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|CREDIT AGREEMENT AND GUARANTY|
dated as of
August 5, 2021
by and among
OYSTER POINT PHARMA, INC.,
as the Borrower,
THE SUBSIDIARY GUARANTORS FROM TIME TO TIME PARTY HERETO,
as the Subsidiary Guarantors,
THE LENDERS FROM TIME TO TIME PARTY HERETO,
as the Lenders,
ORBIMED ROYALTY & CREDIT OPPORTUNITIES III, LP
as the Initial Lender and Agent
TABLE OF CONTENTS
TABLE OF CONTENTS
TABLE OF CONTENTS
TABLE OF CONTENTS
SCHEDULES AND EXHIBITS
Schedule 1 – Commitments
Schedule 7.05(b) – Material Products
Schedule 7.05(c) – Obligor Intellectual Property
Schedule 7.06(a) – Certain Litigation
Schedule 7.06(c) – Labor Matters
Schedule 7.12(a) – Subsidiaries of the Borrower
Schedule 7.12(b) – Other Equity Interests Owned by the Borrower and its Subsidiaries
Schedule 7.13(a) – Existing Indebtedness
Schedule 7.13(b) – Existing Liens
Schedule 7.14 – Material Agreements
Schedule 7.15 – Restrictive Agreements
Schedule 7.16 – Real Property
Schedule 7.17 – Pension Matters
Schedule 7.19(b) – Regulatory Approvals
Schedule 7.20 – Transactions with Affiliates
Schedule 7.23 – Deposit and Disbursement Accounts
Schedule 7.24 – Royalties and Other Payments
Schedule 9.05(a) – Existing Investments
Schedule 9.05(m) Other Permitted Investments
Schedule 9.09 – Permitted Asset Sales
Schedule 9.13 – Permitted Sales and Leasebacks
Exhibit A – Form of Note
Exhibit B – Form of Borrowing Notice
Exhibit C – Form of Guaranty Assumption Agreement
Exhibit D-1 – Form of U.S. Tax Compliance Certificate (For Foreign Lenders That Are Not Partnerships for U.S. Federal Income Tax Purposes)
Exhibit D-2 – Form of U.S. Tax Compliance Certificate (For Foreign Participants That Are Not Partnerships for U.S. Federal Income Tax Purposes)
Exhibit D-3 – Form of U.S. Tax Compliance Certificate (For Foreign Participants That Are Partnerships for U.S. Federal Income Tax Purposes)
Exhibit D-4 – Form of U.S. Tax Compliance Certificate (For Foreign Lenders That Are Partnerships for U.S. Federal Income Tax Purposes)
Exhibit E – Form of Compliance Certificate
Exhibit F – Form of Assignment and Assumption
Exhibit G – Form of Information Certificate
Exhibit H – Form of Intercompany Subordination Agreement
Exhibit I – Form of Solvency Certificate
TABLE OF CONTENTS
CREDIT AGREEMENT AND GUARANTY
CREDIT AGREEMENT AND GUARANTY, dated as of August 5, 2021 (this “Agreement”), by and among Oyster Point Pharma, Inc., a Delaware corporation (the “Borrower”), certain of the Subsidiaries of the Borrower that may be required to provide Guaranties from time to time hereunder, OrbiMed Royalty & Credit Opportunities III, LP (the “Initial Lender”) and each other lender that may from time to time become a party hereto (each, including the Initial Lender, a “Lender” and collectively, the “Lenders”), and OrbiMed Royalty & Credit Opportunities III, LP, as administrative agent for the Lenders (in such capacity, the “Agent”).
WHEREAS, the Borrower has requested that the Lenders provide a senior secured delayed draw term loan facility to the Borrower in an aggregate principal amount of $125,000,000, with up to $45,000,000 in aggregate principal amount of Loans to be available after the Closing Date and or prior to August 13, 2021 (the “Tranche 1 Loan”), up to $50,000,000 in aggregate principal amount of Loans to be available after the Tranche 1 Borrowing Date but on or prior to June 30, 2022 (the “Tranche 2 Loan”), and up to $30,000,000 in aggregate principal amount of Loans to be available after the Tranche 2 Borrowing Date but on or prior to June 30, 2023 (the “Tranche 3 Loan”), in each case, subject to the terms and conditions set forth herein, including the applicable conditions precedent set forth in Section 6 hereof; and
WHEREAS, the Lenders are willing, on the terms and subject to the conditions set forth herein, to provide such senior secured delayed draw term loan facility.
NOW, THEREFORE, the parties hereto agree as follows:
1.01Certain Defined Terms. As used herein (including the preamble and recitals), the following terms have the following respective meanings:
“Acquisition” means any transaction, or any series of related transactions, by which any Person directly or indirectly, by means of an amalgamation, consolidation, merger, purchase of Equity Interests or other assets, tender offer, or similar transaction having the same effect as any of the foregoing, (i) acquires any business or all or substantially all of the assets of any other Person, (ii) acquires all or substantially all of a business line or unit or division of any other Person, (iii) acquires control of Equity Interests of another Person representing more than fifty percent (50%) of the ordinary voting power for the election of directors or other governing body if the business affairs of such Person are managed by a board of directors or other governing body, determined on a fully-diluted, as-if-converted or exercised basis, or (iv) acquires control of more than fifty percent (50%) of the Equity Interests in any Person engaged in any business that
is not managed by a board of directors or other governing body, determined on a fully-diluted, as-if-converted or exercised basis.
“Advanced Development” means, with respect to any proposed Product and the indication of use for such Product, that a Phase III Clinical Trial or any later stage of clinical trial is initiated (i.e., dosing of the first patient in such clinical trial) with respect to such Product for such indication.
“Adverse Regulatory Event” means the occurrence of any of the following events or circumstances after the date on which the OC-01 Approval is received:
(a) the failure of the Borrower or any of its Subsidiaries to hold, directly or through licensees or agents, in full force and effect, all Regulatory Approvals necessary or required pursuant to applicable Law for the Borrower or any such Subsidiary to conduct its then ongoing Commercialization and Development Activities;
(b) if required by any applicable Law, the failure of the Borrower or any of its Subsidiaries to make or file with the FDA or any other applicable Regulatory Authority, in compliance with applicable Law, any required notice, registration, listing, supplemental application or notification or report;
(c) the Borrower or any of its Subsidiaries or, to the knowledge of the Borrower, any agent, supplier, licensor or licensee of the Borrower or any of its Subsidiaries, receives any written notice with respect to any Product or any Commercialization and Development Activities with respect thereto from the FDA or any other Regulatory Authority asserting (i) that such Person lacks a required Regulatory Approval with respect to any Product or Commercialization and Development Activity, (ii) a material breach of applicable Laws or Regulatory Approvals (or any similar order, injunction or decree) or (iii) that such Regulatory Authority has commenced any regulatory enforcement action, investigation or inquiry (other than routine or periodic inspections or post-marketing reviews), or has issued a warning letter, with respect to any Product or any Commercialization and Development Activities with respect thereto, including, without limitation, any such notice that requires (or is reasonably likely to require or cause) the Borrower or any of its Subsidiaries to discontinue, withdraw or recall the marketing or sale of any Product, or requires or causes (or is reasonably likely to require or cause) a cessation or delay in the manufacture or sale of any Product, which discontinuance, withdrawal, recall, cessation or delay will last (or is reasonably expected to last) in excess of ninety (90) days; or
(d) with respect to any Product or Commercialization and Development Activity with respect thereto of the Borrower or any Subsidiary, (i) any Regulatory Authority commences any criminal, injunctive, seizure, detention, civil penalty or other enforcement action or, (ii) the Borrower or any Subsidiary enters into any consent decree, plea agreement or other settlement with any Regulatory Authority with respect to any of the foregoing, or (iii) the Borrower or any Subsidiary either (x) recalls voluntarily (1) OC-01 for the treatment of dry eye disease or the treatment of the signs and symptoms of
dry eye disease, or (2) as of any time of determination, any other Material Product that, for the Test Period immediately last ended, has generated in excess of $2,000,000 of the Borrower’s and its Subsidiaries’ consolidated third-party gross revenues, or (y) voluntarily halts or discontinues the marketing or sale of any Material Product described in the foregoing clause (x) for a period of ninety (90) consecutive days or longer.
“Affected Financial Institution” means (a) any EEA Financial Institution or (b) any UK Financial Institution.
“Affiliate” means, with respect to a specified Person, another Person that directly, or indirectly through one or more intermediaries, Controls, is Controlled by, or is under common Control with, the Person specified; provided that with respect to any Lender, an Affiliate of such Lender shall include, without limitation, all of such Lender’s Related Funds.
“Agent” has the meaning set forth in the preamble hereto.
“Agreement” has the meaning set forth in the preamble hereto.
“Applicable Margin” means eight and one tenth of one percent (8.10%) per annum, as such percentage may be increased pursuant to Section 3.02(b).
“Applicable Period” has the meaning set forth in the definition of “Revenue Sharing Fee Cap Amount”.
“Asset Sale” has the meaning set forth in Section 9.09.
“Assignment and Assumption” means an assignment and assumption entered into by a Lender and an assignee of such Lender in substantially the form of Exhibit F.
“Bail-In Action” means the exercise of any Write-Down and Conversion Powers by the applicable Resolution Authority in respect of any liability of an Affected Financial Institution.
“Bail-In Legislation” means, (a) with respect to any EEA Member Country implementing Article 55 of Directive 2014/59/EU of the European Parliament and of the Council of the European Union, the implementing law for such EEA Member Country from time to time which is described in the EU Bail-In Legislation Schedule and (b) with respect to the United Kingdom, Part I of the United Kingdom Banking Act 2009 (as amended from time to time) and any other law, regulation or rule applicable in the United Kingdom relating to the resolution of unsound or failing banks, investment firms or other financial institutions or their affiliates (other than through liquidation, administration or other insolvency proceedings).
“Bankruptcy Code” means Title 11 of the United States Code entitled “Bankruptcy.”
“Benchmark Rate” means Daily Simple SOFR; provided that if Daily Simple SOFR can no longer be determined by the Agent for any reason (in its sole discretion, which determination shall be conclusive absent manifest error), including as a result of Daily Simple SOFR not being available or published on a current basis or as a result of the occurrence of a Benchmark
Transition Event, then the Agent and the Borrower shall endeavor, in good faith, to establish an alternate rate of interest to Daily Simple SOFR that gives due consideration to the then prevailing market convention for determining a rate of interest for middle-market loans in the United States at such time, and shall enter into an amendment to this Agreement to reflect such alternate rate of interest and such other related changes to this Agreement as may be applicable; provided, further that, until such alternate rate of interest is agreed upon by the Agent and the Borrower, the Benchmark Rate for purposes hereof and of each other Loan Document shall be the Wall Street Journal Prime Rate. The Agent’s determination of interest rates shall be binding on all parties to the Loan Documents in the absence of manifest error.
“Benchmark Transition Event” means the occurrence of one or more of the following events with respect to the Benchmark Rate:
(a) a public statement or publication of information by or on behalf of the administrator of the Benchmark Rate announcing that such administrator has ceased or will cease to provide the Benchmark Rate, permanently or indefinitely; provided that, at the time of such statement or publication, there is no successor administrator that will continue to provide the Benchmark Rate;
(b) a public statement or publication of information by the Governmental Authority governing or regulating the administrator of the Benchmark Rate, the U.S. Federal Reserve System, an insolvency official with jurisdiction over the administrator for the Benchmark Rate, a resolution authority with jurisdiction over the administrator for the Benchmark Rate or a court or an entity with similar insolvency or resolution authority over the administrator for the Benchmark Rate, which in any case states that the administrator of the Benchmark Rate has ceased or will cease to provide the Benchmark Rate permanently or indefinitely; provided that, at the time of such statement or publication, there is no successor administrator that will continue to provide the Benchmark Rate; or
(c) a public statement or publication of information by the Governmental Authority governing or regulating the administrator of the Benchmark Rate announcing that the Benchmark Rate is no longer representative.
For the avoidance of doubt, a “Benchmark Transition Event” will be deemed to have occurred with respect to any Benchmark Rate if a public statement or publication of information set forth above has occurred with respect to each then-current Available Tenor of such Benchmark (or the published component used in the calculation thereof).
“Beneficial Ownership Regulation” means 31 C.F.R. § 1010.230.
“Benefit Plan” means any employee benefit plan as defined in Section 3(3) of ERISA (whether governed by the laws of the United States or otherwise) to which any Obligor or Subsidiary thereof incurs or otherwise has any obligation or liability, contingent or otherwise.
“Board” means, with respect to any Person, the board of directors (or equivalent management or oversight body) of such Person or any committee thereof duly authorized to act on behalf of such board or equivalent body.
“Borrower” has the meaning set forth in the preamble hereto.
“Borrowing” means, as the context may require, the borrowing of the Tranche 1 Loans on the Tranche 1 Borrowing Date, the borrowing of the Tranche 2 Loans on the Tranche 2 Borrowing Date, or the borrowing of the Tranche 3 Loans on the Tranche 3 Borrowing Date.
“Borrowing Date” means, as the context may require, either the Tranche 1 Borrowing Date (for Tranche 1 Loans), the Tranche 2 Borrowing Date (for Tranche 2 Loans), or the Tranche 3 Borrowing Date (for Tranche 3 Loans).
“Borrowing Notice” means a written notice substantially in the form of Exhibit B.
“Business Day” means a day (other than a Saturday or Sunday) on which commercial banks are not authorized or required to close in New York, New York.
“Buyout Amount” means at any time of determination during any Applicable Period, an amount equal to (x) the Revenue Sharing Fee Cap Amount in effect for such Applicable Period minus (y) the aggregate amount of Revenue Sharing Fees paid to and received by the Agent (by wire transfer of immediately available funds for) for the period from the Closing Date until the date immediately prior to such time of determination; provided that the Buyout Amount shall not be less than zero.
“Capital Lease Obligation” means, as to any Person, any obligation of such Person to pay rent or other amounts under a lease of (or other agreement conveying the right to use) real and/or personal property, which obligation is required to be classified and accounted for as a capital lease on a balance sheet of such Person under GAAP and, for purposes of this Agreement, the amount of any such obligation shall be the capitalized amount thereof, determined in accordance with GAAP.
“Casualty Event” means the damage, destruction or condemnation, as the case may be, of any property of any Person.
“Change of Control” means an event or series of events (including any Acquisition) that causes or results in any of the following: (i) any Person or “group” (as such terms are used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, but excluding any employee benefit plan of such person or its Subsidiaries, and any person or entity acting in its capacity as trustee, agent or other fiduciary or administrator of any such plan) becomes the “beneficial owner” (as defined in Rules 13d-3 and 13d-5 under the Securities Exchange Act of 1934, except that a person or group shall be deemed to have “beneficial ownership” of all securities that such person or group has the right to acquire, whether such right is exercisable immediately or only after the passage of time (such right, an “option right”)), directly or indirectly, of forty-five percent (45%) or more of the Equity Interests of the Borrower entitled to vote for members of the
board of directors or equivalent governing body of the Borrower on a fully-diluted basis (and taking into account all such securities that such person or group has the right to acquire pursuant to any option right), (ii) during any period of twenty-four (24) consecutive months, a majority of the members of the Board of the Borrower cease to be composed of individuals (a) who were members of such Board on the first day of such period, (b) whose election or nomination to such Board was approved by individuals referred to in clause (a) above constituting at the time of such election or nomination at least a majority of such Board or (c) whose election or nomination to such Board was approved by individuals referred to in clauses (a) and (b) above constituting at the time of such election or nomination at least a majority of such Board, (iii) the Borrower shall cease to own, directly or indirectly, beneficially and of record, one hundred percent (100%) of the issued and outstanding Equity Interests of each of its Subsidiaries, free and clear of all Liens (other than (x) Specified Permitted Liens or (y) as a result of an Asset Sale of such Subsidiary permitted pursuant to Section 9.09) or (iv) the sale of all or substantially all of the property or business of the Borrower and its Subsidiaries, taken as a whole.
“Claim” means any claim, demand, complaint, grievance, action, application, suit, cause of action, order, charge, indictment, prosecution, judgment, challenge or other similar process, assessment or reassessment, whether made, converted or assessed in connection with a debt, liability, dispute, breach, failure, Patent challenge or otherwise.
“Closing Date” means August 5, 2021.
“Code” means the U.S. Internal Revenue Code of 1986, as amended.
“Collateral” means any asset or property in which a Lien is purported to be granted under any Loan Document, including any “Collateral” (or equivalent term) as defined in any Security Document (other than Excluded Property).
“Commercialization and Development Activities” means, with respect to any Product, any combination of (i) research, development, manufacturing, quality compliance, use, sale, licensing, importation, exportation, shipping, storage, handling, designing, labeling, marketing, promotion, supply, dispensing, distribution, testing, packaging, purchasing or other commercialization activity, (ii) receipt of payment or other remuneration in respect of any of the foregoing (including, without limitation, in respect of licensing, royalty or similar payments) or (iii) any similar or other activities the purpose of which is to commercially exploit such Product.
“Commitment” means, with respect to each Lender, the obligation of such Lender to make Loans to the Borrower on the applicable Borrowing Date in accordance with the terms and conditions of this Agreement, which commitments are in the amounts set forth opposite such Lender’s name on Schedule 1 hereto, as such Schedule may be amended from time to time pursuant to an Assignment and Assumption or otherwise; provided that the aggregate Commitments of all Lenders on the Closing Date equals $125,000,000.
“Commodity Account” means any commodity account, as such term is defined in Section 9-102 of the NY UCC.
“Connection Income Taxes” means Other Connection Taxes that are imposed on or measured by net income (however denominated) or that are franchise Taxes or branch profits Taxes.
“Contingent Payment Obligations” has the meaning set forth in clause (iv) of the definition of “Indebtedness”.
“Contract” means any contract, license, lease, agreement, obligation, promise, undertaking, understanding, arrangement, document, commitment, entitlement, indenture, instrument, or engagement under which a Person has, or will have, any liability or contingent liability (in each case, whether written or oral, express or implied, and whether in respect of monetary or payment obligations, performance obligations or otherwise), in each case, other than the Loan Documents.
“Control” means, in respect of a particular Person, the possession, by one or more other Persons, directly or indirectly, of the power to direct or cause the direction of the management or policies of such particular Person, whether through the ability to exercise voting power, by contract or otherwise. “Controlling” and “Controlled” (and similar derivatives) have meanings correlative thereto.
“Controlled Account” has the meaning set forth in Section 8.17(a).
“Controlled Investment Affiliates” means, as to any Person (the “Controlling Person”), any Affiliate of such Controlling Person that (i) is Controlled, directly or indirectly by such Controlling Person, or (ii) was organized by such Controlling Person (or any Person Controlled by such Controlling Person) for the purpose of making equity or debt investments in the Borrower or other portfolio companies of such Controlling Person.
“Copyright” means all copyrights (whether registered or not), copyright registrations and applications for copyright registrations, including all renewals and extensions thereof, foreign copyrights and any other rights corresponding thereto throughout the world.
“Daily Simple SOFR” means, for any day (a “SOFR Rate Day”), a rate per annum equal to SOFR for the day (such day “i”) that is three (3) U.S. Government Securities Business Days prior to (i) if such SOFR Rate Day is a U.S. Government Securities Business Day, such SOFR Rate Day or (ii) if such SOFR Rate Day is not a U.S. Government Securities Business Day, the U.S. Government Securities Business Day immediately preceding such SOFR Rate Day, in each case, as such SOFR is published by the SOFR Administrator on the SOFR Administrator’s Website. If the SOFR in respect of such day “i” has not been published on the SOFR Administrator’s Website and the Benchmark Rate is Daily Simple SOFR, then the SOFR for such day “i” will be the SOFR as published in respect of the first preceding U.S. Government Securities Business Day for which such SOFR was published on the SOFR Administrator’s Website; provided that any SOFR determined pursuant to this sentence shall be utilized for purposes of calculation of Daily Simple SOFR for no more than three (3) consecutive SOFR Rate Days. Any change in Daily Simple SOFR due to a change in SOFR shall be effective from and including the effective date of such change in SOFR without notice to the Borrower.
“Default” means any Event of Default and any event that, upon the giving of notice, the lapse of time or both, would constitute an Event of Default.
“Default Rate” has the meaning set forth in Section 3.02(b).
“Deposit Account” means any deposit account, as such term is defined in Section 9-102 of the NY UCC.
“Designated Jurisdiction” means any country or territory to the extent that such country or territory is the subject of any Sanction.
“Disqualified Equity Interests” means, with respect to any Person, any Equity Interest of such Person that, by its terms (or by the terms of any security or other Equity Interest into which it is convertible or for which it is exchangeable upon exercise or otherwise), or upon the happening of any event or condition (i) matures or is mandatorily redeemable (other than solely for Qualified Equity Interests), including pursuant to a sinking fund obligation or otherwise, (ii) is redeemable at the option of the holder thereof (other than solely for Qualified Equity Interests), in whole or in part, (iii) provides for the scheduled payments of dividends or other distributions in cash or other securities that would constitute Disqualified Equity Interests, or (iv) is or becomes convertible into or exchangeable for Indebtedness or any other Equity Interests that would constitute Disqualified Equity Interests, in each case, prior to the date that is one hundred and eighty (180) days after the Maturity Date; provided that (x) Equity Interests that satisfy the qualifications set forth in the definition of “Permitted Convertible Indebtedness” shall not constitute Disqualified Equity Interests of the Borrower for purposes of this Agreement and (y) if such Equity Interests are issued pursuant to any plan for the benefit of directors, officers, employees or consultants of such Person or by any such plan to such directors, officers, employees or consultants, such Equity Interests shall not constitute Disqualified Equity Interests solely to the extent they may be required to be repurchased by such Person upon the death, disability, retirement or termination of employment or service of such director, officer, employee or consultant or in order to satisfy applicable statutory or regulatory obligations.
“Disqualified Institution” means, on any date, any Person that (i) is a competitor of the Borrower or any of its Subsidiaries, a vulture debt fund or a distressed debt fund and (ii) is designated by the Borrower as a “Disqualified Institution” by written notice to the Agent prior to the Closing Date (or, if after the Closing Date, is reasonably acceptable to the Agent); provided that “Disqualified Institutions” shall exclude any Person that the Borrower has designated as no longer being a “Disqualified Institution” by written notice delivered to the Agent from time to time.
“Dollars” and “$” means lawful money of the United States of America.
“Early Prepayment Fee” means, with respect to any prepayment (or other payment made prior to the Maturity Date) of all or any portion of the outstanding principal amount of the Loans, whether pursuant to Sections 3.01(a), 3.01(b), 3.03(a), 3.03(b) or 11.02 (including as a result of the occurrence of any Event of Default described in Section 11.01 (including Section 11.01(h)))
or otherwise1, a fee equal to, for any prepayment that occurs (A) on or prior to the first anniversary of the Closing Date, ten percent (10.0%) of the principal amount so prepaid, (B) after the first anniversary of the Closing Date and on or prior to the second anniversary of the Closing Date, eight percent (8.0%) of the principal amount so prepaid, (C) after the second anniversary of the Closing Date and on or prior to the third anniversary of the Closing Date, six percent (6.0%) of the principal amount so prepaid, and (D) after the third anniversary of the Closing Date and on or prior to the fourth anniversary of the Closing Date, four percent (4.0%) of the principal amount so prepaid; provided that no Early Prepayment Fee shall be payable at any time on or after the earlier to occur of (x) the Tranche 2 Borrowing Date and (y) the fourth anniversary of the Closing Date.
“EEA Financial Institution” means (i) any credit institution or investment firm established in any EEA Member Country which is subject to the supervision of an EEA Resolution Authority, (ii) any entity established in an EEA Member Country which is a parent of an institution described in clause (i) of this definition, or (iii) any financial institution established in an EEA Member Country which is a subsidiary of an institution described in clauses (i) or (ii) of this definition and is subject to consolidated supervision with its parent.
“EEA Member Country” means any of the member states of the European Union, Iceland, Liechtenstein, and Norway.
“EEA Resolution Authority” means any public administrative authority or any person entrusted with public administrative authority of any EEA Member Country (including any delegee) having responsibility for the resolution of any EEA Financial Institution.
“Eligible Transferee” means and includes (i) any commercial bank, (ii) any insurance company, (iii) any finance company, (iv) any financial institution, (v) any investment fund that invests in loans or other obligations for borrowed money, (vi) with respect to any Lender, any of its Affiliates, and (vii) any other “accredited investor” (as defined in Regulation D of the Securities Act) that is principally in the business of managing investments or holding assets for investment purposes (other than any natural person).
“Environmental Law” means any Law or Governmental Approval relating to pollution or protection of the environment or the treatment, storage, disposal, release, threatened release or handling of hazardous materials, and all local laws and regulations, whether U.S. or non-U.S., related to environmental matters and any specific agreements entered into with any competent authorities which include commitments related to environmental matters.
“Equity Interests” means, with respect to any Person (for purposes of this defined term, an “issuer”), all shares of, interests or participations in, or other equivalents in respect of such issuer’s capital stock, including all membership interests, partnership interests or equivalents (including warrants, options and similar rights), that are directly or indirectly exchangeable, exercisable or otherwise convertible into, such issuer’s capital stock, whether now outstanding or
1 NTD: Revision is consistent with language in Section 3.03(c).
issued after the Closing Date, and in each case, however classified or designated and whether voting or non-voting.
“Equivalent Amount” means, with respect to an amount denominated in a single currency, the amount in another currency that could be purchased by the amount in the former currency determined by reference to the Exchange Rate at the time of determination.
“ERISA” means the United States Employee Retirement Income Security Act of 1974, as amended.
“ERISA Affiliate” means, collectively, any Obligor, Subsidiary thereof, and any Person under common control, or treated as a single employer, with any Obligor or Subsidiary thereof, within the meaning of Section 414(b), (c), (m) or (o) of the Code.
“ERISA Event” means (i) a reportable event as defined in Section 4043 of ERISA with respect to a Title IV Plan, excluding, however, such events as to which the PBGC by regulation has waived the requirement of Section 4043(a) of ERISA that it be notified within thirty (30) days of the occurrence of such event; (ii) the applicability of the requirements of Section 4043(b) of ERISA with respect to a contributing sponsor, as defined in Section 4001(a)(13) of ERISA, to any Title IV Plan where an event described in paragraph (9), (10), (11), (12) or (13) of Section 4043(c) of ERISA is reasonably expected to occur with respect to such plan within the following thirty (30) days; (iii) a withdrawal by any Obligor or any ERISA Affiliate thereof from a Title IV Plan or the termination of any Title IV Plan resulting in liability under Sections 4063 or 4064 of ERISA to an Obligor; (iv) the withdrawal of any Obligor or any ERISA Affiliate thereof in a complete or partial withdrawal (within the meaning of Section 4203 and 4205 of ERISA) from any Multiemployer Plan if there is any potential liability therefor, or the receipt by any Obligor or any ERISA Affiliate thereof of notice from any Multiemployer Plan that it is in reorganization or insolvency pursuant to Section 4241 or 4245 of ERISA; (v) the filing of a notice of intent to terminate, the treatment of a plan amendment as a termination under Section 4041 or 4041A of ERISA, or the commencement of proceedings by the PBGC to terminate a Title IV Plan or Multiemployer Plan; (vi) the imposition of liability on any Obligor or any ERISA Affiliate thereof pursuant to Sections 4062(e) or 4069 of ERISA or by reason of the application of Section 4212(c) of ERISA; (vii) the failure by any Obligor or any ERISA Affiliate thereof to make any required contribution to a Plan, or the failure to meet the minimum funding standard of Section 412 of the Code with respect to any Title IV Plan (whether or not waived in accordance with Section 412(c) of the Code) or the failure to make by its due date a required installment under Section 430 of the Code with respect to any Title IV Plan or the failure to make any required contribution to a Multiemployer Plan; (viii) the determination that any Title IV Plan is considered an at-risk plan or a plan in endangered to critical status within the meaning of Sections 430, 431 and 432 of the Code or Sections 303, 304 and 305 of ERISA; (ix) an event or condition which could reasonably be expected to constitute grounds under Section 4042 of ERISA for the termination of, or the appointment of a trustee to administer, any Title IV Plan or Multiemployer Plan; (x) the imposition of any liability under Title I or Title IV of ERISA, other than PBGC premiums due but not delinquent under Section 4007 of ERISA, upon any Obligor or any ERISA Affiliate thereof; (xi) an application for a funding waiver under Section 303 of
ERISA or an extension of any amortization period pursuant to Section 412 of the Code with respect to any Title IV Plan; (xii) the occurrence of a non-exempt prohibited transaction under Sections 406 or 407 of ERISA for which any Obligor or any Subsidiary thereof may be directly or indirectly liable; (xiii) a violation of the applicable requirements of Section 404 or 405 of ERISA or the exclusive benefit rule under Section 401(a) of the Code by any fiduciary or disqualified person for which any Obligor or any ERISA Affiliate thereof may be directly or indirectly liable; (xiv) the occurrence of an act or omission which could reasonably be expected to give rise to the imposition on any Obligor or any ERISA Affiliate thereof of fines, penalties, taxes or related charges under Chapter 43 of the Code or under Sections 409, 502(c), (i) or (1) or 4071 of ERISA; (xv) the assertion of a material claim (other than routine claims for benefits) against any Plan or the assets thereof, or against any Obligor or any Subsidiary thereof in connection with any such Plan; (xvi) receipt from the IRS of notice of the failure of any Qualified Plan to qualify under Section 401(a) of the Code, or the failure of any trust forming part of any Qualified Plan to fail to qualify for exemption from taxation under Section 501(a) of the Code; (xvii) the imposition of any Lien (or the fulfillment of the conditions for the imposition of any Lien) on any of the rights, properties or assets of any Obligor or any ERISA Affiliate thereof, in either case pursuant to Title I or Title IV of ERISA, including Section 302(f) or 303(k) of ERISA or to Section 401(a)(29) or 430(k) of the Code; (xviii) the establishment or amendment by any Obligor or any Subsidiary thereof of any “welfare plan”, as such term is defined in Section 3(1) of ERISA, that provides post-employment welfare benefits in a manner that would increase the liability of any Obligor other than those benefits required under the Consolidated Omnibus Budget Reconciliation Act or other applicable Laws; or (xix) any Foreign Benefit Event.
“ERISA Funding Rules” means the rules regarding minimum required contributions (including any installment payment thereof) to Title IV Plans, as set forth in Sections 412, 430, 431, 432 and 436 of the Code and Sections 302, 303, 304 and 305 of ERISA.
“EU Bail-In Legislation Schedule” means the EU Bail-In Legislation Schedule published by the Loan Market Association (or any successor Person), as in effect from time to time.
“Event of Default” has the meaning set forth in Section 11.01.
“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
“Exchange Rate” means, as of any date of determination, the rate at which any currency may be exchanged into another currency, as set forth on the relevant Bloomberg screen at or about 11:00 a.m. (New York City time) on such date. In the event that such rate does not appear on the Bloomberg screen, the “Exchange Rate” shall be determined by reference to such other publicly available service for displaying exchange rates as may be reasonably designated by the Agent.
“Excluded Accounts” means, collectively, (i) Deposit Accounts with cash balances of less than, and Securities Accounts and Commodity Accounts with a value of less than, $25,000
for each such Deposit Account, Securities Account and Commodity Account and less than $150,000 in the aggregate for all such Deposit Accounts, Securities Accounts and Commodity Accounts, (ii) Federal A/R Accounts, (iii) accounts used exclusively for payroll, the withheld employee portion of payroll taxes and other employee wage and benefit payments, (iv) merchant accounts (such as Paypal or Square), (v) escrow and trust accounts established or maintained in the ordinary course of business, (vi) accounts used solely for customs, insurance and fiduciary purposes established or maintained in the ordinary course of business and (vii) accounts constituting cash collateral accounts subject to Liens permitted under Sections 9.02(o) and (s).
“Excluded Property” means, collectively, (i) all fee-owned real property having a fair market value of $1,000,000 or less and all real property constituting leaseholds, (ii) any United States intent-to-use trademark application prior to the filing of a “Statement of Use” or “Amendment to Allege Use” with respect thereto, to the extent, if any, that, and solely during the period, if any, in which, the grant of a security interest therein would impair the validity or enforceability of such intent-to-use trademark application under applicable U.S. federal law (it being understood and agreed that after such period, such interest in such trademark application shall be subject to a security interest in favor of the Agent and shall be included in the Collateral), (iii) items described in clauses (ii) through (iv) in the definition of “Excluded Accounts”, and (iv) any lease, license, permit or other agreement or any property or right subject thereto (including pursuant to a purchase money security interest or Capital Lease Obligation) to the extent that such grant of a security interest (a) is prohibited by any applicable law of a governmental authority or (b) constitutes a breach or default under or results in the termination of or requires any consent not obtained under, any contract, license, agreement, instrument or other document evidencing or giving rise to such property, except (A) to the extent that the terms in such contract, license, instrument or other document providing for such prohibition, breach, default or termination, or requiring such consent are not permitted under the terms and conditions of this Agreement or (B) to the extent that such applicable law or the term in such contract, license, agreement, instrument or other document providing for such prohibition, breach, default or termination or requiring such consent is ineffective under Section 9-406, 9-407, 9-408 or 9-409 of the UCC (or any successor provision or provisions) of any relevant jurisdiction or any other applicable law (including the Bankruptcy Code) or principles of equity; provided, however, that such security interest shall attach immediately at such time as such applicable law is not effective or applicable, or such prohibition, breach, default or termination is no longer applicable or is waived, and to the extent severable, shall attach immediately to any portion of the Collateral that does not result in such consequences.
“Excluded Taxes” means any of the following Taxes imposed on or with respect to a Recipient or required to be withheld or deducted from a payment to a Recipient: (i) Taxes imposed on or measured by net income (however denominated), franchise Taxes and branch profits Taxes, in each case, (x) imposed as a result of such Recipient being organized under the laws of, or having its principal office or, in the case of any Lender, its applicable lending office located in, the jurisdiction imposing such Tax (or any political subdivisions thereof) or (y) that are Other Connection Taxes, (ii) in the case of a Lender, withholding Taxes imposed on amounts payable to or for the account of such Lender with respect to an applicable interest in a Loan or Commitment pursuant to a law in effect on the date on which (1) such Lender acquires such
interest in the Loan or Commitment or (2) such Lender changes its lending office, except in each case to the extent that, pursuant to Section 5.03, amounts with respect to such Taxes were payable either to such Lender’s assignor immediately before such Lender became a party hereto or to such Lender immediately before it changed its lending office, (iii) Taxes attributable to such Recipient’s failure to comply with Section 5.03(f), and (iv) any withholding Taxes imposed under FATCA.
“Exclusive License” (and its derivatives) means and refers to any license of Intellectual Property that is exclusive (whether as to use, geography or otherwise) and is not terminable by the licensor at any time upon ninety (90) days’ (or less) prior written notice.
“Exculpated Party” has the meaning set forth in Section 14.03(b)(ii).
“Exit Fee” has the meaning set forth in Section 3.05.
“Expense Deposit” means the cash deposit referenced in the Summary of Terms.
“FATCA” means Sections 1471 through 1474 of the Code, as of the date of this Agreement (or any amended or successor version that is substantively comparable and not materially more onerous to comply with), any current or future regulations or official interpretations thereof and any agreements entered into pursuant to Section 1471(b)(1) of the Code and any fiscal or regulatory legislation, rules or practices adopted pursuant to any intergovernmental agreement, treaty or convention among Governmental Authorities and implementing such Sections of the Code.
“FD&C Act” means the U.S. Food, Drug and Cosmetic Act of 1938 (or any successor thereto), as amended from time to time, and the rules, regulations, guidelines, guidance documents and compliance policy guides issued or promulgated thereunder.
“FDA” means the U.S. Food and Drug Administration and any successor entity.
“Federal A/R Account” means any Deposit Account the sole purpose of which is to receive direct payments of Medicare or Medicaid accounts receivable or other accounts receivable under which the federal government of the United States is the account debtor, including Medicare and Medicaid receivables and “health-care-insurance receivables” (as defined in the NY UCC).
“Federal Funds Effective Rate” means, for any day, the greater of (i) the rate calculated by the Federal Reserve Bank of New York based on such day’s federal funds transactions by depositary institutions (as determined in such manner as the Federal Reserve Bank of New York sets forth on its public website from time to time) and published on the next succeeding Business Day by the Federal Reserve Bank of New York as the federal funds effective rate and (ii) zero percent (0%).
“Foreign Benefit Event” means, with respect to any Foreign Pension Plan, (a) the existence of unfunded liabilities in excess of the amount permitted under any applicable Law, or
in excess of the amount that would be permitted absent a waiver from a Governmental Authority, (b) the failure to make the required contributions or payments, under any applicable Law, on or before the due date for such contributions or payments, (c) the receipt of a notice by a Governmental Authority relating to the intention to terminate any such Foreign Pension Plan or to appoint a trustee or similar official to administer any such Foreign Pension Plan, or alleging the insolvency of any such Foreign Pension Plan, (d) the incurrence of any liability in excess of $1,000,000 by the Borrower or any of its Subsidiaries under applicable Law on account of the complete or partial termination of such Foreign Pension Plan or the complete or partial withdrawal of any participating employer therein, or (e) the occurrence of any transaction that is prohibited under any applicable Law and that could reasonably be expected to result in the incurrence of any liability by the Borrower or any of its Subsidiaries, or the imposition on the Borrower or any of its Subsidiaries of any fine, excise tax or penalty resulting from any noncompliance with any applicable Law, in each case in excess of $1,000,000.
“Foreign Lender” means a Lender that is not a U.S. Person.
“Foreign Pension Plan” means any benefit plan that under applicable Law, other than the Laws of the United States or any political subdivision thereof, is required to be funded through a trust or other funding vehicle other than a trust or funding vehicle maintained exclusively by a Governmental Authority.
“GAAP” means generally accepted accounting principles in the United States, as in effect from time to time, set forth in the opinions and pronouncements of the Accounting Principles Board and the American Institute of Certified Public Accountants, in the statements and pronouncements of the Financial Accounting Standards Board and in such other statements by such other entity as may be in general use by significant segments of the accounting profession that are applicable to the circumstances as of the date of determination. All references to “GAAP” used herein shall be to GAAP applied consistently with the principles used in the preparation of the financial statements delivered pursuant to Section 6.01(e)(i).
“Governmental Approval” means any consent, authorization, approval, order, license, franchise, permit, certification, accreditation, registration, clearance, exemption, filing or notice that is issued or granted by or from (or pursuant to any act of) any Governmental Authority, including any application or submission related to any of the foregoing.
“Governmental Authority” means any nation, government, branch of power (whether executive, legislative or judicial), state, province or municipality or other political subdivision thereof and any entity exercising executive, legislative, judicial, monetary, regulatory or administrative functions of or pertaining to government, including without limitation regulatory authorities, governmental departments, agencies, commissions, bureaus, officials, ministers, courts, bodies, boards, tribunals and dispute settlement panels, and other law-, rule- or regulation-making organizations or entities of any state, territory, county, city or other political subdivision of any country, including the FDA and any other agency, branch or other governmental body, whether U.S. or non-U.S., that has regulatory, supervisory or administrative authority or oversight over, or is charged with the responsibility or vested with the authority to administer or enforce, any Healthcare Laws.
“Guaranty” of or by any Person (the “guarantor”) means any obligation, contingent or otherwise, of the guarantor guaranteeing or having the economic effect of guaranteeing any Indebtedness or other monetary obligation of any other Person (the “primary obligor”) in any manner, whether directly or indirectly, and including any obligation of the guarantor, direct or indirect, (i) to purchase or pay (or advance or supply funds for the purchase or payment of) such Indebtedness or other monetary obligation to purchase (or to advance or supply funds for the purchase of) any security for the payment thereof, (ii) to purchase or lease property, securities or services for the purpose of assuring the owner of such Indebtedness of the payment thereof, (iii) to maintain working capital, equity capital or any other financial statement condition or liquidity of the primary obligor so as to enable the primary obligor to pay such Indebtedness or other monetary obligation or (iv) as an account party in respect of any letter of credit or letter of guaranty issued to support such Indebtedness or monetary obligation; provided that the term Guaranty shall not include endorsements for collection or deposit in the ordinary course of business or indemnification obligations incurred in the ordinary course of business or in connection with transactions permitted by this Agreement. The amount of any Guaranty shall be deemed to be an amount equal to the stated or determinable amount of the related primary obligation, or portion thereof, in respect of which such Guaranty is made or, if not stated or determinable, the maximum reasonably anticipated liability in respect thereof as determined by the guaranteeing Person in good faith.
“Guaranty Assumption Agreement” means a Guaranty Assumption Agreement substantially in the form of Exhibit C, executed by any Subsidiary that, pursuant to Section 8.12 is required to become a “Subsidiary Guarantor”.
“Guaranteed Obligations” has the meaning set forth in Section 13.01.
“Hazardous Material” means any substance, element, chemical, compound, product, solid, gas, liquid, waste, by-product, pollutant, contaminant or material which is hazardous or toxic, and includes, without limitation, (i) asbestos, polychlorinated biphenyls and petroleum (including crude oil or any fraction thereof) and (ii) any material classified or regulated as “hazardous” or “toxic” or words of like import pursuant to an Environmental Law.
“Healthcare Laws” means, collectively, all applicable Laws, Regulatory Approvals or binding Contracts with any Regulatory Authority applicable to any Product, the ownership or use of any Product or the regulation of any Commercialization and Development Activities with respect thereto conducted by or on behalf of the Borrower or any of its Subsidiaries, whether U.S. or non-U.S., federal, state, local or equivalent, relating to the provision of medical or other professional healthcare services or supplies, billing and collection practices relating to the payment for healthcare services or supplies, insurance law (including law related to payment for “no-fault” claims) and workers compensation law as they relate to the provision of, and billing and payment for, healthcare services, patient healthcare, patient healthcare information, patient abuse, the quality and adequacy of medical care, rate-setting, equipment, personnel, operating policies, fee splitting, including, without limitation, the federal Anti-kickback Statute (42 U.S.C. § 1320a7b(b)) (the “Federal Anti-Kickback Statute”), the Physician Self-Referral Statute (42 U.S.C. § 1395nn) (the “Stark Law”), the Physician Payments Sunshine Act (42 U.S.C.
§ 1320a-7h), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a7b(a)), all criminal laws relating to health care fraud and abuse, including but not limited to 18 U.S.C. Sections 286, 287, 1035, 1347 and 1349, and the health care fraud criminal provisions under the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. §§ 1320d et seq.), the exclusion law (42 U.S.C. § 1320a-7), the civil monetary penalties law (42 U.S.C. § 1320a-7a), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.), the FD&C Act, the statutes, regulations and binding directives of applicable federal healthcare programs, including but not limited to Medicare (Title XVIII of the Social Security Act) and Medicaid (Title XIX of the Social Security Act), any binding collection and reporting requirements relating to applicable federal health care programs, the statutes, regulations, and binding directives relating to the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations pursuant to the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8), any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the Public Health Service Act (42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs, and any rules and regulations promulgated pursuant to the statutes listed herein.
“Healthcare Permit” means, with respect to any Person and its ordinary course business activities, any Regulatory Approval (i) issued or required under any Healthcare Laws applicable to such activities of such Person, including activities related to the provision of billing or invoicing for the sale of goods or services regulated or administered under any Healthcare Laws, or (ii) issued to such Person or required to be held by such Person under any Healthcare Laws.
“Hedging Agreement” means any interest rate exchange agreement, foreign currency exchange agreement, commodity price protection agreement or other interest or currency exchange rate or commodity price hedging arrangement.
“Immaterial Subsidiary” means any direct or indirect Subsidiary of the Borrower that (i) does not own or, except to the extent such license is a non-exclusive license or non-exclusive sublicense granted by any Obligor to such Subsidiary in connection with Commercialization and Development Activities, license any Material Intellectual Property and (ii) as of the most recent fiscal quarter of the Borrower in respect of which financial statements were (or were required to be) delivered pursuant to Section 8.01(b) or (c), for the Test Period then ended, (a) had (x) assets representing 2.5% or less of the Borrower’s and its Subsidiaries’ Total Assets as of the end of such Test Period and (y) generated less than 2.5% of the Borrower’s and its Subsidiaries’ consolidated third-party gross revenues as of the end of such Test Period and (b) when taken together with all other then-existing Immaterial Subsidiaries, (x) the aggregate assets of all such Immaterial Subsidiaries would represent less than 5.0% or less of the Borrower’s and its Subsidiaries’ Total Assets as of the end of such Test Period and (y) the aggregate consolidated third-party gross revenue generated by all such Immaterial Subsidiaries would be less than 5.0% of the Borrower’s and its Subsidiaries’ consolidated third-party gross revenues as of the end of such Test Period; provided, further, the Borrower may in its sole discretion designate any Immaterial Subsidiary as a Subsidiary Guarantor.
“Impermissible Qualification” means any qualification or exception to the opinion or certification of any independent public accountant as to any financial statement of the Borrower or any of its Subsidiaries that relates to the limited scope of examination of matters relevant to such financial statement.
“Indebtedness” of any Person means, without duplication, (i) all obligations of such Person for borrowed money, (ii) all obligations of such Person evidenced by bonds, debentures, notes, loan agreements or similar instruments, (iii) all obligations of such Person under conditional sale or other title retention agreements relating to property acquired by such Person, (iv) all obligations of such Person in respect of the deferred purchase price of property or services ((A) excluding (x) accounts payable incurred in the ordinary course of business not overdue by more than one hundred twenty (120) days and (y) intercompany charges of expenses and deferred revenue payroll liabilities and deferred compensation but (B) including earn-out payments, purchase price adjustments, indemnity requirements, royalties, milestones, deferred purchase price obligations and similar contingent payment obligations (such obligations arising pursuant to clause (B), “Contingent Payment Obligations”)), (v) all Indebtedness of others secured by (or for which the holder of such Indebtedness has an existing right, contingent or otherwise, to be secured by) any Lien on property owned or acquired by such Person, whether or not the Indebtedness secured thereby has been assumed, (vi) all Guaranties by such Person of Indebtedness of others, (vii) all Capital Lease Obligations of such Person, (viii) all obligations, contingent or otherwise, of such Person as an account party in respect of letters of credit and letters of guaranty, (ix) obligations under any Hedging Agreement, currency swaps, forwards, futures or derivatives transactions, (x) all obligations, contingent or otherwise, of such Person in respect of bankers’ acceptances, and (xi) any Disqualified Equity Interests of such Person. The Indebtedness of any Person shall include the Indebtedness of any other entity (including any partnership in which such Person is a general partner) to the extent such Person is liable therefor as a result of such Person’s ownership interest in or other relationship with such entity, except to the extent the terms of such Indebtedness provide that such Person is not liable therefor.
“Indemnified Party” has the meaning set forth in Section 14.03(b)(ii).
“Indemnified Taxes” means (i) Taxes, other than Excluded Taxes, imposed on or with respect to any payment made by or on account of any Obligation and (ii) to the extent not otherwise described in clause (i), Other Taxes.
“Information Certificate” means an Information and Collateral Certificate, in substantially the form set forth in Exhibit G.
“Initial Lender” has the meaning set forth in the preamble hereto.
“Insolvency Proceeding” means (i) any case, action or proceeding before any court or other Governmental Authority relating to bankruptcy, reorganization, insolvency, liquidation, receivership, dissolution, winding-up or relief of debtors, or (ii) any general assignment for the benefit of creditors, composition, marshaling of assets for creditors, or other, similar arrangement in respect of any Person’s creditors generally or any substantial portion of such Person’s
creditors, in each case undertaken under U.S. federal, state or foreign law, including the Bankruptcy Code.
“Intellectual Property” means all Patents, Trademarks, Copyrights, and Technical Information, whether registered or not, U.S. or non-U.S., including (without limitation) all of the following:
(i) applications, registrations, amendments and extensions relating to such Intellectual Property;
(ii) rights and privileges arising under any applicable Laws with respect to such Intellectual Property;
(iii) rights to sue for or collect any damages for any past, present or future infringements of such Intellectual Property; and
(iv) rights of the same or similar effect or nature in any jurisdiction corresponding to such Intellectual Property throughout the world.
“Intercompany Subordination Agreement” means a subordination agreement to be executed and delivered by the Borrower and each of its Subsidiaries, pursuant to which all obligations in respect of any Indebtedness owing to any such Person by any Obligor shall be subordinated to the prior payment in full in cash of all Obligations, such agreement to be substantially in the form attached hereto as Exhibit H.
“Interest Period” means, with respect to any Borrowing, (i) initially, the period commencing on (and including) the Borrowing Date on which such Borrowing occurred and ending on (and including) the last day of the calendar month in which such Borrowing was made, and (ii) thereafter, the period beginning on (and including) the first day of each succeeding calendar month and ending on the earlier of (and including) (x) the last day of such calendar month and (y) the Maturity Date.
“Interest Rate” means, for any Interest Period, the sum of (i) the Applicable Margin plus (ii) the greater of (x) the Benchmark Rate in effect on such day on the first day of such Interest Period and (y) fourth tenths of one percent (0.40%) per annum.
“Invention” means any novel, inventive or useful art, apparatus, method, process, machine (including any article or device), manufacture or composition of matter, or any novel, inventive and useful improvement in any art, method, process, machine (including article or device), manufacture or composition of matter.
“Investment” means, for any Person: (i) the acquisition (whether for cash, property, services or securities or otherwise) of Equity Interests, bonds, notes, debentures, partnership or other ownership interests or other securities of any other Person; (ii) the making of any deposit with, or advance, loan, assumption of debt, the purchase or other acquisition of any other debt or equity participation in, or other extension of credit to, or capital contribution in any other Person
(including the purchase of property from another Person subject to an understanding or agreement, contingent or otherwise, to resell such property to such Person), but excluding any such advance, loan or extension of credit having a term not exceeding one hundred eighty (180) days arising in connection with the sale of inventory or supplies by such Person in the ordinary course of business; (iii) the entering into of any Guaranty of, or other contingent obligation with respect to, Indebtedness or other liability of any other Person and (without duplication) any amount committed to be advanced, lent or extended to such Person; (iv) the entering into of any Hedging Agreement; or (v) without duplication, any Acquisition. The amount of an Investment will be determined at the time the Investment is made without giving effect to any subsequent changes in value.
“IRS” means the U.S. Internal Revenue Service.
“Law” means any U.S. or non-U.S. federal, state, provincial, territorial, municipal or local statute, treaty, rule, guideline, regulation, ordinance, code or administrative or judicial precedent or authority, including any interpretation or administration thereof by any Governmental Authority charged with the enforcement, interpretation or administration thereof, and all applicable administrative orders, directed duties, requests, licenses, authorizations and permits of, and agreements with, any Governmental Authority, in each case whether or not having the force of law.
“Lenders” has the meaning set forth in the preamble hereto.
“Lien” means any mortgage, lien, pledge, charge or other security interest, or any lease, title retention agreement, mortgage, restriction, easement, right-of-way, option or adverse claim (of ownership or possession) or other encumbrance of any kind or character whatsoever or any preferential arrangement that has the practical effect of creating a security interest.
“Loan” means, as the context may require, any Tranche 1 Loan, any Tranche 2 Loan or any Tranche 3 Loan, and “Loans” means, collectively, all or any combination of the foregoing, as the case may be.
“Loan Documents” means, collectively, this Agreement, the Notes, the Security Documents, any Guaranty Assumption Agreement, any Information Certificate, the Intercompany Subordination Agreement, any Borrowing Notice and any other guaranty, security agreement, subordination agreement, intercreditor agreement or other present or future document, instrument, agreement, certificate or other amendment, waiver or modification of the foregoing, delivered to the Agent or any Lender in connection with this Agreement (including, without limitation, in connection with Section 8.12) or any of the other Loan Documents, in each case, as amended, restated, supplemented and/or otherwise modified from time to time.
“Loss” means judgments, debts, liabilities, expenses, costs, damages or losses, contingent or otherwise, whether liquidated or unliquidated, matured or unmatured, disputed or undisputed, contractual, legal or equitable, including loss of value, professional fees, including reasonable fees and disbursements of legal counsel on a full indemnity basis, and all costs incurred in investigating or pursuing any Claim or any proceeding relating to any Claim.
“Majority Lenders” means, at any time, Lenders having at such time in excess of fifty percent (50%) of the aggregate Commitments (or, if such Commitments are terminated, the outstanding principal amount of the Loans) then in effect.
“Major Market Material Intellectual Property” means Material Intellectual Property registered or applied for with the U.S. Copyright Office or U.S. Patent and Trademark Office or any equivalent Governmental Authority in Canada, the United Kingdom, the European Union or any member state of the European Union.
“Margin Stock” means “margin stock” within the meaning of Regulation U and Regulation X.
“Market Cap” means, as of any date of determination, the product of (i) the number of outstanding shares of the Borrower’s common stock, multiplied by (ii) the volume weighted average sale price for the Borrower’s common stock during the period of thirty (30) consecutive trading days ended immediately prior to such date of determination on NASDAQ-GS as reported by, or based upon data reported by, Bloomberg Financial Markets or an equivalent, reliable reporting service reasonably acceptable to the Borrower and the Agent.
“Material Adverse Change” and “Material Adverse Effect” mean any event, occurrence, fact, development or circumstance that has had, or could reasonably be expected to have, a material adverse change in or effect on (i) the business, condition (financial or otherwise), operations, liabilities (actual or contingent) or property of the Borrower and its Subsidiaries taken as a whole, (ii) the ability of the Obligors, taken as a whole, to perform their obligations under the Loan Documents, as and when due, or (iii) the legality, validity, binding effect or enforceability against any Obligor of any Loan Documents to which it is a party or the rights and remedies available to or conferred upon the Agent or the Lenders under any Loan Document.
“Material Agreement” means each of (i) the Pfizer License Agreement and (ii) any Contract to which the Borrower or any of its Subsidiaries is a party or a beneficiary from time to time, or to which any assets or properties of the Borrower or any of its Subsidiaries are bound (a) the absence or termination of which could reasonably be expected to result in a Material Adverse Effect or (b) without duplication, is reasonably expected to, directly or indirectly (x) result in payments or receipts (including royalty, licensing or similar payments) made to the Borrower or any of its Subsidiaries during the Test Period then ended in an aggregate amount in excess of $1,000,000 or (y) require payments or expenditures (including royalty, licensing or similar payments) to be made by the Borrower or any of its Subsidiaries during the Test Period then ended in an aggregate amount in excess of $1,000,000 (as each such Contract may be amended, restated, supplemented and/or otherwise modified from time to time as permitted hereunder (subject to the restrictions set forth in Section 9.12)).
“Material Indebtedness” means (i) the Permitted Convertible Indebtedness and (ii) at any time, any other Indebtedness of the Borrower or any of its Subsidiaries, the outstanding principal amount of which, individually or in the aggregate, exceeds $1,000,000 (or the Equivalent Amount in other currencies).
“Material Intellectual Property” means all Intellectual Property owned or licensed by the Borrower and its Subsidiaries (i) that is a Patent which contains one or more claims that cover the sale, offer for sale, manufacture, use or importation of the Material Products or their use, whether such use is approved or not, and all Patents and applications that claim priority to any such Patent that contain such claims, (ii) that is Technical Information or a Trademark or Copyright that is used or useful in connection with all Commercialization and Development Activities, as currently conducted or as currently anticipated to be conducted, with respect to the Material Products, (iii) the loss of which could reasonably be expected to result in a Material Adverse Effect or (iv) that has a fair market value in excess of $1,000,000.
“Material Product” means (i) OC-01 for the treatment of dry eye disease or the treatment of the signs and symptoms of dry eye disease and (ii) any other Product for any other indication that (x) as of any date of determination, has generated in excess of $1,000,000 of Net Revenue during the last ended Test Period or (y) is in Advanced Development and, as of any time of determination, is reasonably expected to result, directly or indirectly, in Net Revenue with respect to such Product and such indication in excess of $1,000,000 during the immediately succeeding period of four (4) consecutive fiscal quarters, as reasonably projected by the Borrower in good faith.
“Material Regulatory Event” means an Adverse Regulatory Event that, individually or when taken together with each other Adverse Regulatory Event that has occurred since the Closing Date, (i) has resulted in a Material Adverse Effect or (ii) has resulted in fines, penalties or Losses (including loss of revenue) in excess of $1,000,000.
“Maturity Date” means August 5, 2027.
“Medicaid” means that government-sponsored entitlement program under Title XIX, P.L. 89-97 of the Social Security Act, which provides federal grants to states for medical assistance based on specific eligibility criteria, as set forth on Section 1396, et seq. of Title 42 of the United States Code.
“Medicare” means that government-sponsored insurance program under Title XVIII, P.L. 89-97, of the Social Security Act, which provides for a health insurance system for eligible elderly and disabled individuals, as set forth at Section 1395, et seq. of Title 42 of the United States Code.
“Mortgage” means a mortgage, deed of trust, deed to secure debt or similar security instrument made or to be made by a Person owning an interest in real property granting a Lien on such interest in real estate as security for the payment of Obligations which shall be in a form and substance reasonably acceptable to Agent.
“Multiemployer Plan” means any multiemployer plan, as defined in Section 400l(a)(3) of ERISA, to which any Obligor incurs or otherwise has any obligation or liability, contingent or otherwise (including as a result of being an ERISA Affiliate of another Person).
“Net Cash Proceeds” means, (a) with respect to any Casualty Event experienced or suffered or any Specified Asset Sale consummated by the Borrower or any of its Subsidiaries, the amount of cash proceeds actually received (directly or indirectly), including, without limitation, with respect to a Casualty Event, in the form of insurance proceeds or condemnation awards, from time to time by or on behalf of the Borrower or such Subsidiaries after deducting therefrom only (i) reasonable fees, costs and expenses related thereto incurred by the Borrower or such Subsidiary in connection therewith (including, without limitation, any legal, accounting and investment banking fees, brokerage and sales commissions; provided such fees, costs and expenses shall only be deducted to the extent, that the amounts so deducted are (x) actually paid to a Person that is not an Affiliate of the Borrower or any of its Subsidiaries and (y) properly attributable to such Casualty Event or Specified Asset Sale, as the case may be; (ii) Taxes (including transfer Taxes or net income Taxes) paid or payable in connection therewith; (iii) amounts required to be repaid on account of any Indebtedness permitted under Section 9.01 (other than the Obligations) that are required to be repaid as a result of such Casualty Event or Specified Asset Sale; (iv) (A) with respect to Specified Asset Sales, reserves for any liabilities attributable to the seller’s indemnities and representations and warranties to the purchaser in respect of such Specified Asset Sales (including pension and other post-employment benefit liabilities and liabilities related to environmental matters or against any indemnification obligations (fixed or contingent) associated with such transaction) and (B) with respect to Casualty Events, reserves for any indemnities and against liabilities associated with the property damaged, destructed or condemned in such Casualty Events, in each case, that are determined by the Borrower in good faith as a reserve in accordance with GAAP; provided, in each case, that to the extent such indemnification payments are not made and are no longer reserved for, such reserve amount shall constitute Net Cash Proceeds); (v) with respect to an Specified Asset Sale, cash escrows to the Borrower or any of its Subsidiaries from the sale price for such Specified Asset Sales; provided that any cash released from such escrow shall constitute Net Cash Proceeds upon such release; and (vi) with respect to Casualty Events, costs of preparing assets for transfer upon a taking or condemnation; and (b) with respect to any incurrence of Indebtedness by the Borrower or any of its Subsidiaries, the amount of cash proceeds actually received (directly or indirectly) after deducting therefrom only attorneys’ fees, investment banking fees, accountants’ fees, underwriting discounts and commissions and other customary costs, fees and expenses actually incurred in connection therewith.
“Net Revenue” means, for any relevant fiscal period, the consolidated total net revenues of the Borrower and its Subsidiaries for such fiscal period, as recognized on the income statement of the Borrower and its Subsidiaries for such fiscal period, determined on a consolidated basis in accordance with GAAP, inclusive (without limitation) of all such net revenue resulting from sales, royalty payments, milestone payments, license payments and other forms of consideration paid to the Borrower or any of its Subsidiaries (whether recurring or non-recurring) related to any Commercialization and Development Activities of any Product.
“Note” means a promissory note, in substantially the form of Exhibit A hereto, executed and delivered by the Borrower to any Lender in accordance with Section 2.03.
“NY UCC” means the UCC as in effect from time to time in New York.
“Obligations” means, all amounts, obligations, liabilities, covenants and duties of every type and description (including all Guaranteed Obligations) owing by any Obligor to any Secured Party, any indemnitee hereunder or any participant, arising out of, under, or in connection with, any Loan Document, whether direct or indirect (regardless of whether acquired by assignment), absolute or contingent, due or to become due, whether liquidated or not, now existing or hereafter arising and however acquired, and whether or not evidenced by any instrument or for the payment of money, including, without duplication, (i) all Loans, (ii) all interest, whether or not accruing after the filing of any petition in bankruptcy or after the commencement of any insolvency, reorganization or similar proceeding, and whether or not a claim for post-filing or post-petition interest is allowed in any such proceeding, and (iii) all other fees, expenses (including fees, charges and disbursement of counsel), interest, commissions, charges, costs, disbursements, indemnities and reimbursement of amounts paid and other sums chargeable to such Obligor under any Loan Document.
“Obligor Intellectual Property” means, at any time of determination, Intellectual Property owned by, licensed to or otherwise held by any Obligor at such time including, without limitation, the Intellectual Property listed on Schedule 7.05(c).
“Obligors” means, collectively, the Borrower, the Subsidiary Guarantors and their respective successors and permitted assigns.
“OC-01” means OC-01, a nasal spray that contains varenicline in any form as the active ingredient, including the Product that is presently the subject of a New Drug Application under section 505(b)(2) of FD&C Act.
“OC-01 Approval” has the meaning set forth in Section 6.02(g).
“OC-01 Net Recurring Revenue” means, for any relevant fiscal period, the OC-01 Net Revenue for such period, excluding any portion of such OC-01 Net Revenue for such period resulting from one-time or non-recurring royalty, product or sales milestone payments or licensing payments in respect of OC-01.
“OC-01 Net Revenue” means, for any relevant fiscal period, the Net Revenue from the direct or indirect sale or licensing of OC-01.
“OFAC” means the U.S. Department of the Treasury’s Office of Foreign Assets Control.
“Organic Document” means, for any Person, such Person’s formation documents, including, as applicable its certificate of incorporation, bylaws, certificate of partnership, partnership agreement, certificate of formation, limited liability agreement, operating agreement and all shareholder agreements, voting trusts and similar agreements and arrangements applicable to such Person’s Equity Interests, or any equivalent document of any of the foregoing.
“Other Connection Taxes” means, with respect to any Recipient, Taxes imposed as a result of a present or former connection between such Recipient and the jurisdiction imposing such Tax (other than connections arising solely from such Recipient having executed, delivered,
become a party to, performed its obligations under, received payments under, received or perfected a security interest under, engaged in any other transaction pursuant to or enforced any Loan Document, or sold or assigned an interest in any Loan or Loan Document).
“Other Taxes” means all present or future stamp, court or documentary, intangible, recording, filing or similar Taxes that arise from any payment made under, from the execution, delivery, performance, enforcement or registration of, from the receipt or perfection of a security interest under, or otherwise with respect to, any Loan Document, except any such Taxes that are Other Connection Taxes imposed with respect to an assignment.
“Participant” has the meaning set forth in Section 14.05(e).
“Participant Register” has the meaning set forth in Section 14.05(g).
“Patents” means all patents and patent applications, including (i) the Inventions and improvements described and claimed therein and any patent or patent application that claims priority to the same priority documents, (ii) patents and patent applications in any form in any worldwide jurisdiction, including but not limited to the right to seek, continue or file reissues, oppositions, divisions, continuations, renewals, extensions, expired, abandoned, rulings from any governmental authority regarding including ones arising from any proceeding such as Inter Partes review, and continuations in part thereof and (iii) all patents, patent rights in any form and other additions in connection therewith, whether in or related to the United States or any foreign country or other jurisdiction.
“Patriot Act” has the meaning set forth in Section 14.20.
“Payment Date” means (i) the last day of each Interest Period (provided that if such last day of any Interest Period is not a Business Day, then the Payment Date shall be the next succeeding Business Day) and (ii) the Maturity Date.
“PBGC” means the United States Pension Benefit Guaranty Corporation referred to and defined in ERISA and any successor entity performing similar functions.
“Permitted Acquisition” means any Acquisition by the Borrower or any of its Subsidiaries; provided that:
(a) immediately prior to, and after giving effect to such Acquisition, no Default shall have occurred and be continuing or could reasonably be expected to result therefrom;
(b) all transactions in connection therewith shall be consummated, in all material respects, in accordance with all applicable Laws;
(c) in the case of an Acquisition of Equity Interests of any Person, all of such Equity Interests (except for any such securities in the nature of directors’ qualifying shares required pursuant to any applicable Law) shall be owned by the Borrower or a wholly-owned, direct or indirect Subsidiary of the Borrower, and, in the event of an
Acquisition that results in the creation or acquisition of a new Subsidiary of the Borrower, the Borrower shall cause such new Subsidiary to comply with the terms of Section 8.12(a), if applicable;
(d) such Person (in the case of an Acquisition of Equity Interests of such Person) or assets (in the case of an Acquisition of assets or a division of such Person) shall be engaged or used, as the case may be, in businesses or lines of business that would be permitted pursuant to Section 9.04;
(e) on a pro forma basis after giving effect to such Acquisition, the Borrower and its Subsidiaries shall be in compliance with the financial covenant set forth in Section 10;
(f) the fair market value of the consideration (whether cash or non-cash) paid by or on behalf of the Borrower and its Subsidiaries in such Acquisition, when taken together with the fair market value of all such consideration paid by or on behalf of the Borrower and its Subsidiaries in connection with all other Permitted Acquisitions consummated or effected since the Closing Date (in each case, inclusive of all Contingent Payment Obligations, post-closing adjustments, payments on “seller notes” or otherwise, to the extent actually paid), does not exceed $3,000,000 in the aggregate during any fiscal year or $5,000,000 in the aggregate during the term of this Agreement;
(g) to the extent that all or any portion of the purchase price for any such Acquisition is paid in Equity Interests, all such Equity Interests shall be Qualified Equity Interests or otherwise permitted under Section 9.01;
(h) in the case of any Acquisition that has a purchase price in excess of $1,000,000, the Borrower shall have provided the Agent with at least ten (10) Business Days’ prior written notice of any such Acquisition, together with (i) a copy of the draft purchase agreement related to the proposed Acquisition (and any related material documents requested by the Agent), (ii) any available quarterly and annual financial statements of the Person whose Equity Interests or assets are being acquired for the twelve (12) month period ending thirty (30) days immediately prior to such Acquisition, including any audited financial statements that are available, (iii) copies of any due diligence reports prepared by or on behalf of the Borrower or its applicable Subsidiary, as applicable, prior to such Acquisition (to the extent the Borrower is permitted to provide the same to the Agent and the third-party which has prepared such diligence reports consents to such disclosure upon execution and delivery of a customary non-reliance agreement by the Agent), (iv) a certificate of a Responsible Officer of the Borrower (prepared in reasonable detail), certifying that the Acquisition complies with the requirements of this definition and (v) any other information reasonably requested by the Agent and available to the Obligors; and
(i) neither the Borrower nor any of its Subsidiaries shall, in connection with (and upon giving effect to) any such Acquisition, assume or remain liable with respect to, or be subject to (x) any Indebtedness of the related seller or the business, Person or
properties acquired, except to the extent permitted pursuant to Section 9.01 or (y) any Lien on any business, Person or assets acquired, except to the extent permitted pursuant to Section 9.02.
“Permitted Bond Hedge Transaction” means any bond hedge, capped call or similar option transaction entered into by the Borrower in respect of the Borrower’s common stock and entered into in connection with the issuance of Permitted Convertible Indebtedness; provided that (i) the terms, conditions and covenants of each such transaction shall be customary for transactions of such type, as determined in good faith by the Borrower, (ii) such transaction is consummated substantially simultaneously with the issuance of such Permitted Convertible Indebtedness and paid for out of the proceeds thereof and (iii) the purchase price for such Permitted Bond Hedge Transaction (a) does not exceed the Net Cash Proceeds received by the Borrower from the issuance of Permitted Convertible Indebtedness and (b) is financed with the proceeds of such issuance.
“Permitted Cash Equivalent Investments” means (i) 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, (ii) commercial paper maturing no more than two hundred and seventy (270) days after the date of its creation and having the highest rating from either Standard & Poor’s Ratings Group or Moody’s Investors Service, Inc., (iii) certificates of deposit, banker’s acceptances and time deposits maturing no more than one hundred eighty (180) days after the date of acquisition, issued or guaranteed by any domestic office of any commercial bank that (x) is organized under the laws of the United States or any State thereof and (y) has combined capital and surplus of at least $500,000,000, (iv) any investments permitted to be made by the Borrower’s written investment policy adopted by its Board in effect on the Closing Date (as amended from time to time subject to the consent of the Agent (not to be unreasonably withheld or delayed) and (v) any money market funds that comply with (x) the criteria set forth in SEC Rule 2a-7 under the Investment Company Act of 1940, (y) are rated AAA and Aaa (or equivalent rating) by both Standard & Poor’s Ratings Group and Moody’s Investors Service, Inc. and (z) have portfolio assets of at least $5,000,000,000.
“Permitted Convertible Indebtedness” means unsecured Indebtedness in the form of notes issued by the Borrower that (i) as of the date of issuance thereof contains terms, conditions, covenants, conversion or exchange rights, redemption rights and offer to repurchase rights, in each case, as are typical and customary for notes of such type, (ii) is convertible or exchangeable into a fixed number of shares of common stock of the Borrower (or Qualified Equity Interests following a merger event or other change of common stock of the Borrower), cash or a combination thereof (such amount of cash determined by reference to the price of the Borrower’s common stock or such Qualified Equity Interests), and cash in lieu of fractional shares of common stock of the Borrower, (iii) has a stated final maturity date that is no earlier than the date that is one hundred eighty (180) days after the Maturity Date (the “Earliest Date”), (iv) shall not be required to be repaid, prepaid, redeemed, repurchased or defeased (whether through scheduled amortization, principal payments, mandatory redemptions or payments of principal or otherwise), whether on one or more fixed dates, prior to the Earliest Date, except (x) upon the
occurrence of an event of default, “fundamental change” or equivalent or (y) following the Borrower’s election to redeem such notes to the extent expressly permitted pursuant to Section 9.07(d) or as otherwise consented to by the Majority Lenders; provided that the right to convert such Indebtedness into Qualified Equity Interests, cash or any combination thereof shall not be deemed to violate this clause (iv), (v) is not supported by a Guaranty made or issued by any Subsidiary of the Borrower that is not an Obligor and (vi) does not provide for or require the payment of cash interest in excess of five and a half (5.5%) per annum2.
“Permitted Indebtedness” means any Indebtedness permitted under Section 9.01.
“Permitted Liens” means any Liens permitted under Section 9.02.
“Permitted Refinancing” means, with respect to any Indebtedness, any refinancing, extension, renewal or replacement of such Indebtedness; provided that such refinancing, extension, renewal or replacement shall not (i) increase the outstanding principal amount of the Indebtedness above the outstanding principal amount of the Indebtedness being refinanced, extended, renewed or replaced plus accrued and unpaid interest and premiums thereon as of the time of such refinancing, (ii) contain terms relating to outstanding principal amount, amortization, maturity, collateral security (if any) or subordination (if any), or other material terms that, taken as a whole, are less favorable in any material respect to the Borrower and its Subsidiaries or the Secured Parties (as determined in good faith by the Borrower) than the terms of any agreement or instrument governing the Indebtedness being refinanced, extended, renewed or replaced, (iii) have an interest rate not exceeding the then applicable market interest rate (as reasonably determined by the Borrower in good faith), (iv) contain any new requirement to grant any Lien or to give any Guaranty that was not an existing requirement of the Indebtedness being refinanced, extended, renewed or replaced and (v) after giving effect to such refinancing, extension, renewal or replacement, no Default shall have occurred (or could reasonably be expected to occur) as a result thereof.
“Person” means any individual, corporation, company, voluntary association, partnership, limited liability company, joint venture, trust, unincorporated organization or Governmental Authority or other entity of whatever nature.
“Pfizer License Agreement” means that certain Non-Exclusive Patent License Agreement, dated as of October 18, 2019, by and between Pfizer Inc. and the Borrower, as amended, restated, supplemented and/or otherwise modified from time to time (subject to the restrictions set forth in Section 9.12).
“Phase III Clinical Trial” means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product for patients having the disease or condition being studied, and as described in 21 C.F.R. § 312.21(c), as amended from time to time, and any foreign equivalent thereof.
2 NTD: Rate to be redacted in the publicly filed version of the agreement
“Plan” means any employee pension benefit plan (other than a Multiemployer Plan) subject to the provisions of Title IV of ERISA or Section 412 of the Code or Section 302 of ERISA, and in respect of which the Borrower or any ERISA Affiliate is (or, if such plan were terminated, would under Section 4069 of ERISA be deemed to be) an “employer” as defined in Section 3(5) of ERISA.
“Prepayment Date” has the meaning set forth in Section 3.03(a)(i).
“Prepayment Price” has the meaning set forth in Section 3.03(a)(i).
“Proceeding” has the meaning set forth in Section 14.03(b)(ii).
“Product” means all pharmaceutical products that are in process of development or developed, distributed, imported, exported, labeled, promoted, licensed, marketed, sold or otherwise commercialized by the Borrower or any of its Subsidiaries at any time, including by way of an outbound license or similar arrangement to a third party for distribution, marketing, sale or other commercialization.
“Product Related Information” means, with respect to any Product, all books, records, lists, ledgers, files, manuals, Contracts, correspondence, reports, plans, drawings, data and other information of every kind (in any form or medium), including related to Intellectual Property, and all techniques and other know-how, that is necessary or useful for any Commercialization and Development Activities with respect to such Product, including (i) branding materials, packaging and other marketing, promotion and sales materials and information, (ii) clinical data, information included or supporting any Regulatory Approval and all other documents, records, files, data and other information necessary to or useful for Commercialization and Development Activities, (iii) litigation and dispute records, and accounting records, and (iv) all other information, techniques and know-how necessary or useful in connection with the Commercialization and Development Activities for any Product.
“Prohibited Payment” means any bribe, rebate, payoff, influence payment, kickback or other payment or gift of money or anything of value (including meals or entertainment) to any officer, employee or ceremonial office holder of any government or instrumentality thereof, political party or supra-national organization (such as the United Nations), any political candidate, any royal family member or any other person who is connected or associated personally with any of the foregoing that is prohibited under any applicable Law for the purpose of influencing any act or decision of such payee in such payee’s official capacity, inducing such payee to do or omit to do any act in violation of such payee’s lawful duty, securing any improper advantage or inducing such payee to use such payee’s influence with a government or instrumentality thereof to affect or influence any act or decision of such government or instrumentality.
“Proportionate Share” means, with respect to each Lender, the percentage obtained by dividing (i) the sum of all Commitments (or, if the Commitments are terminated, the outstanding principal amount of the Loans) of such Lender then in effect by (ii) the sum of all Commitments
(or, if the Commitments are terminated, the outstanding principal amount of the Loans) of all Lenders then in effect.
“Qualified Equity Interest” means, with respect to any Person, any Equity Interest of such Person that is not a Disqualified Equity Interest.
“Qualified Plan” means an employee benefit plan (as defined in Section 3(3) of ERISA) other than a Multiemployer Plan (i) that is or was at any time maintained or sponsored by any Obligor or any ERISA Affiliate thereof or to which any Obligor or any ERISA Affiliate thereof has ever made, or was ever obligated to make, contributions, and (ii) that is intended to be tax qualified under Section 401(a) of the Code.
“Recipient” means any Lender or the Agent, as applicable.
“Referral Source” has the meaning set forth in Section 7.07(c).
“Register” has the meaning set forth in Section 14.05(d).
“Regulation T” means Regulation T of the Board of Governors of the Federal Reserve System, as amended.
“Regulation U” means Regulation U of the Board of Governors of the Federal Reserve System, as amended.
“Regulation X” means Regulation X of the Board of Governors of the Federal Reserve System, as amended.
“Regulatory Approval” means, with respect to any Product or Commercialization and Development Activities, any Healthcare Permit or other Governmental Approval, whether U.S. or non-U.S., that is required to be held or maintained by, or for the benefit of the Borrower or any of its Subsidiaries with respect thereto, including all Product Standards, applications, pre-approvals and post-approvals, governmental pricing approvals, reimbursement approvals and approvals of applications for regulatory exclusivity, clearances, licenses, notifications, registrations or authorizations of any Regulatory Authority, in each case necessary for the ownership, use or other commercialization of such Product or for any such Commercialization and Development Activities.
“Regulatory Authority” means any Governmental Authority, whether U.S. or non-U.S., that is concerned with or has regulatory or supervisory oversight with respect to any Product or any Commercialization and Development Activities with respect to any Product, including the FDA and all equivalent Governmental Authorities, whether U.S. or non-U.S.
“Related Fund” means, with respect to any Lender, a fund which is managed or advised by the same investment manager or investment adviser as such Lender or, if it is managed by a different investment manager or investment adviser, a fund whose investment manager or investment adviser is an Affiliate of the investment manager or investment adviser of such Lender.
“Related Parties” has the meaning set forth in Section 14.16.
“Resolution Authority” means an EEA Resolution Authority or, with respect to any UK Financial Institution, a UK Resolution Authority.
“Responsible Officer” of any Person means each of the president, chief executive officer, chief financial officer and similar officer of such Person.
“Restricted Payment” means any dividend or other distribution (whether in cash, Equity Interests or other property) with respect to any Equity Interests of the Borrower or any of its Subsidiaries, or any payment (whether in cash, Equity Interests or other property), including any sinking fund or similar deposit, on account of the purchase, redemption, retirement, acquisition, cancellation or termination of any such Equity Interests of the Borrower or any of its Subsidiaries, or any option, warrant or other right to acquire any such Equity Interests of the Borrower or any of its Subsidiaries.
“Restrictive Agreement” means any Contract or other arrangement that prohibits, restricts or imposes any condition upon the ability of the Borrower or any of its Subsidiaries (i) to create, incur or permit to exist any Lien upon any of its properties or assets (other than (x) customary provisions in Contracts (including, without limitation, leases and licenses of Intellectual Property) restricting the assignment thereof or, in the case of any lease or license, the sublease or sublicense or other disposition of the applicable leased or licensed property and (y) restrictions or conditions imposed by any Contract governing Permitted Indebtedness secured by Liens permitted under Sections 9.02(b), (c), (i), (j), (m), (o), (s),
Oyster Point Pharma Announces FDA Approval of TYRVAYA™ (varenicline solution) Nasal Spray for the Treatment of the Signs and Symptoms of Dry Eye Disease
•TYRVAYA is the first and only nasal spray approved for the treatment of the signs and symptoms of dry eye disease
•TYRVAYA is designed to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease
•TYRVAYA was studied in a broad patient population of adults with mild, moderate or severe dry eye disease
•TYRVAYA will be available with a prescription in November 2021
•Oyster Point to host conference call today at 8:00 a.m. ET
PRINCETON, N.J., October 18, 2021 – Oyster Point Pharma, Inc. (Nasdaq: OYST), today announced that the U.S. Food and Drug Administration (FDA) has approved TYRVAYA™ (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease. TYRVAYA Nasal Spray is the first and only nasal spray approved for the treatment of dry eye disease. TYRVAYA Nasal Spray is believed to bind to cholinergic receptors to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Oyster Point Pharma is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies to treat ophthalmic diseases.
Experience the interactive Multichannel News release here: https://www.multivu.com/players/English/8955851-oyster-point-pharma-fda-approval-tyrvaya/.
TYRVAYA Nasal Spray is a highly selective cholinergic agonist delivered twice daily as an aqueous nasal spray into each nostril to activate basal tear production. Nasal spray administration provides a new way to treat dry eye disease without administering medication onto an already irritated ocular surface. In addition, nasal delivery may allow some patients who have difficulty independently administering topical eye drops to administer independently their prescribed dry eye disease therapy.
Jeffrey Nau, Ph.D., MMS, president and CEO of Oyster Point Pharma commented, “The approval of TYRVAYA Nasal Spray marks a milestone for patients and eye care professionals by providing a new drug treatment option for the signs and symptoms of dry eye disease with a differentiated route of administration that is believed to leverage a nerve pathway that can be accessed within the nose.” Dr. Nau further stated, “In any therapeutic area, it’s always an exciting moment when you follow the science and develop a truly innovative pharmaceutical treatment option for patients that addresses an important unmet medical need. In conjunction with the FDA, it has been an honor to work alongside my colleagues at Oyster Point to bring TYRVAYA Nasal Spray to the dry eye disease community. We look forward to making TYRVAYA Nasal Spray available to eye care professionals and their patients.”
Ed Holland, M.D., Director of Cornea Services at Cincinnati Eye Institute and Professor of Ophthalmology at the University of Cincinnati said, “I see many patients in my practice whose lives are impacted by dry eye disease. TYRVAYA Nasal Spray is a new pharmaceutical approach with a differentiated mechanism of action for the dry eye disease community. Having a product that provides clinically meaningful production of basal tear film as early as four weeks is incredible for the dry eye patient.”
TYRVAYA Nasal Spray was studied in the ONSET-1, ONSET-2, and MYSTIC clinical trials in over 1,000 patients with mild, moderate or severe dry eye disease. In ONSET-1 and ONSET-2, the majority of patients were female (74%), the mean (standard deviation [SD]) age was 61 (12.5) years, the mean (SD) baseline anesthetized Schirmer’s score was 5.1 mm (2.9), and the mean (SD) baseline eye dryness score (EDS) was 59.3 (21.6). Use of artificial tears was allowed during the studies. Enrollment criteria included minimal signs [i.e., anesthetized Schirmer’s score (range, 0-10 mm) and corneal fluorescein staining (range, 2-14)] and enrollment was not limited by baseline EDS (range, 2-100).
Basal tear production was measured by change from baseline in anesthetized Schirmer’s score, based on a test that utilizes calibrated filter paper to wick tears and measure tear volume. Eye dryness was measured by change from baseline in Eye Dryness Score, a visual analogue scale where patients rated their level of eye dryness discomfort, with a greater reduction in score indicating greater symptom relief. Eye dryness score was evaluated both in the Controlled Adverse Environment (CAE®) * and in the clinic environment.
TYRVAYA-treated patients showed statistically significant improvements in tear film production as assessed using the anesthetized Schirmer’s score (0-35 mm) at Week 4. Of the patients treated with TYRVAYA, 52% achieved ≥10 mm increase in Schirmer’s score from baseline in the ONSET-1 study, and 47% achieved ≥10 mm increase in Schirmer’s score from baseline in the ONSET-2 study, compared to 14% and 28% of vehicle-treated patients in the ONSET-1 study and the ONSET-2 study, respectively at Week 4 (p<0.01 in both studies). Of the patients treated with TYRVAYA, the mean change in Schirmer’s score was 11.7 mm and 11.3 mm as compared to 3.2 mm and 6.3 mm in the vehicle treated patients in the ONSET-1 study and ONSET-2 study, respectively at Week 4.
In the Controlled Adverse Environment (CAE®), in ONSET-1 the observed mean change from baseline in Eye Dryness Score at week 3 was -16.0 mm in TYRVAYA-treated patients (n=45) compared to -4.4 mm in vehicle-treated patients (n=42). This endpoint was met (p<0.01). In ONSET-2, the observed mean change from baseline in Eye Dryness Score at week 4 was -10.3 mm in TYRVAYA-treated patients (n=187) compared to -7.4 mm in vehicle-treated patients (n=169). This endpoint was not met (p>0.05).
In the clinic environment, in ONSET-1 the mean change from baseline in Eye Dryness Score at week 4 was -18.9 mm in TYRVAYA-treated patients (n=46) compared to -5.4 mm in vehicle-treated patients (n=43). This endpoint was met (p=0.01). In ONSET-2, the mean change from baseline in Eye Dryness Score at week 4 was -19.8 mm in TYRVAYA-treated patients (n=255) compared to -15.4 mm in vehicle-treated patients (n=248). As the CAE® endpoint was not statistically significant, this secondary endpoint was not eligible for statistical testing and was not met.
The most common adverse reaction reported in 82% of patients was sneezing. Events that were reported in 5-16% of patients were cough, throat irritation, and instillation-site (nose) irritation.
TYRVAYA Nasal Spray will be available with a prescription in November 2021 in cartons containing two multidose nasal spray bottles. Each nasal spray bottle covers treatment for 15 days, administered twice daily into each nostril. Samples that provide 15 days of treatment will also be made available to eye care providers.
Conference Call Information
Oyster Point Pharma will host a live conference call and webcast today at 8:00 a.m. Eastern Time to discuss the FDA approval of TYRVAYA Nasal Spray for the treatment of the signs and symptoms of dry eye disease. To access the live call by phone, please dial (855) 548-1220 (US/Canada) or (602) 563-8619 (International). The
conference ID number is 5491078. The webcast will be made available on the company’s website at www.oysterpointrx.com under the “Events & Presentations” section found here.
Oyster Point’s Commitment to Patient Access
Oyster Point is committed to supporting the dry eye disease community by supporting access to medication for appropriate patients. The company has launched a patient support program called TEAMTyrvayaä. For more information on the program and how to enroll, please visit www.Tyrvaya-Pro.com.
About Dry Eye Disease and the Role of Tear Film
Dry eye disease is a chronic condition that impacts an estimated 38 million people in the U.S. and is growing in prevalence1,2. It can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision, and eye fatigue. Dry eye disease is a multifactorial disease of the ocular surface characterized by disruption of the tear film. Human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins3. Natural tear film protects and lubricates the eyes, washes away foreign particles, contains growth factors and antimicrobial components, and creates a smooth surface that forms the primary refractive surface of the eye.
About TYRVAYA™ (varenicline solution) Nasal Spray
TYRVAYA (varenicline solution) Nasal Spray 0.03 mg (formerly referred to as OC-01) is a highly selective cholinergic agonist that is FDA-approved to treat the signs and symptoms of dry eye disease as a multidose nasal spray. The parasympathetic nervous system, the “rest and digest” system of the body, controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose. The efficacy of TYRVAYA Nasal Spray in dry eye disease is believed to be the result of varenicline’s activity at heteromeric sub-type(s) of the nicotinic acetylcholine (nACh) receptor where its binding produces agonist activity and activates the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease. Varenicline binds with high affinity and selectivity at human α4β2, α4α6β2, α3β4, α3α5β4 and α7 neuronal nicotinic acetylcholine receptors. The exact mechanism of action is unknown at this time.
TYRVAYA™ Important Safety Information
The most common adverse reaction reported in 82% of patients was sneezing. Events that were reported in 5-16% of patients were cough, throat irritation, and instillation-site (nose) irritation. There are no contraindications associated with TYRVAYAÔ (varenicline solution) Nasal Spray.
Please see full Prescribing Information at www.tyrvaya-pro.com/prescribinginformation.
About Oyster Point Pharma, Inc.
Oyster Point Pharma is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases. In October 2021, Oyster Point Pharma received FDA-approval for TYRVAYAÔ (varenicline solution) Nasal Spray for the treatment of the signs and symptoms of dry eye disease. Oyster Point has a growing pipeline of clinical and pre-clinical programs and continues to expand its research and development pipeline through internal innovation and external collaborations. Oyster Point is continuously striving to advance breakthrough science and deliver therapies seeking to address the unmet needs of patients with ophthalmic disease and the eye care professionals who take care of them. For more information, visit www.oysterpointrx.com and follow @OysterPointRx on Twitter and LinkedIn.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that reflect the current beliefs, expectations and assumptions of Oyster Point Pharma (the “Company” or “our”) regarding the future of the Company’s business, our future plans and strategies, regulatory approvals, preclinical and clinical results, future financial condition and other future conditions. All statements other than statements of historical facts contained in this press release, including express or implied statements regarding plans and objectives of management for future operations, future results of operations and financial
position, business strategy, product candidates, regulatory approvals, planned future product commercialization, planned preclinical studies and clinical trials, expected results of preclinical studies or clinical trials, and their timing and likelihood of success, expected research and development commercialization costs, are forward-looking statements. The words “if approved,” “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things: our plans and potential for success relating to commercializing TYRVAYA; the beneficial characteristics, safety, efficacy and therapeutic effects of TYRVAYA and our preclinical and clinical product candidates; our plans relating to the further development and manufacturing of TYRVAYA and our preclinical and clinical candidates, including potential additional indications or disease areas to be evaluated and pursued; the timing of initiation of our future preclinical studies or clinical trials; the uncertainties inherent in pharmaceutical research and development, including preclinical study and clinical trial results and additional analysis of existing data; the likelihood of clinical trials demonstrating safety and efficacy of our product candidates, and other positive results; the timing or likelihood of regulatory filings and approvals TYRVAYA and our clinical and preclinical candidates, including in potential additional indications for TYRVAYA and potential filings in additional jurisdictions; our plans and ability to obtain or protect intellectual property rights including extensions of existing patent terms where available; our ability to recruit and retain key personnel needed to develop and commercialize our product candidates, if approved, and to grow our company; existing regulations and regulatory developments in the United States and other jurisdictions; our continued reliance on third parties to conduct additional preclinical studies and clinical trials of our product candidates, and for the manufacture of our product candidates for potential commercialization and for preclinical studies and clinical trials; the impact of the COVID-19 pandemic on our business, operations, and regulatory and clinical development timelines; the accuracy of our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; our financial performance; market conditions; the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements; and other risks described in the “Risk Factors” section included in our public filings that we have made and will make with the Securities and Exchange Commission (SEC). The Company is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
LifeSci Advisors, LLC
1.Market-Scope. 2020 Dry Eye Products Report: A Global Market Analysis for 2019 to 2025. October 2020.
2.Tsubota K, Pflugfelder S, Liu Z, Baudouin C. Defining dry eye from a clinical perspective. Int J Mol Sci. 2020;21(23):1-24.
3.Willcox, M. D., Argüeso, P., Georgiev, G. A., Holopainen, J. M., Laurie, G. W., Millar, T. J., … & Jones, L. (2017). TFOS DEWS II tear film report. The ocular surface, 15(3), 366-403.
*Controlled Adverse Environment (CAE(R)) is a registered trademark of Ora, Inc.