Exclusive License Agreement by and between the Registrant and Mercury Pharma Group Limited, dated January 3, 2023
Exhibit 10.9
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS NOT MATERIAL AND IS THE TYPE OF INFORMATION THAT THE REGISTRANT CUSTOMARILY AND ACTUALLY TREATS AS PRIVATE AND CONFIDENTIAL. [***] INDICATES THAT INFORMATION HAS BEEN REDACTED.
EXCLUSIVE LICENSE AND SUPPLY AGREEMENT
by and between
APPLIED THERAPEUTICS, INC.
and
MERCURY PHARMA GROUP LIMITED
January 3, 2023
TABLE OF CONTENTS
i
EXCLUSIVE LICENSE AND SUPPLY AGREEMENT
This Exclusive License and Supply Agreement (this “Agreement”) dated as of January 3, 2023 is made by and between Applied Therapeutics, Inc., a company organized and existing under the laws of the State of Delaware in the U.S. with its head office at 545 5th Ave Suite 1400, New York, NY 10017 (“Applied”), and Mercury Pharma Group Limited (trading as Advanz Pharma Holdings), a company organized and existing under the laws of England and Wales with its head office at Capital House, 85 King William Street, London, EC4N 7BL, United Kingdom and registered under number 02330913 (“Advanz”) (each, a “Party” and collectively, the “Parties”).
WHEREAS, Applied is engaged in, among other things, Developing the Compound and the Product and owns or otherwise controls certain Patent Rights and Technology relating thereto;
WHEREAS, Advanz has experience and expertise in the marketing and selling of pharmaceutical products, and desires to acquire the licenses set out in this Agreement including an exclusive license in the Territory to Commercialize the Product in the Field, upon the terms and subject to the conditions set forth herein; and
WHEREAS, Applied desires to grant such license to Advanz.
NOW, THEREFORE, in consideration of the mutual covenants and agreements provided herein, Applied and Advanz hereby agree as follows:
For purposes of this Agreement, the following definitions shall be applicable:
each to the extent necessary or useful for the Exploitation of the Compound or Product in the Field in the Territory and which are “Applied Patent Rights” or “Applied Technology” as appropriate.
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in existence at the time of disclosure; (b) wholly disclosed in published literature, or otherwise is or becomes generally known to the public through no breach by Advanz of this Agreement; (c) obtained by Advanz or its Affiliates from a Third Party free from any obligation of confidentiality to Applied or its Affiliates (including in the exercise of its rights or performance of its obligations under this Agreement); or (d) independently developed by Advanz or its Affiliates without use of or reference to the Applied Confidential Information.
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. For the avoidance of doubt, “Facility” includes the facilities of Applied’s Third Party contract manufacturers.
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1.100“Party” or “Parties” shall have the meaning assigned to such terms in the Preamble.
1.101“Patent Application” means any application for a Patent.
1.102“Patent Challenge” shall have the meaning assigned to it in Section 2.6(a).
1.103“Patent Rights” means Patents and Patent Applications.
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1.104“Patents” means issued patents, whether U.S. or foreign, including all continuations, continuations-in-part, divisions, provisionals and renewals, and letters of patent granted with respect to any of the foregoing, patents of addition, supplementary protection certificates, registration or confirmation patents and all reissues, re-examination and extensions thereof.
1.105“Person” means an individual, corporation, partnership, company, joint venture, unincorporated organization, limited liability company or partnership, sole proprietorship, association, bank, trust company or trust, whether or not legal entities, or any Governmental Authority.
1.106“Pharmacovigilance Agreement” shall have the meaning assigned to it in Section 5.4.
1.107“PMAC Members” shall have the meaning assigned to it in Section 6.1(b).
1.108“Price Approval” means, in any Country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).
1.109“Pricing and Market Access Activities” means, with respect to the Product in the Field in the Territory, strategy, activities and undertakings regarding: (a) pricing and price terms, including obtaining and maintaining Price Approvals, negotiating discounts, rebates and other price-related matters with payors and purchasers or in relation to formulary placement for Products; (b) reimbursement programs; and (c) all other market access matters, including establishing and maintaining relationships, and contracting with hospitals, pharmacies, group purchasing organizations and healthcare insurers and other similar Third Parties.
1.110“Pricing and Market Access Committee” or the “PMAC” shall have the meaning assigned to it in Section 6.1(a).
1.111“Product” means any pharmaceutical product that contains the Compound, as the sole active ingredient or together with one or more other active ingredients, in any dosage form, strength or formulation.
1.112“Product Non-Conformance” shall have the meaning assigned to it in Section 8.7(a).
1.113“Product Recall” shall mean any Advanz Recall or Applied Recall.
1.114“Product Specifications” means those Manufacturing, performance, quality-control release, and other specifications for the Compound or Product (including Bulk Product) for use in the Field in the Territory, which are initially as set forth in the applicable Marketing Authorization for the Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.
1.115“Proposal” shall have the meaning assigned to it in Section 2.5(b).
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1.116“Purchase Order” shall have the meaning assigned to it in Section 8.4(a).
1.117“PV and Risk Management Studies” means any (a) post authorization safety study (“PASS”); (b) risk management plan (“RMP”) requirement (such as product safety or disease registry); and (c) pharmacovigilance surveillance activity with respect to the Compound or Product, in each case, for use in the Field in the Territory, as required by any Regulatory Authority in any Country in the Territory following receipt of a Marketing Authorization for the Product for use in such Licensed Indication.
1.118“Quality Agreement” means the Quality Agreement to be entered into between Applied and Advanz with respect to the Bulk Product being supplied by Applied for commercial supply to Advanz under the terms of this Agreement.
1.119“Regulatory Activities” means the Advanz Regulatory Activities or any regulatory activities undertaken by Applied with respect to the Product, as applicable.
1.120“Regulatory Approval” means any approval, with respect to any Country, that are necessary for the Commercialization or other Exploitation of a pharmaceutical product in such Country. “Regulatory Approval” (a) includes all approvals, product and establishment licenses, registrations or authorizations of any federal, state or local authority, department, bureau or other Governmental Authority, necessary for the manufacture, use, storage, importation, export, transport, sale, or placing on the market of a pharmaceutical product in a Country and (b) includes any Marketing Authorization.
1.121“Regulatory Authority” means, in respect of a particular Country, the Governmental Authority having responsibility for granting Regulatory Approvals in such Country.
1.122“Regulatory Filing” means all applications, filings, submissions, approvals, licenses, registrations, permits, notifications and authorizations (or waivers) with respect to the Commercialization or other Exploitation of a compound or pharmaceutical product made to or received from any Regulatory Authority in the Territory, including any Marketing Authorization Applications and labels.
1.123“Reimbursing Party” shall have the meaning assigned to it in Section 10.1(b).
1.124“Requested Actions” shall have the meaning assigned to it in Section 8.14(c).
1.125“Required Existing Studies” means all clinical studies for the Compound or Product which are ongoing at the Effective Date including: (a) the long-term extension trial evaluating the safety and pharmacokinetics of the Compound, in adult human subjects with Galactosemia being conducted by Applied and referred to as the ACTION-Galactosemia study (the “AT-007-1006 Study”), (b) the pediatric trial evaluating the safety, pharmacokinetics and reduction in the toxic biomarker, galactitol, as well as long-term clinical outcomes, such as speech, memory, cognition, behavior, growth and development and motor skills of the Compound in children (ages 2-17) being conducted by Applied and referred to as the ACTION-Galactosemia Kids study (the “AT-007-1002 Study”); and (c) the registrational clinical trial evaluating biomarker efficacy, clinical outcomes and safety in human subjects (ages 16 and older) with SORD treated with the Compound
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vs. placebo being conducted by Applied and referred to as the INSPIRE study (the “AT-007-1005 Study”).
1.126“Required Post-MA Studies” means, in each case, with respect to the Product for use in the Field in the Territory, any (a) pre-clinical or clinical study as part of a pediatric investigational plan (a “PIP”) required by a Regulatory Authority within the Territory, either as a condition of expanding the approved Indication under a Marketing Authorization for another subpopulation or as an associated commitment of a Marketing Authorization; (b) confirmatory studies for Galactosemia for adults if the Product is being Commercialized under conditional Marketing Authorization; (c) post authorization efficacy study (“PAES”) including for paediatric use in respect of Galactosemia and in general in respect of SORD (but not including, for clarity, any studies under the foregoing subsection (a)); or (d) other pre-clinical or clinical trial, in each case of the foregoing (c) and (d), as required by any Regulatory Authority in any Country in the Territory to maintain an existing Marketing Authorization for the Product for use in such Licensed Indication.
1.127“ROFO Negotiation Period” shall have the meaning assigned to it in Section 2.5(b).
1.128“ROFO Product” shall have the meaning assigned to it in Section 2.5(a).
1.129“ROFO Response Period” shall have the meaning assigned to it in Section 2.5(b).
1.130“Royalties” shall have the meaning assigned to it in Section 9.3.
1.131“Safety Stock” shall have the meaning assigned to it in Section 8.11(b).
1.132“Secondary Source Site” shall have the meaning assigned to it in Section 8.12.
1.133“Secondary Packaging and Release” means finishing, labelling, packaging (including design of artwork and any translations) and quality release activities to the extent relating to the Product for use in the Field in the Territory.
1.134“Secondary Packaging and Release Estimated Cost” shall have the meaning assigned to it in Section 8.6(d).
1.135“Shelf Life Requirements” shall have the meaning assigned to it in Section 8.4(e).
1.136“SORD” means sorbitol dehydrogenase deficiency.
1.137“Step-In Notice” means notification by Advanz to Applied that it intends to exercise its Step-In Rights in accordance with Section 8.14.
1.138“Step-In Rights” means the right of Advanz to step-in to continue any activities undertaken or required to be undertaken by Applied or any other Person on Applied’s behalf relating to or associated with the Exploitation of the Product in accordance with this Agreement, as and to the extent applicable, pursuant to Section 8.14.
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1.139“Sublicense” means the grant by Advanz of a sublicense under any of the rights licensed by Applied to Advanz pursuant to Section 2.1.
1.140“Sublicensee” means a Third Party to whom Advanz has granted a Sublicense in accordance with the terms and conditions set forth herein.
1.141“Supply Shortage” shall have the meaning assigned to it in Section 8.13.
1.142“Tax” means any U.S. and non-U.S. federal, state, local, regional, municipal, or other tax or taxation, levy, duty, charge, withholding, or other assessment of any kind (including any related fine, penalty, addition to tax, surcharge, or interest) imposed by, or payable to, a Governmental Authority, including sales, use, excise, stamp, transfer, property, value added, goods and services, withholding, and franchise taxes
1.143“Technology” means all technical, scientific, regulatory and other information, results, knowledge, techniques and data (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, safety, quality control, and preclinical and clinical data), in whatever form and whether or not confidential, patented or patentable, including inventions, invention disclosures, discoveries, plans, processes, practices, methods, knowledge, instructions, skill, experience, ideas, concepts, formulae, formulations, compositions, specifications and manufacturing data or descriptions. “Technology” does not include Intellectual Property claiming any of the foregoing.
1.144“Term” shall have the meaning assigned to it in Section 15.1.
1.145“Territory” means those Countries set forth on Exhibit D attached hereto.
1.146 “Third Party” means any Person other than Advanz, Applied, or any of their respective Affiliates.
1.147“Third Party Claim” shall have the meaning assigned to it in Section 17.4(a).
1.148“Third Party License” means each license agreement between Applied and a Third Party pursuant to which or from which Applied licenses in Applied Patent Rights or Applied Technology as of the Effective Date, as notified to Advanz and set out in Exhibit E attached hereto.
1.149“Third Party Product Claim” shall have the meaning assigned to it in Section 17.3(a).
1.150“Total Supply Price” shall have the meaning assigned to it in Section 8.5(a)(ii).
1.151“Trademarks” means trade names, brand names, trade dress, logos, slogans, trademarks and service marks and all other indicia of origin (whether registered or unregistered), and registrations, applications for registration, renewals and extensions thereof, together with all translations, adaptations, combinations and derivations thereof and all goodwill associated therewith.
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1.152“United Kingdom” means the United Kingdom of Great Britain and Northern Ireland.
1.153“United States” or “U.S.” means the United States of America, including its territories and possessions.
1.154“Valid Claim” means (a) a claim of an issued and unexpired Patent which has not been held unpatentable, invalid or unenforceable in a final decision of a court or other Governmental Authority of competent jurisdiction from which no appeal may be or has been taken, and which has not been admitted to be invalid or unenforceable through reissue, re-examination or disclaimer; or (b) a claim of a Patent Application, which claim has been pending less than [***] from the original priority date of such claim in a given jurisdiction, unless or until such claim thereafter issues as a claim of an issued Patent (from and after which time the same shall be deemed a Valid Claim subject to clause (a) above).
1.155“VAT” has the meaning assigned to it in Section 10.9(b).
1.156Construction. Except where expressly stated otherwise in this Agreement, the following rules of interpretation apply to this Agreement: (a) “include,” “includes” and “including” are not limiting and mean include, includes and including, without limitation; (b) definitions contained in this Agreement are applicable to the singular as well as the plural forms of such terms; (c) references to an agreement, statute or instrument mean such agreement, statute or instrument as from time to time amended, modified or supplemented; (d) references to a Person are also to its permitted successors and assigns; (e) references to a “Section,” or “Exhibit” refer to a Section of, or any Exhibit to, this Agreement unless otherwise indicated; (f) the word “will” shall be construed to have the same meaning and effect as the word “shall”; (g) the word “any” shall mean “any and all” unless otherwise indicated by context; (h) the headings in this Agreement are for convenience only and shall not affect its construction; (i) a reference to a particular law or regulation is a reference to it as amended, extended or re-enacted from time to time and includes any subordinate legislation made from time to time under that legislation or legislative provision; (j) except as otherwise required in accordance with Section 3.1, references to “writing” or “written” shall include emails; and (k) nothing in this Agreement shall in any way restrict or limit any obligation of either Party to mitigate any loss or damage they may suffer in consequence of any breach by the other Party of the terms of this Agreement, in consequence of any matter giving rise to a claim against the other Party or otherwise in connection with this agreement.
| (i) | Secondary Packaging and Release in accordance with Section 8; |
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| (ii) | Commercializing the Product; and |
| (iii) | the performance of Advanz’s obligations under Sections 5 and 6; |
| (i) | have Manufactured the Product for the Field in the Territory in accordance with Section 8.14; |
| (ii) | conduct Development of the Product to the extent permitted by Section 4.3(c) or Section 8.14; and |
| (iii) | undertake infringement proceedings as set out in Sections 7.4 and 11; and |
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| (i) | its contractors and other vendors for or in relation to Secondary Packaging and Release activities; |
| (ii) | its Affiliates, which Sublicense shall automatically terminate when such Affiliate ceases to be an Affiliate of Advanz; and |
| (iii) | reputable Third Parties, with respect to rights to Commercialize, conduct Regulatory Activities and Pricing and Market Access Activities in relation to the Product in the Territory; |
provided that Advanz must obtain the express written consent of Applied prior to entering into a Sublicense with a Third Party hereunder (excluding for the avoidance of doubt, any sublicenses granted pursuant to the foregoing subsections (i) or (ii)), such consent not to be unreasonably withheld, conditioned or delayed and to be provided within ten (10) days of Advanz’s request. For clarity, the Parties acknowledge and agree that Advanz’s contractors and logistics providers are not Sublicensees for the purpose of this Agreement to the extent such contractors and logistics providers do not obtain a sublicense under any Third Party Licenses and Advanz shall be entitled to engage such Third Parties without Applied’s consent and the provisions of this Section 2.4 other than Section 2.4(e) shall not apply to such arrangements.
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| (i) | such Additional Indication shall not be included in the ROFO Product’s then-existing Marketing Authorizations in the Territory; |
| (ii) | the Licensed Trademarks shall not be applied to the Additional Indication; and |
| (iii) | within [***] after the end of the ROFO Negotiation Period or at such other time as the Parties mutually agree in writing, the Parties shall discuss the potential adverse impact that the Commercialization of the ROFO Product in the Territory for use in any such Additional Indication by a Third Party may have on the Commercialization of the ROFO Product by Advanz for use in the Field in the Territory provided that such discussions do not (A) involve the sharing of commercially sensitive information about the |
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| distribution strategy of Third Parties; nor (B) otherwise aim at coordinating the distribution strategy of Advanz and/or any Third Parties. Each Party agrees that Advanz’s commercial obligations under this Agreement will be adjusted if Advanz can reasonably demonstrate that the Commercialization of the ROFO Product in the Territory for use in any such Additional Indication by a Third Party will compromise the potential for Advanz’s sale of the Product. |
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| (i) | If data from the Required Post-MA Study (A) is to be used or referred to as part of any regulatory or market access requirement or commitment outside the Territory as well as within the Territory, or (B) would benefit Commercialization of the Product outside the Territory as well within the Territory, then Applied shall bear [***] of the Costs and Expenses, and Advanz shall bear [***] of the Costs and Expenses; and |
| (ii) | If data from the Required Post-MA Study is to be used or referred to as part of any regulatory or market access requirement or commitment only within the Territory, Applied shall bear [***] of the Costs and Expenses, and Advanz shall bear [***] of the Costs and Expenses except that [***] the Costs and Expenses relating to any Required Post-MA Study set out in limb (C) of the Required Post-MA Study definition. |
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any Country outside the Territory) to comply with Applicable Laws and requirements of Regulatory Authorities in relation to the Product. Notwithstanding anything to the contrary herein, the Pharmacovigilance Agreement shall provide that Applied shall own and maintain the global safety database for the Product. Except as may be otherwise mutually agreed in the Pharmacovigilance Agreement, each Party will bear its own Costs and Expenses in connection with its activities thereunder.
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the right, but not the obligation, to be present at and participate in any such audit or inspection relating specifically to the Product, at its sole cost and expense.
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| (i) | on an exclusive basis with respect to Secondary Packaging and Release in accordance with Section 8, Commercialization of the Product for use in the Field in the Territory and the performance of Advanz’s obligations under Sections 5 and 6 for purposes of performing such obligations; |
| (ii) | on a sole basis (which for the purposes of this Section 7.4(a)(ii) shall be interpreted to include a right for Applied to sub-license its rights under this license to Applied’s Bulk Product contract manufacturer) with respect to the performance of Advanz’s obligations under Sections 7.4(g) and 11 and undertaking any activities required during Step-In to have Manufactured the Product for the Field in the Territory in accordance with Section 8.14, to conduct Development of the Product to the extent permitted by Section 4.3(c) and to undertake infringement proceedings in accordance with Section 7.4 or 11; and |
| (iii) | on a non-exclusive basis with respect to permitting Advanz to exercise any of its other rights and perform any other obligations set out in this Agreement, |
each in accordance with this Agreement.
Advanz shall cooperate with Applied in respect of recording (and take any actions reasonably requested by Applied to record) this trademark license (including, as may be appropriate, executing a short form thereof for purposes of recordation) with the appropriate Governmental Authorities throughout the Territory to the extent reasonably required or requested by Applied (and Applied shall be responsible for paying all Costs and Expenses associated with such recordation). Where applicable under Section 16.3, Advanz shall cooperate with Applied to effect a cancellation or termination of any such recordation with the appropriate Governmental Authorities in the Territory, and, if requested by Applied, Advanz agrees to grant to Applied an irrevocable power of attorney coupled with an interest to effect such cancellation within twenty (20) days after the termination of this Agreement.
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| (i) | The quality of the Product (including all associated packaging and labeling bearing the Licensed Trademarks) sold or distributed by Advanz in the Territory under or in connection with the Licensed Trademarks and the use by Advanz of the Licensed Trademarks (including in marketing, advertising and promotional materials) shall, subject to Applied’s compliance with Section 8.2, comply with cGMP and cGDP. |
| (ii) | Advanz shall (A) comply with all Applicable Laws pertaining to the proper use and designation of the Licensed Trademarks, (B) use the Licensed Trademarks only in the form and manner and with appropriate legends as prescribed or otherwise approved from time to time during the Term by Applied, (C) display the proper form of trademark notice associated with the Licensed Trademarks, (D) not use any Licensed Trademark as a corporate name, business name, or trade name, (E) not use any Licensed Trademark in a manner that would reasonably be expected to materially impair the validity, reputation, or distinctiveness of any Licensed Trademark or create a combination mark with any other Trademarks, (F) use any Licensed Trademark at a level of quality set out in Section 7.4(e)(i), and (G) not use any Licensed Trademark in a manner that would reasonably be expected to materially tarnish, impair or otherwise adversely affect the reputation of Advanz, Applied or any of their respective Affiliates. |
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| (i) | Applied shall at its cost: |
| (A) | institute litigation or take other remedial measures in connection with Third Party infringement or other violation of Licensed Trademarks in the Major Markets; and |
| (B) | use Commercially Reasonable Efforts to institute litigation or take other remedial measures in connection with Third Party infringement or other violation of Licensed Trademarks in all other Countries in the Territory. |
| (ii) | If Applied elects not to initiate litigation or take other remedial measures against a Third Party who is alleged to be infringing or otherwise violating a Licensed Trademark in a Country other than a Major Market in the Territory in the Field within [***] of Advanz’s request that Applied do the same (provided that, if Applied intends to undertake such defense, Applied shall notify Advanz that it intends to do so with [***] of Advanz’s request), then it shall consult with Advanz to discuss the repercussions of such a decision on Advanz’s other markets in the Territory. If Advanz, at its sole but reasonable discretion, considers that a failure to institute litigation or take other remedial measures will have an adverse impact on Advanz’s business relating to the Products, then Advanz shall have the right to initiate litigation or take other remedial measures at its own cost. Applied shall provide to Advanz all reasonable assistance in connection with such litigation or other remedial measures. Advanz shall be entitled to retain any recoveries obtained resulting from any such litigation or other measures. |
| (iii) | Applied shall have the sole right, but not the obligation, to institute litigation or take other remedial measures in connection with Third Party infringement or other violation of Licensed Trademarks outside the Territory or outside of the Field. |
| (iv) | Any Costs and Expenses incurred by Applied instituting litigation or taking other remedial measures under Section 7.4(g)(i), (ii) or (iii) shall be the responsibility of Applied. All recoveries obtained by Applied resulting |
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| from such litigation or other appropriate action under Section 7.4(g)(i), (ii) or (iii) shall be retained by Applied. |
In each case, for patient end use in the Field in the Territory pursuant to and in accordance with this Agreement and the Quality Agreement. Subject to Section 8.6(d), Advanz shall be responsible for Secondary Packaging and Release for the Product for use in the Field in the Territory, including all specialty pharmaceutical services, logistics and distribution. If Advanz’s Step-In Rights are exercised in accordance with Section 8.14, Applied shall reasonably assist Advanz in procuring that Applied’s Bulk Product’s contract manufacturer enters into a quality agreement with Advanz with respect to such supply arrangements.
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Product Specifications; provided that Advanz shall comply with all handling, storage and other requirements under Applicable Laws and the Regulatory Approvals from and delivery to Advanz of Bulk Product by Applied. Applied shall have no responsibility or liability to Advanz hereunder for any non-compliance arising from the acts or omissions of Advanz, its Affiliates or sublicensees from the point of delivery to Advanz.
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| (i) | Applied has provided Advanz with details of its current COGs together with an estimate of the COGs for Bulk Product in the first Calendar Year of the first Launch. At least [***] preceding the first requested delivery date for Bulk Product, Applied shall, based on the Initial Forecast and Long Range Forecast delivered concurrently with the Initial Forecast, update its previous estimate in good faith of the COGs for Bulk Product for the remainder of the Calendar Year in which the first Launch occurs. Thereafter, Applied shall, based on the then-current Forecast and Long Range Forecast, estimate in good faith the COGs for Bulk Product for such successive Calendar Year (being the “Estimated Cost”), and shall notify Advanz in writing prior to [***] of each successive Calendar Year of such Estimated Cost with: (y) reasonable supporting documentation regarding the calculation of such Estimated Costs; (z) evidence to support any increase in Estimated Cost compared to the then current Estimated Cost. Any increase in the Estimated Costs compared to the then current COGs shall be reasonable and evidence-based. Should Applied’s Bulk Product contract manufacturer’s costs decrease, the Estimated Cost shall reflect such decrease accordingly and |
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| Applied shall provide the supporting documentation and evidence set out at (y) and (z) in respect of such decrease. |
| (ii) | Each delivery of Bulk Product under a Purchase Order hereunder shall be accompanied by an invoice. Applied shall invoice Bulk Product at [***] (the “Total Supply Price”). Advanz shall issue payment against such invoices within thirty (30) days after the end of the calendar month in which the invoice is received. Applied shall include the following information, where applicable, on all invoices: the type, description, and quantity of the Bulk Product delivered; the date of shipment; the Total Supply Price; any applicable taxes, transportation charges or other charges provided for in the applicable Purchase Order; and the applicable Purchase Order number. |
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| (i) | Advanz shall have [***] following its receipt of each shipment of Bulk Product to inspect such shipment. If Advanz determines that all or any part of a shipment of Bulk Product suffers from any Product Non-Conformance in any material respect, it shall provide Applied a Notice of Non-Conformance in compliance with the procedures set forth in the Quality Agreement(s). |
| (ii) | Latent defects shall be communicated to Applied, together with appropriate detail, within [***] of the date on which such latent defect was first discovered by Advanz. |
| (iii) | Failure to provide such written notice within such time periods specified in this Section 8.7(b), as applicable, shall be deemed acceptance of such shipment of Bulk Product by Advanz, and Applied shall have no responsibility or liability to Advanz therefor in respect of any such Product Non-Conformance. |
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provided that such Safety Stock shall not be subject to the Shelf Life Requirements until such time as Applied has registered a shelf life of [***] in respect of the Bulk Product, at which point all inventory Bulk Product shall have a minimum shelf life of [***].
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out in Section 8.14(b); (b) rights to use the Secondary Source Site in accordance with Section 8.12; and/or (c) claim direct damages for breach of contract in accordance with this Agreement.
Notwithstanding the foregoing and in accordance with Section 1.156(k), Advanz shall use Commercially Reasonable Efforts to work with any Secondary Source Site and use any of its safety stock approved in the Marketing Authorization in order to mitigate any damages for breach of contract.
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Event Milestone | Event Milestone Payment | Payable |
|---|---|---|
Successful Completion of the AT-007-1002 Study, where “Successful Completion” means [***] | [***] | Within fifteen (15) Business Days from the date of receipt of the invoice applicable to such Event Milestone Payment |
Successful Completion of the AT-007-1005 Study, where “Successful Completion” means [***] | [***] | Within fifteen (15) Business Days from the date of receipt of the invoice applicable to such Event Milestone Payment |
Grant of a centralized Marketing Authorization by the EMA allowing sale of the Product in the Territory for use in Galactosemia, which Marketing Authorization may be a conditional authorization or authorization with respect to a sub-population of patients | [***] | Within fifteen (15) Business Days from the date of the occurrence of such Event Milestone |
Grant of a centralized Marketing Authorization by the EMA allowing sale of the Product in the Territory for use in SORD, which Marketing Authorization may be a conditional authorization or authorization with respect to a sub-population of patients | [***] | Within fifteen (15) Business Days from the date of occurrence of such Event Milestone |
Annual Net Sales for the Product in the Territory exceeds [***] in a Calendar Year (“Commercial Event Milestone 1”) | [***] | Subject to Section 9.2(b)(iii)(B) |
Annual Net Sales for the Product in the Territory exceeds [***] in a Calendar Year (“Commercial Event Milestone 2”) | [***] | Subject to Section 9.2(b)(iii)(B) |
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Event Milestone | Event Milestone Payment | Payable |
|---|---|---|
Annual Net Sales for the Product in the Territory exceeds [***] in a Calendar Year (“Commercial Event Milestone 3”) | [***] | Subject to Section 9.2(b)(iii)(B) |
Annual Net Sales for the Product in the Territory exceeds [***] in a Calendar Year (“Commercial Event Milestone 4”) | [***] | Subject to Section 9.2(b)(iii)(B) |
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“blocked” funds shall be deposited to the credit of Applied in such depository as Applied designates subject to such Applicable Laws or Advanz or its Affiliates shall otherwise pay Applied an amount equal to such “blocked” funds.
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Applied shall at its cost, subject to Sections 11.2 through 11.3, (x) reject the competence of the Unitary Patent Court in respect of any Applied Patent Rights; and (y) maintain and defend the Patents in the Territory sublicensed to Advanz under this Agreement which are the subject of
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the Columbia License (the “Columbia Patents”) by duly filing all necessary papers and paying any fees required by Applicable Laws of the particular Country in which the Patent was granted.
Applied shall be responsible for all the Costs and Expenses it incurs in connection with the actions taken under this Section 11.1 (subject to Sections 11.2 and 11.3).
| (i) | Advanz is subject to a final court or other binding order or ruling requiring any payments, including the payment of a royalty to a Third Party holder of |
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| Patent Rights in respect of sales of the Product in a Country in the Territory; or |
| (ii) | Applied is subject to a final court or other binding order or ruling requiring any payments, including the payment of a royalty to a Third Party holder of Patent Rights in respect of sales of the Product in a Country in the Territory, the amount of such payments made a Party to the Third Party holder of Patent Rights shall be shared equally between the Parties such that (A) if Advanz make such payment [***] of such amount shall be deducted from Royalties for such Calendar Quarter in which they are due and payable; and (B) if Applied makes such payment, Advanz shall promptly reimburse Applied in respect of [***] of such amount. For clarity, any litigation relating to the foregoing shall be handled as provided in Section 11.6. |
| (i) | Applied shall have the first right, but not the obligation, to institute litigation or take other remedial measures in connection with Third Party infringement or other violation of the Applied Patent Rights occurring in the Field within the Territory. If Applied chooses not to initiate litigation or take other remedial measures against a Third Party who is alleged to be infringing or otherwise violating the Applied Patent Rights in the Territory in the Field (other than Applied Patent Rights directed solely to an Out-of-Scope Product) within [***] of Advanz’s request that Applied do the same (provided that, if Applied intends to initiate such litigation or remedial measures, Applied shall notify Advanz that it intends to do so with [***] of Advanz’s request), then Advanz shall have the right to initiate litigation or take other appropriate action to the extent (A) such Third Party infringement or other violation would reasonably be expected to impair or has impaired the Commercialization of the Product in the Field in the Territory (subject to obtaining Applied’s prior written approval, such approval not to be unreasonably withheld, conditioned or delayed) and (B) such litigation or other appropriate action does not conflict with the enforcement rights (and otherwise complies with the rights) of the owner of any Applied Patent Rights under a Third Party License. Applied shall notify Advanz promptly if it becomes aware that the owner of any Applied Patent Rights under a Third Party License intends to initiate litigation or take other appropriate action. Each Party agrees to reasonably cooperate with the other in connection with any such litigation or measures taken by such other Party in accordance with this Section 11.5(a)(i) (including, as may be required, timely joining as a party in any such litigation). The Party initiating such litigation or other measures shall bear: (x) all Costs and |
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| Expenses; (y) any losses in connection with any such litigation or other measures; and (z) be entitled to retain any recoveries obtained resulting from any such litigation or other measures after making any payments to the owner of any Applied Patent Right or Applied Technology required under a Third Party License, subject to such amounts being evidenced in writing to Advanz where Advanz is the Party taking the action and bearing the Costs and Expenses. The Party initiating such litigation or other measures in accordance with this Section 11.5(a)(i) shall consult with the other Party as to the strategy for the same and shall consider in good faith any comments from the other Party and keep the other Party reasonably informed of any steps taken with respect thereto. |
| (ii) | Applied shall have the sole right, but not the obligation, to institute litigation or take other remedial measures in connection with Third Party infringement or other violation of any Applied Patent Rights occurring outside of the Territory and with respect to Third Party infringement or other violation of any Applied Patent Rights directed solely to any Out-of-Scope Product or occurring outside the Field (within or outside of the Territory), and any such litigation or remedial measures shall be at Applied’s sole cost and expense. Applied shall retain all recoveries received by Applied and bear all losses arising as a result of its enforcement of Applied Patent Rights under this Section 11.5(a)(ii). |
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of the other Party, which shall not be unreasonably delayed, conditioned or withheld) if such settlement would reasonably be expected to have a material adverse effect on the rights or interest of the other Party or any of its Affiliates or impose any costs or liability on, or involve any admission by, the other Party or any of its Affiliates. In the event Advanz is defending against such claim or action, Applied shall have the right to join such defense using its own counsel at its own cost and expense. The Party defending such litigation or other measures shall bear all Costs and Expenses and any losses in connection with any such litigation or other measures and be entitled to retain any recoveries obtained resulting from any such litigation or other measures after making any payments to the owner of any Applied Patent Right or Applied Technology required under a Third Party License, subject to such amounts being evidenced in writing to Advanz where Advanz is the defending Party and provided that, in respect of Section 11.6(a), where either Party is subject to a final court or other binding order or ruling requiring any payments, including the payment of a royalty to a Third Party holder of Patent Rights in respect of sales of the Product in a Country in the Territory, the amount of such payments made a Party to the Third Party holder of Patent Rights shall be shared [***] between the Parties such that (x) if Advanz make such payment [***] of such amount shall be deducted from Royalties for such Calendar Quarter in which they are due and payable; and (y) if Applied makes such payment, Advanz shall promptly reimburse Applied in respect of [***] of such amount.
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Either Party may terminate this Agreement upon written notice to the other Party, if the other Party files, or has filed against it, a petition for voluntary or involuntary bankruptcy or pursuant to any other insolvency law seeking to adjudicate it as bankrupt or insolvent, or seeking dissolution, liquidation, winding up, reorganization, arrangement, adjustment, protection, relief of debtors, an assignment for the benefit of creditors, or seeking the entry of an order for relief or the appointment of a receiver, trustee, assignee for the benefit of creditors, custodian or other similar official for any such Person or for any substantial part of its property, and, if such proceeding is commenced involuntarily, either such proceeding shall remain undismissed or unstayed for a period of sixty (60) days. The voluntary commencement of any of the foregoing proceedings by a Party shall result in an immediate right to terminate by the other Party.
| (i) | Subject to the provisos set out in Section 7.1, Applied may terminate this Agreement in its entirety, or if otherwise as agreed by the Parties (which may include termination on a Country by Country basis), upon at least ninety (90) days’ written notice to Advanz, if Advanz does not either: |
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| (A) | Launch the Product for each Licensed Indication in Germany within [***] after the grant of any Marketing Authorization for the Product for such Licensed Indication(s) by EMA; or |
| (B) | Launch the Product for each Licensed Indication in France within [***] from securing Price Approval and/or Third Party reimbursement approval (as applicable) whether pursuant to an Early Access Program or otherwise; or |
| (C) | Launch the Product for each Licensed Indication in each of Italy, Spain and the United Kingdom within [***] after the grant of a Marketing Authorization for the Product for such Licensed Indication by EMA or the MHRA (whichever is the later); [***]; |
provided, however, that in each case, that Advanz shall have sixty (60) days from receipt of such notice to Launch the Product for use in such Licensed Indication in such Country(ies).
| (ii) | Termination for failure to achieve Minimum Sales/Quantities: Applied may terminate this Agreement in its entirety, upon ninety (90) days’ written notice to Advanz, if Advanz has not achieved at least [***] in cumulative Net Sales by the later of: |
| (A) | [***] |
| (B) | the date on which Advanz has [***], |
provided in (B) that Advanz has submitted the Product for, and used Commercially Reasonable Efforts to prosecute Price Approval in each of the Major Markets for Galactosemia within [***] and provided, however, that Advanz shall have sixty (60) days from receipt of such notice to cure such failure (where any cure may include payment of any shortfall in Royalties on Net Sales below [***].
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termination of this Agreement for any reason (a) shall be without prejudice to and shall not impair or limit in any manner (i) Applied’s right to receive payment from Advanz of Royalties or Commercial Event Milestone Payments in respect of sales of Product in the Territory occurring prior to the effective date of such termination, whether or not the due date for such payment is after such effective date of termination; (ii) Applied’s right to receive the applicable Event Milestone Payment in respect of any Event Milestone which occurs prior to the effective date of termination, whether or not the due date for such payment is after such effective date of termination, (iii) Applied’s right to receive payment from Advanz in accordance with this Agreement for any Bulk Product ordered by Advanz and delivered pursuant to this Agreement prior to the effective date of such termination, whether or not the due date for such payment is after such effective date of termination, provided that such Bulk Product is Manufactured and delivered in accordance with the terms of this Agreement; and (iv) any remedies that either Party may have and (b) shall not release a Party hereto from any indebtedness, liability, payment or other obligation incurred hereunder (including liability for breach of this Agreement) by such Party prior to the effective date of termination.
| (i) | all licenses granted to Advanz by Applied under this Agreement shall be retained by Advanz and shall survive termination of this Agreement on the same terms on which they were granted; provided that such licenses under Applied Technology, Applied Patents and Licensed Trademarks shall be expanded to enable the continuation or commencement by Advanz of any activities either undertaken by Applied or any other Person on Applied’s behalf or required to be undertaken by Applied or any other Person on Applied’s behalf, in each case, relating to or associated with the Exploitation of the Product for use in the Field in the Territory (including in relation to Development and Manufacture of the Product) in accordance with this Agreement; |
| (ii) | ownership of any Marketing Authorization Application or Marketing Authorization relating to the Compound or the Product which is held by Advanz, its Affiliates or designees, shall continue to be held by such entity; |
| (iii) | to the extent permitted by such Third Party, (x) all Third Party contract manufacturing/supply agreement(s) and any contract development agreements, to the extent applicable to the Product in the Field in the Territory, shall be assigned to Advanz by Applied (unless Advanz notifies Applied otherwise in writing) and (y) Applied shall ensure that (and shall procure the same to the extent Applied has not entered into such agreements as of the Effective Date) it has adequate arrangements to give full effect to such assignments. Applied shall facilitate the assignment process (including making any introductions) and shall not do anything to prejudice Advanz’s rights under such licenses or agreements without the prior consent |
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| of Advanz (such consent not to be unreasonably withheld, conditioned or delayed); |
| (iv) | if it has not already done so in accordance with the terms hereunder, Advanz may notify Applied that it wishes to use its Secondary Source Site, or if Step-In is otherwise triggered, in each case, Applied shall provide all reasonable assistance to Advanz to effect the transfer of Manufacturing of Bulk Product; |
| (v) | Applied shall provide to Advanz copies of any reports or other materials in its possession or control forming part of the Applied Technology including those required for any Regulatory Filing related to the Product (e.g. Dossiers, Required Existing Studies, Required Post-MA Studies and, subject to Section 4.3(d), Other Post Approval Studies conducted by Applied) to enable Advanz to continue to Develop, Manufacture and Commercialize the Product in the Field in the Territory; |
| (vi) | Advanz shall retain all materials in its possession relating to the Product and/or which it requires to continue to Develop, Manufacture and Commercialize the Product in the Field in the Territory, including: |
| (A) | all Regulatory Filings, Regulatory Approvals, Price Approvals, contracts and other agreements relating to Pricing and Market Access Activities in Advanz’s possession or control to the extent related to the Product; |
| (B) | all reports, records, information (including drug master files, if any), regulatory correspondence, correspondence with respect to Pricing and Market Access Activities, and other materials in Advanz’s possession or control to the extent relating to the Product in the Field in the Territory; |
| (C) | all materials bearing any Licensed Trademarks; and |
| (D) | all Applied Confidential Information (which shall remain subject to Section 12); |
| (vii) | without limiting Section 8.15, Sections 9.2 and 9.3 shall survive notwithstanding references to the duration of the Term, and Advanz shall remain liable to pay any Royalties and any Event Milestone Payments to the extent due and payable; |
| (viii) | Applied shall transfer to Advanz all inventory of the Bulk Product which is subject to a Purchase Order and has not yet been provided, and Advanz shall be entitled to sell all of its inventory of the Bulk Product. For the avoidance of doubt, Advanz’s remedies set out in Sections 8.7(b) and (d) shall apply to any such inventory; |
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| (ix) | Applied shall, upon request of Advanz, return or destroy all Advanz Confidential Information disclosed to it pursuant to this Agreement, including all copies and extracts of documents, as promptly as practicable following receipt of such request, except that copies may be kept for the purpose of complying with continuing obligations under this Agreement to the extent and for so long as necessary to perform its obligations or exercise its rights under this Section 16.3(a). Notwithstanding the foregoing, Applied also shall be permitted to retain such additional copies of or any computer records or files containing Advanz Confidential Information (A) to the extent necessary to comply with Applicable Laws or (B) that have been created solely by Applied’s automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with Applied’s standard archiving and back-up procedures, but not for any other use or purpose. For the avoidance of doubt, any Confidential Information of Advanz retained by Applied in accordance with this Section 16.3(a) shall remain Confidential Information of the disclosing Party and subject to Section 12; |
| (x) | for clarity, Advanz’s termination of the Agreement under Section 16.1(f) shall trigger its Step-In rights under Section 8.14(a); and |
| (xi) | the following Sections of this Agreement shall survive such termination under Section 16.1(f): Sections 2.1, 2.2, 2.3, 2.4, 2.6, 2.7, 4.3(c) and (d), 5.4 (as required to comply with Applicable Laws), 7.3, 7.4, 8.14, 8.15 (as required to give effect to this Section 16.3(a)), 9, 10, 11, 12, 13.5(a), 13.6, 16.1(b), 16.1(c), 16.1(d), 16.1(e), 16.2, 16.3(b), 17 (including Section 17.5 notwithstanding references to the duration of the Term therein), 18, 19.2 through 19.16 (inclusive), Exhibit H (to the extent required by the Third Party Licenses) and any other Exhibits to the extent required for interpretation purposes. |
| (i) | Advanz shall (or, in each case, shall cause its designee, if applicable, to), promptly after such termination, supply to Applied or its designee the following materials; provided that such materials shall be supplied in the form and format in which such materials are maintained by Advanz in the ordinary course of business (provided that Advanz shall use Commercially Reasonable Efforts to provide such materials in a form and format useable by Applied): |
| (A) | all Regulatory Filings (including Marketing Authorizations), Regulatory Approvals, Price Approvals, contracts and other agreements in Advanz’s or, if applicable, its designee’s, possession or control to the extent related to a Product; |
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| (B) | all reports, records, information (including drug master files, if any), regulatory correspondence and data, correspondence with respect to Pricing and Market Access Activities, and other materials in Advanz’s or, if applicable, its designee’s, possession or control to the extent relating to a Product; |
| (C) | all materials bearing any Licensed Trademarks; |
| (D) | assign to Applied any and all right, title or interest of Advanz in any Trademarks actually used in commerce by Advanz or its Affiliates in connection with a Product (including in any Licensed Trademarks and any goodwill associated therewith), excluding, for clarity, the corporate or trade name or logo of Advanz or its Affiliates. In furtherance of the foregoing Advanz shall execute an assignment of any such Trademarks in favor of Applied or an Applied Affiliate identified by Applied and Applied (or such Applied Affiliate designee) shall be responsible for recording such assignment with the appropriate governmental trademark authorities; provided that Advanz shall cooperate in facilitating such assignment and recordation by timely executing all necessary documents provided to it by Applied. |
| (ii) | Advanz hereby does, on behalf of itself and any of its applicable designees, (and shall) assign to Applied, or an Applied Affiliate identified by Applied, all of Advanz’s or its Affiliates’ or designee’s (as applicable) right, title and interest in and to the materials transferred or delivered or deliverable by Advanz pursuant to Section 16.3(b)(i), to the extent Advanz or any of its Affiliates or designees control such materials, which assignment shall include, for the avoidance of doubt, transfer of all physical items relating to Marketing Authorizations and Marketing Authorization Applications for the Product in Advanz’s or any of its Affiliate’s or designee’s name and commencement of the transfer process with the applicable Regulatory Authorities; |
| (iii) | Advanz hereby does (and shall) assign to Applied any applicable sublicenses to the extent related to the Product and/or Third Party agreements, with respect to significant services to be performed by Third Parties to the extent related to the Product, unless Applied has advised Advanz that it will not require such assignment. |
| (iv) | Without limitation of the generality of the foregoing, upon Applied’s request, the Parties shall use diligent efforts to complete the transition of the Commercialization of the Product, as well as Advanz’s responsibilities hereunder with respect thereto (including pharmacovigilance and Pricing and Market Access Activities) and at Applied’s election and request, and to extent reasonably possible and legally permissible, transfer and sale of some or all Product inventory and Bulk Product then in possession or control of |
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| Advanz, its Affiliates or sublicensees at cost to Applied (or its sublicensee or Third Party designee) as soon as is reasonably possible, in a low risk, orderly fashion. |
| (v) | Each of Advanz and Applied shall, upon request of the other Party, return or destroy all Applied Confidential Information and Advanz Confidential Information disclosed to it pursuant to this Agreement, including all copies and extracts of documents, as promptly as practicable following receipt of such request, except that one (1) copy may be kept for the purpose of complying with continuing obligations under this Agreement including relating to termination (e.g., under Section 16.1(b)(iv)) to the extent and for so long as necessary to perform its obligations or exercise its rights under this Section 16.3(b). Notwithstanding the foregoing, such other Party also shall be permitted to retain such additional copies of or any computer records or files containing such Confidential Information (A) to the extent necessary to comply with Applicable Laws or (B) that have been created solely by such Party’s automatic archiving and back-up procedures, to the extent created and retained in a manner consistent with such other Party’s standard archiving and back-up procedures, but not for any other use or purpose. For the avoidance of doubt, any Confidential Information of the disclosing Party retained by the receiving Party in accordance with this Section 16.3(b) shall remain Confidential Information of the disclosing Party and subject to Section 12. |
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herein); (b) the determination of Applied not to initiate an Applied Recall in the exercise of its discretion under Section 5.5(c); or (c) the gross negligence or willful misconduct of, or violation of Applicable Laws by, Applied, its Affiliates or sublicensees, or their respective employees, contractors or agents in the performance of this Agreement, except to the extent such Damages result from any of Advanz’s acts or omissions that are not in accordance with this Agreement.
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| (i) | EITHER PARTY SHALL BE ENTITLED TO CLAIM DAMAGES FOR DIRECT LOSS OF PROFITS UP TO A LIMIT OF [***] PER CALENDAR YEAR. |
| (ii) | IN NO EVENT SHALL EITHER PARTY OR ANY OF ITS RESPECTIVE AFFILIATES BE LIABLE UNDER OR IN CONNECTION WITH THIS AGREEMENT FOR ANY LOSS OF REVENUES OR CONTRACTS, BUSINESS INTERRUPTION, INDIRECT LOSS OF PROFITS OR ANY OTHER INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER IN CONTRACT, UNDER A WARRANTY, TORT (INCLUDING NEGLIGENCE), UNDER STATUTE OR OTHERWISE. |
THE FOREGOING SENTENCE SHALL NOT LIMIT THE OBLIGATIONS OF EITHER PARTY TO INDEMNIFY THE OTHER PARTY FROM AND AGAINST THIRD PARTY CLAIMS UNDER SECTION 17.3 OR LIABILITIES RESULTING FROM A BREACH OF THE CONFIDENTIALITY
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OBLIGATIONS UNDER SECTION 12 ABOVE, OR ANY LIABILITY ARISING OUT OF ANY INFRINGEMENT OR OTHER VIOLATION OF THE APPLIED PATENT RIGHTS, THE APPLIED TECHNOLOGY OR THE LICENSED TRADEMARKS AS A CONSEQUENCE OF THEIR USE BY ADVANZ OR ITS AFFILIATES OTHER THAN IN ACCORDANCE WITH THIS AGREEMENT.
| (i) | death or personal injury to the extent caused by the negligence or willful default of a Party or its employees; |
| (ii) | fraud or fraudulent misrepresentation; |
| (iii) | any breach of any obligations implied by section 12 of the Sale of Goods Act 1979 or section 2 of the Supply of Goods and Services Act 1982; |
| (iv) | any other liability to the extent the same cannot be excluded or limited by Applicable Laws; or |
| (v) | its payment obligations under this Agreement. |
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| (i) | There shall be three arbitrators, one of which shall be appointed by Applied and another of which shall be appointed by Advanz, in each case, within twenty (20) days of the date of delivery of the notice of arbitration. The third arbitrator, who shall serve as the president of the tribunal, shall be jointly appointed by the two Party-appointed arbitrators within twenty (20) days of the date of appointment of the second arbitrator to be appointed. Any arbitrator not timely appointed as provided herein shall be appointed, |
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| at the written request of any Party to the arbitration, by the London Court of International Arbitration. |
| (ii) | The seat of arbitration shall be London, England. The language of the arbitration shall be English. The Parties agree that the award rendered by the arbitral tribunal shall be final and binding and enforceable against the Parties and their respective assets in any court of competent jurisdiction. Unless determined otherwise by the arbitral tribunal, each Party shall pay its own Costs and Expenses in connection with the arbitration, except that the Parties shall pay an equal share of all Costs and Expenses related to compensation of the arbitral tribunal and site and administrative fees. The arbitral tribunal shall not award any damages excluded by Section 17.6. |
| (iii) | Any arbitration hereunder shall be confidential, and neither the Parties nor their agents shall disclose to any Third Party not involved in the arbitration the existence or status of the arbitration, any information made known or documents produced in the arbitration not otherwise available to them or in the public domain, or any awards arising from the arbitration, except and to the extent that disclosure is required by Applicable Laws or is required to protect or pursue a legal right. |
| (iv) | For any proceeding in aid of arbitration or to seek interim relief (such as an injunction) against the other Party to protect its rights and interests, or to enforce the obligations of the other Party, each Party irrevocably and unconditionally consents and submits to the exclusive jurisdiction and venue of the courts of England and Wales located in London, England (“English Courts”), and to the non-exclusive jurisdiction and venue of English Courts for any action to enforce any arbitration award obtained pursuant to this Agreement. In any such action: (i) each Party irrevocably waives, to the fullest extent it may effectively do so, any objection, including any objection to the laying of venue or based on the grounds of forum non conveniens or any right of objection to jurisdiction on account of its place of incorporation or domicile, which it may now or hereafter have to the bringing of any such action or proceeding in the English Courts; (ii) each Party irrevocably consents to service of process in the manner provided for notices in this Agreement or in any other manner permitted by Applicable Laws; and (iii) each Party waives any right to trial by jury in any court. Notwithstanding the foregoing, the arbitral tribunal also shall have full authority to grant provisional remedies and to direct the Parties to request that any court modify or vacate any provisional, temporary or preliminary relief issued by a court hereunder. |
| (v) | Each Party shall continue to perform obligations hereunder, when any bona fide Dispute is pending. |
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by and construed in accordance with the laws of the State of New York, without reference to or reliance upon its rules regarding conflicts of laws and shall be subject to the dispute resolution provisions set forth in the applicable Third Party License.
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If to Applied:
545 5th Avenue, Suite 1400
New York, NY 10017
Attn: Shoshana Shendelman, Chief Executive Officer
with a copy to:
Skadden, Arps, Slate, Meagher & Flom LLP
One Manhattan West
New York, NY 10001
Attn: Michael Schwartz
If to Advanz:
Capital House
1st Floor
85 King William Street
London
EC4N 7BL
Attn: Chief Corporate Development Officer
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with a copy to:
Capital House
1st Floor
85 King William Street
London
EC4N 7BL
and by email to:
***@***
Attn: General Counsel
Notices hereunder shall be deemed to be effective (a) upon receipt if personally delivered; (b) on the tenth (10th) Business Day following the date of mailing if sent by registered or certified air mail; (c) on the second (2nd) Business Day following the date of transmission or delivery to the overnight courier if sent by facsimile or overnight courier; and (d) subject to Section 3.1, if sent by email on the earliest of a receipt of a delivery or read receipt email from the correct address, on receipt of confirmation of receipt from the recipient or twenty-four (24) hours from delivery if sent to the correct email address and no notice of delivery failure is received. A Party may change its address listed above by sending notice to the other Party in accordance with this Section 19.8.
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reasonably believes will materially prejudice Applied’s ability to perform its obligations, shall constitute a “Financial Stability Event.”
Without prejudice to any other rights or remedies of Advanz, upon the occurrence of a Financial Stability Event, Advanz shall have the right to require Applied to: (i) provide to Advanz such relevant financial information (given the nature of the Financial Stability Event) relating to Applied as Advanz may reasonably require (which Applied shall promptly provide); and/or (ii) arrange a meeting between Advanz’s CEO and/or CFO (or equivalent role) and Applied’s CEO and/or CFO (or equivalent role) whom Applied shall make available for this purpose, as soon as reasonably practicable, to determine whether a continuity plan is required. At such meeting, discussions between the Parties shall take into consideration how to avoid placing Applied’s assets including the Product in jeopardy and delaying access of the Product to patients.
Following such meeting, if Advanz determines that a continuity plan is required, Applied shall promptly submit to Advanz for its approval (and once approved, implement), a continuity plan to deal with the consequences of the Financial Stability Event as soon as reasonably practicable (the “Continuity Plan”). If mutually agreed by both Parties, the Continuity Plan shall include rights for Advanz to exercise some or all of its Step-In Rights under Section 8.14(a) following issue of a Step-In Notice to Applied.
[Signature Page Follows]
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IN WITNESS WHEREOF the Parties hereto have caused this Agreement to be executed by their duly authorized officers upon the date set out below.
APPLIED THERAPEUTICS, INC. | MERCURY PHARMA GROUP LIMITED |
| |
By: ___________________________ Title: | By:____________________________ Name: Title: |
Exhibit A
Compound
Exhibit A-1
Exhibit B
Applied Patent Rights
[***]
Exhibit B-1
Exhibit C
Licensed Trademarks
[***]
Exhibit C-1
Exhibit D
Territory
Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom
Exhibit D-1
Exhibit E
Third Party Licenses
1.Columbia License
2.Miami License
Exhibit E-1
Exhibit F
Press Release
For immediate release
ADVANZ PHARMA to receive exclusive rights from Applied Therapeutics to commercialise AT-007 (govorestat) in Europe
● | ADVANZ PHARMA secures exclusive rights to register and commercialise AT-007, a Phase 3 development compound for the treatment of several rare neurological diseases, including Galactosemia and SORD Deficiency, in the European Economic Area, the UK, and Switzerland |
● | ADVANZ PHARMA will leverage its existing specialty, hospital, and rare disease expertise and infrastructure to ensure successful commercialisation and patient access |
London, UK – January 4, 2023: ADVANZ PHARMA Corp. (“ADVANZ” or “the Company”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that it has entered into an exclusive agreement with Applied Therapeutics, a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need.
Under the terms of the agreement, Applied Therapeutics will be responsible for the clinical development and supply of AT-007, while ADVANZ will manage the registration and commercialisation in the European Economic Area, the UK, and Switzerland.
Steffen Wagner, CEO of ADVANZ, commented: “We are very excited to announce this partnership with Applied Therapeutics, which is fully aligned with ADVANZ’s strategy to be a partner of choice for commercialisation of specialty, hospital, and rare disease medicines in Europe.”
Exhibit F-1
“We believe ADVANZ PHARMA is an ideal partner for commercialisation of AT-007 in Europe,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. “ADVANZ PHARMA’s commitment to improving the lives of patients alongside their critical infrastructure and expertise in rare diseases positions them well for commercial success. This partnership brings us one step closer to making AT-007 available to patients with Galactosemia and SORD Deficiency – both debilitating rare diseases with no other therapies currently available.”
Susanna El-Armale, Chief Corporate Development Officer of ADVANZ, stated: “This partnership with Applied Therapeutics delivers on our commitment to bring innovative products to market that serve an unmet medical need and it supports our ambition to build a strong product pipeline to drive ADVANZ’s mid- and long-term growth.”
Ends
About AT-007
AT-007 is a central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI) in development for the treatment of several rare neurological diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG. In clinical trials, AT-007 significantly reduced plasma galactitol levels vs. placebo in adults and children with Galactosemia. AT-007 is currently being studied in a Phase 3 clinical outcomes trial (ACTION-Galactosemia Kids) in children ages 2-17 with Galactosemia, as well as a long-term open-label study in adults with Galactosemia. In a pilot study in adults with SORD Deficiency, AT-007 significantly reduced blood sorbitol levels. AT-007 is currently being studied in a Phase 3 trial (INSPIRE) investigating biomarker efficacy and clinical outcomes in adults and children 16 years and older with SORD Deficiency. The drug has been generally safe and well tolerated in all clinical studies to date.
About ADVANZ PHARMA
ADVANZ PHARMA is a global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe. The company has commercial affiliates in Europe, North America and Australia, and a Centre of Excellence in Mumbai, India, as well as an established global network of commercial partners throughout the rest of the world. With an agile and experienced team, including direct sales, marketing, and medical capabilities across Europe’s major markets, Canada, and Australia, ADVANZ PHARMA is committed to improving lives of patients by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. The company has a broad expertise in several therapeutic areas including hepatology, gastroenterology, critical care, anti-infectives, endocrinology, oncology, and more broadly rare disease medicines, making ADVANZ PHARMA a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines.
For more information, please visit our Website or Linkedin.
For media inquiries, please contact:
Exhibit F-2
Courtney Baines
ADVANZ PHARMA Corp.
Tel: +44 ###-###-#### Email: ***@***
Exhibit F-3
Applied Therapeutics Announces Partnership with Advanz Pharma for Commercialization of AT-007 (Govorestat) in Europe
●Advanz Pharma will leverage its specialty, hospital, and rare disease expertise and infrastructure to commercialize AT-007 in Europe for both Galactosemia and SORD Deficiency
●Applied Therapeutics will receive milestone payments of over €130 million and 20% royalty payments on net sales in Europe
●Deal strengthens Applied Therapeutics’ capital position and extends cash runway through key milestones
NEW YORK, January 4, 2023– Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today announced a partnership with Advanz Pharma, a pharmaceutical company with a strategic focus on commercialization of specialty, hospital, and rare disease medicines, for commercialization of AT-007 (govorestat) in Europe.
“We believe Advanz Pharma is an ideal partner for commercialization of AT-007 in Europe,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. “Advanz Pharma’s commitment to improving the lives of patients alongside their critical infrastructure and expertise in rare diseases positions them well for commercial success. This partnership brings us one step closer to making AT-007 available to patients with Galactosemia and SORD Deficiency – both debilitating rare diseases with no other therapies currently available – and strengthens Applied Therapeutics’ capital position.”
“We are pleased to partner with Applied Therapeutics,” said Susanna El-Armale, Chief Corporate Development Officer of Advanz. “We believe that AT-007 represents a compelling scientific opportunity to treat rare diseases, including Galactosemia and SORD Deficiency. This partnership delivers on our commitment to bring innovative products to market that serve an unmet medical need and to build a strong product pipeline to drive Advanz’s mid- and long-term growth.”
Under the terms of the agreement:
● | Applied Therapeutics will receive certain near-term development milestones upon clinical trial completion and marketing authorization in Europe as well as commercial sales milestones, which in the aggregate amount to over €130 million, including €10 million upfront due upon signing. |
● | Applied Therapeutics will receive royalties on any future net sales of AT-007 in Europe of 20%. |
● | Applied Therapeutics will continue to be responsible for the development, manufacturing and supply of AT-007, and Advanz Pharma will be responsible for packaging, distribution and commercialization in Europe. |
● | Advanz Pharma receives exclusive commercial rights in the European Economic Area, Switzerland, and the UK for AT-007 in Galactosemia and SORD Deficiency, with certain rights to future indications for AT-007 in Europe. |
About AT-007
AT-007 is a central nervous system (CNS) penetrant Aldose Reductase inhibitor (ARI) in development for the treatment of several rare neurological diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG. In clinical trials, AT-007 significantly reduced plasma galactitol levels vs. placebo in adults and children with Galactosemia. AT-007 is currently being studied in a Phase 3 clinical outcomes trial (ACTION-Galactosemia Kids) in children ages 2-17 with Galactosemia, as well as a long-term open-label study in adults with Galactosemia. In a pilot study in adults with SORD Deficiency, AT-007 significantly reduced blood sorbitol levels. AT-007 is currently being studied in a Phase 3 trial (INSPIRE) investigating
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biomarker efficacy and clinical outcomes in adults and children 16 years and older with SORD Deficiency. The drug has been generally safe and well tolerated in all clinical studies to date.
About Applied Therapeutics
Applied Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need. The Company’s lead drug candidate, AT-007, is a novel central nervous system penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Galactosemia, SORD Deficiency, and PMM2-CDG. The Company is also developing AT-001, a novel potent ARI, for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis of the heart. The preclinical pipeline also includes AT-003, an ARI designed to cross through the back of the eye when dosed orally, for the treatment of Diabetic retinopathy.
To learn more, please visit www.appliedtherapeutics.com and follow the company on Twitter @Applied_Tx.
About Advanz Pharma
ADVANZ PHARMA is a global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe and Canada. The company has commercial affiliates in Europe, North America and Australia, and a Centre of Excellence in Mumbai, India, as well as an established global network of commercial partners throughout the rest of the world. With an agile and experienced team, including direct sales, marketing, and medical capabilities across Europe’s major markets, Canada, and Australia, ADVANZ PHARMA is committed to improving lives of patients by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. The company has a broad expertise in several therapeutic areas including hepatology, gastroenterology, CNS, critical care, anti-infectives, endocrinology, oncology, and more broadly rare disease medicines, making ADVANZ PHARMA a partner of choice for the commercialization of specialty, hospital, and rare disease medicines.
Forward-Looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding the strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the anticipated benefits of the Company’s partnership with Advanz Pharma and (ii) the expected development milestone payments. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved.
Such risks and uncertainties include, without limitation, (i) our plans to develop, market and commercialize our product candidates, (ii) the initiation, timing, progress and results of our current and future preclinical studies and clinical trials and our research and development programs, (iii) our ability to take advantage of expedited regulatory pathways for any of our product candidates, (iv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing, (v) our ability to successfully acquire or license additional product candidates on reasonable terms and advance product candidates into, and successfully complete, clinical studies, (vi) our ability to maintain and establish collaborations or obtain
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additional funding, (vii) our ability to obtain and timing of regulatory approval of our current and future product candidates, (viii) the anticipated indications for our product candidates, if approved, (ix) our expectations regarding the potential market size and the rate and degree of market acceptance of such product candidates, (x) our ability to fund our working capital requirements and expectations regarding the sufficiency of our capital resources, (xi) the implementation of our business model and strategic plans for our business and product candidates, (xii) our intellectual property position and the duration of our patent rights, (xiii) developments or disputes concerning our intellectual property or other proprietary rights, (xiv) our expectations regarding government and third-party payor coverage and reimbursement, (xv) our ability to compete in the markets we serve, (xvi) the impact of government laws and regulations and liabilities thereunder, (xvii) developments relating to our competitors and our industry, (xvii) the impact of the COVID-19 pandemic on the timing and progress of our ongoing clinical trials and our business in general and (xiv) other factors that may impact our financial results. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur at all. Factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
Contacts
Investors:
Maghan Meyers
(212) 600-1902
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Media:
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Applied Therapeutics, Inc.
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