lender (and its successors and assigns), any Taxes other than (a) (i) Taxes imposed on or measured by one or more alternative bases one of which is a Persons net income, (ii) franchise Taxes, and (iii) branch profits Taxes, in each case, imposed by the United States or with respect to such Person by any Governmental Authority under the Laws of which such Person is organized or in which it maintains its applicable lending office, or imposed as a result of a present or former connection between such Person and the jurisdiction imposing such Tax (other than connections arising solely from such Person having executed, delivered, become a party to, performed its obligations under, received payments under, received or perfected a security interest under, engaged in any other transaction pursuant to or enforced any Loan Document), (b) any U.S. federal withholding Taxes imposed on amounts payable to or for the account of a Lender with respect to an applicable interest in any Loan or Commitment pursuant to a Law in effect on the date on which (i) such Lender acquires such interest in the Loan or Commitment or (ii) such Lender changes its lending office, except in each case to the extent that, pursuant to Section 4.3, amounts with respect to such Taxes were payable either to such Lender (or its assignor, if any) immediately before such Person became a party hereto or to such Person immediately before the time of designation of a new lending office, (c) Taxes attributable to such Persons failure to comply with Section 4.3(e), and (d) any U.S. federal withholding Taxes or other amounts imposed or payable under FATCA.
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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 Borrowers or any Subsidiarys Capital Securities.
Original Lender means OrbiMed Royalty Opportunities II, L.P.
Other Connection Taxes means, with respect to any Lender, Taxes imposed as a result of a present or former connection between such Lender and the jurisdiction imposing such Tax (other than connections arising from such Lender having executed, delivered, become a party to, performed its obligations under, received payments under, received or perfected a security interest under, engaged in any other transaction pursuant to or enforced any Loan Document, or sold or assigned an interest in any Loan or Loan Document).
Other Taxes means any and all stamp, court, documentary, intangible, recording, filing or similar Taxes 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), except any such Taxes that are Other Connection Taxes imposed with respect to an assignment.
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.
Party and Parties have the meanings set forth in the preamble hereto.
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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 any 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, authorizations, consents, waivers, franchises, variances and similar rights issued by or obtained from any Governmental Authority or any other Person, including, without limitation, 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 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 applicable 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, without limitation, equity interests) acquired with respect to the entity acquired to the extent required to comply with the requirements of Section 7.8;
(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) of such other Person shall have duly approved such purchase or other acquisition;
(d) the total cash and non-cash consideration (other than common stock of the Borrower) paid by or on behalf of the Borrower and its Subsidiaries for any such purchase or other acquisition, when aggregated with the consideration (other than common stock of the Borrower) 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 $1,500,000 in any Fiscal Year and an aggregate cumulative amount of $3,000,000;
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(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 (other than common stock of the Borrower) in excess of $1,000,000, (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 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 (i) 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 (ii) 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.
Photrexa means the pharmaceutical product manufactured, distributed, offered for sale or sold under the PHOTREXA brand or any successor product with the active ingredient of riboflavin phosphate sodium in dextran ophthalmic solution.
Photrexa Viscous means the pharmaceutical product manufactured, distributed, offered for sale or sold under the PHOTREXA VISCOUS brand or any successor product with the active ingredient of riboflavin phosphate sodium in ophthalmic solution.
PHSA means the Public Health Service 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.
PIK Interest has the meaning set forth in Section 3.4(a)(ii).
Privacy Laws means all applicable security and privacy standards regarding protected health information under (i) 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 (collectively HIPAA) and (ii) any applicable state privacy Laws.
Product means (i) Photrexa, (ii) Photrexa Viscous, (iii) Borrower Medical Devices and (iv) 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.
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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 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 (including human tissue supply agreements), 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 Securities and Exchange Act of 1934.
Purchase Money Indebtedness means Indebtedness (1) 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 (a) the cost of the equipment being financed and (b) the fair market value of such equipment; and (2) incurred to finance such acquisition by the Borrower or a Subsidiary of such equipment.
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 Borrower or any direct or indirect parent of Borrower which generates cash proceeds of at least $50,000,000 and results in a listing of such entitys Capital Securities on a public securities exchange; provided that such direct or indirect parent, if any, shall have become a Loan Party hereunder.
Receiving Party means the Party receiving Confidential Information.
Recipient 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.
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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, including any Investigational Application.
Related Parties means the 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) fourteen percent (14%) of the principal amount of any prepayment or repayment of the Borrower on the Initial Loan or the Delayed Draw Loan, as applicable, if such prepayment or repayment is made or required to be made on or prior to the 12-month anniversary of the Closing Date;
(b) nine percent (9%) of the principal amount of any prepayment or repayment of the Borrower on the Initial Loan or the Delayed Draw Loan, as applicable, if such prepayment or repayment is not required to be made prior to, and is made or required to be made after, the 12-month anniversary of the Closing Date, but on or prior to the 24-month anniversary of the Closing Date;
(c) five percent (5%) of the principal amount of any prepayment or repayment of the Borrower on the Initial Loan or the Delayed Draw Loan, as applicable, if such prepayment or repayment is not required to be made prior to, and is made or required to be made after, the 24-month anniversary of the Closing Date, but on or prior to the 36-month anniversary of the Closing Date;
(d) three percent (3%) of the principal amount of any prepayment or repayment of the Borrower on the Initial Loan or the Delayed Draw Loan, as applicable, if such prepayment or repayment is not required to be made prior to, and is made or required to be made after, the 36-month anniversary of the Closing Date, but on or prior to the 48-month anniversary of the Closing Date; or
(e) zero percent (0%) of the principal amount of any prepayment or repayment of the Borrower on the Initial Loan or the Delayed Draw Loan, as applicable, if such prepayment or repayment is not required to be made on or prior to, and is made or required to be made after, the 48-month anniversary of the Closing Date.
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Restricted Payment means (i) 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 (ii) 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 & Poors Rating Services, a division of The McGraw-Hill Companies, Inc.
Sanctions means any international economic sanction administered or enforced by the United States Government (including, without limitation, OFAC), the United Nations Security Council, the European Union, Her Majestys Treasury or other relevant sanctions authority.
SEC means the 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 (i) the fair value of the property of such Person is greater than the total amount of liabilities, including contingent liabilities, of such Person, (ii) 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, (iii) 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, (iv) 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 (v) 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
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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, 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) (i) that is not a capital lease in accordance with GAAP and (ii) 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 or fees in the nature of a tax, deductions or withholdings, now or hereafter imposed, levied, collected, withheld or assessed by any Governmental Authority, and all interest, penalties or similar liabilities with respect thereto.
Third Party means any Person other than the Borrower or any of its Subsidiaries.
Termination Date means the date on which all Obligations (other than inchoate indemnity obligations) have been paid in full in cash and the Commitment shall have terminated.
Trademark means any trademark, service mark, trade name, logo, symbol, trade dress, domain name, corporate name or other indicator of source or origin, and all applications and registrations 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 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.
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Warrant is defined in Section 4.3(e).
Warrant Agreement means the Warrant Agreement, dated as of the date hereof, between the Borrower and the Lender.
wholly owned Subsidiary means any direct or indirect Subsidiaries of Borrower, all of the outstanding Capital Securities of which (other than any directors qualifying shares or 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.
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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 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, except as set forth in Section 3.4(a)(ii), 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
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the Loans, in an amount equal to 100% of such proceeds (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 and Section 3.7; provided, however, that no such payment shall be required on account of any Net Casualty Proceeds or Net Asset Sales Proceeds that are intended to be reinvested in the ordinary course of the Loan Parties business within 180 days in replacement assets used or useful in their business; provided, further, that if any such Net Casualty Proceeds or Net Asset Sales Proceeds have not in fact been so re-invested at the expiration of such 180 day period then any such Net Casualty Proceeds or Net Asset Sales Proceeds shall be paid to Lender, if requested by the Lender, as provided herein at such time.
(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).
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.
(a) During any applicable Interest Period:
(i) Interest payable in cash by the Borrower shall accrue on the Loans during such Interest Period at a rate per annum equal to the Applicable Margin; and
(ii) the Loans shall accrue additional interest (PIK Interest) during such Interest Period at a rate per annum equal to the higher of (x) the LIBO Rate for such Interest Period and (y) 1.00%, and such PIK Interest shall be added to the outstanding principal amount of the Loans on the last day of each Fiscal Quarter until the Maturity Date.
(b) The interest rate shall be recalculated and, if necessary, adjusted for each Interest Period, in each case pursuant to the terms hereof.
(c) All references hereunder to the principal amount of the Loans shall include any PIK Interest, if any, so added to the principal.
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% per annum.
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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) other than with respect to the PIK Interest, on the last day of each Fiscal Quarter; 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. Any repayment or prepayment of principal pursuant to this Article III (other than any repayments of principal made on the Maturity Date) shall be accompanied by the Repayment Premium.
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 Lenders 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. The Borrower shall not be required to compensate the Lender pursuant to this Section for any increased costs or reductions incurred more than 180 days prior to the date that such Lender notifies the Borrower of the Change in Law giving rise to such increased costs or reductions and of such Lenders intention to claim compensation therefor; provided further that, if the Change in Law giving rise to such increased costs or reductions is retroactive, then the 180-day period referred to above shall be extended to include the period of retroactive effect thereof.
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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 Persons 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.
SECTION 4.3 Taxes. The Borrower covenants and agrees as follows with respect to Taxes.
(a) Except as required by applicable Law, any and all payments by the Borrower 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 payment shall be increased by the amount necessary so that after the withholding or deduction for or on account of such Taxes, the amount received by the Lender is equal to the amount that it would have received had no such withholding or deduction of Taxes been made; and
(ii) the Borrower shall 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 shall pay all Other Taxes imposed with respect to the Loans or any Loan Document 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 made, the Borrower shall furnish to the Lender a copy of an official receipt (or a certified copy thereof) or other evidence of such payment reasonably satisfactory to the Lender evidencing the payment of such Taxes or Other Taxes.
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(d) The Borrower shall indemnify the Lender for any Non-Excluded Taxes and Other Taxes levied, imposed or assessed with respect to the Loans or any Loan Document 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 or to any Governmental Authority in respect of the indemnification obligations of the Borrower provided in this clause shall constitute a payment in respect of which the provisions of clause (a) and this clause shall apply.
(e) On the Closing Date, and on the date on which a subsequent successor or assignee of the Lender otherwise acquires an interest in this Agreement, as applicable, and at such other times as may be necessary in the determination of Borrower (in the reasonable exercise of its discretion), the Lender (and any successor or assign of the Lender) shall deliver to the Borrower two (2) properly completed and signed original IRS Forms W-8BEN, W-8BEN-E, W-8EXP, W-8ECI or W-8IMY (along with a Form W-9, W-8BEN-E or W-8BEN for each beneficial owner that will receive, directly or indirectly, any consideration payable or otherwise deliverable pursuant to this Agreement) or IRS Form W-9 (or any successor form), as applicable, and such other documentation required under the Code and reasonably requested by Borrower to establish the appropriate amount of any deduction or withholding of United States federal Tax, if any, with respect to any payments to Lender (or its successors or assigns), including any such additional documentation reasonably requested by Borrower as may be necessary for Borrower to comply with its obligations under FATCA. Lender (and each of its successors or assigns) shall, from time to time after the initial delivery by such Person of such forms, certificates or other evidence, whenever a lapse in time, change in circumstances or Law, or additional guidance by a Governmental Authority renders such forms, certificates or other evidence obsolete or inaccurate in any material respect, promptly deliver to Borrower two (2) new originals of Internal Revenue Service Forms W-8BEN, W-8BEN-E, W-8EXP, W-8ECI, or W-8IMY (along with Forms W-9, W-8BEN-E or W-8BEN for each beneficial owner for whom it expects to receive a payment) or Form W-9, or any successor form, as the case may be, properly completed and duly
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executed by such Person, and such other documentation required under the Code and reasonably requested by Borrower to confirm or establish the extent to which such Person is or is not subject to deduction, backup withholding or withholding of U.S. federal Tax with respect to payments to such Person under this Agreement, or notify Borrower of its inability to deliver any such forms, certificates or other evidence.
(f) For all applicable income Tax purposes, the aggregate purchase price and the fair market value of the warrants issued by the Borrower pursuant to the Warrant Agreement (the Warrants) in connection with the Initial Loan shall be determined collectively by the Borrower and the Lender, acting in good faith, on or before thirty (30) days following the Closing Date. The issue price for the interest in the Initial Loan issued pursuant to this Agreement (and any Note issued in connection therewith) shall equal (i) the face value of the Lenders interest in the Initial Loan (or any corresponding Note), minus (ii) the fair market value of the Warrants issued in connection with the Initial Loan, as determined in accordance with the first sentence of this clause (f). The Lender and the Borrower agree (x) that the Initial Loan is part of an investment unit issued within the meaning of Section 1273(c)(2) of the Code, which also includes the Warrants, and (y) that the allocation provided in this Section 4.3(f) will be used for purposes of Section 1273(c)(2) of the Code. The Borrower and the Lender agree to make any determinations under Treasury Regulations §1.1273-2(h)(2) consistent with the foregoing and to file all required tax returns consistently with the foregoing, as applicable, except as otherwise required by applicable Law.
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
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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, (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 then outstanding owing to the Lender (other than inchoate indemnity obligations), 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 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 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. If prior to the commencement of any Interest Period, 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. In the event of any such determination, the Loans shall, until the Lender has advised the Borrower that the circumstances giving rise to such notice no longer exist, bear interest at the interest rate in effect for the immediately preceding Interest Period.
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 hereto, 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 5.18 and 5.19). The obligation of the Lender to make the Delayed Draw Loan shall be subject to the prior making of the Initial Loan, 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, 5.18 and 5.19.
SECTION 5.2 Secretarys 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 Persons Secretary or Assistant Secretary, managing member or general partner, as applicable, as to
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(a) resolutions of each such Persons Board of Directors (or other managing body, in the case of other than a corporation) then in full force and effect authorizing the execution, delivery and performance of each Loan Document and the Warrant Agreement to be executed by such Person and the transactions contemplated hereby and thereby;
(b) the incumbency and signatures of those of its officers, managing member or general partner, as applicable, authorized to act with respect to each Loan Document to be executed by such Person; and
(c) the full force and validity of each Organic Document of such Person and 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 (i) the representations and warranties set forth in each Loan Document shall, in each case, be true and correct in all material respects (except with respect to any representation or warranty qualified by materiality or Material Adverse Effect, which representation or warranty shall be true and correct in all respects), (ii) 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 conditions set forth in this Article V have been satisfied. All documents and agreements required to be appended to the Closing Date Certificate, if any, shall be in form and substance satisfactory to the Lender, shall have been executed and delivered by the requisite parties, and shall be in full force and effect.
SECTION 5.4 Payment of Outstanding Indebtedness, Etc. All Indebtedness identified in Schedule 8.2(b), together with all interest, all 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.
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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, 2013, December 31, 2014, and December 31, 2015.
(b) unaudited consolidated balance sheets of the Borrower and the Subsidiaries for each fiscal quarter ended after December 31, 2015, together with the related consolidated statement of operations, shareholders 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 February 28, 2017 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. The Lender shall have received executed counterparts of the Guarantee, dated as of the date hereof, duly executed and delivered by each Subsidiary in existence on the Closing Date.
SECTION 5.10 Security Agreements. The Lender shall have received executed counterparts of the Security Agreement, dated as of the date hereof, duly executed and delivered by the Borrower and each Subsidiary in existence on the Closing Date, together with
(a) certificates (in the case of Capital Securities that are securities (as defined in the UCC)) evidencing all of the issued and outstanding Capital Securities owned by the Borrower or any Subsidiary in the Subsidiaries, which certificates in each case 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;
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(b) financing statements suitable in form for naming the Borrower and each 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, and (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) subject to Section 7.14, landlord access agreements and bailee letters in form and substance satisfactory to the Lender from each landlord to the Borrower or any Subsidiary and each other Person that has possession of any Collateral (as defined in the Security Agreement), provided, that neither Borrower nor any Subsidiary shall be required to obtain as a condition to closing or at any time any such agreement for (i) Equipment and other property consisting of demonstration units or located at clinical sites or trade and exhibition shows or (ii) other locations with less than $100,000 of Collateral; and
(e) subject to Section 7.14, evidence that all deposit accounts, lockboxes, disbursement accounts, investment accounts or other similar accounts of the Borrower and each Subsidiary are Controlled Accounts (other than Excluded Accounts).
SECTION 5.11 Intellectual Property Security Agreements. The Lender shall have received 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.
SECTION 5.12 Warrant Agreement. The Lender shall have received an executed counterpart of the Warrant Agreement, dated as of the date hereof, executed and delivered by an Authorized Officer of the Borrower.
SECTION 5.13 Opinions of Counsel. The Lender shall have received opinions, dated the Closing Date and addressed to the Lender, from Cooley LLP, counsel to the Borrower and the Subsidiaries, in form and substance reasonably satisfactory to the Lender.
SECTION 5.14 Insurance. Subject to Section 7.14, 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.
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SECTION 5.15 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 5.16 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.A. Patriot Act.
SECTION 5.17 Satisfactory Legal Form. All documents executed or submitted pursuant hereto by or on behalf of the Borrower or any Subsidiary shall be reasonably 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 5.18 Revenue Base. The Lender shall be satisfied in its reasonable discretion that the Revenue Base for the twelve full calendar months prior to the Delayed Draw Closing Date was at least $25,000,000.
SECTION 5.19 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, 6.19 and 6.22, each such updated Schedule to be complete and accurate in all material respects 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 Drawing Closing Date, to the Lender as set forth in this Article.
SECTION 6.1 Organization, Etc. 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 qualify as a foreign entity would 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 material 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.
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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 Persons corporate powers, have been duly authorized by all necessary corporate action, and do not
(a) contravene (i) the Borrowers or any Subsidiarys Organic Documents, (ii) any court decree or order binding on or affecting the Borrower or any Subsidiary or (iii) any law or governmental 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 Borrowers or any Subsidiarys properties (except as permitted by this Agreement) or (ii) a default under any material contract, agreement, or instrument binding on or affecting the Borrower or any Subsidiary.
SECTION 6.3 Government Approval, Regulation, Etc. No authorization or approval 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 or the Warrant Agreement 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. 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 subject, in the case of unaudited financial statements, to changes resulting from normal, year-end audit adjustments, nominal adjustments in non-cash stock based compensation resulting from completion of, and updates to Code Section 409A valuations, 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. Except as set forth on Schedule 6.6, there has been no material adverse change in the business, financial performance or condition, operations (including the results thereof), assets or properties of the Borrower or any Subsidiary since December 31, 2015.
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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 $500,000 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 $500,000 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 applicable Environmental Law or to obtain, maintain or comply with any Permit under or in connection with any applicable Environmental Law (Environmental Permit), (ii) is or has been subject to any Environmental Liability, (iii) has received notice in writing (or, to its knowledge, otherwise) of any Environmental Liability, or (iv) knows of any basis for any Environmental Liability, in each case of (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 $500,000.
SECTION 6.8 Subsidiaries. The Borrower has no Subsidiaries except those Subsidiaries which 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 or Section 8.7.
SECTION 6.9 Ownership of Properties. The Borrower and each Subsidiary owns (i) in the case of owned real property, good and marketable fee title to, and (ii) 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. Except as set forth on Schedule 6.10, the Borrower and each Subsidiary has filed all federal income tax and all other material tax returns and reports or permitted extensions relating thereto 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 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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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 material 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. 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 Internal Revenue Service on which it is 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.
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 in light of the circumstances under which they were made; provided, that, with respect to projected financial information, each Loan Party represents only that such information was prepared in good faith based upon assumptions believed to be reasonable at the time.
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, F.R.S. Board Regulation U or Regulation X. Terms for which meanings are provided in F.R.S. Board Regulation U or Regulation X or any regulations substituted therefor, as from time to time in effect, are used in this Section with such meanings.
SECTION 6.14 Solvency. The Borrower and its Subsidiaries taken as a whole, both before and after giving effect to the Loans, are Solvent.
SECTION 6.15 Intellectual Property.
(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 material so defined as Patents,(ii) registered and material unregistered Trademarks (including domain names) and any
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pending registrations for Trademarks, (iii) any other registered Intellectual Property and (iv) any commercially significant unregistered Intellectual Property, in each case owned or licensed by 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 and (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.
(b) With respect to all material Intellectual Property listed, or required to be listed, on Schedule 6.15(a):
(i) the Borrower or a Subsidiary, as applicable, 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 except to the extent such expiration, lapse, forfeiture, cancellation or abandonment is deemed in the best interest the business as determined by Borrower in its reasonable business judgment;
(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 except to the extent such non-payment would not reasonably be expected to cause a Material Adverse Effect;
(iii) there is no proceeding challenging the validity or enforceability of any such Intellectual Property that the Borrower has knowledge of, 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, to the knowledge of the Borrower, 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
(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, subject to any exclusive licenses granted thereunder and listed on Schedule 6.15(a).
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(c) To the knowledge of the Borrower, no Third Party is committing any act of Infringement of any material Intellectual Property listed, or required to be listed, on Schedule 6.15(a).
(d) With respect to each material 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, to the Borrowers knowledge, 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) such license agreement is not currently subject to any material breach or default by the Borrower, any of its respective Subsidiaries or, to the knowledge of the Borrower, any other party thereto. 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 terminate such license agreement (except to the extent such license is terminated or otherwise cancelled pursuant to the terms thereof and not as a result of a breach by the Borrower or any Subsidiary thereunder or pursuant to the Borrowers reasonable judgment (and not as a result of a breach by the Borrower or any Subsidiary 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. Set forth on Schedule 6.16 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 of the Borrower or any of the Subsidiaries, with an adequate description of the parties thereto, subject matter thereof and amendments and modifications thereto. As of such dates, respectively, each such Material 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) such Material Agreement is not currently subject to any material breach or default by the Borrower, any of its respective Subsidiaries or, to the knowledge of the Borrower, any other party thereto and (iii) none of the Borrower or any of the Subsidiaries has taken any action that would permit any other Person party to any such Material Agreement to terminate such Material Agreement.
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SECTION 6.17 Permits. The Borrower and the Subsidiaries have all material Permits, including Environmental Permits, necessary or required for the ownership, operation and conduct of their business and the distribution of the Products, except, in the case of any Permits other than those which are necessary to sell the KXL System in the United States, to the extent the failure to have the same would not reasonably be expected to have a Material Adverse Effect. All such Permits are validly held and there are no material defaults thereunder.
SECTION 6.18 Regulatory Matters.
(a) The business of the Borrower and its Subsidiaries has been, and currently is, being conducted in material compliance with all applicable U.S. federal, state, 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). The Products were researched, developed, designed, and validated in compliance in all material respects with all applicable Laws, including the FD&C Act, PHSA, CLIA, Privacy Laws and state laws, and have been and continue to be performed, marketed, and conducted in compliance in all material respects with all applicable Laws, including the FD&C Act, PHSA, 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 Borrowers knowledge no investigation by any Governmental Authority with respect to the Borrower is pending or threatened. The Borrower has not received any written communication from any Person (including any Governmental Authority) alleging any material noncompliance with any applicable Laws or any written communication from any Governmental Authority or accrediting organization of any material issues, problems, or concerns regarding the quality or performance of the Products, and to the knowledge of the Borrower, there is no basis for any adverse regulatory action against the Borrower or any of the Subsidiaries or, to the knowledge of the Borrower, their respective suppliers, with respect to the Products. Without limiting the foregoing, (A) to the knowledge of Borrower (1) there have been no product recalls, safety alerts, 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, (2) no such product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like have been requested, demanded or ordered by any Governmental Authority, and, to the knowledge of the Borrower, there is no basis for the issuance of any such product recalls, safety alerts, corrections, withdrawals, marketing suspensions, removals or the like by any Person with respect to any Products, and (B) the Borrower has not 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
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been commenced or threatened in writing by any Governmental Authority with respect to or in connection with any Products, or any consent decrees (including plea agreements) which relate to any Products, 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 the Products or for the issuance of any consent decrees.
(c) The Borrower 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 Borrowers business. All such Key Permits are valid, and in full force and effect and Borrower 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. The Borrower has not 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 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 Borrowers possession or control. The Borrower has made available to the Lender all material adverse event reports and communications to or from 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 or operated by the Borrower or any of 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 to Borrowers knowledge, any of their respective agents or representatives to the FDA, CMS, or any other Governmental Authority, and there has been no failure by Borrower or its Subsidiaries to disclose any material fact required to be disclosed to the FDA or any other Governmental Authority.
(e) With respect to 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 the Borrower, their respective suppliers, relating to the Products have been conducted, and are currently being conducted, in compliance in all material respects to the extent required by the applicable requirements of the FD&C Act, the PHSA and other requirements of the FDA and all other Governmental Authorities, including, without limitation, cGMPs 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 the
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Products at any facility. To Borrowers knowledge, no Product in the inventory of the Borrower or any of its Subsidiaries is adulterated or misbranded in any material respect. All labels and labeling (including package inserts) and product information are in material compliance with applicable FDA and other Governmental Authority requirements, and the Products are in material compliance with all classification, registration, listing, marking, tracking, reporting, recordkeeping and audit requirements of the FDA and any other Governmental Authority.
(f) All manufacturing facilities owned or operated by the Borrower or any of the Subsidiaries, or to Borrowers knowledge used in the production of any Product, are and have been operated in material compliance with cGMPs and all other applicable laws. The FDA has not issued to Borrower, or to Borrowers knowledge any other Person, any Form 483, Warning Letter, or untitled letter with respect to any such facility, or otherwise alleged of Borrower, or to Borrowers knowledge of any other Person, any material non-compliance with cGMPs. All manufacturing facilities owned or operated by the Borrower or any of its Subsidiaries are operated in material compliance with other applicable federal, state and local Laws.
(g) No right of the Borrower 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 to Borrowers knowledge, the Borrower has not been the subject of any inspection, investigation, or audit, by any Governmental Authority in connection with any alleged improper activity.
(h) There is no arrangement relating to the Borrower 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 for its services have been true and correct in all material respects and, to the Borrowers 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) Neither the Borrower nor, to the Borrowers knowledge, any individual who is an officer, director, manager, employee, agent or managing agent of the Borrower has been convicted of, charged with or, to the Borrowers 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 Borrowers knowledge, within the past five (5) years, has been convicted of, charged with or, to the Borrowers knowledge, investigated for a violation of Laws related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, 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 responsibility, financial misconduct, obstruction of an investigation or controlled substances. Neither the Borrower nor, to
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the Borrowers knowledge, any individual who is an officer, director, employee, stockholder, agent or managing agent of the Borrower 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 are pending or, to the Borrowers knowledge, threatened against the Borrower or any individual who is an officer, director, manager, employee, agent or managing agent of the Borrower.
(j) All studies, tests and preclinical and clinical trials conducted relating to the Products, 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 compliance in all material respects with all applicable Laws, procedures and controls pursuant to, where applicable, cGCPs and current good laboratory practices and other applicable laws, rules and regulations. 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 required by applicable Law, the Borrower has obtained all necessary Regulatory Authorizations, including an Investigational Application for the conduct of any clinical investigations conducted by or on behalf of the Borrower.
(k) To the Borrowers knowledge, none of the clinical investigators in any clinical trial conducted by or on behalf of the Borrower has been or is disqualified or otherwise sanctioned by the FDA, the Department of Health and Human Services, or any Governmental Authority and, to the Borrowers knowledge, no such disqualification, or other sanction of any such clinical investigator is pending or threatened. The Borrower has not received any written or, to its knowledge, other notices or correspondence from the FDA or any other Governmental Authority requiring or threatening the termination or suspension of any clinical trials conducted by, or on behalf of, the Borrower.
(l) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair the Borrowers 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 the Products in any material manner, subject to Liens securing the Obligations.
SECTION 6.19 Transactions with Affiliates. Except as set forth on Schedule 6.19 and except for employment agreements and equity financings, none of the Borrower or any Subsidiary has entered into, renewed, extended or been a part to, any transaction (including the purchase, sale, lease, transfer or exchange of property or assets of any kind or the rendering of services of any kind) with any of its Affiliates during the three-year period immediately prior to the Closing Date.
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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, such Schedule correctly identifies the name and address 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 (other than Excluded Accounts) is a Controlled Account as required pursuant to Section 7.13.
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.
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) So long as the Borrower is not a Publicly Reporting Company, 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 adjustments, nominal adjustments in non-cash stock-based compensation resulting from completion of, and updates to, Code Section 409A valuations, and except for the absence of footnotes), unaudited reports of (x) the Revenue Base for
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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 (y) 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;
(b) as soon as available and in any event within 45 days after the end of each of the first three Fiscal Quarters of each Fiscal Year, 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 adjustments, nominal adjustments in non-cash stock-based compensation resulting from completion of, and updates to, Code Section 409A valuations, and except for the absence of footnotes);
(c) as soon as available and in any event within 180 days after the end of each Fiscal Year beginning with the Fiscal Year ended December 31, 2016, a copy of the consolidated balance sheet of the Borrower and its 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 reasonably acceptable to the Lender, it being understood that Grant Thornton LLP are the current auditors of the Borrower and are deemed acceptable to Lender;
(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 financial covenant set forth in Section 8.4, as applicable, and stating that no Default has occurred and is continuing (or, if a Default has occurred, specifying the details of such Default and the action that the Borrower or any of the Subsidiaries has taken or proposes to take with respect thereto), (ii) 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 (iii) 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);
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(e) as soon as possible and in any event within five Business 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 five Business Days after the Borrower obtains knowledge of (i) the occurrence of any material adverse development with respect to any litigation, action, proceeding or labor controversy described in Schedule 6.7(a) or (ii) the commencement of any litigation, action, proceeding or labor controversy of the type and materiality described in Section 6.7, notice thereof and, to the extent the Lender requests, copies of all documentation relating thereto;
(g) as soon as possible and in any event within five Business Days after the Borrower obtains knowledge of any return, recovery, dispute or claim related to Product or inventory that involves more than $500,000.
(h) as soon as possible and in any event within five Business Days after the Borrower obtains knowledge of (i) any written or, to its knowledge, other 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) written or, to its knowledge, other correspondence received from 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 its Subsidiaries files with the SEC or any national securities exchange, unless, so long as the Borrower is a Publicly Reporting Company, copies of such reports, notices, prospectuses and registration statements are publicly available on the SECs EDGAR system within two Business Days of the sending or filing thereof;
(j) 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;
(k) within 45 days after the end of each Fiscal Quarter for the Fiscal Quarter most recently ended, a report listing (i) all Material Agreements entered into during such Fiscal Quarter and (ii) all existing Material Agreements amended or terminated during such Fiscal Quarter;
(l) as soon as available, but in any event not later than January 31 of each calendar year, the Borrowers financial and business projections and budget for such year, with evidence of approval thereof by the Borrowers board of directors; and
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(m) such other financial and other information as the Lender may from time to time reasonably request (including information and reports in such detail as 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 preserve and maintain its legal existence (except as otherwise permitted by Section 8.7), perform in all material respects its obligations under Material Agreements to which the Borrower or any of the Subsidiaries is a party, and comply in all material respects with all applicable Laws and orders, including the payment (before the same become delinquent), of all material 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 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 workers compensation, employers 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 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 use commercially reasonable efforts to have the insurer provide that no cancellation or modification as to the amount or scope of coverage of the policies will be made without 30 days (10 days notice for non-payment of premium) prior written notice to 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 permit the Lender or any of its representatives, at reasonable times during regular business hours and intervals upon reasonable prior written notice to the Borrower, to visit the Borrowers or any of the Subsidiaries offices, to discuss the Borrowers or any of the Subsidiaries financial or other matters with its officers and employees, and its independent public accountants (and the Borrower hereby authorizes such independent public accountant to discuss the Borrowers and any of the Subsidiaries financial and other matters with the Lender or its representatives whether or not any representative of the Borrower or any of the Subsidiaries is present) and to examine (and photocopy extracts from) any of its books and records; provided, that so long as no Event of Default has occurred and is continuing, the Borrower shall only be required to pay any fees incurred in connection with the Lenders visits once in any calendar year. The Borrower shall pay any fees of such independent public accountant incurred in connection with the Lenders exercise of its rights pursuant to this Section but unless an Event of Default has occurred and is continuing at the time of its exercise of such rights, not for more than one visit in any calendar year.
SECTION 7.6 Environmental Law Covenant. Each of the Borrower and each of the Subsidiaries will (i) use and operate all of its and their businesses, facilities and properties in material compliance with all Environmental Laws, and keep and maintain all material Environmental Permits and remain in compliance in all material respects therewith except in each case to the extent such non-compliance would not reasonably be expected to cause a Material Adverse Effect, and (ii) 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 that would reasonably be expected to cause a Material Adverse Effect. The Borrower and each of the Subsidiaries will promptly resolve, remedy and mitigate any such non-compliance or Environmental Liabilities in accordance with reasonable business practices, 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 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
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cause any subsequently acquired or organized Subsidiary to execute a supplement (in form and substance reasonably satisfactory to the Lender) to the Guarantee and each other applicable Loan Document in favor of the Lender, effective upon its acquisition or formation. The Borrower will promptly notify the Lender of any subsequently acquired ownership interest in real property 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 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 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 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.
SECTION 7.9 Obtaining of Permits, Etc. With respect to Products, 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 and material in the proper conduct of its business, except, in the case of any Permits and accreditations other than those which are necessary to sell the KXL System in the United States, where the failure to do so would not reasonably be expected to have a Material Adverse Effect.
SECTION 7.10 Product Licenses. The Borrower and each of the Subsidiaries shall maintain each Key Permit 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, manufacture, store, label, sell, promote, import or distribute the Products, except, in the case of any Permits and Regulatory Authorizations other than those which are necessary to sell the KXL System in the United States, where the failure to do so would not reasonably be expected to have a Material Adverse Effect.
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) in all material respects maintain in full force and effect all material Regulatory Authorizations, contract rights, authorizations or other rights necessary for the operations of its business, and comply with the terms and conditions applicable to the foregoing; (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
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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) in all material respects design, manufacture, store, label, sell, promote, import and distribute all Products in compliance with cGMPs, the FD&C Act, the PHSA, the Controlled Substances Act, and other applicable laws, rules and regulations; (iv) in all material respects conduct all studies, tests and preclinical and clinical trials relating to the Products in accordance with all cGCPs, and other applicable laws, rules and regulations; (v) operate all manufacturing facilities in material compliance with cGMPs, the Controlled Substances Act, and all other applicable laws, rules and regulations; (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 material 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; (vii) notify the Lender, promptly after having knowledge thereof, of any material Infringement or other violation by any Person of its material Intellectual Property; (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 material Intellectual Property, including Patents, developed or controlled by the Borrower or any of the Subsidiaries, except in the event that the Borrower determines in its reasonable commercial judgment not to do so; and (ix) notify the Lender, promptly after learning thereof, of any claim by any Person that the conduct of the Borrowers or any of the Subsidiaries 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 the products of the Borrower or any of its Subsidiaries, or considering any of the foregoing;
(ii) the Borrower or any of its Subsidiaries becoming subject to any administrative or regulatory action, any FDA or EMA inspection or any non-routine inspection by any other Person that results in the receipt of inspectional observations (e.g., on FDA Form 483), a warning letter, untitled letter, or notice of violation letter, or any product of the Borrower or any of its Subsidiaries 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 are pending or threatened against the Borrower or any of its Subsidiaries; 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, 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 material inbound license or similar agreement (other than over-the-counter or open-source software that is commercially available to the public and other than with respect to any agreement set forth on Schedule 6.16): (i) 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 Borrowers and the Subsidiaries business and financial condition; and (ii) 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 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 accounts exclusively used for (i) payroll, payroll taxes and other employee wage and benefit programs to or for the benefit of the Borrowers or a Subsidiarys 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, and (ii) accounts solely containing deposits subject to Liens permitted by Section 8.3(n) (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 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); and
(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.
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SECTION 7.14 Post-Closing Items.
(a) On or before thirty (30) days (or such later date as agreed by Lender) following the Closing Date, the Lender shall have received (a) landlord access and bailee agreements from Expeditors Warehouse, List Logistics LLC, Sharp Packaging Solutions and Ajinomoto Althea, Inc. with respect to the properties commonly known as (1) Unit 6, Horizon Logistics Park, Swords, Dublin, Ireland, (2) 1560 Osgood Street, Bldg. 70, North Andover, Massachusetts 01845, (3) 7451 Keebler Way, Allentown, Pennsylvania 18106, and (4) 11040 Roselle Street, San Diego, California 92121, in each case in form and substance satisfactory to the Lender and (b) insurance endorsements required under Section 5.14 of this Agreement.
(b) On or before thirty (30) days (or such later date as agreed by Lender) following the Closing Date, the Borrower, the Lender and Silicon Valley Bank shall have entered into an account control agreement for the Borrowers accounts numbered [ ], [ ], [ ], [ ], [ ] and [ ] maintained by Silicon Valley Bank, in form and substance reasonably acceptable to the Lender.
SECTION 7.15 Quarterly Update Call; Board Materials.
(a) The chief executive officer and other members of senior management requested by the Lender shall hold a meeting with the Lender by teleconference within one month after the delivery by Borrower of its financial statements pursuant to Sections 7.1(a) and (b), to, at a minimum, discuss business operations and matters referenced in the board materials previously delivered to the Lender pursuant to clause (b) below and review financial statements, in each case with respect to the Borrower and its Subsidiaries.
(b) The Borrower shall concurrently deliver to the Lender all notices and any materials delivered to the board of directors or any committees thereof in connection with a board meeting or action to be taken by written consent, including a draft of any material resolutions or actions proposed to be adopted by written consent.
(c) If any materials delivered to the board of directors of the Borrower or any committee thereof are, in the reasonable good faith judgment of the board of directors, not appropriate to be delivered to the Lender in order to avoid a conflict of interest on the part of the Lender or would result in disclosure of trade secrets or to preserve an attorney-client privilege, then such materials shall not be delivered to the Lender, so long as the Lender is given notice of the occurrence of such judgment by the board of directors and that certain materials will not be delivered to the Lender.
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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, supplemental, related, ancillary thereto or any reasonable extensions thereof.
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 has 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 $250,000 in the aggregate outstanding at any time;
(f) Permitted Subordinated Indebtedness;
(g) Indebtedness of any Subsidiary or the Borrower owing to the Borrower or any Subsidiary;
(h) Indebtedness consisting of guarantees resulting from endorsement of negotiable instruments for collection by the Borrower or any Subsidiary in the ordinary course of business;
(i) Indebtedness in connection with corporate credit cards, purchasing cards or bank card products in an aggregate principal amount at any time outstanding not to exceed $1,000,000;
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(j) Indebtedness in respect of any agreement providing for treasury, depositary, or cash management services, including in connection with any automated clearing house transfers of funds or any similar transactions, securities settlements, foreign exchange contracts, assumed settlement, netting services, overdraft protections and other cash management, intercompany cash pooling and similar arrangements, in each case in the ordinary course of business;
(k) Indebtedness with respect to letters of credit outstanding, provided that at any time in any given calendar year, the outstanding principal amount of such Indebtedness shall not exceed $1,000,000 at any time outstanding;
(l) advances or deposits in the ordinary course of business and not constituting Indebtedness for borrowed money from customers, vendors or partners;
(m) workers compensation claims, payment obligations in connection with health, disability or other types of social security benefits, unemployment or other insurance obligations, reclamation and statutory obligations, in each case incurred in the ordinary course of Borrowers or its Subsidiaries business;
(n) Indebtedness (other than for borrowed money) that may be deemed to exist pursuant to any warranty or contractual service obligations, performance, surety, statutory, appeal, bid or completion of performance guarantees or similar obligations incurred in the ordinary course of business; and
(o) other Indebtedness of the Borrower and the Subsidiaries in an aggregate amount at any time outstanding not to exceed $250,000.
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 clause (b) of Section 8.2;
(c) Liens existing as of the Closing Date and disclosed in Schedule 8.3(c) securing Indebtedness described in clause (c) of Section 8.2, 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 permanently reduced subsequent to 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;
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(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) cash deposits in the ordinary course of business to secure the performance of obligations under commercial supply and/or manufacturing agreements and Liens incurred or deposits made in the ordinary course of business in connection with workers 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 60 days after the entry thereof or with respect to which execution has been stayed or the payment of which is covered in full (subject to a customary deductible) by insurance maintained with responsible insurance companies and 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;
(k) licenses and/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) bankers liens, rights of setoff and Liens in favor of financial institutions incurred made in the ordinary course of business arising in connection with the Borrowers or any Subsidiarys deposit accounts or securities accounts held at such institutions to secure solely payment of fees and similar costs and expenses and provided such accounts are maintained in compliance with Section 7.13(a) hereof;
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(m) licenses or sublicenses, leases or subleases of property granted in the ordinary course of the Borrowers or its Subsidiarys business;
(n) Liens on cash and Cash Equivalent Investments not to exceed $1,000,000 in the aggregate securing Indebtedness permitted under Section 8.2(j), and Liens on cash and Cash Equivalent Investments not to exceed $1,000,000 in the aggregate securing Indebtedness permitted under Section 8.2(k);
(o) the interests of lessors under operating leases;
(p) Liens in favor of customs and revenue authorities arising as a matter of law to secure payment of custom duties that are promptly paid on or before the date they become due; and
(q) Liens on insurance proceeds securing the payment of financed insurance premiums that are promptly paid on or before the date they become due (provided that such Liens extend only to such insurance proceeds and not to any other property or assets).
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 clause (e) of Section 8.3.
SECTION 8.4 Minimum Liquidity. The Liquidity of the Borrower shall not at any time be less than $3,000,000. 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) hereof.
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;
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(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 connection with the purchase price of goods or services, in each case in the ordinary course of business;
(f) Permitted Acquisitions;
(g) Investments by the Borrower or any Subsidiary in the Borrower or any Guarantor;
(h) Investments consisting of security deposits with utilities, landlords and other like Persons made in the ordinary course of business;
(i) employee loans, travel advances and guarantees in accordance with the Borrower or a Subsidiarys usual and customary practices with respect thereto (if permitted by applicable law) which in the aggregate shall not exceed $250,000 outstanding at any time;
(j) Investments consisting of loans to employees, officers, or directors relating to the purchase of equity securities of the Borrower or its Subsidiaries pursuant to employee stock purchase plans or agreements approved by the Borrowers Board of Directors, not to exceed the aggregate amount of $1,000,000 outstanding at any time;
(k) Investments acquired as a result of a Permitted Acquisition to the extent that such Investments were not made in contemplation of or in connection with such Permitted Acquisition and were in existence prior to the date of such Permitted Acquisition;
(l) Investments permitted by Borrowers investment policy as approved by the Borrowers board of directors and in effect as of the date hereof;
(m) Investments consisting of the endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of business; and
(n) other Investments in an 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 (i) Restricted Payments made by the Borrower or Subsidiaries to the Borrower or any Subsidiaries, (ii) the declaration and payment of dividends by the Borrower with respect to its capital stock payable solely in additional shares of its Capital Securities; (iii) payments in respect of the repurchase of Capital
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Securities from former officers, directors , employees, consultants or other holders of Capital Securities of the Borrower and the Subsidiaries in connection with the termination of such Persons services or pursuant to stock repurchase plans or agreements, employee stock option agreements, restricted stock agreements, equity incentive plans or other similar agreements or plans, not to exceed an aggregate amount of $250,000 in any Fiscal Year; (iv) purchases of Capital Securities in connection with the exercise of stock options by way of cashless exercise, or in connection with the satisfaction of withholding tax obligations not to exceed $250,000 in any Fiscal Year or $250,000 in the aggregate in connection with a Qualified IPO; (v) the conversion of convertible securities into Qualified Capital Securities pursuant to the terms of such convertible securities or otherwise in exchange thereof; and (vi) payment of cash in lieu of fractional shares of Capital Securities arising out of stock dividends, splits or combinations in connection with exercises or conversions of options, warrants and other convertible securities, in an amount not to exceed $50,000 in the aggregate.
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 further, in connection with any Permitted Acquisition, the Borrower or any Subsidiary of the Borrower may merge into or consolidate with any other Person or permit any other Person to merge into or consolidate with it, so long as (i) the Person surviving such merger with any Subsidiary shall be a direct or indirect wholly-owned Subsidiary of the Borrower and a Guarantor, and (ii) 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 (i) is inventory or obsolete, damaged, worn out or surplus property Disposed of in the ordinary course of its business, (ii) is permitted by Section 8.7, (iii) is from a Loan Party to a Loan Party (provided that such Loan Party takes such actions as the Lender may reasonably request to ensure the perfection and priority of the Liens in favor of the Lender over such transferred assets); (iv) licenses for the use of the Intellectual Property of the Borrower or its Subsidiaries that are on a non-exclusive basis or on an exclusive basis so long as such exclusive licensing is limited to geographic areas, particular fields of use, a subset of products for customers or limited time periods and so long as after giving effect to such licenses the Loan Parties continue to retain sufficient rights to use their Intellectual Property as to enable them to continue to conduct their business in the ordinary course; (v) transfers of cash for equivalent value; (vi) dispositions consisting
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of the sale, transfer, assignment or other disposition of unpaid and overdue accounts receivable in connection with the collection, compromise or settlement thereof in the ordinary course of business and not as part of a financing transaction; (vii) dispositions of property to the extent that (x) such property is exchanged for credit against the purchase price of similar replacement property or (y) the proceeds (determined on an after-tax basis) of such disposition are applied to the purchase price of such replacement; (viii) dispositions resulting from Casualty Events; (ix) equipment sales to distribution or commercialization partners and transfers of Equipment and other property consisting of demonstration units or located at clinical sites or trade and exhibition shows; and (x) other Dispositions pursuant to this clause (x) solely for cash consideration, not to exceed $250,000 in the aggregate for all such Dispositions in any fiscal year.
SECTION 8.9 Modification of Certain Agreements. 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 (i) any Organic Documents of the Borrower or any of the Subsidiaries, if the result would have an adverse effect on the rights or remedies of the Lender under this Agreement or any Loan Document, or (ii) 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.
SECTION 8.10 Transactions with Affiliates. 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 (i) is between or among the Loan Parties or any of their respective Subsidiaries, (ii) is on fair and reasonable terms no less favorable to the Borrower or any Subsidiary than it could obtain in an arms-length transaction with a Person that is not one of its Affiliates and 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, (iii) consists of the issuance of Capital Securities to Affiliates in exchange for cash, (iv) consists of compensation, benefits, reimbursement and indemnification, of, and other employment arrangements with, directors, officers and employees of the Borrower or any Subsidiary in the ordinary course of business, (v) Investments permitted under Section 8.5(i) or (j) or (vi) is a transaction listed on Schedule 8.10.
SECTION 8.11 Restrictive Agreements, Etc. None of the Borrower or any of the Subsidiaries will enter into any agreement prohibiting (i) the creation or assumption of any Lien upon its properties, revenues or assets, whether now owned or hereafter acquired, (ii) the ability of the Borrower or any of the Subsidiaries to amend or otherwise modify any Loan Document, or (iii) the ability of the Borrower or any Subsidiary to make any payments, directly or indirectly, to the Borrower, including by
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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 (x) in any Loan Document, or (y) in the case of clause (i), (a) in any agreement governing any Indebtedness permitted by clause (e) of Section 8.2 as to the assets financed with the proceeds of such Indebtedness and (b) customary provisions in contracts (including without limitation leases and inbound licenses or Intellectual Property) restricting the assignment thereof.
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. The Borrower and each of the Subsidiaries will exercise commercially reasonable efforts not to enter into any (i) 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 reasons related to the 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, or (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 (ii) amendment with respect to any existing Product Agreement to the extent the amendment would add to such existing Product Agreement either of the provisions in the foregoing clause (a) or (b).
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 (i) change its legal name or any trade name used to identify it in the conduct of its business or ownership of its properties without 10 days prior written notice to the Lender, (ii) change its jurisdiction of organization or legal structure, (iii) 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 after the Closing Date) without 20 days prior written notice to the Lender, ( iv) change its federal taxpayer identification number or organizational number (or equivalent) without 20 days prior written notice to the Lender, (v) replace its chief executive officer or chief financial officer without written notification to the Lender within 30 days thereafter, or (vi) change its Fiscal Year or any of its Fiscal Quarters.
SECTION 8.15 Benefit Plans. None of the Borrower or any Subsidiary will (i) become the sponsor of, incur any responsibility to contribute to or otherwise incur actual or potential liability with respect to, any Benefit Plan, (ii) allow any employee benefit plan as defined in section 3(3) of ERISA that provides retirement benefits, is
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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, (iii) allow the assets of any tax qualified retirement plan to become invested in Capital Securities of the Borrower or any Subsidiary, (iv) 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 law, or (v) 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 entities has any actual or potential liability), to become self-insured.
ARTICLE IX
EVENTS OF DEFAULT
SECTION 9.1 Listing of Events of Default. Each of the following events or occurrences described in this Article shall constitute an Event of Default.
(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 three 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 when made or deemed to have been made in any material respect.
(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, 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 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 $500,000, or a default shall occur in the performance or observance of any obligation or condition with
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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 $1,000,000 (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.
(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 in or 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 and unstayed; 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
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(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 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 Borrowers or any Subsidiarys material rights or interests thereunder is terminated or amended in any manner adverse to the Borrower or any Subsidiary in any material respect.
(k) Material Adverse Change. Any circumstance occurs that has had or would reasonably be expected to have a Material Adverse Effect.
(l) Key Person Event. If Reza Zadno ceases to be employed full time by the Borrower and actively working as the President and Chief Executive Officer, unless within 180 days after such individual 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, EMA or any other Governmental Authority (A) issues a letter or other communication asserting that any Product related to the KXL System 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 of their Products or the manufacturing facilities therefor, that causes the Borrower or such Subsidiary to discontinue marketing or withdraw any of its Products related to the KXL System, or causes a delay in the manufacture or offering of any of its Products related to the KXL System, 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 liability to the Borrower and the Subsidiaries in excess of $1,000,000; or (iii) the Borrower or any of the Subsidiaries enters into a settlement agreement with the FDA, CMS, EMA 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 $1,000,000.
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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.
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/or 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 hereto, or at such other address or facsimile number as may be designated by such party in a notice to the other parties, and a copy of all notices shall be given by email at the email address for a party set forth therein, if any, or at such other email address as designated by such party 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.
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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, who may be retained by or on behalf of the Lender) in connection with
(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 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 officers, directors, 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 hereto or the parties hereto and third parties (collectively, the Indemnified Liabilities), including, without limitation, Indemnified Liabilities arising out of or relating to (i) 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 (ii) any Environmental Liability, except in any and all cases to the extent such is caused by the gross
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negligence or willful misconduct of the Indemnified Parties. 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. This Section 10.4 shall not apply with respect to Taxes other than any Taxes that represent losses, costs, liabilities, obligations and damages, and expenses, etc. arising from any non-Tax claim.
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 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 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 hereto 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 (e.g., pdf or tiff) 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). The Loan Documents constitute the entire understanding among the parties hereto with respect to the subject matter thereof and supersede any prior agreements, written or oral, with respect thereto.
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SECTION 10.10 Successors and Assigns. This Agreement shall be binding upon and shall inure to the benefit of the parties hereto 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; and provided further that, except upon the occurrence and during the continuation of an Event of Default, the Lender may not assign or transfer it rights or obligations hereunder to any other Person without the consent of the Borrower (not to be unreasonably withheld or delayed), except to any Eligible Transferee.
SECTION 10.11 Other Transactions. Nothing contained herein shall preclude the Lender, from engaging in any transaction, in 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 LENDERS 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.
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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 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 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 Partys employees, advisors or consultants who have a need to know such information to assist such Party in the performance of such Partys obligations or in the exercise of such Partys rights hereunder and who are subject to reasonable obligations of confidentiality (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 Lenders rights hereunder and (iii) potential and actual investors in, or lenders to, the Lender (including, in each of the foregoing cases, such Persons employees, advisors or consultants); provided that in each case, (x) each such Recipient shall be subject to reasonable obligations of confidentiality and (y) unless an Event of Default has occurred and is continuing, no such disclosure shall be permitted to any direct competitor of the Borrower or any Subsidiary; and (b) 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 (sub)licensees, permitted subcontractors, investment bankers, investors, lenders (including, in each of the foregoing cases, such Persons 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 (including the Loan Documents and the terms and conditions thereof) 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 Partys 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 and
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reasonably practicable, will notify the Disclosing Party of the Receiving Partys 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 (including, without limitation, an opportunity to seek (at the Borrowers sole expense) a protective order or other appropriate remedy); provided, however, that no such notice will be required in respect of disclosures of Confidential Information to regulatory authorities having or claiming to have jurisdiction over the Receiving Party in connection with routine regulatory examinations. In the event that no such protective order or other remedy is obtained or that the Disclosing Party waives compliance with the provisions hereof, the Receiving Party and its Representatives may disclose such Confidential Information as may be required or requested pursuant to such laws or judicial process.
SECTION 10.15 Exceptions to Confidentiality. The Receiving Partys obligations set forth in this Agreement shall not extend to any Confidential Information of the Disclosing Party:
(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.
AVEDRO, INC., | ||
as the Borrower | ||
By: | /s/ Reza Zadno | |
Name: Reza Zadno | ||
Title: CEO | ||
ORBIMED ROYALTY OPPORTUNITIES II, LP, | ||
as the Lender | ||
By: OrbiMed Advisors LLC, its investment manager | ||
By: | /s/ Sven Borho | |
Name: Sven Borho | ||
Title: Member |
Signature Page to Credit Agreement