Asset Purchase Agreement by and between Secura Bio, Inc. and Verastem, Inc
ASSET PURCHASE AGREEMENT
BY AND BETWEEN
SECURA BIO, INC. (“PURCHASER”) and
VERASTEM, INC. (“SELLER”)
Dated as of August 10, 2020
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. OMISSIONS ARE DESIGNATED [***]
TABLE OF CONTENTS
Exhibit ACertain Definitions
Exhibit BGeneral Assignment and Bill of Sale
Exhibit CIP Assignment
Exhibit DPatent Assignment
Exhibit ETrademark Assignment
Exhibit FTerm Sheet for Transition Services Agreement
ASSET PURCHASE AGREEMENT
THIS ASSET PURCHASE AGREEMENT (this “Agreement”) is dated as of August 10, 2020, by and between:
(A)Secura Bio, Inc., a Delaware corporation (“Purchaser”) and
(B)Verastem, Inc., a Delaware corporation (“Seller”).
The capitalized terms used in this Agreement are defined in Exhibit A hereto, unless otherwise defined herein.
WHEREAS, Seller and Verastem Europe GmbH, a wholly-owned subsidiary of Seller incorporated in Germany (the “Seller Subsidiary” and, together with Seller, the “Seller Entities”) are engaged in, among other things, certain activities relating to the Business; and
WHEREAS, Seller desires to sell to, or cause the Seller Subsidiary to sell to, Purchaser, and Purchaser desires to purchase from the Seller Entities, certain assets of the Seller Entities used in the Business, on the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the foregoing recitals and the mutual representations, warranties, covenants and promises contained herein, the adequacy and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
UP-FRONT CONSIDERATION FOR TRANSFER
CONTINGENT PAYMENTS AND RELATED OBLIGATIONS.
Table A: Regulatory Milestone Events and Payments
Regulatory Milestone Event
Regulatory Milestone Payment
The first Regulatory Approval (excluding pricing and reimbursement approval) for the commercial sale of Copiktra in the European Union (EU) by the European Commission or by the competent authority of any EU Member State for the treatment of Peripheral T-Cell Lymphoma.
Regulatory Milestone Event
Regulatory Milestone Payment
The first approval of an NDA for Copiktra in the United States by the United States Food and Drug Administration (the “FDA”) for the treatment of Peripheral T-Cell Lymphoma (the “US PTCL Approval”).
Each of the Milestone Payments set forth in Table A above will be payable only once.
Table B: Sales Milestone Payments
Total Net Sales
Sales Milestone Payment
Total Net Sales exceeding $100,000,000
Total Net Sales exceeding $200,000,000
Total Net Sales exceeding $300,000,000 (the “Third Sales Milestone”).
Purchaser will make each Sales Milestone Payment set forth in Table B above to Seller within thirty (30) days after the end of the calendar quarter in which the corresponding Total Net Sales threshold set forth in Table B is met, and such payment will be accompanied by a notice identifying the Net Sales and the amount payable to Seller under this Section 3.1(b); provided, that to the extent the Third Sales Milestone is achieved prior to the achievement of the US PTCL Approval, the payment set forth opposite the Third Sales Milestone in Table B above will not become payable unless and until such time as the US PTCL Approval is achieved (at which point, for the avoidance of doubt, such payment will be payable). In the event that more than one of the Total Net Sales thresholds set forth in Table B above are achieved in the same calendar quarter, then each applicable Sales Milestone Payment will become due and payable to Seller following the conclusion of such calendar quarter. Each of the Milestone Payments set forth in Table B above will be payable only once.
CLOSING AND CLOSING DELIVERIES
REPRESENTATIONS AND WARRANTIES OF SELLER
Except as set forth on Schedule 5 (the “Seller Disclosure Schedule”) attached to this Agreement, Seller hereby represents and warrants to Purchaser as of the date of this Agreement and as of the Closing Date as follows:
Notwithstanding any provisions of this Agreement to the contrary, the foregoing provisions of this Section 5.5 constitute the sole representations or warranties of the Seller Entities relating to Taxes. Nothing in the Agreement, including this Section 5.5, shall be construed as providing a representation or warranty with respect to the existence, amount, expiration date or limitations on (or availability of) any Tax loss, credit, carryforward or similar Tax attribute.
REPRESENTATIONS AND WARRANTIES OF PURCHASER
Purchaser hereby represents and warrants to Seller as of the date of this Agreement and as of the Closing Date as follows:
CONDITIONS TO CLOSING
At any time prior to the Closing, this Agreement may be terminated by written notice explaining the reason for such termination:
To Purchaser at:Secura Bio, Inc.
1995 Village Center Circle, Suite 128
Las Vegas, Nevada 89134
Attention:Mark E. Spring
With copies to:Paul Hastings LLP
4747 Executive Drive
San Diego, CA 92121
Attention: Deyan Spiridonov
To any of the
Seller Entities at:Verastem, Inc.
117 Kendrick Street, Suite 500
Needham, Massachusetts, 02494
Attention: Brian M. Stuglik
With copies to:Ropes & Gray LLP
800 Boylston Street
Boston, MA 02199-3600
Attention: Marko Zatylny
[Signatures Follow on a Separate Page]
IN WITNESS WHEREOF, each of the parties has caused this Agreement to be executed on its behalf by their respective officers thereunto duly authorized all as of the date first written above.
SECURA BIO, INC.
By: /s/ Joseph M. Limberg
Name:Joseph M. Limberg
Title:President and Chief Executive Officer
[Signature Page to Asset Purchase Agreement]
By: /s/ Brian Stuglik
Name: Brian Stuglik
Title: Chief Executive Officer
[Signature Page to Asset Purchase Agreement]
“Accounts Receivable” shall have the meaning specified in Section 1.2(a)(ii).
“Action” means any claim, action, suit, arbitration, inquiry, audit, proceeding or investigation.
“Affiliate” of any Person shall mean any Person directly or indirectly controlling, controlled by, or under common control with, such Person; provided, however, that, for the purposes of this definition, “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”), as used with respect to any Person, shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities, by Contract, or otherwise.
“Agreement” shall have the meaning specified in the Preamble.
“Antitrust Laws” shall mean the Sherman Act, as amended, the Clayton Act, as amended, the HSR Act, the Federal Trade Commission Act, as amended, and all other federal, state and foreign statutes, rules, regulations, orders, decrees, administrative and judicial doctrines, and other laws that are designed or intended to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade or lessening of competition through merger or acquisition.
“Approval” shall have the meaning specified in Section 7.5(a).
“Assigned Contracts” shall have the meaning specified in Section 1.1(c).
“Assignment Consent” shall have the meaning specified in Section 1.4(a).
“Assumed Liabilities” shall mean all liabilities and obligations, contingent or otherwise of the Seller Entities to the extent arising out of, resulting from or related to the Business or the Purchased Assets after the Closing or the operation of the Business as conducted after the Closing, except the Excluded Liabilities. “Assumed Liabilities” shall include: (i) all liabilities and obligations of the Seller Entities or their Affiliates, as applicable, under the Assigned Contracts arising on or after the Closing Date to the extent not related to pre-closing breaches of such Assigned Contracts by any Seller Entity or its Affiliates; (ii) all liabilities and obligations related to Product warranty claims (regardless of whether the applicable warranty is express or implied) or commercialization activities after the Closing, in each case, with respect to Product sold on or after the Closing Date; (iii) all liabilities or obligations with respect to claims, whether founded upon negligence, breach, strict liability or other legal theory, seeking compensation or recovery for personal injury or property damage and resulting from defects or alleged defects or an alleged failure to warn for Product sold on or after the Closing Date; (iv) subject to the provisions of Article 13, all liabilities and obligations to the extent resulting from the alleged or actual infringement, misappropriation, or violation of a third party’s Intellectual Property Rights resulting from the use, commercialization, development, manufacture, sale, offer for sale or importation of the Product; (v) all liabilities and obligations for any returns with respect to Product sold on or
after the Closing Date; (vi) all liabilities and obligations under the Non-Assignable Assets to the extent that the Seller Entities are cooperating in a commercially reasonable arrangement designed to provide Purchaser or its designee with the benefits of such Non-Assignable Asset after the Closing; (vii) all liabilities and obligations assumed by Purchaser under this Agreement or any other Transaction Agreement; and (viii) subject to the provisions of Article 11 and Article 13, all liabilities for Taxes related to the Purchased Assets, the Business or the Assumed Liabilities that are attributable to a Post-Closing Tax Period; provided, however, that Assumed Liabilities shall not include (1) any accounts payable of the Seller Entities as of the Closing or (2) subject to the provisions of Article 11 and Article 13, any liability for Taxes with respect to the Purchased Assets for a Pre-Closing Tax Period.
“Audit Opinion” shall have the meaning specified in Section 8.1(b).
“Audited Financial Statements” shall have the meaning specified in Section 8.1(b).
“Audited Financials” shall have the meaning specified in Section 5.2.
“Books and Records” shall have the meaning specified in Section 1.1(h).
“Business” shall mean the research, development (including preclinical studies and Clinical Trials), manufacture, registration (including applications and submissions for Regulatory Approval and any other activities to secure and maintain market access (including any phase IV/post-approval clinical study that is not required to obtain or maintain Regulatory Approval)), use, import, export, marketing, promotion, offering for sale, sale, licensing, sublicensing, testing, support, supply, storage and distribution of the Products and any components or intermediates thereof or therefor, in each case, in the Field, each as conducted by or on behalf of the Seller Entities or any of the Existing Licensees as of the Closing and, for clarity, including any and all of the foregoing with respect to any Products currently in development by or on behalf of any of the Seller Entities or any of the Existing Licensees as of the Closing. For clarity, “Business” includes all operations and activities undertaken by or on behalf of any of the Seller Entities or any of the Existing Licensees pursuant to or in connection with the exercise of any rights or licenses granted to any of the Seller Entities pursuant to the Infinity Agreement or sublicenses of such rights and licenses granted to any of the Existing Licensees as of the Closing.
“Business Data” means all non-public Trade Secrets and Know-How included in the Seller Intellectual Property.
“Business Day” shall mean any day other than (i) a Saturday or a Sunday or (ii) a day on which banking and savings and loan institutions are closed in New York, New York.
“Clinical Trial” shall mean a human clinical study conducted on human subjects that is designed to (i) establish the metabolism and pharmacologic actions of a pharmaceutical product in humans, the side effects associated with increasing doses, structure-activity relationships, and mechanism of action in humans, (ii) investigate the safety and efficacy of the pharmaceutical product for its intended use, and to define warnings, precautions and adverse reactions that may be associated with the pharmaceutical product in the dosage range to be prescribed, (iii) support Regulatory Approval of such pharmaceutical product or label expansion
of such pharmaceutical product, and/or (iv) confirm the clinical benefit of a pharmaceutical product in a particular indication.
“Closing” shall have the meaning specified in Section 4.1.
“Closing Date” shall have the meaning specified in Section 4.1.
“Code” shall mean the United States Internal Revenue Code of 1986, as amended.
“Combination Product” means a finished dosage form of a product that contains or is comprised of a Product and one or more other pharmaceutical or biological products, and that is either (a) packaged together with the Product for sale or shipment as a single unit at a single price, or (b) marketed and sold collectively with the Product as a single product at a single price.
“Competing Product” shall mean any pharmaceutical product that is a PI3K delta inhibitor that is indicated for CLL (chronic lymphocytic leukemia), FL (follicular lymphoma), SLL (small lymphocytic lymphoma) or PTCL (peripheral t-cell lymphoma) and that is delivered orally, for clarity, including Copiktra in the Field.
“Competing Transaction” shall have the meaning specified in Section 7.2.
“Compound” means a compound and any references to a Compound shall include all of its various chemical forms, including acids, bases, salts, metabolites, esters, isomers, enantiomers, pro-drug forms, hydrates, solvates, polymorphs and degradants thereof in crystal, powder or other form.
“Confidential Information” shall mean all Trade Secrets and Know-How and other confidential or proprietary information of a Person, including information derived from reports, investigations, research, work in progress, codes, marketing and sales programs, financial projections, cost summaries, pricing formulae, contract analyses, financial information, projections, confidential filings with any state or federal agency, and all other confidential concepts, methods of doing business, ideas, materials or information prepared or performed for, by or on behalf of such Person by its employees, officers, directors, agents, representatives, or consultants.
“Confidentiality Agreement” shall mean that certain Confidential Disclosure Agreement between Purchaser and Seller, effective as of February 17, 2020.
“Consent” shall mean any approval, consent, ratification, permission, waiver or authorization (including any Governmental Approval).
“Consolidated Return” shall mean any consolidated, combined or unitary Tax Return filed with respect to a group that includes through the Closing Date a Seller Entity or any Affiliate of the Seller Entities.
“Contingent Payments” shall mean the Milestone Payments, the Royalty Payments and the Product License Payments.
“Contract” shall mean any written agreement, contract, obligation, promise, understanding, arrangement, commitment or undertaking of any nature.
“Convertible Promissory Note Purchase Agreement” shall mean that certain Convertible Note Purchase Agreement, dated as of August 10, 2020, by and among the Purchaser and the Investors listed on Schedule I thereto.
“Copiktra” shall mean the product currently marketed and sold by the Seller Entities as of the Closing under the name “COPIKTRA” containing the Compound known as IPI-145 or Duvelisib (as such Compound is further described in Schedule A-1 to the Seller Disclosure Schedule) in its current, FDA-approved formulation, strengths and dosage form in the Field and any other Compound thereof.
“Copyrights” shall mean all works of authorship, copyrightable works and copyrights, including all copyright registrations and applications, whether published or unpublished.
“COVID-19” shall mean SARS-CoV-2 or COVID-19, and any evolutions thereof or related or associated epidemics, pandemics or disease outbreaks.
“COVID-19 Measures” shall mean any quarantine, “shelter in place,” “stay at home,” workforce reduction, social distancing, shut down, closure, sequester or any other law, order, directive, guidelines or recommendations by any Governmental Authority in connection with or in respect to COVID-19.
“CSPC” shall have the meaning set forth in the definition of “Existing Licenses.”
“Damages” shall mean and include any loss, damage, injury, settlement, judgment, award, fine, penalty, Tax, cost, fee or expense of any nature (including documented and reasonable fees and expenses of counsel, consultants, experts and other documented and reasonable professional fees).
“Diligent Efforts” shall mean the efforts that a prudent Person desirous of achieving a result would use in similar circumstances to achieve that result as expeditiously as possible; provided, however, that a Person required to use “Diligent Efforts” under this Agreement will not be thereby required to take actions that would result in a material adverse change in the benefits to such Person under this Agreement or any of the Material License Agreements. Without limiting the generality of the foregoing, in determining Diligent Efforts with respect to the development and commercialization of the Product or the Compound known as “IPI-145” or “Duvelisib” or “INK1197”, the parties shall take into account the following: the market potential of the Product or such Compound, safety and efficacy, product profile, competitiveness of the marketplace for the Product, the proprietary position of the Product, the regulatory structure involved, the availability and level of reimbursement for such treatment by third party payors or health insurance plans, the potential total profitability of the Product marketed or to be marketed and other relevant factors affecting the cost, risk and timing of development and the total potential reward to be obtained if the Product is commercialized.
“Direct IP Indemnification Limit” shall have the meaning specified in Section 13.6(b).
“Drop-Dead Date” shall have the meaning specified in Section 12.1(d).
“Early Access Program” shall mean any program that provides patients with a Product for a use that has not been approved for marketing in any country or region in the Territory and that is not primarily intended to obtain information about the safety or effectiveness of a drug. “Early Access Programs” shall include treatment INDs / protocols, and named patient programs.
“Employee Benefit Plan” shall mean each plan, arrangement, program or policy, whether funded or unfunded, including each (i) employee pension benefit plan within the meaning of Section 3(2) of ERISA, (ii) employee welfare benefit plan within the meaning of Section 3(1) of ERISA, and (iii) bonus or other incentive, remuneration, severance, fringe-benefit, retention, change-of-control, profit-sharing, equity-based or deferred compensation arrangement.
“Encumbrance” shall mean any lien, pledge, hypothecation, charge, mortgage, security interest or other similar encumbrance, in each case excluding any Permitted Encumbrance.
“Entity” shall mean any corporation (including any non-profit corporation), general partnership, limited partnership, limited liability partnership, joint venture, estate, trust or company (including any limited liability company or joint stock company) or other similar entity.
“Environmental Claim” shall mean any claim, action, investigation or notice against or involving the Business or the Purchased Assets by any Governmental Authority alleging liability under or a violation of any Environmental Law.
“Environmental Laws” shall mean all statutes, laws and regulations of any Governmental Authority relating to pollution or protection or preservation of human health or safety (in relation to exposure to Hazardous Substances) or the environment, including statutes, laws and regulations relating to emissions, discharges, releases or threatened releases of Hazardous Substances, or otherwise relating to the manufacture, processing, distribution, use, treatment, generation, storage, containment (whether above ground or underground), disposal, transport or handling of Hazardous Substances.
“Evaluation Material” shall have the meaning specified in Section 8.5(a).
“Excluded Assets” shall have the meaning specified in Section 1.2.
“Excluded Liability” shall have the meaning specified in Section 1.3.
“Existing Licensee” shall have the meaning set forth in the definition of “Existing Licenses”.
“Existing Licenses” shall mean each of: (i) that certain License and Collaboration Agreement entered into as of July 25, 2019 by and between Seller and Sanofi; (ii) that certain License and Collaboration Agreement entered into as of June 5, 2018 by and between Seller and Yakult Honsha Co., Ltd.; and (iii) that certain License and Collaboration Agreement entered into
as of September 25, 2018 by and between Seller and CSPC Pharmaceutical Group Limited (as amended and restated by and between Seller, CSPC Pharmaceutical Group Limited and CSPC Pharmaceutical Co., Ltd. on October 29, 2018 (CSPC Pharmaceutical Group Limited and CSPC Pharmaceutical Co., Ltd., collectively, “CSPC”)) (each of Sanofi, Yakult Honsha Co., Ltd, and CSPC, an “Existing Licensee”).
“FDA” shall have the meaning specified in Section 3.1(a).
“FDCA” shall have the meaning specified in Section 5.20(d).
“Field” shall mean the treatment, prevention, palliation or diagnosis of any oncology indication in humans or animals.
“Financials” shall have the meaning specified in Section 5.2.
“FIRPTA Certificate” shall have the meaning specified in Section 4.2(g).
“First Commercial Sale” shall mean, with respect to a given Product in a given country or region of the Territory, the first sale of such Product after the Closing by Purchaser, its Affiliates, licensees (including Existing Licensees) or sublicensees to a third party in such country after such Product has been granted Regulatory Approval by the appropriate Governmental Authority for commercial sale in such country; provided that, any sale occurring under an Early Access Program shall be deemed a “First Commercial Sale” for purposes hereunder.
“Fraud” shall mean actual and intentional fraud under Delaware law (including the requisite elements of a (i) false representation of fact made by the defendant, (ii) the defendant’s knowledge or belief that the representation was false or the defendant’s reckless indifference to the truth of that representation, (iii) the defendant’s intention to induce the plaintiff to act or refrain from acting, (iv) the plaintiff’s action or inaction taken in justifiable reliance upon the representation, and (v) damage to the plaintiff caused by such reliance).
“GAAP” shall mean United States generally accepted accounting principles in effect from time to time.
“General Assignment and Bill of Sale” shall have the meaning specified in Section 4.2(a).
“Generic Competition” means, with respect to a Product in a country in the Royalty Territory, that the sales of one (1) or more Generic Products in such country achieve, in the aggregate during any calendar quarter, more than twenty-five percent (25%) of the sum of (i) the aggregate unit sales of such Product sold by Purchaser or its Affiliates or licensees in such country, and (ii) the aggregate unit sales of such Generic Product in such country, as measured by IMS standard units sold based on data provided by IMS International, or if such data is not available, such other reliable data source as reasonably agreed upon by Purchaser and Seller.
“Generic Product” means with respect to a Product, any pharmaceutical product that (i) is sold by a third party (other than Purchaser’s Affiliates or licensees); (ii) is approved for marketing or sale by a Regulatory Authority as a substitutable generic for such Product, (iii) has
received Regulatory Approval based on reference to or reliance on data contained in an earlier Regulatory Approval for such Product (including any IND, NDA or other application or submission for Regulatory Approval) and (iv) contains the same active pharmaceutical ingredient as the active pharmaceutical ingredient in such Product.
“Government Pricing Programs” means the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8), any state supplemental rebate or other state drug price reporting program, the 340B Drug Pricing Program (42 U.S.C. § 256b), Medicare average sales price reporting (42 U.S.C. § 1395w-3a), the VA Federal Supply Schedule Program (38 U.S.C. § 8126) and the Tricare Retail Pharmacy Program (10 U.S.C. § 1074g, 32 C.F.R. § 199.21).
“Governmental Approval” shall mean any: (i) permit, license, certificate, concession, Consent, clearance, confirmation, exemption, franchise, certification, designation, rating, registration, variance, qualification or accreditation issued, granted, given or otherwise made available by or under the authority of any Governmental Authority or pursuant to any Legal Requirement, including all applications for any of the foregoing, together with any renewals, extensions or modifications thereof and additions thereto (“Permits”); (ii) with respect to a pharmaceutical or biological product in a country or regulatory jurisdiction, the approval or other action of a Governmental Authority necessary for the testing, manufacturing, marketing, labeling, distribution, advertising, commercial sale or use of such product in such country or regulatory jurisdiction, including the authorization of an Investigational New Drug Application or NDA by the FDA or any analogous approval in jurisdictions other than the United States, and including any “orphan drug” or similar designation, but, in all cases, excluding any separate pricing or reimbursement approval, where required (“Regulatory Approval”); or (iii) right under any Contract with any Governmental Authority.
“Governmental Authority” shall mean any: (i) nation, principality, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (ii) federal, state, local, municipal, foreign or other government; (iii) governmental or quasi-governmental authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or Entity and any court or other tribunal); (iv) multinational organization or body; or (v) individual, Entity or body exercising, or entitled to exercise, any executive, legislative, judicial, administrative, arbitral, regulatory, police, military or taxing authority or power.
“Hazardous Substances” means any hazardous material, substance, pollutant, contaminant, waste, chemical substance or mixture, pesticide, petroleum, petroleum product or byproduct, asbestos or asbestos-containing material, polychlorinated biphenyls or other substance or materials for which liability is imposed or standards of conduct established pursuant to any Environmental Laws, including all substances defined or regulated as “Hazardous,” “Toxic” or a “Pollutant” pursuant to any Environmental Law.
“HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.
“Incremental Taxes” shall have the meaning specified in Section 14.5.
“IND” shall mean an Investigational New Drug Application submitted to the FDA, or an analogous application or submission with any analogous agency or Governmental Authority outside of the United States for the purposes of obtaining permission to conduct Clinical Trials.
“Indemnitee” shall have the meaning specified in Section 13.4.
“Indemnitor” shall have the meaning specified in Section 13.4.
“Independent Auditor” shall have the meaning specified in Section 8.1(b).
“Infinity” shall have the meaning specified in Section 3.5(a)
“Infinity Agreement” shall have the meaning specified in Section 3.5(a)
“Infinity Default Event” shall have the meaning specified in Section 3.5(c).
“Initial Public Offering” shall mean the first underwritten public offering of common shares of Purchaser registered under the Securities Act of 1933, as amended.
“INK” shall have the meaning specified in Section 5.8(l).
“Intellectual Property Rights” shall mean and include all intellectual property and all rights in and to intellectual property, including the following and all rights of the following types: (i) Patents, Trade Secrets and Know-How, Copyrights, and Trademarks, (ii) domain names and the registrations thereof, social media accounts and handles, websites and website content, (iii) any rights similar, corresponding or equivalent to any of the foregoing anywhere in the world, and (iv) all tangible embodiments of any of the foregoing.
“Interim Financials” shall have the meaning specified in Section 5.2.
“IP Indemnification Limit” shall have the meaning specified in Section 13.6(a).
“IT Systems” means all hardware, servers, data communication equipment, software, information technology systems and computer networks (including third party provided systems and services) that are owned or used by (but only to the extent under the control of) any of the Seller Entities in connection with the operation of the Business.
“Legal Requirement” shall mean any law, statute, legislation, constitution, principle of common law, resolution, ordinance, code, edict, decree, proclamation, treaty, convention, rule, regulation, permit, ruling, directive, pronouncement, requirement (licensing or otherwise), specification, determination, decision, opinion or interpretation that is, has been issued, enacted, adopted, passed, approved, promulgated, made, implemented or otherwise put into effect by or under the authority of any Governmental Authority.
“Licensed Intellectual Property Rights” shall mean all Intellectual Property Rights (including Registered Intellectual Property Rights) that are (i) owned by third parties and (ii) used or held for use in the operation of, or otherwise related to, operation of the Business or any of the Products, including any such Intellectual Property Rights licensed or sublicensed to a Seller Entity
for use in the operation of the Business pursuant to any Material License Agreement or any other Contract included in the Purchased Assets.
“Marketing Authorization” shall mean the grant of all necessary permits, registrations, authorizations, governmental licenses and approvals (or waivers) required for the manufacture, promotion, marketing, storage, import, export, transport, distribution, use, offer for sale, sale or other commercialization of a Product in any country.
“Material Adverse Effect” shall mean, with respect to the Business, taken as a whole, or to the Purchased Assets, taken as a whole, any event, change or effect that, when taken individually or together with all other adverse events, changes and effects, (a) is or would reasonably be expected to be materially adverse to the financial condition, assets, business or operations of the Business, taken as a whole, or to the Purchased Assets, taken as a whole or (b) would prevent or materially delay consummation of the Transactions; provided, however, that any events, changes or effects will not be deemed to constitute a Material Adverse Effect to the extent resulting from (i) general changes or conditions in general economic, political or market conditions or in the industries (or therapeutic areas) in which the Business operates, except to the extent that such changes or conditions in the industries (or therapeutic areas) in which the Business operates have a materially disproportionate effect on the Business, taken as a whole, compared with other companies or businesses operating in such industries (or therapeutic areas); (ii) the loss or departure (or threatened loss or departure) of directors, officers, employees, or other service providers of the Business, or the termination, reduction (or potential reduction) or any other adverse development (or potential adverse development) in the Business’s relationships with any of its customers, suppliers, distributors or other business partners, in each case as a result of the announcement or pendency of this Agreement or the Transactions or the performance by the parties of the obligations hereunder; (iii) any failure by any Seller Entity or the Business to meet internal projections or forecasts for any period (provided that the underlying causes of such failure may be taken into account in determining whether there has been a Material Adverse Effect); (iv) acts of war or terrorism (or the escalation of the foregoing) or natural disasters or other force majeure events; (v) any epidemic, pandemic or disease outbreak (including COVID-19), or any law, regulation, statute, directive, pronouncement or guideline issued by a Governmental Authority, the Centers for Disease Control and Prevention, the World Health Organization or industry group providing for business closures, “sheltering-in-place” or other restrictions that relate to, or arise out of, an epidemic, pandemic or disease outbreak (including COVID-19) or any change in such law, regulation, statute, directive, pronouncement or guideline or interpretation thereof following the date of this Agreement; (vi) changes in any Legal Requirements applicable to the Business or applicable accounting regulations or principles or the interpretation thereof; (vii) the acts or omissions of, or circumstances affecting, Purchaser or its Affiliates; (viii) compliance by the Seller Entities or any of their Affiliates with a request by Purchaser that the Seller Entities or any of their Affiliates take an action (or refrain from taking an action) to the extent such action or inaction is in compliance with such request; and (ix) any action taken by the Seller Entities or any of their Affiliates as required by this Agreement (other than any action to comply with Section 7.1 of this Agreement) or with Purchaser’s written consent.
“Material Contracts” shall have the meaning specified in Section 5.11(a).
“Material License Agreements” shall mean the Existing Licenses and the Infinity Agreement.
“MHLW” means the Japanese Ministry of Health, Labour and Welfare and any successor agency.
“Milestone Payments” shall have the meaning specified in Section 3.1(b).
“NDA” means with respect to a Product, a New Drug Application and all supplements and amendments thereto filed with the FDA with respect to such Product, including all documents, data, correspondence, and other information concerning such Product which are necessary for, or included in any material correspondence provided to or received from Governmental Authorities related to such filings or any Marketing Authorization to use, sell, supply or market such Product in the United States. For clarity, for purposes of Table A in Section 3.1(a), “NDA” shall include a supplemental New Drug Application.
“Net Sales” shall mean, with respect to sales of a Product in a particular period, the gross amounts invoiced by Purchaser, its Affiliates, licensees or its sublicensees from the arms-length, commercial sales or other dispositions (excluding sales or dispositions for use in Clinical Trials or other scientific testing, for research and development, or for compassionate use, in any case for which Purchaser, its Affiliates, licensees or its sublicensees receive no substantial revenue) of such Product to unrelated third parties during such period net of reserves for doubtful accounts or bad debt determined in accordance with GAAP (provided, that any such amounts excluded via such reserve that are subsequently actually received by Purchaser shall be included through an adjustment in the calendar quarter following such receipt thereof), less the following deductions (to the extent included in the gross amount invoiced or otherwise directly paid or incurred by Purchaser, its licensees, Affiliates or its sublicensees):
provided, however, that no deduction shall be made for any amounts payable under the Infinity Agreement, including any royalties paid or payable thereunder.
Such amounts shall be determined from the books and records of Purchaser, its Affiliates, licensees and its sublicensees, in each case maintained in accordance with GAAP, consistently applied.
Where such Product is sold as a Combination Product, the Net Sales for such Combination Product shall be adjusted by multiplying the actual Net Sales of the Combination Product by the fraction A/(A+B) where A is the actual average of the invoice price (on a per unit basis) of such Product when sold in stand-alone form, and B is the sum of the actual average of the invoice prices (on a per unit basis) of the other product or product component that is part of the Combination Product, if such other active product or product component is sold separately. If the other product or product component is not sold separately, then the Net Sales of such Product as a part of the Combination Product shall be as reasonably determined by Purchaser acting in good faith based on the respective values of the components of such Combination Product; provided that, if Seller reasonably disputes such determination by Purchaser in good faith and the parties cannot reach agreement with respect to such determination, then such dispute will be resolved as follows: upon the written request of either party to the other party, the parties shall refer such dispute for resolution to an independent third party expert agreed upon by the parties within thirty (30) days of such non-requesting party receiving such written request. Such independent third party expert will have extensive experience with respect to the commercialization of pharmaceutical products and extensive knowledge of pricing and industry trends in the pharmaceutical industry (or who has such other similar credentials as agreed by the parties), and unless otherwise agreed by the parties, must not be a current or former employee, contractor, agent or consultant of either party or its Affiliates. The requesting party will promptly engage such expert and the parties will share the out-of-pocket costs incurred in connection with the engagement of such expert equally. Within thirty (30) days of the engagement of such expert by the disputing party, such expert will deliver its written decision to the parties (including a detailed report as to such expert’s rationale for such decision), and such decision will be binding on the parties. Notwithstanding any provision in this Agreement to the contrary, (A) if a Product is sold for co-administration with another product or product component that is not a Product, then Purchaser (or its applicable Affiliate or licensee) will not discount, or disproportionately apply deductions to Net Sales to the invoice price of such Product, by a greater percentage than the percentage at which the invoice price of the other (co-administered) product or product components are discounted; and (B) if a Product is sold as a Combination Product, then Purchaser or its applicable Affiliate or licensee will not discount (or disproportionately apply deductions to Net Sales to) the invoice price of such Product included in such Combination Product by a greater percentage than the percentage at which the invoice price of the other products or product components in such Combination Product are discounted.
“Non-Assignable Asset” shall have the meaning specified in Section 1.4(a).
“Operational Know-How” shall have the meaning specified in Section 8.5(a).
“Order” shall mean any: (a) temporary, preliminary or permanent order, judgment, injunction, edict, decree, ruling, pronouncement, determination, decision, opinion, verdict, sentence, stipulation, subpoena, writ, penalty or award that is or has been issued, made, entered, rendered or otherwise put into effect by or under the authority of any court, administrative agency or other Governmental Authority or any arbitrator or arbitration panel; or (b) Contract with any Governmental Authority that is or has been entered into in connection with any Proceeding.
“Patents” shall mean all United States and foreign patents and utility models and applications therefor (including provisional applications) and all reissues, divisions, re-examinations, revisions, additions, renewals, extensions, confirmations, registrations, provisionals, continuations and continuations-in-part thereof, any confirmation patent or registration patent or patent of addition based on any such patent, patent term extensions, and supplemental protection certificates or requests for continued examinations and foreign counterparts thereof.
“Permits” shall have the meaning specified in the definition of “Governmental Approval”.
“Permitted Encumbrance” shall mean (1) statutory Encumbrances for Taxes or other governmental charges not yet due and payable or the amount or validity of which is being contested in good faith by appropriate proceedings and for which adequate reserves have been established by the Seller Entities in accordance with GAAP; (2) mechanics’, materialmen’s, architects’, warehousemen’s, landlords’ and other like statutory Encumbrances arising or incurred in the ordinary course of business, either securing payments not yet due or that are being contested in good faith by appropriate proceedings and for which appropriate reserves have been set aside; (3) such Encumbrances as do not materially affect the use or value of the properties or assets subject thereto or affected thereby or otherwise materially impair business operations at such properties; (4) licenses and other grants in Intellectual Property Rights; (5) zoning, building codes and other land use laws; and (6) Encumbrances resulting from the action or inaction of Purchaser or any of its Affiliates.
“Person” shall mean any individual, Entity or Governmental Authority.
“Personal Data” means any information of or about a natural person, the Processing of which is protected by applicable Legal Requirements.
“Post-Closing Consideration” shall have the meaning specified in Section 2.1.
“Post-Closing Tax Period” shall mean any Tax period beginning after the Closing Date or, in the case of any Straddle Period, the portion of such Straddle Period beginning after the Closing Date.
“Pre-Closing Tax Period” shall mean any Tax period ending on or before the Closing Date or, in the case of any Straddle Period, the portion of such Straddle Period ending on the end of the Closing Date.
“Prior Company Counsel” shall mean Ropes & Gray LLP and any other legal counsel from time to time retained by the Seller Entities prior to the Closing.
“Privacy and Information Security Requirements” means, to the extent applicable to the Seller Entities, all Legal Requirements governing the Processing of Personal Data, including, to the extent applicable to the Seller Entities, the European Union General Data Protection Regulation 2016/679 (“GDPR”) and all other laws supplementing, amending or replacing the GDPR, the Gramm-Leach-Bliley Act, 113 Stat. 1338 (as amended), and the Federal Trade Commission Act, 15 U.S.C. §§ 41-58 (as amended).
“Proceeding” shall mean any action, suit, litigation, arbitration, proceeding (including any civil, criminal, administrative, investigative or appellate proceeding), prosecution, contest, hearing, inquiry, inquest, audit, examination or investigation that is, has been or may in the future be commenced, brought, conducted or heard at law or in equity or before any Governmental Authority.
“Process” (or “Processing” or “Processes” or “Processed”) means the collection, use, storage, processing, recording, distribution, transfer, import, export, protection (including security measures), disposal or disclosure or other activity regarding data (whether electronically or in any other form or medium).
“Product” shall mean and include any and all preparations, kits, articles of manufacture, compositions of matter, materials, compounds, components and products which are, or which contain or comprise the Compound known as “IPI-145” or “Duvelisib” or “INK1197” (as such Compound is further described in Schedule A-1 to the Seller Disclosure Schedule), including any and all of its various chemical forms, including acids, bases, salts, metabolites, esters, isomers, enantiomers, pro-drug forms, hydrates, solvates, polymorphs and degradants thereof, in each case, that has substantially the same pharmacological effect, in crystal, powder or other form, and including (a) any preparations, kits, articles of manufacture, compositions of matter, materials, compounds, components and products which contain two or more active pharmaceutical ingredients, at least one of which is a Compound referenced above, and (b) all formulations and modes of administration and dosage forms of any of the foregoing. Without limiting the foregoing, “Product” shall include, for clarity, any and all of the foregoing currently referred to or marketed by any of the Seller Entities as “COPIKTRA” in all formulations, modes of administration and dosage forms thereof and all such combination products, in each case, whether currently approved or currently in development, including in development in Clinical Trials, and including those referred to as: “DYNAMO”, “DUO” (including any related to the “DUO Extension Study”), “Rollover”, “Contempo”, “Fresco”, “Synchrony”, “Dynamo+R”.
“Product License Payments” shall have the meaning specified in Section 3.1(c).
“Purchase Price” shall have the meaning specified in Section 2.1.
“Purchase Price Allocation” shall have the meaning specified in Section 11.1.
“Purchased Assets” shall have the meaning specified in Section 1.1.
“Purchased Inventory” shall have the meaning specified in Section 1.1(a).
“Purchaser” shall have the meaning specified in the Preamble.
“Purchaser Assignment and Assumption Agreements” shall have the meaning specified in Section 4.2(b).
“Purchaser Damages” shall have the meaning specified in Section 13.1.
“Purchaser Indemnified Persons” shall have the meaning specified in Section 13.1.
“Purchaser Material Adverse Effect” shall mean any event, change or effect that, when taken individually or together with all other such events, changes or effects, would reasonably be expected to have, individually or in the aggregate, (a) a material adverse effect on the ability of Purchaser to consummate the Transactions contemplated hereby or (b) cause a material delay in the ability of Purchaser to consummate the Transactions contemplated hereby.
“Purchaser’s Fundamental Representations” shall have the meaning specified in Section 13.3.
“Purchaser’s Indemnification Cap” shall have the meaning specified in Section 13.5(b).
“Purchaser’s Indemnification Deductible” shall have the meaning specified in Section 13.5(b).
“Registered Intellectual Property Rights” shall mean all: (i) Patents and pending Patent applications; (ii) registered Trademarks and pending applications to register Trademarks; (iii) Copyright registrations and pending applications to register Copyrights; and (iv) domain names and the registrations thereof.
“Regulatory Application” means an application submitted to a Governmental Authority that issues Regulatory Approvals.
“Regulatory Approval” shall have the meaning specified in the definition of “Governmental Approval”.
“Regulatory Authority” shall mean any Governmental Authority that has jurisdiction over the approval, clearance, marketing, manufacture, sale and distribution of biopharmaceutical products in a country or territory, including the FDA, the European Commission and the competent authorities of the EU Member States, and MHLW.
“Regulatory Documentation” means, with respect to any Product or any component thereof, all INDs, NDAs, and other Regulatory Applications submitted to any Regulatory
Authority, copies of Regulatory Approvals and other Governmental Approvals, regulatory materials, drug dossiers, master files (including Drug Master Files, as defined in 21 C.F.R. §314.420 and any non-United States equivalents), and any other reports, records, regulatory correspondence, meeting minutes, telephone logs, and other materials relating to Regulatory Approval of such Product or any component thereof (including any underlying safety and effectiveness data whether or not submitted to any Regulatory Authority), or required to research, develop (including Clinical Trials), manufacture or commercialize such Product or any component thereof, including any information that relates to pharmacology, toxicology, chemistry, manufacturing and controls data, batch records, safety and efficacy, and any safety database required to be maintained for Regulatory Authorities.
“Regulatory Milestone Event” shall have the meaning specified in Section 3.1(a).
“Regulatory Milestone Payment” shall have the meaning specified in Section 3.1(a).
“Representatives” shall mean officers, directors, employees and Affiliates.
“Restricted Business” shall have the meaning specified in Section 8.7.
“Restricted Information” shall have the meaning specified in Section 8.5(a).
“Royalty Payments” shall have the meaning specified in Section 3.2(a).
“Royalty Rate” shall have the meaning specified in Section 3.2(a).
“Royalty Term” shall mean, with respect to the Product in a given country in the Royalty Territory, the period beginning upon the date of the First Commercial Sale of such Product in such country and ending on the later of (a) the tenth anniversary of such date or (b) the expiration of all Valid Claims of the Patents included in the Seller Intellectual Property that cover or claim such Product.
“Royalty Territory” shall mean the United States (including its territories), the European Union, and the United Kingdom of Great Britain and Northern Ireland.
“Sales Milestone Payment” shall have the meaning specified in Section 3.1(b).
“SEC” shall have the meaning specified in Section 3.8(c).
“SEC Financial Statements” shall have the meaning specified in Section 8.1(b).
“Select Intellectual Property Representations” shall mean those representations and warranties of Seller set forth in (i) Section 5.8(b) and (ii) Section 5.8(c).
“Seller” shall have the meaning specified in the Preamble.
“Seller Damages” shall have the meaning specified in Section 13.2.
“Seller Disclosure Schedule” shall have the meaning specified in Article 5.
“Seller Entities” shall have the meaning specified in the Recitals. Notwithstanding the foregoing, the “Seller Entities” shall be deemed to include any other Affiliates of Seller that own or hold any right, title or interest in, to or under any of the Purchased Assets.
“Seller Indemnified Persons” shall have the meaning specified in Section 13.2.
“Seller Intellectual Property” shall mean (i) the Seller Registered Intellectual Property Rights and (ii) all other Intellectual Property Rights owned or purported to be owned by any of the Seller Entities and used or held for use in the operation of, or otherwise relating to, the Business or any of the Products; provided, however that the Seller Intellectual Property shall not include U.S. provisional patent application no. 63/005,969.
“Seller Marks” shall mean (i) the VERASTEM brand, (ii) any Seller Entities’ corporate names, corporate service marks, corporate logos, or other “house brands” and (iii) any Trademark (in word or design form) that is listed on Schedule 1.2(a)(iv) or otherwise contains in whole or in part, or is derived from or is confusingly similar to any of the foregoing but, in each case, excluding the Trademarks listed on Schedule 5.8(d).
“Seller Registered Intellectual Property Rights” shall mean the Registered Intellectual Property Rights owned or purported to be owned by Seller or any of its Affiliates used or held for use in the operation of, or otherwise relating to, the Business or any of the Products, including the Registered Intellectual Property Rights listed or required to be listed on Schedule 5.8(d)(i).
“Seller Regulatory Approvals” means any and all (i) Regulatory Approvals and (ii) Regulatory Applications, in either case that are (A) owned or otherwise controlled by Seller or any of its Affiliates on the Closing Date and (B) related to the Business.
“Seller Subsidiary” shall have the meaning specified in the Recitals.
“Seller Taxes” shall mean: (i) all Taxes imposed on any Seller Entity for any taxable period, (ii) all Taxes related to the Purchased Assets, the Business, or the Assumed Liabilities that are attributable to any Pre-Closing Tax Period (calculated for any Straddle Period in accordance with Section 11.3), (iii) all Transfer Taxes for which the Seller is responsible pursuant to Section 11.2, and (iv) all Taxes imposed on Purchaser or any of its Affiliates as a transferee or successor of any Seller Entity.
“Seller’s Fundamental Representations” shall have the meaning specified in Section 10.1(a).
“Seller’s Indemnification Cap” shall have the meaning specified in Section 13.5(a).
“Seller’s Indemnification Deductible” shall have the meaning specified in Section 13.5(a).
“Seller’s knowledge” and similar phrases shall mean the actual knowledge of Brian Stuglik, Rob Gagnon, Daniel Paterson and Cathy Carew.
“Senior Secured Collateral Agent” means ATHYRIUM OPPORTUNITIES III ACQUISITION LP, a Delaware limited partnership, in its capacity as Collateral Agent for the Senior Secured Note Purchasers.
“Senior Secured Note Purchase Agreement” shall mean that certain Note Purchase Agreement, dated as of March 1, 2019, by and among the Purchaser, the guarantors from time to time party thereto, the Senior Secured Note Purchasers and the Senior Secured Collateral Agent, as amended by that certain Amendment Number One and Waiver to Note Purchase Agreement, dated as of May 28, 2020, and that certain Amendment Number Two to Note Purchase Agreement dated as of the date hereof, and as further amended, restated, supplemented or otherwise modified prior to the date hereof.
“Senior Secured Note Purchasers” means the “Purchasers” as defined in the Senior Secured Note Purchase Agreement.
“Shared Contracts” shall mean all Contracts listed on Schedule 1.5, which Contracts relate in part, but not primarily, to the Business. For clarity, the Material License Agreements are not Shared Contracts.
“Solvent” shall mean: (a) the fair, salable value of Seller’s tangible assets is in excess of the total amount of its liabilities (including, for purposes of this definition, all liabilities, whether or not reflected on a balance sheet prepared in accordance with generally accepted accounting principles, and whether direct or indirect, fixed or contingent, secured or unsecured and disputed or undisputed); (b) Seller is able to pay its debts or obligations in the ordinary course as they mature; and (c) Seller has capital sufficient to carry on the operation of its businesses.
“Straddle Period” shall have the meaning specified in Section 11.3(b).
“Sublicense Revenue Payments” shall mean any and all consideration received by Purchaser or its Affiliates specifically for a license or sublicense of rights granted with respect to Copiktra, including license or distribution fees, milestone or option payments, or license maintenance fees.
“Subsidiary” shall mean, with respect to any Person, any Entity in which such Person has a fifty percent (50%) or greater interest.
“Tax” (and, with correlative meaning, “Taxes” and “Taxable”) shall mean all forms of taxation imposed by any Tax Authority, including all national, state or local taxes (including income, value added, occupation, real and personal property, social security, gross receipts, sales, use, ad valorem, franchise, profits, license, withholding, payroll, employment, excise, severance, occupation, premium or windfall profit taxes, escheat or unclaimed property, stamp duty, customs and other import or export duties, estimated and other taxes), assessments, charges, or similar amounts imposed by any Tax Authority, together with any interest, penalties and additions to tax imposed with respect thereto or imposed in connection with any failure to properly file a Tax Return.
“Tax Authority” shall mean a Governmental Authority responsible for the imposition, assessment or collection of any Tax (domestic or foreign).
“Tax Return” shall mean any report, return, statement, declaration, notice, certificate or other document filed or required to be filed with any Tax Authority in connection with the determination, assessment, collection or payment of any Tax.
“Territory” shall mean worldwide.
“Third Sales Milestone” shall have the meaning specified in Section 3.1(b).
“Total Net Sales” shall have the meaning specified in Section 3.1(b).
“Trade Secrets and Know-How” shall mean and include the following and all trade secret and other intellectual property rights in or to the following: technical information, know-how, data, materials, proprietary information and confidential information, including processing, manufacturing and marketing information, developments, inventions (whether patentable or unpatentable and whether or not reduced to practice), discoveries, processes, methods, practices, ideas, improvements, related papers, invention disclosures, blueprints, drawings, research data and results, flowcharts, diagrams, diagrams, protocols, studies, chemical compositions, formulae, diaries, notebooks, specifications, designs, methods of manufacture, processing techniques, data, databases and data collections, data processing techniques, compilations of information, customer and supplier lists, pricing and cost information, and business and marketing plans and proposals, expertise and other technology applicable to formulations, compositions or products or to their manufacture, development, registration, use or marketing or to methods of assaying or testing them or processes for their manufacture, formulations containing them or compositions incorporating or comprising them, and including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical and analytical, safety, quality control, manufacturing, nonclinical and clinical data, regulatory data and filings, instructions, processes, formulae, expertise and information, reports, documentation, notes, and other materials relevant to the research, development, manufacture, use, importation, offering for sale or sale of, or which may be useful in studying, testing, developing, producing or formulating, products, or intermediates for the synthesis thereof, and all claims and rights related thereto.
“Trademark Assignment” shall have the meaning specified in Section 4.2(c).
“Trademarks” shall mean any and all trademarks, service marks, trade dress, logos, product names, brand names, sub-brand names, slogans, trade names, including all common law trademark rights, and all applications and registrations for any of the foregoing, and all goodwill associated with any of the foregoing throughout the world.
“Transaction(s)” shall mean, collectively, the transactions contemplated by this Agreement.
“Transaction Agreements” shall mean this Agreement and the General Assignment and Bill of Sale, the Purchaser Assignment and Assumption Agreements, the IP Assignment, the Patent Assignment, the Trademark Assignment and the Transition Services Agreement.
“Transfer Taxes” shall mean all federal, state, local or foreign sales, use, transfer, real property transfer, mortgage recording, stamp duty, value-added or similar Taxes that may be imposed in connection with the Transaction.
“Treasury Regulation” shall mean the regulations promulgated under the Code by the United States Treasury and Internal Revenue Service.
“Unaudited Financial Statements” shall have the meaning specified in Section 8.1(b).
“Up-Front Purchase Price” shall have the meaning specified in Section 2.1.
“US PTCL Approval” shall have the meaning specified in Section 3.1(a).
“Usage Guidelines” shall have the meaning specified in Section 7.10(b).
“Valid Claim” means a claim of any (i) issued Patent that has not expired, lapsed, or been finally canceled or abandoned, been dedicated to the public or disclaimed or been held unenforceable, invalid or permanently canceled by a court or administrative agency of competent jurisdiction in an order or decision from which no appeal can be taken or from which no appeal was taken in the time permitted, including through opposition, re-examination, reissue or disclaimer or (ii) pending Patent application that has not been finally abandoned, finally rejected or expired (after the earlier of exhaustion of all appeals actually taken or the expiration of the time allowed for all appeals); provided, however, that if a claim of a pending Patent application has not issued within five (5) years after the earliest effective priority filing date for the Patent application from which such claim takes priority, such claim shall not constitute a Valid Claim for the purposes of this Agreement unless and until a Patent issues for such claim.
“VAT” shall mean (i) value added tax as provided for in the Value Added Tax Act 1994 of the United Kingdom and legislation supplemental thereto, TVA or any other system of value added tax as provided for in Council Directive 2006/112/EC applied in any Member State of the European Union and (ii) any other similar turnover, goods and services, consumption, sales or purchase, tax or duty levied by any other jurisdiction whether central, regional or local.
“Worker Notification Law” shall have the meaning specified in Section 1.3(c).