Asset Purchase Agreement by and among Amphastar Pharmaceuticals, Inc., Amphastar Medication Co., LLC, and Eli Lilly and Company, dated April 21, 2023
Exhibit 10.1
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS ([***]), HAS BEEN OMITTED BECAUSE
THE INFORMATION (I) IS NOT MATERIAL AND
(II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED
ASSET PURCHASE AGREEMENT
BY AND AMONG
ELI LILLY AND COMPANY,
AMPHASTAR MEDICATION CO., LLC,
AND
Amphastar Pharmaceuticals, Inc.
DATED AS OF
APRIL 21, 2023
TABLE OF CONTENTS
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EXHIBITS
Exhibit ABill of Sale and Assignment and Assumption Agreement
Exhibit BIntellectual Property License Agreement
Exhibit CIP Assignment Agreement
Exhibit DManufacturing Services Agreement
Exhibit ELocemia Assumption Agreement
Exhibit FTransition Services Agreement
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ASSET PURCHASE AGREEMENT
THIS ASSET PURCHASE AGREEMENT (this “Agreement”), dated as of April 21, 2023, is made by and among Amphastar Medication Co., LLC, a Delaware limited liability company (“Buyer”), Eli Lilly and Company, an Indiana corporation (“Seller”), and, solely for the purpose of Section 7.6 and Section 12.15 (and any provision of Article I or Article XII to give effect thereto), Amphastar Pharmaceuticals, Inc., a Delaware corporation (“Buyer Guarantor”).
WHEREAS, Seller sells the pharmaceutical product that currently is marketed for sale to consumers under the trademark BAQSIMI®, and in connection therewith, operates the Business; and
WHEREAS, Seller wishes to sell to Buyer, and Buyer wishes to purchase from Seller the Transferred Assets and assume the Assumed Liabilities, in each case, upon the terms and subject to the conditions set forth in this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants herein contained and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Parties hereby agree as follows:
DEFINITIONS
“Accounting Firm” has the meaning set forth in Section 3.2(k).
“Affiliate” means, with respect to any Person, any other Person that controls, is controlled by or is under common control with such Person (and for this purpose, the term control means the power to direct the management and policies of a Person (directly or indirectly), whether through ownership of voting securities, by Contract or otherwise (and the terms controlling and controlled have meanings correlative to the foregoing)).
“Aggregate Net Sales Earnout” has the meaning set forth in Section 3.2(c).
“Aggregate Net Sales Milestone” has the meaning set forth in Section 3.2(c).
“Agreement” has the meaning set forth in the preamble.
“Allocation” means an allocation of the Purchase Price and the absolute value of the Assumed Liabilities among the Transferred Assets prepared by Seller in accordance with Section 1060 of the Code and the Treasury Regulations thereunder.
“Allocation Statement” has the meaning set forth in Section 3.4(a).
“Ancillary Agreements” means the Bill of Sale and Assignment and Assumption Agreement, the IP Assignment Agreement, the Manufacturing Services Agreement, the Locemia
Assumption Agreement, the Transition Services Agreement, the Confidentiality Agreement, the Intellectual Property License Agreement and the other documents, instruments, exhibits, annexes, schedules or certificates contemplated hereby and thereby.
“Annual Net Sales Earnout” has the meaning set forth in Section 3.2(b).
“Annual Net Sales Milestone” has the meaning set forth in Section 3.2(b).
“Anti-Corruption Laws” means the United States Foreign Corrupt Practices Act and similar anti-corruption or anti-bribery laws of any other jurisdiction (national, state or local) where Seller operates concerning or relating to public sector or private sector bribery or corruption and applicable to the Historical Business or the Product.
“Assumed Liabilities” has the meaning set forth in Section 2.3(a).
“Audit” has the meaning set forth in Section 8.8(a).
“Audit Firm” has the meaning set forth in Section 8.8(a).
“Bill of Sale and Assignment and Assumption Agreement” means the Bill of Sale and Assignment and Assumption Agreement, in the form attached hereto as Exhibit A.
“Business” means any and all of the following activities as conducted by Seller or any of its Subsidiaries, as of the date hereof or as of the Closing Date, with respect to the Product: development, manufacturing, researching (including non-clinical and clinical research), testing, and commercialization (including marketing, promotion, pricing, selling, importing and exporting).
“Business Counterparties” has the meaning set forth in Section 7.3.
“Business Day” means any day other than a Saturday, Sunday or other day on which banks in New York City, New York or Indianapolis, Indiana are permitted or required to close by applicable Law.
“Business Financials” has the meaning set forth in Section 5.6.
“Business Sale” has the meaning set forth in Section 12.7.
“Buyer” has the meaning set forth in the preamble.
“Buyer Business” means any and all of the following activities as conducted by or on behalf of Buyer or any of its Affiliates, following the Closing, with respect to the Product: development, manufacturing, researching (including non-clinical and clinical research), testing, and commercialization (including marketing, promotion, pricing, selling, importing and exporting).
“Buyer Credit Agreement” has the meaning set forth in Section 3.2(l).
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“Buyer Fundamental Representations” means the representations and warranties made in Section 6.1 (Buyer’s Organization; Good Standing), Section 6.2 (Authority; Enforceability) and Section 6.7 (Brokers).
“Buyer Guarantor” has the meaning set forth in the preamble.
“Buyer Indemnified Parties” has the meaning set forth in Section 11.2.
“Buyer Officer’s Certificate” has the meaning set forth in Section 9.3(c).
“Closing” and “Closing Date” have the respective meanings set forth in Section 4.1.
“Closing Payment” has the meaning set forth in Section 3.1.
“Code” means the United States Internal Revenue Code of 1986, as amended.
“Commercially Reasonable Efforts” means, with respect to performance by or on behalf of Buyer or any of its Affiliates of any applicable activities hereunder with respect to the Product or any other Milestone Product, the expenditure of efforts and resources consistent with those expended by a similarly situated pharmaceutical company (taken as a whole and after giving effect to the transactions contemplated by this Agreement) to develop, manufacture, commercialize, sell and otherwise exploit pharmaceutical products owned by such company or to which such company has exclusive rights and that are at a similar stage of development or product life and with similar market potential taking into account issues of safety and efficacy, the competitiveness of third-party products in development and in the marketplace, the proprietary position of the product (including with respect to patent or regulatory exclusivity), the regulatory approval status and the profitability of the applicable product, and other relevant legal, medical or commercial factors, in each case, without taking into account the requirement to make any payment under this Agreement with respect to the Earnout Consideration. Commercially Reasonable Efforts does not require that Buyer or any of its Affiliates develop, manufacture, commercialize, or sell Buyer Guarantor’s injectable glucagon product in an identical manner as the Product, so long as the efforts used and employed to develop, manufacture, commercialize, sell and otherwise exploit the Product is at least comparable in the aggregate to the efforts used with respect to Buyer Guarantor’s injectable glucagon product, taking into account the factors set forth in the preceding sentence.
“Commitment Letter” has the meaning set forth in Section 6.10(a).
“Confidentiality Agreement” has the meaning set forth in Section 7.4.
“Contract” means any legally binding contract, agreement, instrument, license, lease, or understanding of any kind to which a Person is a party to or by which a Person or its assets is bound, whether oral or written, together with amendments, supplements and other modifications thereto.
“Contract Year” means the twelve (12) consecutive calendar months period starting on the first day of the first calendar month following the Closing Date (unless the Closing Date occurs on the first day of a calendar month, in which case the twelve (12) consecutive calendar months period
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shall start on the Closing Date) and each subsequent twelve (12) consecutive calendar month period commencing on the anniversary of such date.
“Control” means, with respect to any asset or property, including Intellectual Property, a Person’s possession, whether by ownership, license, or otherwise, of the legal right to grant the right to access or use, or to grant a license or a sublicense to, such asset or property, including Intellectual Property, without violating the rights of any Third Party or any terms of any Contract between such Person (or any of its Affiliates) and any Third Party, or any applicable Law.
“Controlling Party” has the meaning set forth in Section 11.5(b).
“Copyright” means rights in works of authorship (including advertisements and publications), copyrights (including in software), and database rights.
“Covered Material Contracts” has the meaning set forth in Section 5.19(b).
“COVID-19” means COVID-19 or SARS-COV-2, including any future resurgence, evolutions, mutations or variants thereof and/or any related or associated disease outbreaks, epidemics and/or pandemics.
“COVID-19 Measures” means any quarantine, “shelter in place,” “stay at home,” workforce reduction, social distancing, shut down, closure, safety or similar Law, binding directive or guidelines promulgated by any Governmental Authority, including the Centers for Disease Control and Prevention and the World Health Organization, in each case, in connection with or in response to COVID-19, including any Law passed by any Governmental Authority in response to COVID-19.
“Data Room” means the electronic data room entitled “Brockhouse”, hosted by Datasite and located at https://datasite.com.
“De Minimis Threshold” has the meaning set forth in Section 11.4(e).
“Debt Commitment Letter” has the meaning set forth in Section 6.10(a).
“Debt Financing Parties” has the meaning set forth in Section 8.9(a).
“Deductible” has the meaning set forth in Section 11.4(e).
“Deferred Payment” has the meaning set forth in Section 3.3(a).
“Definitive Financing Agreements” has the meaning set forth in Section 8.9(a).
“Demo Version” means the demonstration version of the device relating to the Product that is provided by Seller or any of its Subsidiaries to Third Parties for training purposes.
“Direct Claim” has the meaning set forth in Section 11.5(d).
“Earnout Consideration” means the Annual Net Sales Earnouts and the Aggregate Net Sales Earnout.
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“Earnout Consideration Dispute Notice” has the meaning set forth in Section 3.2(j).
“Earnout Dispute Period” has the meaning set forth in Section 3.2(j).
“Earnout Expiration Date” has the meaning set forth in Section 3.2(a).
“Employee” means any current or former employee, consultant or director of Seller or any of its Subsidiaries.
“Employee Benefit Plan” means any plan, program, policy, practice, contract, agreement or other arrangement providing for compensation, severance, termination pay, deferred compensation, performance awards, stock or stock-related awards, fringe benefits or other employee benefits or remuneration of any kind, whether written or unwritten or otherwise, funded or unfunded, including each “employee benefit plan,” within the meaning of Section 3(3) of ERISA which is maintained, contributed to, or required to be contributed to, by Seller or any of its Subsidiaries for the benefit of any Employee, or with respect to which Seller or any of its Subsidiaries has any liability or obligation, and, in each case, other than any such plan or arrangement maintained or to which contributions are required by any Governmental Authority.
“Employment Agreement” means each management, employment, severance, consulting, relocation, repatriation, expatriation, visa, work permit or other agreement, contract or understanding between Seller or any of its Subsidiaries and any Employee.
“Employment Liabilities” means any and all Liabilities of any kind relating to any Employee Benefit Plan, Employment Agreement or otherwise relating to an Employee and his or her employment with Seller or any of its Subsidiaries.
“Encumbrance” means any mortgage, charge, lien, license, claim, option, right of first refusal, first offer or first negotiation, security interest, easement, right of way, pledge or encumbrance of any kind or character whatsoever.
“Enforceability Exceptions” has the meaning set forth in Section 5.2.
“ERISA” means the Employee Retirement Income Security Act of 1974, as amended.
“Excluded Actions” has the meaning set forth in Section 2.2(b)(xii).
“Excluded Assets” has the meaning set forth in Section 2.2(b).
“Excluded Liabilities” has the meaning set forth in Section 2.3(b).
“Excluded Taxes” means without duplication, (a) all Taxes of Seller and its Subsidiaries for any Tax period, (b) all Taxes relating to the Historical Business, the Transferred Assets or the Assumed Liabilities for any Pre-Closing Tax Period (determined in the case of a Proration Period in accordance with Section 8.4(b)) and (c) Seller’s allocable share of Transfer Taxes pursuant to Section 8.4(a).
“Exhibits” means, collectively, the Exhibits referred to throughout this Agreement.
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“Expiration Date” has the meaning set forth in Section 11.1.
“FDA” means the U.S. Food and Drug Administration.
“Fee Letters” has the meaning set forth in Section 6.10(a).
“Financing” means the debt financing incurred or intended to be incurred pursuant to the Commitment Letter, including the borrowing of loans contemplated by the Commitment Letter.
“Financing Conditions” has the meaning set forth in Section 6.10(a).
“Financing Sources” means the agents, arrangers, lenders and other entities that have committed to provide or arrange the Financing, including the parties to the Commitment Letter or any related engagement letter in respect of the Financing or to any joinder agreements, credit agreements, indentures, notes, purchase agreements or other agreements entered pursuant thereto, together with their Affiliates’ and their and their Affiliates’ current, former or future officers, directors, employees, partners, trustees, shareholders, equityholders, managers, members, limited partners, controlling persons, agents and Representatives of each of them and the successors and assigns of the foregoing Persons (but in each case excluding Buyer and any of its Affiliates), in each case, in their capacities as such.
“Fraud” means an act, committed by a Party in relation to this Agreement or the transactions contemplated by this Agreement, with intent to deceive another Party, or to induce such other Party to enter into this Agreement and requires: (a) a false representation in Article V or Article VI of this Agreement, (b) actual knowledge that such representation is false or the Person making such representation believes it is false, (c) the intention to induce the other Person to whom such representation is made to enter into this Agreement or otherwise act or refrain from acting in reliance upon it, (d) causing that other Person, in reliance upon such false representation to enter into this Agreement or otherwise take or refrain from taking action and (e) causing such other Person to suffer damage by reason of such reliance. For the avoidance of doubt, “Fraud” does not include, and no claim may be made by any Person in relation to this Agreement or the transactions contemplated by this Agreement for, constructive fraud or other claims based on constructive knowledge, negligence, recklessness, misrepresentation, equitable fraud or similar theories.
“General Cap” has the meaning set forth in Section 11.4(a)(i).
“Governmental Authority” means any supra-national, federal, foreign, national, state, county, local, municipal or other governmental, regulatory or administrative authority, agency, commission or other instrumentality, any court, tribunal or arbitral body with competent jurisdiction.
“Governmental Official” means any (a) officer, agent, or employee of a Governmental Authority, (b) person acting in an official capacity for or on behalf of a Governmental Authority, (c) candidate for government or political office, (d) director, officer, employee or agent of a government-owned or mixed-capital company or (e) member of a royal family.
“Governmental Order” means any order, writ, judgment, injunction, decree, stipulation, determination or award entered by any Governmental Authority.
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“Guaranteed Obligations” has the meaning set forth in Section 12.15.
“Health Care Laws” means all health care Laws applicable to the Product or the Historical Business, including research (including non-clinical and clinical research), development, testing, production, processing, manufacture, packaging, transfer, storage, distribution, approval, labeling, marketing, promotion, pricing, selling, importing, or exporting of the Product or any drug substance, active ingredient, delivery device or component thereof, including licensing, accreditation, and certification, establishment registration, product listing, good manufacturing practices, record-keeping, adverse event reporting, reporting of corrections, removals, and recalls, reimbursement and sale of Product, including: the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b); any criminal laws relating to health care fraud and abuse, including to 18 U.S.C. Sections 286 and 287 and the health care fraud criminal provisions under HIPAA; the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b; the Exclusion Statute, 42 U.S.C. § 1320a-7; HIPAA; the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq. and applicable implementing regulations and final guidance issued by the FDA (collectively, the “FDCA”), including those requirements relating to current good manufacturing practices, good laboratory practices, good clinical practices and investigational use; the Public Health Service Act, 42 U.S.C. §§ 201 et seq.; the Federal Trade Commission Act; the Controlled Substances Act; the Patient Protection and Affordable Care Act, Pub. L. 111-148, as amended by the Health Care and Education Reconciliation Act of 2010, Pub. L. 111-152; Title XVIII of the Social Security Act, 42 U.S.C. §§ 1395-1395lll (Medicare); Title XIX of the Social Security Act, 42 U.S.C. §§ 1396-1396w-5 (Medicaid); 10 U.S.C. § 1071 et seq (TRICARE); the Sunshine Act, 42 U.S.C. § 1320a-7h, and similar state and foreign laws related to transparency and reporting of payments and transfers of value to healthcare professionals and teaching hospitals; all implementing rules and regulations promulgated pursuant to the foregoing laws; and similar foreign, federal, state and local laws and regulations.
“HIPAA” means the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (Title XIII of the American Recovery and Reinvestment Act of 2009), as the same may be amended, modified or supplemented from time to time and any successor statute thereto, and together with any and all Laws promulgated from time to time thereunder.
“Historical Business” means any and all of the following activities as conducted by Seller or any of its Subsidiaries historically, as of the date hereof or as of the Closing (unless the relevant provision of this Agreement expressly refers to the conduct of the Historical Business at some other specific time, in which case “Historical Business” shall refer to such business as conducted by Seller or any of its Subsidiaries at such time), with respect to the Product: development, manufacturing, researching (including non-clinical and clinical research), testing, and commercialization (including marketing, promotion, pricing, selling, importing and exporting).
“Historical Business Financials” has the meaning set forth in Section 8.8(a).
“HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.
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“IND” means an investigational new drug application or clinical trial application filed in accordance with 21 C.F.R. Part 312, as amended, with the FDA or any comparable foreign Governmental Authority, including all documents, data and other information concerning the applicable drug that are contained in such application.
“Indemnified Party” has the meaning set forth in Section 11.5(a).
“Indemnifying Party” has the meaning set forth in Section 11.5(a).
“Industry Codes” means all applicable rules of non-governmental bodies such as pharmaceutical industry trade associations and self-regulatory organizations that are generally accepted as “good practice” within the research based pharmaceutical industry, including those relating to good marketing practices and the relationship of pharmaceutical companies with health care providers and patients.
“Intellectual Property” means (a) Patents; (b) Know-How; (c) Trademarks and Domain Names and (d) Copyrights.
“Intellectual Property License Agreement” means the Intellectual Property License Agreement, in the form attached hereto as Exhibit B.
“Internal Compliance Codes” means Seller’s internal policies and procedures intended to ensure that the Seller complies with applicable Laws, Industry Codes, and Seller’s internal ethical, medical and similar standards.
“IP Assignment Agreement” means the IP assignment agreement, in the form attached hereto as Exhibit C.
“Know-How” means all technical information, know-how and data, including inventions (whether patentable or not), patent disclosures, discoveries, trade secrets, specifications, instructions, processes and formulae, including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical, safety, quality control, preclinical and clinical data.
“Knowledge” of Seller means all such facts, circumstances or other information of which the applicable Person set forth on Section 1.1(a) of the Seller Schedules is actually aware after having performed a reasonable inquiry of such Person’s direct reports.
“Law” means any applicable law, judgment, order, decree, statute, ordinance, rule, code, regulation, directive or other requirement or rule of law enacted, issued or promulgated by any Governmental Authority.
“Liability” means any debt, liability, claim, expense, commitment, duty, cost, fee, loss, damage, guarantee, endorsement or obligation of whatever kind, whether direct or indirect, accrued or fixed, absolute or contingent, matured or not, known or unknown, asserted or unasserted, liquidated or unliquidated, incurred or consequential, due or to become due, on or off balance sheet or determined or determinable (including liabilities as guarantor or otherwise with respect to obligations of others, and contingent liabilities, regardless of whether claims in respect
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thereof have been asserted), including those arising under any Contract, applicable Law or Proceeding, accounts payable and royalties payable.
“Locemia Assumption Agreement” means the Locemia Assumption Agreement, in the form attached hereto as Exhibit E.
“Locemia Purchase Agreement” means that certain Asset Purchase Agreement, dated as of October 9, 2015, by and between Locemia Solutions ULC and Seller, including any amendments, supplements and other modifications thereto.
“Losses” means any and all damages, losses, liabilities, judgments, Taxes, penalties, costs and expenses (including reasonable out-of-pocket legal fees and expenses incurred in investigating, defending against, settling and/or prosecuting any of the foregoing); provided, that “Losses” shall not include (i) any diminution in value, punitive or exemplary damages, in each case except to the extent such damages are determined to be payable to a Third Party in a final non-appealable judgment by a Governmental Authority made with respect to such Third Party’s claim, or (ii) damages calculated on multiples of earnings or other similar metric approaches.
“Manufacturing Services Agreement” means that Manufacturing Services Agreement to be entered into at the Closing, substantially in the form attached hereto as Exhibit D, with such changes as may be mutually agreed upon between the parties hereto.
“Material Adverse Effect” means any event, development, occurrence, change or effect that, individually or in the aggregate, has had, or would reasonably be expected to have, a material adverse effect on the Transferred Assets or the financial condition, assets, liabilities or results of operations of the Business, taken as a whole; provided, however, that any event, development, change or effect arising out of, resulting from or attributable to (a) any event, development, occurrence or change or series of events, developments, occurrences or changes affecting (i) the U.S. (or any other country or jurisdiction in which the Business operates or in which products or services of the Business are used or distributed) economy or the global economy generally or capital, financial, banking, credit or securities markets generally, including changes in interest or exchange rates, (ii) political conditions generally of the U.S. or any other country or jurisdiction in which the Business operates or in which products or services of the Business are used or distributed or (iii) any industry generally in which the Business operates or in which products or services of the Business are used or distributed, (b) the negotiation, pendency, announcement or consummation of the transactions contemplated by, or the performance of obligations under, this Agreement or any other Transaction Agreement, including adverse effects related to (i) the identity of Buyer or its Affiliates, (ii) threatened or actual loss of, or disruption in, any customer, employee or landlord relationships or (iii) loss of any personnel, (c) any changes in applicable Law or U.S. GAAP, or accounting principles, practices or policies that Seller required to adopt, or the enforcement or interpretation thereof, (d) actions taken or omitted following the date hereof at the written request or with the written consent of Buyer, or taken by Buyer or its Affiliates with respect to the transactions contemplated hereby, (e) the occurrence of any act of God or other calamity or force majeure events (whether or not declared as such), including any strike, labor dispute, civil disturbance, embargo, pandemic (including the COVID-19 pandemic, and any future resurgence, or evolutions or mutations, of COVID-19 or related disease outbreaks, epidemics or pandemics), natural disaster, fire, flood, hurricane, tornado, or other similar weather event, (f) any hostilities,
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acts of war (whether or not declared), sabotage, terrorism, military actions, cyber-attacks or malware attacks or any escalation or worsening of any such hostilities, act of war, sabotage, terrorism, military actions, or cyber-attacks or malware attacks, (g) any failure to meet internal or published projections, estimates or forecasts of revenues, earnings, or other measures of financial or operating performance for any period (provided, that the underlying causes of such failures (subject to the other provisions of this definition) shall not be excluded) or (h) Excluded Assets or Excluded Liabilities shall not, in any such case, either alone or in combination constitute or be deemed to contribute to a Material Adverse Effect, and otherwise shall not be taken into account in determining whether a Material Adverse Effect has occurred or would be reasonably likely to occur; provided, further, that, in the case of clauses (a), (c), (e) or (f), the event, development, occurrence, change or effect referred to therein does not disproportionately adversely affect the Transferred Assets or the Business, taken as a whole, as compared to other comparable companies in the industries in which the Business operates (in which case only the incremental disproportionate adverse effect may be taken into account in determining whether a Material Adverse Effect has occurred).
“Material Business Contracts” has the meaning set forth in Section 5.19(a).
“Milestone Event” means an Annual Net Sales Milestone or the Aggregate Net Sales Milestone.
“Milestone Payment Date” has the meaning set forth in Section 3.2(d).
“Milestone Product” means (a) any product consisting of a formulation containing glucagon for nasal administration (including the Product), (b) any reformulation, improvement, enhancement, combination, refinement, supplement, or modification of or to any of the foregoing products in (a) (including any change, modification, or improvement to or replacement of the delivery device) ((a) and (b), collectively, the “Nasal Glucagon Products”), in each case of this clause (b) containing glucagon for nasal administration, and (c), solely for determining Net Sales with respect to the Earnout Consideration, any Other Milestone Product.
“NDA” means a new drug application for a drug submitted in accordance with 505(b) of the FDCA and 21 C.F.R. Part 314, and all amendments and supplements, including all documents, non-clinical and clinical data, chemistry, manufacturing and control information, reports, submissions, communications with any Regulatory Authority, and other information concerning the applicable drug and contained within or referenced by the new drug application in the U.S., and any comparable marketing application submitted to any comparable foreign Governmental Authority, and all amendments and supplements thereto.
“Net Sales” means the gross amount invoiced by a Product Party to any other Person for a Milestone Product (or a combination product containing a Milestone Product) in the Territory less the following items (but only to the extent attributable to a Milestone Product and to the extent actually incurred, given, accrued or specifically allocated for): (a) trade, quantity and cash discounts allowed; (b) discounts, refunds, rebates, chargebacks, retroactive price adjustments (including adjustments arising from consumer discount programs or other similar programs), and any other similar allowances or adjustments which effectively reduce the net selling price of a Milestone Product, (c) Milestone Product returns and allowances, (d) wholesaler distribution fees,
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and (e) any other customary adjustments in accordance with U.S. GAAP as generally and consistently applied by Buyer Guarantor in the preparation of its financial statements filed with the SEC to determine “net sales.”
With respect to a particular country and reporting period, if any Milestone Product is sold as part of a combination product with any other active ingredient(s), then the Parties will determine in good faith the appropriate allocation percentage of Net Sales of the combination product to the applicable Milestone Product (by determining the relative value of the Milestone Product to the combination product) for the purposes of calculating any Earnout Consideration (and agreement to such determination will not be unreasonably withheld by either Party). For greater certainty, (x) the combination of the Product with any device(s) or other functional component(s) shall not be deemed a sale of a combination product and (y) the Product is not a combination product.
Such amounts shall be determined from the books and records of the Product Parties maintained in accordance with U.S. GAAP consistently applied. Buyer further agrees in determining such amounts, it will use Buyer’s then-current standard procedures and methodology, including Buyer’s then-current standard exchange rate methodology for the translation of foreign currency sales into U.S. Dollars. Notwithstanding the foregoing, for any Product Party that is not Buyer or its Affiliates, such books and records may be maintained in accordance with the accounting standards, consistently applied, of such Product Party, and Buyer’s determinations of such amounts may be made based on reports provided by such Product Party to Buyer.
Sales or commercial dispositions of Milestone Products between or among Product Parties and their Affiliates shall be excluded from the computation of Net Sales (except where such Product Parties or Affiliates are end users of a Milestone Product), but Net Sales shall include the subsequent final sales to Third Parties by Product Parties or their Affiliates. Notwithstanding the foregoing, if a Milestone Product is sold or otherwise commercially disposed of for consideration other than cash or in a transaction that is not at arm’s length between buyer and seller, then the gross amount to be included in the calculation of Net Sales shall be the amount that would have been invoiced had the transaction been conducted at arm’s length and for cash. Such amount that would have been invoiced shall be determined, wherever possible, by reference to the average selling price of a Milestone Product in arm’s length transactions in the relevant country. For the avoidance of doubt, (i) any royalties owed by the Product Parties to Third Parties resulting from sales of Milestone Products shall not be a deduction from the gross amount invoiced in the calculation of Net Sales as described in the first sentence of this definition (and for the further avoidance of doubt, Seller shall not be required to share with or reimburse Buyer for any royalties or other payments payable by the Product Parties to Third Parties, which shall be borne entirely by Buyer) and (ii) costs and Liabilities associated with any claim that a Milestone Product does not comply with all applicable Laws with respect to all Milestone Products sold after the Closing Date shall not be a deduction from the gross amount invoiced in the calculation of Net Sales as described in the first sentence of this definition. In no event shall any particular amount of deduction identified above be deducted more than once in calculating Net Sales (i.e., no “double counting” of deductions).
Without limiting the foregoing, the definition of “Net Sales” shall also include, for purposes of this Agreement, the “Net Sales” (as defined in Exhibit B (Net Economic Benefit) to
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the Transition Services Agreement) of Seller or any of its Affiliates or any contractor or agent acting on behalf of Seller or any of its Affiliates.
“Non-Controlling Party” has the meaning set forth in Section 11.5(b).
“Non-Transferable Asset” has the meaning set forth in Section 2.4(a).
“Other Milestone Product” means any product (other than a Nasal Glucagon Product) that (a) infringes a valid claim of a Patent included in the definition of Seller Product Intellectual Property or (b) is manufactured using any Restricted Manufacturing Know-How. The Parties agree that none of Buyer’s products as of the Closing Date, whether in clinical development or commercialization stage, are Other Milestone Products until and unless such product infringes a valid claim of a Buyer Licensed Patent (as defined in the Intellectual Property License Agreement) or is manufactured using the Restricted Manufacturing Know-How.
“Outside Date” has the meaning set forth in Section 10.1(d).
“Party” or “Parties” means Buyer and Seller, and solely for the purpose of Section 7.6 and Section 12.15 (and any provision of Article I or Article XII to give effect thereto), Buyer Guarantor.
“Patents” means patents and patent applications, including any utility models and design patents, and any continuations, continuations-in-part, divisionals, substitutions, reexaminations, reissues, registrations, corrections, additions, confirmation patents, revivals, or any similar modifications of any such patents, and any extensions or restorations of such patents, and any equivalent rights, whether domestic, international, or foreign.
“Permits” means all consents, approvals, authorizations, certificates, filings, notices, permits, concessions, registrations, franchises, licenses or rights of or issued by any Regulatory Authority or other Governmental Authority, including Regulatory Approvals.
“Permitted Business Transfer” has the meaning set forth in Section 3.2(m).
“Permitted Encumbrances” means: (a) Encumbrances for Taxes, assessments and charges or levies of any Governmental Authority not yet due and payable or that may thereafter be paid without penalty or that are being contested in good faith; (b) Encumbrances imposed by statutory or common law materialmen’s, mechanics’, carriers’, workmens’ and repairmen’s liens and transfer restrictions imposed by national, federal or state securities laws; (c) Encumbrances imposed in the ordinary course of business that are not yet due and payable or that may thereafter be paid without penalty or that are being contested in good faith; (d) pledges or deposits to secure obligations under applicable Law to secure public or statutory obligations; (e) liens, title retention arrangements or deposits to secure the performance of bids, trade contracts (other than for borrowed money), conditional sales contracts, leases, statutory obligations, surety and appeal bonds, performance bonds and other obligations of a like nature incurred in the ordinary course of business; (f) non-exclusive licenses of Intellectual Property granted by Seller or its Subsidiaries to a service provider or supplier in the ordinary course of business and (g) other Encumbrances that do not impair, and are not reasonably expected to impair, the continued use and operation of the
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assets to which they relate in the conduct of the Business or the Buyer Business in any material respect.
“Permitted License” has the meaning set forth in Section 3.2(m).
“Permitted Licensee” has the meaning set forth in Section 3.2(m).
“Permitted Transferee” has the meaning set forth in Section 3.2(m).
“Person” means any individual, corporation, partnership, limited liability company, joint venture, trust, business association, organization, Governmental Authority or other entity.
“Personal Information” means, in addition to any definition for any similar term (e.g., “personal data” or “personally identifiable information”) provided by applicable Laws, all information that identifies, could be used to identify or is otherwise associated with an individual person (including employees), whether or not such information is directly associated with an identified individual person. For the avoidance of doubt, the definition of “Personal Information” does not include “protected health information,” as defined in HIPAA (as defined herein).
“Post-Closing Audit” has the meaning set forth in Section 8.8(b).
“Post-Closing Business Financials” has the meaning set forth in Section 8.8(b).
“Pre-Closing Tax Period” means (a) any taxable period ending on or before the Closing Date and (b) with respect to any Straddle Period, the portion of such taxable period ending on and including the Closing Date.
“Pricing and Tender Agreements” means the Contracts listed on Section 1.1(e) of the Seller Schedules.
“Proceeding” means any civil, criminal, judicial, administrative or arbitral action, suit, hearing, litigation, proceeding (public or private), claim, cause of action, complaint, audit, mediation, arbitration, investigation or other similar dispute, in each case, by or before any Governmental Authority.
“Product” means any powdered formulation containing glucagon for nasal administration and the related unit dose system for powder marketed for sale (a) by or under the authority of Seller or any of its Subsidiaries to consumers, or (b) for which an application for Regulatory Approval has been submitted to a Regulatory Authority by or under the authority of Seller or any of its Subsidiaries, including the formulation and dose system marketed for sale by or under the authority of Seller of any of its Subsidiaries to consumers as of the date hereof as BAQSIMI®.
“Product Copyrights” means Copyrights Controlled by Seller or its Affiliates as of the date hereof and primarily related to the Product or the Demo Version.
“Product Intellectual Property” means (a) Product Patents, (b) Product Trademark and Domain Names, (c) Product Copyrights and (d) Product Know-How; provided, that Intellectual
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Property owned by the Persons listed in Section 1.1(b) of the Seller Schedules will not be deemed to be Controlled by Seller or any of its Subsidiaries for the purposes of this definition.
“Product Know-How” means Know-How Controlled by Seller or its Affiliates as of the date hereof or the Closing and primarily related to the Product or the Demo Version.
“Product Liabilities” means all claims, Liabilities and Proceedings related to or arising from actual or alleged harm, injury, damage or death to Persons, or damage to property or businesses, including the Historical Business, irrespective of the legal theory asserted, and resulting from or alleged to result from the use, sale or manufacture of any of the Product.
“Product Parties” means collectively, Buyer, its Affiliates or its or their respective assignees or successors-in-interest with respect to a Milestone Product or Product Intellectual Property or any Third Party to whom any of the foregoing has granted a license or sublicense or other rights to commercialize, market or sell any Milestone Product, including any Permitted Transferee or Permitted Licensee, and each, a “Product Party.”
“Product Patents” means (a) the Patents listed in Section 1.1(c) of the Seller Schedules; (b) any continuations, continuations-in-part, divisionals, or other patent applications that claim priority to any of the patent applications or patents referenced in clause (a) or that share a common claim of priority therewith and any foreign counterparts of the foregoing; (c) any patents issuing on any such patent applications (of either clause (a) or clause (b)); (d) any substitutions, reexaminations, reissues, registrations, corrections, additions, confirmation patents, revivals, and/or any similar modifications of any such patents referenced in clauses (a)-(c); and (e) any extensions (including pediatric exclusivity, patent term extension, and supplementary patent certificate extensions), or restorations of such patents (referenced in clauses (a)-(d)), in each case, whether domestic or foreign, including all rights of priority, rights to file and prosecute, and the like.
“Product Trademark and Domain Names” means Trademark and Domain Names on Section 1.1(c) of the Seller Schedules.
“Promotional Materials” has the meaning set forth in Section 2.2(a)(vi).
“Proration Period” has the meaning set forth in Section 8.4(b).
“Purchase Price” has the meaning set forth in Section 3.1.
“Purchaser Termination Fee” has the meaning set forth in Section 10.3(b).
“Records” has the meaning set forth in Section 2.2(a)(i).
“Registered Intellectual Property” has the meaning set forth in Section 5.17(a).
“Regulatory Actions” has the meaning set forth in Section 7.6(d).
“Regulatory Approvals” means with respect to the Product in the applicable regulatory jurisdiction, all permits, licenses, certificates, approvals, clearances, or other authorizations of or
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recognized by the applicable Regulatory Authority necessary to conduct clinical trials of, manufacture, distribute, market, sell or use such Product in such regulatory jurisdiction in accordance with applicable Law (including NDAs or other equivalent applications in the United States or any other jurisdiction, INDs or their foreign equivalents, and pricing and reimbursement approvals, and all supplements and amendments to any of the foregoing).
“Regulatory Authority” means any applicable supranational, federal, foreign, national, regional, state, provincial, local or municipal regulatory agencies, departments, bureaus, commissions, councils, notified body, competent authority, institutional review board or ethics committee, or other Governmental Authority (including the FDA, Federal Trade Commission, Office of Inspector General, Centers for Medicare & Medicaid Services, and similar authorities in any state or foreign jurisdiction) regulating or otherwise exercising authority with respect to the Product.
“Regulatory Laws” shall mean, collectively, any Laws that are designed or intended to prohibit, restrict or regulate actions with respect to a Product or having the purpose or effect of monopolization or lessening of competition through merger or acquisition or restraint of trade or that affect foreign investment, national security or national interest of any jurisdiction.
“Related Party” means any officer or director of Seller or any of its Subsidiaries (or any immediate family member of any of such Person, or any trust, partnership or corporation in which any such Person has or has had an interest).
“Representatives” means the directors, officers, employees, agents, Subsidiaries or advisors (including attorneys, accountants, investment bankers, financial advisers and other consultants and advisors) of the specified Party and such specified Party’s Affiliates.
“Required Business Financials” has the meaning set forth in Section 8.8(a).
“Restricted Business” means the initiation or conduct of a phase 3 clinical trial for, the submission of an NDA for, or the commercialization of a nasal glucagon product for the treatment of hypoglycemia.
“Restricted Business Acquisition” means the ownership, license or obtaining by Seller or any of its Subsidiaries of an interest or right otherwise prohibited by Section 7.9 if (a) no more than 20% of such Person’s revenues were derived from a Restricted Business (measured by the most current annual financial statements published or prepared by the acquired Person in the ordinary course of business) or (b) more than 20% of such Person’s revenues were derived from a Restricted Business (measured by the most current annual financial statements published or prepared by the acquired Person in the ordinary course of business) and within eighteen months after the closing of such acquisition Seller or its Subsidiaries discontinues or enters into a definitive agreement to divest a portion of such Restricted Business such that Seller would otherwise be in compliance with clause (a) of this definition.
“Restricted Manufacturing Know-How” has the meaning set forth in the Intellectual Property License Agreement.
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“Right of Reference or Use” means a “Right of Reference or Use” as such term is defined in 21 C.F.R. §314.3(b), and any non-United States equivalents.
“Schedules” means the Seller Schedules.
“SEC” means the United States Securities and Exchange Commission.
“Seller” has the meaning set forth in the preamble.
“Seller Fundamental Representations” means the representations and warranties of Seller set forth in Section 5.1 (Seller Organization; Good Standing), Section 5.2 (Authority; Enforceability), Section 5.5(a) (Title to Transferred Assets) and Section 5.14 (Brokers).
“Seller Indemnified Parties” has the meaning set forth in Section 11.3.
“Seller IP Sufficiency Representations” means the representations and warranties of Seller set forth in Section 5.17(b).
“Seller Licensed Intellectual Property” has the meaning set forth in the Intellectual Property License Agreement.
“Seller Officer’s Certificate” has the meaning set forth in Section 9.2(d).
“Seller Product Intellectual Property” means all Product Intellectual Property that is owned by Seller or any of its Affiliates as of the date hereof.
“Seller Schedules” means, collectively, the disclosure schedules, dated as of the date hereof, delivered by Seller to Buyer, as amended in accordance with this Agreement, which forms a part of this Agreement.
“Seller SEC Document” means each report, schedule, form, statement, prospectus, registration or other document filed with or furnished to the SEC by Seller during the period beginning on January 1, 2022 and ending as of the date hereof.
“Significant Customer” has the meaning set forth in Section 5.20(a).
“Significant Supplier” has the meaning set forth in Section 5.20(b).
“Specified Letter” means a pre-consummation letter from the Federal Trade Commission in similar form to that set forth in its blog post dated August 3, 2021 and posted at this link: https://www.ftc.gov/system/files/attachments/blog_posts/Adjusting%20merger%20review%20to%20deal%20with%20the%20surge%20in%20merger%20filings/sample_pre-consummation_warning_letter.pdf.
“Straddle Period” means any taxable period that begins on or before and ends after the Closing Date.
“Subsidiary” shall mean, with respect to any Person, any corporation, limited liability company, partnership, association, trust or other entity or organization, of which (a) such first
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Person directly or indirectly owns or controls at least a majority of the securities or other interests having by their terms ordinary voting power to elect a majority of the board of directors or others performing similar functions or (b) such first Person is the general partner or managing member.
“Substitute Debt Financing” has the meaning set forth in Section 8.9(b).
“Tax Contest” means any audit, examination, voluntary disclosure or other administrative or judicial proceeding, contest, assessment, notice of deficiency, or other adjustment or proposed adjustment with respect to Taxes of Seller, or its operation of the Historical Business or the Transferred Assets.
“Tax Return” means any report, return, information statement, election, and other forms and documents (including all amendments thereof) relating to and filed or required to be filed with a taxing authority in connection with any Taxes.
“Tax(es)” means (a) all U.S. federal, state, local and non-U.S. taxes, including income, gross receipts, license, excise, sales, use, transfer, registration, value added, severance, stamp, environmental, customs duties, franchise, profits, withholding, escheat, unclaimed property, real property, personal property or other taxes of any kind whatsoever that may be imposed by any Governmental Authority together with all interest, penalties, fines, additions to tax or additional amounts or charges imposed by any Governmental Authority in connection therewith, (b) any Liability for the payment of any amounts of the type described in clause (a) of this definition as a result of being or having been a member of an affiliated, consolidated, combined, unitary or similar group for any period (including any arrangement for group or consortium relief or similar arrangement), and (c) any Liability for the payment of any amounts of the type described in clauses (a) or (b) of this definition as a transferee or successor or as a result of any express or implied obligation to indemnify any other Person or as a result of any obligation under any agreement or arrangement with any other Person with respect to such amounts and including any Liability for taxes of a predecessor or transferor or otherwise by operation of Law.
“Third Party” means any Person, other than the Parties and their respective Affiliates.
“Third Party Claim” has the meaning set forth in Section 11.5(a).
“Third Party Consents” has the meaning set forth in Section 7.7.
“Trademarks and Domain Names” means all trademarks, service marks, trade names, certification marks, service names, industrial designs, brand marks, trade dress rights, identifying symbols, logos, emblems, signs, insignia and domain names and other indicia of origin, all applications and registrations for any of the foregoing, and all goodwill associated therewith.
“Transaction Agreements” means this Agreement and the Ancillary Agreements.
“Transaction Amounts” has the meaning set forth in Section 6.10(d).
“Transaction Dispute” has the meaning set forth in Section 12.11(a).
“Transfer Taxes” has the meaning set forth in Section 8.4(a).
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“Transferred Actions” has the meaning set forth in Section 2.2(a)(viii).
“Transferred Assets” has the meaning set forth in Section 2.2(a).
“Transferred Contracts” has the meaning set forth in Section 2.2(a)(ix).
“Transferred Personal Property” has the meaning set forth in Section 2.2(a)(v).
“Transferred Records” has the meaning set forth in Section 2.2(a)(i).
“Transferred Regulatory Documentation” has the meaning set forth in Section 2.2(a)(ii).
“Transition Services Agreement” means the Transition Services Agreement, in the form attached hereto as Exhibit F.
“U.S.” means the United States of America.
“U.S. GAAP” means U. S. Generally Accepted Accounting Principles.
“Update Report” has the meaning set forth in Section 3.2(j).
“Willful Breach” means, with respect to any breaches or failures by a Party to perform any of the covenants or other agreements contained in this Agreement, a deliberate and intentional act or a deliberate and intentional failure to act, which act or failure to act constitutes in and of itself a material breach of this Agreement inasmuch as the resulting material breach was the conscious object of the act or failure to act.
SALE AND PURCHASE OF TRANSFERRED ASSETS
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For the avoidance of doubt and notwithstanding anything to the contrary in this Section 2.3(a), in no event shall any Liability of Seller under the Manufacturing Services Agreement or Transition Services Agreement be considered an Assumed Liability.
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PURCHASE PRICE
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Annual Net Sales Milestone |
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$175,000,000 |
$200,000,000 |
$200,000,000 |
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THE CLOSING
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REPRESENTATIONS AND WARRANTIES OF SELLER
Seller hereby represents and warrants to Buyer as of the date hereof and as of the Closing Date (other than any representations and warranties made as of a specific date, which representations and warranties shall be as of such date) that, except as set forth in the Seller Schedules or as expressly disclosed in any Seller SEC Document (other than any cautionary or forward-looking information contained in the “Risk Factors” or “Forward-Looking Statements” of any such Seller SEC Documents) to the extent that such disclosure references BAQSIMI or the relevance of such disclosure would be apparent on its face to a reader of such Seller SEC Document:
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by Seller, and assuming the due authorization, execution and delivery of this Agreement by Buyer, this Agreement constitutes, and upon the due authorization, execution and delivery thereof by Buyer, the other Transaction Agreements will constitute the legal, valid and binding obligation of Seller, enforceable against Seller in accordance with the terms hereof, subject to the effect of any applicable Laws relating to bankruptcy, insolvency, reorganization, moratorium, fraudulent transfer and other similar applicable Laws relating to or affecting creditors’ rights generally from time to time in effect and to general principles of equity, regardless of whether considered in a Proceeding in equity or at law (the “Enforceability Exceptions”).
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(3) years, in violation in any material respect of any Laws or Governmental Orders applicable to the conduct of the Historical Business, any Transferred Asset or the Product except, in each case, as would not, individually or in the aggregate, be material to the Business as a whole.
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NEITHER SELLER NOR ANY OTHER PERSON MAKES ANY OTHER EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY WITH RESPECT TO SELLER OR ITS AFFILIATES, THE BUSINESS OR THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT AND THE ANCILLARY AGREEMENTS AND ANY RIGHTS OR OBLIGATIONS (INCLUDING THE ASSUMED LIABILITIES) TO BE TRANSFERRED HEREUNDER AND THEREUNDER OR PURSUANT HERETO OR THERETO, AND SELLER DISCLAIMS (ON BEHALF OF ITSELF AND ITS AFFILIATES) ANY OTHER REPRESENTATIONS OR WARRANTIES, WHETHER MADE BY SELLER OR ANY OF ITS AFFILIATES OR REPRESENTATIVES. EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES EXPRESSLY CONTAINED IN THIS Article V (AS MODIFIED BY THE SELLER SCHEDULES) AND THE ANCILLARY AGREEMENTS, SELLER HEREBY DISCLAIMS (ON BEHALF OF ITSELF AND ITS AFFILIATES) ALL LIABILITY AND RESPONSIBILITY FOR ANY REPRESENTATION, WARRANTY, PROJECTION, FORECAST, STATEMENT, OR INFORMATION MADE, COMMUNICATED, OR FURNISHED (ORALLY OR IN WRITING) TO BUYER OR ITS AFFILIATES OR REPRESENTATIVES (INCLUDING ANY OPINION, INFORMATION, PROJECTION, OR ADVICE THAT MAY HAVE BEEN OR MAY BE PROVIDED TO BUYER BY ANY REPRESENTATIVE OF SELLER OR ANY OF ITS AFFILIATES). WITHOUT LIMITING THE FOREGOING, SELLER MAKES NO REPRESENTATIONS OR WARRANTIES TO BUYER REGARDING THE PROBABLE SUCCESS, VALUE OR PROFITABILITY OF THE PRODUCT. NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS SECTION 5.26 OR ANY OTHER TERM HEREIN OR IN ANY ANCILLARY AGREEMENT, NOTHING IN THIS SECTION 5.26 OR IN ANY SUCH TERM SHALL LIMIT ANY RECOURSE SELLER OR ANY OF ITS AFFILIATES WOULD HAVE IN THE CASE OF FRAUD.
REPRESENTATIONS AND WARRANTIES OF BUYER
Buyer hereby represents and warrants to Seller as follows as of the date hereof and as of the Closing Date (other than any representations and warranties made as of a specific date, which representations and warranties shall be as of such date):
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Article VI, Section 3.2(l), Section 3.3(d) and Section 12.15 hereof AND THE ANCILLARY AGREEMENTS, NEITHER BUYER NOR ANY OTHER PERSON MAKES ANY OTHER EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY WITH RESPECT TO BUYER OR THE TRANSACTIONS CONTEMPLATED BY THIS AGREEMENT AND THE ANCILLARY AGREEMENTS AND BUYER DISCLAIMS (ON BEHALF OF ITSELF AND ITS AFFILIATES) ANY OTHER REPRESENTATIONS AND WARRANTIES, WHETHER MADE BY BUYER OR ANY OF ITS AFFILIATES OR REPRESENTATIVES.
CERTAIN COVENANTS AND AGREEMENTS
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confidentiality obligations under the Confidentiality Agreement shall terminate; provided, however, that Buyer’s confidentiality obligations shall terminate only in respect of that portion of the “Confidential Information” (as defined in the Confidentiality Agreement) exclusively relating to the Historical Business or otherwise constituting a Transferred Asset, and for all other “Confidential Information”, the Confidentiality Agreement shall continue in full force and effect in accordance with its terms. If, for any reason, the Closing does not occur, then the Confidentiality Agreement shall continue in full force and effect following the termination of this Agreement in accordance with its terms. Upon Closing, all Confidential Information to the extent it constitutes Transferred Assets shall solely and exclusively vest with Buyer and notwithstanding any conflicting provision of the Confidentiality Agreement, except in connection with the performance of Seller’s obligations under any of the Transaction Agreements, Seller and its Subsidiaries and their respective Representatives will be obligated to maintain the confidentiality of such Confidential Information and to not use such Confidential Information after the Closing without the express written consent of Buyer for a period of seven (7) years after the Closing; provided, that, with respect to any such Confidential Information that constitutes a trade secret under applicable Law such confidentiality obligations shall continue so long as the Confidential Information maintains its status as a trade secret. Notwithstanding anything to the contrary in the Confidentiality Agreement, the terms of this Agreement shall be deemed the “Confidential Information” of both Parties, and each Party shall maintain the confidentiality of such information in accordance with the terms of the Confidentiality Agreement and this Section 7.4. Notwithstanding anything in this Section 7.4 to the contrary, each Party shall have the right to disclose Confidential Information or the terms of this Agreement or any other Transaction Agreement (a) as may be required by Law (including any disclosure obligations under the federal securities Laws or applicable accounting principles), the rules and regulations of any national securities exchange upon which the securities of Seller, Buyer or their respective Affiliates are listed or to any Governmental Authority (including federal, state, or foreign taxing authorities) with jurisdiction over such Party upon request by such Governmental Authority or (b) to any bona fide potential or actual investor, acquiror, merger partner, or other financial or commercial partner for the sole purpose of evaluating or carrying out an actual or potential investment, acquisition or other business relationship, in each case, involving the Product, the Transferred Assets or the Assumed Liabilities; provided, that in connection with such disclosure, such Party shall inform each disclosee of the confidential nature of such information and require each disclosee to execute a customary non-disclosure agreement pursuant to which such disclosee agrees to treat such information as confidential.
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loss, net of any expenses (including any deductibles retained by Seller) incurred in connection with the receipt of such proceeds, to be applied to restore or replace such Transferred Asset.
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required to compensate any Third Party, commence or participate in any Proceeding or offer or grant any accommodation (financial or otherwise, including any accommodation or arrangement to remain secondarily liable or contingently liable for any Assumed Liability) to any Third Party (a) to obtain any Third Party Consent or (b) in connection with Seller’s or Buyer’s obligations under Section 2.4 or Section 8.1.
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ADDITIONAL COVENANTS AND AGREEMENTS
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CONDITIONS PRECEDENT
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TERMINATION, AMENDMENT AND WAIVER
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INDEMNIFICATION
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terms, is required to be performed after the Closing shall survive the Closing and will remain in full force and effect thereafter until fully performed.
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GENERAL PROVISIONS
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| |
| if to Seller, to: |
| Eli Lilly and Company |
| Lilly Corporate Center |
| Indianapolis, Indiana 46285 |
| Telephone: (317) 276-2000 |
| Attention: Senior Vice President and Head of Corporate Business Development |
| |
| with a copy (which shall not constitute notice) to: |
| |
| Eli Lilly and Company |
| Lilly Corporate Center |
| Indianapolis, IN 46285 |
| Telephone: (317) 276-2000 |
| Email: [***] |
| Attention: Senior Vice President - Transactions and Contracting |
| |
| with a copy (which shall not constitute notice) to: |
| |
| Kirkland & Ellis LLP |
| 601 Lexington Avenue |
| New York, NY 10022 |
| Telephone: (212) 446-4800 |
| Attention: |
| [***] |
| [***] |
| Email: [***] |
| [***] |
| |
| |
| if to Buyer, to: |
| Amphastar Pharmaceuticals, Inc. |
| 11570 Sixth Street |
| Rancho Cucamonga, CA 91730 |
| Telephone: (800) 423-4136 |
| Email: [***] |
| Attention: Chief Financial Officer |
| |
| with a copy to: |
| |
| Amphastar Pharmaceuticals, Inc. |
| 11570 Sixth Street |
| Rancho Cucamonga, CA 91730 |
| Telephone: (800) 423-4136 |
| Email: [***] |
| Attention: EVP Corporate Administration Center |
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| |
| with a copy (which shall not constitute notice) to: |
| |
| Wilson Sonsini Goodrich & Rosati |
| One Market Plaza |
| Spear Tower, Suite 3300 |
| San Francisco, CA 94105 |
| Attention: [***] |
| [***] |
| Email: [***] |
| [***] |
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understanding of Seller and Buyer with respect to the subject matter hereof and thereof and supersede all prior negotiations, correspondence, understandings, agreements and contracts, whether written or oral, among the Parties and thereto respecting the subject matter hereof and thereof.
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Transaction Agreement except as expressly set forth in this Agreement shall operate as a waiver thereof, nor shall any single or partial exercise of such right, power or remedy by such Person preclude any other or further exercise thereof or the exercise of any other right, power or remedy. Notwithstanding anything to the contrary set forth above, this Section 12.9, Section 12.7, Section 12.8, Section 12.11(b), Section 12.11(d), Section 12.11(f), Section 12.12(b) and Section 12.16 (and any provision of this Agreement to the extent an amendment, modification, waiver or termination of such provision would modify the substance of any such section, and any related definitions insofar as they affect such sections) shall not be amended, waived or otherwise modified in a manner that is adverse to the interests of any Financing Source without the prior written consent of such Financing Source.
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headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement; (j) Seller and Buyer have each participated in the negotiation and drafting of this Agreement and if an ambiguity or question of interpretation should arise, this Agreement shall be construed as if drafted jointly by the Parties and no presumption or burden of proof shall arise favoring or burdening any Party by virtue of the authorship of any of the provisions in this Agreement; (k) a reference to any Person includes such Person’s permitted successors and permitted assigns; (l) any reference to “days” means calendar days unless Business Days are expressly specified; (m) when calculating the period of time before which, within which or following which any act is to be done or step taken pursuant to this Agreement, the date that is the reference date in calculating such period shall be excluded and, if the last day of such period is not a Business Day, the period shall end on the next succeeding Business Day; (n) prior drafts of this Agreement or the other Transaction Agreements or the fact that any clauses have been added, deleted or otherwise modified from any prior drafts of this Agreement or any of the other Transaction Agreements shall not be used as an aid of construction or otherwise constitute evidence of the intent of the Parties, and no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of such prior drafts and (o) “will” and “shall” are to be interpreted to have the same meaning.
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at any time and from time to time, without notice to or further consent of Buyer Guarantor, reduce or waive any of the Guaranteed Obligations, and may also make any agreement with Buyer for the extension, renewal, payment, compromise, discharge or release thereof, in whole or in part, without in any way impairing or affecting Buyer Guarantor’s obligations under this Section 12.15 or affecting the validity or enforceability of this Section 12.15 (except to the extent the Guaranteed Obligations are increased thereby). Buyer Guarantor hereby agrees that the obligations of Buyer Guarantor hereunder shall not be released or discharged, in whole or in part, in each case, or otherwise affected by: (a) the failure or delay on the part of Seller to assert any claim or demand or to enforce any right or remedy against Buyer or Buyer Guarantor; (b) any change in the time, place or manner of payment of any of the Guaranteed Obligations, or any rescission, waiver, compromise, consolidation or other amendment or modification of any of the terms or provisions of this Agreement or any other agreement entered in connection with the Guaranteed Obligations or (c) any insolvency, bankruptcy, reorganization or other similar proceeding instituted by or against Buyer or any other Person now or hereafter liable with respect to the Guaranteed Obligations. Buyer Guarantor hereby waives promptness, diligence, presentment, demand for payment, notice of non-performance, default, dishonor and protest, notice of any Guaranteed Obligations incurred and all other notices of any kind, all defenses which may be available by virtue of any stay, moratorium or other similar law now or hereafter in effect or any right to require the marshaling of assets of Buyer or any other Person now or hereafter liable with respect to the Guaranteed Obligations. To the fullest extent permitted by Law, Buyer Guarantor hereby irrevocably and unconditionally waives any and all rights or defenses arising by reason of any Law which would otherwise require any election of remedies by Seller. Buyer Guarantor represents and warrants to Seller that the guarantee hereunder constitutes the legal, valid and binding agreement of Buyer Guarantor enforceable against Buyer Guarantor in accordance with the terms of this Section 12.15, subject to the Enforceability Exceptions. Buyer Guarantor is a legal entity duly organized, validly existing and in good standing under the laws of Delaware. Buyer Guarantor has the requisite corporate power and authority to execute and deliver this Agreement and to perform its obligations hereunder. Buyer Guarantor has taken all actions or proceedings required to be taken by or on the part of Buyer Guarantor to authorize and permit the execution and delivery by Buyer Guarantor of this Agreement and the performance by Buyer Guarantor of its obligations hereunder. This Agreement has been duly executed and delivered by Buyer Guarantor. Assuming that (i) the parties to the Commitment Letter (other than Buyer or any of its Affiliates) perform their obligations in accordance with the terms of the Commitment Letter and (ii) the satisfaction or waiver of the conditions set forth in Section 9.2(a), Buyer Guarantor will have at the Closing sufficient funds to satisfy all of Buyer’s obligations under this Agreement to be satisfied at the Closing, including the payment in full of the Closing Payment and all other amounts to be paid by Buyer pursuant to this Agreement on the Closing Date.
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each of its Affiliates and each of its and its Affiliates’ respective shareholders, partners, members, directors, officers, employees, agents, trustees, advisors, administrators, managers, representatives and successors and assigns) agrees not to commence (and if commenced agrees to dismiss or otherwise terminate) any Proceeding against any Financing Source in connection with this Agreement, the Financing, the Commitment Letter or any transaction contemplated hereby or thereby (including any Proceeding relating to the Financing or the Commitment Letter). In furtherance of and not in limitation of the foregoing waiver, it is agreed that no Financing Source shall have any liability for any claims, losses, settlements, liabilities, damages, costs, expenses, fines or penalties to Seller (or any of its Affiliates or any of its or its Affiliates’ respective shareholders, partners, members, directors, officers, employees, agents, trustees, advisors, administrators, managers, representatives and successors and assigns) in connection with this Agreement or any transaction contemplated hereby or thereby (including any Proceeding relating to the Financing or the Commitment Letter). Nothing in this Section 12.16 shall in any way limit or qualify the rights of Buyer in respect of the Financing under the express terms of the Commitment Letter. Without limiting the foregoing, no Financing Source shall be subject to any special, consequential, punitive or indirect damages or damages of a tortious nature to Seller (or any of its Affiliates or any of its or its Affiliates’ respective its shareholders, partners, members, directors, officers, employees, agents, trustees, advisors, administrators, managers, representatives and successors and assigns).
[signature page follows]
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IN WITNESS WHEREOF, the Parties have caused this Asset Purchase Agreement to be signed by their respective representatives thereunto duly authorized, all as of the date first written above.
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| ELI LILLY AND COMPANY | |
| | |
| By: | /s/ David A. Ricks |
| | Name: David A. Ricks |
| | Title: Chair and Chief Executive Officer |
| | |
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| AMPHASTAR MEDICATION CO., LLC | |
| | |
| By: | /s/ Jacob Liawatidewi |
| | Name: Jacob Liawatidewi-Amph |
| | Title: Authorized Signatory |
| | |
| | |
| AMPHASTAR PHARMACEUTICALS, INC., | |
| | |
| By: | /s/ Bill Peters |
| | Name: Bill Peters |
| | Title: Authorized Signatory |
[Signature Page to Asset Purchase Agreement]