EXCLUSIVE LICENSE AGREEMENT
Exhibit 10.10
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[*] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. |
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This Exclusive License Agreement (βAgreementβ) is entered into as of AprilΒ 26 2013 (βEffective Dateβ), by and between Rose U LLC, a California limited liability company (βLicensorβ), and Dermira,Β Inc., a Delaware corporation (βDermiraβ) (collectively, the βPartiesβ and individually, a βPartyβ).
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RECITALS
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A.Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Licensor is the owner of the Patent Rights and Technology (as defined below), and has also licensed the Xxxxxxx Data (as defined below) and obtained certain other rights from Xxxxxxx Laboratories,Β Inc. (βXxxxxxxβ) pursuant to a License and Post-Termination Agreement dated AprilΒ 26 2013 (the βXxxxxxx Agreementβ), a copy of which is attached as Appendix B;
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B.Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Licensor desires to license the Patent Rights and Technology and sublicense the Xxxxxxx Data, to Dermira, and Dermira desires to obtain such license and sublicense, all upon the terms and conditions and as further set forth in this Agreement.
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C.Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Concurrently with the execution of this Agreement, Dermira and Xxxxxxx are entering into a letter agreement (the βXxxxxxx Side Letterβ), a copy of which is attached as Appendix C, pursuant to which, among other things, Dermira agrees to pay license fees arising from the use of the Xxxxxxx Data directly to Xxxxxxx and indemnify Xxxxxxx.
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NOW, THEREFORE, Licensor and Dermira agree as follows:
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ARTICLEΒ 1
DEFINITIONS
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SectionΒ 1.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βAffiliateβ means, with respect to a person, any corporation, partnership, business joint venture or other entity that directly or indirectly controls, is controlled by or is under common control of such person.Β For purposes of this section, βcontrolβ means possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of the entity in question (whether through ownership of securities or other ownership interests, by contract or otherwise).
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SectionΒ 1.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βCombination Productβ means a product that is a combination of a Licensed Product with one or more other products that contain an active pharmaceutical ingredient that is not a Licensed Product (such other products, βNLPsβ).
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SectionΒ 1.3Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βCommercially Reasonable Effortsβ means efforts that, taken together, would constitute a reasonable level of effort by [*] to develop and commercialize in a [*] manner, one of such companyβs [*] giving full consideration to all [*].
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*Confidential Treatment Requested
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SectionΒ 1.4Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β β [*] Paymentβ has the meaning given to it in the Xxxxxxx Agreement.
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SectionΒ 1.5Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βFDAβ means the United States Food and Drug Administration.
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SectionΒ 1.6Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βFieldβ means the use of topical products containing [*] or other compounds identified in the patents listed in Appendix A, for any indications, including without limitation, for the treatment and prevention of hyperhidrosis, [*], or excessive sweating, provided that the indications included in the βFieldβ as it applies to the use of Xxxxxxx Data shall be limited to the treatment and prevention of hyperhidrosis [*], or excessive sweating.Β For clarity, the Field, in all cases, includes such products sold [*].
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SectionΒ 1.7Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βGeneric Productβ means, with respect to a Licensed Product, a product that (1)Β (a)Β contains as an active ingredient, active moiety, or molecular entity which is the same active ingredient, active moiety, or molecular entity as such Licensed Product; (b)Β is approved by the Regulatory Authority in such country for use in such country for the same human indication within the Field as such Licensed Product; and (c)Β is substitutable or interchangeable for such Licensed Product by healthcare practitioners or pharmacists in the applicable country; or (2)Β obtains marketing approval pursuant to an abbreviated regulatory approval process relying in whole or in part on marketing approvals for the Licensed Product or data submitted to a Regulatory Authority by or on behalf of Dermira or a Dermira Affiliate or a Sublicensee for a Licensed Product; or (3)Β otherwise references the Licensed Product to obtain such marketing approval based on a demonstration of bioequivalence or biosimilarity to a Licensed Product.
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SectionΒ 1.8Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βImprovementβ means, with respect to Dermira or Licensor, as applicable, any and all new or useful know-how, discoveries, inventions, contributions, findings, improvements, and enhancements to a Licensed Product for use in the Field, including, without limitation, any enhancements of its use, dosage, form, presentation (including packaging, applicators and the like) and/or formulation, whether or not patented or patentable, conceived, reduced to practice or otherwise developed by or for such Party, either solely or jointly, as the case may be.Β βImprovementβ also means the change in regulatory classification or status of a Licensed Product (e.g. from prescription pharmaceutical to over-the-counter pharmaceutical).
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SectionΒ 1.9Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βKnow-How Royalty Termβ means the period calculated on a [*] basis commencing on the first commercial sale of the first Licensed Product in the [*] and ending [*] thereafter; provided that in no event shall the Know-How Royalty Term for any [*] extend beyond the date that is [*] following the commencement of the first Know-How Royalty Term.
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SectionΒ 1.10Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βLicensed Productβ means any product, process or service in the Field which incorporates in whole or in part, or the use or sale of which absent this license would otherwise infringe, the Patent Rights and Technology or the Xxxxxxx Data.
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SectionΒ 1.11Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βLiquidity Eventβ means (i)Β an initial public offering of Dermiraβs common stock on any nationally recognized stock exchange (including without limitation NASDAQ, NYSE, TSE, London Stock Exchange, or equivalents in other countries) at a price
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per share representing an enterprise value for Dermira equal to at least [*] times the aggregate amount of invested capital (including all equity and unrepaid debt investments) received by Dermira prior to such offering; or (ii)Β a merger, acquisition, or the sale of all or substantially all of Dermiraβs assets or of the assets of a division or product line that includes the Licensed Product.
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SectionΒ 1.12Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βNet Salesβ means the gross amount invoiced or otherwise received by Dermira or a Dermira Affiliate or a Sublicensee from sales of Licensed Product, whether or not assembled (and, except as provided below with respect to Combination Products, without excluding any components or subassemblies thereof), less the following items but only insofar as they actually pertain to the disposition of such Licensed Product by Dermira or an Affiliate of Dermira or a Sublicensee: (a)Β any import, export, sale, use, or excise taxes (including value added taxes to the extent that such value added tax is incurred and not reimbursed, refunded, or credited under a tax authority); (b)Β costs of transportation, packing, and insurance from the place of manufacture to the customerβs premises or point of sale; (c)Β credits for returns, allowances, or trades, or allowances for uncollectable accounts; or (d)Β discounts for prompt payment or volume purchases, or other discounts or rebates paid or credited to promote the inclusion of Licensed Product in applicable formulary programs.Β Sales among Dermira, Affiliates of Dermira and Sublicensees shall be excluded from the computation of Net Sales.
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In the event a Licensed Product is sold in a country as part of a Combination Product, then for purposes of determining payments due to Licensor under this Agreement, Net Sales shall be calculated by multiplying the Net Sales of the Combination Product by the fraction A over A+B, in which:
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βAβ is the Gross Selling Price of the Licensed Product when such Licensed Product is sold in the relevant country in substantial quantities where the Licensed Product is the sole active pharmaceutical ingredient, and
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βBβ is the Gross Selling Price of the NLPs contained in the Combination Product sold separately in the relevant country in substantial quantities.
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All Gross Selling Prices of the Licensed Product and NLPs shall be calculated as the average Gross Selling Prices of such products in the relevant country during the applicable accounting period for which the Net Sales are being calculated.Β In the event that no separate sale of either the Licensed Product as the sole active pharmaceutical ingredient or the NLPs are made in the relevant country during the accounting period in which the sale was made, or if the Gross Selling Price for a Licensed Product or NLP cannot be determined for an accounting period, Net Sales allocable to the Licensed Product and NLPs shall be determined by mutual agreement reached in good faith by the Parties prior to the end of the accounting period in question based on an equitable method of determining same that takes into account the relative contribution of each active pharmaceutical ingredient in the Combination Product, and relative value to the end user of each active pharmaceutical ingredient.Β For purposes of this definition, βGross Selling Priceβ means the gross price at which a product containing the active pharmaceutical ingredient in question is sold to a third party, before discounts, deductions, credits, taxes or allowances.
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SectionΒ 1.13Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βPatent Rights and Technologyβ means: (a)Β Licensorβs rights under all patents, and patent applications listed on Appendix A, as well as all foreign counterpart patents and patent applications (including future foreign counterparts to the patents and patent applications listed in Appendix A or described in β(b)β and β(c)β below); (b)Β all reissues, reexaminations, renewals, extensions, divisionals, continuations, and continuations-in-part of the patents and patent applications listed in Appendix A and/or described in β(c)β below, and any patents which issue on the foregoing; (c)Β unless Dermira elects otherwise with respect to a given patent or patent application, all patent applications that are owned by Licensor or an Affiliate of Licensor during the Term, or to which Licensor or an Affiliate of Licensor otherwise acquires rights during the Term, which are Improvements or enhancements of the patents or patent applications listed in Appendix A and/or described in (b)Β above; and (d)Β any know-how or other enabling information relating to the use of [*] (or other compounds identified in the patents listed in Appendix A) in the Field that is or comes into the possession and control of Licensor or its Affiliates (other than the Xxxxxxx Data) during the Term.
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SectionΒ 1.14Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βProgram Inventory and Suppliesβ has the meaning given to it in the Xxxxxxx Agreement.
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SectionΒ 1.15Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βQuarterβ means each period of three (3)Β consecutive months during the Term ending on a Quarter Date provided that the period from the: (a)Β Effective Date until the first Quarter Date is deemed to be a Quarter; and (b)Β last Quarter Date prior to termination, through the termination date, of this Agreement is deemed to be a Quarter.
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SectionΒ 1.16Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βQuarter Dateβ means one of MarchΒ 31, JuneΒ 30, SeptemberΒ 30, or DecemberΒ 31.
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SectionΒ 1.17Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βRegionβ means each of [*].
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SectionΒ 1.18Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βRegulatory Authorityβ means the FDA and/or its equivalent in other countries of the Territory, or any successor entity thereto.
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SectionΒ 1.19Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βRegulatory Materialsβ means the regulatory applications, submissions, notifications, registrations, regulatory approvals or other submissions or correspondence assigned to Licensor under the Xxxxxxx Agreement, or that relate to the use of [*] (or other compounds identified in the patents or patent applications listed in Appendix A) in the Field and are in or during the Term come into the possession and control of Licensor.Β For clarity, the Regulatory Materials include [*].
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SectionΒ 1.21Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βRose U Patentsβ means the issued patents identified as the βRose U Patentsβ in Appendix A; and βNon-Rose U Patentsβ means all patent rights included in the Patent Rights and Technology, other than the Rose U Patents.
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SectionΒ 1.23Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βXxxxxxx Dataβhas the meaning given to it in the Xxxxxxx Agreement.
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SectionΒ 1.25Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βSublicense Agreementβ means a written agreement under which Dermira or a Dermira Affiliate grants a sublicense of the rights granted under SectionΒ 2.1 or 2.2 to a Sublicensee which rights include the right to commercialize Licensed Product.
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SectionΒ 1.27Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βSublicensing Revenueβ means amounts received by Dermira or an Affiliate of Dermira under a Sublicense Agreement in the form of [*], in each case to the extent attributable to the grant of sublicenses of the Patent Rights and Technology or Xxxxxxx Data.Β For clarity, Sublicensing Revenue shall not include (without limitation): (i)Β payments in return for research services or activities, including costs of materials, equipment or clinical testing; (ii)Β payments for the manufacturing and supply of Licensed Product, (iii)Β bona-fide equity or debt investments, or amounts received by Dermira in respect of any sale or assignment of assets; or (iv)Β reimbursements of patent prosecution costs and patent maintenance expenses.
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SectionΒ 1.28Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βTermβ has the meaning given to it in ArticleΒ 13.
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SectionΒ 1.29Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βTerritoryβ means all countries, states and territories worldwide.
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SectionΒ 1.30Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β βValid Claimβ means either: (a)Β a claim of an issued and unexpired patent included within the Patents Rights and Technology, which has not been permanently revoked or declared unenforceable or invalid by an unreversed and unappealable or unreversed and unappealed decision of a court or other appropriate body of competent jurisdiction, and that has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise, or (b)Β a claim of a pending patent application included within the Patents Rights and Technology, which claim (i)Β was filed in good faith and has not been irretrievably cancelled, withdrawn or abandoned or finally disallowed without the possibility of appeal or refiling of such application, and (ii)Β has not been pending for more than [*] from the earliest priority date of the pending application reciting such claim.
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ARTICLEΒ 2
GRANT OF RIGHTS; TECHNOLOGY TRANSFER
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SectionΒ 2.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β License to Patent Rights and Technology.Β Subject to the terms of this Agreement, Licensor hereby grants Dermira and its Affiliates an exclusive (even as to Licensor), worldwide, perpetual license under the Patent Rights and Technology to research, develop, have developed, make, have made, promote, have promoted, import, have imported, distribute, have distributed, use, have used, sell, have sold, offer for sale, have offered for sale, sublicense through multiple tiers and otherwise fully exploit any and all products, processes and services whatsoever, throughout the Territory in the Field.
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SectionΒ 2.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Sublicense to Xxxxxxx Data.Β Subject to the terms of this Agreement, Licensor hereby grants Dermira and its Affiliates a worldwide, exclusive (except as to Xxxxxxx and its Affiliates) license (including the right to grant sublicenses through multiple tiers pursuant
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to the provisions of SectionΒ 2.3) to use the Xxxxxxx Data in the Field.Β Xxxxxxx and its Affiliates are intended third party beneficiaries of this Agreement.
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SectionΒ 2.3Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Sublicenses.Β Dermira and its Affiliates shall have the right to grant sublicenses (through multiple tiers) to third parties (each such third party, a βSublicenseeβ) of the rights licensed under Sections 2.1 and 2.2.Β Sublicenses of the rights granted to Dermira and its Affiliates under SectionΒ 2.2 may only be granted to a third party to which Dermira, an Affiliate of Dermira or a Sublicensee grants the right to research, develop or commercialize products in the Field using Xxxxxxx Data.Β However, notwithstanding the grant of sublicenses by Dermira and/or its Affiliates hereunder, Dermira shall remain obligated to pay all milestone payments under SectionΒ 4.1 that become due as a result of activities by Affiliates of Dermira or Sublicensees, and all royalties due to Licensor with respect to Net Sales of Licensed Products by Affiliates of Dermira and Sublicensees.Β Any sublicense agreement, whether by Dermira or an Affiliate of Dermira or a Sublicensee, shall not be inconsistent with the terms of this Agreement nor exceed the scope of the license granted to Dermira under this Agreement and shall include (i)Β an obligation of the Sublicensee to indemnify Licensor and its Affiliates as provided in SectionΒ 11.1 and Xxxxxxx and its Affiliates as provided in the Xxxxxxx Side Letter, subject to conditions and procedures substantially equivalent to those contained in SectionΒ 11.2 and the Xxxxxxx Side Letter, (ii)Β confidentiality obligations of the Sublicensee no less protective of the Xxxxxxx Data than those contained in ArticleΒ 9, and (iii)Β an express statement that Xxxxxxx and its Affiliates are intended third party beneficiaries of such sublicense agreement.Β Dermira shall promptly thereafter provide Licensor a true and correct copy of each such sublicense, provided that Dermira or the Sublicensee may redact confidential provisions of the sublicense agreement that are not reasonably required for Licensor to confirm compliance with this Agreement (but not the identity of the Sublicensee).Β Licensor agrees that the obligations in (i)Β and (iii)Β above and the obligation to provide copies of sublicenses shall not apply to sublicense agreements entered into by Dermira or its Affiliates or a Sublicensee with contract research organizations, contract manufacturing organizations and similar third parties performing services for the benefit of Dermira or its Affiliates or a Sublicensee which sublicense does not include any right to commercialize Licensed Product.
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SectionΒ 2.4Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Technology Transfer Obligations.
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(a)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Patent Rights and Technology.Β Promptly following the Effective Date, Licensor shall provide Dermira with copies of all documents (whether in written or electronic form) in Licensorβs possession or control which embody any know-how or information included in the Patent Rights and Technology.
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(b)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Xxxxxxx Data.Β Promptly following the Effective Date, Licensor shall (or shall cause Xxxxxxx to) provide Dermira with copies of all documents (whether in written or electronic form) listed on ExhibitΒ A-1 to the Xxxxxxx Agreement or that otherwise come into the possession or control of Licensor and describe or contain any Xxxxxxx Data, and shall cause Xxxxxxx to provide Dermira with such technical assistance and access to and cooperation of Xxxxxxx personnel as Dermira may reasonably request in connection with the delivery to Dermira of factual knowledge and information relating to the Xxxxxxx Data, Regulatory Materials and Program Inventory and Supplies, subject to the terms and condition of SectionΒ 3.3 of the Xxxxxxx Agreement.Β Dermira shall reimburse Licensor for any out-of-pocket expenses of Xxxxxxx for
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which Licensor becomes liable under SectionΒ 3.3 of the Xxxxxxx Agreement to the extent such expenses have been approved in advance by Dermira in writing.
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(c)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Regulatory Materials.Β Licensor hereby assigns to Dermira all of its right, title and interest in and to the Regulatory Materials, and promptly following the Effective Date shall (or shall cause Xxxxxxx to) promptly deliver the Regulatory Materials (whether in written or electronic form) to Dermira and take (and cause under the Xxxxxxx Agreement Xxxxxxx to take) such additional steps and execute such additional documents as Dermira may reasonably request in order to effect such assignment and delivery, including the transfer of any regulatory applications into the name of Dermira.
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SectionΒ 2.5Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Program Inventory and Supplies.Β Promptly following the Effective Date, to the extent the Program Inventory and Supplies still exists and to the extent it is able to under the terms of the Xxxxxxx Agreement, Licensor shall (or shall cause Xxxxxxx to) assign, transfer and deliver the Program Inventory and Supplies to Dermira, and shall cause Xxxxxxx to take such additional steps and execute such additional documents as Dermira may reasonably request in order to effect such assignment, transfer and delivery.Β In addition, Licensor will cause Xxxxxxx to use commercially reasonable efforts subject to the provisions of SectionΒ 3.4.2 of the Xxxxxxx Agreement to (i)Β introduce Dermira to the contract manufacturing organization (βCMOβ) that provided the Program Inventory and Supplies to Xxxxxxx, and (ii)Β facilitate the transition of manufacturing to aΒ CMO designated by Dermira, provided that Xxxxxxx shall not be obligated to place any orders from a CMO on behalf of Dermira nor to provide any other assistance with respect to a CMO except as specifically set forth in SectionΒ 3.4.2 of the Xxxxxxx Agreement.Β Upon the request of Dermira, Licensor will cause Xxxxxxx to provide such Xxxxxxx consent as is reasonably necessary to allow Dermira to work with service providers who have provided services to Xxxxxxx in connection with the [*] Program (as defined in the Xxxxxxx Agreement), including consenting to the use by such contractors of any Xxxxxxx Data in the possession or control of such contractors to provide services to Dermira, its Affiliates or any Sublicensees.
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SectionΒ 2.6Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Amendment or Termination of Xxxxxxx Agreement.Β Licensor acknowledges that the rights and obligations arising under the Xxxxxxx Agreement are fundamental to Dermiraβs willingness to agree to the terms and conditions of this Agreement, and therefore Licensor agrees that it shall (i)Β promptly notify Dermira of any notices or other communications received by Licensor from Xxxxxxx that relate to alleged breaches or violations of the Xxxxxxx Agreement and (ii)Β shall not agree to any amendment, modification or termination of the Xxxxxxx Agreement without Dermiraβs prior written consent.Β If the Xxxxxxx Agreement is terminated prior to its expiration, the provisions of SectionΒ 8.3 of the Xxxxxxx Agreement and Paragraph 4 of the Xxxxxxx Side Letter shall apply such that the sublicense to the Xxxxxxx Data granted by Licensor to Dermira under this Agreement shall be automatically assigned to and assumed by Xxxxxxx and this Agreement shall be deemed amended to provide for such assignment in part of the rights and obligations of Dermira relating to the Xxxxxxx Data under this Agreement.Β Such assignment and assumption of the sublicense to the Xxxxxxx Data shall not affect the other provisions of this Agreement, including without limitation, the license of the Patent Rights and Technology to Dermira and the milestone, royalty and other payment obligations of Dermira to Licensor under ArticleΒ 4.
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ARTICLEΒ 3
DILIGENCE
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SectionΒ 3.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Diligence Obligation.Β As an inducement to Licensor to enter into this Agreement, Dermira agrees to use Commercially Reasonable Efforts to proceed with the development, manufacture, sale, and lease of Licensed Products in [*], and the development of markets for such Licensed Products in applicable [*] countries.Β The foregoing obligations shall include, where consistent with the Commercially Reasonable Efforts standard, an obligation to select commercially capable Sublicensees and to monitor and enforce the terms of sublicense agreements between Dermira and such Sublicensees.
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SectionΒ 3.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Progress Reports.Β In connection with this obligation, Dermira shall provide annual progress reports on SeptemberΒ 1 of each year detailing its progress through the year ending JuneΒ 30 toward commercialization of the Licensed Products.Β Such report shall include, at a minimum, a summary of work completed, key scientific discoveries, summary of work in progress, current schedule of anticipated events or milestones, and market plans for introduction of Licensed Product.
Β
SectionΒ 3.3Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Disputes as to Diligence.Β If Licensor believes that Dermira is out of compliance with its diligence obligations (including the obligation to use Commercially Reasonable Efforts as specified in SectionΒ 3.1), Licensor shall notify Dermira of such belief and Licensorβs grounds for such belief, including a reasonably detailed written statement of the minimum steps that Licensor believes Dermira would have to take during the ensuing [*] to bring itself into compliance with such obligations. If Dermira believes in good faith that it is in compliance with such diligence obligations, or that such steps are more than would be required in order to bring Dermira into such compliance during such ensuing [*], then Dermira may seek to resolve the matter with Licensor, either through good faith negotiations or pursuant to arbitration in accordance with SectionΒ 15.2.Β In the event that Licensor seeks to resolve such matter through arbitration, the following additional provisions shall apply:Β (i)Β the arbitrator(s)Β selected pursuant to the procedure described in SectionΒ 15.2 shall have, as part of their relevant industry expertise, experience with pharmaceutical development and commercialization, (ii)Β the purpose of the arbitration shall be initially to determine if Dermira was, as asserted by Licensor, failing to comply with the applicable diligence obligations and if such non-compliance was material, (iii)Β if the arbitrator determines that Dermira was materially failing to comply with such diligence obligations, then Dermira and Licensor shall each submit to the arbitrator a written proposal that sets forth a commercially reasonable (using the standard established under the definition of βCommercially Reasonable Effortsβ) set of tasks, and a reasonable timeline that includes specific dates for completing such tasks (such timeline not to exceed [*]), that Dermira shall undertake in order to satisfy the specific diligence obligations for such period.Β The arbitrator(s)Β shall review the written proposals submitted by Dermira and Licensor, and shall determine which of the written proposals shall be adopted as the plan for complying with the applicable diligence obligations (the βCure Planβ).Β If Dermira then materially fails to perform the tasks set forth in the Cure Plan within the timeline established by such Cure Plan, and fails to cure such noncompliance within [*] after written notice by Licensor, then Licensor shall be entitled, as Licensorβs sole remedy, to terminate the licenses granted in SectionΒ 2.1 and 2.2, solely with respect to the specific territories
Β
*Confidential Treatment Requested
Β
Β
and/or applications for which Dermira has failed to exercise the level of diligence required by SectionΒ 3.1.
Β
ARTICLEΒ 4
MILESTONE PAYMENT, ROYALTIES AND PAYMENT TERMS
Β
In consideration for the licenses granted pursuant to this Agreement, Dermira shall pay Licensor or Xxxxxxx (as set out below) the onetime milestone payments and shall pay Licensor the royalties identified below.
Β
SectionΒ 4.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Milestone Payments.Β Dermira shall pay Licensor the following noncreditable, nonrefundable milestone payments in accordance with the milestone events listed below:
Β
MilestoneΒ Event |
Β |
AmountΒ Due |
Β | |
Upon [*] |
Β |
Β |
[*] |
Β |
Upon [*]for a Licensed Product [*] |
Β |
Β |
[*] |
Β |
Upon Dermiraβs [*] of a Licensed Product |
Β |
Β |
[*] |
Β |
Upon [*] for a Licensed Product [*] |
Β |
Β |
[*] |
Β |
Upon [*] of a Licensed Product in the [*] |
Β |
Β |
[*] |
Β |
Upon [*] of a Licensed Product in the [*] |
Β |
Β |
[*] |
Β |
In the event of [*] for Licensed Product [*] |
Β |
Β |
[*] |
Β |
[*]
Β
For avoidance of doubt, each milestone payment above will be payable once regardless of whether milestones are achieved with respect to multiple products.
Β
*Confidential Treatment Requested
Β
Β
[*]
Β
In addition, Dermira shall pay Xxxxxxx the [*] Payment as and if it becomes payable under the terms of the Xxxxxxx Side Letter.
Β
SectionΒ 4.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Royalty Payments.Β Dermira shall pay Licensor the following royalties and other amounts:
Β
(a)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Net Sales.
Β
(i)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Dermira shall pay Licensor a royalty on Net Sales as follows:
Β
(A)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β [*]% of Net Sales in the Territory until [*] (the βRose U Patent Royalty Termβ),
Β
(B)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Following the Rose U Patent Royalty Term:
Β
a.Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β For Licensed Product which at the time of sale are [*]% of Net Sales in the country of sale;
Β
b.Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Until the expiration of the applicable Know-How Royalty Term, for Licensed Product which at the time of sale are [*]% of Net Sales in the country of sale;
Β
c.Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Following the expiration of the applicable Know-How Royalty Term, the licenses granted hereunder for Licensed Product which at the time of sale are [*] shall be considered fully paid up, and Dermira shall have no obligation to pay royalties on any Net Sales on such Licensed Products occurring after such date in such countries; and
Β
d.Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Following the expiration of the last to occur of (i)Β the last Know-How Royalty Term, and (ii)Β the last Valid Claim of the Non-Rose U Patents, the licenses granted hereunder for all Licensed Products shall be considered fully paid up and Dermira shall have no obligation to pay royalties on any Net Sales of any Licensed Products occurring after such date.
Β
(ii)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β This SectionΒ 4.2(a)(ii)Β applies only after the expiration of the Rose U Patent Royalty Term and only to adjust the royalty rate under SectionΒ 4.2(a)(i)(B)a above.Β If at any time one or more third parties launches, sells or otherwise distributes a Generic Product in any country and such Generic Product(s)Β account for [*] percent [*] or more of aggregate prescriptions of Licensed Product and all Generic Products in the given country in any given
Β
*Confidential Treatment Requested
Β
Β
Quarter according to [*] (or any similar third party mutually agreed by the Parties), then the royalty rate under SectionΒ 4.2(a)(i)(B)a, from and after the date such Generic Product(s)Β account forΒ [*] percent [*] or more of aggregate prescriptions of Licensed Product and all Generic Products in the given country in any given Quarter as determined above, shall be [*]%.
Β
(iii)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β If Dermira is required or otherwise determines it necessary to pay additional royalties or other amounts to third parties in respect of intellectual property rights included in a Licensed Product (other than the [*] Payment), then the royalties for such Licensed Product that are due pursuant to SectionΒ 4.2(a)(i)(A)Β and SectionΒ 4.2(a)(i)(B)Β (as may be revised by the application of SectionΒ 4.2(a)(ii)) shall be reduced by [*] percent [*] of the amount of royalties or other amounts paid to such third parties, provided that in no event will the royalties payable to Licensor be reduced to less than [*] percent [*] of the amounts specified in SectionΒ 4.2(a)(i)(A)Β and 4.2(a)(i)(B)Β (as may be revised by the application of SectionΒ 4.2(a)(ii)).
Β
(b)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Sublicensing Revenue Payments.Β In addition, until the expiration of the last Valid Claim included in the applicable sublicensing agreement, Dermira shall pay Licensor a royalty equal to a percentage of the Sublicensing Revenue received by Dermira from a Sublicensee, determined based on the date that the applicable sublicensing agreement is entered into by Dermira and the Sublicensee in accordance with the following schedule:
Β
EffectiveΒ DateΒ ofΒ SublicensingΒ Agreement |
Β |
ApplicableΒ Percentage |
Β |
Within [*] after Effective Date |
Β |
[*]% |
Β |
More than [*] after Effective Date |
Β |
[*]% |
Β |
Β
In the event the Sublicensing Revenue is nonmonetary (including without limitation a cross-license), it shall be assigned a fair market value in good faith and the specified percentage of that fair market value shall be paid to Licensor.
Β
(c)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Crediting of [*] Payment.Β Dermira shall be entitled to deduct from amounts payable to Licensor under this SectionΒ 4.2 an amount equal to the [*] Payment paid by Dermira to Xxxxxxx under the Xxxxxxx Side Letter as follows: after Dermira has paid the [*] Payment to Xxxxxxx, Xxxxxxx shall be entitled to reduce royalties on Net Sales or Sublicensing Revenue otherwise payable under this SectionΒ 4.2 by [*] percent [*]%) until the full amount of the [*] Payment has been credited against such portion of royalties on Net Sales or Sublicensing Revenue payable by Dermira under this SectionΒ 4.2 after Dermiraβs payment of the [*] Payment.
Β
(d)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Liquidity Events.Β In the event that Dermira undergoes a Liquidity Event during the Rose U Patent Royalty Term, it shall pay Licensor a royalty of $[*].Β For avoidance of doubt, the Liquidity EventΒ payment will be payable once regardless of whether Dermira or its successors undergo multiple Liquidity Events.
Β
(e)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Worldwide Scope.Β The parties acknowledge that Licensed Products, and components incorporated with or into Licensed Products, are mobile and may be transported from country to country across the world.Β Accordingly, for ease of accounting and the
Β
*Confidential Treatment Requested
Β
Β
convenience of the parties in calculating payments due Licensor, the royalties and other amounts due under this Agreement are based on worldwide sales of Licensed Products regardless of whether a particular Licensed Product is covered by a current patent claim in the country of manufacture, sale, use, or importation, and the parties acknowledge that the amounts due Licensor under this Agreement have been reduced to account for this.
Β
SectionΒ 4.3Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Payment Terms.Β All payments made pursuant to this Agreement shall be in U.S. dollars.
Β
(a)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Milestone Payments.Β Milestone payments payable to Licensor pursuant to SectionΒ 4.1 that become payable during the Term shall be paid by Dermira to Licensor within [*] of the completion of the milestone event giving rise to such payment as set forth in SectionΒ 4.1.Β [*] Payment arising under the Xxxxxxx Side Letter shall be paid by Dermira in accordance with the terms of the Xxxxxxx Side Letter.
Β
(b)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Royalties.Β Any payments pursuant to SectionΒ 4.2 that become due and payable during the Term shall be paid by Dermira to Licensor within [*] after the end of the Quarter in which the Net Sales occurred or Sublicensing Revenue is received by Dermira.
Β
(c)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Service Fees.Β Any payments due to Licensor that are not paid within the time provided in this Agreement shall be subject to a service charge of [*] percent per month, calculated on the number of days such payment is delinquent, or, if lower, the maximum charge permitted under applicable law.Β This SectionΒ 4.3(c)Β shall in no way limit any other remedies available to Licensor.
Β
SectionΒ 4.4Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Royalty Reports.Β No later than [*] after each Quarter Date commencing after the earlier of (i)Β first commercial sale of a Licensed Product, and (ii)Β the first Sublicense Agreement entered into by Dermira or an Affiliate of Dermira, Dermira shall provide Licensor with a written statement that identifies the: (a)Β Net Sales (including without limitation information broken out by country, product name, entity making sale, and details of amounts deducted from the proceeds invoiced for the purpose of calculating Net Sales) received during the Quarter in question; (b)Β Sublicensing Revenue received during the Quarter in question; and (c)Β any royalties due and payable to Licensor pursuant to this Agreement.Β Each report shall also identify any Sublicense Agreements entered into with a Sublicensee during the Quarter and a report detailing the compensation received from each such Sublicensee that quarter broken out in the same way as the reports described above.
Β
SectionΒ 4.5Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Right to Audit.
Β
(a)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Dermira shall keep and maintain records for a period of [*] showing the manufacture, sale, use, sublicensing, and other disposition of Licensed Products sold or otherwise disposed of under this Agreement in sufficient detail to enable an outside accountant to determine the amounts due under this Agreement.Β Dermira will permit an accountant from a nationally-recognized accounting firm designated by Licensor, and who has entered into a confidentiality agreement in a form reasonably requested by Dermira, to review Dermiraβs records related to Licensed Products, milestone payments and royalties payable
Β
*Confidential Treatment Requested
Β
Β
pursuant to this Agreement.Β The designated accountant will have access to such records during regular business hours and upon at least [*] prior written notice, for the purpose of verifying the accuracy of any royalty paid or payable under this Agreement for the [*] preceding such an audit.Β Licensor may not exercise this right more than once in any calendar year.Β Licensor will provide Dermira with a copy of any report prepared as a result of the audit.Β Licensor shall bear the full cost of such audit unless such audit discloses an underpayment by Dermira to Licensor of more than [*] of the amount due in any Quarter examined, in which case, Dermira shall bear the full cost of the audit.
Β
(b)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Except for purposes of enforcing this Agreement, or as otherwise required by law, Licensor agrees to hold confidential all non-public, confidential information learned in the course of any examination of Dermiraβs books and records under this Agreement.
Β
SectionΒ 4.6Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Payment Adjustments.Β Any adjustment to royalty or milestone payments made by Dermira to Licensor (whether payment or reimbursement, as the case may be) required as a result of an audit conducted pursuant to SectionΒ 4.5 shall be made within [*] after the date on which the accountant conducting the audit issues a written report to Licensor and Dermira containing the results of the audit.
Β
SectionΒ 4.7Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Audit Conditions.Β Dermira will supply all records to Licensor and its accountant in the English language and such records will be collated, indexed or otherwise mapped and made available for review in a well-lighted, climate-controlled location at Dermiraβs facilities.Β Dermira agrees that all records relating to this Agreement subject to audit will be maintained and presented by English speaking personnel within Dermiraβs organization who have authority and responsibility for such records.
Β
ARTICLEΒ 5
LICENSED PRODUCT DEVELOPMENT AND RIGHTS
Β
SectionΒ 5.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Dermira Future Development and Inventions.Β Dermira shall be responsible, at its sole cost and expense and in accordance with its obligations under ArticleΒ 3, for the formulation, preclinical, clinical development and registration work to develop and market Licensed Products (βDevelopment Workβ).
Β
SectionΒ 5.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Intellectual Property Ownership.Β As between Licensor and Dermira, Dermira will have and retain ownership of all right, title and interest to technology and intellectual property developed by Dermira, its Affiliates and their personnel, whether or not relating to the Patent Rights and Technology.Β Without limiting the generality of the foregoing, Dermira shall be the owner of any Improvements to the Licensed Product developed by Dermira, its Affiliates or their personnel as part of the Development Work under SectionΒ 5.1.
Β
ARTICLEΒ 6
PATENT PROSECUTION
Β
SectionΒ 6.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Responsibility for Prosecution of Patent Rights and Technology.Β Dermira shall be responsible for (and shall use Commercially Reasonable Efforts toward) the
Β
*Confidential Treatment Requested
Β
Β
prosecution and maintenance of the U.S. and foreign patents and patent applications included in the Patent Rights and Technology, using counsel of its choice, and shall bear all expenses incurred in connection with such prosecution or maintenance.Β Dermira shall provide Licensor with copies of relevant documentation so that Licensor may be informed and apprised of the continuing prosecution of such patent applications.Β Dermira shall provide LicensorΒ with an opportunity to review and comment on the text of each patent application and material responses to office actions before filing, and shall take Licensorβs comments and suggestions into consideration when framing responses and submissions to patent offices.Β At Dermiraβs sole expense, Licensor agrees to reasonably cooperate with Dermira in preparing, filing, prosecuting and maintaining any such patent applications and patents (including without limitation by using reasonable efforts to make the applicable inventor(s)Β available to Dermira as a liaison and resource during patent prosecution), and Licensor agrees to execute any documents as shall be necessary for such purpose.
Β
SectionΒ 6.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Abandoned Patents.Β Notwithstanding SectionΒ 6.1, if Dermira elects to abandon prosecution of a patent or patent application included in the Patent Rights and Technology, then Dermira shall notify Licensor in writing and if Licensor so elects by written notice to Dermira within [*] thereafter, then (a)Β such patent or patent application shall no longer be part of the Patent Rights and Technology and (b)Β Licensor shall be entitled (at its own expense) to assume and continue the prosecution and maintenance of such abandoned patent or patent application.
Β
ARTICLEΒ 7
INFRINGEMENT
Β
SectionΒ 7.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Notification of Infringement.Β Each Party agrees to provide written notice to the other Party promptly after becoming aware of any suspected infringement or alleged infringement of the Patent Rights and Technology.Β Such notifying Party shall provide the other Party with any available evidence of such suspected infringement or alleged infringement.
Β
SectionΒ 7.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Right to Pursue Infringers.
Β
(a)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β In the event of suspected infringement of the Patent Rights and Technology by a third party, Dermira shall have the first right to enforce the Patent Rights and Technology, and shall be entitled to (in consultation with counsel of its choice) control all aspects of any enforcement action, including without limitation the degree, timing, object, and methods of enforcement (such methods including but not limited to licensing, litigating for damages and injunctive relief, and settling disputes).Β If requested by Dermira (and at Dermiraβs expense) Licensor (i)Β shall join in (or if necessary, initiate) a suit against alleged infringers of the Patent Rights and Technology, and (ii)Β provide (at Dermiraβs expense) all assistance, information and authority reasonably requested by Dermira in connection with any enforcement action initiated or requested by Dermira.Β In the event of an enforcement action initiated or requested by Dermira pursuant to this SectionΒ 7.2(a), Dermira shall be entitled to retain any amounts awarded or received by way of judgment or settlement, except that any amounts received by Dermira in excess of Dermiraβs costs and expenses associated with such enforcement action shall be treated
Β
*Confidential Treatment Requested
Β
Β
as Sublicensing Revenue and shall be subject to the payment obligations contained in SectionΒ 4.2(b).
Β
(b)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Notwithstanding SectionΒ 7.2(a), if Licensor has provided Dermira with written notice of suspected infringement or alleged infringement of the Patent Rights and Technology, and Dermira does not within [*] after such notice (the βDermira First Right Periodβ) elect to initiate settlement discussions or an enforcement action with respect to such infringement, then Licensor shall have the right, exercisable at any time within [*] after the expiration of the Dermira First Right Period to notify Dermira in writing that it wishes to initiate an enforcement action against the alleged infringers, in which case:
Β
(i)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β If Dermira so elects within [*] after receiving such notice from Licensor, then (A)Β Dermira and Licensor shall be entitled to jointly control all aspects of such enforcement action (it being understood that unless Dermira in its sole discretion agrees in writing, the Parties shall not be entitled to enter into any settlement that provides the alleged infringer with any rights or license to the Patent Rights and Technology), (B)Β the expenses of such enforcement shall be shared equally by Dermira and Licensor, and each Party shall provide any assistance, information and authority reasonably requested by the other in connection with such enforcement action, and (C)Β all recoveries awarded or received by way of judgment or settlement will first be allocated to each Party [*] to reimburse all attorneyβs costs, fees, and other related expenses incurred by such Party, with any remaining amount shared [*] between the Parties.
Β
(ii)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β If Dermira declines to participate in such enforcement action or fails to respond within [*] after receiving such notice, then (A)Β Licensor shall be entitled to control all aspects of such enforcement action, provided that unless Dermira in its sole discretion agrees in writing, Licensor shall not be entitled to enter into any settlement that provides the alleged infringer with any rights or license to the Patent Rights and Technology, andΒ (B)Β such enforcement action shall be at Licensorβs sole cost and expense, provided that Dermira shall (at Licensorβs expense) provide any assistance, information and authority reasonably requested by Licensor in connection with such enforcement action, and (C)Β Licensor shall be entitled to retain [*] awarded or received by way of judgment or settlement.
Β
ARTICLEΒ 8
REPRESENTATIONS AND WARRANTIES
Β
SectionΒ 8.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Licensor Representations and Warranties.Β Licensor represents and warrants to Dermira that: (a)Β Licensor has full power to make the assignments and transfers and grant the rights, licenses and privileges granted in this Agreement; (b)Β Licensor has not licensed, pledged, granted a security interest in, encumbered or assigned any of the Patent Rights and Technology, Xxxxxxx Data, Regulatory Materials, or Program Inventory and Supplies to any third party, other than Xxxxxxxβx retention of certain rights to Xxxxxxx Data under the Xxxxxxx Agreement, and the license of certain Patent Rights and Technology pursuant to a prior license described in Recital A of the Xxxxxxx Agreement which was terminated by Xxxxxxx (with no remaining rights to Patent Rights (as defined therein) held by the former licensee) pursuant to a termination notice
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*Confidential Treatment Requested
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issued by Xxxxxxx on [*]; (c)Β the Xxxxxxx Agreement has been executed and delivered by Licensor and Xxxxxxx and remains in full force and effect; (d)Β there no patents or patent applications in the name of [*] in existence as of the Effective Date related to the Field which have not been assigned to Licensor, and (e)Β Licensor will ensure that any inventions or discoveries made by [*] during the Term which would be included in Patent Rights and Technology if assigned to Licensor are assigned by [*] to Licensor.
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SectionΒ 8.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Dermira Representations and Warranties.Β Dermira represents and warrants that: (a)Β it has full power and authority to enter into this Agreement; and (b)Β in exercising its rights under this Agreement, it shall fully comply with the requirements of any and all applicable laws, regulations, rules, and orders of any governmental body having jurisdiction over the exercise of the rights hereunder.
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SectionΒ 8.3Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Disclaimer; Negation of Warranties by Licensor.
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EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLEΒ 8, LICENSOR MAKES NO WARRANTIES OR REPRESENTATION (EXPRESS,Β IMPLIED, STATUTORY, OR OTHERWISE) WITH RESPECT TO THE SUBJECT MATTER HEREOF, AND SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED WARRANTIES OR REPRESENTATIONS OF ANY KIND,Β INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, AND ALL WARRANTIES AND REPRESENTATIONS OF NONINFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS.
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Nothing contained in this Agreement shall be construed as:
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(a)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β a warranty or representation by Licensor as to the validity, enforceability, or scope of any of the Patent Rights and Technology;
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(b)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β a warranty or representation by Licensor that the manufacture, sale, offer for sale, lease, import, use, or other exploitation of the Licensed Products will be free from infringement of intellectual property rights of third parties;
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(c)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β conferring any rights to use in advertising, publicity, or other marketing activities any name, trademark, or other designation of either party, except as otherwise expressly set forth herein;
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(d)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β granting by implication, estoppel, or otherwise any licenses or rights under patents or other rights of Licensor or other persons other than the Patent Rights and Technology and the Xxxxxxx Data; or
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(e)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β an obligation to furnish any technical information or know-how except as expressly provided.
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*Confidential Treatment Requested
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ARTICLEΒ 9
CONFIDENTIALITY
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SectionΒ 9.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Treatment of Confidential Information.Β Each Party agrees that all inventions, processes, materials, chemicals, know-how and ideas, and all other business, technical and financial information, it obtains from the other Party (which includes disclosures by Xxxxxxx in the case of disclosures by Licensor) is the confidential property of the disclosing Party (βConfidential Informationβ of the disclosing Party). Except as expressly allowed in this Agreement, the receiving Party will hold in confidence and not use or disclose any Confidential Information of the disclosing Party; provided, however, that Dermira, its Affiliates and Sublicensees may disclose information relating to the Patent Rights and Technology and the Xxxxxxx Data (a)Β to actual or potential Sublicensees, investors or acquirers provided that each such actual or potential Sublicensee, investor or acquirer agrees in writing to abide by confidentiality and non-use restrictions similar to those contained in this paragraph, (b)Β to consultants, contractors, suppliers and Affiliates, provided that each such consultant, contractor, supplier and Affiliate agrees in writing to abide by confidentiality and non-use restrictions similar to those contained in this paragraph, and (c)Β to legal, financial, and tax advisors of Dermira or its Affiliates or of a Sublicensee, provided that such advisors are subject to confidentiality obligations with respect to any Confidential Information.Β No provision of this paragraph shall be interpreted to prevent Dermira, its Affiliates or a Sublicensee from making disclosures of Confidential Information to Regulatory Authorities as necessary: (i)Β for the research and development of Licensed Products; or (ii)Β to seek or obtain patents.Β Furthermore, Licensor agrees (without limitation on Licensorβs obligations under ArticleΒ 2) that during the Term, Licensor shall treat the Patent Rights and Technology as Confidential Information of Dermira.Β Dermira acknowledges that, pursuant to SectionΒ 9.1 of the Xxxxxxx Agreement, if Xxxxxxx reasonably believes that a potential sublicensee of Dermira of rights to commercialize Licensed Product may be using any of the Xxxxxxx Data in breach of any confidentiality or non-use obligation to Dermira or sublicense or other authorization provided by Dermira, Xxxxxxx may request in writing of Licensor whether Dermira disclosed the Xxxxxxx Data to such third party or an Affiliate or representative thereof, and Dermira shall provide Licensor with the information for Licensor to answer Xxxxxxxβx request, provided that answering such request does not constitute a breach of any legal obligation of Dermira to such third party, including representing to Licensor whether Dermira made such a disclosure.Β Dermira will ensure that any non-disclosure or other agreement with such a third party under which Xxxxxxx Data is disclosed, does not prevent Dermira from making such a disclosure in response to a court order.
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SectionΒ 9.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Release from Restrictions.Β The provisions of SectionΒ 9.1 shall not apply to any Confidential Information disclosed hereunder which:
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(a)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β was known or used by the receiving Party prior to its date of disclosure to the receiving Party, as evidenced by the prior written records of the receiving Party; or
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(b)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β either before or after the date of the disclosure to the receiving Party is lawfully disclosed to the receiving Party by sources other than the disclosing Party rightfully in possession of such information, and such source was not under a duty of confidentiality with respect to such information; or
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(c)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β either before or after the date of the disclosure to the receiving Party becomes published or generally known to the public, through no fault or omission on the part of the receiving Party or an affiliated party; or
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(d)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β is independently developed by or for the receiving Party without reference to or reliance upon the Confidential Information; or
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(e)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β is required to be disclosed by the receiving Party to comply with applicable laws, court order, or governmental regulations, provided that the receiving Party (i)Β provides (A)Β prior written notice of such disclosure requirement to the other Party and (B)Β an adequate opportunity to seek appropriate legal relief to prevent such disclosure or limit use and further disclosure of the Confidential Information and (ii)Β takes reasonable and lawful actions to avoid and/or minimize the degree of such disclosure, and provided, further, that the receiving Party shall furnish only such portion of the Confidential Information that is legally required to be disclosed and shall promptly inform the disclosing Party in writing of which portion of the Confidential Information was so disclosed.
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Notwithstanding the foregoing or anything set forth herein or otherwise, and for the avoidance of doubt, [*]Β shall be considered to be Confidential Information.
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ARTICLEΒ 10
MARKING
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Prior to their expiration, Dermira, its Affiliates, and its Sublicensees shall xxxx, or shall cause to be marked, each Licensed Product with a notice that the Licensed Product is βLicensed under one or more of U.S. Patents Nos. [*]β and/or all such additional patents covered by this Agreement as they issue and shall otherwise so xxxx Licensed Products in accordance with applicable patent laws and practices of the country in which the Licensed Product is sold.Β To the extent permitted and effective pursuant to applicable law, however, and if marking the Licensed Product is not practicable, then the Licensed Product will be considered marked if the above notice is included in a manual or literature accompanying the Licensed Product.
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ARTICLEΒ 11
INDEMNIFICATION
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SectionΒ 11.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β By Dermira.Β Dermira shall indemnify, defend, and hold Licensor, its members, employees, directors, officers, successors and assigns and [*] (individually and collectively βLicensor Indemniteesβ) harmless from and against any and all third party claims, actions, suits, proceedings, demands, costs, expenses (including
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reasonable attorneysβ fees), liabilities and/or losses (collectively, βLossesβ) arising out of or in connection with third party claims based on the exercise or practice by Dermira, its Affiliates and/or its Sublicensees of the rights and licenses granted under this Agreement by Licensor, including without limitation (i)Β the development, manufacture, use, sale or other disposition of Licensed Products by Dermira, or its Affiliates and Sublicensees and (ii)Β the use by any person of Licensed Products made, used, sold or otherwise distributed by Dermira, or its Affiliates and Sublicensees; provided, however, that the foregoing indemnification obligations shall not apply to any claim arising out of the gross negligence or willful misconduct of a Licensor Indemnitee or any breach of Licensorβs representations and warranties under ArticleΒ 8.Β Notwithstanding the foregoing, Dermiraβs indemnification and defense obligations under this SectionΒ 11.1 shall not apply to the extent that the act of such indemnification itself would constitute a violation of California Civil Code SectionΒ 2773.
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SectionΒ 11.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Indemnification and Defense Procedure.Β A Licensor Indemnitee (each, an βIndemnified Personβ) shall reasonably promptly notify Dermira (the βIndemnifying Partyβ) in writing, of any claim for which indemnification may be sought under SectionΒ 11.1; provided, however, that any delay in notification shall not nullify any indemnification obligation except to the extent of actual and substantial prejudice.Β The Indemnifying Party shall control the investigation, trial, defense and settlement of such lawsuit or action (including all negotiations to effect a settlement) and any appeal arising therefrom.Β The Indemnified Person may, at its own cost, participate in such investigation, trial and defense of such lawsuit or action and any resulting appeal.Β At the Indemnifying Partyβs expense, the Indemnified Person shall reasonably cooperate in good faith with the Indemnifying Party at all times during the pendency of the claim or lawsuit including, without limitation, promptly providing the Indemnifying Party with all available information and documents concerning the claim that are in the Indemnified Personβs possession.Β Notwithstanding the foregoing, an Indemnified Personβs consent, which shall not be unreasonably withheld, shall be obtained in the event any compromise or settlement under this ArticleΒ 11 that includes a finding or admission of any violation of any law by such Indemnified Person, or requires the payment of any money by the Indemnified Person.
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SectionΒ 11.3Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Indemnification and Personal Liability Disclaimer.Β Licensor shall have no obligation of defense, contribution, or indemnity with respect to any actual or alleged intellectual property infringement, product liability, personal injury, or otherwise with respect to the Patent Rights and Technology or otherwise arising from this Agreement.Β Licensor shall have no liability arising out of any such actual or alleged intellectual property infringements, product liability, or personal injury.Β However, the foregoing provisions of this SectionΒ 11.3 shall not limit Licensorβs obligations or liability with respect to any breach of Licensorβs representations and warranties under ArticleΒ 8.
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SectionΒ 11.4Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Indemnification of Xxxxxxx.Β Dermira, its Affiliates and Sublicensees shall indemnify Xxxxxxx and its Affiliates, and other related indemnified persons as set out in the Xxxxxxx Side Letter.
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ARTICLEΒ 12
LIMITATION OF LIABILITY
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IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY FOR ANY SPECIAL,Β INCIDENTAL,Β INDIRECT, OR CONSEQUENTIAL DAMAGES,Β INCLUDING BUT NOT LIMITED TO THE LOSS OF OPPORTUNITY, OR LOSS OF REVENUE OR PROFIT HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY (INCLUDING NEGLIGENCE), EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
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ARTICLEΒ 13
TERM
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Unless terminated earlier, as provided in this Agreement, the term of this Agreement shall commence on the Effective Date and continue in full force and effect until the later of (i)Β the expiry of the last Valid Claim, or (ii)Β expiration of the last Know-How Royalty Term (the βTermβ), provided that upon expiration of the Term, the licenses granted to Dermira and its Affiliates pursuant to SectionΒ 2.1, 2.2 and 2.3 shall become nonexclusive, irrevocable and royalty-free and remain in full force and effect in perpetuity.Β Notwithstanding the foregoing, the sublicense to Xxxxxxx Data shall not become irrevocable before the date that isΒ [*]Β following the Effective Date.
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ARTICLEΒ 14
TERMINATION
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This Agreement may be terminated as follows:
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SectionΒ 14.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β By Licensor.Β During the Term, Licensor shall be permitted to immediately terminate this Agreement in the event Dermira commits a material breach of this Agreement (other than ArticleΒ 3) and fails to cure such breach within [*] (or in the event of a breach of Dermiraβs payment obligations that is not being disputed in good faith, within [*]) after Dermira receives written notice from Licensor identifying this Agreement and the action giving rise to the claimed material breach.Β Any actual or alleged breach by Dermira of its obligations under ArticleΒ 3 shall be governed by, and Licensorβs remedies for such breach shall be as set forth in, ArticleΒ 3.Β In addition, Licensor shall be permitted to immediately terminate the sublicense to the Xxxxxxx Data in the event Dermira commits a material breach of this Agreement or the Xxxxxxx Side Letter which causes Licensor to be in material breach of the Xxxxxxx Agreement and Dermira fails to cure such breach within [*] after Dermira receives written notice from Licensor or Xxxxxxx identifying this Agreement and the action giving rise to the material breach.Β In addition, in the event that Xxxxxxx and Dermira become involved in an arbitration under Paragraph 10 of the Xxxxxxx Side Letter, to avoid having two dispute proceedings being conducted at the same time, if Licensor wishes to issue a written notice of material breach of this Agreement to Dermira prior to the completion of the Xxxxxxx - Dermira arbitration proceedings, in addition to Licensorβs other rights under this SectionΒ 14.1, Licensor may elect to issue such notice but specify that the notice will become
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effective only simultaneously with the arbitrator issuing its decision in the Xxxxxxx - Dermira arbitration.
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SectionΒ 14.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β By Dermira.Β During the Term, Dermira shall be permitted to immediately terminate this Agreement in the event:
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(a)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Licensor commits a material breach of this Agreement and fails to cure such breach within [*] after Licensor receives written notice from Dermira identifying this Agreement and the action giving rise to the claimed material breach; or
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(b)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β In Dermiraβs sole and reasonable opinion [*] of Licensed Products is [*] Licensed Product or, before or after approval of Licensed Products for sale [*].Β Upon any termination pursuant to this SectionΒ 14.2(b), (x)Β all rights to the Patent Rights and Technology shall revert to Licensor, and (y)Β Dermira agrees, subject to Licensorβs agreement to a release of claims against Dermira and its Affiliates in a form reasonably requested by Dermira, to (1)Β [*], and (2)Β for a period of [*] after such termination to provide Licensor (at Licensorβs expense) with such technical assistance and access to and cooperation of Dermira personnel as Licensor may reasonably request in connection with the license of such Improvements to Licensor.
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SectionΒ 14.3Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Termination for Insolvency.Β Either Party may terminate this Agreement immediately upon delivery of written notice to the other Party: (i)Β upon the institution by or against the other Party of insolvency, receivership or bankruptcy proceedings or any other proceedings for the settlement of the other Partyβs debts, and provided in the case of an involuntary proceeding initiated against a Party that such proceeding is not stayed or dismissed within [*] after its initiation; (ii)Β upon the other Partyβs making an assignment for the benefit of creditors; (iii)Β upon the other Partyβs dissolution or ceasing to do business; or (iv)Β upon the appointment of a receiver or receiver and manager, trustee, administrator or official manager or agent of a secured or unsecured creditor to any of the other Partyβs property.Β For clarity, in the event of a dissolution of Licensor, unless this Agreement is affirmatively terminated by Dermira by written notice as permitted under this SectionΒ 14.3, it shall remain in full force and effect and be binding upon Licensorβs successors and assigns resulting from such dissolution, as provided in ArticleΒ 18.
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SectionΒ 14.4Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Effect of Insolvency or Bankruptcy of Licensor.Β The Parties acknowledge and agree that all rights and licenses to intellectual property granted to Dermira and its Affiliates and Sublicensees pursuant to this Agreement are, for all purposes of SectionΒ 365(n)Β of the United Stated Bankruptcy Code, as amended (the βBankruptcy Codeβ), licenses of rights to βintellectual propertyβ as defined in the Bankruptcy Code, and that in the event Licensor becomes a debtor in bankruptcy, the provisions of SectionΒ 365(n)Β of the Bankruptcy Code shall apply and each of Dermira and each Sublicensee shall continue to have rights under such
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*Confidential Treatment Requested
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licenses as long as such party continues to fulfill all of its obligations, including its obligations to pay royalties, under this Agreement, as and to the extent provided in SectionΒ 365(n).
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SectionΒ 14.5Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Effect of Termination.Β Expiration or termination of this Agreement for any reason shall not release the other Party from any liability that at the time of such termination or expiration has already accrued to the other Party.Β Upon the expiration or termination of this Agreement, (a)Β the license granted to Dermira and its Affiliates shall terminate, and (b)Β any sublicense of the rights granted to Dermira and its Affiliates hereunder shall automatically be assigned to and assumed by Licensor, and shall remain in full force and effect with Licensor as the licensor instead of Dermira or its Affiliate (provided that, unless Licensor agrees in writing otherwise, the obligations of Licensor under the assigned sublicenses will not be greater than the obligations of Licensor under this Agreement).Β Within [*] after any expiration or termination, Dermira shall pay any and all amounts owing to Licensor, and all royalties accrued, as of the date of such expiration or termination.
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ARTICLEΒ 15
DISPUTE RESOLUTION
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SectionΒ 15.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Mandatory Procedures.Β The Parties agree that any dispute arising out of or relating to this Agreement shall be resolved solely by means of the procedures set forth in this Article, and that such procedures constitute legally binding obligations that are an essential provision of this Agreement.Β If either Party fails to observe the procedures of this Article, as may be modified by their written agreement, the other Party may bring an action for specific performance of these procedures in any court of competent jurisdiction.
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SectionΒ 15.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Arbitration.Β The Parties shall endeavor to resolve in good faith any disputes or conflicts arising from or relating to the subject matter of this Agreement, failing which either Party shall submit such conflict for resolution to an executive officer of Dermira and Licensor.Β If the executive officers of Dermira and Licensor are unable to resolve such conflict within [*] after such conflict is submitted to them for resolution, such conflict may be submitted to binding arbitration in accordance with the rulesΒ of arbitration of the American Arbitration Association (in accordance with its Commercial Arbitration RulesΒ then in effect and this Agreement) and heard before a arbitrator or panel of arbitrators selected as follows: (i)Β for a period of [*] after submission of a dispute to arbitration, the Parties shall confer in good faith to attempt to mutually agree as to the selection of a single arbitrator with relevant industry expertise, and if they so agree then the dispute will be heard before the single arbitrator so selected, and (ii)Β if after such [*] period, the Parties have failed to reach mutual agreement, then each Party shall select an arbitrator with relevant industry expertise, the two arbitrators so selected shall select a third arbitrator with relevant industry expertise, and the dispute shall be heard before the three arbitrator panel so selected.Β Such arbitration will be held in Palo Alto, California and conducted in English.Β The arbitrator(s)Β will apply California law, without regard to its conflict of laws rulesΒ or principles.Β The arbitrator(s)Β will allow such discovery as is appropriate for the purpose of arbitration in accomplishing a fair, speedy and cost-effective resolution of the dispute.Β The arbitrator(s)Β will have the authority to award compensatory damages only.Β Any award by the arbitrator(s)Β will be accompanied by a written opinion setting forth the findings of fact and conclusions of law relied
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upon in reaching the decision.Β The award rendered by the arbitrator(s)Β will be final, binding and, except as permitted by applicable law, non-appealable.
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ARTICLEΒ 16
GOVERNING LAW; JURISDICTION
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This Agreement and all disputes arising out of or related to this Agreement shall be governed by the laws of the state of California, without regard to conflict of laws principles.Β The Parties hereby agree that any dispute arising out of this Agreement that is not subject to arbitration pursuant to ArticleΒ 15 shall be subject to the exclusive jurisdiction of and venue in the federal and state courts within Santa Xxxxx County, California.Β Each Party hereby irrevocably consents to the personal and exclusive jurisdiction and venue of such courts.
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ARTICLEΒ 17
NOTICE
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Any notices required or permitted under this Agreement shall be in writing, in English, specifically refer to this Agreement, and shall be sent by prepaid registered or certified mail, return receipt requested; by recognized overnight courier; or by personal delivery, in each case addressed to the other Party as follows:
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If to Dermira: |
If to Licensor: |
0000 Xxxxxxxx Xxxx, Xxx. #000 Xxxxxxx Xxxx, Xxxxxxxxxx 9406 |
Rose U LLC [*] Xxxx Xxxx, XX 00000 |
Attention: Chief Executive Officer Fax: (000) 000-0000 |
Attention: [*] |
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With a copy to: |
With a copy to: |
FenwickΒ & West LLP Silicon Valley Center 000 Xxxxxxxxxx Xxxxxx 00xx Xxxxx Xxx Xxxxxxxxx, XX 00000 Attention: Xxxxxxx Xxxxx Fax: (000) 000-0000 |
[*] |
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Either Party may designate a different address, telephone number and/or facsimile number by giving notice, pursuant to this Article, to the other Party.Β Any notice given pursuant to this ArticleΒ shall be deemed to have been given:Β (a)Β three (3)Β business days after sent by prepaid registered or certified mail; (b)Β two (2)Β business days after sent by recognized overnight courier and (c)Β when received if by personal delivery.
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ARTICLEΒ 18
ASSIGNMENT
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Neither Party may assign or transfer this Agreement or any rights or obligations under this Agreement, whether voluntary or by operation of law, without the prior written consent of the other Party; provided, however, that a Party may (without requirement to obtain the other Partyβs consent) assign or transfer this Agreement to any successor or third party in connection with a merger, acquisition or sale of all or substantially all of the assets of such Party that relate to the business activities conducted pursuant to this Agreement (and, for clarity, in the case of an assignment by Dermira in connection with a Liquidity Event, Dermira shall timely make any payment required under SectionΒ 4.2(c)Β above).Β In addition, in the event of an assignment or transfer of this Agreement by Dermira to a third party in connection with a sale of all or substantially all of the assets of Dermira that relate to the business activities conducted pursuant to this Agreement, Dermira shall make any payments arising from such assignment to Xxxxxxx that are required to be made under the Xxxxxxx Side Letter.Β Any assignment or transfer or attempted assignment or transfer of this Agreement made in contravention of the terms of this ArticleΒ shall be null, void and without effect.Β Subject to the foregoing, this Agreement shall be binding on and inure to the benefit of the Partiesβ respective successors and permitted assigns.
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ARTICLEΒ 19
WAIVER
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No failure or delay on the part of a Party in exercising any right under this Agreement will operate as a waiver of, or impair, any such right, unless a waiver is made in writing signed by the waiving Party.Β No single or partial exercise of any such right will preclude any other or further exercise thereof or the exercise of any other right.Β No waiver of any such right will be deemed a waiver of any other right under this Agreement.
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ARTICLEΒ 20
PARTIAL INVALIDITY
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If any provision of this Agreement is held to be invalid, illegal, or unenforceable by a court of competent jurisdiction:Β (a)Β such provision will be deemed amended to conform to applicable laws of such jurisdiction so as to be valid and enforceable, or, if it cannot be so amended without materially altering the intention of the Parties, it will be stricken; (b)Β the remaining provisions shall remain in full force and effect; (c)Β the validity, legality and enforceability of such provision will not in any way be affected or impaired in any other jurisdiction and (d)Β the remainder of this Agreement will remain in full force and effect.Β The Parties agree to renegotiate in good faith any term of this Agreement held to be invalid, illegal or unenforceable and agree to be bound by the mutually agreed substitute provision in order to give the most approximate effect intended by the Parties.
Β
Β
ARTICLEΒ 21
HEADINGS
Β
All headings are for convenience only and shall not affect the meaning of any provision of this Agreement.
Β
ARTICLEΒ 22
FORCE MAJEURE
Β
A Party shall be excused from (and not liable to the other Party for) any failure or delay in performance of any obligation under this Agreement (other than obligations to make payment) to the extent such failure or delay is due to an event or circumstance beyond the reasonable control of such Party, including, without limitation, war, rebellion, civil commotion, strikes, lock-outs or industrial disputes; fire, explosion, earthquake, acts of God, flood, drought or bad weather; acts of terror or the requisitioning or other act or order by any government department, council or other constituted body (a βForce Majeureβ).Β In the event of a Force Majeure, the non-performing Party will promptly notify the other Party thereof and use its best efforts to resume performance as soon as practicable.
Β
ARTICLEΒ 23
NO PUBLICITY
Β
Neither Party shall make any public or press announcement about this Agreement, its terms or its business relationship with the other Party, without the prior written consent of the other Party.Β The form and content of any such announcement shall be subject to the prior approval of each Party.
Β
ARTICLEΒ 24
USE OF NAME, SYMBOLS AND MARKS
Β
Licensor and Dermira shall not use the name, symbols and/or marks of the other Party in any form of publicity without the prior written authorization of the other Party.Β However, each Party has the right to use the other Partyβs name on governmental filings and elsewhere as required by law.
Β
ARTICLEΒ 25
SURVIVAL
Β
The terms and provisions of Articles 1, 5, 8, 9, 11, 12, 13, 14.5 and 15 through 30 shall survive any expiration or termination of this Agreement.
Β
Β
ARTICLEΒ 26
INDEPENDENT CONTRACTOR
Β
Licensorβs status and relationship with Dermira shall be that of an independent contractor, and Licensor shall not state or imply, directly or indirectly, that it is empowered or authorized to commit or bind Dermira or to incur any liabilities or expenses on behalf of Dermira or to enter into any oral or written agreement in the name of or on behalf of Dermira.Β Nothing in this Agreement shall create, expressly or by implication, a partnership, joint venture, agency or other association of the Parties.
Β
ARTICLEΒ 27
MULTIPLE COUNTERPARTS
Β
This Agreement may be executed in two (2)Β identical counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument.
Β
ARTICLEΒ 28
AMENDMENT
Β
This Agreement may be amended, supplemented or otherwise modified only by means of a written instrument signed by both Parties.
Β
ARTICLEΒ 29
ENTIRE AGREEMENT
Β
This Agreement including the Appendices hereto, constitutes the entire agreement between the Parties with respect to its subject matter and supersedes all prior agreements or understandings, oral or written, between the Parties relating to the subject matter of this Agreement.
Β
ARTICLEΒ 30
[*]
[*] shall have no liability or obligation to Dermira or any other parties arising out of this Agreement and shall be direct and intended third-party beneficiaries of ArticleΒ 11 (Indemnification) and this Article, entitled to enforce the same directly against Dermira.
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*Confidential Treatment Requested
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IN WITNESS WHEREOF, the Parties have caused their duly authorized officers to execute and deliver this Exclusive License Agreement as of the Effective Date.
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Β
βLICENSORβ |
βDERMIRAβ | |||
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Β | |||
Β |
Β | |||
ROSE U LLC |
||||
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Signature: |
/s/ Xxxxxxx X. Xxxxx |
Β |
Signature: |
/s/ Xxxxxx Xxxxxxx |
Β |
Β |
Β |
Β |
Β |
Print: |
Xxxxxxx X. Xxxxx |
Β |
Print: |
Xxxxxx Xxxxxxx |
Β |
Β |
Β |
Β |
Β |
Title: |
Secretary Treasurer |
Β |
Title: |
Chief Executive Officer |
Β |
Β |
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Date: |
April 2, 2013 |
Β |
Date: |
April 26, 2013 |
Β |
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[SIGNATURE PAGE TO EXCLUSIVE LICENSE AGREEMENT]
Β
Β
APPENDIX A
Β
LIST OF PATENT APPLICATIONS AND PATENTS
Β
ROSE U PATENTS
[*]
Β
NON-ROSE U PATENTS
[*]
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*Confidential Treatment Requested
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Β
APPENDIX B
Β
XXXXXXX AGREEMENT
Β
(ATTACHED)
Β
Β
LICENSE AND POST-TERMINATION AGREEMENT
Β
This License and Post-Termination Agreement (this βAgreementβ) is entered into as of AprilΒ 26, 2013 (βEffective Dateβ), by and between Xxxxxxx Laboratories,Β Inc. (βXxxxxxxβ), a Delaware corporation with a place of business at 20 X.X. Xxxxxxxxx Drive, Research Xxxxxxxx Xxxx, XX 00000 and Rose U LLC, (βRose Uβ) a California limited liability company with a place of business at [*], Xxxx Xxxx, XX 00000.Β Each of Rose U and Xxxxxxx may be referred to herein as a βPartyβ and collectively as the βPartiesβ.
Β
RECITALS
Β
X.Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Xxxx U and Connetics Corporation (βConneticsβ) entered into an Exclusive Patent License Agreement dated [*], which agreement was amended on [*] (the βPrior License Agreementβ). Xxxxxxx acquired Connetics on DecemberΒ 29, 2006, and as a result of such acquisition, Xxxxxxx became the successor in interest to, and assumed the rights and obligations of, Connetics under the Prior License Agreement.
Β
B.Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β On [*], Xxxxxxx notified Rose U in writing that Xxxxxxx had terminated the Prior License Agreement pursuant to Section [*] of the Prior License Agreement effectively immediately as of the date of the letter.
Β
C.Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Pursuant to SectionΒ [*]Β of the Prior License Agreement, upon the termination of such agreement, the Parties are required to negotiate in good faith the licensing of the data generated by Connetics/Xxxxxxx supporting the development work under such agreement to Rose U at a mutually agreed upon compensation.Β The Parties have engaged in such negotiations.
Β
X.Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Xxxx U and Xxxxxxx now wish to enter into this Agreement in order to document certain agreements and understandings relating to the termination of the Prior License Agreement, and to provide Rose U with certain rights to such data developed by Connetics/Xxxxxxx, and other matters, in connection with the Prior License Agreement, all upon the terms and conditions set forth in this Agreement.
Β
NOW, THEREFORE, the parties agree as follows:
Β
ARTICLEΒ 1.Β DEFINITIONS
Β
βAffiliateβ means, with respect to a person, any corporation, partnership, business joint venture or other entity that directly or indirectly controls, is controlled by or is under common control with such person. For purposes of this definition, βcontrolβ means possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of the entity in question (whether through ownership of securities or other ownership interests, by contract or otherwise).
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*Confidential Treatment Requested
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βControlβ or βControlledβ means, with respect to any item of Xxxxxxx Data, patent rights, or other intellectual property right, the possession (whether by ownership or license) by a Party of the ability to grant to the other Party access, a license or a sublicense (as applicable), or to extend other rights as provided in this Agreement, to such intellectual property right, without violating the terms of any agreement or other arrangements with any third party.
Β
βDermiraβ means Dermira,Β Inc. and any successor or assign of Dermira,Β Inc. through merger, reorganization, consolidation or sale of all or substantially all of the assets of Dermira,Β Inc. to which the sublicense of the rights granted under this Agreement relates.Β Dermira shall also be considered to be a Designated Sublicensee where such defined term is used throughout this Agreement.
Β
βDesignated Sublicenseeβ is defined in SectionΒ 3.5.
Β
βFieldβ shall mean the use of topical products containing [*] or other compounds identified in the Rose U Patents for the treatment and prevention of hyperhidrosis, [*], or excessive sweating.Β For clarity, the Field includes such products sold [*].
Β
β[*] Programβ means the programs of research and development conducted by Connetics, Xxxxxxx, or any combination of the foregoing directly and through their Affiliates and contractors relating to applications of [*] or other compounds identified in the Rose U Patents, including as undertaken in relation to [*] and any similar registrations with regulatory authorities.
Β
βLicensed Productβ means any product, process or service (i)Β that incorporates in whole or in part Xxxxxxx Data, or (ii)Β in the Field that incorporates [*], provided that Licensed Product does not include a Pre-Existing Product, where a βPre-Existing Productβ means a product, process or service in the Field that (a)Β incorporates [*], (b)Β does not incorporate, in whole or in part, any Xxxxxxx Data and (c)Β was in clinical development by a Designated Sublicensee or an Affiliate or permitted sublicensee of a Designated Sublicensee or an Affiliate of any such sublicensee prior to any access to Xxxxxxx Data by the relevant entity; provided, that such entity shall promptly provide Xxxxxxx proof of such development prior to the date of access to Xxxxxxx Data upon the request of Xxxxxxx.Β Rose U represents and warrants that neither Rose U, Dermira,Β Inc. nor any of their Affiliates has any product, process or service in the Field that incorporates [*] in clinical development as of the Effective Date.
Β
βProgram Inventory and Suppliesβ means the drug substance, drug product and inventory relating to the [*] Program owned or Controlled by Xxxxxxx or its Affiliates that is specified on ExhibitΒ A-2.
Β
βRegulatory Materialsβ means regulatory applications, submissions, notifications, registrations, regulatory approvals or other submissions or correspondence made to, with or from a regulatory authority prior to the Effective Date in connection with the [*] Program. Regulatory Materials include Investigational New Drug applications, drug approval applications, or any similar applications with regulatory authorities anywhere in the world, amendments and supplements for any of the foregoing, and applications for pricing approvals.Β For clarity, the
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*Confidential Treatment Requested
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Regulatory Materials include [*].
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βRose U Patentsβ means U.S. Patents [*].
Β
βXxxxxxx Dataβ means the documentation, reports and data relating to the [*] Program that is specified on ExhibitΒ A-1 that is owned or Controlled by Xxxxxxx or its Affiliates and was developed or used in connection with the [*] Program, together with any additional information delivered by Xxxxxxx pursuant to SectionΒ 3.3.
Β
βXxxxxxxβx Knowledgeβ means the actual knowledge of [*] with no further investigation.
Β
ARTICLEΒ 2.Β TERMINATION OF PRIOR LICENSE AGREEMENT; RELEASE
Β
SectionΒ 2.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Termination.Β Rose U and Xxxxxxx acknowledge and agree that the Prior License Agreement was terminated.
Β
SectionΒ 2.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Release.Β Rose U and Xxxxxxx (each, a βReleasorβ), on behalf of themselves and their heirs, executors, administrators, predecessors, subsidiaries, affiliates, successors, and assigns, knowingly and voluntarily release and discharge the other and the otherβs respective officers, directors, stockholders, members, employees, agents and affiliates (collectively, the βReleased Partiesβ), from any and all claims, liabilities, damages and obligations that each Party may have against any such Released Party, through the Effective Date based upon any matter, cause or thing whatsoever related to or arising out of the Prior License Agreement and the resulting relationship between the parties (collectively, the βReleased Mattersβ).Β This release shall not extend to the Partiesβ rights to enforce the terms and conditions of this Agreement, all of which rights shall be preserved.Β Releasor hereby covenants and agrees not to bring suit in any forum, or prosecute in any fashion, any suit or other legal proceeding of any sort at any time, now or in the future, against any Released Party with respect to any of the Released Matters.
Β
ARTICLEΒ 3.Β TRANSFER OF [*] PROGRAM
Β
SectionΒ 3.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Assignment of Patent Rights.Β In connection with this Agreement, Xxxxxxx has assigned and transferred all of its and its Affiliatesβ right, title and interest in and to certain patent rights to Xxxx X.Β Such assignment was formalized by the execution and delivery by Xxxxxxx to Rose U of an assignment in the form attached as ExhibitΒ A-3 (the patents, applications and rights assigned pursuant thereto, theΒ βAssignedΒ Patent Applicationsβ).
Β
SectionΒ 3.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β License to Xxxxxxx Data.Β Subject to the terms of this Agreement (including but not limited to SectionΒ 3.5.4 hereof), Xxxxxxx hereby grants Rose U a worldwide, exclusive (except as to Xxxxxxx and its Affiliates) license (including the right to grant sublicenses through multiple tiers pursuant to the provisions of SectionΒ 3.5 hereof) to use the Xxxxxxx Data in the Field.
Β
SectionΒ 3.3Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Delivery of Xxxxxxx Data.Β Promptly following the Effective Date, Xxxxxxx shall transfer and assign to Rose U copies of all documents (whether in written or electronic
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*Confidential Treatment Requested
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form) listed on ExhibitΒ A-1.Β Additionally, for a period of [*] after the Effective Date, Xxxxxxx shall provide Rose U or Dermira at no cost to Rose U (other than reimbursement of Xxxxxxxβx actual out-of-pocket expenses, which shall be paid by Rose U to Xxxxxxx) with such technical assistance and access to and cooperation of Xxxxxxx personnel as Rose U or Dermira may reasonably request in connection with the delivery to Rose U of factual knowledge and information relating to the Xxxxxxx Data, Regulatory Materials and Program Inventory and Supplies, provided that in no event shall Xxxxxxx be required to provide more than [*] of employee time for such purpose (the βTechnical Assistanceβ).
Β
SectionΒ 3.4Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Regulatory Materials and Program Inventory and Supplies.
Β
3.4.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Xxxxxxx hereby assigns to Rose U all of its right, title and interest in and to the Regulatory Materials.Β At the request of Rose U, Xxxxxxx shall promptly deliver the Regulatory Materials to Rose U and shall take such additional steps and execute such additional documents as Rose U may reasonably request in order to effect such assignment and delivery, including the transfer of any regulatory applications into the name of Xxxx X.
Β
3.4.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Upon Rose Uβs request within [*] of the Effective Date, Xxxxxxx shall, to the extent it is able to do so in compliance with its internal policies and to the extent such Program Inventory and Supplies still exists, assign, transfer and deliver the Program Inventory and Supplies to Rose U and shall take such additional steps and execute such additional documents as Rose U may reasonably request in order to effect such assignment, transfer and delivery.Β In addition, if requested by Rose U or Dermira, Xxxxxxx shall use commercially reasonable efforts, but only during such [*] period (such time spent by Xxxxxxx to count toward the [*] cap on Technical Assistance), to (i)Β introduce Rose U and/or Dermira to the contract manufacturing organization (βCMOβ) that provided the Program Inventory and Supplies to Xxxxxxx, and (ii)Β facilitate the transition of manufacturing to a CMO designated by Rose U or Dermira, provided that Xxxxxxx shall not be obligated to place any orders from a CMO on behalf of Rose U or Dermira nor to provide any other assistance with respect to a CMO except as specifically set forth in this SectionΒ 3.4.2.Β If Rose U does not request delivery of the Program Inventory and Supplies within [*] of the Effective Date or if Xxxxxxx determines that its internal policies prevent Xxxxxxx from transferring any or all of the Program Inventory and Supplies to Rose U or that such Program Inventory and Supplies no longer exist, Xxxxxxx may destroy such materials at its sole discretion without notice to Xxxx X.Β Upon the request of Rose U or Dermira, Xxxxxxx will provide such Xxxxxxx consent as is reasonably necessary to allow Rose U or Designated Sublicensees to work with service providers who have provided services to Xxxxxxx in connection with the [*] Program, including consenting to the use by such contractors of any Xxxxxxx Data in the possession or control of such contractors to provide services to Rose U or Designated Sublicensees.
Β
SectionΒ 3.5Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Sublicenses.
Β
3.5.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β The license granted to Rose U pursuant to SectionΒ 3.2 includes the right to grant sublicenses of such rights through multiple layers of sublicenses to third parties or Affiliates (each such sublicensee, a βDesignated Sublicenseeβ) to which Rose U or a Designated Sublicensee is granting the right to research, develop or commercialize products in the Field using Xxxxxxx Data.
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*Confidential Treatment Requested
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3.5.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Any sublicense agreement, whether by Rose U or a Designated Sublicensee, shall not be inconsistent with the terms of this Agreement nor exceed the scope of the license granted to Rose U under this Agreement and shall include (i)Β an obligation of the Designated Sublicensee to indemnify Xxxxxxx and its Affiliates as provided in SectionΒ 6.1 hereof, subject to conditions and procedures substantially equivalent to those contained in SectionΒ 6.2 and ArticleΒ 7, (ii)Β confidentiality obligations of the Designated Sublicensee no less protective of the Xxxxxxx Data than those contained in ArticleΒ 9 of this Agreement, and (iii)Β an express statement that Xxxxxxx and its Affiliates are intended third party beneficiaries of such sublicense agreement.Β Rose U shall promptly thereafter provide Xxxxxxx a true and correct copy of each such sublicense, provided that Rose U or the Designated Sublicensee may redact confidential provisions of the sublicense agreement that are not reasonably required for Xxxxxxx to confirm compliance with this Agreement (but not the identity of the Designated Sublicensee).
Β
3.5.3Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Rose U represents and warrants that the copy it has provided to Xxxxxxx of the sublicense it is entering into with Dermira simultaneously with this Agreement is a true and correct copy thereof (the βRose U-Dermira Sublicenseβ), except that the financial terms regarding the amounts to be paid by Dermira to Rose U have been redacted from the copy provided to Xxxxxxx.
Β
3.5.4Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Simultaneous with Dermira and Rose U entering into the Rose U-Dermira Sublicense, Dermira and Xxxxxxx are entering into a letter agreement in the form attached as ExhibitΒ B (the βSide Letter Agreementβ).Β If the Rose U-Dermira Sublicense is terminated for any reason, then in the event that Rose U seeks to engage a subsequent Designated Sublicensee to replace Dermira, Rose U may request such subsequent Designated Sublicensee to enter into a letter agreement with Xxxxxxx substantially in the form of ExhibitΒ B (a βSubsequent Side Letter Agreementβ), with any changes made thereto only as Xxxxxxx finds acceptable.Β Xxxxxxx may, in its sole discretion, agree or decline to enter into a Subsequent Side Letter Agreement.Β In the event that Xxxxxxx declines to enter into the Subsequent Side Letter Agreement, Rose U may still elect to sublicense to such subsequent Designated Sublicensee but the provisions of SectionΒ 4.3 herein shall not apply and Rose U shall be liable to Xxxxxxx to make the [*] Payment.Β If Xxxxxxx does elect to enter into a Subsequent Side Letter Agreement with such Designated Sublicensee, then the provisions of SectionΒ 4.3 herein shall continue to apply with the subsequent Designated Sublicensee replacing Dermira in such section of this Agreement.Β Rose U acknowledges the possibility of the license grant in SectionΒ 3.2 hereof (the βLicense Grantβ) being converted to a non-exclusive grant pursuant to Paragraph 10 of the Side Letter Agreement.Β Notwithstanding the foregoing, in the event that Rose U sends a notice to Dermira to terminate the Rose U-Dermira Sublicense for material breach prior to or simultaneously with an arbitrator decision to order such a conversion of the License Grant (such that the Side Letter Agreement would be terminated pursuant to Paragraph 11 thereof if the Rose U-Dermira Sublicense were terminated), then the License Grant shall remain as βexclusive (except as to Xxxxxxx and its Affiliates).β
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3.5.5Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β For clarity, the definition of βDesignated Sublicenseeβ shall include any permitted subsequent sublicensees permitted in accordance with this SectionΒ 3.5.
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*Confidential Treatment Requested
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ARTICLEΒ 4.Β PAYMENTS, AND PAYMENT TERMS
Β
SectionΒ 4.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Payments.Β Subject to SectionΒ 4.3 (and, as applicable in the event the Rose U-Dermira Sublicense is terminated, SectionΒ 3.5.4), Rose U shall pay Xxxxxxx [*] US dollars (US $[*]) upon [*] (the β[*] Paymentβ), at which point no further royalties or other amounts shall be due and payable and the license granted hereunder shall be deemed fully paid-up and royalty-free.
Β
SectionΒ 4.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Payment Terms. Β Subject to SectionΒ 4.3, the [*] Payment shall be made directly by Rose U to Xxxxxxx in US dollars, by wire transfer of immediately available funds to an account designated by Xxxxxxx in writing, as Xxxxxxx may update from time to time.Β The [*] Payment shall be made within [*] following [*].Β In no event shall Rose U have any right to reclaim the [*] Payment or any part thereof.
Β
SectionΒ 4.3Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Payment by Dermira or Subsequent Designated Sublicensee Directly to Xxxxxxx.Β The Parties acknowledge and agree that, through the Side Letter Agreement, Dermira has assumed Rose Uβs obligation to pay the [*] Payment that arises from [*].Β For clarity, no other obligations of Rose U, including any indemnity obligations hereunder, are being transferred to Dermira.Β Accordingly, as long as the Side Letter Agreement remains in place, Xxxxxxx will not seek payment of any such [*] Payment from Rose U, and will instead seek payment from Dermira pursuant to the terms of the Side Letter Agreement.Β Similarly if the Rose U-Dermira Sublicense is terminated, and Rose U requests a subsequent Designated Sublicensee to replace Dermira and to enter into a Subsequent Side Letter Agreement with Xxxxxxx, and Xxxxxxx at its sole discretion elects to enter into such Subsequent Side Letter Agreement (all in accordance with SectionΒ 3.5.4 hereof), then such Designated Sublicensee would assume Rose Uβs obligation to pay the [*] Payment that arises from [*] of a Licensed Product [*] by such Designated Sublicensee or its sublicensees.Β Accordingly, in such case Xxxxxxx would not seek payment of any such [*] Payment from Rose U, and would instead seek payment from the subsequent Designated Sublicensee pursuant to the terms of the Subsequent Side Letter Agreement.
Β
ARTICLEΒ 5.Β REPRESENTATIONS AND WARRANTIES
Β
SectionΒ 5.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Xxxxxxx Representations and Warranties.Β Xxxxxxx represents and warrants to Rose U as follows:
Β
(a)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Xxxxxxx has the full corporate right, power and authority to enter into and perform its obligations under this Agreement;
Β
(b)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β this Agreement is legally binding upon Xxxxxxx and enforceable in accordance with its terms, and the execution, delivery, and performance of this Agreement by
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Xxxxxxx does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound;
Β
(c)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β to Xxxxxxxβx Knowledge, neither Xxxxxxx nor any of its employees or any of its contractors involved in the [*] Program or their personnel, have been βdebarredβ by the FDA, or subject to a similar sanction from another regulatory, or convicted of a felony under the laws of the United States for conduct relating to regulations under the FDCA; and
Β
(d)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β other than as may be set forth in the Xxxxxxx Data, to Xxxxxxxβx Knowledge, it is not aware of any materially adverse regulatory action that has been taken or determination that has been made with respect to the [*] Program, nor to Xxxxxxxβx Knowledge is it aware of any materially adverse safety or toxicology data relating to the use of topical products containing [*].
Β
SectionΒ 5.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Rose U Representations and Warranties. RoseΒ U represents and warrants to Xxxxxxx as follows:
Β
(a)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Rose U has the full limited liability company right, power and authority to enter into and perform its obligations under this Agreement; and
Β
(b)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β this Agreement is legally binding upon Rose U and enforceable in accordance with its terms, and the execution, delivery, and performance of this Agreement by Rose U does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound.
Β
SectionΒ 5.3Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β DISCLAIMER; NEGATION OF WARRANTIES.Β EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLEΒ 5, NEITHER XXXXXXX NOR XXXX U MAKES ANY WARRANTIES OR REPRESENTATIONS (EXPRESS,Β IMPLIED, STATUTORY, OR OTHERWISE) WITH RESPECT TO THE SUBJECT MATTER HEREOF, AND SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED WARRANTIES OR REPRESENTATIONS OF ANY KIND,Β INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, AND ALL WARRANTIES AND REPRESENTATIONS OF NONINFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS.
Β
ARTICLEΒ 6.Β INDEMNIFICATION
Β
SectionΒ 6.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Subject to the limitations set forth in ArticleΒ 7 hereof, and notwithstanding any transfer to Dermira or a subsequent Designated Sublicensee of Rose Uβs obligation to make the [*] Payment, Rose U shall indemnify, defend, and hold Xxxxxxx and its Affiliates, and their stockholders, employees, directors, officers, successors and assigns (individually and collectively βIndemnified Personsβ) harmless from and against any claims, actions, suits, proceedings, demands, costs, expenses (including reasonable attorneysβ fees), liabilities and/or losses (collectively, βLossesβ) arising out of or in connection with third party claims based on (a)Β the development, manufacture, use, sale or other disposition of Licensed Products by Rose U or any Designated Sublicensee, or (b)Β the use by any person of Licensed Products made, used, sold or otherwise distributed by Rose U or any Designated Sublicensee.
Β
*Confidential Treatment Requested
Β
Β
Rose U shall contractually require Dermira to, and shall contractually require each subsequent Designated Sublicensee to, provide the same indemnity in favor of the Indemnified Persons as to each such Designated Sublicensee and its subsequent sublicensees.
Β
SectionΒ 6.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Indemnification and Defense Procedure.Β An Indemnified Person shall reasonably promptly notify Rose U and any relevant Designated Sublicensee from which the Indemnified Person elects to seek indemnification under this ArticleΒ 6 (each such Party, the βIndemnifying Partyβ) in writing, of any claim for which indemnification may be sought under this ArticleΒ 6; provided however that any delay in notification shall not nullify any indemnification obligation except to the extent of actual prejudice.Β The Indemnifying Party shall have the right, using counsel acceptable to the Indemnified Person, to control the investigation, trial, defense and settlement of such lawsuit or action (including all negotiations to effect a settlement) and any appeal arising therefrom, provided (a)Β that such claim involves (and continues to involve) solely monetary damages, (b)Β that the Indemnifying Party has notified the Indemnified Persons in writing of its intention to do so within [*] of receiving notice of a claim from the Indemnified Persons, and (c)Β that the Indemnifying Party shall diligently contest the claim (clauses a, b and c hereof, the βLitigation Conditionsβ).Β The Indemnified Person may, at its own cost, participate in such investigation, trial and defense of such lawsuit or action and any resulting appeal.Β At the Indemnifying Partyβs expense, the Indemnified Person shall reasonably cooperate in good faith with it at all times during the pendency of the claim or lawsuit including, without limitation, promptly providing all available information and documents concerning the claim that are in the Indemnified Personβs possession.Β The Indemnifying Party shall not have, or shall lose, as applicable, the right to control the investigation, trial, defense and settlement of such lawsuit or action in the event that any of the Litigation Conditions are not, or are no longer, met, as applicable.Β An Indemnified Personβs consent shall be required in the event that any proposed compromise or settlement under this ArticleΒ 6 (i)Β includes a finding or admission of any violation of any law by such Indemnified Person, or (ii)Β requires the payment of any money by the Indemnified Person, or (iii)Β requires the Indemnified Person to take, or to forebear taking, any action, or (iv)Β does not provide for a complete release by such third party claimant of the Indemnified Person.
Β
ARTICLEΒ 7.Β LIMITATION OF LIABILITY
Β
SectionΒ 7.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER OR ANY THIRD PARTY FOR ANY SPECIAL,Β INCIDENTAL,Β INDIRECT, OR CONSEQUENTIAL DAMAGES,Β INCLUDING BUT NOT LIMITED TO THE LOSS OF OPPORTUNITY, OR LOSS OF REVENUE OR PROFIT HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY (INCLUDING NEGLIGENCE), EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
Β
ARTICLEΒ 8.Β TERM; TERMINATION
Β
SectionΒ 8.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Term.Β Unless terminated earlier as provided in this Agreement, the term of this Agreement shall commence on the Effective Date and continue in full force and effect until [*] from the Effective Date.Β Upon expiration of the term, Rose Uβs license to the Xxxxxxx Data shall become an irrevocable, royalty free, sublicensable, non-exclusive license to
Β
*Confidential Treatment Requested
Β
Β
the Xxxxxxx Data.Β Expiration of the term pursuant to this SectionΒ 8.1 shall not affect the assignment of rights pursuant to SectionΒ 3.1 herein.
Β
SectionΒ 8.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Termination for Breach.Β Each Party shall be entitled to terminate this Agreement by written notice to the other Party in the event that the other Party commits a material breach of this Agreement and does not cure such breach within [*] after written notice from the non-breaching Party; provided, however, that the Release set forth in SectionΒ 2.2 is irrevocable.
Β
SectionΒ 8.3Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Effect of Termination.Β Upon the termination of this Agreement other than pursuant to SectionΒ 8.1: (i)Β the licenses granted to Rose U under SectionΒ 3.2 (and the obligations to pay fees under ArticleΒ 4) shall terminate; and (ii)Β any sublicense of the rights granted to Rose U hereunder shall automatically be assigned to and assumed by Xxxxxxx, and shall remain in full force and effect with Xxxxxxx as the licensor instead of Rose U (provided that, unless Xxxxxxx agrees in writing otherwise, the obligations of Xxxxxxx under the assigned sublicenses will not be greater than the obligations of Xxxxxxx under this Agreement).Β Expiration or termination of this Agreement for any reason shall not release the other Party hereto from any liability that at the time of such termination or expiration has already accrued to such other Party.
Β
ARTICLEΒ 9.Β CONFIDENTIALITY
Β
SectionΒ 9.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Treatment of Confidential Information.Β Each Party agrees (and Rose U agrees on behalf of each Designated Sublicensee) that all inventions, processes, materials, chemicals, know-how and ideas and all other business, technical and financial information it obtains from the other Party under this Agreement are the confidential property of the disclosing Party (βConfidential Informationβ of the disclosing Party).Β Except as expressly allowed in this Agreement, the receiving Party will hold in confidence and not use or disclose any Confidential Information of the disclosing Party; provided, however, that Rose U and the Designated Sublicensees may disclose information relating to the Xxxxxxx Data (a)Β to actual or potential Designated Sublicensees (including, for the avoidance of doubt, disclosure by Rose U to Dermira and disclosure by the Designated Sublicensees to each of its or their actual or potential Designated Sublicensees), investors or acquirers, provided that each such actual or potential Designated Sublicensee (including, for the avoidance of doubt, Dermira), investor or acquirer agrees in writing to abide by confidentiality and non-use restrictions similar to those contained in this paragraph, and (b)Β to consultants, contractors, suppliers and Affiliates, provided that each such consultant, contractor, supplier and Affiliate agrees in writing to abide by confidentiality and non-use restrictions similar to those contained in this paragraph, and (c)Β to legal, financial, and tax advisors of Rose U or Designated Sublicensees, provided that such advisors are subject to confidentiality obligations with respect to any Confidential Information.Β No provision of this paragraph shall be interpreted to prevent Rose U or a Designated Sublicensee from making disclosures of Confidential Information to regulatory authorities as necessary: (i)Β for the research and development of Licensed Products; or (ii)Β to seek or obtain patents.Β Notwithstanding anything to the contrary herein, in recognition of Dermiraβs concerns with respect to disclosing to Xxxxxxx the identities of its potential sublicensees of rights to commercialize Licensed Product except in the case that it actually enters into a sublicense with one (in which case a copy of the sublicense must be delivered to Xxxxxxx in accordance with SectionΒ 3.5.2 hereof), the Parties agree that if Xxxxxxx reasonably believes that such a third party may be using any of the Xxxxxxx Data in
Β
*Confidential Treatment Requested
Β
Β
breach of any confidentiality or non-use obligation to Rose U or Dermira or sublicense or other authorization provided by Rose U or Dermira, Xxxxxxx may request in writing of Rose U whether Rose U or Dermira disclosed the Xxxxxxx Data to such third party or an Affiliate or representative thereof, and Rose U shall answer Xxxxxxxβx request, provided that answering such request does not constitute a breach of any legal obligation of Rose U or Dermira to such third party including representing to Xxxxxxx whether Dermira made such a disclosure.Β Rose U and Dermira will ensure that any non-disclosure or other agreement with such a third party under which Xxxxxxx Data is disclosed, does not prevent Rose U or Dermira from making such a disclosure in response to a court order.
Β
SectionΒ 9.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Release from Restrictions.Β The provisions of SectionΒ 9.1 shall not apply to any Confidential Information disclosed under this Agreement that:
Β
(a)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β was known or used by the receiving Party prior to its date of disclosure to the receiving Party, as evidenced by the prior written records of the receiving Party; or
Β
(b)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β either before or after the date of the disclosure to the receiving Party is lawfully disclosed to the receiving Party by sources other than the disclosing Party rightfully in possession of such information, and such source was not under a duty of confidentiality with respect to such information; or
Β
(c)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β either before or after the date of the disclosure to the receiving Party becomes published or generally known to the public, through no fault or omission on the part of the receiving Party or an affiliated party; or
Β
(d)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β is independently developed by or for the receiving Party without reference to or reliance upon the Confidential Information; or
Β
(e)Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β is required to be disclosed by the receiving Party to comply with applicable laws, court order, or governmental regulations, provided that the receiving Party (i)Β provides (A)Β prior written notice of such disclosure requirement to the other Party and (B)Β an adequate opportunity to seek appropriate legal relief to prevent such disclosure or limit use and further disclosure of the Confidential Information and (ii)Β takes reasonable and lawful actions to avoid and/or minimize the degree of such disclosure, and provided, further, that the receiving Party shall furnish only such portion of the Confidential Information that is legally required to be disclosed and shall promptly inform the disclosing Party in writing of which portion of the Confidential Information was so disclosed.
Β
Notwithstanding the foregoing or anything set forth herein or otherwise, and for the avoidance of doubt, [*] shall be considered to be Confidential Information.
Β
ARTICLEΒ 10.Β DISPUTE RESOLUTION AND JURISDICTION
Β
SectionΒ 10.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Mandatory Procedures.Β The Parties agree that any dispute arising out of or relating to this Agreement shall be resolved solely by means of the procedures set forth in this Article, and that such procedures constitute legally binding obligations that are an essential
Β
*Confidential Treatment Requested
Β
Β
provision of this Agreement.Β If either Party fails to observe the procedures of this Article, as may be modified by their written agreement, the other Party may bring an action for specific performance of these procedures in any court of competent jurisdiction.
Β
SectionΒ 10.2Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Negotiation. Β The Parties shall endeavor to resolve in good faith any disputes or conflict arising from or relating to the subject matter of this Agreement, failing which either Party may submit such dispute for resolution to appropriate senior management of Rose U and Xxxxxxx.Β If such senior management representatives are unable to resolve such dispute within [*] after such conflict is submitted to them for resolution, either Party may refer the dispute for mediation as set forth in SectionΒ 10.3.
Β
SectionΒ 10.3Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Mediation.Β If the Parties are unable to resolve a dispute arising out of or relating to this Agreement through the negotiation procedures set forth in SectionΒ 10.2, the Parties agree that they shall submit such dispute for confidential mediation under the CPR Mediation Procedure then in effect at the start of mediation with the International Institute for Conflict PreventionΒ & Resolution (xxx.xxxxxx.xxx) (the βCPRβ).Β Unless otherwise agreed, the Parties shall select a mediator from the CPR Panels of Distinguished Neutrals.Β If the Parties cannot agree, they will defer to the CPR to select a mediator.Β The cost of the mediator shall be borne equally by the Parties.Β Any dispute not resolved within [*] (or within such other time period as may be agreed to by the Parties in writing) after appointment of a mediator shall be finally resolved by arbitration pursuant to SectionΒ 10.4.
Β
SectionΒ 10.4Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Arbitration.Β If the Parties are unable to resolve a dispute arising out of or relating to this Agreement through the negotiation procedures set forth in SectionΒ 10.2 and the mediation procedures set forth in SectionΒ 10.3, the Parties agree that they shall submit such dispute for final settlement via binding arbitration.Β The arbitration shall be conducted under the Commercial Arbitration RulesΒ of the American Arbitration Association in effect at the time of the arbitration, except as they may be modified herein or by mutual agreement of the Parties, and heard before a single arbitrator as selected in accordance with the Commercial Arbitration Rules.Β Such arbitration will be held in [*] and shall be conducted in English.Β Each Party shall be responsible for its own expenses in connection therewith.Β The Parties hereby submit to the non-exclusive jurisdiction of the United States District Court for the [*] for the limited purpose of enforcing this Agreement to arbitrate.Β The arbitration award shall be final and binding, and judgment over the award may be entered by any court having jurisdiction thereof or having jurisdiction over the relevant Party and its assets.
Β
ARTICLEΒ 11.Β GOVERNING LAW
Β
SectionΒ 11.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β This Agreement and all disputes arising out of or related to this Agreement shall be governed by the laws of the state of Delaware, without regard to conflict of laws principles.
Β
ARTICLEΒ 12.Β NOTICE
Β
SectionΒ 12.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Any notices required or permitted under this Agreement shall be in writing, in English, specifically refer to this Agreement, and shall be sent by prepaid registered
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*Confidential Treatment Requested
Β
Β
or certified mail, return receipt requested; by recognized overnight courier; or by personal delivery, in each case addressed to the other Party as follows:
Β
IfΒ toΒ RoseΒ U: |
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IfΒ toΒ Xxxxxxx: |
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Β |
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Rose U LLC [*] Xxxx Xxxx, XX 00000 Attention: [*] |
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Xxxxxxx Laboratories,Β Inc. 20 XX Xxxxxxxxx Drive XX Xxx 00000 Xxxxxxxx Xxxxxxxx Xxxx, X.X. 00000 Attention: Alliance Management |
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With a copy to: |
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With a copy to: |
Β |
Β |
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[*] Β Β Β Β Β Β |
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GlaxoSmithKline, LLC 0000 Xxxxxxxxxxx Xxxxxxxxx Mail Code XX0000 Xxxx xx Xxxxxxx, XX 00000 Attn: V.P. and Associate General Counsel Legal Operations β Business Development Transactions |
Β
Either Party may designate a different address, telephone number, or facsimile number by giving notice, pursuant to this Article, to the other Party.Β Any notice given pursuant to this ArticleΒ shall be deemed to have been given: (a) [*] after sent by prepaid registered or certified mail; (b)Β [*] after sent by recognized overnight courier and (c)Β when received if by personalΒ delivery.
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ARTICLEΒ 13.Β ASSIGNMENT
Β
SectionΒ 13.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Neither Party may assign or transfer this Agreement or any rights or obligations under this Agreement, whether voluntary or by operation of law, without the prior written consent of the other Party, provided that (a)Β Xxxxxxx shall be permitted to assign this Agreement in connection with the sale or disposition of all or substantially all of the assets or business to which this Agreement pertains, and (b)Β Rose U shall be permitted to assign this Agreement in connection with the sale or disposition of all or substantially all of the assets or business to which this Agreement pertains provided that, prior to Xxxxxxxβx receipt of the [*] Payment and except in the case of a sale or disposition to Dermira or an Affiliate of Dermira (provided that in no event will Dermira or the Affiliate of Dermira be relieved of its liability to make the [*] Payment to Xxxxxxx under the terms of the Side Letter Agreement), the assignee may not be a party to which the Xxxxxxx Data has been sublicensed or any Affiliate thereof.Β Any assignment or transfer or attempted assignment or transfer of this Agreement made in contravention of the terms of this ArticleΒ shall be null, void
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*Confidential Treatment Requested
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and without effect.Β Subject to the foregoing, this Agreement shall be binding on and inure to the benefit of the Partiesβ respective successors and permitted assigns.
Β
ARTICLEΒ 14.Β WAIVER
Β
SectionΒ 14.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β No failure or delay on the part of a Party in exercising any right under this Agreement will operate as a waiver of, or impair, any such right, unless a waiver is made in writing signed by the waiving Party.Β No single or partial exercise of any such right will preclude any other or further exercise thereof or the exercise of any other right.Β No waiver of any such right will be deemed a waiver of any other right under this Agreement.
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ARTICLEΒ 15.Β PARTIAL INVALIDITY
Β
SectionΒ 15.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β If any provision of this Agreement is held to be invalid, illegal, or unenforceable by a court of competent jurisdiction: (a)Β such provision will be deemed amended to conform to applicable laws of such jurisdiction so as to be valid and enforceable, or, if it cannot be so amended without materially altering the intention of the Parties, it will be stricken; (b)Β the remaining provisions shall remain in full force and effect; (c)Β the validity, legality and enforceability of such provision will not in any way be affected or impaired in any other jurisdiction and (d)Β the remainder of this Agreement will remain in full force and effect.Β The Parties agree to renegotiate in good faith any term of this Agreement held to be invalid, illegal or unenforceable and agree to be bound by the mutually agreed substitute provision in order to give the most approximate effect intended by the Parties.
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ARTICLEΒ 16.Β HEADINGS
Β
SectionΒ 16.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β All headings are for convenience only and shall not affect the meaning of any provision of this Agreement.
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ARTICLEΒ 17.Β NO PUBLICITY
Β
SectionΒ 17.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Neither Party shall make any public or press announcement or other disclosure to any third party about this Agreement, its terms or its business relationship with the other Party, without the prior written consent of the other Party; provided, that Rose U may disclose and may permit Dermira to disclose this agreement to a third party that is subject to confidentiality restrictions substantially similar to the proviso in SectionΒ 9.1 hereof in connection with a possible sublicense or other transaction relating to its rights hereunder to such third party.Β The form and content of any such announcement shall be subject to the prior approval of each Party.
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ARTICLEΒ 18.Β USE OF NAME, SYMBOLS AND MARKS
Β
SectionΒ 18.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Xxxxxxx and Xxxx U shall not use the name, symbols and/or marks of the other Party in any form of publicity without the prior written authorization of the other Party.Β However, each Party has the right to use the other Partyβs name on governmental filings and elsewhere as required byΒ law.
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ARTICLEΒ 19.Β INDEPENDENT CONTRACTOR
Β
SectionΒ 19.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Each Partyβs status and relationship with the other Party shall be that of an independent contractor, and neither Party shall state or imply, directly or indirectly, that it is empowered or authorized to commit or bind the other Party or to incur any liabilities or expenses on behalf of the other Party or to enter into any oral or written agreement in the name of or on behalf of the other Party.Β Nothing in this Agreement shall create, expressly or by implication, a partnership, joint venture, agency or other association of the Parties.
Β
ARTICLEΒ 20.Β MULTIPLE COUNTERPARTS
Β
SectionΒ 20.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β This Agreement may be executed in two (2)Β identical counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument.
Β
ARTICLEΒ 21.Β AMENDMENT
Β
SectionΒ 21.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β This Agreement may be amended, supplemented, or otherwise modified only by means of a written instrument signed by both Parties.
Β
ARTICLEΒ 22.Β ENTIRE AGREEMENT
Β
SectionΒ 22.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β This Agreement including the Exhibits hereto constitutes the entire agreement between the Parties with respect to its subject matter and supersedes all prior agreements or understandings, oral or written, between the Parties relating to the subject matter of this Agreement.
Β
ARTICLEΒ 23.Β NO THIRD PARTY BENEFICIARIES AND NO LIABILITY OF LLC MEMBERS
Β
SectionΒ 23.1Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Β Nothing express or implied in this Agreement is intended to confer, nor shall anything herein confer, upon any person other than the Parties and their permitted successors or assigns any rights, remedies, obligations or liabilities whatsoever.Β For the avoidance of doubt, [*] in their individual capacities shall have no personal liability or obligation to Xxxxxxx or any other parties arising out of this Agreement and Xxxxxxx will not bring a claim directly against [*] in their individual capacities relating to this Agreement; provided, that nothing in this SectionΒ shall limit any claims against Xxxx X.
Β
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
Β
*Confidential Treatment Requested
Β
Β
IN WITNESS WHEREOF, the Parties have caused their duly authorized officers to execute and deliver this License and Post-Termination Agreement as of the Effective Date.
Β
βXXXXXXXβ |
Β |
βROSE Uβ |
XXXXXXX LABORATORIES,Β INC. |
Β |
ROSE U, LLC |
Β |
Β |
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Signature: |
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Signature: |
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/s/ Xxxxxx X. Xxxxx |
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/s/ Xxxxxxx X. Xxxxx |
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Print: |
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Print: |
Xxxxxx X. Xxxxx |
Β |
Xxxxxxx X. Xxxxx |
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Title: |
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Title: |
Assistant Secretary |
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Secretary / Treasurer |
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Date: |
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Date: |
4/26/13 |
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April 2, 2013 |
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[SIGNATURE PAGE TO LICENSE AND POST-TERMINATION AGREEMENT]
Β
Β
ExhibitΒ A-1
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Xxxxxxx Data
Β
To the extent existing:
[*]
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*Confidential Treatment Requested
Β
Β
ExhibitΒ A-2
Β
Program Inventory and Supplies
Β
[*]
Β
*Confidential Treatment Requested
Β
Β
ExhibitΒ A-3
Β
ASSIGNMENT
Β
WHEREAS, [*], incorporated in [*], having an address of [*], a [*] of [*], a [*] corporation, having an address at [*], (collectively, hereinafter the βASSIGNORβ), are the owner of the invention listed in Schedule I attached herewith (hereinafter the βPatentsβ), and
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WHEREAS, Rose U, a limited liability corporation (hereinafter βASSIGNEEβ), having an address at [*], Xxxx Xxxx, Xxxxxxxxxx, 00000, is desirous of acquiring ASSIGNORβs entire right, title and interest in and to said Patents, and in and to any application for or issued Letters Patent therefore, and any and all Letters Patent continuations, divisions, continuations in part, extensions, substitutions, reissues and reexaminations therefore;
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NOW, THEREFORE, TO ALL WHOM IT MAYΒ CONCERN, BE IT KNOWN, that the said ASSIGNORβs, for and in consideration of the payment by ASSIGNEE of one dollar ($1.00) and other good and valuable consideration, hereby sells, assigns, transfers and conveys all right title and interest in and to the Patents to ASSIGNEE, its successors and assigns, ASSIGNORβs entire right, title and interest in and to said Patents and any application for or issued Letters Patent therefore, including any extensions or adjustments in term thereof and any continuations, divisions, continuations-in-part, extensions, substitutions, reissues and reexaminations thereof, TO HAVE AND TO HOLD THE SAME;
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AND the said ASSIGNOR, for the considerations aforesaid, does hereby covenant and agree to and with the said ASSIGNEE, its successors and assigns, that it has the full power to make this assignment and that the rights assigned are not encumbered by any grant, license or right heretofore given, and that said ASSIGNOR, it successors and assigns, shall and will use commercially reasonable efforts to procure or make, execute, and deliver any and all other instruments, and any and all further application papers; affidavits, assignments or other documents which may be required or necessary to secure to and vest in said ASSIGNEE, its successors and assigns, the whole right, title and interest in and to said Patents, Letters Patent, applications for Letters Patent, rights, title, benefits, privileges and advantages hereby sold, assigned, transferred and conveyed or intended so to be.
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IN WITNESS WHEREOF, this agreement is executed below by an authorized representative of [*]:
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Schedule I to ASSIGNMENT
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EXHIBITΒ B
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DERMIRA β XXXXXXX LETTER AGREEMENT
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AprilΒ 26, 2013
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[*]
VP, Global Business DevelopmentΒ & Licensing
Xxxxxxx Laboratories,Β Inc.
20 XX Xxxxxxxxx Drive
XX Xxx 00000
Xxxxxxxx Xxxxxxxx Xxxx, XX 00000
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Re: Sublicense to Dermira,Β Inc. (βDermiraβ) under the License and Post-Termination Agreement between Xxxxxxx Laboratories,Β Inc. (βXxxxxxxβ)Β and Rose U LLC (βRose Uβ) effective AprilΒ 26, 2013 (the βLicense and Post-Termination Agreementβ)
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Dear [*]:
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1)Β Β Β Β Β Β Β Β Β Β Β Β As you know, Dermira is in the process of negotiating a license agreement with Rose U (the βRose U-Dermira License Agreementβ) which includes a sublicense of certain development data and related information which were licensed, in the first instance, by Rose U from Xxxxxxx under the License and Post-Termination Agreement (the βSublicenseβ).Β Defined terms used in this letter agreement shall have the meaning given to them in the License and Post-Termination Agreement.
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2)Β Β Β Β Β Β Β Β Β Β Β Β Dermira now seeks certain agreements from Xxxxxxx regarding the rights sublicensed by Rose U to Dermira which have as their source the License and Post-Termination Agreement and in return Xxxxxxx requires Dermira to confirm certain obligations to Xxxxxxx arising from such sublicense.
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3)Β Β Β Β Β Β Β Β Β Β Β Β Without in any way diminishing Dermiraβs obligation to indemnify Xxxxxxx set out below, Xxxxxxx agrees that the obligation in Sections 3.5.2(i)Β and (iii)Β of the License and Post-Termination Agreement to include certain terms in sublicense agreements and the obligation to provide Xxxxxxx with copies of sublicense agreements shall not apply to sublicense agreements entered into by Dermira or its Designated Sublicensees with contract research organizations, contract manufacturing organizations and similar third parties performing services for the benefit of Dermira or its Affiliates or Designated Sublicensees which sublicense does not include any right to commercialize Licensed Product.
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4)Β Β Β Β Β Β Β Β Β Β Β Β Consistent with SectionΒ 8.3 of the License and Post-Termination Agreement, in the event of a termination of the License and Post-Termination Agreement, the Sublicense granted by Rose U to Dermira under the Rose U-Dermira License Agreement shall survive such termination subject to the terms of the Rose U-Dermira License Agreement and this letter agreement and shall automatically be assigned to and assumed by Xxxxxxx and remain in full force and effect with Xxxxxxx as the licensor instead of Rose U, provided that, unless Xxxxxxx agrees in writing otherwise, the obligations of Xxxxxxx under the assigned Sublicense will not be greater than the obligations of Xxxxxxx under this Agreement, and further provided that a default by Dermira was not the cause of such termination and at the time of such termination Dermira is not in material breach of the Rose U-Dermira License Agreement or this letter agreement.
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5)Β Β Β Β Β Β Β Β Β Β Β Β Dermira shall directly pay Xxxxxxx the [*] Payment upon [*] (the β[*]β).Β Dermira shall pay the [*] Payment directly to Xxxxxxx in accordance with SectionΒ 4.2 of the License and Post-Termination Agreement.Β Xxxxxxx shall be entitled to terminate this letter agreement and the Sublicense to Dermira by written notice to
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Dermira in the event that Dermira fails to pay Xxxxxxx the [*] Payment when due and does not cure such breach within [*] after written notice from Xxxxxxx to Dermira.
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6)Β Β Β Β Β Β Β Β Β Β Β Β Dermira shall indemnify, defend, and hold Xxxxxxx and its Affiliates, and their stockholders, employees, directors, officers, successors and assigns (individually and collectively βIndemnified Personsβ) harmless from and against any claims, actions, suits, proceedings, demands, costs, expenses (including reasonable attorneysβ fees), liabilities and/or losses (collectively, βLossesβ) arising out of or in connection with third party claims based on (a)Β the development, manufacture, use, sale or other disposition of Licensed Products (as such term is defined in the License and Post-Termination Agreement) by Dermira, any Dermira sublicensee or any subsequent sublicensee, or (b)Β the use by any person of Licensed Products made, used, sold or otherwise distributed by Dermira, any Dermira sublicensee or any subsequent sublicensee.Β Dermira shall contractually require each of its sublicensees (other than contract research organizations, contract manufacturing organizations and similar third parties performing services for the benefit of Dermira or its Affiliates or Designated Sublicensees who do not receive any right to commercialize Licensed Product) to provide the same indemnity in favor of the Indemnified Persons as to such sublicensee and its subsequent sublicensees (subject to conditions and procedures substantially equivalent to those contained in paragraphs numbered 7 and 8 below).
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7)Β Β Β Β Β Β Β Β Β Β Β Β An Indemnified Person shall reasonably promptly notify Dermira and any relevant Designated Sublicensee from which the Indemnified Person elects to seek indemnification hereunderΒ (each such person, the βIndemnifying Partyβ) in writing, of any claim for which indemnification may be sought under this indemnification; provided however that any delay in notification shall not nullify any indemnification obligation except to the extent of actual prejudice.Β The Indemnifying Party shall have the right, using counsel acceptable to the Indemnified Person, to control the investigation, trial, defense and settlement of such lawsuit or action (including all negotiations to effect a settlement) and any appeal arising therefrom, provided (a)Β that such claim involves (and continues to involve) solely monetary damages, (b)Β that the Indemnifying Party has notified the Indemnified Persons in writing of its intention to do so within [*] of receiving notice of a claim from the Indemnified Persons, and (c)Β that the Indemnifying Party shall diligently contest the claim (clauses a, b and c hereof, the βLitigation Conditionsβ).Β The Indemnified Person may, at its own cost, participate in such investigation, trial and defense of such lawsuit or action and any resulting appeal.Β At the Indemnifying Partyβs expense, the Indemnified Person shall reasonably cooperate in good faith with it at all times during the pendency of the claim or lawsuit including, without limitation, promptly providing all available information and documents concerning the claim that are in the Indemnified Personβs possession.Β The Indemnifying Party shall not have, or shall lose, as applicable, the right to control the investigation, trial, defense and settlement of such lawsuit or action in the event that any of the Litigation Conditions are not, or are no longer, met, as applicable.Β An Indemnified Personβs consent shall be required in the event that any proposed compromise or settlement under this indemnification (i)Β includes a finding or admission of any violation of any law by such Indemnified Person, or (ii)Β requires the payment of any money by the Indemnified Person, or (iii)Β requires the Indemnified Person to take, or to forebear taking, any action, or (iv)Β does not provide for a complete release by such third party claimant of the Indemnified Person.
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8)Β Β Β Β Β Β Β Β Β Β Β Β IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY FOR ANY SPECIAL,Β INCIDENTAL,Β INDIRECT, OR CONSEQUENTIAL DAMAGES,Β INCLUDING BUT NOT LIMITED TO THE LOSS OF OPPORTUNITY, OR LOSS OF REVENUE OR PROFIT HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY (INCLUDING NEGLIGENCE), EVEN IF THE OTHER PERSON HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
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9)Β Β Β Β Β Β Β Β Β Β Β Β Subject to Paragraph 10 hereof, Dermira shall only have the right to assign this letter agreement to a third party in connection with an assignment of the Rose U-Dermira License Agreement arising from (a)Β a merger, consolidation or reorganization of Dermira or a sale of all or substantially all of the assets of Dermira (an βAcquisition Transactionβ), or (b)Β a sale of all or substantially all of the assets of Dermira to which the Rose U-Dermira License Agreement relates (an βAssignment Transactionβ), and Dermira agrees that it shall so assign this letter agreement in any such scenario where the Rose U-Dermira License Agreement has been assigned, provided that, in the case of an Assignment Transaction, (i)Β Dermira shall
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not be relieved of its obligations under this letter agreement but shall be jointly and severally liable with the assignee hereunder, and (ii)[*].Β Any further assignments from Dermira or a subsequent assignee to a different third party assignee shall only be made in accordance with Paragraph 9 hereof, and, following an Assignment Transaction, Dermira shall continue not to be relieved of its obligations under this letter agreement but shall be jointly and severally liable with its assignee and any such further assignees hereunder.Β Any assignment or transfer or attempted assignment or transfer of this letter agreement made in contravention of the terms of this Paragraph shall be null, void and without effect.Β Subject to the foregoing, this letter agreement shall be binding on and inure to the benefit of Dermiraβs respective successors and permitted assigns.
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10)Β Β Β Β Β Providing that the [*] Payment has not yet been made, until the [*] anniversary of the date hereof, Dermira shall use Commercially Reasonable Efforts to develop and commercialize a Licensed Product, whether by itself, through an Affiliate, or a through a Designated Sublicensee.Β In the event that Xxxxxxx reasonably believes Dermira is not using such Commercially Reasonable Efforts, Dermira and Xxxxxxx shall meet to discuss the issue.Β In the event that Dermira and Xxxxxxx cannot reach resolution on such matter, Dermira and Xxxxxxx agree to engage in a dispute resolution process equivalent to that set forth ArticleΒ 10 of the License and Post-Termination Agreement.Β Dermira and Xxxxxxx agree that the result of such dispute resolution process by binding arbitration (but not pursuant to the negotiation in SectionΒ 10.2 or the non-binding mediation in SectionΒ 10.3, through which resolution Dermira and Xxxxxxx may mutually agree as they choose) shall be limited to a finding by the arbitrator that either (a)Β Dermira owes Xxxxxxx (i)Β none, (ii)Β all or (iii)Β some portion to be decided by the arbitrator of the [*] Payment, or that (b)Β the license grant to Rose U in the License and Post-Termination Agreement shall (i)Β be converted into a non-exclusive license such that Xxxxxxx may license the Xxxxxxx Data to other parties of its choice or (ii)Β shall remain in place with no change.Β In the License and Post-Termination Agreement executed as the date hereof, Rose U is agreeing to such possibility of the conversion of the license grant to Rose U from βexclusive (except as to Xxxxxxx and its Affiliates)β to βnon-exclusiveβ as set forth in this Paragraph 10.Β For the purposes of this Paragraph 10, βCommercially Reasonable Effortsβ means efforts that, taken together, would constitute a reasonable level of effort by [*] to develop and commercialize in a [*] manner, one of such companyβs [*] giving full consideration to all [*] .
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11)Β Β Β Β Β This letter agreement shall terminate upon any termination of the Rose U-Dermira License Agreement, unless such termination was effected by the acquisition of Rose U by Dermira or an Affiliate thereof, or unless, in a series of related transactions, Dermiraβs [*] program related to the Rose U-Dermira License Agreement has been substantially divested and this letter agreement is terminated and not assigned in conjunction therewith and a new license agreement has been entered into by and between the assignee of Dermiraβs [*] program related to the Rose U-Dermira License Agreement and Rose U, in either of which case this letter agreement shall not terminate. Notwithstanding the foregoing, paragraphs numbered 6, 7, 8, and this Paragraph 11 shall survive any termination of this letter agreement, and provided that Dermiraβs obligations under Paragraph 5, 9 and 10 shall survive any termination of this letter agreement but only if the [*] Payment or payment obligation in Paragraph 9 or 10 accrued prior to termination but was not received by Xxxxxxx prior to termination.
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If you are in agreement with the foregoing, kindly sign and date this letter where indicated below and return an executed copy to me at your convenience.
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Very truly yours, |
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/s/ Xxx Xxxxxxx |
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Xxx Xxxxxxx |
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Chief Executive Officer |
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The foregoing is hereby agreed to
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Xxxxxxx Laboratories,Β Inc.
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/s/ Xxxxxx X. Xxxxx |
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Xxxxxx X. Xxxxx |
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Assistant Secretary |
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4/26/13 |
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[SIGNATURE PAGE TO DERMIRA β XXXXXXX LETTER AGREEMENT]
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APPENDIX C
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XXXXXXX SIDE LETTER
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(ATTACHED)
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