LICENSE AGREEMENT
Exhibit 10.2
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
by and between
XOMA (US) LLC
and
NOVARTIS PHARMA AG
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TABLE OF CONTENTS
i
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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ii
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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List of Exhibits and Schedules
iii
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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This LICENSE AGREEMENT (the “Agreement”) is entered into as of the 24th day of August, 2017 (the “Effective Date”) by and between XOMA (US) LLC, a limited liability company organized under the laws of Delaware having offices at 0000 Xxxxxxx Xx., Xxxxxxxx, XX, XXX, 00000 (“XOMA”), and Novartis Pharma AG, a company limited by shares (Aktiengesellschaft) incorporated under the laws of Switzerland and registered in the Commercial Register of the Canton of Basel-Stadt, Switzerland, under number CHE-106.052.527 whose registered office is at Xxxxxxxxxxxx 00, 0000 Xxxxx, Xxxxxxxxxxx (“Novartis”). XOMA and Novartis are each referred to herein by name or as a “Party” or, collectively, as the “Parties.”
RECITALS
WHEREAS, XOMA possesses proprietary technology and intellectual property, development and supply rights with respect to the Antibody and Products (as defined below);
WHEREAS, Novartis possesses expertise in the manufacture, development and commercialization of human therapeutic products;
WHEREAS, the Parties desire that XOMA grant Novartis exclusive rights and that Novartis be solely responsible for the further Development and Commercialization of the Antibody and Products in the Field in the Territory (each, as defined below), in exchange for certain milestones and royalties to be paid to XOMA and the other consideration referenced herein, all on the terms and conditions set forth herein; and
WHEREAS, simultaneously with the execution and delivery of this Agreement, XOMA Corporation is signing a Guaranty dated the Effective Date guarantying the full and prompt payment and performance of all of XOMA’s obligations under this Agreement.
NOW, THEREFORE, in consideration of the premises and mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
As used in this Agreement, the following terms will have the meanings set forth in this ARTICLE I unless context dictates otherwise:
“ACA” means the Patient Protection and Affordable Care Act, as the same may be amended or supplemented from time to time.
“Accounting Standards” means, with respect to XOMA, GAAP, and means, with respect to Novartis, IFRS, in each case, as generally and consistently applied throughout the Party’s organization. Each Party shall promptly notify the other in the event that it changes the
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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Accounting Standards pursuant to which its records are maintained; provided, however, that each Party may only use internationally recognized accounting principles (e.g., IFRS, GAAP, etc.).
“Acquiror IP” means, in connection with a Change of Control of XOMA, any Patents and/or Know-How owned or controlled by a Third Party acquiror of XOMA immediately prior to the date of the Change of Control or developed or generated thereafter by such Third Party acquiror without use of or access to the XOMA IP existing immediately prior to such date.
“Affiliate” means any Person that directly or indirectly controls or is controlled by or is under common control with a Party. For the purpose of this definition, “control,” “controls” or “controlled” means ownership (directly or through one (1) or more Affiliates) of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors (in the case of a corporation) or fifty percent (50%) or more of the equity interests (in the case of any other type of legal entity), status as a general partner in any partnership, any other arrangement whereby a Person controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity or the ability to cause the direction of the management or policies of a corporation or other entity. The Parties acknowledge that in the case of certain entities organized under the Laws of certain countries, the maximum percentage ownership permitted by Law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence; provided, that such foreign investor has the power to direct the management and policies of such entity.
“AIA Proceedings” means post-issuance patent challenges and other proceedings under the U.S. Xxxxx-Xxxxx America Invents Act.
“Antibody” means gevokizumab, also known as XOMA-052, and any isoforms, allelic variants, mutants, polymorphisms, modified forms and fragments thereof, and human and non-human counterparts of the foregoing.
“Antitrust Laws” shall mean any federal, state, or foreign statutes, rules, regulations, orders, or decrees that are designed to prohibit, restrict, or regulate actions having the purpose or effect of monopolization or restraint of trade, including the Xxxxxxx Act, the HSR Act, and the Xxxxxxx Act.
“Biosimilar” a biological medicinal product for human use which (a) is highly similar to a reference biological medicinal product that has Regulatory Approval in the country in question; (b) has no clinically meaningful differences from such reference product in terms of quality, safety and efficacy, and (c) is approved for use (i) in the United States as a biosimilar biologic product (as defined in the ACA) pursuant to an abbreviated regulatory approval process established under the ACA; (ii) in the EU as a similar biologic medicinal product pursuant to Directive 2001/83/EC or Regulation (EC) No 726/2004 (as applicable); and/or (iii) in any other country pursuant to an equivalent regime in such country. A product shall not be considered to be a Biosimilar if (A) Novartis or any of its Affiliates or sublicensees was involved in the Development of such product, or (B) such product is commercialized by any sublicensee of
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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Novartis or any of its Affiliates or by any Person who obtained such product in a chain of distribution that included Novartis or any of its Affiliates or sublicensees.
“BLA” means a Biologics License Application filed with the FDA in the United States with respect to a Product, as defined in Title 21 of the U.S. Code of Federal Regulations, Section 601.2 et seq., or a comparable filing for Regulatory Approval in a jurisdiction other than the United States.
“Business Day” means any day that is not a Saturday, Sunday or other day on which commercial banks are authorized or required to be closed, as the case may be, in Basel, Switzerland or San Francisco, California.
“Calendar Quarter” means a period of three (3) consecutive months ending on the last day of March, June, September, or December, respectively.
“Calendar Year” means a period of twelve (12) consecutive months beginning on January 1 and ending on December 31.
“cGCP” means current Good Clinical Practices as defined in U.S. Regulations 21 C.F.R. § 50, 54, 56, 312 and 314, and applicable ICH standards as each may be amended from time to time.
“cGLP” means current Good Laboratory Practices as defined in U.S. Regulations 21 C.F.R. § 58 and applicable FDA then-current laboratory review and inspection requirements, as each may be amended from time to time.
“cGMP” means current Good Manufacturing Practices pursuant to U.S. Regulations 21 C.F.R. § 211, et seq., and applicable ICH standards as each may be amended from time to time.
“Change of Control” means, with respect to a Party: (a) completion of a merger, reorganization, amalgamation, arrangement, share exchange, consolidation, tender or exchange offer, private purchase, business combination, recapitalization or other transaction involving such Party or such Party’s ultimate parent as a result of which the stockholders of such Party or parent immediately preceding such transaction hold less than fifty percent (50%) of the outstanding shares, or less than fifty percent (50%) of the outstanding voting power, respectively, of the ultimate company or entity resulting from such transaction immediately after consummation thereof (including a company or entity which as a result of such transaction owns the then-outstanding securities of a Party or all or substantially all of a Party’s assets, either directly or through one (1) or more subsidiaries); (b) the adoption of a plan relating to the liquidation or dissolution of a Party or its ultimate parent, other than in connection with a corporate reorganization (without limitation of clause (a), above); (c) the sale or disposition to a Third Party of all or substantially all the assets of a Party (determined on a consolidated basis); or (d) the sale or disposition to a Third Party of assets or businesses that constitute fifty percent (50%) or more of the total revenue or assets of a Party (determined on a consolidated basis). The entity(ies)
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gaining control of such Party pursuant to a transaction described in the preceding sentence are referred to herein as the “Acquiror.”
“Combination Product” means any pharmaceutical or biological product (in any formulation) containing one (1) or more active pharmaceutical ingredients in addition to the Antibody.
“Commercialization” and “Commercialize” means all activities undertaken relating to the marketing, promotion (including advertising, detailing, sponsored product or continuing medical education), use, offering for sale, importing for sale, exporting for sale, distribution and sale of a Product and the commercial manufacturing of a Product, as well as, in each case, maintaining Regulatory Approvals necessary or useful to undertake such activities.
“Commercially Reasonable Efforts” means the expenditure of those efforts and resources used consistent with the usual practice of Novartis or its applicable Affiliates in pursuing Development or Commercialization of other similar pharmaceutical or biological products proprietary to Novartis or its Affiliates with similar market and economic potential and at a similar stage in Development or product life, taking into account efficacy, safety, approved labeling, the competitiveness of alternative products in the marketplace, the patent and other proprietary position of the product, the likelihood of regulatory approval given the regulatory structure involved[*] and all other Commercially Relevant Factors. It is anticipated that the level of effort may change over time, reflecting changes in the status of the Antibody or a Product, as applicable.
“Commercially Relevant Factors” means, with respect to the Development or Commercialization of the Antibody or a Product by Novartis or its Affiliates, all relevant factors that may affect the Development or Commercialization of the Antibody or such Product, including (as applicable): safety, efficacy, quality or stability; product profile (including product modality, category and mechanism of action); stage of Development or life cycle status; Development and Commercialization costs and risk; feasibility and cost of manufacture; the likelihood of obtaining Regulatory Approvals (including satisfactory price approvals) and the timing of such approvals; the current guidance and requirements for Regulatory Approval and the current and projected regulatory status, including expectations for post-approval commitments; labeling or anticipated labeling; the then-current competitive environment and the likely competitive environment at the time of projected entry into the market; past performance; present and future market potential; existing or projected pricing, sales, reimbursement and profitability; pricing or reimbursement changes in relevant countries; proprietary position, strength and duration of patent protection and anticipated exclusivity; and the [*].
“Control”, “Controls” or “Controlled” means, with respect to any Know-How, Patents, proprietary information or trade secrets, or other intellectual property rights (collectively, “Rights”), the legal authority or right (whether by ownership, license or otherwise) of a Party to grant a license or a sublicense of or under such Rights to the other Party, or to otherwise disclose such proprietary information or trade secrets to the other Party, without breaching the terms of
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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any agreement with a Third Party, or misappropriating the proprietary information or trade secrets of a Third Party.
“Cover”, “Covering” or “Covered” means, with respect to a product, composition, technology, process or method, that, in the absence of ownership of or a license granted under a Valid XOMA Claim, the manufacture, use, offer for sale, sale or importation of such product or composition, or the practice of such technology, process or method, would infringe such Valid XOMA Claim (or, in the case of a Valid XOMA Claim that has not yet issued, would infringe such Valid XOMA Claim if it were to issue as then being prosecuted in good faith).
“Develop” or “Development” means all research, discovery, pre-clinical development, clinical development, and regulatory activities with respect to the Antibody and Products, including optimization, non-clinical testing, pharmacology studies, toxicology studies, formulation, chemical analysis, bioanalytical analysis, material performance studies (such as measurements of stability, physical form, dissolution, or visual or spectroscopic analysis, and the like), manufacturing process development and scale-up (including with respect to active pharmaceutical ingredient and drug product production), quality assurance and quality control, technical support, pharmacokinetic studies, clinical studies, regulatory affairs activities, and manufacturing, use and importation in support of such activities, in each case to the extent required or useful to obtain any Regulatory Approvals from the FDA or any other applicable Regulatory Authority.
“Dollars” or “$” means the legal tender of the U.S.
“EMA” means the European Medicines Agency, and any successor entity thereto.
“Executive Officers” means the Chief Executive Officer (or his designee) of XOMA and the Head BD&L (or his designee) of Novartis International AG, an Affiliate of Novartis.
“FDA” means the U.S. Food and Drug Administration, and any successor entity thereto.
“Field” means [*] indications and uses, including [*] indications and therapeutic uses.
“First Commercial Sale” means, with respect to a Product, the first arm’s length sale to a Third Party for use or consumption of any such Product in a country. For clarity, the First Commercial Sale shall not include any sale by a Party to its Affiliates or sublicensees (unless such Person is the end user of a Product).
“Fixed Dose Combination Product” means a Combination Product administered in fixed-dose form.
“GAAP” means United States generally accepted accounting principles consistently applied by the applicable Person.
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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“HSR Act” means the United States Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder.
“ICH” means the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
“IFRS” means International Financial Reporting Standards, as amended from time to time.
“Indication” means the specific human disease or condition for which a Product has received Regulatory Approval, the approved label claim of which identifies such Indication; provided, that during the Development of the Antibody or a Product (prior to Regulatory Approval), the Indication(s) for the Antibody or such Product shall be the Indication(s) that are targeted by such Development efforts, as reflected in the applicable development plan and clinical trial protocols.
“IND” means (a) an Investigational New Drug Application as defined in the U.S. Food, Drug & Cosmetics Act and applicable regulations promulgated thereunder by the FDA; (b) a Clinical Trial Authorization filed with EU member states; or (c) the equivalent application to the equivalent Regulatory Authority in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of an investigational new drug in humans in such jurisdiction.
“Indebtedness” means (without duplication), as to any Person, (a) all obligations for the payment of principal, interest, penalties, fees or other liabilities for borrowed money (including guarantees and notes payable), incurred or assumed, (b) all obligations of such Person for the deferred purchase price of property or services, (c) any obligations to reimburse the issuer of any letter of credit, surety bond, debentures, promissory notes, performance bond or other guarantee of contractual performance, (d) all Indebtedness of Third Parties secured by a Lien on property owned or acquired by such Person, (e) any obligation that would be required to be reflected as debt on the balance sheet of such Person under the Accounting Standards and (f) all Indebtedness of others referred to in clauses (a) through (e) above guaranteed directly or indirectly in any manner by such Person, or in effect guaranteed directly or indirectly by such Person through an agreement to pay or purchase such Indebtedness, to advance or supply funds for the payment or purchase of such Indebtedness or otherwise to assure a creditor against loss, in each case including all accrued interest and prepayment penalties, if any, and (g) all contingent obligations in respect of indebtedness or obligations of others of the kinds referred to in clauses (a) through (f) above.
“Initial Payment” means Thirty Million Dollars (US$30,000,000).
“Know-How” means all technical or proprietary information, know-how and data, including inventions (whether patentable or not), discoveries, trade secrets, specifications, instructions, processes, formulae, materials, expertise and other technology applicable to compounds, formulations, compositions, products or to their manufacture, development, registration, use or commercialization or methods of assaying or testing them or processes for
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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their manufacture, formulations containing them, compositions incorporating or comprising them and including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical and analytical, safety, quality control, manufacturing, preclinical and clinical data, instructions, processes, formulae, expertise and information, regulatory filings and copies thereof, relevant to the development, manufacture, use or commercialization of and/or which may be useful in studying, testing, development, production or formulation of products, or intermediates for the synthesis thereof.
“Law” or “Laws” means all laws, statutes, rules, regulations, orders, judgments, guidelines or ordinances having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision.
“Liens” means all liens, claims, security interests, licenses, security interests, restrictions on ownership or transferability or other encumbrances of any kind.
[*] means, with respect to [*], the following has occurred: [*].
“Major European Country” means any of France, Germany, Italy, Spain or the United Kingdom.
“Net Sales” means the net sales on behalf of Novartis and any of its Affiliates or sublicensees (each, a “Selling Party”) for any Product sold to Third Parties other than sublicensees in bona fide, arm’s-length transactions, [*]. The deductions booked on an accrual basis [*] to calculate the recorded net sales from gross sales include, [*]:
(b) | amounts repaid or credited by reasons of defects, rejections, recalls or returns; |
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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In the case of any sale or other disposal of a Product between or among Novartis and its Affiliates or sublicensees, for resale, Net Sales shall be calculated only on the value charged or invoiced on the first arm’s-length sale thereafter to a Third Party. In the case of any sale which is not invoiced or is delivered before invoice, Net Sales shall be calculated at the time [*]. In the case of any sale or other disposal for value, such as barter or counter-trade, of any Product, or part thereof, other than in an arm’s-length transaction exclusively for money, Net Sales shall be calculated on the value of the non-cash consideration received or the fair market price (if higher) of a Product in the country of sale or disposal.
In the event a Product is sold as a Fixed Dose Combination Product, the Net Sales of a Product, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales of the Fixed Dose Combination Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average sale price in a particular country of a Product containing the Antibody as the sole active ingredient when sold separately in finished form and B is the weighted average sale price in that country of the product(s) containing the other component(s) as the sole active ingredient(s) when sold separately in finished form. Regarding prices comprised in the weighted average price when sold separately referred to above, if these are available for different dosages from the dosages of the Antibody and other active ingredient components that are included in the Fixed Dose Combination Product, then [*] in calculating the royalty-bearing Net Sales of the Fixed Dose Combination Product. In the event that such weighted average sale price cannot be determined for both a Product and the other product(s) in combination, or if the Combination Product is not a Fixed Dose Combination Product, the calculation of Net Sales for purposes of determining royalty payments shall be [*].
For the avoidance of doubt, sales between Novartis, its Affiliates and its sublicensees shall not be considered Net Sales (unless such Person is the end user of a Product).
“Novartis Note Agreement” means that certain Secured Note Agreement by and between XOMA (US) LLC and Chiron Corporation, dated as of May 26, 2005; as amended, by that certain letter agreement by and between XOMA (US) LLC and Novartis Vaccines and Diagnostics, Inc. (f/k/a Chiron Corporation), dated as of June 19, 2015; as amended, by that certain letter agreement by and between XOMA (US) LLC and Novartis Vaccines and Diagnostics, Inc. (f/k/a Chiron Corporation) which was assigned to Novartis Institutes for BioMedical Research, Inc. immediately prior to the execution of such letter agreement, dated as of September 30, 2015.
“Patent” means (a) all patents and patent applications in any country or supranational jurisdiction in the Territory, (b) any substitutions, divisionals, continuations, continuations-in-part, provisional applications, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like of any such patents or patent applications, and (c) foreign counterparts of any of the foregoing.
“Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, governmental authority or agency, or any other entity not specifically listed herein.
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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“Phase II Clinical Trial” means a clinical study of an investigational product in patients with the primary objective of characterizing efficacy as well as generating more detailed safety, tolerability, and pharmacokinetics information. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and shall be deemed commenced when the first patient in such study has received his or her initial dose of a product. Any clinical study conducted under a protocol which identifies such study as a “Phase II” study (but excluding any study identified as a “Phase I/II” study unless such study otherwise satisfies the criteria in the first sentence of this definition) shall be deemed to be a Phase II Clinical Trial.
“Phase III Clinical Trial” means a clinical study of an investigational product in patients with the primary objective of confirming with statistical significance the efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. § 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The investigational product can be administered to patients as a single agent or in combination with other investigational or marketed agents and shall be deemed commenced when the first patient in such study has received his or her initial dose of a product. Any clinical study conducted under a protocol which identifies such study as a “Phase III” or “pivotal” study shall be deemed to be a Phase III Clinical Trial.
“Proceeding” means any action, suit, proceeding, claim, arbitration, audit of governmental authority, criminal prosecution, unfair labor practice charge or complaint, examination, inquiry or investigation.
“Product” means any pharmaceutical or biological product containing the Antibody (alone or with other active ingredients), in all forms, presentations, formulations, methods of administration and dosage forms. For the purposes of this Agreement, Product shall be deemed to include a Biosimilar of the Antibody.
“Prosecution and Maintenance” or “Prosecute and Maintain” means, with regard to a Patent, the preparation, filing, prosecution and maintenance of such Patent, as well as re-examinations, reissues, appeals, and requests for patent term adjustments and patent term extensions with respect to such Patent, together with the initiation or defense of interferences, the initiation or defense of oppositions and other similar proceedings with respect to the particular Patent, and any appeals therefrom, and any AIA Proceedings. For clarification, “Prosecution and Maintenance” or “Prosecute and Maintain” shall not include any other enforcement actions taken with respect to a Patent.
“Regulatory Approval” means, with respect to a Product in any country or jurisdiction, the approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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“Regulatory Authority” means any governmental agency or authority responsible for granting Regulatory Approvals for Products, including the FDA, EMA and any corresponding national or regional regulatory authorities.
“Regulatory Materials” means regulatory applications, notifications, and registrations for Regulatory Approvals or other submissions made to or with a Regulatory Authority, together with all related correspondence to or from such Regulatory Authority, with respect or related to the Development or Commercialization of a Product in a particular country, territory or possession in the Territory. Regulatory Materials include INDs, BLAs, and amendments and supplements to any of the foregoing, and applications for pricing approvals.
“Xxxxxxx Xxxx Release” means receipt by Novartis of the Servier Payoff Letter completed and fully executed by XXXX and Servier.
“Servier Loan” means all of the Indebtedness and other obligations due or payable under that certain Loan Agreement by and between XOMA (US) LLC on the one hand, and Les Laboratoires Servier and Institut de Recherches Servier (together, “Servier”) on the other, dated as of December 30, 2010 (as amended, by that certain Consent, Transfer, Assumption and Amendment Agreement by and among XOMA Ireland Limited, XOMA (US) LLC and Les Laboratoires Servier, dated as of August 12, 2013; as amended, by that certain Amendment No. 2 to the Loan Agreement by and between XOMA (US) LLC and Servier, dated as of January 9, 2015; as amended, by that certain Amendment No. 3 to the Loan Agreement by and between XOMA (US) LLC and Servier, dated as of January 17, 2017; and as may be further amended by the parties thereto, subject to the terms of this Agreement) (the “Servier Loan Agreement”) and any other Indebtedness due or payable between XOMA (US) LLC or any XOMA Affiliates and Servier and any Servier Affiliates related to any intellectual property licensed pursuant to this Agreement.
“Servier Payoff Letter” means the payoff letter substantially in the form attached as EXHIBIT E, with such amendments or modifications approved in writing by Novartis, which approval shall not be unreasonably withheld or delayed.
“Stock Purchase Agreement” means that certain Common Stock Purchase Agreement between Novartis and XOMA Corporation, dated the Effective Date.
“Territory” means all countries of the world.
“Third Party” means any Person other than XOMA or Novartis that is not an Affiliate of XOMA or of Novartis.
“United States” or “U.S.” means the United States of America and all of its territories and possessions.
“Valid XOMA Claim” means with respect to any country, (a) a claim of an issued and unexpired Patent that is a XOMA Patent, or (b) a claim in a filed but not yet granted patent
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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application that is a XOMA Patent where such claim has not yet been pending for longer than [*] years following the filing of the earliest application from which said patent application derives priority, in each case where such claim has not been (w) disclaimed, cancelled, withdrawn or abandoned, (x) dedicated to the public, (y) declared invalid, unenforceable, unpatentable or revoked by a decision of a court, government agency or other authority, or (z) admitted to be invalid or unenforceable through reexamination, reissue or otherwise; provided, that if such a claim ceases to be a Valid XOMA Claim by reason of the foregoing (w) through (z), then such claim shall again be deemed a Valid XOMA Claim in the event such claim subsequently issues within a XOMA Patent.
“XOMA IP” means XOMA Know-How and XOMA Patents.
“XOMA Know-How” means Know-How, other than any Know-How that is part of any Acquiror IP, that is Controlled by XOMA or its Affiliates [*] for the Development or Commercialization of the Antibody and/or Products.
“XOMA Patents” mean any Patents, other than any Patents that are part of any Acquiror IP, that are Controlled by XOMA or its Affiliates [*], that claim the Antibody and/or any Products and/or the use, manufacture or sale thereof, [*] including those set forth on EXHIBIT A.
“XOMA Product Patents” means all patents and patent applications claiming priority to US 60/692,830 (XOMA’s “gevo family 1”).
“XOMA Regulatory Materials” means all Regulatory Materials and Regulatory Approvals owned or Controlled by XOMA or its Affiliates relating to the Antibody or Products in the Territory, whether as of the Effective Date or during the Term.
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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AcquirorDefinition of ‘Change of Control’ in ARTICLE I
Phase I/IIDefinition of ‘Phase II Clinical Trial’ in ARTICLE I
Phase IIDefinition of ‘Phase II Clinical Trial’ in ARTICLE I
Phase IIIDefinition of ‘Phase III Clinical Trial’ in ARTICLE I
pivotalDefinition of ‘Phase III Clinical Trial’ in ARTICLE I
RightsDefinition of ‘Control’ in ARTICLE I
Selling PartyDefinition of ‘Net Sales’ in ARTICLE I
ServierDefinition of ‘Servier Loan’ in ARTICLE I
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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Servier Loan AgreementDefinition of ‘Servier Loan’ in ARTICLE I
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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“(e) Maturity Date. Unless earlier accelerated by the reason of the occurrence of an Event of Default (as provided in Section 5 below), any unpaid principal amount of any Loan owed by the Company to the Lender together with all accrued and unpaid interest thereon, shall be due and payable in full on September 30, 2022.”
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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20
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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21
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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22
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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23
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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Product, and that the milestones and Net Sales levels set forth in this Agreement or that have otherwise been discussed by the Parties are merely intended to define the milestone payments and royalty obligations to XOMA in the event such milestones or Net Sales levels are achieved. Neither Party provides any representation, warranty or guarantee that the Development of any Product will be successful, that Regulatory Approval for any Product will be obtained, or that any other particular results will be achieved with respect to the Commercialization of any Product hereunder.
24
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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25
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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[*] shall be responsible for all costs and expenses associated with its Prosecution and Maintenance activities of those [*]
26
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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27
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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other Party or its Affiliates or representatives (the “Disclosing Party”), including trade secrets, Know-How, inventions or discoveries, proprietary information, formulae, processes, techniques and information relating to a Party’s past, present and future marketing, financial and Development activities of any product or potential product or useful technology of the Disclosing Party and the pricing thereof (collectively, “Confidential Information”), except to the extent that it can be established by the Receiving Party that such Confidential Information:
All XOMA Know-How that is specific to the Development and/or manufacture of the Antibody and the XOMA Regulatory Materials shall be considered Confidential Information of both XOMA and Novartis (it being understood that both XOMA and Novartis will be deemed to be the Disclosing Party with respect thereto and the exceptions in Sections 6.1(a) and (e) shall not apply to XOMA with respect to such XOMA Know-How and the XOMA Regulatory Materials). Subject to and without prejudice to the foregoing, any Confidential Information disclosed by either Party (or their Affiliates) prior to the Effective Date pursuant to the Confidentiality Agreement between Novartis International AG and XOMA, dated July 6, 2017 (the “Existing Confidentiality Agreement”) shall be Confidential Information of such Party for all purposes under this Agreement, it being understood and agreed that this Agreement supersedes and replaces the Existing Confidentiality Agreement with respect to such Confidential Information and the rights and obligations of the Parties with respect thereto.
28
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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29
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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30
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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31
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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32
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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33
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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34
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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described herein or any transaction relating to intellectual property licensed under this Agreement under the Antitrust Laws. Neither XOMA nor any of its respective Affiliates shall, without Novartis’ prior written consent, in Novartis’ sole discretion, take or commit to take any action that limits Novartis’ freedom of action with respect to or Novartis’ ability to retain the license and other rights granted to it hereunder or otherwise receive the full benefits of this Agreement or any transaction relating to intellectual property licensed under this Agreement.
in each case, provided, that, such indemnity shall not apply to the extent such Losses arise from a cause or event described in clause (a), (b), (c) or (d) of Section 8.2.
35
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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“Novartis Indemnitees”), from and against any and all Losses, arising out of or resulting from any and all Claims against any Novartis Indemnitee based upon:
in each case, provided, that, such indemnity shall not apply to the extent such Losses arise from a cause or event described in clause (a), (b) or (c) of Section 8.1.
36
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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37
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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38
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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39
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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40
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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41
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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Convention on Contracts for the International Sale of Goods shall not apply to this Agreement or any subject matter hereof.
If to XOMA:
XOMA (US) LLC
42
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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0000 Xxxxxxx Xxxxxx
Xxxxxxxx, Xxxxxxxxxx 00000
Attention: Legal Department
With a required copy to:
Xxxxxx LLP
0000 Xxxxxxx Xxxxxx
Xxxx Xxxx, XX 00000-0000
Attention: Xxxxxxx Xxxxxx
If to Novartis:
Novartis Pharma AG
Xxxxxxxxxxxx 00
0000 Xxxxx
Xxxxxxxxxxx
Attention: Head, BD&L
With a required copy to:
Novartis Pharma AG
Xxxxxxxxxxxx 00
0000 Xxxxx
Xxxxxxxxxxx
Attention: General Counsel
or to such other address for such Party as it shall have specified by like notice to the other Parties; provided, that notices of a change of address shall be effective only upon receipt thereof. If delivered personally, the date of delivery shall be deemed to be the date on which such notice or request was given. If sent by overnight express courier service, the date of delivery shall be deemed to be the next Business Day after such notice or request was deposited with such service. If sent by certified mail, the date of delivery shall be deemed to be the third (3rd) Business Day after such notice or request was deposited with the U.S. Postal Service.
43
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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Novartis to refrain from being directly or indirectly involved in the provision of goods, services or technical data that may be prohibited by applicable Trade Control Laws.
44
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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hereby waives the application in connection with the interpretation and construction of this Agreement of any rule of Law to the effect that ambiguous or conflicting terms or provisions contained in this Agreement shall be interpreted or construed against the Party whose attorney prepared the executed draft or any earlier draft of this Agreement. Any reference in this Agreement to an Article, Section, subsection, paragraph, clause, Schedule or Exhibit shall be deemed to be a reference to any Article, Section, subsection, paragraph, clause, Schedule or Exhibit, of or to, as the case may be, this Agreement. Except where the context otherwise requires, (a) any reference to any Law refers to such Law as from time to time enacted, repealed or amended or any replacement thereof, (b) the words “herein,” “hereof” and “hereunder,” and words of similar import, refer to this Agreement in its entirety and not to any particular provision hereof, (c) the words “include,” “includes,” and “including,” shall be deemed to be followed by the phrase “but not limited to,” “without limitation” or words of similar import, (d) the word “or” is used in the inclusive sense (and/or), (e) provisions that refer to Persons acting “under the authority of Novartis” shall include Novartis’ Affiliates or sublicensees and those Persons acting “under the authority of XOMA” shall include XOMA’s Affiliates or licensees (other than Novartis); conversely, those Persons acting “under the authority of Novartis” shall exclude XOMA, its Affiliates and licensees and those Persons acting “under the authority of XOMA” shall exclude Novartis, its Affiliates and sublicensees; (f) the word “notice” shall require notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement; (g) words of any gender include the other gender; (h) words using the singular or plural number also include the plural or singular number, respectively; and (i) provisions that require that a Party or the Parties “agree,” “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing.
45
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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requirement that XOMA exhaust any right, power or remedy, or proceed directly against such Affiliate, for any obligation or performance hereunder prior to proceeding directly against Novartis.
[Signature page to follow]
46
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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[Signature page to License Agreement]
IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
XOMA (US) LLC
By: /s/ Xxxxx X. Xxxx______________
Name: Xxxxx X. Xxxx
Title: Chief Executive Officer
NOVARTIS PHARMA AG
By: /s/ Xxxx Xxxxxxxx______________
Name: Xxxx Xxxxxxxx
Title: As Attorney
By: /s/ Xxx Xxxxxx________________
Name: Xxx Xxxxxx
Title: As Attorney
1
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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Confidential
EXHIBIT A – XOMA Patents
[*] (9 pages omitted)
A-1
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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Confidential
EXHIBIT B – Form of Novartis Invoice
B-1
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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B-2
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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Confidential
EXHIBIT C – Inventory
[*] (2 pages omitted)
C-1
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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Confidential
EXHIBIT D – XOMA Third Party Agreements
[*]
D-1
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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Confidential
EXHIBIT E – Form of Servier Payoff Letter
E-1
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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August 24, 2017
XOMA (US) LLC
0000 Xxxxxxx Xxxxxx
Xxxxxxxx, XX 00000
Xxxxxx Xxxxxx
Attention: Chief Financial Officer
FAX: 000-000-0000
Re:Payoff Letter
Ladies and Gentlemen:
Reference is made to (i) that certain Loan Agreement, dated as of December 30, 2010, as amended and assigned by the Consent, Transfer, Assumption and Amendment Agreement, dated as of August 12, 2013, as further amended by Amendment No2 to the Loan Agreement, dated as of January 9, 2015, and Amendment No3 to the Loan Agreement, dated as of January 17, 2017 (as so amended, and as further amended, restated, supplemented or otherwise modified from time to time through the date hereof, the “Loan Agreement”), each between XOMA (US) LLC, a Delaware limited liability company (as successor by assignment to XOMA Ireland Limited, “XOMA” or “you”) and Les Laboratoires Servier (“Servier” or “us”) and the other entities from time to time party thereto, and (ii) the other agreements, documents and instruments executed in connection therewith (as each may be further amended, restated, supplemented or otherwise modified from time to time through the date hereof, together with the Loan Agreement, collectively, the “Secured Agreements”). You have informed us that, on or about August 25, 2017, you expect to satisfy, in full, all of the Obligations under the Loan Agreement and the other Secured Agreements, including all monies, liabilities and obligations secured thereunder. All capitalized terms used but otherwise not defined herein shall have the meanings set forth in the Loan Agreement.
Upon Servier’s receipt on August 25, 2017, by federal funds wire transfer (or similar transfer of immediately available funds) in accordance with the instructions set for the below, of an amount equal to €12,022,451, which amount shall be increased by an amount equal to €576 (representing per diem interest) for each day thereafter that the Payoff Amount remains unpaid (such amount, the “Payoff Amount”, and the date upon which such wire is received, the “Payoff Effective Time”), Servier agrees to deliver (or cause to be delivered) to XOMA the original Promissory Note (marked as “cancelled”) and all other instruments in Servier’s possession, if any, and other releases of liens, discharges, terminations and release documentation, executed by Servier (if applicable) releasing Servier’s Liens (as hereinafter defined) on all of the assets and property of XOMA subject to such Liens (the “Collateral”).
Upon the Payoff Effective Time, Servier agrees and acknowledges that (i) all Obligations, including without limitation outstanding indebtedness (including, without limitation, for principal, interest and fees) and other obligations of XOMA under or relating to the Secured Agreements, shall be deemed paid and satisfied in full and irrevocably discharged, terminated and released, (ii) all security interests and other liens and encumbrances (“Liens”) granted to or held by Servier in any assets of XOMA as security for such Obligations shall be automatically, forever and
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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irrevocably satisfied, released and discharged, (iii) the Loan Agreement and the other Secured Agreements shall be automatically terminated and of no further force or effect, and neither XOMA nor any other Person shall have a right to draw funds thereunder, and (iv) XOMA or its agent or designee shall be authorized, without further action, notice or consent, to file the UCC termination statement attached hereto as Exhibit A, and all other instruments, releases and documents evidencing the release of Servier’s Liens on the Collateral. Further, Servier agrees to execute such documents and take all additional actions reasonably requested by XXXX, from time to time, to release its Liens on the Collateral and evidence the termination of the Obligations. XOMA agrees to pay Servier for all reasonable out-of-pocket costs and expenses incurred by Servier in connection with the matters referred to in the previous sentence, and acknowledges that Servier’s execution of and/or delivery of documents releasing any security interest or claim in any Collateral of XOMA as set forth herein is made without recourse, representation, warranty or other assurance of any kind by Servier and hereby confirms that the commitments of Servier to make any Advance or incur liabilities under the Secured Agreements are terminated as of the Payoff Effective Time, and, as of the Payoff Effective Time, Servier shall have no further obligation to make Advances to XOMA or any other Person under the Secured Agreements.
The Payoff Amount referred to above should be sent to the following account of Servier:
[*]
This Agreement shall be governed by the internal laws of the State of New York. No party may assign its rights, duties or obligations under this Agreement without the prior written consent of the other parties. This Agreement may be executed in any number of separate counterparts, each of which shall, collectively and separately, constitute one agreement. Delivery of an executed counterpart of this letter by electronic means (e.g., facsimile or .pdf) shall be equally as effective as delivery of an original executed counterpart and shall not affect the validity, enforceability, and binding effect of this letter. The undersigned parties have signed below to indicate their consent to be bound by the terms and conditions of this Agreement.
[REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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If you need additional information, please do not hesitate to contact us.
Very truly yours,
LES LABORATOIRES SERVIER
By:___________________________
Name:
Title:
INSTITUT DE RECHERCHES SERVIER
By:___________________________
Name:
Title:
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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ACCEPTED and AGREED:
XOMA (US) LLC
By:_________________________
Name:
Title:
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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EXHIBIT A
UCC TERMINATION STATEMENT
See attached.
A-1
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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Confidential
SCHEDULE 1 – Exceptions to Representations and Warranties
[*] (2 pages omitted)
Sched.1-1
[*] = Certain portions of this exhibit (indicated by asterisks) have been omitted as the registrant has determined that the information is both not material and is the type that the registrant treats as private or confidential.
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