Document:

Exhibit 10.7

 

AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT

 

THIS AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT (as the same may from time to time be amended, modified, supplemented or restated, this “Agreement”) dated as of June 30, 2014 (the “Effective Date”) among OXFORD FINANCE LLC, a Delaware limited liability company with an office located at 133 North Fairfax Street, Alexandria, Virginia 22314 (“Oxford”), as collateral agent (in such capacity, “Collateral Agent”), the Lenders listed on Schedule 1.1 hereof or otherwise a party hereto from time to time including Oxford in its capacity as a Lender (each a “Lender” and collectively, the “Lenders”), and SIENTRA, INC., a Delaware corporation, with offices located at 6769 Hollister Avenue Suite 201, Santa Barbara, CA 93117 (“Borrower”), amends and restates in its entirety that certain Loan and Security Agreement dated as of January 17, 2013 by and among Collateral Agent, Oxford, in its capacity as a Lender, and other lenders party thereto from time to time and Borrower (the “Original Agreement”) and provides the terms on which the Lenders shall lend to Borrower and Borrower shall repay the Lenders.  The parties agree as follows:

 

1.                                      ACCOUNTING AND OTHER TERMS

 

1.1                               Accounting terms not defined in this Agreement shall be construed in accordance with GAAP. Calculations and determinations must be made in accordance with GAAP. Capitalized terms not otherwise defined in this Agreement shall have the meanings set forth in Section 13.  All other terms contained in this Agreement, unless otherwise indicated, shall have the meaning provided by the Code to the extent such terms are defined therein.  All references to “Dollars” or “$” are United States Dollars, unless otherwise noted.

 

2.                                      LOANS AND TERMS OF PAYMENT

 

2.1                               Promise to Pay.  Borrower hereby unconditionally promises to pay each Lender, the outstanding principal amount of all Term Loans advanced to Borrower by such Lender and accrued and unpaid interest thereon and any other amounts due hereunder as and when due in accordance with this Agreement.

 

2.2                               Term Loans.

 

(a)                                 Availability.

 

(i)                                     Subject to the terms and conditions of the Original Agreement, the Lenders, severally and not jointly, loaned to Borrower (A) on the Effective Date (as defined in the Original Agreement) an advance according to each Original Lender’s Term A Loan Commitment (as defined in the Original Agreement) as set forth on Schedule 1.1 of the Original Agreement (such term loans referred to singly as “Term A Loan”, and collectively as “Term A Loans”) in the principal aggregate amount of Seven Million and Five Hundred Thousand Dollars ($7,500,000), (B) on August 1, 2013 an advance according to each Original Lender’s Term B Loan Commitment (as defined in the Original Agreement) as set forth on Schedule 1.1 of the Original Agreement (such term loans referred to singly as “Term B Loan”, and collectively as “Term B Loans”) in the principal aggregate amount of Two Million and Five Hundred Thousand Dollars ($2,500,000) and (C) on December 13, 2013 an advance according to each Original Lender’s Term C Loan Commitment (as defined in the Original Agreement) as set forth on Schedule 1.1 of the Original Agreement (such term loans referred to singly as “Term C Loan”, and collectively as “Term C Loans”) (Term A Loans, Term B Loans and Term C Loans, collectively, “Original Term Loans”) in the principal aggregate amount of Five Million Dollars ($5,000,000).  The entire principal aggregate amount of the Original Term Loans remains outstanding on the date hereof and shall, as of the Effective Date (as defined herein), be governed by the terms and provisions of this Agreement.  After repayment, no Original Term Loans may be re-borrowed.

 

(ii)                                  Subject to the terms and conditions of this Agreement, the Lenders agree, severally and not jointly, to make term loans to Borrower on the Effective Date in an aggregate amount of Ten Million Dollars ($10,000,000) (which, for the purposes of clarity, shall not include the entire aggregate principal amount of Original Term Loans outstanding on the Effective Date) according to each Lender’s Term D Loan Commitment as set forth on Schedule 1.1 hereto (such term loans are hereinafter referred to singly as a “Term D Loan”, and collectively as the “Term D Loans”; each Term D Loan and Original Term Loan is hereinafter referred 

 

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to singly as a “Term Loan” and the Term D Loans and Original Term Loans are hereinafter referred to collectively as the “Term Loans”).  After repayment, no Term D Loan may be re-borrowed.

 

(b)                                 Repayment.

 

(i)                                     Borrower shall make monthly payments of interest only commencing on the first (1st) Payment Date following the Funding Date of the Term Loans (and in the case of Original Term Loans, commencing on July 1, 2014), and continuing on the Payment Date of each successive month thereafter through and including the Payment Date immediately preceding the Amortization Date.  Borrower agrees to pay, on the Funding Date of each Term Loan advanced hereunder, any initial partial monthly interest payment otherwise due for the period between the Funding Date of such Term Loan and the first Payment Date thereof.

 

(ii)                                  Commencing on the Amortization Date for the Original Term Loans, and continuing on the Payment Date of each month thereafter, Borrower shall make consecutive equal monthly payments of principal and interest, in arrears, to each Lender, as calculated by Collateral Agent (which calculations shall be deemed correct absent manifest error) based upon: (1) the amount of such Lender’s Original Term Loan, (2) the effective rate of interest, as determined in Section 2.3(a), and (3) a repayment schedule equal to nineteen (19) months.

 

(iii)                               Commencing on the Amortization Date for the Term D Loans, and continuing on the Payment Date of each month thereafter, Borrower shall make consecutive equal monthly payments of principal and interest, in arrears, to each Lender, as calculated by Collateral Agent (which calculations shall be deemed correct absent manifest error) based upon: (1) the amount of such Lender’s Term D Loan, (2) the effective rate of interest, as determined in Section 2.3(a), and (3) a repayment schedule equal to (A) forty-two (42) months if the IPO Event does not occur or (B) thirty (30) months if the IPO Event does occur.

 

(iv)                              All unpaid principal and accrued and unpaid interest with respect to each Term Loan is due and payable in full on the Maturity Date of such Term Loan.  Each Term Loan may only be prepaid in accordance with Sections 2.2(c) and 2.2(d).

 

(c)                                  Mandatory Prepayments.  If the Term Loans are accelerated following the occurrence of an Event of Default, Borrower shall immediately pay to Lenders, payable to each Lender in accordance with its respective Pro Rata Share, an amount equal to the sum of: (i) all outstanding principal of the Term Loans plus accrued and unpaid interest thereon through the prepayment date, (ii) the Final Payment, plus (iii) all other Obligations that are due and payable, including Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts.  Notwithstanding (but without duplication with) the foregoing, on the Maturity Date, if the Final Payment had not previously been paid in full in connection with the prepayment of the Term Loans in full, Borrower shall pay to Collateral Agent, for payment to each Lender in accordance with its respective Pro Rata Share, the Final Payment in respect of the Term Loans.

 

(d)                                 Permitted Prepayment of Term Loans.  Borrower shall also have the option to prepay all or part of the Term Loans, at any time or at multiple times, provided Borrower (i) provides written notice to Collateral Agent of its election to prepay the Term Loans at least ten (10) business days prior to such prepayment, (ii) prepays (if prepaying only a part of Term Loans) such part of the Term Loans in a denomination that is equal to or greater than Five Million Dollars ($5,000,000), and (iii) pays to the Lenders on the date of such prepayment, payable to each Lender in accordance with its respective Pro Rata Share, an amount equal to the sum of (A) the portion of outstanding principal of such Term Loans being prepaid plus all accrued and unpaid interest thereon through the prepayment date, (B) the applicable Final Payment with respect to the portion of Term Loans being prepaid, and (C) all other Obligations that are due and payable, including Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts.  For the purposes of clarity, any partial prepayment shall be applied pro-rata to all outstanding amounts under each Term Loan.

 

2.3                               Payment of Interest on the Credit Extensions.

 

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(a)                                 Interest Rate.  Subject to Section 2.3(b), the principal amount outstanding under the Term Loans shall accrue interest at a fixed per annum rate (which rate shall be fixed for the duration of the applicable Term Loan) equal to the Basic Rate, determined by Collateral Agent on the Funding Date of the applicable Term Loan, which interest shall be payable monthly in arrears in accordance with Sections 2.2(b) and 2.3(e).  Interest shall accrue on each Term Loan commencing on, and including, the Funding Date of such Term Loan, and shall accrue on the principal amount outstanding under such Term Loan through and including the day on which such Term Loan is paid in full.

 

(b)                                 Default Rate.  Immediately upon the occurrence and during the continuance of an Event of Default, Obligations shall accrue interest at a fixed per annum rate equal to the rate that is otherwise applicable thereto plus five percentage points (5.00%) (the “Default Rate”).  Payment or acceptance of the increased interest rate provided in this Section 2.3(b) is not a permitted alternative to timely payment and shall not constitute a waiver of any Event of Default or otherwise prejudice or limit any rights or remedies of Collateral Agent.

 

(c)                                  360-Day Year.  Interest shall be computed on the basis of a three hundred sixty (360) day year consisting of twelve (12) months of thirty (30) days.

 

(d)                                 Debit of Accounts.  .  Collateral Agent and each Lender may debit (or ACH) any deposit accounts, maintained by Borrower or any of its Subsidiaries, including the Designated Deposit Account, for principal and interest payments or any other amounts Borrower owes the Lenders under the Loan Documents when due.  Any such debits (or ACH activity) shall not constitute a set-off.

 

(e)                                  Payments.  Except as otherwise expressly provided herein, all payments by Borrower under the Loan Documents shall be made to the respective Lender to which such payments are owed, at such Lender’s office in immediately available funds on the date specified herein.  Unless otherwise provided, interest is payable monthly on the Payment Date of each month.  Payments of principal and/or interest received after 2:00 PM Eastern time are considered received at the opening of business on the next Business Day.  When a payment is due on a day that is not a Business Day, the payment is due the next Business Day and additional fees or interest, as applicable, shall continue to accrue until paid.  All payments to be made by Borrower hereunder or under any other Loan Document, including payments of principal and interest, and all fees, expenses, indemnities and reimbursements, shall be made without set-off, recoupment or counterclaim, in lawful money of the United States and in immediately available funds.

 

2.4                               Secured Promissory Notes.  The Term D Loans shall be evidenced by a secured promissory note or notes in the form attached as Exhibit D hereto, and shall be repayable as set forth in this Agreement.  The Original Term Loans shall be evidenced by the secured promissory notes issued pursuant to the Original Agreement (such secured promissory notes together with the secured promissory notes issued hereunder in the form attached as Exhibit D hereto, the “Secured Promissory Notes”).  Borrower irrevocably authorizes each Lender to make or cause to be made, on or about the Funding Date of any Term Loan or at the time of receipt of any payment of principal on such Lender’s Secured Promissory Note, an appropriate notation on such Lender’s Secured Promissory Note Record reflecting the making of such Term Loan or (as the case may be) the receipt of such payment.  The outstanding amount of each Term Loan set forth on such Lender’s Secured Promissory Note Record shall be prima facie evidence of the principal amount thereof owing and unpaid to such Lender absent manifest error, but the failure to record, or any error in so recording, any such amount on such Lender’s Secured Promissory Note Record shall not limit or otherwise affect the obligations of Borrower under any Secured Promissory Note or any other Loan Document to make payments of principal of or interest on any Secured Promissory Note when due.  Upon receipt of an affidavit of an officer of a Lender as to the loss, theft, destruction, or mutilation of its Secured Promissory Note, Borrower shall issue, in lieu thereof, a replacement Secured Promissory Note in the same principal amount thereof and of like tenor.

 

2.5                               Fees.  Borrower shall pay to Collateral Agent:

 

(a)                                 Facility Fee.  A fully earned, non-refundable facility fee of Fifty Thousand Dollars ($50,000) to be shared between the Lenders pursuant to their respective Commitment Percentages which has already been paid by the Borrower on or about June 10, 2014;

 

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(b)                                 Make Whole Fee.  A fully earned, non-refundable “make whole” fee of Forty Seven Thousand Dollars ($47,000) to be shared between the Lenders pursuant to their respective Commitment Percentages payable on the Effective Date;

 

(c)                                  Final Payment.  The Final Payment, when due hereunder, to be shared between the Lenders in accordance with their respective Pro Rata Shares;

 

(d)                                 Intentionally Left Blank;

 

(e)                                  Lenders’ Expenses.  All Lenders’ Expenses (including reasonable attorneys’ fees and expenses for documentation and negotiation of this Agreement) incurred through and after the Effective Date, when due.

 

2.6                               Withholding.  Payments received by the Lenders from Borrower hereunder will be made free and clear of and without deduction for any and all present or future taxes, levies, imposts, duties, deductions, withholdings, assessments, fees or other charges imposed by any governmental authority (including any interest, additions to tax or penalties applicable thereto).  Specifically, however, if at any time any Governmental Authority, applicable law, regulation or international agreement requires Borrower to make any withholding or deduction from any such payment or other sum payable hereunder to the Lenders, Borrower hereby covenants and agrees that the amount due from Borrower with respect to such payment or other sum payable hereunder will be increased to the extent necessary to ensure that, after the making of such required withholding or deduction, each Lender receives a net sum equal to the sum which it would have received had no withholding or deduction been required and Borrower shall pay the full amount withheld or deducted to the relevant Governmental Authority.  Borrower will, upon request, furnish the Lenders with proof reasonably satisfactory to the Lenders indicating that Borrower has made such withholding payment; provided, however, that Borrower need not make any withholding payment if the amount or validity of such withholding payment is contested in good faith by appropriate and timely proceedings and as to which payment in full is bonded or reserved against by Borrower.  The agreements and obligations of Borrower contained in this Section 2.6 shall survive the termination of this Agreement.

 

2.7                               Warrants.  On or before the funding of the Term D Loan, Borrower shall issue one or more Warrants to each Lender making such Term Loan, for the purchase of shares of the Borrower’s common stock, par value $0.01 per share, for an aggregate purchase price equal to two and one-half percent (2.50%) of the amount of Term D Loan that such Lender has committed to fund (in accordance with its Commitment Percentage).  Each Warrant shall be exercisable for period of seven (7) years from its date of issuance.  The Warrants issued pursuant to the Original Agreement shall continue to be outstanding and effective in accordance with their respective terms.

 

3.                                      CONDITIONS OF LOANS

 

3.1                               Conditions Precedent to Initial Credit Extension.  Each Lender’s obligation to make a Term D Loan is subject to the condition precedent that Collateral Agent and each Lender shall consent to or shall have received, in form and substance reasonably satisfactory to Collateral Agent and each Lender, such documents, and completion of such other matters, as Collateral Agent and each Lender may reasonably deem necessary or appropriate, including, without limitation:

 

(a)                                 original Loan Documents, each duly executed by Borrower and each Subsidiary, as applicable;

 

(b)                                 duly executed original Control Agreements with respect to any Collateral Accounts maintained by Borrower or any of its Subsidiaries (other than for deposit accounts exclusively used for payroll, payroll taxes and other employee wage and benefit payments to or for the benefit of Borrower’s, or any of its Subsidiaries’, employees and identified to Collateral Agent by Borrower as such in the Perfection Certificate);

 

(c)                                  duly executed original Secured Promissory Notes in favor of each Lender, and one or more Warrants issued to each Lender, according to its Term D Loan Commitment Percentage;

 

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(d)                                 the Operating Documents and good standing certificates of Borrower and its Subsidiaries certified by the Secretary of State (or equivalent agency) of Borrower’s and such Subsidiaries’ jurisdiction of organization or formation and each jurisdiction in which Borrower and each Subsidiary is qualified to conduct business, each as of a date no earlier than thirty (30) days prior to the Effective Date;

 

(e)                                  a completed Perfection Certificate for Borrower and each of its Subsidiaries;

 

(f)                                   the Annual Projections, for the current calendar year;

 

(g)                                  duly executed original officer’s certificate for Borrower and each Subsidiary that is a party to the Loan Documents, in a form acceptable to Collateral Agent and the Lenders;

 

(h)                                 certified copies, dated as of date no earlier than thirty (30) days prior to the Effective Date, of financing statement searches, as Collateral Agent shall request, accompanied by written evidence (including any UCC termination statements) that the Liens indicated in any such financing statements either constitute Permitted Liens or have been or, in connection with the initial Credit Extension, will be terminated or released;

 

(i)                                     a landlord’s consent executed in favor of Collateral Agent in respect of all of Borrower’s and each Subsidiaries’ leased locations;

 

(j)                                    a bailee waiver executed in favor of Collateral Agent in respect of each third party bailee where Borrower or any Subsidiary maintains Collateral having a book value in excess of One Hundred Thousand Dollars ($100,000.00);

 

(k)                                 a duly executed legal opinion of counsel to Borrower dated as of the Effective Date;

 

(l)                                     evidence reasonably satisfactory to Collateral Agent and the Lenders that the insurance policies required by Section 6.5 hereof are in full force and effect, together with appropriate evidence showing loss payable and/or additional insured clauses or endorsements in favor of Collateral Agent, for the ratable benefit of the Lenders; and

 

(m)                             a copy of any applicable Registration Rights Agreement or Investors’ Rights Agreement and any amendments thereto;

 

(n)                                 payment of the fees and Lenders’ Expenses then due as specified in Section 2.5 hereof.

 

3.2                               Conditions Precedent to all Credit Extensions.  The obligation of each Lender to make each Credit Extension, including the initial Credit Extension, is subject to the following conditions precedent:

 

(a)                                 receipt by Collateral Agent of an executed Disbursement Letter in the form of Exhibit B attached hereto;

 

(b)                                 the representations and warranties in Section 5 hereof shall be true, accurate and complete in all material respects on the date of the Disbursement Letter and on the Funding Date of each Credit Extension; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall only be required to be true, accurate and complete in all material respects as of such date, and no Event of Default shall have occurred and be continuing or result from the Credit Extension.  Each Credit Extension is Borrower’s representation and warranty on that date that the representations and warranties in Section 5 hereof are true, accurate and complete in all material respects; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall only be required to be true, accurate and complete in all material respects as of such date;

 

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(c)                                  in such Lender’s sole discretion, there has not been any Material Adverse Change;

 

(d)                                 to the extent not delivered at the Effective Date and otherwise required hereunder, duly executed original Secured Promissory Notes and Warrants, in number, form and content reasonably acceptable to each Lender, and in favor of each Lender according to its Commitment Percentage, with respect to each Credit Extension made by such Lender after the Effective Date; and

 

(e)                                  payment of the fees and Lenders’ Expenses then due as specified in Section 2.5 hereof.

 

3.3                               Covenant to Deliver.  Borrower agrees to deliver to Collateral Agent and the Lenders each item required to be delivered to Collateral Agent under this Agreement as a condition precedent to any Credit Extension.  Borrower expressly agrees that a Credit Extension made prior to the receipt by Collateral Agent or any Lender of any such item shall not constitute a waiver by Collateral Agent or any Lender of Borrower’s obligation to deliver such item, and any such Credit Extension in the absence of a required item shall be made in each Lender’s sole discretion.

 

3.4                               Procedures for Borrowing.  Subject to the prior satisfaction of all other applicable conditions to the making of a Term Loan set forth in this Agreement, to obtain a Term Loan, Borrower shall notify the Lenders (which notice shall be irrevocable) by electronic mail, facsimile, or telephone by 2:00 PM Eastern time three (3) Business Days prior to the date the Term Loan is to be made.  Together with any such electronic, facsimile or telephonic notification, Borrower shall deliver to the Lenders by electronic mail or facsimile a completed Disbursement Letter executed by a Responsible Officer or his or her designee.  The Lenders may rely on any telephone notice given by a person whom a Lender reasonably believes is a Responsible Officer or designee.  On the Funding Date, each Lender shall credit and/or transfer (as applicable) to the Designated Deposit Account, an amount equal to its Term Loan Commitment.

 

4.                                      CREATION OF SECURITY INTEREST

 

4.1                               Grant of Security Interest.  Borrower hereby grants Collateral Agent, for the ratable benefit of the Lenders, to secure the payment and performance in full of all of the Obligations, a continuing security interest in, and pledges to Collateral Agent, for the ratable benefit of the Lenders, the Collateral, wherever located, whether now owned or hereafter acquired or arising, and all proceeds and products thereof.  Borrower represents, warrants, and covenants that the security interest granted herein is and shall at all times continue to be a first priority perfected security interest in the Collateral, subject only to Permitted Liens that are permitted by the terms of this Agreement to have priority to Collateral Agent’s Lien.  If Borrower shall acquire a commercial tort claim (as defined in the Code), Borrower, shall promptly notify Collateral Agent in a writing signed by Borrower, as the case may be, of the general details thereof (and further details as may be required by Collateral Agent; however, no such notification needs to be made with respect to claims and counterclaims related to the lawsuits, ongoing on the Effective Date, involving Mentor Worldwide LLC) and grant to Collateral Agent, for the ratable benefit of the Lenders, in such writing a security interest therein and in the proceeds thereof, all upon the terms of this Agreement, with such writing to be in form and substance reasonably satisfactory to Collateral Agent.

 

If this Agreement is terminated, Collateral Agent’s Lien in the Collateral shall continue until the Obligations (other than inchoate indemnity obligations) are repaid in full in cash.  Upon payment in full in cash of the Obligations (other than inchoate indemnity obligations) and at such time as the Lenders’ obligation to make Credit Extensions has terminated, Collateral Agent shall, at the sole cost and expense of Borrower, release its Liens in the Collateral and all rights therein shall revert to Borrower.

 

4.2                               Authorization to File Financing Statements.  Borrower hereby authorizes Collateral Agent to file financing statements or take any other action required to perfect Collateral Agent’s security interests in the Collateral, without notice to Borrower, with all appropriate jurisdictions to perfect or protect Collateral Agent’s interest or rights under the Loan Documents, including a notice that any disposition of the Collateral, except to the extent permitted by the terms of this Agreement, by Borrower, or any other Person, shall be deemed to violate the rights of Collateral Agent under the Code.

 

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5.                                      REPRESENTATIONS AND WARRANTIES

 

Borrower represents and warrants to Collateral Agent and the Lenders as follows at all times:

 

5.1                               Due Organization, Authorization: Power and Authority.  Borrower and each of its Subsidiaries is duly existing and in good standing as a Registered Organization in its jurisdictions of organization or formation and Borrower and each of its Subsidiaries is qualified and licensed to do business and is in good standing in any jurisdiction in which the conduct of its businesses or its ownership of property requires that it be qualified except where the failure to do so could not reasonably be expected to have a Material Adverse Change.  In connection with this Agreement, Borrower and each of its Subsidiaries has delivered to Collateral Agent an updated completed perfection certificate signed by an officer of Borrower or such Subsidiary (each a “Perfection Certificate” and collectively, the “Perfection Certificates”).  Borrower represents and warrants that (a) Borrower and each of its Subsidiaries’ exact legal name is that which is indicated on its respective Perfection Certificate and on the signature page of each Loan Document to which it is a party; (b) Borrower and each of its Subsidiaries is an organization of the type and is organized in the jurisdiction set forth on its respective Perfection Certificate; (c) each Perfection Certificate accurately sets forth each of Borrower’s and its Subsidiaries’ organizational identification number or accurately states that Borrower or such Subsidiary has none; (d) each Perfection Certificate accurately sets forth Borrower’s and each of its Subsidiaries’ place of business, or, if more than one, its chief executive office as well as Borrower’s and each of its Subsidiaries’ mailing address (if different than its chief executive office); (e) Borrower and each of its Subsidiaries (and each of its respective predecessors) have not, in the past five (5) years, changed its jurisdiction of organization, organizational structure or type, or any organizational number assigned by its jurisdiction; and (f) all other information set forth on the Perfection Certificates pertaining to Borrower and each of its Subsidiaries, is accurate and complete (it being understood and agreed that Borrower and each of its Subsidiaries may from time to time update certain information in the Perfection Certificates (including the information set forth in clause (d) above) after the Effective Date to the extent permitted by one or more specific provisions in this Agreement); such updated Perfection Certificates subject to the review and approval of Collateral Agent.  If Borrower or any of its Subsidiaries is not now a Registered Organization but later becomes one, Borrower shall notify Collateral Agent of such occurrence and provide Collateral Agent with such Person’s organizational identification number within five (5) Business Days of receiving such organizational identification number.

 

The execution, delivery and performance by Borrower and each of its Subsidiaries of the Loan Documents to which it is a party have been duly authorized, and do not (i) conflict with any of Borrower’s or such Subsidiaries’ organizational documents, including its respective Operating Documents, (ii) contravene, conflict with, constitute a default under or violate any material Requirement of Law applicable thereto, (iii) contravene, conflict or violate any applicable order, writ, judgment, injunction, decree, determination or award of any Governmental Authority by which Borrower or such Subsidiary, or any of their property or assets may be bound or affected, (iv) require any action by, filing, registration, or qualification with, or Governmental Approval from, any Governmental Authority (except such Governmental Approvals which have already been obtained and are in full force and effect) or are being obtained pursuant to Section 6.1(b), or (v) constitute an event of default under any material agreement by which Borrower or any of such Subsidiaries, or their respective properties, is bound.  Neither Borrower nor any of its Subsidiaries is in default under any agreement to which it is a party or by which it or any of its assets is bound in which such default could reasonably be expected to have a Material Adverse Change.

 

5.2                               Collateral.

 

(a)                                 Borrower and each its Subsidiaries have good title to, have rights in, and the power to transfer each item of the Collateral upon which it purports to grant a Lien under the Loan Documents, free and clear of any and all Liens except Permitted Liens, and neither Borrower nor any of its Subsidiaries have any Deposit Accounts, Securities Accounts, Commodity Accounts or other investment accounts other than the Collateral Accounts or the other investment accounts, if any, described in the Perfection Certificates delivered to Collateral Agent in connection herewith with respect of which Borrower or such Subsidiary has given Collateral Agent notice and taken such actions as are necessary to give Collateral Agent a perfected security interest therein.  The Accounts are bona fide, existing obligations of the Account Debtors.

 

(b)                                 On the Effective Date, and except as disclosed on the Perfection Certificate, none of the Collateral is in the possession of any third party bailee (such as a warehouse) where the book value of such 

 

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Collateral in the possession of any bailee is in excess of One Hundred Thousand Dollars ($100,000.00).  None of the components of the Collateral shall be maintained at locations other than as disclosed in the Perfection Certificates on the Effective Date or as permitted pursuant to Section 6.11.

 

(c)                                  All Eligible Domestic Inventory is in all material respects of good and marketable quality, free from material defects.

 

(d)                                 Borrower and each of its Subsidiaries is the sole owner of the Intellectual Property each respectively purports to own, free and clear of all Liens other than Permitted Liens.  Except as noted on the Perfection Certificates, neither Borrower nor any of its Subsidiaries is a party to, nor is bound by, any material license or other material agreement with respect to which Borrower or such Subsidiary is the licensee that (i) prohibits or otherwise restricts Borrower or its Subsidiaries from granting a security interest in Borrower’s or such Subsidiaries’ interest in such material license or material agreement or any other property, or (ii) for which a default under or termination of could interfere with Collateral Agent’s or any Lender’s right to sell any Collateral.  Borrower shall provide written notice to Collateral Agent and each Lender within ten (10) days of Borrower or any of its Subsidiaries entering into or becoming bound by any license or agreement with respect to which Borrower or any Subsidiary is the licensee (other than over-the-counter software that is commercially available to the public).  Borrower shall, and shall cause its Subsidiaries to, take such commercially reasonable steps as Collateral Agent and any Lender requests to obtain the consent of, or waiver by, any Person whose consent or waiver is necessary for (i) all licenses or agreements with respect to which Borrower or any Subsidiary is the licensee to be deemed “Collateral” and for Collateral Agent and each Lender to have a security interest in it that might otherwise be restricted or prohibited by law or by the terms of any such license or agreement, whether now existing or entered into in the future, and (ii) Collateral Agent and each Lender shall have the ability in the event of a liquidation of any Collateral to dispose of such Collateral in accordance with Collateral Agent’s and such Lender’s rights and remedies under this Agreement and the other Loan Documents.

 

5.3                               Litigation.  Except as disclosed (i) on the Perfection Certificates, or (ii) in accordance with Section 6.9 hereof, there are no actions, suits, investigations, or proceedings pending or, to the knowledge of the Responsible Officers, threatened in writing by or against Borrower or any of its Subsidiaries involving more than One Hundred Thousand Dollars ($100,000.00).

 

5.4                               No Material Deterioration in Financial Condition; Financial Statements.  All consolidated financial statements for Borrower and its Subsidiaries, delivered to Collateral Agent fairly present, in conformity with GAAP, subject to normal year-end adjustments and footnotes in the case of financial statements delivered pursuant to Section 6.2(a)(i), in all material respects the consolidated financial condition of Borrower and its Subsidiaries, and the consolidated results of operations of Borrower and its Subsidiaries.  There has not been any material deterioration in the consolidated financial condition of Borrower and its Subsidiaries since the date of the most recent financial statements submitted to any Lender.

 

5.5                               Solvency.  Borrower and each of its Subsidiaries is Solvent.

 

5.6                               Regulatory Compliance.  Neither Borrower nor any of its Subsidiaries is an “investment company” or a company “controlled” by an “investment company” under the Investment Company Act of 1940, as amended.  Neither Borrower nor any of its Subsidiaries is engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and U of the Federal Reserve Board of Governors).  Borrower and each of its Subsidiaries has complied in all material respects with the Federal Fair Labor Standards Act.  Neither Borrower nor any of its Subsidiaries is a “holding company” or an “affiliate” of a “holding company” or a “subsidiary company” of a “holding company” as each term is defined and used in the Public Utility Holding Company Act of 2005.  Neither Borrower nor any of its Subsidiaries has violated any laws, ordinances or rules, the violation of which could reasonably be expected to have a Material Adverse Change.  Neither Borrower’s nor any of its Subsidiaries’ properties or assets has been used by Borrower or such Subsidiary or, to Borrower’s knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than in material compliance with applicable laws.  Borrower and each of its Subsidiaries has obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Governmental Authorities that are necessary to continue their respective businesses as currently conducted.

 

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None of Borrower, any of its Subsidiaries, or any of Borrower’s or its Subsidiaries’ Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engaging in or conspiring to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person.  None of Borrower, any of its Subsidiaries, or to the knowledge of Borrower and any of their Affiliates or agents, acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law.

 

5.7                               Investments.  Neither Borrower nor any of its Subsidiaries owns any stock, shares, partnership interests or other equity securities except for Permitted Investments.

 

5.8                               Tax Returns and Payments; Pension Contributions.  Borrower and each of its Subsidiaries has timely filed all required tax returns and reports, and Borrower and each of its Subsidiaries, has timely paid all foreign, federal, state, and local taxes, assessments, deposits and contributions owed by Borrower and such Subsidiaries, in all jurisdictions in which Borrower or any such Subsidiary is subject to taxes, including the United States, unless such taxes are being contested in accordance with the following sentence.  Borrower and each of its Subsidiaries, may defer payment of any contested taxes, provided that Borrower or such Subsidiary, (a) in good faith contests its obligation to pay the taxes by appropriate proceedings promptly and diligently instituted and conducted, (b) notifies Collateral Agent in writing of the commencement of, and any material development in, the proceedings, and (c) posts bonds or takes any other steps required to prevent the Governmental Authority levying such contested taxes from obtaining a Lien upon any of the Collateral that is other than a “Permitted Lien.”  Neither Borrower nor any of its Subsidiaries is aware of any claims or adjustments proposed for any of Borrower’s or such Subsidiaries’, prior tax years which could result in additional taxes becoming due and payable by Borrower or its Subsidiaries.  Borrower and each of its Subsidiaries have paid all amounts necessary to fund all present pension, profit sharing and deferred compensation plans in accordance with their terms, and neither Borrower nor any of its Subsidiaries have, withdrawn from participation in, and have not permitted partial or complete termination of, or permitted the occurrence of any other event with respect to, any such plan which could reasonably be expected to result in any liability of Borrower or its Subsidiaries, including any liability to the Pension Benefit Guaranty Corporation or its successors or any other Governmental Authority.

 

5.9                               Use of Proceeds.  Borrower shall use the proceeds of the Credit Extensions solely as working capital and to fund its general business requirements in accordance with the provisions of this Agreement, and not for personal, family, household or agricultural purposes.

 

5.10                        Full Disclosure.  No written representation, warranty or other statement of Borrower or any of its Subsidiaries in any certificate or written statement given to Collateral Agent or any Lender, as of the date such representation, warranty, or other statement was made, taken together with all such written certificates and written statements given to Collateral Agent or any Lender, contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements contained in the certificates or statements not misleading in light of the circumstances in which they were made (it being recognized that the projections and forecasts provided by Borrower to the Collateral Agent in good faith and based upon reasonable assumptions are not viewed as facts and that actual results during the period or periods covered by such projections and forecasts may differ from the projected or forecasted results).

 

5.11                        Definition of “Knowledge.”  For purposes of the Loan Documents, whenever a representation or warranty is made to Borrower’s knowledge or awareness, to the “best of” Borrower’s knowledge, or with a similar qualification, knowledge or awareness means the actual knowledge, after reasonable investigation, of the Responsible Officers.

 

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6.                                      AFFIRMATIVE COVENANTS

 

Borrower shall, and shall cause each of its Subsidiaries to, do all of the following:

 

6.1                               Government Compliance.

 

(a)                                 Maintain its and all its Subsidiaries’ legal existence and good standing in their respective jurisdictions of organization and maintain qualification in each jurisdiction in which the failure to so qualify could reasonably be expected to have a Material Adverse Change.  Comply with all laws, ordinances and regulations to which Borrower or any of its Subsidiaries is subject, the noncompliance with which could reasonably be expected to have a Material Adverse Change.

 

(b)                                 Obtain and keep in full force and effect, all of the Governmental Approvals necessary for the performance by Borrower and its Subsidiaries of their respective businesses and obligations under the Loan Documents and the grant of a security interest to Collateral Agent for the ratable benefit of the Lenders, in all of the Collateral.  Borrower shall promptly provide copies to Collateral Agent of any material Governmental Approvals obtained by Borrower or any of its Subsidiaries.

 

6.2                               Financial Statements, Reports, Certificates.

 

(a)                                 Deliver to each Lender:

 

(i)                                     as soon as available, but no later than thirty (30) days after the last day of each month, a company prepared consolidated and consolidating balance sheet, income statement and cash flow statement covering the consolidated operations of Borrower and its Subsidiaries for such month certified by a Responsible Officer and in a form reasonably satisfactory to Collateral Agent;

 

(ii)                                  prior to an IPO Event, as soon as available, but no later than two hundred ten (210) days after the last day of Borrower’s fiscal year or within five (5) days of filing with the SEC, audited consolidated financial statements prepared under GAAP, consistently applied, together with an unqualified opinion on the financial statements from an independent certified public accounting firm acceptable to Collateral Agent in its reasonable discretion provided that KPMG LLP shall be deemed acceptable to the Collateral Agent;

 

(iii)                               As soon as available after presentation thereof by management of Borrower to Borrower’s Board of Directors, but no later than thirty (30) days after the last day of each of Borrower’s fiscal years, Borrower’s annual financial projections for the entire current fiscal year (and, if applicable, for future fiscal years) as presented by management of Borrower to Borrower’s Board of Directors, which such annual financial projections shall be set forth in a month-by-month format (the annual financial projections that were originally delivered to Collateral Agent and the Lenders and attached hereto as Exhibit E, are referred to herein as the “Annual Projections”; provided that, any revisions of the Annual Projections presented by management of Borrower to Borrower’s Board of Directors shall be delivered to Collateral Agent and the Lenders no later than ten (10) business days after such presentation and, unless Collateral Agent notifies Borrower to the contrary in writing within thirty (30) days after receipt thereof, the term “Annual Projections” shall include such revisions);

 

(iv)                              within five (5) days of delivery, copies of all material written statements, reports and notices made available to Borrower’s security holders or holders of Subordinated Debt;

 

(v)                                 after an IPO Event and in any event that Borrower becomes subject to the reporting requirements under the Securities Exchange Act of 1934, as amended, within five (5) days of filing, all reports on Form 10-K, 10-Q and 8-K filed with the Securities and Exchange Commission,

 

(vi)                              prompt notice of any amendments of or other changes to the capitalization table of Borrower and to the Operating Documents of Borrower or any of its Subsidiaries, together with any copies reflecting such amendments or changes with respect thereto;

 

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(vii)                           prompt notice of (A) any material change in the composition of the Intellectual Property, (B) the registration of any copyright, including any subsequent ownership right of Borrower or any of its Subsidiaries in or to any registered copyright, patent or registered trademark, including a copy of any such registration, and (C) any event that could reasonably be expected to materially and adversely affect the value of the Intellectual Property;

 

(viii)                        as soon as available, but no later than thirty (30) days after the last day of each month, copies of the month-end account statements for each Collateral Account maintained by Borrower or its Subsidiaries, which statements may be provided to Collateral Agent and each Lender by Borrower or directly from the applicable institution(s), and

 

(ix)                              other financial information as reasonably requested by Collateral Agent or any Lender.

 

Notwithstanding the foregoing, documents required to be delivered pursuant to the terms hereof (to the extent any such documents are included in materials otherwise filed with the SEC) may be delivered electronically and if so delivered, shall be deemed to have been delivered on the date on which Borrower posts such documents, or provides a link thereto, on Borrower’s website on the internet at Borrower’s website address.

 

(b)                                 Concurrently with the delivery of the financial statements specified in Section 6.2(a)(i) above but no later than thirty (30) days after the last day of each month, deliver to each Lender, a duly completed Compliance Certificate signed by a Responsible Officer.

 

(c)                                  Keep proper books of record and account in accordance with GAAP in all material respects subject to normal year-end adjustments and footnotes, in which full, true and correct entries shall be made of all dealings and transactions in relation to its business and activities.  Borrower shall, and shall cause each of its Subsidiaries to, allow, at the sole cost of Borrower, Collateral Agent or any Lender, during regular business hours upon reasonable prior notice (provided that no notice shall be required when an Event of Default has occurred and is continuing), to visit and inspect any of its properties, to examine and make abstracts or copies from any of its books and records, and to conduct a collateral audit and analysis of its operations and the Collateral.  Such audits and/or inspections shall be conducted no more often than once every year unless (and more frequently if) an Event of Default has occurred and is continuing.

 

6.3                               Inventory; Returns.  Keep all Inventory in good and marketable condition, free from material defects.  Returns and allowances between Borrower, or any of its Subsidiaries, and their respective Account Debtors shall follow Borrower’s, or such Subsidiary’s, customary practices as they exist at the Effective Date.  Borrower must promptly notify Collateral Agent and the Lenders of all returns, recoveries, disputes and claims that involve more than One Hundred Thousand Dollars ($100,000.00) individually or in the aggregate in any calendar year.

 

6.4                               Taxes; Pensions.  Timely file and require each of its Subsidiaries to timely file, all required tax returns and reports and timely pay, and require each of its Subsidiaries to timely file, all foreign, federal, state, and local taxes, assessments, deposits and contributions owed by Borrower or its Subsidiaries, except for deferred payment of any taxes contested pursuant to the terms of Section 5.8 hereof, and shall deliver to Lenders, on demand, appropriate certificates attesting to such payments, and pay all amounts necessary to fund all present pension, profit sharing and deferred compensation plans in accordance with the terms of such plans.

 

6.5                               Insurance.  Keep Borrower’s and its Subsidiaries’ business and the Collateral insured for risks and in amounts standard for companies in Borrower’s and its Subsidiaries’ industry and location, it being acknowledged that the insurance maintained by Borrower as of the Effective Date complies with this Section 6.5.  Insurance policies shall be in a form, with companies, and in amounts that are reasonably satisfactory to Collateral Agent and Lenders.  All property policies shall have a lender’s loss payable endorsement showing Collateral Agent as lender loss payee and waive subrogation against Collateral Agent, and all liability policies shall show, or have endorsements showing, Collateral Agent, as additional insured.  The Collateral Agent shall be named as lender loss payee and/or additional insured with respect to any such insurance providing coverage in respect of any Collateral, and each provider of any such insurance shall agree, by endorsement upon the policy or policies issued by it or by independent instruments furnished to the Collateral Agent, that it will give the Collateral Agent thirty (30) days prior 

 

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written notice before any such policy or policies shall be materially altered or canceled.  At Collateral Agent’s request, Borrower shall deliver certified copies of policies and evidence of all premium payments.  Proceeds payable under any policy (other than those proceeds, payable under the Borrower’s directors’ and officers’ insurance policy, which are related to legal costs incurred in connection with the defense of certain directors, officers or employees of Borrower in the lawsuits involving Mentor Worldwide LLC) shall, at Collateral Agent’s option, be payable to Collateral Agent, for the ratable benefit of the Lenders, on account of the Obligations.  Notwithstanding the foregoing, (a) so long as no Event of Default has occurred and is continuing, Borrower shall have the option of applying the proceeds of any casualty policy up to Seven Hundred Fifty Thousand Dollars ($750,000.00) with respect to any loss, but not exceeding Seven Hundred Fifty Thousand Dollars ($750,000.00), in the aggregate for all losses under all casualty policies in any one year, toward the replacement or repair of destroyed or damaged property; provided that any such replaced or repaired property (i) shall be of equal or like value as the replaced or repaired Collateral and (ii) shall be deemed Collateral in which Collateral Agent has been granted a first priority security interest, and (b) after the occurrence and during the continuance of an Event of Default, all proceeds payable under such casualty policy shall, at the option of Collateral Agent, be payable to Collateral Agent, for the ratable benefit of the Lenders, on account of the Obligations.  If Borrower or any of its Subsidiaries fails to obtain insurance as required under this Section 6.5 or to pay any amount or furnish any required proof of payment to third persons, Collateral Agent and/or any Lender may make, at Borrower’s expense, all or part of such payment or obtain such insurance policies required in this Section 6.5, and take any action under the policies Collateral Agent or such Lender deems prudent.

 

6.6                               Operating Accounts.

 

(a)                                 Maintain all of Borrower’s and its Subsidiaries’ Collateral Accounts in accounts which are subject to a Control Agreement in favor of Collateral Agent.  The provisions of the previous sentence shall not apply to deposit accounts exclusively used for payroll, payroll taxes and other employee wage and benefit payments to or for the benefit of Borrower’s, or any of its Subsidiaries’, employees and identified to Collateral Agent by Borrower as such in the Perfection Certificates.

 

(b)                                 Borrower shall provide Collateral Agent five (5) days’ prior written notice before Borrower or any of its Subsidiaries establishes any Collateral Account at or with any Person other than Wells Fargo Bank, N.A. In addition, for each Collateral Account that Borrower or any of its Subsidiaries, at any time maintains, Borrower or such Subsidiary shall cause the applicable bank or financial institution at or with which such Collateral Account is maintained to execute and deliver a Control Agreement or other appropriate instrument with respect to such Collateral Account to perfect Collateral Agent’s Lien in such Collateral Account in accordance with the terms hereunder prior to the establishment of such Collateral Account, which Control Agreement may not be terminated without prior written consent of Collateral Agent.  The provisions of the previous sentence shall not apply to deposit accounts exclusively used for payroll, payroll taxes and other employee wage and benefit payments to or for the benefit of Borrower’s, or any of its Subsidiaries’, employees and identified to Collateral Agent by Borrower as such in the Perfection Certificates.

 

(c)                                  Neither Borrower nor any of its Subsidiaries shall maintain any Collateral Accounts except Collateral Accounts maintained in accordance with Sections 6.6(a) and (b).

 

6.7                               Protection of Intellectual Property Rights.  Borrower and each of its Subsidiaries shall: (a) use commercially reasonable efforts to protect, defend and maintain the validity and enforceability of its Intellectual Property that is material to Borrower’s business; (b) promptly advise Collateral Agent in writing of material infringement by a third party of Intellectual Property that is material to its business; and (c) not allow any Intellectual Property material to Borrower’s business to be abandoned, forfeited or dedicated to the public without Collateral Agent’s prior written consent.

 

6.8                               Litigation Cooperation.  Commencing on the Effective Date and continuing through the termination of this Agreement, make available to Collateral Agent and the Lenders, without expense to Collateral Agent or the Lenders, Borrower and each of Borrower’s officers, employees and agents and Borrower’s Books, to the extent that Collateral Agent or any Lender may reasonably deem them necessary to prosecute or defend any third-party suit or proceeding instituted by or against Collateral Agent or any Lender with respect to any Collateral or relating to Borrower.

 

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6.9                               Notices of Litigation and Default.  Borrower will give prompt written notice to Collateral Agent and the Lenders of any litigation or governmental proceedings pending or threatened (in writing) against Borrower or any of its Subsidiaries, which could reasonably be expected to result in damages or costs to Borrower or any of its Subsidiaries of One Hundred Thousand Dollars ($100,000.00) or more or which could reasonably be expected to have a Material Adverse Change.  Without limiting or contradicting any other more specific provision of this Agreement, promptly (and in any event within three (3) Business Days) upon Borrower becoming aware of the existence of any Event of Default or event which, with the giving of notice or passage of time, or both, would constitute an Event of Default, Borrower shall give written notice to Collateral Agent and the Lenders of such occurrence, which such notice shall include a reasonably detailed description of such Event of Default or event which, with the giving of notice or passage of time, or both, would constitute an Event of Default.

 

6.10                        Intentionally Omitted.

 

6.11                        Landlord Waivers; Bailee Waivers.  In the event that Borrower or any of its Subsidiaries, after the Effective Date, intends to add any new offices or business locations, including warehouses, or otherwise store any portion of the Collateral with, or deliver any portion of the Collateral to, a bailee, in each case pursuant to Section 7.2, then the Borrower or such Subsidiary will first notify the Collateral Agent in writing and in the event that the Collateral at any new location is valued in excess of One Hundred Thousand ($100,000.00) in the aggregate, such bailee or landlord, as applicable, must execute and deliver a bailee waiver or landlord waiver, as applicable, in form and substance reasonably satisfactory to Collateral Agent within thirty (30) days following the addition of any new offices or business locations, or any such storage with or delivery to any such bailee, as the case may be.

 

6.12                        Creation/Acquisition of Subsidiaries.  In the event Borrower, or any of its Subsidiaries creates or acquires any Subsidiary, Borrower shall provide prior written notice to Collateral Agent and each Lender of the creation or acquisition of such new Subsidiary and take all such action as may be reasonably required by Collateral Agent or any Lender to cause each such Subsidiary to become a co-Borrower hereunder or to guarantee the Obligations of Borrower under the Loan Documents and, in each case, grant a continuing pledge and security interest in and to the assets of such Subsidiary (substantially as described on Exhibit A hereto); and Borrower (or its Subsidiary, as applicable) shall grant and pledge to Collateral Agent, for the ratable benefit of the Lenders, a perfected security interest in the stock, units or other evidence of ownership of each such newly created Subsidiary.

 

6.13                        Further Assurances.

 

(a)                                 Execute any further instruments and take further action as Collateral Agent or any Lender reasonably requests to perfect or continue Collateral Agent’s Lien in the Collateral or to effect the purposes of this Agreement.

 

(b)                                 Deliver to Collateral Agent and Lenders, within five (5) days after the same are sent or received, copies of all material written correspondence, reports, documents and other filings with any Governmental Authority that could reasonably be expected to have a material adverse effect on any of the Governmental Approvals material to Borrower’s business or otherwise could reasonably be expected to have a Material Adverse Change.

 

7.                                      NEGATIVE COVENANTS

 

Borrower shall not, and shall not permit any of its Subsidiaries to, do any of the following without the prior written consent of the Required Lenders:

 

7.1                               Dispositions.  Convey, sell, lease, transfer, assign, dispose of or otherwise make cash payments consisting of (collectively, “Transfer”), or permit any of its Subsidiaries to Transfer, all or any part of its business or property, except for Transfers (a) consisting of cash payments to trade creditors in the ordinary course of business; (b) of Inventory in the ordinary course of business; (c) of worn-out or obsolete Equipment; (d) in connection with Permitted Liens, Permitted Investments and Permitted Licenses; (e) other Transfers in an aggregate amount not to exceed $100,000 in any fiscal year; and (f) Transfers in addition to those specifically enumerated above, to the extent the same are specifically reflected in the Annual Projections.

 

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7.2                               Changes in Business, Management, Ownership, or Business Locations.  (a) Engage in or permit any of its Subsidiaries to engage in any business other than the businesses engaged in by Borrower as of the Effective Date or reasonably related thereto; (b) liquidate or dissolve; or (c) (i) (A) prior to an IPO Event, any Key Person shall cease to be actively engaged in the management of Borrower unless a replacement for such Key Person is approved by Borrower’s Board of Directors and engaged by Borrower within ninety (90) days of such change, and (B) after an IPO Event, any Key Person shall cease to be actively engaged in the management of Borrower unless a notice thereof is given to Collateral Agent within four (4) Business Days of such event, or (ii) enter into any transaction or series of related transactions in which the stockholders of Borrower who were not stockholders immediately prior to the first such transaction own more than forty nine percent (49%) of the voting stock of Borrower immediately after giving effect to such transaction or related series of such transactions (other than by the sale of Borrower’s equity securities in a public offering, a private placement of public equity or to venture capital investors so long as Borrower identifies to Collateral Agent the venture capital investors prior to the closing of the transaction).  Borrower shall not, without at least fifteen (15) days’ prior written notice to Collateral Agent: (A) add any new offices or business locations, including warehouses (unless such new offices or business locations contain less than One Hundred Thousand Dollars ($100,000.00) in assets or property of Borrower or any of its Subsidiaries); (B) change its jurisdiction of organization, (C) change its organizational structure or type, (D) change its legal name, or (E) change any organizational number (if any) assigned by its jurisdiction of organization.

 

7.3                               Mergers or Acquisitions.  Merge or consolidate, or permit any of its Subsidiaries to merge or consolidate, with any other Person, or acquire, or permit any of its Subsidiaries to acquire, all or substantially all of the capital stock, shares or property of another Person.  A Subsidiary may merge or consolidate into another Subsidiary (provided such surviving Subsidiary is a “co-Borrower” hereunder or has provided a secured Guaranty of Borrower’s Obligations hereunder) or with (or into) Borrower provided Borrower is the surviving legal entity, and as long as no Event of Default is occurring prior thereto or arises as a result therefrom.  Without limiting the foregoing, Borrower (without Collateral Agent’s prior written consent) may only enter into a binding contractual arrangement with another Person to attempt to facilitate a merger or acquisition of Borrower, if (i) no Event of Default exists when such agreement is entered into by Borrower, (ii) such agreement does not give such Person the right to claim any fees, payments or damages from Borrower or any of its Subsidiaries in an aggregate amount equal to or greater than Two Hundred And Fifty Thousand Dollars ($250,000.00), and (iii) Borrower notifies Collateral Agent in advance of entering into such an agreement.

 

7.4                               Indebtedness.  Create, incur, assume, or be liable for any Indebtedness, or permit any Subsidiary to do so, other than Permitted Indebtedness.

 

7.5                               Encumbrance.  Create, incur, allow, or suffer any Lien on any of its property, or assign or convey any right to receive income, including the sale of any Accounts, or permit any of its Subsidiaries to do so, except for Permitted Liens, or permit any Collateral not to be subject to the first priority security interest granted herein (except for Permitted Liens that are permitted by the terms of this Agreement to have priority over Collateral Agent’s Lien), or enter into any agreement, document, instrument or other arrangement (except with or in favor of Collateral Agent, for the ratable benefit of the Lenders) with any Person which directly or indirectly prohibits or has the effect of prohibiting Borrower, or any of its Subsidiaries, from assigning, mortgaging, pledging, granting a security interest in or upon, or encumbering any of Borrower’s or such Subsidiary’s Intellectual Property, except as is otherwise permitted in Section 7.1 hereof and the definition of “Permitted Liens” herein.

 

7.6                               Maintenance of Collateral Accounts.  Maintain any Collateral Account except pursuant to the terms of Section 6.6 hereof.

 

7.7                               Distributions; Investments.  (a) Pay any dividends (other than dividends payable solely in capital stock) or make any distribution or payment in respect of or redeem, retire or purchase any capital stock (other than repurchases pursuant to the terms of employment agreements, employee stock purchase plans, employee restricted stock agreements, stockholder rights plans, director or consultant stock option plans, or similar plans, provided such repurchases do not exceed One Hundred Thousand Dollars ($100,000.00) in the aggregate per fiscal year) or (b) directly or indirectly make any Investment other than Permitted Investments, or permit any of its Subsidiaries to do so.

 

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7.8                               Transactions with Affiliates.  Directly or indirectly enter into or permit to exist any material transaction with any Affiliate of Borrower or any of its Subsidiaries, except for (a) transactions that are in the ordinary course of Borrower’s or such Subsidiary’s business, upon fair and reasonable terms that are no less favorable to Borrower or such Subsidiary than would be obtained in an arm’s length transaction with a non-affiliated Person, (b) Subordinated Debt or equity investments by Borrower’s investors in Borrower or its Subsidiaries, (c) transactions existing on the Effective Date and disclosed to the Collateral Agent, and (d) compensation and indemnification of, and other employment arrangements with, directors, officers and employees of Borrower or any Subsidiary entered into in the ordinary course of business.

 

7.9                               Subordinated Debt.  (a) Make or permit any payment on any Subordinated Debt, except under the terms of the subordination, intercreditor, or other similar agreement to which such Subordinated Debt is subject, or (b) amend any provision in any document relating to the Subordinated Debt which would increase the amount thereof or adversely affect the subordination thereof to Obligations owed to the Lenders.

 

7.10                        Compliance.  Become an “investment company” or a company controlled by an “investment company”, under the Investment Company Act of 1940, as amended, or undertake as one of its important activities extending credit to purchase or carry margin stock (as defined in Regulation U of the Board of Governors of the Federal Reserve System), or use the proceeds of any Credit Extension for that purpose; fail to meet the minimum funding requirements of ERISA, permit a Reportable Event or Prohibited Transaction, as defined in ERISA, to occur; fail to comply with the Federal Fair Labor Standards Act or violate any other law or regulation, if the violation could reasonably be expected to have a Material Adverse Change, or permit any of its Subsidiaries to do so; withdraw or permit any Subsidiary to withdraw from participation in, permit partial or complete termination of, or permit the occurrence of any other event with respect to, any present pension, profit sharing and deferred compensation plan which could reasonably be expected to result in any liability of Borrower or any of its Subsidiaries, including any liability to the Pension Benefit Guaranty Corporation or its successors or any other Governmental Authority.

 

7.11                        Compliance with Anti-Terrorism Laws.  Collateral Agent hereby notifies Borrower and each of its Subsidiaries that pursuant to the requirements of Anti-Terrorism Laws, and Collateral Agent’s policies and practices, Collateral Agent is required to obtain, verify and record certain information and documentation that identifies Borrower and each of its Subsidiaries and their principals, which information includes the name and address of Borrower and each of its Subsidiaries and their principals and such other information that will allow Collateral Agent to identify such party in accordance with Anti-Terrorism Laws.  Neither Borrower nor any of its Subsidiaries shall, nor shall Borrower or any of its Subsidiaries permit any Affiliate to, directly or indirectly, knowingly enter into any documents, instruments, agreements or contracts with any Person listed on the OFAC Lists.  Borrower and each of its Subsidiaries shall immediately notify Collateral Agent if Borrower or such Subsidiary has knowledge that Borrower, or any Subsidiary or Affiliate of Borrower, is listed on the OFAC Lists or (a) is convicted on, (b) pleads nolo contendere to, (c) is indicted on, or (d) is arraigned and held over on charges involving money laundering or predicate crimes to money laundering.  Neither Borrower nor any of its Subsidiaries shall, nor shall Borrower or any of its Subsidiaries, permit any Affiliate to, directly or indirectly, (i) conduct any business or engage in any transaction or dealing with any Blocked Person, including, without limitation, the making or receiving of any contribution of funds, goods or services to or for the benefit of any Blocked Person, (ii) deal in, or otherwise engage in any transaction relating to, any property or interests in property blocked pursuant to Executive Order No. 13224 or any similar executive order or other Anti-Terrorism Law, or (iii) engage in or conspire to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding, or attempts to violate, any of the prohibitions set forth in Executive Order No. 13224 or other Anti-Terrorism Law.

 

8.                                      EVENTS OF DEFAULT

 

Any one of the following shall constitute an event of default (an “Event of Default”) under this Agreement:

 

8.1                               Payment Default.  Borrower fails to (a) make any payment of principal or interest on any Credit Extension on its due date, or (b) pay any other Obligations within three (3) Business Days after such Obligations are due and payable (which three (3) Business Day grace period shall not apply to payments due on the Maturity Date or 

 

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the date of acceleration pursuant to Section 9.1 (a) hereof).  During the cure period, the failure to cure the payment default is not an Event of Default (but no Credit Extension will be made during the cure period);

 

8.2                               Covenant Default.

 

(a)                                 Borrower or any of its Subsidiaries fails or neglects to perform any obligation in Sections 6.2 (Financial Statements, Reports, Certificates), 6.4 (Taxes), 6.5 (Insurance), 6.6 (Operating Accounts) ̧6.7 (Protection of Intellectual Property Rights), 6.11 (Landlord Waivers; Bailee Waivers), or 6.12 (Creation/Acquisition of Subsidiaries) or Borrower violates any covenant in Section 7; or

 

(b)                                 Borrower, or any of its Subsidiaries, fails or neglects to perform, keep, or observe any other term, provision, condition, covenant or agreement contained in this Agreement or any Loan Documents, and as to any default (other than those specified in this Section 8) under such other term, provision, condition, covenant or agreement that can be cured, has failed to cure the default within fifteen (15) days following receipt of notice by Borrower from Collateral Agent of the occurrence thereof; provided, however, that if the default cannot by its nature be cured within the fifteen (15) day period or cannot after diligent attempts by Borrower be cured within such fifteen (15) day period, and such default is likely to be cured within a reasonable time, then Borrower shall have an additional period (which shall not in any case exceed thirty (30) days) to attempt to cure such default, and within such reasonable time period the failure to cure the default shall not be deemed an Event of Default (but no Credit Extensions shall be made during such cure period).  Grace periods provided under this Section shall not apply, among other things, to financial covenants or any other covenants set forth in subsection (a) above;

 

8.3                               Material Adverse Change.  A Material Adverse Change occurs;

 

8.4                               Attachment; Levy; Restraint on Business.

 

(a)                                 (i) The service of process seeking to attach, by trustee or similar process, any funds of Borrower or any of its Subsidiaries or of any entity under control of Borrower or its Subsidiaries on deposit with any Lender or any Lender’s Affiliate or any bank or other institution at which Borrower or any of its Subsidiaries maintains a Collateral Account, or (ii) a notice of lien, levy, or assessment is filed against Borrower or any of its Subsidiaries or their respective assets by any government agency, and the same under subclauses (i) and (ii) hereof are not, within ten (10) days after the occurrence thereof, discharged or stayed (whether through the posting of a bond or otherwise); provided, however, no Credit Extensions shall be made during any ten (10) day cure period; and

 

(b)                                 (i) any material portion of Borrower’s or any of its Subsidiaries’ assets is attached, seized, levied on, or comes into possession of a trustee or receiver, or (ii) any court order enjoins, restrains, or prevents Borrower or any of its Subsidiaries from conducting any part of its business;

 

8.5                               Insolvency.  (a) Borrower or any of its Subsidiaries is or becomes Insolvent; (b) Borrower or any of its Subsidiaries begins an Insolvency Proceeding; or (c) an Insolvency Proceeding is begun against Borrower or any of its Subsidiaries and not dismissed or stayed within forty-five (45) days (but no Credit Extensions shall be made while Borrower or any Subsidiary is Insolvent and/or until any Insolvency Proceeding is dismissed);

 

8.6                               Other Agreements.  There is a default in any agreement to which Borrower or any of its Subsidiaries is a party with a third party or parties resulting in a right by such third party or parties, whether or not exercised, to accelerate the maturity of any Indebtedness in an amount in excess of Two Hundred And Fifty Thousand Dollars ($250,000.00);

 

8.7                               Judgments.  One or more judgments, orders, or decrees for the payment of money in an amount, individually or in the aggregate, of at least Two Hundred And Fifty Thousand Dollars ($250,000.00) (not covered by independent third-party insurance as to which liability has been accepted by such insurance carrier) shall be rendered against Borrower or any of its Subsidiaries and shall remain unsatisfied, unvacated, or unstayed for a period of ten (10) days after the entry thereof (provided that no Credit Extensions will be made prior to the satisfaction, vacation, or stay of such judgment, order or decree);

 

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8.8                               Misrepresentations.  Borrower or any of its Subsidiaries or any Person acting for Borrower or any of its Subsidiaries makes any representation, warranty, or other statement now or later in this Agreement, any Loan Document or in any writing delivered to Collateral Agent and/or Lenders or to induce Collateral Agent and/or the Lenders to enter this Agreement or any Loan Document, and such representation, warranty, or other statement is incorrect in any material respect when made;

 

8.9                               Subordinated Debt.  A default or breach occurs under any agreement between Borrower or any of its Subsidiaries and any creditor of Borrower or any of its Subsidiaries that signed a subordination, intercreditor, or other similar agreement with Collateral Agent or the Lenders, or any creditor that has signed such an agreement with Collateral Agent or the Lenders breaches any terms of such agreement;

 

8.10                        Governmental Approvals.  Any Governmental Approval shall have been revoked, rescinded, suspended, modified in an adverse manner, or not renewed in the ordinary course for a full term and such revocation, rescission, suspension, modification or non-renewal has resulted in or could reasonably be expected to result in a Material Adverse Change; or

 

8.11                        Lien Priority.  Any Lien created hereunder or by any other Loan Document shall at any time fail to constitute a valid and perfected Lien on any of the Collateral purported to be secured thereby, subject to no prior or equal Lien, other than (i) Permitted Liens which are permitted to have priority in accordance with the terms of this Agreement and (ii) Liens whose perfection or creation requires steps in addition to, or other than, the filing of a UCC financing statement with the Secretary of State for the State of Delaware, entering into a Control Agreement or entering into any of the Loan Documents and which steps the Collateral Agent fails to take.

 

9.                                      RIGHTS AND REMEDIES

 

9.1                               Rights and Remedies.

 

(a)                                 Upon the occurrence and during the continuance of an Event of Default, Collateral Agent may, and at the written direction of Required Lenders shall, without notice or demand, do any or all of the following: (i) deliver notice of the Event of Default to Borrower, (ii) by notice to Borrower declare all Obligations immediately due and payable (but if an Event of Default described in Section 8.5 occurs all Obligations shall be immediately due and payable without any action by Collateral Agent or the Lenders) or (iii) by notice to Borrower suspend or terminate the obligations, if any, of the Lenders to advance money or extend credit for Borrower’s benefit under this Agreement or under any other agreement between Borrower and Collateral Agent and/or the Lenders (but if an Event of Default described in Section 8.5 occurs all obligations, if any, of the Lenders to advance money or extend credit for Borrower’s benefit under this Agreement or under any other agreement between Borrower and Collateral Agent and/or the Lenders shall be immediately terminated without any action by Collateral Agent or the Lenders).

 

(b)                                 Without limiting the rights of Collateral Agent and the Lenders set forth in Section 9.1(a) above, upon the occurrence and during the continuance of an Event of Default, Collateral Agent shall have the right at the written direction of the Required Lenders, without notice or demand, to do any or all of the following:

 

(i)                                     foreclose upon and/or sell or otherwise liquidate, the Collateral;

 

(ii)                                  apply to the Obligations any (a) balances and deposits of Borrower that Collateral Agent or any Lender holds or controls, or (b) any amount held or controlled by Collateral Agent or any Lender owing to or for the credit or the account of Borrower; and/or

 

(iii)                               commence and prosecute an Insolvency Proceeding or consent to Borrower commencing any Insolvency Proceeding.

 

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(c)                                  Without limiting the rights of Collateral Agent and the Lenders set forth in Sections 9.1(a) and (b) above, upon the occurrence and during the continuance of an Event of Default, Collateral Agent shall have the right, without notice or demand, to do any or all of the following:

 

(i)                                     settle or adjust disputes and claims directly with Account Debtors for amounts on terms and in any order that Collateral Agent considers advisable, notify any Person owing Borrower money of Collateral Agent’s security interest in such funds, and verify the amount of such account;

 

(ii)                                  make any payments and do any acts it considers necessary or reasonable to protect the Collateral and/or its security interest in the Collateral.  Borrower shall assemble the Collateral if Collateral Agent requests and make it available in a location as Collateral Agent reasonably designates.  Collateral Agent may enter premises where the Collateral is located, take and maintain possession of any part of the Collateral, and pay, purchase, contest, or compromise any Lien which appears to be prior or superior to its security interest and pay all expenses incurred.  Borrower grants Collateral Agent a license to enter and occupy any of its premises, without charge, to exercise any of Collateral Agent’s rights or remedies;

 

(iii)                               ship, reclaim, recover, store, finish, maintain, repair, prepare for sale, and/or advertise for sale, the Collateral.  Collateral Agent is hereby granted a non-exclusive, royalty-free license or other right to use, without charge, Borrower’s and each of its Subsidiaries’ labels, patents, copyrights, mask works, rights of use of any name, trade secrets, trade names, trademarks, service marks, and advertising matter, or any similar property as it pertains to the Collateral, in completing production of, advertising for sale, and selling any Collateral and, in connection with Collateral Agent’s exercise of its rights under this Section 9.1, Borrower’s and each of its Subsidiaries’ rights under all licenses and all franchise agreements inure to Collateral Agent, for the benefit of the Lenders;

 

(iv)                              place a “hold” on any account maintained with Collateral Agent or the Lenders and/or deliver a notice of exclusive control, any entitlement order, or other directions or instructions pursuant to any Control Agreement or similar agreements providing control of any Collateral;

 

(v)                                 demand and receive possession of Borrower’s Books;

 

(vi)                              appoint a receiver to seize, manage and realize any of the Collateral, and such receiver shall have any right and authority as any competent court will grant or authorize in accordance with any applicable law, including any power or authority to manage the business of Borrower or any of its Subsidiaries; and

 

(vii)                           subject to clauses 9.1(a) and (b), exercise all rights and remedies available to Collateral Agent and each Lender under the Loan Documents or at law or equity, including all remedies provided under the Code (including disposal of the Collateral pursuant to the terms thereof).

 

Notwithstanding any provision of this Section 9.1 to the contrary, upon the occurrence of any Event of Default, Collateral Agent shall have the right to exercise any and all remedies referenced in this Section 9.1 without the written consent of Required Lenders following the occurrence of an Exigent Circumstance.  As used in the immediately preceding sentence, “Exigent Circumstance” means any event or circumstance that, in the reasonable judgment of Collateral Agent, imminently threatens the ability of Collateral Agent to realize upon all or any material portion of the Collateral, such as, without limitation, fraudulent removal, concealment, or abscondment thereof, destruction or material waste thereof, or failure of Borrower or any of its Subsidiaries after reasonable demand to maintain or reinstate adequate casualty insurance coverage, or which, in the judgment of Collateral Agent, could reasonably be expected to result in a material diminution in value of the Collateral.

 

9.2                               Power of Attorney.  Borrower hereby irrevocably appoints Collateral Agent as its lawful attorney-in-fact, exercisable upon the occurrence and during the continuance of an Event of Default, to: (a) endorse Borrower’s or any of its Subsidiaries’ name on any checks or other forms of payment or security; (b) sign Borrower’s or any of its Subsidiaries’ name on any invoice or bill of lading for any Account or drafts against Account Debtors; (c) settle and adjust disputes and claims about the Accounts directly with Account Debtors, for amounts and on terms Collateral Agent determines reasonable; (d) make, settle, and adjust all claims under 

 

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Borrower’s insurance policies; (e) pay, contest or settle any Lien, charge, encumbrance, security interest, and adverse claim in or to the Collateral, or any judgment based thereon, or otherwise take any action to terminate or discharge the same; and (f) transfer the Collateral into the name of Collateral Agent or a third party as the Code or any applicable law permits.  Borrower hereby appoints Collateral Agent as its lawful attorney-in-fact to sign Borrower’s or any of its Subsidiaries’ name on any documents necessary to perfect or continue the perfection of Collateral Agent’s security interest in the Collateral regardless of whether an Event of Default has occurred until all Obligations (other than inchoate indemnity obligations) have been satisfied in full and Collateral Agent and the Lenders are under no further obligation to make Credit Extensions hereunder.  Collateral Agent’s foregoing appointment as Borrower’s or any of its Subsidiaries’ attorney in fact, and all of Collateral Agent’s rights and powers, coupled with an interest, are irrevocable until all Obligations (other than inchoate indemnity obligations) have been fully repaid and performed and Collateral Agent’s and the Lenders’ obligation to provide Credit Extensions terminates.

 

9.3                               Protective Payments.  If Borrower or any of its Subsidiaries fail to obtain the insurance called for by Section 6.5 or fails to pay any premium thereon or fails to pay any other amount which Borrower or any of its Subsidiaries is obligated to pay under this Agreement or any other Loan Document, Collateral Agent may obtain such insurance or make such payment, and all amounts so paid by Collateral Agent are Lenders’ Expenses and immediately due and payable, bearing interest at the Default Rate, and secured by the Collateral.  Collateral Agent will make reasonable efforts to provide Borrower with notice of Collateral Agent obtaining such insurance or making such payment at the time it is obtained or paid or within a reasonable time thereafter.  No such payments by Collateral Agent are deemed an agreement to make similar payments in the future or Collateral Agent’s waiver of any Event of Default.

 

9.4                               Application of Payments and Proceeds.  Notwithstanding anything to the contrary contained in this Agreement, upon the occurrence and during the continuance of an Event of Default, (a) Borrower irrevocably waives the right to direct the application of any and all payments at any time or times thereafter received by Collateral Agent from or on behalf of Borrower or any of its Subsidiaries of all or any part of the Obligations, and, as between Borrower on the one hand and Collateral Agent and Lenders on the other, Collateral Agent shall have the continuing and exclusive right to apply and to reapply any and all payments received against the Obligations in such manner as Collateral Agent may deem advisable notwithstanding any previous application by Collateral Agent, and (b) the proceeds of any sale of, or other realization upon all or any part of the Collateral shall be applied: first, to the Lenders’ Expenses; second, to accrued and unpaid interest on the Obligations (including any interest which, but for the provisions of the United States Bankruptcy Code, would have accrued on such amounts); third, to the principal amount of the Obligations outstanding; and fourth, to any other indebtedness or obligations of Borrower owing to Collateral Agent or any Lender under the Loan Documents.  Any balance remaining shall be delivered to Borrower or to whoever may be lawfully entitled to receive such balance or as a court of competent jurisdiction may direct.  In carrying out the foregoing, (x) amounts received shall be applied in the numerical order provided until exhausted prior to the application to the next succeeding category, and (y) each of the Persons entitled to receive a payment in any particular category shall receive an amount equal to its pro rata share of amounts available to be applied pursuant thereto for such category.  Any reference in this Agreement to an allocation between or sharing by the Lenders of any right, interest or obligation “ratably,” “proportionally” or in similar terms shall refer to Pro Rata Share unless expressly provided otherwise.  Collateral Agent, or if applicable, each Lender, shall promptly remit to the other Lenders such sums as may be necessary to ensure the ratable repayment of each Lender’s portion of any Term Loan and the ratable distribution of interest, fees and reimbursements paid or made by Borrower.  Notwithstanding the foregoing, a Lender receiving a scheduled payment shall not be responsible for determining whether the other Lenders also received their scheduled payment on such date; provided, however, if it is later determined that a Lender received more than its ratable share of scheduled payments made on any date or dates, then such Lender shall remit to Collateral Agent or other Lenders such sums as may be necessary to ensure the ratable payment of such scheduled payments, as instructed by Collateral Agent.  If any payment or distribution of any kind or character, whether in cash, properties or securities, shall be received by a Lender in excess of its ratable share, then the portion of such payment or distribution in excess of such Lender’s ratable share shall be received by such Lender in trust for and shall be promptly paid over to the other Lender for application to the payments of amounts due on the other Lenders’ claims.  To the extent any payment for the account of Borrower is required to be returned as a voidable transfer or otherwise, the Lenders shall contribute to one another as is necessary to ensure that such return of payment is on a pro rata basis.  If any Lender shall obtain possession of any Collateral, it shall hold such 

 

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Collateral for itself and as agent and bailee for Collateral Agent and other Lenders for purposes of perfecting Collateral Agent’s security interest therein.

 

9.5                               Liability for Collateral.  So long as Collateral Agent and the Lenders comply with reasonable banking practices regarding the safekeeping of the Collateral in the possession or under the control of Collateral Agent and the Lenders, Collateral Agent and the Lenders shall not be liable or responsible for: (a) the safekeeping of the Collateral; (b) any loss or damage to the Collateral; (c) any diminution in the value of the Collateral; or (d) any act or default of any carrier, warehouseman, bailee, or other Person.  Borrower bears all risk of loss, damage or destruction of the Collateral.

 

9.6                               No Waiver; Remedies Cumulative.  Failure by Collateral Agent or any Lender, at any time or times, to require strict performance by Borrower of any provision of this Agreement or any other Loan Document shall not waive, affect, or diminish any right of Collateral Agent or any Lender thereafter to demand strict performance and compliance herewith or therewith.  No waiver hereunder shall be effective unless signed by Collateral Agent and the Required Lenders and then is only effective for the specific instance and purpose for which it is given.  The rights and remedies of Collateral Agent and the Lenders under this Agreement and the other Loan Documents are cumulative.  Collateral Agent and the Lenders have all rights and remedies provided under the Code, any applicable law, by law, or in equity.  The exercise by Collateral Agent or any Lender of one right or remedy is not an election, and Collateral Agent’s or any Lender’s waiver of any Event of Default is not a continuing waiver.  Collateral Agent’s or any Lender’s delay in exercising any remedy is not a waiver, election, or acquiescence.

 

9.7                               Demand Waiver.  Borrower waives, to the fullest extent permitted by law, demand, notice of default or dishonor, notice of payment and nonpayment, notice of any default, nonpayment at maturity, release, compromise, settlement, extension, or renewal of accounts, documents, instruments, chattel paper, and guarantees held by Collateral Agent or any Lender on which Borrower or any Subsidiary is liable.

 

10.                               NOTICES

 

All notices, consents, requests, approvals, demands, or other communication (collectively, “Communication”) by any party to this Agreement or any other Loan Document must be in writing and shall be deemed to have been validly served, given, or delivered: (a) upon the earlier of actual receipt and three (3) Business Days after deposit in the U.S. mail, first class, registered or certified mail return receipt requested, with proper postage prepaid; (b) upon transmission, when sent by facsimile transmission; (c) one (1) Business Day after deposit with a reputable overnight courier with all charges prepaid; or (d) when delivered, if hand-delivered by messenger, all of which shall be addressed to the party to be notified and sent to the address, facsimile number, or email address indicated below.  Any of Collateral Agent, Lender or Borrower may change its mailing address or facsimile number by giving the other party written notice thereof in accordance with the terms of this Section 10.

 

	
If to Borrower:
    	
 
    	
SIENTRA, INC.

6769 Hollister Avenue, Suite 201

Santa Barbara, CA 93117

Attn: Chief Financial Officer

Fax: (805) 562-8401

Email: Matt.Pigeon@sientra.com
    
	
 
    	
 
    	
 
    
	
with a copy (which shall not constitute   notice) to:
    	
 
    	
COOLEY LLP

25 E. Anapamu Street, 3rd Floor

Santa Barbara, California 93101

Attn: C. Thomas Hopkins, Esq.

Fax: (310) 496-3228

Email: THopkins@cooley.com
    

 

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If to Collateral Agent:
    	
 
    	
OXFORD FINANCE LLC

133 North Fairfax Street

Alexandria, Virginia 22314

Attention: Legal Department

Fax: (703) 519-5225

Email: LegalDepartment@oxfordfinance.com
    
	
 
    	
 
    	
 
    
	
with a copy (which shall not constitute   notice) to:
    	
 
    	
Greenberg Traurig, LLP

One International Place

Boston, MA 02110

Attn: Jonathan Bell, Esq.

Fax: (617) 310-6001

Email: bellj@gtlaw.com
    

 

 

11.                               CHOICE OF LAW, VENUE AND JURY TRIAL WAIVER, AND JUDICIAL REFERENCE

 

California law governs the Loan Documents without regard to principles of conflicts of law.  Borrower, Collateral Agent and each Lender each submit to the exclusive jurisdiction of the State and Federal courts in Santa Barbara County, California; provided, however, that nothing in this Agreement shall be deemed to operate to preclude Collateral Agent or any Lender from bringing suit or taking other legal action in any other jurisdiction to realize on the Collateral or any other security for the Obligations, or to enforce a judgment or other court order in favor of Collateral Agent or any Lender.  Borrower expressly submits and consents in advance to such jurisdiction in any action or suit commenced in any such court, and Borrower hereby waives any objection that it may have based upon lack of personal jurisdiction, improper venue, or forum non conveniens and hereby consents to the granting of such legal or equitable relief as is deemed appropriate by such court.  Borrower hereby waives personal service of the summons, complaints, and other process issued in such action or suit and agrees that service of such summons, complaints, and other process may be made by registered or certified mail addressed to Borrower at the address set forth in, or subsequently provided by Borrower in accordance with, Section 10 of this Agreement and that service so made shall be deemed completed upon the earlier to occur of Borrower’s actual receipt thereof or three (3) days after deposit in the U.S. mails, proper postage prepaid.

 

TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, BORROWER, COLLATERAL AGENT AND EACH LENDER EACH WAIVE THEIR RIGHT TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION ARISING OUT OF OR BASED UPON THIS AGREEMENT, THE LOAN DOCUMENTS OR ANY CONTEMPLATED TRANSACTION, INCLUDING CONTRACT, TORT, BREACH OF DUTY AND ALL OTHER CLAIMS. THIS WAIVER IS A MATERIAL INDUCEMENT FOR EACH PARTY TO ENTER INTO THIS AGREEMENT. EACH PARTY HAS REVIEWED THIS WAIVER WITH ITS COUNSEL.

 

WITHOUT INTENDING IN ANY WAY TO LIMIT THE PARTIES’ AGREEMENT TO WAIVE THEIR RESPECTIVE RIGHT TO A TRIAL BY JURY, if the above waiver of the right to a trial by jury is not enforceable, the parties hereto agree that any and all disputes or controversies of any nature between them arising at any time shall be decided by a reference to a private judge, mutually selected by the parties (or, if they cannot agree, by the Presiding Judge of the Santa Barbara County, California Superior Court) appointed in accordance with California Code of Civil Procedure Section 638 (or pursuant to comparable provisions of federal law if the dispute falls within the exclusive jurisdiction of the federal courts), sitting without a jury, in Santa Clara County, California; and the parties hereby submit to the jurisdiction of such court.  The reference proceedings shall be conducted pursuant to and in accordance with the provisions of California Code of Civil Procedure §§ 638 through 645.1, inclusive.  The private judge shall have the power, among others, to grant provisional relief, including without limitation, entering temporary restraining orders, issuing preliminary and permanent injunctions and appointing receivers.  All such proceedings shall be closed to the public and confidential and all records relating thereto shall be permanently sealed.  If during the course of any dispute, a party desires to seek provisional relief, but a judge has not been appointed at that point pursuant to the judicial reference procedures, then such party may apply to the Santa Barbara County, California Superior Court for such relief.  The proceeding before the private judge shall be conducted in the same manner as it would be before a court under the rules of evidence applicable to judicial proceedings.  The 

 

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parties shall be entitled to discovery which shall be conducted in the same manner as it would be before a court under the rules of discovery applicable to judicial proceedings.  The private judge shall oversee discovery and may enforce all discovery rules and orders applicable to judicial proceedings in the same manner as a trial court judge.  The parties agree that the selected or appointed private judge shall have the power to decide all issues in the action or proceeding, whether of fact or of law, and shall report a statement of decision thereon pursuant to California Code of Civil Procedure § 644(a).  Nothing in this paragraph shall limit the right of any party at any time to exercise self-help remedies, foreclose against collateral, or obtain provisional remedies.  The private judge shall also determine all issues relating to the applicability, interpretation, and enforceability of this paragraph.

 

12.                               GENERAL PROVISIONS

 

12.1                        Successors and Assigns.  This Agreement binds and is for the benefit of the successors and permitted assigns of each party.  Borrower may not transfer, pledge or assign this Agreement or any rights or obligations under it without Collateral Agent’s and each Lender’s prior written consent (which may be granted or withheld in Collateral Agent’s and each Lender’s discretion, subject to Section 12.6).  The Lenders have the right, without the consent of or notice to Borrower, to sell, transfer, assign, pledge, negotiate, or grant participation in (any such sale, transfer, assignment, negotiation, or grant of a participation, a “Lender Transfer”) all or any part of, or any interest in, the Lenders’ obligations, rights, and benefits under this Agreement and the other Loan Documents; provided, however, that any such Lender Transfer (other than a transfer, pledge, sale or assignment to an Eligible Assignee) of its obligations, rights, and benefits under this Agreement and the other Loan Documents shall require the prior written consent of the Required Lenders (such approved assignee, an “Approved Lender”).  Borrower and Collateral Agent shall be entitled to continue to deal solely and directly with such Lender in connection with the interests so assigned until Collateral Agent shall have received and accepted an effective assignment agreement in form satisfactory to Collateral Agent executed, delivered and fully completed by the applicable parties thereto, and shall have received such other information regarding such Eligible Assignee or Approved Lender as Collateral Agent reasonably shall require.  Notwithstanding anything to the contrary contained herein, so long as no Event of Default has occurred and is continuing, no Lender Transfer (other than a Lender Transfer (i) in respect of the Warrants or (ii) in connection with (x) assignments by a Lender due to a forced divestiture at the request of any regulatory agency; or (y) upon the occurrence of a default, event of default or similar occurrence with respect to a Lender’s own financing or securitization transactions) shall be permitted, without Borrower’s consent, to any Person which is an Affiliate or Subsidiary of Borrower, a direct competitor of Borrower or a vulture hedge fund, each as determined by Collateral Agent.

 

12.2                        Indemnification.  Borrower agrees to indemnify, defend and hold Collateral Agent and the Lenders and their respective directors, officers, employees, agents, attorneys, or any other Person affiliated with or representing Collateral Agent or the Lenders (each, an “Indemnified Person”) harmless against: (a) all obligations, demands, claims, and liabilities (collectively, “Claims”) asserted by any other party in connection with; related to; following; or arising from, out of or under, the transactions contemplated by the Loan Documents; and (b) all losses or Lenders’ Expenses incurred, or paid by Indemnified Person in connection with; related to; following; or arising from, out of or under, the transactions contemplated by the Loan Documents between Collateral Agent, and/or the Lenders and Borrower (including reasonable attorneys’ fees and expenses), except for Claims and/or losses directly caused by such Indemnified Person’s gross negligence or willful misconduct.  Borrower hereby further indemnifies, defends and holds each Indemnified Person harmless from and against any and all liabilities, obligations, losses, damages, penalties, actions, judgments, suits, claims, costs, expenses and disbursements of any kind or nature whatsoever (including the fees and disbursements of counsel for such Indemnified Person) in connection with any investigative, response, remedial, administrative or judicial matter or proceeding, whether or not such Indemnified Person shall be designated a party thereto and including any such proceeding initiated by or on behalf of Borrower, and the reasonable expenses of investigation by engineers, environmental consultants and similar technical personnel and any commission, fee or compensation claimed by any broker (other than any broker retained by Collateral Agent or Lenders) asserting any right to payment for the transactions contemplated hereby which may be imposed on, incurred by or asserted against such Indemnified Person as a result of or in connection with the transactions contemplated hereby and the use or intended use of the proceeds of the loan proceeds except for liabilities, obligations, losses, damages, penalties, actions, judgments, suits, claims, costs, expenses and disbursements directly caused by such Indemnified Person’s gross negligence or willful misconduct.

 

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12.3                        Time of Essence.  Time is of the essence for the performance of all Obligations in this Agreement.

 

12.4                        Severability of Provisions.  Each provision of this Agreement is severable from every other provision in determining the enforceability of any provision.

 

12.5                        Correction of Loan Documents.  Collateral Agent and the Lenders may correct patent errors and fill in any blanks in this Agreement and the other Loan Documents consistent with the agreement of the parties.

 

12.6                        Amendments in Writing; Integration.  (a) No amendment, modification, termination or waiver of any provision of this Agreement or any other Loan Document, no approval or consent thereunder, or any consent to any departure by Borrower or any of its Subsidiaries therefrom, shall in any event be effective unless the same shall be in writing and signed by Borrower, Collateral Agent and the Required Lenders provided that:

 

(i)                                     no such amendment, waiver or other modification that would have the effect of increasing or reducing a Lender’s Term Loan Commitment or Commitment Percentage shall be effective as to such Lender without such Lender’s written consent;

 

(ii)                                  no such amendment, waiver or modification that would affect the rights and duties of Collateral Agent shall be effective without Collateral Agent’s written consent or signature;

 

(iii)                               no such amendment, waiver or other modification shall, unless signed by all the Lenders directly affected thereby, (A) reduce the principal of, rate of interest on or any fees with respect to any Term Loan or forgive any principal, interest (other than default interest) or fees (other than late charges) with respect to any Term Loan (B) postpone the date fixed for, or waive, any payment of principal of any Term Loan or of interest on any Term Loan (other than default interest) or any fees provided for hereunder (other than late charges or for any termination of any commitment); (C) change the definition of the term “Required Lenders” or the percentage of Lenders which shall be required for the Lenders to take any action hereunder; (D) release all or substantially all of any material portion of the Collateral, authorize Borrower to sell or otherwise dispose of all or substantially all or any material portion of the Collateral or release any Guarantor of all or any portion of the Obligations or its guaranty obligations with respect thereto, except, in each case with respect to this clause (D), as otherwise may be expressly permitted under this Agreement or the other Loan Documents (including in connection with any disposition permitted hereunder); (E) amend, waive or otherwise modify this Section 12.6 or the definitions of the terms used in this Section 12.6 insofar as the definitions affect the substance of this Section 12.6; (F) consent to the assignment, delegation or other transfer by Borrower of any of its rights and obligations under any Loan Document or release Borrower of its payment obligations under any Loan Document, except, in each case with respect to this clause (F), pursuant to a merger or consolidation permitted pursuant to this Agreement; (G) amend any of the provisions of Section 9.4 or amend any of the definitions of Pro Rata Share, Term Loan Commitment, Commitment Percentage or that provide for the Lenders to receive their Pro Rata Shares of any fees, payments, setoffs or proceeds of Collateral hereunder; (H) subordinate the Liens granted in favor of Collateral Agent securing the Obligations; or (I) amend any of the provisions of Section 12.10.  It is hereby understood and agreed that all Lenders shall be deemed directly affected by an amendment, waiver or other modification of the type described in the preceding clauses (C), (D), (E), (F), (G) and (H) of the preceding sentence;

 

(iv)                              the provisions of the foregoing clauses (i), (ii) and (iii) are subject to the provisions of any interlender or agency agreement among the Lenders and Collateral Agent pursuant to which any Lender may agree to give its consent in connection with any amendment, waiver or modification of the Loan Documents only in the event of the unanimous agreement of all Lenders.

 

(b)                                 Other than as expressly provided for in Section 12.6(a)(i)-(iii), Collateral Agent may, if requested by the Required Lenders, from time to time designate covenants in this Agreement less restrictive by notification to a representative of Borrower.

 

(c)                                  This Agreement and the Loan Documents represent the entire agreement about this subject matter and supersede prior negotiations or agreements.  All prior agreements, understandings, 

 

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representations, warranties, and negotiations between the parties about the subject matter of this Agreement and the Loan Documents merge into this Agreement and the Loan Documents.

 

12.7                        Counterparts.  This Agreement may be executed in any number of counterparts and by different parties on separate counterparts, each of which, when executed and delivered, is an original, and all taken together, constitute one Agreement.

 

12.8                        Survival.  All covenants, representations and warranties made in this Agreement continue in full force and effect until this Agreement has terminated pursuant to its terms and all Obligations (other than inchoate indemnity obligations and any other obligations which, by their terms, are to survive the termination of this Agreement) have been satisfied.  The obligation of Borrower in Section 12.2 to indemnify each Lender and Collateral Agent, as well as the confidentiality provisions in Section 12.9 below, shall survive until the statute of limitations with respect to such claim or cause of action shall have run.

 

12.9                        Confidentiality.  In handling any confidential information of Borrower, the Lenders and Collateral Agent shall exercise the same degree of care that it exercises for their own proprietary information, but disclosure of information may be made: (a) subject to the terms and conditions of this Agreement, to the Lenders’ and Collateral Agent’s Subsidiaries or Affiliates, or in connection with a Lender’s own financing or securitization transactions and upon the occurrence of a default, event of default or similar occurrence with respect to such financing or securitization transaction; (b) to prospective transferees (other than those identified in (a) above) or purchasers of any interest in the Credit Extensions (provided, however, the Lenders and Collateral Agent shall, except upon the occurrence and during the continuance of an Event of Default, obtain such prospective transferee’s or purchaser’s agreement to the terms of this provision or to similar confidentiality terms); (c) as required by law, regulation, subpoena, or other order; (d) to Lenders’ or Collateral Agent’s regulators or as otherwise required in connection with an examination or audit; (e) as Collateral Agent reasonably considers appropriate in exercising remedies under the Loan Documents; and (f) to third party service providers of the Lenders and/or Collateral Agent so long as such service providers have executed a confidentiality agreement with the Lenders and Collateral Agent with terms no less restrictive than those contained herein.  Confidential information does not include information that either: (i) is in the public domain or in the Lenders’ and/or Collateral Agent’s possession when disclosed to the Lenders and/or Collateral Agent, or becomes part of the public domain after disclosure to the Lenders and/or Collateral Agent; or (ii) is disclosed to the Lenders and/or Collateral Agent by a third party, if the Lenders and/or Collateral Agent does not know that the third party is prohibited from disclosing the information.  Except as limited above, Collateral Agent and the Lenders may use confidential information for the development of client databases, reporting purposes, market analysis and similar internal purposes.  The provisions of the immediately preceding sentence shall survive the termination of this Agreement.  The agreements provided under this Section 12.9 supersede all prior agreements, understanding, representations, warranties, and negotiations between the parties about the subject matter of this Section 12.9.

 

12.10                 Right of Set Off.  Borrower hereby grants to Collateral Agent and to each Lender, a lien, security interest and right of set off as security for all Obligations to Collateral Agent and each Lender hereunder, whether now existing or hereafter arising upon and against all deposits, credits, collateral and property, now or hereafter in the possession, custody, safekeeping or control of Collateral Agent or the Lenders or any entity under the control of Collateral Agent or the Lenders (including a Collateral Agent affiliate) or in transit to any of them.  At any time after the occurrence and during the continuance of an Event of Default, without demand or notice, Collateral Agent or the Lenders may set off the same or any part thereof and apply the same to any liability or obligation of Borrower even though unmatured and regardless of the adequacy of any other collateral securing the Obligations.  ANY AND ALL RIGHTS TO REQUIRE COLLATERAL AGENT TO EXERCISE ITS RIGHTS OR REMEDIES WITH RESPECT TO ANY OTHER COLLATERAL WHICH SECURES THE OBLIGATIONS, PRIOR TO EXERCISING ITS RIGHT OF SETOFF WITH RESPECT TO SUCH DEPOSITS, CREDITS OR OTHER PROPERTY OF BORROWER ARE HEREBY KNOWINGLY, VOLUNTARILY AND IRREVOCABLY WAIVED.

 

12.11                 Cooperation of Borrower.  If necessary, Borrower agrees to (i) execute any documents (including new Secured Promissory Notes) reasonably required to effectuate and acknowledge each assignment of a Term Loan Commitment or Loan to an assignee in accordance with Section 12.1, (ii) make Borrower’s management available to meet with Collateral Agent and prospective participants and assignees of Term Loan Commitments or Credit Extensions (which meetings shall be conducted no more often than twice every twelve months unless an 

 

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Event of Default has occurred and is continuing), and (iii) assist Collateral Agent or the Lenders in the preparation of information relating to the financial affairs of Borrower as any prospective participant or assignee of a Term Loan Commitment or Term Loan reasonably may request.  Subject to the provisions of Section 12.9, Borrower authorizes each Lender to disclose to any prospective participant or assignee of a Term Loan Commitment, any and all information in such Lender’s possession concerning Borrower and its financial affairs which has been delivered to such Lender by or on behalf of Borrower pursuant to this Agreement, or which has been delivered to such Lender by or on behalf of Borrower in connection with such Lender’s credit evaluation of Borrower prior to entering into this Agreement.

 

12.12                 Effect of Amendment and Restatement.  Except as otherwise set forth herein, this Agreement is intended to and does completely amend and restate, without novation, the Original Agreement.  All security interests granted under the Original Agreement are hereby confirmed and ratified and shall continue to secure all Obligations under this Agreement.

 

13.                               DEFINITIONS

 

13.1                        Definitions.  As used in this Agreement, the following terms have the following meanings:

 

“Account” is any “account” as defined in the Code with such additions to such term as may hereafter be made, and includes, without limitation, all accounts receivable and other sums owing to Borrower.

 

“Account Debtor” is any “account debtor” as defined in the Code with such additions to such term as may hereafter be made.

 

“Affiliate” of any Person is a Person that owns or controls directly or indirectly the Person, any Person that controls or is controlled by or is under common control with the Person, and each of that Person’s senior executive officers, directors, partners and, for any Person that is a limited liability company, that Person’s managers and members.

 

“Agreement” is defined in the preamble hereof.

 

“Amortization Date” is, (i) with respect to Original Term Loans, August 1, 2015, and (ii) with respect to Term D Loans, (A) August 1, 2015 if the IPO Event does not occur or (B) August 1, 2016, if the IPO Event does occur.

 

“Annual Projections” is defined in Section 6.2(a).

 

“Anti-Terrorism Laws” are any laws relating to terrorism or money laundering, including Executive Order No. 13224 (effective September 24, 2001), the USA PATRIOT Act, the laws comprising or implementing the Bank Secrecy Act, and the laws administered by OFAC.

 

“Approved Fund” is any (i) investment company, fund, trust, securitization vehicle or conduit that is (or will be) engaged in making, purchasing, holding or otherwise investing in commercial loans and similar extensions of credit in the ordinary course of its business or (ii) any Person (other than a natural person) which temporarily warehouses loans for any Lender or any entity described in the preceding clause (i) and that, with respect to each of the preceding clauses (i) and (ii), is administered or managed by (a) a Lender, (b) an Affiliate of a Lender or (c) a Person (other than a natural person) or an Affiliate of a Person (other than a natural person) that administers or manages a Lender.

 

“Approved Lender” is defined in Section 12.1.

 

“Basic Rate” is, with respect to a Term Loan, the per annum rate of interest (based on a year of three hundred sixty (360) days) equal to Eight And Four Tenths percent (8.40%).

 

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“Blocked Person” is any Person: (a) listed in the annex to, or is otherwise subject to the provisions of, Executive Order No. 13224, (b) a Person owned or controlled by, or acting for or on behalf of, any Person that is listed in the annex to, or is otherwise subject to the provisions of, Executive Order No. 13224, (c) a Person with which any Lender is prohibited from dealing or otherwise engaging in any transaction by any Anti-Terrorism Law, (d) a Person that commits, threatens or conspires to commit or supports “terrorism” as defined in Executive Order No. 13224, or (e) a Person that is named a “specially designated national” or “blocked person” on the most current list published by OFAC or other similar list.

 

“Borrower” is defined in the preamble hereof.

 

“Borrower’s Books” are Borrower’s or any of its Subsidiaries’ books and records including ledgers, federal, and state tax returns, records regarding Borrower’s or its Subsidiaries’ assets or liabilities, the Collateral, business operations or financial condition, and all computer programs or storage or any equipment containing such information.

 

“Business Day” is any day that is not a Saturday, Sunday or a day on which Collateral Agent is closed.

 

“Cash Equivalents” are (a) marketable direct obligations issued or unconditionally guaranteed by the United States or any agency or any State thereof having maturities of not more than one (1) year from the date of acquisition; (b) commercial paper maturing no more than one (1) year after its creation and having the highest rating from either Standard & Poor’s Ratings Group or Moody’s Investors Service, Inc., and (c) certificates of deposit maturing no more than one (1) year after issue provided that the account in which any such certificate of deposit is maintained is subject to a Control Agreement in favor of Collateral Agent.  For the avoidance of doubt, the direct purchase by Borrower or any of its Subsidiaries of any Auction Rate Securities, or purchasing participations in, or entering into any type of swap or other derivative transaction, or otherwise holding or engaging in any ownership interest in any type of Auction Rate Security by Borrower or any of its Subsidiaries shall be conclusively determined by the Lenders as an ineligible Cash Equivalent, and any such transaction shall expressly violate each other provision of this Agreement governing Permitted Investments.  Notwithstanding the foregoing, Cash Equivalents does not include and Borrower, and each of its Subsidiaries, are prohibited from purchasing, purchasing participations in, entering into any type of swap or other equivalent derivative transaction, or otherwise holding or engaging in any ownership interest in any type of debt instrument, including, without limitation, any corporate or municipal bonds with a long-term nominal maturity for which the interest rate is reset through a dutch auction and more commonly referred to as an auction rate security (each, an “Auction Rate Security”).

 

“Claims” are defined in Section 12.2.

 

“Code” is the Uniform Commercial Code, as the same may, from time to time, be enacted and in effect in the State of California; provided, that, to the extent that the Code is used to define any term herein or in any Loan Document and such term is defined differently in different Articles or Divisions of the Code, the definition of such term contained in Article or Division 9 shall govern; provided further, that in the event that, by reason of mandatory provisions of law, any or all of the attachment, perfection, or priority of, or remedies with respect to, Collateral Agent’s Lien on any Collateral is governed by the Uniform Commercial Code in effect in a jurisdiction other than the State of California, the term “Code” shall mean the Uniform Commercial Code as enacted and in effect in such other jurisdiction solely for purposes of the provisions thereof relating to such attachment, perfection, priority, or remedies and for purposes of definitions relating to such provisions.

 

“Collateral” is any and all properties, rights and assets of Borrower described on Exhibit A.

 

“Collateral Account” is any Deposit Account, Securities Account, or Commodity Account, or any other bank account maintained by Borrower or any Subsidiary at any time.

 

“Collateral Agent” is, Oxford, not in its individual capacity, but solely in its capacity as agent on behalf of and for the benefit of the Lenders.

 

“Commitment Percentage” is set forth in Schedule 1.1, as amended from time to time.

 

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“Commodity Account” is any “commodity account” as defined in the Code with such additions to such term as may hereafter be made.

 

“Communication” is defined in Section 10.

 

“Compliance Certificate” is that certain certificate in the form attached hereto as Exhibit C.

 

“Contingent Obligation” is, for any Person, any direct or indirect liability, contingent or not, of that Person for (a) any indebtedness, lease, dividend, letter of credit or other obligation of another such as an obligation directly or indirectly guaranteed, endorsed, co-made, discounted or sold with recourse by that Person, or for which that Person is directly or indirectly liable; (b) any obligations for undrawn letters of credit for the account of that Person; and (c) all obligations from any interest rate, currency or commodity swap agreement, interest rate cap or collar agreement, or other agreement or arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices; but “Contingent Obligation” does not include endorsements in the ordinary course of business.  The amount of a Contingent Obligation is the stated or determined amount of the primary obligation for which the Contingent Obligation is made or, if not determinable, the maximum reasonably anticipated liability for it determined by the Person in good faith; but the amount may not exceed the maximum of the obligations under any guarantee or other support arrangement.

 

“Control Agreement” is any control agreement entered into among the depository institution at which Borrower or any of its Subsidiaries maintains a Deposit Account or the securities intermediary or commodity intermediary at which Borrower or any of its Subsidiaries maintains a Securities Account or a Commodity Account, Borrower and such Subsidiary, and Collateral Agent pursuant to which Collateral Agent obtains control (within the meaning of the Code) for the benefit of the Lenders over such Deposit Account, Securities Account, or Commodity Account.

 

“Copyrights” are any and all copyright rights, copyright applications, copyright registrations and like protections in each work or authorship and derivative work thereof, whether published or unpublished and whether or not the same also constitutes a trade secret.

 

“Credit Extension” is any Term Loan or any other extension of credit by Collateral Agent or Lenders for Borrower’s benefit.

 

“Default Rate” is defined in Section 2.3(b).

 

“Deposit Account” is any “deposit account” as defined in the Code with such additions to such term as may hereafter be made.

 

“Designated Deposit Account” is Borrower’s deposit account, account number 4121934822, maintained with Wells Fargo Bank, N.A., or such other replacement account as Borrower may indicate to Collateral Agent so long as such account is subject to a Control Agreement.

 

“Disbursement Letter” is that certain form attached hereto as Exhibit B.

 

“Dollars,” “dollars” and “$” each mean lawful money of the United States.

 

“Effective Date” is defined in the preamble of this Agreement.

 

“Eligible Assignee” is (i) a Lender, (ii) an Affiliate of a Lender, (iii) an Approved Fund and (iv) any commercial bank, savings and loan association or savings bank or any other entity which is an “accredited investor” (as defined in Regulation D under the Securities Act of 1933, as amended) and which extends credit or buys loans as one of its businesses, including insurance companies, mutual funds, lease financing companies and commercial finance companies, in each case, which either (A) has a rating of BBB or higher from Standard & Poor’s Rating Group and a rating of Baa2 or higher from Moody’s Investors Service, Inc. at the date that it becomes a Lender or (B) has total assets in excess of Five Billion Dollars ($5,000,000,000.00), and in each case of clauses (i) through 

 

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(iv), which, through its applicable lending office, is capable of lending to Borrower without the imposition of any withholding or similar taxes; provided that notwithstanding the foregoing, “Eligible Assignee” shall not include, unless an Event of Default has occurred and is continuing, (i) Borrower or any of Borrower’s Affiliates or Subsidiaries or (ii) a direct competitor of Borrower or a vulture hedge fund, each as determined by Collateral Agent.  Notwithstanding the foregoing, (x) in connection with assignments by a Lender due to a forced divestiture at the request of any regulatory agency, the restrictions set forth herein shall not apply and Eligible Assignee shall mean any Person or party and (y) in connection with a Lender’s own financing or securitization transactions, the restrictions set forth herein shall not apply and Eligible Assignee shall mean any Person or party providing such financing or formed to undertake such securitization transaction and any transferee of such Person or party upon the occurrence of a default, event of default or similar occurrence with respect to such financing or securitization transaction; provided that no such sale, transfer, pledge or assignment under this clause (y) shall release such Lender from any of its obligations hereunder or substitute any such Person or party for such Lender as a party hereto until Collateral Agent shall have received and accepted an effective assignment agreement from such Person or party in form satisfactory to Collateral Agent executed, delivered and fully completed by the applicable parties thereto, and shall have received such other information regarding such Eligible Assignee as Collateral Agent reasonably shall require.

 

“Eligible Domestic Inventory” is finished goods kept at the Borrower’s warehouse located within the United States.

 

“Equipment” is all “equipment” as defined in the Code with such additions to such term as may hereafter be made, and includes without limitation all machinery, fixtures, goods, vehicles (including motor vehicles and trailers), and any interest in any of the foregoing.

 

“ERISA” is the Employee Retirement Income Security Act of 1974, as amended, and its regulations.

 

“Event of Default” is defined in Section 8.

 

“Final Payment” is a payment (in addition to and not a substitution for the regular monthly payments of principal plus accrued interest) due on the earliest to occur of (a) the Maturity Date of a Term Loan, or (b) the acceleration of a Term Loan, or (c) the prepayment of Term Loans pursuant to Section 2.2(c) or (d), equal to the aggregate principal amount of Term Loans being paid multiplied by the Final Payment Percentage, payable to Lenders in accordance with their respective Pro Rata Shares (for the avoidance of doubt, the calculation of any Final Payment shall not include the principal amount prepaid in accordance with Section 2.2(d) with respect to which a Final Payment based on such principal amount was made at the time of such prepayment).

 

“Final Payment Percentage” is Six And Five Tenths percent (6.50%).

 

“Foreign Subsidiary” is a Subsidiary that is not an entity organized under the laws of the United States or any territory thereof.

 

“Funding Date” is any date on which a Credit Extension is made to or on account of Borrower which shall be a Business Day.

 

“GAAP” is generally accepted accounting principles set forth in the opinions and pronouncements of the Accounting Principles Board of the American Institute of Certified Public Accountants and statements and pronouncements of the Financial Accounting Standards Board or in such other statements by such other Person as may be approved by a significant segment of the accounting profession in the United States, which are applicable to the circumstances as of the date of determination.

 

“General Intangibles” are all “general intangibles” as defined in the Code in effect on the date hereof with such additions to such term as may hereafter be made, and includes without limitation, all copyright rights, copyright applications, copyright registrations and like protections in each work of authorship and derivative work, whether published or unpublished, any patents, trademarks, service marks and, to the extent permitted under applicable law, any applications therefor, whether registered or not, any trade secret rights, including any rights to 

 

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unpatented inventions, payment intangibles, royalties, contract rights, goodwill, franchise agreements, purchase orders, customer lists, route lists, telephone numbers, domain names, claims, income and other tax refunds, security and other deposits, options to purchase or sell real or personal property, rights in all litigation presently or hereafter pending (whether in contract, tort or otherwise), insurance policies (including without limitation key man, property damage, and business interruption insurance), payments of insurance and rights to payment of any kind.

 

“Governmental Approval” is any consent, authorization, approval, order, license, franchise, permit, certificate, accreditation, registration, filing or notice, of, issued by, from or to, or other act by or in respect of, any Governmental Authority.

 

“Governmental Authority” is any nation or government, any state or other political subdivision thereof, any agency, authority, instrumentality, regulatory body, court, central bank or other entity exercising executive, legislative, judicial, taxing, regulatory or administrative functions of or pertaining to government, any securities exchange and any self-regulatory organization.

 

“Guarantor” is any Person providing a Guaranty in favor of Collateral Agent.

 

“Guaranty” is any guarantee of all or any part of the Obligations, as the same may from time to time be amended, restated, modified or otherwise supplemented.

 

“Indebtedness” is (a) indebtedness for borrowed money or the deferred price of property or services, such as reimbursement and other obligations for surety bonds and letters of credit, (b) obligations evidenced by notes, bonds, debentures or similar instruments, (c) capital lease obligations, and (d) Contingent Obligations.

 

“Indemnified Person” is defined in Section 12.2.

 

“Insolvency Proceeding” is any proceeding by or against any Person under the United States Bankruptcy Code, or any other bankruptcy or insolvency law, including assignments for the benefit of creditors, compositions, extensions generally with its creditors, or proceedings seeking reorganization, arrangement, or other relief.

 

“Insolvent” means not Solvent.

 

“Intellectual Property” means all of Borrower’s or any Subsidiary’s right, title and interest in and to the following:

 

(a)                                 its Copyrights, Trademarks and Patents;

 

(b)                                 any and all trade secrets and trade secret rights, including, without limitation, any rights to unpatented inventions, know-how, operating manuals;

 

(c)                                  any and all source code;

 

(d)                                 any and all design rights which may be available to Borrower;

 

(e)                                  any and all claims for damages by way of past, present and future infringement of any of the foregoing, with the right, but not the obligation, to sue for and collect such damages for said use or infringement of the Intellectual Property rights identified above; and

 

(f)                                   all amendments, renewals and extensions of any of the Copyrights, Trademarks or Patents.

 

“Inventory” is all “inventory” as defined in the Code in effect on the date hereof with such additions to such term as may hereafter be made, and includes without limitation all merchandise, raw materials, parts, supplies, packing and shipping materials, work in process and finished products, including without limitation such inventory 

 

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as is temporarily out of any Person’s custody or possession or in transit and including any returned goods and any documents of title representing any of the above.

 

“Investment” is any beneficial ownership interest in any Person (including stock, partnership interest or other securities), and any loan, advance, payment or capital contribution to any Person.

 

“IPO Event” is the receipt of by Borrower of gross cash proceeds of Fifty Million Dollars ($50,000,000) on or before June 30, 2015 as part of the initial public offering of Borrower’s common stock.

 

“Key Person” is each of Borrower’s (i) Chief Executive Officer, who is Hani Zeini as of the Effective Date and (ii) Chief Financial Officer, who is Matt Pigeon as of the Effective Date.

 

“Lender” is any one of the Lenders.

 

“Lenders” are the Persons identified on Schedule 1.1 hereto and each assignee that becomes a party to this Agreement pursuant to Section 12.1.

 

“Lenders’ Expenses” are (a) all reasonable and documented audit fees and expenses, costs, and expenses (including reasonable and documented attorneys’ fees and expenses, as well as appraisal fees, fees incurred on account of lien searches, inspection fees, and filing fees) for preparing, amending, negotiating, administering, defending and enforcing the Loan Document (including, without limitation, those incurred in connection with appeals or Insolvency Proceedings) or otherwise incurred by Collateral Agent in connection with the Loan Documents provided that, so long as no Event of Default exists, Borrower shall only be liable for audit and inspection cost and expenses related to one audit and/or inspection per fiscal year and (b) all reasonable and documented costs and expenses for defending and enforcing the Loan Documents (including, without limitation, those incurred in connection with appeals or Insolvency Proceedings).

 

“Lien” is a claim, mortgage, deed of trust, levy, charge, pledge, security interest, or other encumbrance of any kind, whether voluntarily incurred or arising by operation of law or otherwise against any property.

 

“Loan Documents” are, collectively, this Agreement, the Warrants, the Perfection Certificates, each Compliance Certificate, each Disbursement Letter, the Post Closing Letter, any subordination agreements, any note, or notes or guaranties executed by Borrower or any other Person, and any other present or future agreement entered into by Borrower, any Guarantor or any other Person for the benefit of the Lenders and Collateral Agent in connection with this Agreement; all as amended, restated, or otherwise modified.

 

“Material Adverse Change” is (a) a material impairment in the perfection or priority of Collateral Agent’s Lien in the Collateral or in the value of such Collateral; (b) a material adverse change in the business, operations or condition (financial or otherwise) of Borrower or any Subsidiary; or (c) a material impairment of the prospect of repayment of any portion of the Obligations.

 

“Maturity Date” is, (A) February 1, 2017 for each Original Term Loan and (B) January 1, 2019 for each Term D Loan.

 

“Obligations” are all of Borrower’s obligations to pay when due any debts, principal, interest, Lenders’ Expenses, the Final Payment, and other amounts Borrower owes the Lenders now or later, in connection with, related to, following, or arising from, out of or under, this Agreement or, the other Loan Documents (other than the Warrants), or otherwise, and including interest accruing after Insolvency Proceedings begin (whether or not allowed) and debts, liabilities, or obligations of Borrower assigned to the Lenders and/or Collateral Agent, and the performance of Borrower’s duties under the Loan Documents (other than the Warrants).

 

“OFAC” is the U.S. Department of Treasury Office of Foreign Assets Control.

 

“OFAC Lists” are, collectively, the Specially Designated Nationals and Blocked Persons List maintained by OFAC pursuant to Executive Order No. 13224, 66 Fed. Reg. 49079 (Sept. 25, 2001) and/or any other list of 

 

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terrorists or other restricted Persons maintained pursuant to any of the rules and regulations of OFAC or pursuant to any other applicable Executive Orders.

 

“Operating Documents” are, for any Person, such Person’s formation documents, as certified by the Secretary of State (or equivalent agency) of such Person’s jurisdiction of organization on a date that is no earlier than thirty (30) days prior to the Effective Date, and, (a) if such Person is a corporation, its bylaws in current form, (b) if such Person is a limited liability company, its limited liability company agreement (or similar agreement), and (c) if such Person is a partnership, its partnership agreement (or similar agreement), each of the foregoing with all current amendments or modifications thereto.

 

“Original Agreement” is defined in the preamble hereof.

 

“Original Term Loan” is defined in Section 2.2(a)(i) hereof.

 

“Patents” means all patents, patent applications and like protections including without limitation improvements, divisions, continuations, renewals, reissues, extensions and continuations-in-part of the same.

 

“Payment Date” is the first (1st) calendar day of each calendar month, commencing on August 1, 2014.

 

“Perfection Certificate” and “Perfection Certificates” is defined in Section 5.1.

 

“Permitted Indebtedness” is:

 

(a)                                 Borrower’s Indebtedness to the Lenders and Collateral Agent under this Agreement and the other Loan Documents;

 

(b)                                 Indebtedness existing on the Effective Date and disclosed on the Perfection Certificate(s);

 

(c)                                  Subordinated Debt;

 

(d)                                 unsecured Indebtedness to trade creditors incurred in the ordinary course of business;

 

(e)                                  Indebtedness consisting of capitalized lease obligations and purchase money Indebtedness, in each case incurred by Borrower or any of its Subsidiaries to finance the acquisition, repair, improvement or construction of fixed or capital assets of such person, provided that (i) the aggregate outstanding principal amount of all such Indebtedness does not exceed Two Hundred And Fifty Thousand Dollars ($250,000.00) at any time and (ii) the principal amount of such Indebtedness does not exceed the lower of the cost or fair market value of the property so acquired or built or of such repairs or improvements financed with such Indebtedness (each measured at the time of such acquisition, repair, improvement or construction is made);

 

(f)                                   Indebtedness incurred as a result of endorsing negotiable instruments received in the ordinary course of Borrower’s business;

 

(g)                                  unsecured business credit card Indebtedness in an aggregate principal amount not in excess of $250,000 at any time outstanding;

 

(h)                                 Indebtedness arising in connection with the financing of insurance premiums;

 

(i)                                     extensions, refinancings, modifications, amendments and restatements of any items of Permitted Indebtedness (a) through (e) above, provided that the principal amount thereof is not increased or the terms thereof are not modified to impose materially more burdensome terms upon Borrower, or its Subsidiary, as the case may be; and

 

(j)                                    other Indebtedness in an aggregate amount not to exceed $100,000.

 

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“Permitted Investments” are:

 

(a)                                 Investments disclosed on the Perfection Certificate(s) and existing on the Effective Date;

 

(b)                                 (i) Investments consisting of cash and Cash Equivalents, and (ii) any Investments permitted by Borrower’s investment policy, as amended from time to time, provided that such investment policy (and any such amendment thereto) has been approved by Borrower’s Board of Directors;

 

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

 

(d)                                 Investments consisting of Deposit Accounts in which Collateral Agent has a perfected security interest;

 

(e)                                  Investments in connection with Transfers permitted by Section 7.1;

 

(f)                                   Investments consisting of (i) travel advances and employee relocation loans and other employee loans and advances in the ordinary course of business, and (ii) loans to employees, officers or directors relating to the purchase of equity securities of Borrower or its Subsidiaries pursuant to employee stock purchase plans or agreements approved by Borrower’s Board of Directors; not to exceed Two Hundred And Fifty Thousand Dollars ($250,000) in the aggregate for (i) and (ii) in any fiscal year;

 

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

 

(h)                                 Investments consisting of notes receivable of, or prepaid royalties and other credit extensions, to customers and suppliers who are not Affiliates, in the ordinary course of business; and

 

(i)                                     non-cash Investments in joint ventures or strategic alliances in the ordinary course of Borrower’s business consisting of the non-exclusive licensing of technology, the development of technology or the providing of technical support.

 

“Permitted Licenses” are (A) licenses of over-the-counter software that is commercially available to the public, and (B) non-exclusive and exclusive licenses for the use of the Intellectual Property of Borrower or any of its Subsidiaries entered into in the ordinary course of business, provided, that, with respect to each such license described in clause (B), (i) no Event of Default has occurred or is continuing at the time of such license; (ii) the license constitutes an arms-length transaction, the terms of which, on their face, do not provide for a sale or assignment of any Intellectual Property and do not restrict the ability of Borrower or any of its Subsidiaries, as applicable, to pledge, grant a security interest in or lien on, or assign or otherwise Transfer any Intellectual Property; (iii) in the case of any exclusive license, (x) Borrower delivers twenty (20) days’ prior written notice and a brief summary of the terms of the proposed license to Collateral Agent and the Lenders and delivers to Collateral Agent and the Lenders copies of the final executed licensing documents in connection with the exclusive license promptly upon consummation thereof, (y) any such license is made in connection with a bona fide corporate collaboration or partnership, and is approved by Borrower’s (or the applicable Subsidiary’s) board of directors, and (z) any such license could not result in a legal transfer of title of the licensed property but may be exclusive in respects other than territory and may be exclusive as to territory only as to discrete geographical areas outside of the United States; and (iv) all upfront payments, royalties, milestone payments or other proceeds arising from the licensing agreement that are payable to Borrower or any of its Subsidiaries are paid to a Deposit Account that is governed by a Control Agreement.

 

“Permitted Liens” are:

 

(a)                                 Liens existing on the Effective Date and disclosed on the Perfection Certificates or arising under this Agreement and the other Loan Documents;

 

 

32

 

(b)                                 Liens for taxes, fees, assessments or other government charges or levies, either (i) not due and payable or (ii) being contested in good faith and for which Borrower maintains adequate reserves on its Books, provided that no notice of any such Lien has been filed or recorded under the Internal Revenue Code of 1986, as amended, and the Treasury Regulations adopted thereunder;

 

(c)                                  liens securing Indebtedness permitted under clause (e) of the definition of “Permitted Indebtedness,” provided that (i) such liens exist prior to the acquisition of, or attach substantially simultaneous with, or within twenty (20) days after the, acquisition, lease, repair, improvement or construction of, such property financed or leased by such Indebtedness and (ii) such liens do not extend to any property of Borrower other than the property (and proceeds thereof) acquired, leased or built, or the improvements or repairs, financed by such Indebtedness;

 

(d)                                 Liens of carriers, warehousemen, mechanics, materialmen, landlords, suppliers, or other Persons that are possessory in nature arising in the ordinary course of business so long as such Liens attach only to Inventory, securing liabilities in the aggregate amount not to exceed Twenty Five Thousand Dollars ($25,000.00), and which are not delinquent or remain payable without penalty or which are being contested in good faith and by appropriate proceedings which proceedings have the effect of preventing the forfeiture or sale of the property subject thereto;

 

(e)                                  Liens to secure payment of workers’ compensation, employment insurance, old-age pensions, social security and other like obligations incurred in the ordinary course of business (other than Liens imposed by ERISA);

 

(f)                                   Liens incurred in the extension, renewal or refinancing of the indebtedness secured by Liens described in (a) through (c), but any extension, renewal or replacement Lien must be limited to the property encumbered by the existing Lien and the principal amount of the indebtedness may not increase;

 

(g)                                  leases or subleases of real property granted in the ordinary course of Borrower’s business (or, if referring to another Person, in the ordinary course of such Person’s business), and leases, subleases, non-exclusive licenses or sublicenses of personal property (other than Intellectual Property) granted in the ordinary course of Borrower’s business (or, if referring to another Person, in the ordinary course of such Person’s business), if the leases, subleases, licenses and sublicenses do not prohibit granting Collateral Agent or any Lender a security interest therein;

 

(h)                                 banker’s liens, rights of setoff and Liens in favor of financial institutions incurred in the ordinary course of business arising in connection with Borrower’s deposit accounts or securities accounts held at such institutions solely to secure payment of fees and similar costs and expenses and provided such accounts are maintained in compliance with Section 6.6(b) hereof;

 

(i)                                     Liens arising from judgments, decrees or attachments in circumstances not constituting an Event of Default under Section 8.4 or 8.7;

 

(j)                                    Liens consisting of Permitted Licenses; and

 

(k)                                 other Liens in an aggregate amount not to exceed $100,000.

 

“Person” is any individual, sole proprietorship, partnership, limited liability company, joint venture, company, trust, unincorporated organization, association, corporation, institution, public benefit corporation, firm, joint stock company, estate, entity or government agency.

 

“Post Closing Letter” is that certain Post Closing Letter dated as of the Effective Date by and between Collateral Agent and Borrower.

 

33

 

“Pro Rata Share” is, as of any date of determination, with respect to each Lender, a percentage (expressed as a decimal, rounded to the ninth decimal place) determined by dividing the outstanding principal amount of Term Loans held by such Lender by the aggregate outstanding principal amount of all Term Loans.

 

“Registered Organization” is any “registered organization” as defined in the Code with such additions to such term as may hereafter be made

 

“Required Lenders” means (i) for so long as all of the Persons that are Lenders on the Effective Date (each an “Original Lender”) have not assigned or transferred any of their interests in their Term Loan, Lenders holding one hundred percent (100%) of the aggregate outstanding principal balance of the Term Loan, or (ii) at any time from and after any Original Lender has assigned or transferred any interest in its Term Loan, Lenders holding at least sixty-six percent (66%) of the aggregate outstanding principal balance of the Term Loan and, in respect of this clause (ii), (A) each Original Lender that has not assigned or transferred any portion of its Term Loan, (B) each assignee or transferee of an Original Lender’s interest in the Term Loan, but only to the extent that such assignee or transferee is an Affiliate or Approved Fund of such Original Lender, and (C) any Person providing financing to any Person described in clauses (A) and (B) above; provided, however, that this clause (C) shall only apply upon the occurrence of a default, event of default or similar occurrence with respect to such financing.

 

“Requirement of Law” is as to any Person, the organizational or governing documents of such Person, and any law (statutory or common), treaty, rule or regulation or determination of an arbitrator or a court or other Governmental Authority, in each case applicable to or binding upon such Person or any of its property or to which such Person or any of its property is subject.

 

“Responsible Officer” is any of the President, Chief Executive Officer, or Chief Financial Officer of Borrower acting alone.

 

“Secured Promissory Note” is defined in Section 2.4.

 

“Secured Promissory Note Record” is a record maintained by each Lender with respect to the outstanding Obligations owed by Borrower to Lender and credits made thereto.

 

“Securities Account” is any “securities account” as defined in the Code with such additions to such term as may hereafter be made.

 

“Solvent” is, with respect to any Person: the fair salable value of such Person’s consolidated assets (including goodwill minus disposition costs) exceeds the fair value of such Person’s liabilities; such Person is not left with unreasonably small capital after the transactions in this Agreement; and such Person is able to pay its debts (including trade debts) as they mature.

 

“Subordinated Debt” is indebtedness incurred by Borrower or any of its Subsidiaries subordinated to all Indebtedness of Borrower and/or its Subsidiaries to the Lenders (pursuant to a subordination, intercreditor, or other similar agreement in form and substance satisfactory to Collateral Agent and the Lenders entered into between Collateral Agent, Borrower, and/or any of its Subsidiaries, and the other creditor), on terms acceptable to Collateral Agent and the Lenders.

 

“Subsidiary” is, with respect to any Person, any Person of which more than fifty percent (50%) of the voting stock or other equity interests (in the case of Persons other than corporations) is owned or controlled, directly or indirectly, by such Person or through one or more intermediaries.

 

“Term Loan” is defined in Section 2.2(a)(ii) hereof.

 

“Term A Loan” is defined in Section 2.2(a)(i) hereof.

 

“Term B Loan” is defined in Section 2.2(a)(i) hereof.

 

34

 

“Term C Loan” is defined in Section 2.2(a)(i) hereof.

 

“Term D Loan” is defined in Section 2.2(a)(ii) hereof.

 

“Term Loan Commitment” is, for any Lender, the obligation of such Lender to make a Term Loan, up to the principal amount shown on Schedule 1.1.  “Term Loan Commitments” means the aggregate amount of such commitments of all Lenders.

 

“Trademarks” means any trademark and servicemark rights, whether registered or not, applications to register and registrations of the same and like protections, and the entire goodwill of the business of Borrower connected with and symbolized by such trademarks.

 

“Transfer” is defined in Section 7.1.

 

“Warrants” are those certain Warrants to Purchase Stock, each substantially in the form attached hereto as Exhibit F, dated as of the Effective Date, or any date thereafter, issued by Borrower in favor of each Lender or such Lender’s Affiliates and those certain Warrants (as defined in the Original Agreement) issued pursuant to the Original Agreement.

 

[Balance of Page Intentionally Left Blank]

 

35

 

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the Effective Date.

 

	
BORROWER:
    	
 
    
	
 
    	
 
    
	
SIENTRA, INC.
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
By
    	
/s/ Hani Zeini
    	
 
    
	
Name:
    	
Hani Zeini
    	
 
    
	
Title:
    	
Founder & CEO
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
COLLATERAL AGENT AND LENDER:
    	
 
    
	
 
    	
 
    
	
OXFORD FINANCE LLC
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
By
    	
/s/   Mark Davis
    	
 
    
	
Name:
    	
Mark Davis
    	
 
    
	
Title:
    	
Vice   President - Finance, Secretary & Treasurer
    	
 
    

 

[Signature page to Loan and Security Agreement]

 

 

SCHEDULE 1.1

 

Lenders and Commitments

 

Original Term Loans*

	
Lender
    	
Term Loan Commitment
    	
Commitment Percentage
    
	
OXFORD FINANCE LLC
    	
$15,000,000
    	
100.00%
    
	
TOTAL
    	
$15,000,000
    	
100.00%
    

 

Term D Loans

	
Lender
    	
Term Loan Commitment
    	
Commitment Percentage
    
	
OXFORD FINANCE LLC
    	
$10,000,000
    	
100.00%
    
	
TOTAL
    	
$10,000,000
    	
100.00%
    

 

Aggregate (all Term Loans)

	
Lender
    	
Term Loan Commitment
    	
Commitment Percentage
    
	
OXFORD FINANCE LLC
    	
$25,000,000
    	
100.00%
    
	
TOTAL
    	
$25,000,000
    	
100.00%
    

 

 

 

* Original Term Loans were made under the Original Agreement on January 17, 2013, August 1, 2013 and December 13, 2013.

 

 

EXHIBIT A

 

Description of Collateral

 

The Collateral consists of all of Borrower’s right, title and interest in and to the following personal property:

 

All goods, Accounts (including health-care receivables), Equipment, Inventory, contract rights or rights to payment of money, leases, license agreements, franchise agreements, General Intangibles (except as noted below), commercial tort claims, documents, instruments (including any promissory notes), chattel paper (whether tangible or electronic), cash, deposit accounts and other Collateral Accounts, all certificates of deposit, fixtures, letters of credit rights (whether or not the letter of credit is evidenced by a writing), securities, and all other investment property, supporting obligations, and financial assets, whether now owned or hereafter acquired, wherever located; and

 

All Borrower’s Books relating to the foregoing, and any and all claims, rights and interests in any of the above and all substitutions for, additions, attachments, accessories, accessions and improvements to and replacements, products, proceeds and insurance proceeds of any or all of the foregoing.

 

Notwithstanding the foregoing, the Collateral does not include (i) any Intellectual Property; provided, however, the Collateral shall include all Accounts and all proceeds of Intellectual Property.  If a judicial authority (including a U.S. Bankruptcy Court) would hold that a security interest in the underlying Intellectual Property is necessary to have a security interest in such Accounts and such property that are proceeds of Intellectual Property, then the Collateral shall automatically, and effective as of the Effective Date, include the Intellectual Property to the extent necessary to permit perfection of Collateral Agent’s security interest in such Accounts and such other property of Debtor that are proceeds of the Intellectual Property; and (ii) more than 65% of the total combined voting power of all classes of stock entitled to vote the shares of capital stock (the “Shares”) of any Foreign Subsidiary, if Debtor demonstrates to Collateral Agent’s reasonable satisfaction that a pledge of more than sixty five percent (65%) of the Shares of such Subsidiary creates a present and existing adverse tax consequence (which include, without limitation, loss of Net Operating Losses) to Debtor under the U.S. Internal Revenue Code; and (iii) any license, lease or contract, in each case if the granting of a Lien in such license or contract is prohibited by or would constitute a default under the agreement governing such license or contract (but (A) only to the extent such prohibition is enforceable under applicable law and (B) other than to the extent that any such term would be rendered ineffective pursuant to Sections 9-406, 9-407, 9-408 or 9-409 (or any other Section) of Division 9 of the Code); provided that upon the termination, lapsing or expiration of any such prohibition, such license or contract, as applicable, shall automatically be subject to the security interest granted in favor of Collateral Agent hereunder and become part of the “Collateral.”

 

Pursuant to the terms of a certain negative pledge arrangement with Collateral Agent and the Lenders, Borrower has agreed not to encumber any of its Intellectual Property.

 

 

EXHIBIT B

 

Form of Disbursement Letter

 

[see attached]

 

 

DISBURSEMENT LETTER

 

[DATE]

 

The undersigned, being the duly elected and acting ____________________ of SIENTRA, INC., a Delaware corporation, with offices located at 6769 Hollister Avenue, Suite 201, Santa Barbara, CA 93117 (“Borrower”), does hereby certify to OXFORD FINANCE LLC (“Oxford” and “Lender”), as collateral agent (the “Collateral Agent”) in connection with that certain Amended and Restated Loan and Security Agreement dated as of June 30, 2014, by and among Borrower, Collateral Agent and the Lenders from time to time party thereto (the “Loan Agreement”; with other capitalized terms used below having the meanings ascribed thereto in the Loan Agreement) that:

 

1.                                      The representations and warranties made by Borrower in Section 5 of the Loan Agreement and in the other Loan Documents are true and correct in all material respects as of the date hereof except to the extent such representations and warranties refer to a specific date.

 

2.                                      No event or condition has occurred that would constitute an Event of Default under the Loan Agreement or any other Loan Document (other than Events of Default that have explicitly been waived by the Collateral Agent and Lenders in writing).

 

3.                                      Borrower is in compliance with the covenants and requirements contained in Sections 4, 6 and 7 of the Loan Agreement.

 

4.                                      All conditions referred to in Section 3 of the Loan Agreement to the making of the Loan requested hereunder have been satisfied or waived by Collateral Agent.

 

5.                                      No Material Adverse Change has occurred.

 

6.                                      The undersigned is a Responsible Officer.

 

[Balance of Page Intentionally Left Blank]

 

 

7.                                      The proceeds of the Term D Loan shall be disbursed as follows:

 

	
Disbursement from   Oxford:
    	
 
    
	
Loan Amount
    	
$                                                                                                          
    
	
Plus:
    	
 
    
	
--Deposit Received
    	
$                                                                                   
    
	
 
    	
 
    
	
Less:
    	
 
    
	
[--Facility Fee
    	
($                                                                             )]
    
	
--Interim Interest
    	
($                                                                           )
    
	
--Lender’s Legal   Fees
    	
($                                                                      )*
    
	
 
    	
 
    
	
Net Proceeds due from   Oxford:
    	
$                                                                                                          
    
	
 
    	
 
    
	
 
    	
 
    
	
TOTAL TERM D LOAN NET PROCEEDS FROM LENDERS
    	
$                                                                                                          
    

 

8.                                      The [Term D Loan] shall amortize in accordance with the Amortization Table attached hereto.

 

9.                                      The aggregate net proceeds of the Term Loans shall be transferred to the Designated Deposit Account as follows:

 

	
Account Name:
    	
SIENTRA, INC.
    
	
 
    	
 
    
	
Bank Name:
    	
Wells Fargo Bank, N.A.
    
	
 
    	
 
    
	
Bank Address:
    	
 
    
	
 
    	
 
    
	
Account Number:                                               
    	
 
    	
 
    
	
 
    	
 
    
	
ABA Number:
    	
 
    

 

[Balance of Page Intentionally Left Blank]

 

* Legal fees and costs are through the Effective Date.  Post-closing legal fees and costs, payable after the Effective Date, to be invoiced and paid post-closing.

 

 

Dated as of the date first set forth above.

 

	
BORROWER:
    	
 
    
	
 
    	
 
    
	
SIENTRA, INC.
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
By
    	
 
    	
 
    
	
Name:
    	
 
    	
 
    
	
Title:
    	
 
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
COLLATERAL AGENT AND   LENDER:
    	
 
    
	
 
    	
 
    
	
OXFORD FINANCE LLC
    	
 
    
	
 
    	
 
    
	
 
    	
 
    
	
By
    	
 
    	
 
    
	
Name:
    	
 
    	
 
    
	
Title:
    	
 
    	
 
    

 

[Signature Page to Disbursement Letter]

 

 

AMORTIZATION TABLE
  (Term D Loan)

 

[see attached]

 

 

EXHIBIT C

 

Compliance Certificate

 

TO:                         OXFORD FINANCE LLC, as Collateral Agent and Lender

 

 

FROM:                  SIENTRA, INC.

 

The undersigned authorized officer (“Officer”) of Sientra, Inc. (“Borrower”), hereby certifies that in accordance with the terms and conditions of the Amended and Restated Loan and Security Agreement by and among Borrower, Collateral Agent, and the Lenders from time to time party thereto (the “Loan Agreement;” capitalized terms used but not otherwise defined herein shall have the meanings given them in the Loan Agreement),

 

(a)           Borrower is in complete compliance for the period ending ______________ with all required covenants except as noted below;

 

(b)           There are no Events of Default, except as noted below;

 

(c)           Except as noted below, all representations and warranties of Borrower stated in the Loan Documents are true and correct in all material respects on this date and for the period described in (a), above; provided, however, that such materiality qualifier shall not be applicable to any representations and warranties that already are qualified or modified by materiality in the text thereof; and provided, further that those representations and warranties expressly referring to a specific date shall be true, accurate and complete in all material respects as of such date.

 

(d)           Borrower, and each of Borrower’s Subsidiaries, has timely filed all required tax returns and reports, Borrower, and each of Borrower’s Subsidiaries, has timely paid all foreign, federal, state, and local taxes, assessments, deposits and contributions owed by Borrower, or Subsidiary, except as otherwise permitted pursuant to the terms of Section 5.8 of the Loan Agreement;

 

(e)           No Liens have been levied or claims made against Borrower or any of its Subsidiaries relating to unpaid employee payroll or benefits of which Borrower has not previously provided written notification to Collateral Agent and the Lenders.

 

Attached are the required documents, if any, supporting our certification(s).  The Officer, on behalf of Borrower, further certifies that the attached financial statements are prepared in accordance with Generally Accepted Accounting Principles (GAAP) and are consistently applied from one period to the next except as explained in an accompanying letter or footnotes and except, in the case of unaudited financial statements, for the absence of footnotes and subject to year-end audit adjustments as to the interim financial statements.

 

Please indicate compliance status since the last Compliance Certificate by circling Yes, No, or N/A under “Complies” column.

 

 

	
 
    	
Reporting Covenant
    	
Requirement
    	
Actual
    	
Complies
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
1)
    	
Financial statements
    	
Monthly within 30 days
    	
 
    	
Yes
    	
No
    	
N/A
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2)
    	
Annual (CPA Audited) statements
    	
Within 120 days after FYE
    	
 
    	
Yes
    	
No
    	
N/A
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
3)
    	
Annual Financial

Projections/Budget (prepared on a monthly   basis)
    	
Annually (within 10 days of FYE), and   when revised
    	
 
    	
Yes
    	
No
    	
N/A
    

 

 

	
4)
    	
A/R & A/P agings
    	
If applicable
    	
 
    	
Yes
    	
No
    	
N/A
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
5)
    	
8-K, 10-K and 10-Q Filings
    	
If applicable, within 5 days of filing
    	
 
    	
Yes
    	
No
    	
N/A
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
6)
    	
Compliance Certificate
    	
Monthly within 30 days
    	
 
    	
Yes
    	
No
    	
N/A
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
7)
    	
IP Report
    	
When required
    	
 
    	
Yes
    	
No
    	
N/A
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
8)
    	
Total amount of Borrower’s cash and   cash equivalents at the last day of the measurement period
    	
 
    	
$                   
    	
Yes
    	
No
    	
N/A
    
	
9)
    	
Total amount of Borrower’s   Subsidiaries’ cash and cash equivalents at the last day of the measurement   period
    	
 
    	
$                   
    	
Yes
    	
No
    	
N/A
    

 

 

Deposit and Securities Accounts
  (Please list all accounts; attach separate sheet if additional space needed)

 

	
 
    	
Institution Name
    	
Account Number
    	
New Account?
    	
Account Control Agreement in place?
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
1)
    	
 
    	
 
    	
Yes
    	
No
    	
Yes
    	
No
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
2)
    	
 
    	
 
    	
Yes
    	
No
    	
Yes
    	
No
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
3)
    	
 
    	
 
    	
Yes
    	
No
    	
Yes
    	
No
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
4)
    	
 
    	
 
    	
Yes
    	
No
    	
Yes
    	
No
    

 

 

 

Other Matters

 

	
1)
    	
Have there been any changes in   management since the last Compliance Certificate?
    	
Yes
    	
No
    
	
 
    	
 
    	
 
    	
 
    
	
2)
    	
Have there been any   transfers/sales/disposals/retirement of Collateral or IP prohibited by the   Loan Agreement?
    	
Yes
    	
No
    
	
 
    	
 
    	
 
    	
 
    
	
3)
    	
Have there been any new or pending   claims or causes of action against Borrower that involve more than One   Hundred Thousand Dollars ($100,000.00)?
    	
Yes
    	
No
    
	
 
    	
 
    	
 
    	
 
    
	
4)
    	
Have there been any amendments of or   other changes to the capitalization table of Borrower and to the Operating   Documents of Borrower or any of its Subsidiaries? If yes, provide copies of   any such amendments or changes with this Compliance Certificate.
    	
Yes
    	
No
    

 

 

Exceptions

 

Please explain any exceptions with respect to the certification above: (If no exceptions exist, state “No exceptions.” Attach separate sheet if additional space needed.)

 

 

	
SIENTRA, INC.
    
	
 
    
	
By
    	
 
    	
 
    
	
Name:
    	
 
    	
 
    
	
Title:
    	
 
    	
 
    

 

 

	
 
    	
LENDER USE ONLY
    
	
 
    	
 
    
	
 
    	
Received by:
    	
 
    	
Date:
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
Verified by:
    	
 
    	
Date:
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
Compliance Status:
    	
Yes
    	
No
    	
 
    	
 
    
							

 

 

EXHIBIT D

 

Form of Secured Promissory Note

 

[see attached]

 

 

SECURED PROMISSORY NOTE
 (Term D Loan)

 

	
$_____________________
    	
Dated: [DATE]
    

 

FOR VALUE RECEIVED, the undersigned, SIENTRA, INC., a Delaware corporation with offices located at 6769 Hollister Avenue Suite 201, Santa Barbara, CA 93117 (“Borrower”) HEREBY PROMISES TO PAY to the order of OXFORD FINANCE LLC (“Lender”) the principal amount of [_______________] MILLION DOLLARS ($______________) or such lesser amount as shall equal the outstanding principal balance of the Term D] Loan made to Borrower by Lender, plus interest on the aggregate unpaid principal amount of such Term D Loan, at the rates and in accordance with the terms of the Amended and Restated Loan and Security Agreement dated June 30, 2014 by and among Borrower, Lender, Oxford Finance LLC, as Collateral Agent, and the other Lenders from time to time party thereto (as amended, restated, supplemented or otherwise modified from time to time, the “Loan Agreement”).  If not sooner paid, the entire principal amount and all accrued and unpaid interest hereunder shall be due and payable on the Maturity Date as set forth in the Loan Agreement.  Any capitalized term not otherwise defined herein shall have the meaning attributed to such term in the Loan Agreement.

 

Principal, interest and all other amounts due with respect to the Term D Loan, are payable in lawful money of the United States of America to Lender as set forth in the Loan Agreement and this Secured Promissory Note (this “Note”).  The principal amount of this Note and the interest rate applicable thereto, and all payments made with respect thereto, shall be recorded by Lender and, prior to any transfer hereof, endorsed on the grid attached hereto which is part of this Note.

 

The Loan Agreement, among other things, (a) provides for the making of a secured Term D Loan by Lender to Borrower, and (b) contains provisions for acceleration of the maturity hereof upon the happening of certain stated events.

 

This Note may not be prepaid except as set forth in Section 2.2 (c) and Section 2.2(d) of the Loan Agreement.

 

This Note and the obligation of Borrower to repay the unpaid principal amount of the Term D Loan, interest on the Term D Loan and all other amounts due Lender under the Loan Agreement is secured under the Loan Agreement.

 

Presentment for payment, demand, notice of protest and all other demands and notices of any kind in connection with the execution, delivery, performance and enforcement of this Note are hereby waived.

 

Borrower shall pay all reasonable fees and expenses, including, without limitation, reasonable attorneys’ fees and costs, incurred by Lender in the enforcement or attempt to enforce any of Borrower’s obligations hereunder not performed when due.

 

This Note shall be governed by, and construed and interpreted in accordance with, the internal laws of the State of California.

 

The ownership of an interest in this Note shall be registered on a record of ownership maintained by Lender or its agent.  Notwithstanding anything else in this Note to the contrary, the right to the principal of, and stated interest on, this Note may be transferred only if the transfer is registered on such record of ownership and the transferee is identified as the owner of an interest in the obligation.  Borrower shall be entitled to treat the registered holder of this Note (as recorded on such record of ownership) as the owner in fact thereof for all purposes and shall not be bound to recognize any equitable or other claim to or interest in this Note on the part of any other person or entity.

 

[Balance of Page Intentionally Left Blank]

 

 

IN WITNESS WHEREOF, Borrower has caused this Note to be duly executed by one of its officers thereunto duly authorized on the date hereof.

 

	
 
    	
BORROWER:
    
	
 
    	
 
    
	
 
    	
SIENTRA, INC.
    
	
 
    	
 
    
	
 
    	
 
    
	
 
    	
By
    	
 
    
	
 
    	
Name:
    	
 
    
	
 
    	
Title:
    	
 
    

 

 

LOAN INTEREST RATE AND PAYMENTS OF PRINCIPAL

 

	
Date
    	
 
    	
Principal
   Amount
    	
 
    	
Interest Rate
    	
 
    	
Scheduled
   Payment Amount
    	
 
    	
Notation By
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    

 

 

CORPORATE BORROWING CERTIFICATE

 

	
BORROWER:
    	
SIENTRA, INC.
    	
DATE: [DATE]
    
	
LENDER:
    	
OXFORD FINANCE LLC, as Collateral Agent and   Lender
    	
 
    

 

 

I hereby certify as follows, as of the date set forth above:

 

1.                                      I am the Secretary, Assistant Secretary or other officer of Borrower.  My title is as set forth below.

 

2.                                      Borrower’s exact legal name is set forth above.  Borrower is a Delaware corporation existing under the laws of the State of Delaware.

 

3.                                      Attached hereto as Exhibit A and Exhibit B, respectively, are true, correct and complete copies of (i) Borrower’s Articles/Certificate of Incorporation (including amendments), as filed with the Secretary of State of the state in which Borrower is incorporated as set forth in paragraph 2 above; and (ii) Borrower’s Bylaws.  Neither such Articles/Certificate of Incorporation nor such Bylaws have been amended, annulled, rescinded, revoked or supplemented, and such Articles/Certificate of Incorporation and such Bylaws remain in full force and effect as of the date hereof.

 

4.                                      The following resolutions were duly and validly adopted by Borrower’s Board of Directors at a duly held meeting of such directors (or pursuant to a unanimous written consent or other authorized corporate action).  Such resolutions are in full force and effect as of the date hereof and have not been in any way modified, repealed, rescinded, amended or revoked, and the Lenders may rely on them until each Lender receives written notice of revocation from Borrower.

 

[Balance of Page Intentionally Left Blank]

 

 

RESOLVED, that any one of the following officers or employees of Borrower, whose names, titles and signatures are below, may act on behalf of Borrower:

 

 

	
Name
    	
 
    	
Title
    	
 
    	
Signature
    	
 
    	
Authorized to
   Add or Remove
    Signatories
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
o
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    	
o
    

 

RESOLVED FURTHER, that any one of the persons designated above with a checked box beside his or her name may, from time to time, add or remove any individuals to and from the above list of persons authorized to act on behalf of Borrower.

 

RESOLVED FURTHER, that such individuals may, on behalf of Borrower:

 

Borrow Money.  Borrow money from the Lenders.

Execute Loan Documents.  Execute any loan documents any Lender requires.

Grant Security.  Grant Collateral Agent a security interest in any of Borrower’s assets.

Negotiate Items.  Negotiate or discount all drafts, trade acceptances, promissory notes, or other indebtedness in which Borrower has an interest and receive cash or otherwise use the proceeds.  Issue Warrants.  Issue warrants for Borrower’s capital stock.

Further Acts.  Designate other individuals to request advances, pay fees and costs and execute other documents or agreements (including documents or agreement that waive Borrower’s right to a jury trial) they believe to be necessary to effectuate such resolutions.

 

RESOLVED FURTHER, that all acts authorized by the above resolutions and any prior acts relating thereto are ratified.

 

[Balance of Page Intentionally Left Blank]

 

 

5.                                      The persons listed above are Borrower’s officers or employees with their titles and signatures shown next to their names.

 

	
 
    	
By:
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
Name:
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
Title:
    	
 
    

 

*** If the Secretary, Assistant Secretary or other certifying officer executing above is designated by the resolutions set forth in paragraph 4 as one of the authorized signing officers, this Certificate must also be signed by a second authorized officer or director of Borrower.

 

I, the _________________________ of Borrower, hereby certify as to paragraphs 1 through 5 above, as

[print title]

of the date set forth above.

 

	
 
    	
By:
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
Name:
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
Title:
    	
 
    

 

[Signature Page to Corporate Borrowing Certificate]

 

 

 

EXHIBIT A

 

Articles/Certificate of Incorporation (including amendments)

 

[see attached]

 

 

EXHIBIT B

 

Bylaws

 

[see attached]

 

 

	
DEBTOR:
    	
SCIENTRA, INC.
    
	
SECURED PARTY:
    	
OXFORD FINANCE LLC,
    
	
 
    	
as Collateral Agent
    

 

EXHIBIT A TO UCC FINANCING STATEMENT

 

Description of Collateral

 

The Collateral consists of all of Debtor’s right, title and interest in and to the following personal property:

 

All goods, Accounts (including health-care receivables), Equipment, Inventory, contract rights or rights to payment of money, leases, license agreements, franchise agreements, General Intangibles (except as noted below), commercial tort claims, documents, instruments (including any promissory notes), chattel paper (whether tangible or electronic), cash, deposit accounts and other Collateral Accounts, all certificates of deposit, fixtures, letters of credit rights (whether or not the letter of credit is evidenced by a writing), securities, and all other investment property, supporting obligations, and financial assets, whether now owned or hereafter acquired, wherever located; and

 

All Debtor’s Books relating to the foregoing, and any and all claims, rights and interests in any of the above and all substitutions for, additions, attachments, accessories, accessions and improvements to and replacements, products, proceeds and insurance proceeds of any or all of the foregoing.

 

Notwithstanding the foregoing, the Collateral does not include (i) any Intellectual Property; provided, however, the Collateral shall include all Accounts and all proceeds of Intellectual Property.  If a judicial authority (including a U.S. Bankruptcy Court) would hold that a security interest in the underlying Intellectual Property is necessary to have a security interest in such Accounts and such property that are proceeds of Intellectual Property, then the Collateral shall automatically, and effective as of the Effective Date, include the Intellectual Property to the extent necessary to permit perfection of Collateral Agent’s security interest in such Accounts and such other property of Debtor that are proceeds of the Intellectual Property; and (ii) more than 65% of the total combined voting power of all classes of stock entitled to vote the shares of capital stock (the “Shares”) of any Foreign Subsidiary, if Debtor demonstrates to Collateral Agent’s reasonable satisfaction that a pledge of more than sixty five percent (65%) of the Shares of such Subsidiary creates a present and existing adverse tax consequence (which include, without limitation, loss of Net Operating Losses) to Debtor under the U.S. Internal Revenue Code; and (iii) any license, lease or contract, in each case if the granting of a Lien in such license or contract is prohibited by or would constitute a default under the agreement governing such license or contract (but (A) only to the extent such prohibition is enforceable under applicable law and (B) other than to the extent that any such term would be rendered ineffective pursuant to Sections 9-406, 9-407, 9-408 or 9-409 (or any other Section) of Division 9 of the Code); provided that upon the termination, lapsing or expiration of any such prohibition, such license or contract, as applicable, shall automatically be subject to the security interest granted in favor of Collateral Agent hereunder and become part of the “Collateral.”

 

Pursuant to the terms of a certain negative pledge arrangement with Collateral Agent and the Lenders, Debtor has agreed not to encumber any of its Intellectual Property.

 

Capitalized terms used but not defined herein have the meanings ascribed in the Uniform Commercial Code in effect in the State of California as in effect from time to time (the “Code”) or, if not defined in the Code, then in the Amended and Restated Loan and Security Agreement by and between Debtor, Secured Party and the other Lenders party thereto (as modified, amended and/or restated from time to time).

 

 

EXHIBIT E

Annual Projections

 

Please see attached

 

 

EXHIBIT F

Warrant

 

Please see attachedExhibit 10.8

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Section 200.80(b)(4) and Rule 406 of the

Securities Act of 1933, as amended.

 

AMENDED AND RESTATED EXCLUSIVITY AGREEMENT

 

This Amended and Restated Exclusivity Agreement (Agreement) is entered into as of the Effective Date (defined below) by and between Silimed-Silicone e Instrumental Medico-Cirugico e Hospitalar LTDA, a company organized under the laws of Brazil on behalf of itself and any affiliated, controlled or otherwise related entity or person including, without limitation, any entity controlled or owned at least in part by the officers and partners (stockholders) of Silimed-Silicone e Instrumental Medico-Cirurgico e Hospitalar Ltda. (collectively, (Manufacturer) and Juliet Medical, Inc., a Delaware corporation (Company) as of the Effective Date.

 

Background

 

Manufacturer manufactures and sells, among other things, various silicone based medical devices, sterile or non-sterile, including but not limited to custom and/or non-custom implantable devices for physicians. Manufacturer and Silimed, Inc., a Texas corporation that is selling its assets, including certain contractual rights to Company pursuant to the Asset Purchase Agreement (as defined below) are parties to an Exclusive Agreement dated December 1, 1997 (the 1997 Agreement) granting Company the right to distribute and sell the Products (as defined below) in the United States. Pursuant to the 1997 Agreement, Company filed for regulatory approval of certain silicone and saline breast implant devices in the United States and is performing clinical trials for such silicone breast implants. Company is also selling tissue expanders, facial implants, testicular implants and other devices pursuant to 510k approvals. Manufacturer and Company desire to amend and restate the 1997 Agreement to reflect the change in circumstances as Company approaches commercial release of the silicone breast implant devices in the United States.

 

NOW, THEREFORE, in consideration of the premises and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Manufacturer and Company agree to amend and restate the 1997 Agreement to read in full as follows:

 

1.                                      DEFINITIONS

 

1.1                               Definitions. Capitalized terms used in this Agreement and not otherwise defined herein shall have the meaning set forth below.

 

Affiliate means with respect to either party, any Person that, directly or indirectly, is controlled by, controls or is under common control with such party. For purposes of this definition, “control” means, with respect to any Person, the direct or indirect ownership of more than fifty percent (50%) of the voting interest in such Person or the possession otherwise, directly or indirectly, of the power to direct the management or policies of such Person.

 

Company IP means individually and collectively all IP Rights (a) owned by Company prior to December 1, 1997 or (b) acquired by Company from another Person at any time during the term of this Agreement or (c) conceived, authored, created or otherwise developed by or on behalf of Company on or after December 1, 1997 in each case to the extent that they relate to the Products or the Product Specifications (including processes and know-how for the manufacture thereof).

 

Confidential Information means all data, specifications, training and any other trade secrets or know-how related to the design, implementation, performance or manufacture of the Products, as well as all other information and data provided by either party to the other party pursuant to this Agreement in written or other tangible medium and marked as confidential except any portion thereof which: (i) is known to the receiving party, as evidenced by the receiving party’s written records, before receipt thereof under this Agreement; (ii) is disclosed to the receiving party by a third person who is under no obligation of confidentiality to the disclosing party hereunder with respect to such information and who otherwise has a right to make such disclosure; (iii) is or becomes generally known in the trade through no fault of the receiving party; or (iv) is independently developed by the receiving party, as evidenced by the receiving party’s written records, without access to such information.

 

Control means, with respect to any IP Rights, possession by a party or its Affiliates of the ability (whether by ownership, license, or otherwise) to grant access, a license, or a sublicense to such IP Rights without violating the 

 

1

 

terms of any agreement or other arrangement with any third party as of the time such party would first be required hereunder to grant the other party such access, license, or sublicense.

 

Effective Date means the “Closing Date” under the certain Asset Purchase Agreement between Silimed, Inc., a Texas corporation, and Company (the Asset Purchase Agreement), which is the date on which Company will purchase from Silimed Inc. certain assets of Silimed, Inc. as described in the Asset Purchase Agreement. The Effective Date shall in no event be later than April 6, 2007.

 

Facility means Manufacturer’s manufacturing facility in Rio de Janeiro, Brazil.

 

FCA means “Free Carrier”, as that expression is defined in Incoterms 2000, ICC Publishing S.A.

 

Force Majeure means any event beyond the control of the parties, including, without limitation, fire, flood, riots, strikes, epidemics, acts of war or terrorism (declared or undeclared and including the continuance, expansion or new outbreak of any war, conflict or terrorism now in existence), embargoes and governmental actions or decrees.

 

Improvements means individually and collectively all discoveries, inventions, know-how, techniques, methodologies, modifications, improvements, works of authorship, designs and data (whether or not protectable under patent, copyright, trade secrecy or similar laws) relating to additions, developments, enhancements, updates and other changes in Products, including but not limited to any extensions of the label claims for any Product(s) and any new designs for the Product(s) that are conceived, created, discovered, developed, or reduced to practice or tangible medium of expression: (a) solely by one or more employees or consultants of Manufacturer at any time in the course of performing the transactions contemplated by this Agreement; or (b) jointly by one or more employees or consultants of Manufacturer and one or more employees or consultants of Company at any time in the course of performing the transactions contemplated by this Agreement; or (c) solely by one or more employees or consultants of Company at any time in the course of performing the transactions contemplated by this Agreement.

 

IP Rights means any and all of the following in any jurisdiction throughout the world: (a) inventions and patents and patent applications for same; (b) copyrights and registrations and applications for same; (c) trademarks, trade names, domain names and other indicia of source or origin; (d) software; (e) Confidential Information, including trade secrets and know-how; and (f) all other intellectual property rights or industrial property rights of any kind or nature (whether or not protectable under patent, copyright, trade secrecy or similar laws) that are conceived, discovered, developed, created or reduced to practice or tangible medium of expression by consultants or employees of a party to this Agreement (or by Silimed, Inc. in the case of Juliet Medical, Inc. as a party) without the use of IP Rights owned or Controlled by the other party to this Agreement (or by Silimed Inc. in the case of Juliet Medical, Inc. as a party) or are otherwise Controlled by such party (or by Silimed Inc. in the case of Juliet Medical, Inc. as a party).

 

Manufacturer IP means all (a) IP Rights owned by Manufacturer prior to December 1, 1997, (b) IP Rights acquired by Manufacturer from another Person, and (c) IP Rights conceived, authored, created or otherwise developed by or on behalf of Manufacturer at any time in each case to the extent that they relate to the Products or the Product Specifications (including processes and know-how for the manufacture thereof).

 

Person means any individual, corporation, association, partnership (general or limited), joint venture, trust, estate, limited liability company, limited liability partnership, unincorporated organization, government (or any agency or political subdivision thereof) or other legal entity or organization.

 

Products means all products for all medical applications which are now or which may hereafter become a part of the Manufacturer’s line of products falling within the scope of the Patents (to the extent Manufacturer has a Patent) all as further described in the applicable Product Specifications, including the silicone breast implants, saline breast implants, polyurethane breast implants, tissue expanders, testicular implants, body contouring implants, facial implants (including maxofacial implants and nostril retainers), urology products (including constrictors and vaginal stents), gastric balloon products and gastric band products identified in Attachment 1 together with any Improvements. Attachment 1 may be amended from time to time in accordance with Section 2.1(b) to add additional products or Improvements to Products as they become part of Manufacturer’s line of products.

 

2

 

Product Approvals means, for the United States, those regulatory approvals required for importation, promotion, pricing, marketing and sale of the Product in such country.

 

Product Specifications means the specifications set forth in Attachment 1 for the Products, as such specifications may be modified from time to time by the mutual agreement of the parties acting in accordance with Section 3.11 to reflect (i) the Product Approvals that issue with respect to the Products or (ii) Improvements and the addition of new products to Manufacturer’s product line.

 

Territory means the United States of America (including its territories).

 

Trademarks means (a) the trademarks, set forth on Attachment 3, and (b) any other trademarks, as may be agreed upon in writing from time to time by the parties for use by Company in connection with the promotion, marketing and sale of the Products in the Territory.

 

1.2                               Other Defined Terms. Each of the following terms has the meanings ascribed to it in the section set forth opposite such term:

 

	
1997 Agreement
    	
Recitals
    
	
AER
    	
Section 5.4
    
	
Agreement
    	
Recitals
    
	
Applicable GMP
    	
Section 5.2
    
	
Company
    	
Recitals
    
	
Excused Supply Failure
    	
Section 3.3
    
	
Firm Order Period
    	
Section 3.1
    
	
ICDR
    	
Section 9.4
    
	
Indemnified Party
    	
Section 7.2
    
	
Indemnifying Party
    	
Section 7.2
    
	
Losses
    	
Section 7.2
    
	
Manufacturer
    	
Recitals
    
	
Regulatory Authority
    	
Section 5.2
    
	
Representative
    	
Section 9.1
    
	
RMA
    	
Section 3.10
    
	
SOPs
    	
Section 5.4
    
	
Supply Forecast
    	
Section 3.1.
    

 

2.                                      DISTRIBUTION RIGHTS; VALIDATION

 

2.1                               Appointment.  (a) Subject to terms and conditions of this Agreement: Manufacturer hereby appoints Company as Manufacturer’s exclusive distributor for the promotion, sale and delivery of the Products in the Territory. Company hereby accepts such appointment as exclusive distributor within the Territory. Company shall use its commercially reasonable efforts to promote and sell the Products in the Territory, subject to delays caused by Regulatory Authorities with respect to the issuance of Product Approvals and to adequate supply of the Products for resale in the Territory.

 

(b)                                 The Manufacturer shall promptly notify Company of any Improvements to Products and of any new products that become part of the Manufacturer’s line of products, and Manufacturer shall provide Company with such notice, the Products Specifications for such Improvements to Products or new products and the pricing for such new products (such pricing to be determined in accordance with Section 3.4). Such Improvements to Products and new products shall automatically become Products subject to this Agreement in accordance with Section 3.11.

 

2.2                               Exclusive Dealing.  (a) Manufacturer shall not provide Products to any third party if Manufacturer knows or has reason to believe that Products provided to such party have been or will be sold for use or used in the Territory. Company shall not provide Products to any third party if Company knows or has reason to believe that Products provided to such third party have been or will be sold for use, or used, outside of the Territory.

 

3

 

(b)                                 Notwithstanding the provisions of Section 2.1 and Section 2.2(a), it is understood and agreed that Manufacturer is party to a supply agreement with [...***...] for the distribution of Manufacturer’s [...***...] product marketed as [...***...] applications. This Agreement shall in no way limit or otherwise affect such supply agreement with respect to such [...***...] product.

 

(c)                                  Except as otherwise provided in Section 2.2(b), Manufacturer shall notify Company if it receives any request to supply Products to any customer located in or for sale, use or distribution in the Territory. It is understood and agreed that it shall not be a breach of this Agreement for Manufacturer to have contact with such customers or customers located in the Territory; provided Manufacturer does not directly or indirectly sell, offer to sell, market, distribute, ship or deliver Products to customers located in the Territory.

 

(d)                                 Company shall notify Manufacturer if it receives any request to supply Products to any customer for sale, use or distribution outside the Territory.

 

2.3                               Competitive Products. During the term of this Agreement, Company shall not, and shall cause its Affiliates not to, market, sell or otherwise distribute in the Territory any product that is directly competitive with any Product that is then being commercially sold or clinically tested by Company in the Territory. It is understood and agreed that a product is “directly competitive with a Product” if it has an elastomer made of silicone and a filler made of either silicone or saline.

 

2.4                               2.3A                      Production Line Validation. Manufacturer hereby represents and warrants to Company that Manufacturer has successfully validated all production line(s) at the Facility upon which Products are produced in accordance with all quality system regulations promulgated under the Applicable GMP.

 

2.5                               Annual Meetings.  (a) No later than ninety (90) days prior to each anniversary of the Effective Date, the parties shall meet, in person or by videoconference or teleconference, to confer regarding (i) the Company’s expectations with respect to Product development and commercialization in the next contract year so that the Manufacturer may consider any changes in the resource allocation required to address such expected demand for Products; and (ii) the Manufacturer’s expectations with respect to pricing for each Product for the next contract year so that the Company may consider its cost structure with respect to the next contract year. The purpose of such meetings is to serve as a venue for the parties to provide timely notice of their respective expectations for the next contract year as well as trends and developments they foresee in order to reduce the likelihood of surprises with respect to either Company’s demand for Products or Manufacturer’s pricing for Products. If meetings are held in person they shall be held at either the headquarters of Manufacturer or the headquarters of the Company on an alternating basis, unless the parties mutually agree to hold such meeting in an alternative venue. The party hosting the meeting shall be responsible for providing an agenda for each meeting at least seven (7) days in advance of such meeting and shall prepare written draft minutes of all meetings in reasonable detail and distribute such draft minutes to the other party for comment and review within seven (7) days after the relevant meeting. The party receiving such minutes shall have seven (7) days to provide comments. The party preparing the minutes shall incorporate timely received comments and distribute finalized minutes within thirty (30) days following the relevant meeting.

 

(b)                                 The parties shall review and approve on a timely basis, but in any case, within thirty (30) days following receipt of finalized minutes, the expected forecasts for Products and the proposed pricing for Products for the next contract year. In the event that the Manufacturer does not approve the Company’s expected forecast for Products or the Company does not approve the Manufacturer’s proposed pricing for any Product(s) as presented at the meeting, then such party shall provide the other party with a detailed statement describing the basis of its concerns and the parties shall in good faith seek to resolve such matter prior to the commencement of the next contract year in accordance with the provisions of this Agreement, including Sections 3.1, 3.3 and 3.4.

 

3.                                      PURCHASE OF PRODUCTS AND TERMS OF SALE.

 

3.1                               Purchase Forecasts. During the term of this Agreement, Company shall provide to Manufacturer, on a quarterly basis, a non-binding rolling forecast of orders of each of the Products with respect to the next twelve (12) months (Supply Forecast). Notwithstanding the foregoing, the forecasts for [...***...] of any 12 month period (Firm Order Period) covered by a Supply Forecast shall represent binding purchase obligations of

 

***Confidential Treatment Requested

 

4

 

Company to purchase all the Products set forth in the Supply Forecast for such Firm Order Period; provided, that (a) the forecast for [...***...] of the Supply Forecast covering the period immediately following receipt of a Product Approval for the United States for a particular Product shall be considered part of the Firm Order Period for such Product and) shall represent a binding purchase obligation of Company to purchase all such Product for such Firm Order Period and (b) the forecast for all “custom” Products shall represent a binding purchase obligation of Company to purchase such “custom” Product.

 

3.2                               Product Orders.  (a) Orders for each Firm Order Period shall be placed by written purchase order and submitted by mail, electronic mail or facsimile, or by other means agreed upon by the parties. No order shall be binding upon Manufacturer until the same shall have been accepted in writing by Manufacturer (including acceptance by EDI). Manufacturer shall accept or reject all orders within five (5) days following receipt of same and shall deliver all orders that are accepted within ninety (90) days following the date such order is received. The parties covenant and agree that any standard printed terms of purchase/sale of Company and Manufacturer provided by either party to the other party shall be disregarded and that the provisions of this Agreement shall govern such purchase and sale.

 

(b)                                 Company shall use [...***...] efforts to maximize sales of Products during the term of this Agreement.

 

3.3                               Obligation to Supply. (a) Manufacturer shall use [...***...] efforts to accept and fill each order for Products submitted by Company; including orders that exceed the Supply Forecast for any month by up to [...***...] percent ([...***...]%) of the amount in the Supply Forecast for such month delivered to Manufacturer ninety (90) days prior to such month. When allocating production with respect to filling orders for Products, Manufacturer shall ensure that Company orders are accepted and filled in a manner that does not differ in any material respect from the priority and fill rate Manufacturer applies to Products ordered by third parties or Manufacturer’s own sales organization; provided, however, the foregoing provision shall not apply to accepting or filling orders that exceed the Supply Forecast. Notwithstanding the foregoing, Manufacturer shall not be in breach of this Section 3.3 if Manufacturer’s failure to supply Products is due to a Force Majeure event or if Manufacturer’s failure is limited to quantities in excess of the quantities specified in this Section 3.3 (any such failure an Excused Supply Failure).

 

(b)                                 If Manufacturer is unable to supply any Product(s) ordered by Company in accordance with the terms of this Agreement other than because of an Excused Supply Failure, then Manufacturer shall use [...***...] efforts to remedy the problem, including by securing an alternative source of supply within a reasonable time at no cost to Company, and any such alternative source of supply shall be on terms substantially identical with the terms of this Agreement. If Manufacturer is unable to remedy such problem within [...***...] after its initial failure to supply (measured from the date that delivery would have been due under Company’s binding Supply Forecast), then Manufacturer shall consult with Company and the parties shall work together to remedy the problem, which may include having Manufacturer reactivate its old manufacturing facility. If Manufacturer is unable to remedy the supply problem after an aggregate period of [...***...]  (or longer as agreed in writing by the parties), commencing with the date upon which such failure to supply began, then Company may at its option, and upon notice to Manufacturer, remedy the supply problem by manufacturing the applicable Product(s) itself or through an alternative source of supply (which shall not be deemed a violation by Company of Section 2.3) using the procedure specified in Section 3.3A or in the alternative, terminate this Agreement with respect to such Product(s) pursuant to Section 8.2 (last sentence).

 

(c)                                  In the event that, for any material period of time (i.e., any period of time that may interrupt Manufacturer’s ability to supply then Products that are the subject of the then most recent Supply Forecast), the Manufacturer Facility or the Manufacturer production line becomes non-operational for any reason whatsoever, Manufacturer will promptly notify Company, and Manufacturer will ensure that the production line for the affected Products is restored and revalidated at the same rate and in a manner that does not differ in any material respect from the priority and restoration rate of any other production line(s) at the Facility.

 

3.3A                      Manufacturing Rights.  (a) If Company notifies Manufacturer that Company will manufacture any Product(s) itself or through a third party as a result of a failure to supply by Manufacturer, Manufacturer shall (i) deliver to Company within thirty (30) days media embodying or disclosing all technology and proprietary or intellectual property rights necessary to enable Company or its designee to manufacture such Product(s) conforming with the applicable Product Specifications; and (ii) provide Company or its designee, upon request, with assistance

 

 

***Confidential Treatment Requested

 

5

 

in establishing a back-up manufacturing line. [...***...] Company shall require any third party Company designates to manufacture Products pursuant to this Section 3.3A, to agree in writing to observe the terms of this Agreement relating to confidentiality and the manufacture of Products.

 

(b)                                 It is understood and agreed that in no case shall [...***...] pursuant to this Section 3.3A.

 

(c)                                  Company may continue to exercise the manufacturing rights provided in this Section 3.3A until Manufacturer notifies Company that it is again able to supply Company’s needs for the applicable Product(s) and substantiates such claim to Company’s reasonable satisfaction. Upon such a showing, Company shall commence purchasing such Product(s) from Manufacturer and Company’s rights under this Section 3.3A shall terminate (with respect to such interruption in supply), provided that: (i) Company shall not be required to cancel any then outstanding purchase orders with any third party operating a back-up manufacturing line established pursuant to this Section 3.3A to the extent such orders have been accepted by such third party and are binding obligations of Company; and (ii) Manufacturer shall pay all cancellation costs incurred by Company in switching its purchases from such third party to Manufacturer. Company shall use commercially reasonable efforts to avoid significant cancellation fees in any third party contracts it enters pursuant to this Section 3.3A. Company shall not order Products from any third party operating a back-up manufacturing line established pursuant to this Section 3.3A for delivery more than [...***...] months following the date of such order.

 

3.4                               Product Prices.  (a) The prices for each of the Products are set forth on Attachment 2.

 

(b)                                 Except as otherwise agreed by the parties or as provided in this Section 3.4, Manufacturer will not increase prices for the Products. Not more than once annually, Manufacturer may increase the prices for the Products to reflect (i) increases in the cost of raw materials, or (ii) increases in the costs of production components utilized in the manufacture of such Products including utilities, packaging materials and labor utilized in such manufacturing plus a pro rata portion of factory overhead costs allocated to the Products purchased by Company pursuant to this Agreement in accordance with normal accounting practices for all products manufactured in the Facility. Price increases shall not include any costs attributable to idle plant capacity (that Manufacturer or any third party may have) or general corporate activities that are not primarily associated with the manufacture of Products, including, by way of example only, salaries and benefits of executive management, administrative support for such management, and all costs of the finance, purchasing, legal, business development and corporate development functions of Manufacturer or overhead (other than Facility overhead for the portions of the Facility used for manufacturing Products). Without limiting the foregoing, Manufacturer will use commercially reasonable efforts to maintain price increases to an amount that does not exceed [...***...] percent ([...***...] %) per annum and shall include with any notice of a price increase documentation of such production cost increases. Company shall have the right, not more than once in any twelve (12) month period, upon reasonable notice to have an independent certified public accountant, selected by Company and reasonably acceptable to Manufacturer, inspect Manufacturer’s books and records for purposes of verifying Manufacturer’s actual production costs for the Products. Manufacturer shall make all applicable books and records available for such inspection during normal business hours at Manufacturer’s facility. Any such audit shall be at the expense of Company, unless such audit discloses that Manufacturer’s reported average production costs for the audited period are less than Manufacturer’s actual production costs for such period by more than [...***...] percent ([...***...]%), in which case Manufacturer shall reimburse Company for such expenses. If any audit discloses that Manufacturer’s actual production cost for a Product is less than the reported production cost, Manufacturer shall promptly make payment to Company of an amount equal to the product of [...***...].

 

(c)                                  Company shall not be required to pay any royalty to Manufacturer for its sale of Product supplied by Manufacturer pursuant to this Agreement.

 

3.5                               Intentionally Omitted.

 

 

***Confidential Treatment Requested

 

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3.6                               Resale Prices. Nothing contained herein shall be deemed to limit in any way the right of Company to determine the prices at which, or the terms on which, the Products purchased by Company may be resold by Company.

 

3.7                               Payment. (a) Company shall pay for Products within thirty (30) days after the date of Manufacturer’s invoice. All payments shall be stated and paid in U.S. Dollars. Except for income taxes that may be assessed against Manufacturer, all taxes and charges that may be imposed by any government taxing authority on the amounts paid by Company to Manufacturer under this Agreement shall be paid by Company for Manufacturer’s account.

 

(b)                                 In the event Company fails to make any payment hereunder in full when due that is not disputed in good faith, the amount due shall accrue interest beginning on the [...***...] day following the final date on which such payment was due, calculated at the annual rate equal to [...***...] ([...***...]%) above the prime interest rate reported in the Wall Street Journal for the due date, calculated from the due date until paid in full. Such payment when made shall be accompanied by all interest so accrued. Said interest and the payment and acceptance thereof shall not negate or waive the right of Manufacturer to any other remedy, legal or equitable, to which it may be entitled because of the delinquency of the payment. In the event Company disputes any payment it shall notify Company in accordance with Section 9.2 and shall pay all undisputed sums in accordance with this Agreement.

 

(c)                                  Intentionally omitted.

 

(d)                                 Nothing in this Section 3.7 shall waive any other rights and remedies Manufacturer may have under law or this Agreement, and all such rights and remedies set forth herein shall be considered cumulative with all other available rights and remedies.

 

3.8                               Shipping.  (a) Manufacturer shall arrange for shipment (according to Company directions) and invoicing to Company of the Products ordered by Company via common carrier (air freight), FCA Rio de Janeiro, Brazil to the carrier selected by Company. Company shall pay all customs, duties and other governmental charges, if any, related to importation and sale of the Product in the Territory following such FCA delivery, and shall have all responsibility for storing and clearing the Products through all United States customs and importation requirements. Manufacturer shall be responsible for clearing the products for export from Brazil.

 

(b)                                 Manufacturer will supply Products to Company in finished and final packaged format for end user sale, (including all trade dress, labeling and warning and handling instructions) as documented in the applicable packaging specifications for each Product. The parties shall adopt such packaging specifications for each Product not later than six (6) months prior to the anticipated date of commercial launch for the applicable Product in the Territory and such packaging specifications shall be appended to this Agreement as Attachment 4.

 

3.9                               Product Samples.  (a) Manufacturer shall provide Company, promptly upon request, with a reasonable number samples of the Products of any current production run, not to exceed [...***...] percent ([...***...]%) of such production run, for testing purposes. Such Product samples shall be shipped to Company in accordance with the provisions set forth in Section 3.8, and Company shall pay the price for such Products in the manner described in Section 3.7.

 

(b)                                 Manufacturer shall also make available to Company, at Company’s expense and upon Company’s request, for regulatory approval purposes, sample Products in accordance with the applicable Product Specifications. In addition, Manufacturer shall supply Company, at no charge, with a mutually agreed number of units of each of the Products for demonstration and marketing purposes and will supply additional units at cost.

 

3.10                        Acceptance.  (a) Company shall notify Manufacturer within thirty (30) days of the receipt of a shipment of the Products (or for shipments delivered to Company’s customer within thirty (30) days following the receipt of the samples for such shipment requested by Company in accordance with Section 3.9(a)) of any apparent non-conformity of the Product to the applicable Product Specifications. If Company fails to so notify Manufacturer, it will be deemed to have accepted the Product; provided that the warranty provided in Section 6.2 and Manufacturer’s obligations under Section 7.2 shall survive acceptance of the Product by Company.

 

 

***Confidential Treatment Requested

 

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(b)           Manufacturer shall perform all in-process and finished product tests or checks required by the applicable Product Specifications and Applicable GMP. For purposes of this Agreement, such tests shall be considered routine and shall be performed at Manufacturer’s expense; provided that in the event that Company requests any tests in addition to the foregoing, Company shall compensate Manufacturer for the cost of such additional tests in accordance with a method to be mutually determined. All tests and test results shall be performed, documented and summarized by Manufacturer in accordance with the applicable Product Specifications and applicable laws, rules and regulations. Manufacturer shall immediately notify Company of any significant out-of-specification analytical results for either in process or finished Product test results.

 

(c)           Company shall not be required to pay Manufacturer for any Products which have been properly rejected for failure to comply with Product Specifications. Manufacturer shall at its expense and at no further cost to Company replace any Products that do not conform to the Product Specifications. All defective units of the Product shall be returned to Manufacturer or its designee if requested by Manufacturer and at Manufacturer’s cost; upon Manufacturer’s request, Company will hold such Products at its premises for inspection by Manufacturer or its designee. Company shall notify Manufacturer in writing of its rejection of Product under this Section 3.10 within thirty (30) days of Company’s receipt thereof, shall request a Return Material Authorization (RMA) number and shall within thirty (30) days of receipt of such RMA number return a sample of such rejected Product to Manufacturer or its designee freight prepaid and properly insured, along with a reasonably detailed statement of the claimed defect and proof of date of purchase unless Manufacturer requests Company to hold such Products at its premises for inspection by Manufacturer or its designee. In the event Manufacturer determines that the returned (or held) Product is defective and properly rejected by Company, Manufacturer shall replace such defective Product (and shall provide Company with an RMA for the balance of the defective lot of Product which shall be returned to Manufacturer freight prepaid and properly insured unless Manufacturer requests that Company have such lot destroyed). Manufacturer shall deliver to Company, freight prepaid, all replacements for Products properly rejected, along with reimbursement of the shipment charges for return of the nonconforming Product (if any). In the event that any rejected Product is determined by Manufacturer to not be defective, Company shall reimburse Manufacturer for all costs and expenses related to the inspection and return of such Product to Company. If there is disagreement between the parties as to whether the Product meets Product Specifications, the parties shall have such Product tested by a mutually agreed upon third party and such third party’s determination as to whether such Product meets Product Specifications shall be binding on the parties. The expense for such testing shall be borne by Company unless it is determined that the Product does not meet the Product Specifications. Pending the outcome of such testing, Manufacturer shall have the right to suspend shipments of the applicable Products in respect of all existing and future orders of such Product.

 

(d)           Company shall notify Manufacturer in writing of any shortage in quantity of any shipment of Product within thirty (30) days of receipt of such Product. In the event of such shortage, Manufacturer shall endeavor to make up and ship the shortage as promptly as possible, but with the substitute shipment occurring no later than thirty (30) days after notice, at no additional cost to Company.

 

3.11        Changes.  (a) The Product Specifications may be modified or changed only by mutual agreement of the Company and Manufacturer. To the extent that such modification or change results in an increase or decrease in the cost of manufacturing any Product or requires additional capital investment or other material changes to the manufacturing process, the parties shall, contemporaneously with the modification to the Product Specifications if not earlier, jointly examine and mutually agree upon the consequences thereof and shall make an appropriate increase or decrease to the purchase price of such Product arising from such modification or change and amend Attachment 2 accordingly. At least six (6) weeks prior notice to the other party is required for any requested Product Specifications change; provided, however, that if any requested Product Specifications change requires additional Product Approval(s), the implementation of such requested change shall in no event be required until four (4) weeks after such approval(s) have been obtained.

 

(b)           Manufacturer shall promptly contact Company in the event that Manufacturer anticipates making changes to any material used to manufacture the Products or in the event Manufacturer considers any such material used to manufacture the Products to be nonconforming or unacceptable and Manufacturer shall not be required to implement any change to the Product Specifications that it reasonably believes will prevent it from being able to perform in accordance with the terms of this Agreement unless such terms are modified. If Manufacturer notifies Company that it believes the preceding sentence is applicable the parties shall meet and attempt to resolve the matter

 

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using the procedure specified in Section 9.2 if necessary; during any such period the Product will continue to be manufactured under the Product Specifications without such modification.

 

(c)           Company shall promptly upon request supply Manufacturer with “flow charts” regarding FDA requirements for any changes made in the material, construction, processing or manufacturing for any Products and any future Products.

 

4.             CONFIDENTIALITY; INTELLECTUAL PROPERTY RIGHTS

 

4.1          Confidentiality. (a) During the term of this Agreement and for [...***...] years thereafter, Manufacturer and Company shall not use for any purpose other than this Agreement and shall not reveal or disclose to third parties the subject matter of this Agreement and any Confidential Information received from the other party as confidential in nature. Any Confidential Information disclosed by either party hereunder to the other party may be used only by employees of the other party or its affiliates who agree to be bound by such party’s obligations hereunder with respect to such Confidential Information and who have a genuine need to know such information for the purposes permitted by this Agreement. The parties shall take reasonable measures to assure that no unauthorized use or disclosure is made by others to whom access to such Confidential Information is granted. Nothing herein shall be construed as preventing a receiving party from using and disclosing any Confidential Information as necessary (i) in prosecuting or defending litigation in accordance with Section 4.3; (ii) in connection with the initiation and conduct of clinical trials; or (iii) in conducting research and development in accordance with this Agreement including with third party collaborators (if such collaborators are subject to written confidentiality agreements with such party).

 

(b)           No public announcement or other disclosure to any third party concerning the existence of or terms of this Agreement shall be made, either directly or indirectly, by either party to this Agreement, except as may be legally required or as may be required for recording purposes, without first obtaining the written approval of the other party and agreement upon the nature and text of such announcement or disclosure. The party desiring to make any such public announcement or other disclosure (pursuant to legal requirement, for recording purposes or otherwise) shall provide the other party with a written copy of the proposed public statement, in reasonably sufficient time prior to public release in order to allow such other party to comment upon such announcement or disclosure.

 

4.2          Licenses.  (a) Manufacturer hereby grants to Company an exclusive, royalty-free, non-transferable (except in accordance with section 10.4) license to use (i) the Trademarks in the Territory in connection with the promotion, marketing, advertising, and sale of Products in the Territory; and (ii) any other Manufacturer IP as necessary or useful to promote, sell and deliver the Products in the Territory. In addition, upon the occurrence of the events described in Section 3.3A and solely in accordance with Section 3.3A Company may practice such intellectual property as necessary or useful for purposes of manufacturing Product in accordance with Section 3.3A.

 

(b)           If at any time Manufacturer believes that any Product(s) do not meet Manufacturer’s commercially reasonable quality expectations, Manufacturer will notify Company and Company will use commercially reasonable efforts to cure any such deficiency within a commercially reasonable period of time and unless such deficiency is resolved to Manufacturer’s reasonable satisfaction, not to be unreasonably withheld, Manufacturer may require Company to cease using the Trademarks in connection with the applicable Products. Upon Manufacturer’s request, Company will provide Manufacturer with samples of its usage of the Trademarks. Any use of the Trademarks will indicate that Manufacturer is the owner of the Trademarks. All uses of the Trademarks and all goodwill associated therewith will inure solely to the benefit of Manufacturer.

 

(c)           Company shall use the Trademarks only in the manners expressly approved by Manufacturer in advance in writing. Company shall use the Trademarks to promote, market, advertise and sell the Products in the Territory. Company may elect to adopt other trademarks for use in the promotion, marketing and sale of the Products (in addition to the Trademarks), in which case Section 4.2(b)-(c) shall not apply to Company’s use of such other marks.

 

4.3          Infringement.  (a) Each of Company and Manufacturer will notify the other party in writing of any infringement or unauthorized use or disclosure of the other party’s IP Rights in the Territory within thirty (30) days after it becomes aware of such infringement or unauthorized use or disclosure.

 

 

***Confidential Treatment Requested

 

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(b)           Subject to Sections 4.3(c) and 4.3(d), each party shall have the exclusive right (but not the obligation) at its own cost to take all legal action in the Territory it deems necessary or advisable to eliminate or minimize the consequences of any infringement or unauthorized use or disclosure of its IP Rights in the Territory.

 

(c)           Without limiting the generality or applicability of Section 4.3(b), Manufacturer shall have the exclusive right (but not the obligation) at its own cost to take all legal action in the Territory it deems necessary or advisable to eliminate or minimize the consequences of any infringement or unauthorized use or disclosure of the Trademarks in the Territory. All proceeds realized upon any judgment or settlement regarding an action undertaken with respect to the Trademarks shall be retained by Manufacturer.

 

(d)           Without limiting the generality or applicability of Section 4.3(b), Company shall have the exclusive right at its own cost to take all legal action in the Territory it deems necessary or advisable to eliminate or minimize the consequences of any infringement or unauthorized use or disclosure of the IP Rights other than Trademarks or Manufacturer Confidential Information as embodied in a Product. For the purpose of taking any such legal action, Company shall have the right, subject to Manufacturer’s prior written consent (which consent shall not be unreasonably withheld) to use the name of Manufacturer as plaintiff, either solely or jointly in accordance with the applicable rules of procedure. Manufacturer shall furnish Company with whatever written authority may be required in order to enable Company to use Manufacturer’s name in connection with any such legal action, and shall otherwise cooperate with Company (at Company’s expense) in connection with any such action. All proceeds realized upon any judgment or settlement regarding an action undertaken with respect to the IP Rights other than Trademarks or Manufacturer Confidential Information as embodied in a Product shall be used to reimburse Company for the costs of litigating or settling such matter and then shall be paid to Company and to Manufacturer in an amount that compensates Company for lost sales in respect of such infringement and Manufacturer in an amount that reflects the sums that would be due Manufacturer from Company based on the lost sales.

 

4.4          Ownership of IP Rights; Retained Rights.  (a) This Agreement does not convey to Company any right, title or interest in or to any Manufacturer IP by implication, estoppel or otherwise except for the license rights expressly granted under Section 4.2. Title to the Manufacturer IP shall at all times remain vested in Manufacturer.

 

(b)           This Agreement does not convey to Manufacturer any right, title or interest in or to any Company IP by implication, estoppel or otherwise except for the license rights expressly granted under Section 4.4(d). Title to the Company IP shall at all times remain vested in Company.

 

(c)           Intentionally Omitted.

 

(d)           Company hereby grants to Manufacturer a non-exclusive, royalty-free, fully paid-up license to use the Company IP to fulfill Manufacturer’s obligations to Company under this Agreement.

 

4.5          Improvements. If the parties jointly undertake any development, modification, enhancement or alteration of the Products after the Effective Date, then: (a) Company shall be the exclusive owner of all Improvements created solely by Company employees or consultants; (b) Manufacturer shall be the exclusive owner of all Improvements created solely by Manufacturer employees or consultants; and (c) the parties shall jointly own all Improvements created jointly by the parties; provided that Manufacturer hereby grants and agrees to grant to Company a perpetual, irrevocable, exclusive, transferable, fully paid-up, royalty-free right and license to use such Improvements in the Territory and Company hereby grants to Manufacturer a perpetual, irrevocable, exclusive, transferable, fully paid-up, royalty-free right and license to use such Improvements outside the Territory. If required, patent counsel mutually acceptable to the parties shall determine inventorship of all Improvements in accordance with U.S. patent law (and other U.S. intellectual property law, if applicable) and which party is entitled to ownership of such Improvements. Any disagreements will be resolved using the procedures described in Section 9.2 and Section 9.6.

 

5.             REGULATORY ACTIVITIES; APPROVALS

 

5.1          Regulatory Approvals.  (a) Company (i) will have sole responsibility and authority, at its sole expense, for obtaining and maintaining Product Approvals for the Products from the FDA or other Regulatory Authority

 

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necessary for the commercial import, export, distribution and sale of the Product in the Territory, and (ii) shall use its commercially reasonable efforts to obtain and maintain all such Product Approvals as soon as reasonably practicable after the Effective Date; this responsibility includes, without limitation, conducting and managing a clinical trial program in the United States, if necessary, as determined by Company. All regulatory’ filings with any Regulatory Authority in the Territory relating to the Product will be made in the name of Company or its designee. Manufacturer will use commercially reasonable efforts to cooperate with all of Company’s efforts to obtain and maintain Product Approvals for the Product, including by providing Company and the Regulatory Authority with such information and assistance as Company may reasonably request regarding the Product, including but not limited to, any and all surgical and clinical studies, documentation, certifications, bio-compatibility studies, and any other information which may be required by the Regulatory Authority or which may have a bearing or positive impact on the approval of any Products for which Company seeks Product Approvals; and Manufacturer will comply with all applicable regulatory requirements (including without limitation design controls, change controls, manufacturing and quality systems and Applicable GMP) reasonably necessary to obtain Regulatory Approval of the Product.

 

(b)           Manufacturer shall, at its expense and its discretion, use commercially reasonable efforts to obtain and maintain any regulatory approvals required for the manufacture of the Product at the Manufacturer Facility. Such regulatory approvals for the manufacture of the product at the Manufacturer Facility shall be applied for and maintained in the name of Manufacturer. Company will use commercially reasonable efforts to cooperate with all of Manufacturer’s efforts to obtain and maintain regulatory approvals for the manufacture of the Product at the Facility, including, without limitation, by providing Manufacturer and the Regulatory Authority with such information and assistance as Manufacturer may reasonably request regarding the Product.

 

(c)           Each party shall keep the other advised of regulatory interactions, activities and correspondence and the registration status of the Products and the Facility on a quarterly basis, except that matters requiring more immediate attention shall be communicated as soon as practicable. Each party shall promptly provide reasonable advice and assistance to the other party as may be necessary to obtain and maintain approvals for the Facility, Applicable GMPs for the manufacture of the Products and Product Approvals for the Products.

 

5.2          Quality Control. (a) Manufacturer shall manufacture the Products in accordance with the Product Specifications. Manufacturer will install and maintain effective quality control systems, conduct quality assurance testing and keep statistical process control records conforming to the then applicable good manufacturing practices regulations of the U.S. Food and Drug Administration under 21 CFR Part 820 or comparable regulations of any other any regulatory agency or authority that has authority to grant registrations, authorizations and approvals necessary for the commercial manufacture of the Products (each, a Regulatory Authority) (the Applicable GMP) and including specifically ISO 9001 certification and ISO 13485 certification.

 

(b)           Manufacturer will comply with Applicable GMP requirements in its manufacturing of the Products. Prior to shipping any Product, Manufacturer will carry out the Product tests specified in the applicable Product Specifications on each Product. If any Product fails to meet the Product Specifications, the Product will be replaced by Manufacturer. No Product will be shipped to Company or its designee without passing all tests specified in the Product Specifications except with Company’s prior written approval.

 

(c)           Manufacturer will maintain manufacturing quality documentation, including records of Manufacturer’s Product tests in accordance with the applicable regulations of the applicable Regulatory Authorities and Manufacturer will certify that Product was manufactured and tested in accordance with the applicable Product Specifications and regulatory requirements. Company may request copies of such manufacturing quality documentation and records and certifications as part of the inspections permitted under Section 5.3(a). Company will maintain quality control documentation, including records of Company’s Product Approval process and records related to Company’s promotion and marketing of the Product.

 

5.3          Inspections.  (a) During regular business hours and upon reasonable advance notice, Manufacturer will permit Company and its agents to inspect the Facility and provide access to Manufacturer’s manufacturing quality control documentation and regulatory files related to the Products to the extent necessary for, and for the sole purpose of assessing Manufacturer’s compliance with the provisions of Sections 5.2 and 6.2 of this Agreement;

 

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provided that such inspections shall be conducted in a manner that does not unreasonably disrupt operations of the Facility.

 

(b)           Manufacturer will allow representatives of any Regulatory Authority with jurisdiction over the manufacture, marketing, distribution and sale of any of the Products in the Territory to inspect the Facility, and will cooperate with such representatives in every reasonable manner. Manufacturer will promptly provide Company with notice of any inspections of the Facility by inspectors of the FDA or any other Regulatory Authority reasonably related to its performance hereunder or the subject matter of this Agreement and will permit Company to attend such inspections. Manufacturer will provide Company with copies of any FDA Form 483 notices of adverse findings, regulatory letters or similar writings it receives from any Regulatory Authority setting forth adverse findings or non¬compliance with applicable laws, regulations or standards relating to the Products supplied by Manufacturer hereunder within two (2) days of its receipt thereof, and Manufacturer’s written response to such Regulatory Authority not later than the date of its submission thereof.

 

(c)           If an inspection pursuant to Section 5.3(a) reveals that the Facility does not satisfy the requirements above in all material respects, then Company will promptly provide to Manufacturer written notice of such fact, which notice will contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps Company believes Manufacturer should undertake in order to remedy such deficiencies. Manufacturer will remedy such deficiencies within a reasonable period of time after receipt of such written notice.

 

5.4          Vigilance; Recalls.  (a) Attachment 5 contains the Company’s standard operating procedures (SOPs) as to Product recalls, which have been mutually agreed upon by the parties. If either party becomes aware of information about any Product indicating that it may not conform to the applicable Product Specifications, or that there are potential issues regarding safety or accuracy of results of Product, it will promptly so notify the other party. The parties will promptly confer to discuss such circumstances and to consider appropriate courses of action, which courses of action will be consistent with the SOPs.

 

(b)           In the event that (i) Company determines that an event, incident, or circumstance may result in the need for a recall or other removal of the Product or any lot or lots thereof from the market; (ii) any Regulatory Authority in the Territory threatens to remove a Product from the market; or (iii) any Regulatory Authority in the Territory requires distribution of a “Dear Doctor” letter or its equivalent regarding the use of Product, Company shall promptly advise Manufacturer in writing, and shall provide Manufacturer with copies of all relevant correspondence, notices and the like. Notwithstanding anything the contrary herein, Company shall have final authority to make all decisions relating to any recall within the Territory and shall pay all costs associated with such recall of the Product for any reason, whether or not requested or ordered by any Regulatory Authority; provided that the foregoing does not limit Company’s right to proceed against Manufacturer pursuant to Section 6.2 to the extent such recall or withdrawal of the Product is the result of (i) any breach by Manufacturer of its duties under the Agreement or (ii) Manufacturer’s negligence or willful-misconduct. If Company initiates any recall of a Product, Manufacturer shall cooperate and provide reasonable assistance to Company in conducting such recall.

 

(c)           Intentionally Omitted.

 

(d)           With respect to any recall, withdrawal, or field correction of a Product, Company or its designee will make all contacts with the FDA and other Regulatory Authorities, and will be responsible for coordinating all of the necessary activities in connection with such recall, withdrawal, or field correction. Company and Manufacturer will coordinate any statements to customers and the media, including, but not limited to, press releases and interviews for publication or broadcast except as otherwise required by applicable law to assure patient safety, and neither party will issue any such statements without consulting with the other. The parties will reasonably cooperate with each other in the conduct of such activities and will perform any acts reasonably requested by the other party to facilitate the recall, withdrawal or field correction. Each party will keep the other party fully informed of progress and in relation to all material decisions or actions such party undertakes pursuant to this Section 5.4(d).

 

(e)           Each party will notify the other party within three (3) business days (unless a shorter period is required under applicable laws or regulations) of any event or complaint that gives rise or could give rise to the need to file a adverse event report within the meaning of the Federal Food, Drug and Cosmetic Act of 1938, as amended or similar report under the laws or regulations administered by any Regulatory Authority (collectively, an AER),

 

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with respect to any Product or the manufacture, distribution or use thereof in accordance with applicable regulations covering AER’s. Each such notice will be Confidential Information under this Agreement. If, as a result of any corrective action or any final, non-appealable or non-appealed governmental or court action, an AER is required to be issued for any Product sold hereunder, Company will bear the costs and expenses of and will be responsible for all corrective actions associated with such AER but the foregoing does not limit Company’s right to proceed against Manufacturer pursuant to Section 6.2 to the extent such AER is the direct result of any breach by Manufacturer of its duties under the Agreement.

 

5.5          Compliance with Laws. Company shall comply with all applicable laws and regulations pertaining to the importation, distribution, sales and marketing of the Products and performance by Company of its obligations under this Agreement. Manufacturer will comply with all applicable laws and regulations pertaining to the manufacture of the Products and in any other manner pertaining to performance by Manufacturer of its obligations under this Agreement.

 

5.6          FDA Approvals. Company shall use its commercially reasonable efforts to obtain promptly all Product Approvals, including, but not limited to, approvals from the FDA necessary for the commercial import, export, distribution and sale of the Product in the Territory.

 

6.             REPRESENTATIONS AND WARRANTIES

 

6.1          Authorization; Enforceability. Each of Manufacturer and Company represents and warrants to the other that: (a) it is a corporation or limited liability company duly organized and validly existing under the laws of its incorporating jurisdiction; (b) it has all requisite corporate power and authority to enter into this Agreement; (c) it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder and consummate the transactions contemplated hereby; (d) this Agreement is a valid and binding obligation of such party enforceable in accordance with its terms; and (e) its execution, delivery and performance of this Agreement will not conflict in any material fashion with the terms of any other agreement or instrument to which it is or becomes a party or by which it is or becomes bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority over it.

 

6.2          Product Warranty. Manufacturer represents and warrants to Company, its successors, assigns, and customers and to users of the Products that each Product supplied to Company hereunder: (a) conforms to the applicable Product Specifications for the applicable period stated in Attachment 6, for each Product described therein; and (b) was manufactured, processed, labeled, packaged, stored and tested (in each case, while in the possession or control of Manufacturer) in accordance with the Product Specifications (including any applicable Product Approvals) and Applicable GMP. This warranty does not apply to any non-conformity of the Products resulting from (i) any alteration, misuse, mishandling or storage in an improper environment in each case by any party other than Manufacturer or its agents or (ii) any labeling approved by Company or any labeling required to be added to the Products by Company. THE FOREGOING WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY GIVEN BY MANUFACTURER WITH RESPECT TO THE PRODUCTS, AND MANUFACTURER DOES NOT GIVE OR MAKE, AND COMPANY IS NOT RELYING ON, ANY OTHER REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, TITLE OR NONINFRINGEMENT IN CONNECTION WITH THE PRODUCTS .

 

7.             RISK ALLOCATION

 

7.1          LIMITATION OF LIABILITY. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR LOST PROFITS OR FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES IN CONNECTION WITH THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT, HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY INCLUDING CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, AND NOTWITHSTANDING THAT SUCH DAMAGES MAY HAVE BEEN IN THE REASONABLE CONTEMPLATION OF THE PARTIES. THE LIMITATIONS OF LIABILITY SET FORTH IN THIS SECTION 7.1 SHALL NOT APPLY TO COMPANY’S PAYMENT OBLIGATIONS SET FORTH IN THIS AGREEMENT, TO BREACH OF CONFIDENTIALITY OBLIGATIONS UNDER SECTION 4.1 OR VIOLATIONS OF

 

13

 

ANOTHER PARTY’S INTELLECTUAL PROPERTY RIGHTS AND SHALL NOT SERVE TO LIMIT A PARTY’S INDEMNIFICATION OBLIGATIONS PROVIDED IN SECTION 7.2 WITH RESPECT TO THIRD PARTY CLAIMS.

 

7.2          Indemnification. Subject to the provisions of Section 7.3, each of Manufacturer and Company (each, in such capacity, an Indemnifying Party) will defend, indemnify and hold harmless the other party, its subsidiaries, parent corporations, affiliates, officers, directors, employees, agents, or representatives and their respective successors and assigns (each, in such capacity, an Indemnified Party) from and against any claim, suit, demand, loss, damage, expense (including reasonable attorney’s fees of indemnitee(s) and those that may be asserted by a third party) or liability (collectively, Losses) imposed upon the Indemnified Party(s) by any third party to the extent arising from or related to: (a) any material breach of such Indemnifying Party’s representations and warranties under this Agreement; (b) any negligence or intentional misconduct by such Indemnifying Party (or its employees, agents or representatives) in performing its obligations under this Agreement; (c) in the case of Manufacturer as the Indemnifying Party an inherent defect in the Products or failure of the Product to comply with the Product Specifications; (d) in the case of Company as the Indemnifying Party (i) any labeling, package insert, warnings or other materials supplied or required by law or this Agreement to be supplied by or at the direction of Company; and (ii) any promotional claims with respect to any Product by Company or by an Affiliate, licensee, sublicensee, distributor or agent of Company; and (e) in the case of Manufacturer as the Indemnifying Party any claim that the Product infringes any patent or other intellectual property right of any third party other than cases in which such infringement arises from a modification proposed by Company to a Product Specification. The foregoing indemnification action shall not apply to the extent that such Losses arose as a result of any Indemnified Party’s negligence, intentional misconduct or breach of this Agreement.

 

7.3          Procedure. To receive the benefit of indemnification under Section 7.2, the Indemnified Party must (a) promptly notify the Indemnifying Party of a claim or suit; provided, that failure to give such notice shall not relieve Indemnifying Party of its indemnification obligations except to the extent that such failure prejudices the rights of Indemnifying Party; (b) provide reasonable cooperation to the Indemnifying Party (and its insurer), as reasonably requested, at Indemnifying Party’s cost and expense; and (c) tender to the Indemnifying Party (and its insurer) full authority to defend or settle the claim or suit; provided that no settlement requiring any admission by the Indemnified Party or that imposes any obligation on the Indemnified Party shall be made without the Indemnified Party’s consent, not to be unreasonably withheld. Neither party, as Indemnifying Party, has any obligation to indemnify the other party in connection with any settlement made without the Indemnifying Party’s written consent. The Indemnified Party has the right to participate at its own expense in the claim or suit and in selecting counsel therefor.

 

7.4          Insurance. Each party shall procure and maintain insurance or self-insurance, including product liability insurance, adequate to cover its obligations hereunder and which are consistent with normal business practices of prudent companies similarly situated at all times during which any Product is being clinically tested with human subjects or commercially distributed or sold by Company. It is understood that such insurance shall not be construed to create a limit of either party’s liability with respect to its indemnification obligations under Section 7.2. Each party shall provide the other with written evidence of such insurance (or financial information that describes the amounts available under any self-insurance facility) upon request. Each party shall provide the other with written notice at least fifteen (15) days prior to the cancellation, non-renewal or material change in such insurance or self-insurance which materially adversely affects the rights of the other party hereunder. If such party does not obtain replacement insurance or take other measures that allow it to provide comparable coverage within such 15-day period, the other party shall have the right to terminate this Agreement effective at the end of such fifteen (15) day period without notice or any additional waiting periods.

 

8.             TERM AND TERMINATION

 

8.1          Term. This Agreement shall take effect as the Effective Date and shall remain in effect until the fifth anniversary of the Effective Date, unless sooner terminated in accordance with Section 8.2 of this Agreement (including the Sections referenced in Section 8.2) or extended in accordance with this Section 8.1. Manufacturer hereby grants Company, or its successors and assigns, an option to renew this Agreement, upon the same terms as herein set forth, for one (1) additional five (5) year period, which option to renew shall automatically take effect at the expiration of the then current term unless written notice of Company’s decision not to renew is delivered to

 

14

 

Manufacturer at least six (6) months prior to the expiration of the then current term. All applicable terms and conditions of this Agreement shall remain in effect during the renewal term, unless expressly amended by mutual agreement of the parties. During any notice period prior to the expiration of the initial term or any renewal term, each party will continue to perform and fulfill all of its respective obligations.

 

8.2          Termination. Subject to Sections 3.3(b) and 3.7 with respect to breaches addressed thereby, either party may terminate this Agreement at any time upon sixty (60) days notice to the other party in the event that the other party shall have breached any of its material obligations hereunder and shall not have cured such default prior to the expiration of the sixty (60) day period, provided that if the breach relates only to a single Product, then the terminating party shall be entitled to terminate this Agreement only with respect to the applicable Product. In addition, either party shall have the right to terminate this Agreement on a Product-by-Product basis upon thirty (30) days notice if a Force Majeure condition (excluding a Force Majeure condition that is the fault of the party seeking to terminate) has prevented performance by the other party for more than forty five (45) consecutive days or more than one hundred twenty (120) days in the aggregate in any 12-month period. The parties may also terminate this Agreement at any time on a Product-by-Product basis upon mutual written agreement of the parties. Company may also terminate this Agreement with respect to a Product upon notice to Manufacturer if Manufacturer fails to cure a breach with respect to such Product under Section 3.3(b) in accordance with Section 3.3(b).

 

8.3          Effect of Termination. (a) Termination of this Agreement shall not affect rights and obligations of either party that may have accrued prior to the effective date of termination or any obligation specifically stated to survive termination. The provisions of Sections 1, 4.1, 4.4-4.5, 5.2(c), 5.4(a)-(d), 6.1-6.2, 7.1-7.3, 8.3, 9, 10.1, 10.3 and 10.5-10.14 shall survive any expiration or termination of this Agreement in accordance with their respective terms. Upon termination of this Agreement for any reason and upon expiration of the applicable sell-out period specified in this Section 8.3, Company shall discontinue any and all use of the licenses granted under Section 4.2.

 

(b)           Upon any termination (including expiration) of this Agreement, each party shall return to the other party or certify in writing to the other party that it has destroyed all documents and other tangible items it or its employees or agents have received or created pertaining, referring or relating to the Confidential Information of the other party; provided, however, that a party is permitted to retain one copy of such materials in its legal files to be used solely to verify compliance with its obligations hereunder.

 

(c)           Upon any termination (including expiration) of this Agreement, Manufacturer and Company will cooperate to minimize disruption to customers for the Product in the Territory. Except in the event of termination arising from Company’s breach of this Agreement, and on a cash-in-advance basis only, Manufacturer will fill existing orders that Manufacturer has received and accepted and will accept additional orders from Company for additional Products that Company is, as of the date of termination notice, contractually obligated to furnish to its customers, to the extent Company does not have sufficient product in its inventory to fulfill such obligations; provided Company notifies Manufacturer of such transactions by the termination date. Any Products manufactured pursuant to the provisions of this Section 8.3(c) shall be subject to the provisions of Section 3 and Section 5 (except as expressly modified by this Section 8.3(c) with respect to payment terms).

 

(d)           If termination is based upon material breach by Company, Manufacturer shall have the right but not the obligation to repurchase some or all of the inventory of the Product held by Company or its Affiliates. The price for such inventory shall be the cost thereof actually paid by Company to Manufacturer. Upon issuance of an RMA to Company by Manufacturer, Company shall ship the Products to Manufacturer freight prepaid. If Manufacturer does not repurchase the inventory under this Section 8.3(d), Company shall have the right to sell out its inventory for a period of [...***...] from the date of termination. Thereafter, Manufacturer shall have the right but not the obligation to repurchase any remaining inventory of the Product in accordance with the provisions of this Section 8.3(d).

 

9.             DISPUTE RESOLUTION.

 

9.1          Designated Contacts. Each party will designate an individual (Representative) who will have the authority to represent such Party in all matters concerning the transactions contemplated by this Agreement. All communications should be addressed to the designated Representative. The initial Company Representative will be Hani Zeini. The initial Manufacturer Representative will be Antoine Robert.

 

 

***Confidential Treatment Requested

 

15

 

9.2          Issue Resolution. In the event that any dispute arises relating to this Agreement, the Representatives shall promptly meet and attempt to resolve same through good faith discussions. If the Representatives are unable to resolve any dispute to their mutual satisfaction within thirty (30) days after they commence discussions regarding same, and do not agree to extend the time for resolution of the issue at the end of their meeting, then either party may initiate alternative dispute resolution in accordance with Section 9.3. Pending resolution of any dispute, both parties will continue their performance under this Agreement including, without limitation, the payment of all amounts due to the other party that are not in dispute.

 

9.3          Arbitration. Any controversy or claim arising between the parties in connection with this Agreement that cannot be resolved using the procedure specified in sections 9.1-9.2, shall be resolved by binding arbitration in accordance with the terms and conditions of Sections 9.3-9.5; provided, that actions by either party seeking equitable or declaratory relief may be brought in court pursuant to Section 10.1 without resort to any of the provisions of this Section 9. This agreement to arbitrate shall continue in full force and effect despite the expiration, rescission or termination of this Agreement. All arbitration shall be undertaken in accordance with the federal policy in the United States favoring arbitration, as set forth in the Federal Arbitration Act, and the decision of the arbitrator(s) shall be enforceable in any court of competent jurisdiction. The parties knowingly and voluntarily waive their rights to have their dispute tried and adjudicated by a judge and jury except as expressly provided herein. The arbitrator(s) shall apply the law of New York and the arbitration shall be held in New York, New York, United States of America.

 

9.4          Arbitration Procedure. Any party may demand arbitration by sending written notice to the other party. The arbitration and the selection of the arbitrator(s) shall be conducted in accordance with such rules as may be agreed upon by the parties, or, failing agreement within thirty (30) days after arbitration is demanded, under the International Arbitration Rules of the American Arbitration Association’s International Centre for Dispute Resolutions (ICDR), as such rules may be modified by this Agreement. If the parties are unable to agree upon a single arbitrator within thirty (30) days following the date arbitration is demanded, then three (3) arbitrators shall be used, one selected by each party within ten (10) days after the conclusion of the thirty (30) day period and a third selected by the first two within ten (10) days thereafter. Unless the parties agree otherwise, they shall be limited in their discovery to directly relevant documents. Responses or objections to a document request shall be served twenty (20) days after receipt of the request. The arbitrator(s) shall resolve any discovery disputes.

 

9.5          Awards. The arbitrator(s) shall only have the authority to award actual money damages (with interest on unpaid amounts from the date due) and the arbitrator(s) shall not have the authority to award exemplary or punitive damages, and the parties expressly waive any claimed right to such damages. The arbitration shall be of each party’s individual claims only, and no claim of any other party shall be subject to arbitration in such proceeding. The costs and expenses of the arbitration, but not the costs and expenses of the parties, shall be shared equally by the parties; provided that if the arbitrator(s) determine(s) that one party prevailed in the proceeding, then the other party shall bear the entire cost and expense of the arbitration. If a party fails to proceed with arbitration, unsuccessfully challenges the arbitration award, or fails to comply with the arbitration award, the other party is entitled to costs, including reasonable attorneys’ fees, for having to compel arbitration or defend or enforce the award. Except as otherwise required by law, the parties and the arbitrator(s) shall maintain as confidential all information or documents obtained during the arbitration process, including the resolution of the dispute.

 

9.6          Intellectual Property. Notwithstanding the provisions of Sections 9.3-9.5, no claim or dispute relating to the ownership, use, enforceability or validity of any IP Rights shall be subject to arbitration; if any such claim or dispute arises and is not resolved by the parties in accordance with Section 9.2, then the parties shall resort to litigation to resolve such matter.

 

10.                               GENERAL PROVISIONS.

 

10.1        Governing Law; Venue. (a) This Agreement shall be governed and construed in accordance with the internal, substantive laws of New York, United States of America, to the exclusion of any choice or conflict of laws rule or provision that would result in the application of the substantive law of any other jurisdiction. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to the transactions contemplated by this Agreement.

 

16

 

(b)           Any action, suit or other proceeding pursuant to, arising under, or touching or concerning this Agreement or the transactions contemplated hereby shall be brought exclusively in any court of competent jurisdiction in New York, New York, United States of America. The parties agree to take any and all necessary or appropriate action to submit to the exclusive jurisdiction of any such court.

 

10.2        Waiver. No provision of or right under this Agreement shall be deemed to have been waived by any act or acquiescence on the part of either party, its agents or employees, but only by an instrument in writing signed by an authorized officer of each party. No waiver by either party of any breach of this Agreement by the other party shall be effective as to any other breach, whether of the same or any other term or condition and whether occurring before or after the date of such waiver.

 

10.3        Independent Contractors. Each party represents that it is acting on its own behalf as an independent contractor and is not acting as an agent for or on behalf of any third party. This Agreement and the relations hereby established by and between Company and Manufacturer do not constitute a partnership, joint venture, franchise, agency or contract of employment.

 

10.4        Assignment. Neither party may assign this Agreement or any of its rights and obligations under this Agreement without the prior written consent of the other party; provided, that either party may assign this Agreement without consent to: (a) any Person to which such party transfers all or substantially all of its assets or with which such party is consolidated or merged; or (b) any Affiliate; provided, further, that in each instance the assignee expressly assumes all obligations imposed on the assigning party by this Agreement in writing and the other party is promptly notified of such assignment. Any attempt to assign this Agreement or any rights or obligations hereunder other than as expressly permitted by this Section 10.4 shall be null and void.

 

10.5        Successors and Assigns. This Agreement shall bind and inure to the benefit of the parties hereto and their respective successors and permitted assigns.

 

10.6        Notices. Unless otherwise provided herein, any notice, report, payment or document to be given by one party to the other shall be in writing and shall be deemed given when delivered personally or mailed by certified or registered mail, postage prepaid (such mailed notice to be effective on the date which is three (3) business days after the date of mailing), or sent by internationally recognized overnight courier (such notice sent by courier to be effective one business day after it is deposited with such courier), or sent by telefax (such notice sent by telefax to be effective when sent, if confirmed by certified or registered mail or overnight courier as aforesaid) to the address set forth on the signature page to this Agreement or to such other place as any party may designate as to itself by written notice to the other party.

 

10.7        Severability. In the event any provision of this Agreement shall for any reason be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other term or provision hereof. The parties agree that they will negotiate in good faith or will permit a court to replace any provision hereof so held invalid, illegal or unenforceable with a valid provision which is as similar as possible in substance to the invalid, illegal or unenforceable provision.

 

10.8        Captions. Captions of the sections and subsections of this Agreement are for reference purposes only and do not constitute terms or conditions of this Agreement and shall not limit or affect the meaning or construction of the terms and conditions hereof.

 

10.9        Word Meanings. Words such as herein, hereinafter, hereof and hereunder refer to this Agreement as a whole and not merely to a section or paragraph in which such words appear, unless the context otherwise requires. The singular shall include the plural, and each masculine, feminine and neuter reference shall include and refer also to the others, unless the context otherwise requires.

 

10.10      Entire Agreement; Amendment. The terms and provisions contained in this Agreement (including the Attachments) constitute the entire understanding of the parties with respect to the transactions and matters contemplated hereby and supersede all prior or contemporaneous communications, representations, agreements and understandings relating to the subject matter hereof, including the 1997 Agreement. No representations,

 

17

 

inducements, promises or agreements, whether oral or otherwise, between the parties not contained in this Agreement shall be of any force or effect. No agreement or understanding amending or extending this Agreement including the Attachments or varying its terms (including any inconsistent terms in any purchase order, acknowledgment or similar form) shall be binding upon either party unless it is in a writing specifically referring to this Agreement and signed by’ a duly authorized representative of each of the parties.

 

10.11      Conflict or Inconsistency. In the event of any conflict or inconsistency between the terms and conditions of this Agreement and any terms or conditions set forth in any purchase order or other document relating to the transactions contemplated by this Agreement, the terms and conditions set forth in this Agreement shall prevail.

 

10.12      Rules of Construction. The parties agree that they have participated equally in the formation of this Agreement and that the language and terms of this Agreement shall not be construed against either party by reason of the extent to which such party or its professional advisors participated in the preparation of this Agreement.

 

10.13      Counterparts. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

10.14      Force Majeure. Except as otherwise provided in this Agreement, a delay or failure of a party to comply with any obligation created by this Agreement that is caused by a Force Majeure condition shall not be a breach of this Agreement.

 

10.15      Further Assurances. Each party covenants and agrees that, subsequent to the execution and delivery of this Agreement and without any additional consideration, it will execute and deliver any further legal instruments and perform any acts which are or may become reasonably necessary to effectuate the purposes of this Agreement.

 

10.16      Canada. Manufacturer will, within thirty (30) days following the Effective Date seek to arrange a meeting among representatives of the Company and the party to which Manufacturer has granted distribution rights for products in the country of Canada (Anexxa Medical Technologies Inc.) for the purpose of determining whether the Company can persuade such distributor to give up its rights to Canada in exchange for a payment from Company. If Company and such distributor are able to reach a mutually satisfactory agreement under which such distributor will relinquish rights to distribute in Canada in exchange for a payment from Company then Manufacturer hereby covenants and agrees that: (a) it will permit such distributor to terminate such distribution agreement without payment of any termination or similar fee; and (b) effective upon the payment of such fee by Company, the country of Canada shall automatically be added to the definition of Territory under this Agreement and the provisions of the last sentence of Section 3.8(a) shall automatically be amended to include as Company’s responsibility clearing Products through all customs and import requirements for Canada.

 

[Remainder of this page intentionally left blank]

 

18

 

IN WITNESS WHEREOF the parties have caused this Agreement to be executed on their behalf by their duly authorized representatives intending it to take effect as an instrument under seal as of the Effective Date.

 

	
Silimed-Silicone e Instrumental   Medico-Cirugico e Hospitalar LTDA
    	
 
    	
Juliet Medical, Inc.
    
	
 
    	
 
    	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/ Antoine Robert
    	
 
    	
 
    	
By:
    	
 /s/Hani Zeini
    
	
Name:  Antoine Robert
    	
 
    	
Name:  Hani Zeini
    
	
Title:  Presidente
    	
 
    	
Title:  Chief Executive Officer
    
	
 
    	
 
    	
 
    
	
Notice Address:
    	
 
    	
Notice Address:
    
	
Silimed-Silicone e   Instrumental Medico-Cirugico
    	
 
    	
Juliet   Medical, Inc.
    
	
E Hospitalar LTDA
    	
 
    	
c/o Orbimed Advisors LLC
    
	
R Figueiredo Rocha, 374
    	
 
    	
New York, NY USA 10017
    
	
Rio de Janeiro, Brazil
    	
 
    	
 
    
	
Fax:  55-212-471-211
    	
 
    	
Fax: 091.212.739.6737
    
	
Email:   antoinerobert@silimied.com.br
    	
 
    	
Email:  hani@julietmedical.com
    
	
Attn:  Antoine Robert, President
    	
 
    	
Attn:  Hani Zeini, Chief Executive Officer
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Attachment 1:  Products; Product Specification
    	
 
    	
 
    
	
Attachment 2:  Pricing
    	
 
    	
 
    
	
Attachment 3:  Trademarks
    	
 
    	
 
    
	
Attachment 4:  Packaging Specifications
    	
 
    	
 
    
	
Attachment 5:  Standard Operating Procedures
    	
 
    	
 
    
	
Attachment 6:  Product Warranty Periods
    	
 
    	
 
    

 

19

 

Attachment 1

 

Mammary Implants:

-Inflatable Mammary Implant (textured surface Posterior Valve)

-Inflatable Mammary Implant (textured surface Anterior Valve)

-Anatomical Inflatable Mammary Implant

-Anatomical Mammary Implant (silicone gel polyurethane foam coated)

-Anatomical Mammary Implant (silicone gel textured surface)

-Mammary Implant (silicone gel smooth surface)

-Mammary Implant (silicone gel polyurethane foam coated surface)

-Mammary Implant (silicone gel textured surface)

-Smooth Surface Mammary Implant (round shape)

-Textured Surface Mammary Implant (round shape)

-Nuance® Mammary Implant

-Enhance® Mammary Implant

-Quartzo® Mammary Implant

-Pitanguy/Rebello Mammary Implant

-Inferior Pole Anatomical System

 

Contour Implants:

-Calf Implant (filled)

-Calf Implant

-Gluteal Implant

-Round and Oval bases --4 Designs

-Round and Oval bases --5 Designs

-Quartzo

-Pectoral Implant

-Silicone Smooth Surface/Texture Surface

-Silicone Texture Only

 

Tissue Expanders:

-Tissue Expanders

-Anatomical Tissue Expanders (breast)

-Gingival Expander

 

Facial Implants:

-Eyelid Suspensor Implant

-Ear Implant

-Medgel Nasal Splint

-Nostril Retainer

-Anatomical Chin Implant

-Chin Implant

-Anatomical Malar Implant

-Malar Implant

-Implant for Nasal Dorsum

-Nasal Implant in “L” Shape

-Zygomatic Implant

 

Hand Surgery Products:

-Tendon Spacer

-Implant for the First Intermetacarpal Space

 

Urology Products:

-Inflatable Periurethral Constrictor

-Vesical Conformer

-Tube for Hypospadius

-Testicular Implant

-Silicone Gel

-Silicone Gel Smoot Surface

-Malleable Penile Implant

-Adjustable Penile Implant

-Vaginal Stent

 

 

Bariatric Products:

-Adjustable Gastric Band

-Gastric Balloon

 

Miscellaneous Products:

-SILICAT Chemotherapy Kit

-Guide for Canula

-Suspension Sheet for Mammoplasty

-Medgel

-Silicone Sheets and Blocks

 

 

Mammary Implants:

-Inflatable Mammary Implant (textured surface Posterior Valve)

-Inflatable Mammary Implant (textured surface Anterior Valve)

-Anatomical Inflatable Mammary Implant

-Anatomical Mammary Implant (silicone gel polyurethane foam coated)

-Anatomical Mammary Implant (silicone gel textured surface)

-Mammary Implant (silicone gel smooth surface)

-Mammary Implant (silicone gel polyurethane foam coated surface)

-Mammary Implant (silicone gel textured surface)

-Smooth Surface Mammary Implant (round shape)

-Textured Surface Mammary Implant (round shape)

-Nuance® Mammary Implant/Enhance® Mammary Implant

-Quartzo® Mammary Implant

-Pitanguy/Rebello Mammary Implant

-inferior Pole Anatomical System

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contour Implants:

-Calf Implant (filled)

-Calf Implant

-Gluteal Implant

-- Round and Oval bases --4 Designs

-- Round and Oval bases --5 Designs

-- Quartzo

-Pectoral Implant

-- Silicone Smooth Surface/Texture Surface

-- Silicone Texture Only

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tissue Expanders

-Tissue Expanders

- Anatomical Tissue Expanders (breast)

- Gingival Expander

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Urology Products:

-Inflatable Periurethral Constrictor

-Vesical Conformer

-Tube for Hypospadius

-Testicular Implant

-- Silicone Gel

-- Silicone Gel Smoot Surface

-Malleable Penile Implant

-Adjustable Penile Implant

-Vaginal Stent

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Bariatric Products

-Adjustable Gastric Bad

- Gastric Balloon

 

 

 

 

 

 

 

 

 

 

Miscellaneous Products:

 

-SILICAT Chemotherapy Kit

-Guide for Canula

-Suspension Sheet for Mammoplasty

-Medgel

-Silicone Sheets and Blocks

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[...***...]

 

 

***Confidential Treatment Requested

 

 

[...***...]

 

 

***Confidential Treatment Requested

 

 

[...***...]

 

 

***Confidential Treatment Requested

 

 

[...***...]

 

 

***Confidential Treatment Requested

 

 

[...***...]

 

 

***Confidential Treatment Requested

 

 

[...***...]

 

 

***Confidential Treatment Requested

 

 

[...***...]

 

 

***Confidential Treatment Requested

 

 

[...***...]

 

 

***Confidential Treatment Requested

 

 

[...***...]

 

 

***Confidential Treatment Requested

 

 

[...***...]

 

 

***Confidential Treatment Requested

 

 

[...***...]

 

 

***Confidential Treatment Requested

 

 

[...***...]

 

 

***Confidential Treatment Requested

 

 

[...***...]

 

 

***Confidential Treatment Requested

 

 

[...***...]

 

 

***Confidential Treatment Requested

 

 

[...***...]

 

 

***Confidential Treatment Requested

 

 

SILIMED-Silicone e Instrumental Médico-Cirúrgico Hospitalar Ltda.

Rua Figueiredo Rocha, 374 – Rio de Janeiro – BRASIL – 21240-660

· (5521) 3687-7140 / 3687-7141 - · (5521) 3687-7000

 

 

Attachment 3:

Trademarks

 

 

 

SILIMED

BIODESIGN

ENHANCE

NUANCE

MEME

REPLICON

 

 

Attachment 4

 

Packaging Specifications

 

SILIMED – 510(K) Products

 

General Information:

 

	
510(K) -PRODUCT
    	
UNITS/
   PACKAGING
    	
STERILE (Y/N)
    	
PACKAGING
    
	
K981851 - OVAL CARVING BLOCK
    	
1
    	
Y
    	
Double   Blister sealed with Tyvek in a cardboard box
    
	
K974482 - GLUTEAL IMPLANT
    	
1
    	
Y
    	
Double   Blister sealed with Tyvek in a cardboard box
    
	
K981852 - TISSUE EXPANDER
    	
1
    	
Y
    	
Double   Blister sealed with Tyvek in a cardboard box
    
	
K042054 - PECTORAL IMPLANT
    	
1
    	
Y
    	
Double   Blister sealed with Tyvek in a cardboard box
    
	
K974480 - CALF IMPLANT
    	
1
    	
Y
    	
Double   Blister sealed with Tyvek in a cardboard box
    
	
K974479 - VAGINAL STENT
    	
1
    	
Y
    	
Double   Blister sealed with Tyvek in a cardboard box
    
	
K981833 - NASAL IMPLANT
    	
1
    	
Y
    	
Double   plastic envelope in a pvc envelope
    
	
K981850 - CHIN IMPLANT
    	
1
    	
Y
    	
Double   plastic envelope in a pvc envelope
    
	
K980221 - NASAL RETAINER
    	
1
    	
Y
    	
Double   plastic envelope in a pvc envelope
    
	
K981835 - MALAR IMPLANT
    	
1
    	
Y
    	
Double   plastic envelope in a pvc envelope
    

 

Unit for Shipping:

 

· SILIMED does not use pallets for shipping.

· The large unit for shipping has the cubical weight of 61.95Kg. The quantity of packagings depends on the size and/or type of products packaging

 

 

Attachment 5

Standard Operating Procedures

 

[to be mutually agreed in accordance with the procedure specified in Section 5.4 prior to shipment of the first Products to Company for commercial sale]

 

 

Attachment 6

Product Warranty Periods

 

	
PRODUCT
    	
WARRANTY PERIOD
    
	
Mammary Implants including:

-Inflatable Mammary   Implant (textured surface Posterior Valve)

-Inflatable Mammary   Implant (textured surface Anterior Valve)

-Anatomical Inflatable   Mammary Implant

-Anatomical Mammary Implant (silicone gel   polyurethane foam coated)

-Anatomical Mammary Implant (silicone gel textured   surface)

-Mammary Implant (silicone gel smooth   surface)

-Mammary Implant (silicone gel polyurethane   foam coated surface)

-Mammary Implant (silicone gel textured   surface)

-Smooth Surface Mammary Implant (round   shape)

-Textured Surface Mammary Implant (round   shape)

-Nuance® Mammary Implant/Enhance® Mammary   Implant

-Quartzo® Mammary Implant

-Pitanguy/Rebello Mammary Implant

-Inferior Pole Anatomical System
    	
10 years from manufacturing date
    
	
 
    	
 
    
	
Contour Implants including:

-Calf Implant (filled)

-Calf Implant

-Gluteal Implant

-- Round and Oval bases   --4 Designs

-- Round and Oval bases   --5 Designs

-- Quartzo

-Pectoral Implant

-- Silicone Smooth Surface/Texture Surface

-- Silicone Texture Only
    	
10 years from manufacturing date
    
	
 
    	
 
    
	
Tissue Expanders

-Tissue Expanders

-Anatomical Tissue Expanders (breast)   -Gingival Expander
    	
5 years from manufacturing date
    
	
 
    	
 
    
	
Facial Implants including:

-Eyelid Suspensor Implant

-Ear Implant

-Medgel Nasal Splint

-Nostril Retainer

-Anatomical Chin Implant -Chin Implant

-Anatomical Malar Implant -Malar Implant

-Implant for Nasal Dorsum   -Nasal Implant in “L” Shape -Zygomatic Implant
    	
10 years from manufacturing date
    
	
 
    	
 
    
	
Hand Surgery Products including:

-Tendon Spacer

-Implant for the First Intermetacarpal   Space
    	
5 years from manufacturing date
    
	
 
    	
 
    
	
Urology Products including:

-Inflatable Periurethral Constrictor

-Vesical Conformer

-Tube for Hypospadius

-Testicular Implant

-Malleable Penile Implant

-Adjustable Penile Implant

-Vaginal Stent
    	
5 years from manufacturing date
    
	
 
    	
 
    

 

1

 

	
Bariatric Products (Bands)   including:

-Adjustable gastric band
    	
10 years from manufacturing date
    
	
Bariatric Products (Balloons)   including:

-Gastric Balloon
    	
1 year from manufacturing date
    
	
 
    	
 
    
	
Miscellaneous Products including:

-SILICAT Chemotherapy Kit

-Guide for Canula

-Suspension Sheet for Mammoplasty

-Medgel

-Silicone Sheets and Blocks
    	
None
    

 

 

Manufacturer will include a certificate showing the date of manufacture with each shipment of each Product. No

Product will be supplied more than 180 days following the date of Manufacture.

 

2

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