IL-1 TARGET LICENSE AGREEMENT
Exhibit 10.1
[*] = 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.
by and between
XOMA (US) LLC
and
NOVARTIS PHARMA AG
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CONFIDENTIAL
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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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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List of Exhibits
iv
[*] = 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 IL-1 TARGET 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 ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇., ▇▇▇▇▇▇▇▇, ▇▇, ▇▇▇, ▇▇▇▇▇ (“XOMA”), and Novartis Pharma AG, 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 ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇, ▇▇ ▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇ (“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 rights with respect to IL-1 Antibodies and IL-1 Products (as defined below);
WHEREAS, Novartis possesses expertise in the manufacture, development and commercialization of human therapeutic products; and
WHEREAS, the Parties desire that XOMA grant Novartis non-exclusive rights with respect to XOMA IL-1 IP to permit Novartis to make, use, sell, offer for sale, import, and otherwise exploit IL-1 Products in the Field in the Territory and an exclusive option with respect to Canakinumab (each, as defined below), in exchange for certain royalties to be paid to XOMA and the other consideration referenced herein, all on the terms and conditions set forth herein.
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 IFRS, as generally and consistently applied throughout Novartis’ organization. Novartis shall promptly notify XOMA in the event that it changes the Accounting Standards pursuant to which its records are maintained; provided, however, that Novartis 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
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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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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. ▇▇▇▇▇-▇▇▇▇▇ America Invents 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.
“BLA” means a Biologics License Application filed with the FDA in the United States with respect to an IL-1 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.
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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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“Canakinumab” means the antibody known as canakinumab and any isoforms, allelic variants, mutants, polymorphisms, modified forms and fragments thereof, and human and non-human counterparts of the foregoing.
“Canakinumab Biosimilar” means a Biosimilar of Canakinumab.
[*] means the period during which [*] or [*] with respect to [*] (a) [*] or (b) [*]
“Canakinumab Patents” mean [*] and/or the [*]
“Canakinumab Product” means any pharmaceutical or biological product containing Canakinumab (alone or with other active ingredients), in all forms, presentations, formulations, methods of administration and dosage forms. For the purposes of this Agreement, Canakinumab Product shall be deemed to include Canakinumab Biosimilars.
“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) 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 CV Canakinumab Product.
“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 any agreement with a Third Party, or misappropriating the proprietary information or trade secrets of a Third Party.
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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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“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 IL-1 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 IL-1 Claim (or, in the case of a Valid XOMA IL-1 Claim that has not yet issued, would infringe such Valid XOMA IL-1 Claim if it were to issue as then being prosecuted in good faith).
“CV Canakinumab Product” means the Canakinumab Product for the CV Indication.
“CV Indication” means the [*] For clarity, a CV Indication [*] including [*] and [*], or [*] or [*] or [*]
“Dollars” or “$”means the legal tender of the U.S.
“EMA” means the European Medicines Agency, and any successor entity thereto.
“Excluded Patents” mean PCT application [*] and all Patents claiming priority 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 [*] and therapeutic uses.
“First Commercial Sale” means, with respect to a CV Canakinumab Product, the first arm’s length sale to a Third Party for use or consumption of any such CV Canakinumab 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 such CV Canakinumab 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.
“Gevokizumab” means the antibody known as gevokizumab, and any isoforms, allelic variants, mutants, polymorphisms, modified forms and fragments thereof, and human and non-human counterparts of the foregoing. For the purposes of this Agreement, Gevokizumab shall be deemed to include any Gevokizumab Biosimilar.
“HSR Act” means the United States ▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇ Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder.
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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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“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.
“IL-1 Antibody” means, [*], any [*] and [*] and [*] and [*] For clarity, [*]
“IL-1 Product” means any pharmaceutical or biological product containing an IL-1 Antibody (alone or with other active ingredients), in all [*] including for [*]
“[*]” means [*].
“IL-1b Target” means the interleukin-1b (IL-1b) family of cytokines that mediate immune and inflammatory reactions.
“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.
“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 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.
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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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“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 any [*] the following has occurred: [*] or [*] or a [*]
“Net Sales” means the net sales on behalf of Novartis and any of its Affiliates or sublicensees (each, a “Selling Party”) for any CV Canakinumab Product sold to Third Parties other than sublicensees in bona fide, arm’s-length transactions, [*] The deductions booked on an accrual [*] to calculate the recorded net sales from gross sales include[*]
| (b) | amounts repaid or credited by reasons of defects, rejections, recalls or returns; |
In the case of any sale or other disposal of a CV Canakinumab 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 CV Canakinumab 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 CV Canakinumab Product in the country of sale or disposal.
In the event a CV Canakinumab Product is sold as a Fixed Dose Combination Product, the Net Sales of a CV Canakinumab Product, for the purposes of determining royalty payments,
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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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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 CV Canakinumab Product containing Canakinumab 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 Canakinumab 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 CV Canakinumab 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 CV Canakinumab Product).
“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.
“[*]” means [*] For clarity, [*]
“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 an IL-1 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 IL-1 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 IL-1 Products, including the FDA, EMA and any corresponding national or regional regulatory authorities.
“Servier Lien Release” means receipt by Novartis of the Servier Payoff Letter completed and fully executed by 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) 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 D, with such amendments or modifications approved in writing by Novartis, which approval shall not be unreasonably withheld or delayed.
“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 IL-1 Claim” means with respect to any country, (a) a claim of an issued and unexpired Patent that is a XOMA IL-1 Patent, or (b) a claim in a filed but not yet granted patent application that is a XOMA IL-1 Patent where such claim has not yet been pending for longer than [*] 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 IL-1 Claim by reason of the foregoing (w) through (z), then such claim shall again be deemed a Valid XOMA IL-1 Claim in the event such claim subsequently issues within a XOMA IL-1 Patent.
“XOMA IL-1 IP” means XOMA IL-1 Know-How and XOMA IL-1 Patents.
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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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“XOMA IL-1 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 [*] to make, have made, use, offer for sale, import, sell, and otherwise commercially exploit any IL-1 Antibody and/or IL-1 Products.
“XOMA IL-1 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 an IL-1 Antibody and/or any IL-1 Products and/or the use, manufacture, import, sale or commercial exploitation thereof, [*] including those set forth on EXHIBIT A. Notwithstanding the foregoing, [*]
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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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ActSection 3.d.i. of Exhibit B
BPCIASection 3.d.ii. of Exhibit B
Competing Infringing ActivitiesSection 3.f. of Exhibit B
Competing ProgramSection 4.b. of Exhibit B
CV Indication RecoverySection 3.g. of Exhibit B
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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[*] = 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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shall [*]. If Novartis elects to exercise the Exclusive Option, after the earliest of (i) [*] (ii) [*] or (iii) [*], Novartis shall provide XOMA with written notice of exercise. If an HSR Filing is required with respect to the exercise of the Exclusive Option, the Parties will cooperate with one another to the extent necessary in the preparation of any such HSR Filing. In such case, the Parties shall each use [*] efforts to ensure that applicable waiting period under the HSR Act or any applicable comparable foreign law in the applicable country expires or is terminated as soon as practicable. Notwithstanding the foregoing, nothing in this Section 2.5 shall require either Party or any of its Affiliates to commit to any divestiture, license (in whole or in part) or any arrangement to hold separate (or any similar arrangement) with respect to any of its products or assets. The Exclusive Option shall be deemed exercised on the date, (i) if an HSR Filing is not required, of Novartis’ notice of exercise or (ii) if an HSR Filing is required, the date of expiration or termination of the applicable waiting period under the HSR Act (such date the “Canakinumab Exclusive License Effective Date”). Effective as of the Canakinumab Exclusive License Effective Date, (x) each of the Canakinumab Non-CV Indication Non-Exclusive License and the Canakinumab CV Indication Non-Exclusive License are hereby converted into the Canakinumab Exclusive License; and (y) the provisions set forth in EXHIBIT B shall apply with respect to the Canakinumab Exclusive License. For clarity purposes, the IL-1 License shall remain in effect and unaffected by Novartis’s decision to exercise or not exercise the Exclusive Option.
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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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[*] = 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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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.
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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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written consent of Novartis; provided, that the foregoing shall not apply to information which is in the public domain or any public disclosure required by Law or governmental regulation or by the rules of any recognized stock exchange. For the avoidance of doubt, Novartis, any of its Affiliates or sublicensees may, without any required consents from XOMA, (a) issue press releases, disclosures, and other public statements as it deems appropriate in connection with the exercise of the licenses and rights with respect to any IL-1 Antibody or IL-1 Products under or in connection with this Agreement, and (b) publish or have published information about clinical trials related to any IL-1 Antibody or IL-1 Products, including the results of such clinical trials; provided, however, if Novartis plans to issue a press release that in its judgment contains material adverse information regarding this Agreement in its entirety or an IL-1 Antibody or IL-1 Product under this Agreement, then Novartis shall use commercially reasonable efforts to provide XOMA with reasonable prior notice of such press release.
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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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(collectively, “Losses”), arising out of or resulting from any and all Third Party suits, claims, actions, proceedings or demands (“Claims”) brought against any XOMA 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 7.2.
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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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in order to prevent immediate and irreparable injury, loss, or damage on a provisional basis, pending the resolution of any dispute hereunder, including under this Section 10.1.
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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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If to XOMA:
XOMA (US) LLC
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▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attention: Legal Department
With a required copy to:
▇▇▇▇▇▇ LLP
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Attention: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
If to Novartis:
Novartis Pharma AG
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Attn: Head, BD&L
With a required copy to:
Novartis Pharma AG
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Attn: 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.
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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in the provision of goods, services or technical data that may be prohibited by applicable export control, economic sanctions laws and anti-boycott regulations of the United States and other governments (“Trade Control Laws”) if performed by Novartis. It shall be in the sole discretion of 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.
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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own choosing, and neither of which has acted under duress or compulsion, whether legal, economic or otherwise. Accordingly, the terms of this Agreement shall be interpreted and construed in accordance with their usual and customary meanings, and each of the Parties hereto 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, Schedule subsection, paragraph, clause, or Exhibit shall be deemed to be a reference to any Article, Section, Schedule, subsection, paragraph, clause, 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.
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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provisions of this Agreement shall apply to any such Affiliate to which this Agreement has been extended to the same extent as such terms and provisions apply to Novartis. Novartis shall remain directly liable for any acts or omissions of its Affiliates, and Novartis hereby expressly waives any 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]
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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[Signature page to IL-1 Target 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/ ▇▇▇▇▇ ▇. ▇▇▇▇______________
Name: ▇▇▇▇▇ ▇. ▇▇▇▇
Title: Chief Executive Officer
NOVARTIS PHARMA AG
By: /s/ ▇▇▇▇ ▇▇▇▇▇▇▇▇______________
Name: ▇▇▇▇ ▇▇▇▇▇▇▇▇
Title: As Attorney
By: /s/ ▇▇▇ ▇▇▇▇▇▇________________
Name: ▇▇▇ ▇▇▇▇▇▇
Title: As Attorney
[*] = 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
[*] (10 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 – Canakinumab Exclusive License Provisions
In addition to the provisions set forth in Section 2.5, effective as of the Canakinumab Exclusive License Effective Date, the provisions identified below shall take effect with respect to the Canakinumab Exclusive License as follows:
| 1. | Sublicensing: |
| a. | Section 2.1.2 of the Agreement is hereby replaced in its entirety with the following new Section 2.1.2: |
“Sublicensing. The license grants in Section 2.1.1 include the right to grant and authorize sublicenses solely in connection with those IL-1 Antibodies and IL-1 Products that are developed by or on behalf of Novartis, its Affiliates and sublicensees in multiple tiers; provided, that (a) [*]; (b) Novartis shall require that each sublicensee comply with all applicable provisions of this Agreement; and (c) Novartis shall remain directly responsible for each sublicensee’s performance in connection with this Agreement.”
| 2. | Financials: |
| a. | Section 3.2.1 of the Agreement is hereby replaced in its entirety with the following new Section 3.2.1: |
“Royalties. On a CV Canakinumab Product-by-CV Canakinumab Product basis, and country-by-country basis, Novartis shall pay royalties at a rate of [*] ([*]) on Net Sales of such CV Canakinumab Product for the CV Indication sold by Novartis, its Affiliates or its sublicensees in the Territory during the remainder of the Royalty Term.”
| b. | A new Section 3.2.2(d) is hereby inserted into the Agreement: |
“Third Party Licenses. In the event that [*] or [*] in connection with [*], or [*] under this Agreement, [*] or otherwise and [*] or [*]; provided, that to the extent (if at all) [*] having [*] under this Agreement, [*] under this Agreement.
Except [*]. Any [*] that [*] and [*] or [*]
| 3. | Intellectual Property: |
ARTICLE IV of the Agreement is hereby amended to insert the new provisions identified below solely as they related to the Canakinumab Exclusive License. For clarity purposes,
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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the provisions set forth in ARTICLE IV shall continue to apply with respect to the IL-1 License.
| a. | Ownership of Intellectual Property Arising Under the Canakinumab Exclusive License. Novartis shall own all data, Patents and Know-How generated, discovered, developed, invented, conceived or reduced to practice by or on behalf of itself, its sublicensees, or Affiliates, whether solely by any such party or jointly by one (1) or more such parties, in connection with the exercise of the Canakinumab Exclusive License under this Agreement, and all intellectual property rights therein, all of which shall be deemed to be “Future IP” under the Agreement. |
| b. | Prosecution and Maintenance of [*] Patents. |
| i. | General. Subject to Section 3.b.ii, as between the Parties, [*] shall diligently and timely Prosecute and Maintain [*] Patents [*] [*] shall keep [*] informed as to material developments with respect to the Prosecution and Maintenance of such [*] Patents, including by timely providing copies of all substantive office actions or any other substantive documents that [*] receives from or submits to any patent office, including notice of all interferences, reissues, re-examinations, oppositions or, subject to Section 3.d., requests for patent term extensions and providing [*] a reasonable opportunity to review and comment on all substantive filings and communications with any patent agency regarding any [*] Patent. [*] shall not unreasonably reject the requests and suggestions of [*] with respect to such drafts and with respect to strategies for filing and prosecuting such [*] Patents in the Territory with the goal of maximizing the exclusive period for Canakinumab and Canakinumab Products as well as any other antibodies that are subject to an exclusive license from [*] or its Affiliates to [*] or its Affiliates. |
| ii. | Filing Decision or Prosecution Lapse. If, during the Term, [*], in exercising its obligations and rights pursuant to Section 3.b.i. to Prosecute and Maintain a [*] Patent in any country, decides not to file such Patent or intends to allow such Patent to lapse or become abandoned without having first filed a substitute Patent, [*] shall notify in writing and consult with [*] regarding such decision or intention at least [*] prior to the date upon which the subject matter of such Patent shall become unpatentable or such Patent shall lapse or become abandoned, and [*] shall thereupon have the right (but not the obligation) to assume the Prosecution and Maintenance thereof at its own expense with counsel of its own choice. If [*] wishes to assume Prosecution and Maintenance of such [*] Patent, [*] shall (A) [*] [*] [*]; (B) promptly provide [*] with the appropriate documents for [*] such Patent in such country; and (C) cooperate and otherwise execute all such documents |
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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| and instruments at the [*] cost and expense, necessary to [*] such Patent in the name of [*] or its designee. |
| c. | Patent Costs. [*] shall be responsible for all costs and expenses associated with its Prosecution and Maintenance activities of [*] Patents under Section 3.b.i.; provided, however, that [*] shall be responsible for all costs and expenses associated with its Prosecution and Maintenance activities of those [*]. |
| d. | Patent Term Extensions. |
| i. | Novartis shall be responsible for determining the strategy for applying for the extension of the term of any [*] Patents with respect to Canakinumab, such as under the “U.S. Drug Price Competition and Patent Term Restoration Act of 1984” (the “Act”), the Supplementary Certificate of Protection of the Member States of the European Union and other similar measures in any other country. If requested by Novartis, and at Novartis’ cost, XOMA shall apply for and use its reasonable efforts to obtain such an extension or, should the Law permit or require Novartis (or one (1) of its respective Affiliates, subcontractors or sublicensees hereunder) to so apply, XOMA hereby gives permission to Novartis to do so (in which case XOMA agrees to cooperate with Novartis in the exercise of such authorization and shall execute such documents and take such additional action as Novartis may reasonably request in connection therewith). Novartis and XOMA agree to cooperate with one another in obtaining any patent extension hereunder as directed by Novartis, and [*]. |
| ii. | Novartis shall be responsible for determining the strategy with respect to certifications, notices and patent enforcement procedures regarding [*] Patents under the Act and the Biologics Price Competition and Innovation Act of 2009 (the “BPCIA”). XOMA shall cooperate, as reasonably requested by Novartis, in a manner consistent with this Section 3.d.ii. XOMA hereby authorizes Novartis to: (a) provide in any BLA or in connection with the BPCIA, a list of XOMA IL-1 Patents as required under the BPCIA; (b) except as otherwise expressly provided in this Agreement, exercise any rights exercisable by Novartis as Patent owner under the Act or the BPCIA; and (c) exercise any rights that may be exercisable by Novartis as reference product sponsor under the BPCIA, including (1) engaging in the Patent resolution provisions of the BPCIA with regard to [*] Patents; and (2) determining which Patents will be the subject of immediate Patent infringement action under § 351(l)(6) of the BPCIA; provided, that with respect to Novartis’ exercise of rights under the BPCIA, Novartis shall consult with a representative of XOMA designated by XOMA in writing and qualified to receive confidential information pursuant to § 365(l) of the BPCIA with respect to Novartis’ exercise of any |
B-3
[*] = 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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| rights exercisable as reference product sponsor, including providing such representative with timely copies of material correspondence relating to such matters, providing such representative the opportunity, reasonably in advance of any related Novartis action, to comment thereon and to consult with and consider in good faith the requests and suggestions of XOMA with respect to such matters |
| e. | Defense of Claims Brought by Third Parties. If [*] receives written notice alleging that the making, using, selling, offering for sale, importing, or other commercial exploitation of Canakinumab or any Canakinumab Product by [*], its Affiliates or sublicensees in the Territory infringes or misappropriates the intellectual property rights of any Third Party, [*] shall promptly notify [*] of the same in writing. In any such instance, [*] shall have the sole right (but not the obligation) to defend such claim, at [*] (subject to any other provision of this Agreement [*] for the underlying infringement or misappropriation, to [*]). |
| f. | Enforcement. [*] shall promptly notify [*] in writing if it reasonably believes that any [*] IP is infringed or misappropriated by a Third Party with respect to the manufacture, sale, offer for sale, use or importation of Canakinumab or any Canakinumab Product (collectively, “Competing Infringing Activities”). [*] shall have the sole right, but not the obligation, to enforce, including as a counterclaim in a defensive proceeding, [*] Patents with respect to Competing Infringing Activity, or to defend any declaratory judgment action with respect thereto provided however that [*] shall not settle any such enforcement action in any manner that would: (i) require any payment or admission of legal wrongdoing by [*]; or (ii) narrow the scope of or have an adverse effect on the enforceability of any [*] IP, in each case without the prior written consent of [*], which consent shall not be unreasonably withheld, delayed or conditioned. [*] shall keep [*] reasonably informed of the progress of any such action, and [*] shall reasonably cooperate with and assist [*] in such litigation as requested by [*], including providing information and materials, at [*] request and expense, and joining as a plaintiff to any action taken by [*] to enforce the [*] Patents in the Field in the Territory. For clarity, [*]. |
| g. | Recovery. That portion of a recovery received under Section 3.f. that is or can reasonably be attributed to a Third Party’s breach of [*] with respect to a CV Canakinumab Product (such portion, the “CV Indication Recovery”), shall be used first to reimburse the Parties for the costs and expenses (including attorneys’ and professional fees) incurred in connection with such action (and not previously reimbursed), and the remainder of such CV Indication Recovery shall be [*]; provided that if such CV Indication Recovery is [*], then such remainder of the CV Indication Recovery (excluding [*] included in such CV Indication Recovery) shall be treated [*]. |
| 4. | [*]. |
B-4
[*] = 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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ARTICLE II of the Agreement is hereby amended to insert the new provision Section 2.6 as follows:
| a. | [*] agrees that, during [*] with respect [*]. |
| b. | If [*]”), then [*], that [*], or [*], and [*] will either (i) [*]; provided, [*], or (ii) [*]. [*]”, as used in this subsection (b), means the [*] without [*]. |
| 5. | Representations and Warranties of XOMA. |
ARTICLE VI of the Agreement is hereby amended to insert the new provision Sections 6.6(a) - (e) as follows:
XOMA hereby represents and warrants to Novartis that, except as set forth in [*], as of the earlier of (i) the date of the Novartis Interest Notice or (ii) the day [*], as applicable:
| 6. | Covenants. |
Effective as of the [*], Section 6.3 of the Agreement is amended by adding the new Section 6.3(c) as follows:
“XOMA will maintain all XOMA Third Party Agreements related to the [*] in effect as of the [*] in full force and effect during the Royalty Term, and will not (i) terminate any such XOMA Third Party Agreement, nor (ii) amend any such XOMA Third Party Agreement, in each case in any manner that adversely effects the rights of Novartis under this Agreement.”
B-5
[*] = 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 – Form of Novartis Invoice
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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C-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 D – Form of Servier Payoff Letter
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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August 24, 2017
XOMA (US) LLC
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▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇
Attention: Chief Financial Officer
FAX: ▇▇▇-▇▇▇-▇▇▇▇
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 irrevocably satisfied, released and discharged, (iii) the Loan Agreement and the other Secured
[*] = 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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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 ▇▇▇▇, 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.
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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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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
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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