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This Master Commercial Supply Agreement (this “Master Commercial Supply Agreement”), is made and entered into as of January 1, 2025 (“Effective Date”), by and between MoonLake Immunotherapeutics AG, a company duly organized and existing under the laws of Switzerland and having its principal place of business at Dorfstrasse 29, 6300 Zug Switzerland (“MoonLake”), and Vetter Pharma International GmbH, a company duly organized and existing under the laws of Germany, and having its principal place of business at Eywiesenstraße 5, 88212 Ravensburg, Germany (“Vetter”), with MoonLake and Vetter hereinafter individually referred to as a “Party” and collectively as the “Parties”.
WITNESSETH:
WHEREAS, the Parties entered into a confidentiality agreement, effective as of June 7, 2021 (the “Confidentiality Agreement”), and into a master development agreement effective as of October 27, 2021, (“MDA”) providing the option for the Parties to enter into a project specific development agreement thereunder (“SOW”); and
WHEREAS, MoonLake desires to engage Vetter in the Manufacture of one or more application systems pre-filled with an API, placebo or other material, each such effort to be covered under one Product Schedule separately;
NOW, THEREFORE, in consideration of the premises and of the mutual covenants and agreements above and hereinafter set forth, and subject to this Master Commercial Supply Agreement, MoonLake and Vetter agree as follows:
ARTICLE 1: DEFINITIONS
For the purposes of this Master Commercial Supply Agreement, any Product Schedule hereunder and any supplements or amendments hereto and thereto, the following capitalized terms, whether used in the singular or plural, shall have the same and uniform meanings assigned to them below, unless a particular context otherwise requires:
“Additional Requirements” has the meaning set forth in Section 2(3).
“Affiliate” means, with respect to a Party, any person, firm, company, or other entity which controls, is directly or indirectly controlled by, or is under common control with such Party; as used herein, “control” means either (i) in the case of a corporate entity, at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors; or (ii) in the case of a non-corporate entity, the power to elect the members of the governing body of such non-corporate entity; or (iii) in either instance, the direct or indirect power to manage, direct or cause the direction of the management and policies of such entity.
“Agreement” means this Master Commercial Supply Agreement, its Annexes (for clarity including the Quality Agreement) and the Product Schedule.
“Annex” means an annex to this Master Commercial Supply Agreement.
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“API” is part of the MoonLake Materials and means the active pharmaceutical ingredient or the bulk drug substance or bulk drug substance solution as specified in the Product Schedule.
“Appendix” means an appendix to the Quality Agreement.
“Article” means an article of this Master Commercial Supply Agreement (and excludes, unless otherwise specified, that of the Quality Agreement or Product Schedule executed hereunder).
“Assistance” means all support or assistance provided under this Master Commercial Supply Agreement, any Product Schedule hereunder or a separate agreement, including any activities set forth in Sections 3(2), 3(8), 4(1) and 6(1).
“Background IP” means, with respect to a Product and a Product Schedule, (i) the Intellectual Property owned or controlled by a Party or any of its Affiliates (independently if related to the scope of this Master Commercial Supply Agreement or a Product Schedule or not) as of the relevant Product Schedule Effective Date, or (ii) the Intellectual Property that is developed by or for, or otherwise comes to be owned or controlled by a Party or any of its Affiliates, separately from and independently of any activities performed under any Product Schedule hereunder or this Master Commercial Supply Agreement.
“Batch Document Package” has the meaning set forth in the Quality Agreement.
“Binding Period” is a time period of any [***] Rolling Forecast, and has the meaning set forth in Exhibit 2 of the Product Schedule; any Product volumes forecasted by MoonLake for the Binding Period are binding for both Parties and the [***] Rolling Forecast in the Binding Period shall constitute a Purchase Order.
“Business Day” means any calendar day other than a Saturday, a Sunday or a calendar day on which commercial banks located in Baden-Württemberg, Germany, or at the principal place of business of MoonLake, are authorized or required by law to be closed.
“Capacity Agreement” has the meaning set forth in Exhibit 2 of the Product Schedule.
“Change of Control” means, with respect to an entity, a transaction or series of related transactions as a result of which a person or entity or group of persons or entities acting in concert directly or indirectly acquires control of the entity or acquires ownership of all or substantially all of its assets. The transaction(s) may be in any form or combination of forms, including an issuance of voting securities, a grant of one or more proxies, a merger (whether or not the entity survives), a consolidation, a share exchange, a reorganization or a transfer of shares or assets. As used in this definition, “control” of an entity means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of the entity, whether through the ownership of more than 50% of voting securities, by contract or otherwise.
“Confidential Information” means any and all (i) information as defined and protected under the Confidentiality Agreement, and any (ii) scientific, technical, financial or business information, material, samples and know-how in whatever form (written, oral or visual) that is directly or
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indirectly furnished or made available to the permitted receiving party (in accordance with the Confidentiality Agreement) or its Affiliates by or on behalf of discloser or its Affiliates that (a) if in tangible form, is labeled in writing as proprietary or confidential, or (b) if disclosed in oral or visual form or, if disclosed in writing without an appropriate letter, label or legend shall constitute Confidential Information that would be apparent to a reasonable person, familiar with the discloser’s business and the industry in which it operates, that such information is of a confidential or proprietary nature the maintenance of which is important to the discloser, whether disclosed by or on behalf of the Parties or their Affiliates under the Confidentiality Agreement, any Product Schedule hereunder or this Master Commercial Supply Agreement. The Purpose of the Confidentiality Agreement shall therefore be hereby amended and shall also cover the activities under this Master Commercial Supply Agreement and any Product Schedule hereunder, including the performance of Services and Manufacture of the Product thereunder.
“Confidentiality Agreement” has the meaning set forth in the first whereas clause.
“Costs” means any and all monetary obligations, including, but not limited to, damages, liabilities, judgements, losses, and costs and/or expenses (including reasonable attorneys’ fees and court costs).
“Defect Notification Period” has the meaning set forth in Section 5(2).
“Delivery Date” means the date, as set forth in a [***] notice provided by Vetter to MoonLake upon which Product will be ready for pick-up at the Facility.
“Developments” means any outcome of developments, application, research - including without limitation (whether patentable or not), improvements, discoveries or enhancements which arise from the respective Party’s or such Party’s Affiliates’ activities performed under this Master Commercial Supply Agreement or any Product Schedule, solely or jointly with the other Party.
“Effective Date” has the meaning set forth in the preamble.
“Exhibit” means an exhibit to a Product Schedule.
“EMA” means the European Medicines Agency or any successor agency.
“Equipment” means the equipment described in Section 2(5), as in more detail agreed upon and set forth in the Product Schedule.
“Facility” means, with respect to a Product, any facility used by or on behalf of Vetter in performing Vetter’s Services as set forth or referred to in the Product Schedule.
“FDA” means the United States Food and Drug Administration or any successor agency.
“Force Majeure” means, in relation to a Party (“Affected Party”), any circumstances beyond the reasonable control of the Affected Party or its Affiliate which directly prevent or have an adverse effect on the Affected Party's performance of its obligations under this Agreement and includes any of the following:
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(a) fire, flood, drought, lightning, fog, storm, earthquake, volcanic ash or other natural disaster, explosion, accident, invasion, war, threat of or preparation for war, armed conflict;
(b) terrorist attack, civil war, civil commotion or riots;
(c) epidemic or pandemic or other biological event or outbreak;
(d) any law or government order, rule, regulation or direction, or any action taken by a governmental body, including but not limited to imposing an embargo, export or import restriction, quota or other restriction or prohibition, or failing to grant a necessary license or consent; and
(e) to the extent beyond the reasonable control of the Affected Party, any labour dispute, including strikes, industrial action or lockouts, other than, in each case, any such labour dispute, including strikes, industrial action or lockouts involving employees of the Affected Party or its Affiliates,
(f) shortage of energy or raw material or any inability to obtain any materials or shipping space, breakdown or delays of carriers or shippers, default or delay by any supplier or sub-contractor or other events due to internalization of operations and services typically and customarily provided by a third party
but, for the avoidance of doubt, does not include any event or thing that, in relation to a Party:
(i) is attributable to the willful act, neglect or failure to take reasonable precautions against such event by that Party; or
(ii) merely increases the cost of that Party’s performance of its obligations; or
(iii) for (a) through (e) results from a failure or delay by any third party in the performance of its obligations under a contract with that Party (unless that third party is itself prevented from or delayed in complying with its obligations as a result of Force Majeure).
“Future Developments” has the meaning set forth in Section 11(7).
“GMP” and “cGMP” have the meaning set forth in the Quality Agreement.
“Intellectual Property” and “IP” means all worldwide (i) patent or patent application, and any patent issuing there from, together with any extensions, reissues, reexaminations, substitutions, renewals, divisions, continuations and continuations-in-part thereof, and any patent or patent application claiming priority to any application in common with any such patent containing a disclosure substantially similar to that of any such patent, all to the extent the foregoing contain claims covering such invention, (ii) copyright registrations and applications and all renewals and extensions thereof, (iii) discoveries, inventions, trade secrets, know-how, techniques, methodologies, modifications, improvements, works of authorship, designs and data (whether or not protectable under patent, copyright, trade secrecy or similar laws), and (iv) Confidential Information, including all applications and registrations with respect to the items identified in clauses (iii)-(iv) (if any), but excluding all trademarks, trade names, service marks, logos and other corporate identifiers.
“Inspection” has the meaning set forth in Section 5(2).
“Inventory” has the meaning set forth in Section 3(8).
“Legal Requirements” means with any and all laws, rules and regulations, (i) with respect to MoonLake of any governmental body or regulatory authority in any jurisdiction, in each case solely to the extent applicable to MoonLake’s business and activities; (ii) with respect to Vetter and/or any of its Affiliates performing under the Agreement, of any governmental body or regulatory authority
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with jurisdiction applicable at the Facility used for the Services and only to the extent applicable to such Service, but notwithstanding the aforesaid, GMP to the extent performing GMP relevant activities; and (iii) with respect to Vetter and/or any of its Affiliates performing under this Agreement through any Vetter Subcontractors or any subcontractors not being a Preferred Subcontractor, of any regulatory authority with jurisdiction at the place of the facility used for the Services and only to the extent applicable to such Service, but notwithstanding the aforesaid, GMP to the extent the subcontractors are performing any GMP relevant activities for Vetter or any of its Affiliates. Any Legal Requirements applicable to MoonLake, to which Vetter and its Affiliates are to adhere (as in the case of such requirements being considered essential for the Product), shall be provided by MoonLake to Vetter in detail and shall, [***], be incorporated into the agreed-upon Process Specifications all as set forth in Section 2(3).
“Manufacture” and “Manufacturing” means any steps, processes, operations and activities required to produce Product for and on behalf of MoonLake at the Facility and specified in the Process Specifications, which might include manufacturing, processing, primary packaging, labeling, preparation for transport, sampling and testing of the Product, Materials and intermediates, receipt of Materials, as well as related Product in-process control, quality control testing, quality assurance and certification activities or the generation of stability data of Product.
“Master Commercial Supply Agreement” has the meaning set forth in the first paragraph of this Master Commercial Supply Agreement.
“Materials” means any components, excipients and materials used for Manufacture and supply of Product, including the MoonLake Materials and any Sourced Materials.
“[***] Rolling Forecast” has the meaning set forth in Exhibit 2 of the Product Schedule.
“MoonLake” has the meaning set forth in the preamble.
“MoonLake Indemnitees” means MoonLake, any of MoonLake’s Affiliates, and their respective officers, directors, agents, employees, successors and permitted assignees.
“MoonLake Material Contractual Value” means, as a reference point for any calculation of the compensation due by Vetter for payment to MoonLake, in case of loss of or damage to any MoonLake Materials (including API) or Product, the mutually agreed contractual value of such amount of MoonLake Materials (in grams or milliliter or units), which value shall be, in Euros, the amount set forth in the Product Schedule. It is agreed between the Parties that the MoonLake Material Contractual Value is to be defined in such a way that for any MoonLake Materials used for a batch (agreed commercial batch size) in no event [***] percent ([***]%) of Vetter’s batch Price is exceeded).
“MoonLake Materials” means any of the Materials procured or supplied by or on behalf of MoonLake under any Product Schedule made under this Master Commercial Supply Agreement as further determined in the Quality Agreement and/or Process Specifications.
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“Non-conforming Product” means Product not Manufactured in accordance with the Process Specifications, subject to Article 5.
“Party” and “Parties” have the respective meaning set forth in the preamble.
“Preferred Subcontractor” has the meaning set forth in Section 2(4).
“Preferred Supplier” has the meaning set forth in Section 3(1)(b).
“Prices” has the meaning set forth in a Product Schedule.
“Price Adjustment” has the meaning set forth in Section 7(2).
“Process Specifications” means the mutually agreed Manufacturing process specifications, generated by Vetter Pharma as contemplated in the Quality Agreement, and agreed upon for the Manufacture of the Product, that define and detail all Manufacturing or Service activities performed at the Facility, including all criteria applicable to the MoonLake Materials, Sourced Materials and instructions agreed to be relevant for such Manufacture, but not including any additional Product acceptance and release requirements.
“Product” means an application system pre-filled with API, a placebo formulation or other solution or material, either alone or in formulation with a diluent or other excipient or adjuvant (for avoidance of doubt, excluding its Manufacturing process), as set forth in more detail in a Product Schedule.
“Product Costs” has the meaning set forth in Section 7(2).
“Product Schedule” has the meaning set forth in Section 2(1).
“Product Schedule Effective Date” means the effective date of a Product Schedule.
“Product Schedule Term” means, with respect to a Product Schedule, the period commencing on the Product Schedule Effective Date and continuing until the Product Schedule is terminated in accordance with the Product Schedule or the Master Commercial Supply Agreement.
“Purchase Order” or “PO” is a document duly signed by or on behalf of MoonLake, which shall be firm, binding and irrevocable and used only for confirming quantities of Product and requested Product delivery dates; provided, however, no pre-printed or other term or condition thereon shall have any force or effect, all of which terms and conditions shall be null and void unless otherwise specifically agreed in writing by and between the Parties and the provisions of this Master Commercial Supply Agreement and the Product Schedule shall be deemed incorporated therein.
“Quality Agreement” means a master commercial quality agreement applicable to all Manufacture to be attached as Annex 2 to this Master Commercial Supply Agreement, with any specifics related to Manufacture of a certain Product to be set forth in an Appendix to be attached to this master quality agreement. Once executed by MoonLake and Vetter Pharma, the Quality Agreement shall be incorporated into and made part of this Master Commercial Supply Agreement by this reference.
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“Recall” has the meaning set forth in Section 10(5) (ii).
“Regulatory Approval” means any approval, consent, notice or permission required from (or, in the case of a notice, given to) a regulatory authority in order to comply with applicable Legal Requirements, including for purposes of Manufacturing, performance of Services, marketing, importing, exporting, testing, distributing, selling or otherwise using the Product.
“Regulatory Filing” has the meaning set forth in the Quality Agreement.
“Replacement Product” has the meaning set forth in Section 5(4).
“Rules” means the Rules of Arbitration of the International Chamber of Commerce.
“Section” means any subsection of an Article.
“Services” has the meaning set forth in Section 2(1).
“SOPs” means such standard operating procedures of Vetter Pharma as are applicable to the Service under an Product Schedule or this Master Commercial Supply Agreement.
“Sourced Materials” means any of the Materials, that under any Product Schedule hereunder, are sourced or procured by Vetter or its Affiliates from Preferred Suppliers on behalf of MoonLake or at the direction of MoonLake (which direction is deemed to be provided by MoonLake signing off on the Process Specifications), as provided for in the Process Specifications and/or agreed upon in writing.
“Sourced Services” has the meaning set forth in Section 2(4).
“SOW” has the meaning set forth in the first whereas clause and shall on a Product basis be identified in the applicable Product Schedule, if any.
“Territory” means all countries under the jurisdiction of the FDA and/or the European Medicines Agency (EMA).
“Vetter” has the meaning set forth in the preamble. “Vetter Indemnitees” means Vetter and any of its Affiliates, Vetter Subcontractors and any of their trustees and/or executors, and their respective officers, directors, agents and employees. “Vetter Maximum Liability Cap” means the maximum permitted total amount of all liability and indemnification obligations of Vetter for [***]. Such maximum shall be the lesser of (i) [***], and (ii) [***]. The Vetter Maximum Liability Cap shall apply to [***]. “Vetter Pharma” means Vetter Pharma-Fertigung GmbH & Co. KG, an Affiliate of Vetter that is duly organized and existing under the laws of Germany and has its principal place of business at Schützenstraße 87, 88212 Ravensburg, Germany. “Vetter Subcontractor” has the meaning set forth in Section 2(4).
ARTICLE 2: SERVICES
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(1) Scope of Services; Product Schedules. As a “master” form of contract, this Master Commercial Supply Agreement allows the Parties to contract for the Manufacture of more than one Product without having to re-negotiate the basic terms contained herein. Following execution of this Master Commercial Supply Agreement, Vetter may agree from time to time to provide certain services for MoonLake related to the Manufacture of Products and other, accompanying services (each, a “Service”) as detailed in one or more associated product schedules, each of which shall (i) be in a form substantially similar to the template attached hereto as Annex 1; (ii) have the minimum content as set forth in such template; (iii) be uniquely and sequentially numbered; and (iv) be agreed upon and executed by the Parties (each, a “Product Schedule”). For each individual Product, a separate Product Schedule shall be prepared by Vetter for review and approval of MoonLake, which Product Schedule shall list and outline the Services related to the Product and provide in writing all specifics thereof. Each Product Schedule shall reference and be subject to the terms and conditions of this Master Commercial Supply Agreement and, if the Services are to be performed in accordance with GMP, those of a Quality Agreement executed between Vetter Pharma and MoonLake that addresses all of the Parties’ respective technical responsibilities for GMP Manufacturing and quality of the Product. Each Product Schedule shall therefore incorporate the terms of this Master Commercial Supply Agreement and any applicable Quality Agreement which shall form an integral part thereof, all of which shall, including any changes or amendments thereto, constitute a separate and independent agreement with respect to the specified Product. Any reference to a Product Schedule shall therefore be a reference also to the terms of this Master Commercial Supply Agreement and its Annexes and to the Quality Agreement and its Appendices, if not otherwise specified.
(2) Performance of Services. Subject to the terms of this Master Commercial Supply Agreement, Vetter shall and shall cause Vetter Pharma to (i) provide the Services set out in the Product Schedule and (ii) perform the Manufacture, and provide the respective Batch Document Package, pursuant to the Process Specifications and the applicable Product Schedule. Except as otherwise agreed to [***] by MoonLake, all Services will be performed at the Facilities identified in the Product Schedule. [***].
(3) Process Specifications. The Manufacturing process for the Product has been implemented under the Development Agreement between the Parties on a batch basis in accordance with then-current specifications, successfully validated in accordance with GMP (if applicable), and finally approved by MoonLake. MoonLake and Vetter shall agree [***] to the final Process Specifications for performance of any Services under any Product Schedule hereunder, and written documentation of such Process Specifications shall be attached to or referenced in the applicable Quality Agreement, or Product Schedule (if no Quality Agreement is required), and incorporated therein by reference. MoonLake shall ensure that the Process Specifications comply with the Regulatory Approvals, Regulatory Filings and any applicable Legal Requirements. If MoonLake requires Vetter to adhere to any additional good manufacturing practices of countries outside the Territory or any requirements coming from MoonLake Legal Requirements, Regulatory Approvals, Regulatory Filings or any Product-specific GMP (either thereof “Additional Requirements”), any such Additional Requirements may be, [***] be incorporated into the agreed Process Specifications. The same applies if MoonLake wishes to update and/or amend Additional Requirements. MoonLake shall provide Vetter Pharma with, included in any such request of Additional Requirements, the country-specific legislation, rules and regulations and practices or requirements of the regulatory authorities and governmental bodies, which may affect the Services, the Manufacture and/or any Assistance, and shall inform Vetter of the effect of any thereof. MoonLake shall keep Vetter
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informed of any changes of any thereof after the Product Schedule Effective Date and shall meet all notice and information requirements as set forth in the Quality Agreement. MoonLake shall also provide Vetter with all information [***] for the performance of the Services and any technical support [***] by Vetter in connection with the same.
(4) Subcontracting and Delegation. Vetter may delegate its responsibilities under this Master Commercial Supply Agreement and any Product Schedule hereunder to any of its Affiliates, including Vetter Pharma, where applicable in accordance with the Quality Agreement. Furthermore, Vetter and MoonLake may make alternative arrangements, as set forth in a Product Schedule, for the performance of certain Services (or part thereof) to be provided by third parties. If Vetter accepts to assist MoonLake in receiving such Services by third parties, [***] (“Sourced Services”), Vetter shall either (i) source any such Sourced Services at third party service providers mutually agreed upon by the Parties or approved by MoonLake in the Quality Agreement or the Process Specifications (“Preferred Subcontractors”) or (ii) directly communicate to and manage such Preferred Subcontractors under MoonLake contracts in the name and on behalf of MoonLake in compliance with MoonLake’s instructions. Third party service providers, including Preferred Subcontractors have to be approved by MoonLake and listed in or attached to the Quality Agreement to the extent they are going to perform any GMP relevant activities. MoonLake shall provide all information that is [***] and hereby provides the required power of attorney for Vetter and/or its Affiliates for the purpose of such assistance. In addition, MoonLake agrees and hereby consents that Vetter and its Affiliates might use own subcontractors for its internal logistic and warehousing operations (currently [***]) and second source laboratories for material qualification (each a “Vetter Subcontractor”). Vetter Subcontractors have to be approved by MoonLake and listed in or attached to the Quality Agreement to the extent they are going to perform any GMP relevant activities. Vetter shall be and remain fully and solely responsible for performance or non-performance of any Vetter Affiliate and Vetter Subcontractors, subject to and to the extent set forth in this Agreement, including Article 10 of this Master Commercial Supply Agreement, whether under this Master Commercial Supply Agreement, any Product Schedule hereunder or Quality Agreement, or under any other agreement or any theory of law. MoonLake shall be and remain fully responsible for performance or non-performance of MoonLake, its Affiliates and its Preferred Subcontractors, subject to and to the extent set forth in this Agreement, including Article 10 of this Master Commercial Supply Agreement.
(5) Equipment. Upon MoonLake’s request [***], Vetter shall cause Vetter Pharma to procure the Equipment, if any, which shall be paid for by MoonLake and owned by Vetter Pharma. Vetter Pharma shall insure the Equipment in the same manner and to the same extent that it maintains insurance for its other, comparable equipment, and shall use the Equipment solely for MoonLake’s benefit hereunder. Vetter shall cause Vetter Pharma to maintain and operate the Equipment in accordance with the SOPs. The costs and/or expenses of routine maintenance and operation of the Equipment shall, subject to such maximum amount per calendar year as may be specified in the applicable Product Schedule, be borne by [***], while any other costs and/or expenses, including those related to repair or replacement of the Equipment, shall be borne by [***]. Any costs incurred for the procurement, repair or replacement of the Equipment shall be invoiced to [***] by [***]. If Product demand increases and MoonLake requests Product volumes in excess of available Vetter Manufacturing capacity, the Parties shall negotiate [***] regarding Vetter Pharma’s procurement of additional Equipment under the same or similar terms as those above.
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(6) Forecasting. The forecasting, ordering, scheduling and other related parameters of Manufacture of Product, shall be as specified in the Product-specific supply chain terms of the applicable Product Schedule, attached thereto as Exhibit 2.
ARTICLE 3: MATERIALS.
(1) Supply of Materials.
(a) Materials provided by MoonLake. MoonLake shall provide to Vetter all MoonLake Materials necessary to perform the Services. The MoonLake Materials shall be delivered [***], in the quantities, to the Facility and at the delivery dates designated by Vetter. Such delivery shall include all documents required for the Services, including quality certificates for the MoonLake Materials as set forth in the Quality Agreement, and, at minimum, with a certificate of analysis and a certificate of conformance, materials safety data sheet, transportation and import documents and any other legally required documents. Vetter may reject any supply and delivery of the MoonLake Materials if any thereof was not (i) ordered by Vetter; (ii) announced within reasonable time prior thereto; (iii) accompanied by complete documentation and (iv) provided ready to use for Services. With respect to the quality and the condition thereof, Vetter shall be entitled to rely on the accuracy of any certificates and information provided for such MoonLake Materials. To the extent necessary to assure successful Manufacture of the Product or to comply with EMA GMP regulations, MoonLake shall procure that Vetter Pharma shall have the right to audit the production of the API in accordance with the Legal Requirements.
(b) Other Materials. Vetter and MoonLake may make alternative arrangements for sourcing of Materials (other than API) to be directly supplied by third parties to Vetter. If Vetter agrees to assist MoonLake in such sourcing of Materials and as provided for in the Product Schedule or otherwise agreed upon [***], Vetter shall (i) order Sourced Materials directly from third party suppliers of MoonLake mutually agreed upon, in the Quality Agreement or otherwise directed or approved by MoonLake [***] (which direction or approval is deemed to be provided by MoonLake signing off on the Process Specifications) (“Preferred Supplier”), or (ii) call off and take delivery of MoonLake Materials under MoonLake contracts with such Preferred Supplier, in each case in quantities and with lead times appropriate to maintain an Inventory as provided for in the Product Schedule. MoonLake shall provide all information that is [***] by Vetter, complete associated Vetter request form and hereby provides the required power of attorney for Vetter and/or its Affiliates for the purpose of such sourcing assistance.
(2) Import. Vetter and MoonLake may agree on certain Assistance regarding import of MoonLake Materials from a country outside of the European Union to Germany if there is no MoonLake Affiliate or MoonLake designee with registered sites in the European Union able to allow for such import, which Assistance shall be provided at the risk and expense of MoonLake. If Vetter agrees to assist MoonLake as provided for in the Product Schedule or otherwise agreed upon [***], Vetter shall act as the importer of record for the so agreed upon MoonLake Materials and such MoonLake Materials shall be delivered [***], in the quantities, to the Facility and at the delivery dates designated by Vetter. Any MoonLake request for import Assistance has to be provided to Vetter [***] prior to the first intended import and thereafter no later than [***] before start of the intended MoonLake shipment in order to allow for preparation and review of any required documents (e.g. § 72 a certification under German law, written confirmation under EU laws etc.) tax/ duties and other customs implications associated with such importation. Vetter will only do the
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customs’ clearance of the MoonLake Materials and pay in advance the related importation value added tax on behalf of MoonLake up to a maximum of [***] Euros, provided, Vetter received the invoice [***] in advance in the event of third party delivery. Vetter shall recover such tax as part of its ongoing business activities as directly attributable to the taxable services that Vetter supplies to MoonLake, if legally permissible; otherwise MoonLake shall refund such advance payments to Vetter, including value added taxes, duties, tariffs, excise taxes (for certain categories of goods), any other fees or duties assessed or imposed by competent government authorities in connection with the importation of goods, third party brokerage fees, classification charges, charges for compliance screening, surcharges, fines, penalties or other charges that may be imposed by customs or tax officials after delivery of the goods, no later than [***] upon advance payment of Vetter. In addition, MoonLake shall pay Vetter an interest charge for such advance payment and any related efforts as set forth in the Product Schedule. MoonLake shall provide any information and documents as may be [***] by Vetter in respect of any thereof or as may be required by Legal Requirements, including the real replacement value of all MoonLake Materials and complete a Vetter questionnaire. In case of any delay due to MoonLake not providing the requested information, documents or payments, Vetter shall inform MoonLake in writing, and MoonLake shall bear all costs resulting from such delay as set forth in Exhibit 2 of the Product Schedule.
(3) Inadequate Delivery. Any inadequate delivery of Materials (whether such inadequacy is one of quality, quantity, missing documents or otherwise) may result in delays in the Manufacture of the Product and the postponement of any associated Delivery Date. In the event of such inadequate delivery, Vetter shall be permitted, [***], to reasonably reschedule the Manufacture and determine a new Delivery Date, following [***] consultation with MoonLake and after taking into account such factors as Facility capacity, other production commitments and similar business factors. Any such postponement of Manufacture due to inadequate delivery of MoonLake and Sourced Materials shall be deemed a cancellation of Manufacture under the respective Purchase Order, for which Vetter shall be compensated as set forth in Exhibit 2 of the Product Schedule if not solely resulting from Vetter’s fault.
(4) Testing of Materials. Prior to use by Vetter in performance of the Services, Vetter shall test or have tested all Materials used for the Manufacture in accordance with the Process Specifications or, in the absence of specific testing requirements, with the SOPs, including an incoming inspection upon delivery to verify correct quantity and labeling and visual inspection to identify obvious defects due to transport. With respect to the quality and the condition of any Materials used in the Services, Vetter may rely on the accuracy of any certificates and information provided for such Materials. Other than set forth in this Master Commercial Supply Agreement, Vetter shall have no obligation to undertake any quality assurance or other activity with regard to Materials, including any additional testing or certification of the same, and Vetter shall not be liable for any defects in the Materials which have not been detected by Vetter performing its testing Services under this Section 3(4) or any Product Schedule hereunder.
(5) Handling and Storage. All MoonLake Materials shall be stored at the Facility in accordance with MoonLake's [***] instructions as agreed upon in the Process Specifications. Without limiting the foregoing, Vetter shall use, transport, and store Materials in a [***] secure environment with sufficient safeguards to prevent tampering, diversion, loss or destruction of MoonLake Materials, all as approved by MoonLake within its initial and subsequent Facility audits. API shall be used for the Manufacture of the Product only. MoonLake shall provide any and all relevant information with respect to the MoonLake Materials and Sourced Materials, including, without limitation, all
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chemical, pharmaceutical and/or biopharmaceutical compositions thereof and, to the extent reasonably known, any impact and interaction thereof on all Materials to be used in the Manufacture of the Product and on the Facility. MoonLake shall specifically inform Vetter if the MoonLake and Sourced Materials require any special handling or processing. If the provision of any such information has the effect, including any result of having to take additional security or safety precautions, of increasing the costs and expenses in performing obligations under the Quality Agreement or hereunder, [***].
(6) Surplus, Inspection. Vetter shall notify MoonLake [***] of any surplus of the MoonLake and Sourced Materials and any such surplus shall, if not usable for the Manufacture, be disposed of, returned to MoonLake or otherwise handled, [***]. All Materials shall be stored at the Facility at no charge to MoonLake except if for longer than [***] after the Delivery Date (or such longer period as may be agreed upon [***]), in which event reasonable storage fees shall, [***], be assessed and invoiced by Vetter. Upon request of MoonLake, Vetter shall provide to MoonLake, within [***] after the end of each calendar month, copies of a computerized inventory list with respect to the MoonLake Materials stored at the Facility.
(7) Risk and Insurance. API and other MoonLake Materials shall at all times remain the property of MoonLake, who shall be and remain responsible and liable for the MoonLake Materials and the quality thereof. To the extent wishing to do so, MoonLake shall be responsible for obtaining adequate all-risk insurance for the MoonLake Materials (whether or not included as part of the Product or otherwise) and/or for all shipment and storage of any thereof, in amounts and on terms satisfactory to MoonLake. Vetter shall have no responsibility or liability to MoonLake, or to any third party on behalf of MoonLake, for any loss of or damage to the MoonLake Materials (whether included as part of the Product or otherwise, whether before Manufacture or thereafter) once delivered to the Facility, unless and then only to the extent that (i) such loss or damage is due to the gross negligence of Vetter and/or any of its Affiliates and/or Vetter Subcontractors and (ii) such occurrence could not have been [***] insured by an all risk property insurance procured by MoonLake, provided, however, that any such liability for the amount of lost or damaged MoonLake Material shall be subject to the limitations of Article 10, including Section 10(5) (i).
(8) Inventory. Based on the Binding Period or the [***] Rolling Forecast (or, to the extent commercially practicable, on any updates), Vetter may have placed, in accordance with its customary business practices, binding orders for Materials for the Products not supplied by MoonLake. MoonLake is hereby informed and accepts that for some Materials there are minimum order requirements (e.g. because of long lead-time or minimum batch sizes) and Vetter will have to order Material quantities that exceed the demand required for the Binding Period or the [***] Rolling Forecast. In addition, Vetter will maintain a stock of Sourced Materials for Manufacture of [***] in accordance with the Product Schedule, but no less than the quantity required for the Manufacture of [***] (all Materials ordered in accordance with any of the foregoing collectively hereinafter the “Inventory”). To the extent such Inventory is ordered in accordance with the foregoing, MoonLake shall be responsible and liable for any reasonable and related costs incurred by Vetter and/or any of its Affiliates, including, but not limited to, related to storage and disposal of and staff planning and working capital costs for any excess and/or obsolete Inventory, not being fit for use due to (a) reduced [***] Rolling Forecast or Capacity Reservation; (b) cancellation or postponement of any Purchase Orders; (c) changes to the Process Specifications or the specifications of Material, including to Legal Requirements; or (d) expiry or termination of this Master Commercial Supply
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Agreement or any Product Schedule hereunder. If requested, MoonLake shall provide Vetter with a written authorization to purchase any Inventory. Vetter may request to retain a higher Inventory volume against down payment by MoonLake, or if feasible, will ask Preferred Suppliers for their Assistance to keep an additional rolling safety consignation stock available at MoonLake’s risk and cost, if the Vetter expenditures for Inventory is considered to be significant due to the MoonLake requested Product demand.
(9) Artwork. MoonLake shall be solely responsible for any and all artwork including, but not limited to, design and content of labels, leaflets and packaging or any other printed material. MoonLake shall ensure that the artwork is compliant with Regulatory Filings, Regulatory Approvals and Legal Requirements. Any changes or supplements to artwork shall be submitted to Vetter [***] at least [***] prior to the desired implementation date, together with the required documentation. MoonLake shall compensate Vetter for any costs and expenses related to any change or supplement and its implementation as well as for any Materials, including labels, leaflets and/or other packaging or printed materials stored at the Facility and becoming obsolete given such change or supplements and their implementation.
ARTICLE 4: PRODUCT DELIVERY.
(1) [***]. Any Product to be delivered by Vetter under any Product Schedule hereunder shall be delivered [***] in accordance with this Agreement. Vetter shall provide MoonLake with [***] advance notice of the Delivery Date, and MoonLake shall arrange for Product pick up and shipment on such date. In the event that Vetter or its Affiliates or subcontractors or external service providers give incidental support or assistance to MoonLake, in a manner or extent exceeding Vetter’s obligations set forth in the preceding sentence, such support or assistance shall be made on behalf of MoonLake (and not of Vetter) and MoonLake shall remain fully liable and responsible for the same. Any major support or assistance by Vetter exceeding its obligations according to this Agreement shall be separately agreed upon [***]. MoonLake shall, at Vetter’s request, provide information required for taxation or reporting purposes in respect of export of the Product.
(2) Late Pick-Up. Unless otherwise agreed between the Parties, if Product is not collected by MoonLake on the Delivery Date, Vetter shall store such Product at the Facility [***] in accordance with the SOPs. For Products not collected within [***] of the Delivery Date, MoonLake shall pay to Vetter such compensation of storage as set forth in the Product Schedule, unless MoonLake has declined to collect the Product based on a claim of Non-conforming Product accepted by Vetter or substantiated by an independent laboratory as provided for by Section 5
(3). (3) Quarantine Shipment. Product not yet released to MoonLake by Vetter may be shipped under quarantine upon [***] request of MoonLake and MoonLake by such request assumes all risks, responsibilities and costs associated with the quarantine shipment.
ARTICLE 5: NON-CONFORMING PRODUCT, INSPECTION, REPLACEMENT.
(1) General. Vetter shall inform MoonLake of any Non-conforming Product discovered during or after Manufacture, and launch an investigation subject to the Quality Agreement and its SOPs. Vetter shall have the discretion to withhold the release of any Product pending the resolution of any potential quality issues. Product that is affected by deviation (of which MoonLake shall be notified
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in writing in accordance with the Quality Agreement) shall not be deemed Non-conforming Product so long as any such deviation has been processed in accordance with the Quality Agreement and does not materially affect the quality of the Product.
(2) Inspection. MoonLake shall [***] perform or have performed an inspection and testing of Product received, and conduct a review and approval of associated Batch Document Package, all as required by Legal Requirements (including GMP) and as necessary for the intended purpose but in no event later than [***] following delivery of each (“Inspection”). For the avoidance of doubt, MoonLake or its relevant Affiliate shall not be required to carry out any laboratory analysis of the Products received unless (i) otherwise expressly stated in the Quality Agreement and/or (ii) mandatory according to Legal Requirements. MoonLake shall notify Vetter [***] upon discovery of any Product or any part of a shipment of Product to MoonLake or its designee or of the associated batch documentation alleged to be Non-conforming, and/or of its rejection of Product based upon defect, such notice to be provided within [***] of delivery (“Defect Notification Period”), provided, however, that such Defect Notification Period shall be (i) reduced to [***] if MoonLake is rejecting such shipment due to transport or obvious external physical damage or quantity discrepancies that are, or would be, evident upon reasonable visual inspection of such packaged Product, and (ii) extended to [***] following the Delivery Date if MoonLake’s rejection is based upon a latent defect, that is, defect of a Product that cannot be detected or would not be evident upon reasonable Inspection (in which case MoonLake must provide notification immediately upon discovery of such latent defect). Any notification by MoonLake of a Non-conforming Product must include a detailed explanation of the alleged defect. In the event MoonLake’s notice of Non-conforming Product is not timely delivered as provided hereunder, the Product in question shall be conclusively presumed satisfactory and deemed accepted by MoonLake.
(3) Investigation, Dispute. Vetter shall have the right to investigate any alleged Non-conforming Product. If, during any calendar quarter, [***] batches are rejected by MoonLake, Vetter shall [***] notify MoonLake and, upon receipt of such notification by MoonLake, the Parties shall meet to discuss, evaluate and analyze the reasons for and implications of the failure of the Manufacture to meet the Process Specifications and the rejection by MoonLake. Pending the same, the Parties shall establish a joint team with the purpose to avoid supply disruptions to the extent reasonably possible and to investigate and address the root cause for the alleged Non-conforming Product, including such root causes outside of Vetter’s responsibility. In case the joint team is not able to identify and remedy the root cause for the alleged Non-conforming Product, Vetter shall have the right, provided that Vetter explained the situation [***] upfront to MoonLake and provided reasonable evidence, and further keeps MoonLake updated on the progress of its investigation in regular intervals, to cease all Manufacturing and not be deemed in default or breach under this Master Commercial Supply Agreement or any Product Schedule hereunder, with all scheduled or other Manufacture not to recommence until such time as final disposition of the rejected batches has been decided upon, and complete investigations (with root cause analysis and corrective action to prevent further batch rejections) have been finalized, which disposition, analysis and corrective action shall be agreed to in writing by the Parties. Vetter shall perform or have performed such investigation, root cause analysis and any corrective action diligently and expeditiously. Prior to the completion thereof, MoonLake may request [***] the recommencement of Manufacture, subject to MoonLake’s assumption of responsibility in the event of further batch rejection for the same or similar reasons. If the Parties disagree as to final disposition, analysis or corrective action, and, if Vetter disagrees with MoonLake’s determination, the Parties shall attempt to resolve such disagreement through direct management discussions, failing of which the Parties shall appoint a
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mutually agreed-upon, independent pharmaceutical laboratory in the European Union to evaluate and determine whether the Product’s Manufacture was in accordance with the Process Specifications as of the Delivery Date. The laboratory’s determination thereof shall be binding upon both Parties as to the facts evaluated, and the laboratory shall act as an expert and not as an arbitrator. The laboratory’s charges and related expenses shall be borne by the Party against whom the determination is made.
(4) Replacement. In the event that (i) Vetter agrees that Product is Non-conforming Product or (ii) Product is determined to be Non-conforming Product pursuant to Section 5(3), and provided that MoonLake has given Vetter [***] notice of defect in accordance with Section 5(2), Vetter shall either reprocess or rework (to the extent permitted in accordance with the Quality Agreement) or replace any Non-conforming Product with Product that is not Non-conforming Product (“Replacement Product”), provided, however, that for the purposes of such rework, reprocessing or replacement, MoonLake shall [***] supply or have supplied the MoonLake Materials necessary for the Manufacture of the Replacement Product. Vetter shall offer to MoonLake the next reasonably available time for Manufacture of such Replacement Product, [***]. If the Non-conforming Product has been caused negligently by Vetter or Vetter Affiliates, any such reprocessing or rework or Manufacture of Replacement Product, including the Batch Documentation Package, will be rendered at the cost and expense of Vetter and without additional charge to MoonLake, and in this event Vetter shall be liable, whether for itself and/or any of its Affiliates, for any related loss of API or other Materials, and shall arrange for return or disposal of the rejected Non-conforming Product, and supply of Replacement Product, all at the cost and expense of Vetter (but subject to the limitations of Article 10, including Section 10 (5)(i)).
ARTICLE 6: REGULATORY FILINGS, INSPECTIONS AND CHANGES.
(1) Product Approval. MoonLake shall ensure all Regulatory Filings and obtain and maintain, [***], all Regulatory Approvals needed for the Product and the Services which are particular to the Product and/or required in accordance with the Legal Requirements. MoonLake shall not distribute or otherwise use the Product without first securing such Regulatory Approvals. Vetter shall cooperate and make every commercially reasonable effort, [***], to provide such information and other Assistance as MoonLake may [***] request in connection with such Regulatory Filings and Regulatory Approvals, all in accordance with and subject to the terms of the Quality Agreement. If approvals by regulatory authorities are needed for the Manufacture (other than set forth in Section 6(2)), all risks, costs and/or expenses thereof shall be borne by [***].
(2) Facility Approval. Vetter has caused and shall cause Vetter Pharma to obtain and maintain, with respect to the Facility, any necessary manufacturing authorization(s) issued by the applicable German health authority and, upon [***] request of MoonLake, Vetter shall make available a copy of such authorization(s).
(3) Audits. MoonLake shall have the right to carry out annual cGMP audits as set forth more detail in the Quality Agreement, with the option to combine such audits with a mutual assessment of pre-agreed environmental, health, safety and sustainability related topics to evaluate Vetter’s compliance with applicable environmental laws and regulations.
(4) Audits – Sub-contractors. Vetter shall be solely responsible for ensuring the GMP compliance status of its Affiliates and as Vetter Subcontractors authorised sub-contractors used in
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relation to the performance of its obligations under this Agreement. Vetter shall carry out such inspections itself on MoonLake’s behalf and shall report its findings to MoonLake in accordance with the timelines set forth in the Quality Agreement.
(5) Inspections and Audits - Costs. Any costs and/or expenses associated with any inspections or audits performed by MoonLake and by any regulatory authority involved under any Product Schedule hereunder with respect to the Services and/or the Product shall be borne by MoonLake, except for costs incurred from inspections by the German health authorities, FDA and/or EMA not directly related to the Product which shall be borne by Vetter (excluding MoonLake costs and expenses, as the case may be). MoonLake shall ensure that MoonLake annual GMP inspections shall not exceed [***] with no more than [***] sub-groups of inspectors or auditors, that inspectors and auditors are bound by confidentiality and non-use obligations similar to those agreed hereunder and shall follow all procedures, instructions and SOPs applicable at the Facility, all to the extent and subject to the terms of the Quality Agreement.
(6) Inspections – Participation of MoonLake. any GMP related inspections by regulatory authorities shall be handled by the Parties in accordance with the Quality Agreement. Notwithstanding the foregoing, nothing in this Section 6(6) shall oblige Vetter to disclose information to MoonLake or any of its Affiliates relating to any other customer of Vetter or those customer’s products to which the inspection relates, if such disclosure could be interpreted as a violation of Vetter’s confidentiality obligation towards other parties.
(7) Change Control, Costs. Any changes to the agreed-upon process of Manufacture or the Process Specifications hereunder shall be carried out in accordance with this Section and the change control procedures set forth in the Quality Agreement, if applicable. The Parties agree that: (i) for changes related to Product, Materials, Facility or any Manufacturing process that arise from Legal Requirements (including Product-specific GMP), for changes made at the discretion or based upon the preference of MoonLake, and for any other changes not described in subsection (ii) hereof, Vetter shall implement such changes (except to the extent commercially unreasonable or in conflict with the business operation of the Facility), and [***] shall bear all [***] costs related thereto; and (ii) for changes that arise from a regulatory requirements of the EMA and/or the FDA that is generally applicable to Vetter and not specific to the Product, and subject to the remaining provisions of this Section 6(7) and those of Section 7(2) below, Vetter shall implement such changes (except to the extent commercially unreasonable or in conflict with the business operation of the Facility), and [***] shall bear all [***] costs and/or expenses directly related thereto. The Parties will during the Product Schedule Term adhere to the change control procedures set forth herein and in the Quality Agreement; provided, however, that in the event that in any year after launch of the Product no Product batch is Manufactured under such Product Schedule, Vetter and its Affiliates may cease the change control procedures for such Product and Product Schedule, and Vetter will notify MoonLake thereof.
(8) Disputes. With respect to any changes, Vetter and MoonLake shall mutually agree on their respective obligations and the allocation of associated costs (consistent with the above) and on any necessary or desired amendments to this Master Commercial Supply Agreement or any Product Schedule or Quality Agreement hereunder. In the event of a dispute regarding a change, MoonLake and Vetter shall discuss [***] how to proceed, provided, however, that Vetter shall not be required to cause Vetter Pharma to continue the Manufacture of the Product (which Manufacture may be
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immediately ceased without it being deemed a breach of this Master Commercial Supply Agreement or any Product Schedule hereunder) if the course of action urged by MoonLake, whether calling for incorporation or non-incorporation of a change, constitutes a violation of any Legal Requirement or if Vetter reasonably explains with supporting evidence why Vetter believes that it constitutes a violation of any Legal Requirement. If such course of action does not constitute a possible violation as set forth in the preceding sentence, but creates an increased risk that Vetter and/or any of its Affiliates is or could be held responsible or liable under a third-party claim, then Vetter shall reasonably explain the situation and the reasons for Vetter’s apprehension to MoonLake, and subject to MoonLake’s express instruction cause Vetter Pharma to continue the Manufacture of the Product and to take such course of action, and MoonLake shall indemnify, defend and hold Vetter and/or any of its Vetter Indemnitees harmless from and against any and all Costs resulting from such third-party claim arising out of such course of action.
ARTICLE 7: PRICES, INVOICES, PAYMENTS AND ADJUSTMENTS.
(1) Prices, Invoices. Vetter’s charges for the Services shall be the Prices set forth in the Product Schedule, plus any taxes (including, but not limited to, value added tax), customs, fees and other duties, if and to the extent applicable. Vetter will invoice upon (i) rendering a Service and (ii) delivery of Product (including CoA or CoC, as agreed in the QA) and (iii) as further set forth in the Product Schedule. Since Vetter provides its Manufacturing Services in certain stages, Vetter shall be allowed to invoice MoonLake also for any Manufacturing Service fully rendered to MoonLake, of which ownership and control of the in-process Product has passed to MoonLake, and for which payment by MoonLake is due. A Manufacturing Service is deemed to be fully rendered upon successful release of the in-process Product for further manufacturing (next process step), following a successful in process control (in accordance with SOPs) and provided that such in process control revealed that there is no critical Deviation. Any Assistance shall be separately agreed upon and either incorporated into the Product Prices or separately invoiced. Each payment under an invoice shall be due and payable [***] of the date of such invoice. Payments by MoonLake shall not be deemed to have been made until Vetter has received such payment. If Vetter receives payment later than [***] of invoice date, Vetter may, [***]. With respect to payments due for Product as to which MoonLake has initiated [***] an investigation or dispute under Section 5(3), MoonLake’s withholding of payment shall not be considered a breach during the pendency of such investigation or dispute, provided, however, that if such investigation demonstrates no Non-conforming Product or failure by Vetter, or MoonLake does not prevail in such dispute, then [***]. Any payments shall be made without any reduction, set-off or counterclaim.
(2) Price Adjustments, Disputes. [***], Vetter may adjust its Prices under the corresponding Product Schedule as follows: (i) In the event of increases in the total cost of (a) the Product, or (b) the Services as arising from general changes to Vetter’s cost structure including, but not limited to, wages, insurance, energy costs and other associated costs and expenses affecting Vetter and/or any of its Affiliates (collectively, “Product Costs”), Vetter shall be permitted to propose an adjustment to its Prices based upon reasonable and documented information which allows MoonLake to verify such increased Product Costs, it being understood that no detailed cost break down must be provided by Vetter.
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(ii) In the event of increases in costs of Materials supplied or Services provided by any third party, Vetter shall be permitted to adjust its Prices accordingly, and any increases shall be borne by MoonLake, provided, however, that [***].
(iii) In the event of changes to the Services including, but not limited to, changes in scope or Material or third party services, regulatory or Legal Requirements (including GMP), or of increased production or overhead costs which arise from changes pursuant to Section 6(4), Vetter may reasonably request price adjustments, which shall be mutually agreed upon and set forth in an amendment of the Product Schedule.
(iv) Should a dispute arise regarding a price adjustment, the Parties shall discuss the same [***] for a period of [***]. If the Parties cannot agree on a price adjustment within such period, the Parties agree to submit the dispute to administered expert proceedings in accordance with the ‘Rules for the Administration of Expert Proceedings of the International Chamber of Commerce’. The expert shall have the right to disclose to either Party the determination only, but not the calculation basis of the Product Costs. The expert’s determination shall be binding upon the Parties, and all fees and expenses of the expert and related proceedings shall be borne by the Party whose proposed price (adjustment) was furthest from the price determined by the expert.
(v) If the Prices for a year are not agreed or determined, the Prices in force during the previous year shall apply pending agreement or determination of the new Prices subject to Section 7(2)(iv). Both Parties shall, [***], finalize their price discussions for the next year latest by December 31 of the ongoing year. Once the new Prices are agreed or determined, they shall apply with effect from 1 January of the relevant year and shall be deemed to come into force from that date for the purposes of this Agreement. Within one month of agreeing or determining the new Prices, MoonLake shall pay Vetter any outstanding sums due for its purchases of Products in the relevant year, together with any applicable VAT, or Vetter shall refund MoonLake for any excess amounts paid on Products purchased in the relevant year as appropriate.
ARTICLE 8: TERM, TERMINATION, CONSEQUENCES, SURVIVAL.
(1) Term and Termination of this Master Commercial Supply Agreement. This Master Commercial Supply Agreement shall remain in full force and effect until the earliest of (i) its termination for breach under Section 8(3); (ii) its special termination pursuant to Sections 8(4) or 8(5); or (iii) its termination without cause, upon a twelve (12) months written notice by either Party to the other and with immediate effect, at any time when all existing Product Schedules (including the associated QAs) have been terminated. In the event of a material breach of this Master Commercial Supply Agreement or of all Product Schedule hereunder by a Party, the non-breaching Party may terminate this Master Commercial Supply Agreement or such Product Schedule, respectively, for cause, by giving written notice of termination to the other Party to be effective if the other Party has not cured such breach within sixty (60) calendar days of receiving written notice of such breach and of the termination by the non-breaching Party. Termination of this Master Commercial Supply Agreement shall automatically terminate all Agreements then in effect.
(2) Term and Termination of Product Schedules. A Product Schedule entered into hereunder shall remain in full force and effect until the earliest of (i) its termination as provided for in the Product Schedule; (ii) its termination for breach under Section 8
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(3); (iii) its special termination pursuant to Sections 8(4) or 8(5); or (iv) the termination of this Master Commercial Supply Agreement pursuant to Sections 8(3), 8(4) or 8(5). (3) Termination for Breach. In the event of a material breach of this Master Commercial Supply Agreement or of a Product Schedule hereunder by a Party, the non-breaching Party may terminate this Master Commercial Supply Agreement or such Product Schedule for cause by giving written notice of breach and termination to the breaching Party, such termination to take effect if the breaching Party has not cured such breach within sixty (60) calendar days of its receipt of such notice.
(4) Special Termination by Vetter. Vetter may terminate
(i) this Master Commercial Supply Agreement or any Product Schedule if MoonLake is the subject of a Change of Control by a third party not being a reputable pharmaceutical company belonging to a group
(a) [***],
(b) [***], or
(c) [***] (any such third party not being a reputable pharmaceutical company in (a)-(c), an “Unqualified Acquirer”),
(ii) [intentionally omitted].
(5) Special termination by MoonLake. MoonLake may terminate this Agreement or any Product Schedule in case Vetter is being taken over by a competitor of MoonLake (for clarity, meaning a company active within the sector of development of dermatology and inflammatory diseases, including rheumatology) before the end of 2029. MoonLake may exercise this termination right with immediate effect only [***] within [***] after receipt of Vetter’s [***] notice of the signing of the change of control transaction or in absence of such a [***] notice within [***] after its knowledge about or the public disclosure of the closing of change of control transaction. However, in addition to the aforementioned Vetter shall inform MoonLake [***] of the change of control transaction.
(6) Special Termination by Either Party. Either Party may terminate this Master Commercial Supply Agreement or any Product Schedule, by written notice to the other Party and with immediate effect, if (i) the other Party makes a general assignment (novation) for the benefit of its creditors and not in accordance with Section 12(3), or (ii) proceedings are commenced in any court of competent jurisdiction by or against such Party (by any third party but not by the other Party) seeking (a) such Party’s reorganization, liquidation, dissolution, arrangement or winding up, or the composition of readjustment of its debts; (b) the appointment of a receiver or trustee for or over such Party’s property, or (c) similar relief in respect of such Party under any law relating to bankruptcy, insolvency, reorganization, winding up or composition or adjustment of debt, wherein any such proceedings continue undismissed, or an order with respect to any of the foregoing is entered and continues unabated, for a period of more than [***].
(6) Consequences. Upon termination of this Master Commercial Supply Agreement or the expiration or termination of an Product Schedule hereunder, neither Vetter nor MoonLake shall have any further obligations (exceeding Section 8(7)) thereunder except that (i) Vetter shall terminate the Services in progress in an orderly manner [***] and in accordance with a schedule set forth by Vetter and provided to MoonLake; (ii) Vetter shall deliver to MoonLake or dispose of, [***], any MoonLake Materials and Sourced Materials in its possession or control dedicated for Manufacture and all Product Manufactured up to the effective date of expiration or termination; (iii) Vetter shall
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invoice MoonLake, and MoonLake shall pay Vetter, for any amounts due and owed Vetter, at the effective date of expiration or termination, for Services performed and all expenses incurred (as specified in the applicable Product Schedule and this Master Commercial Supply Agreement); (iv) Vetter shall make available for pick-up by MoonLake the Equipment, as is and where is at the Facility, if paid for by MoonLake in accordance with Section 2(5); (v) Vetter shall, [***], sell to MoonLake, and MoonLake shall purchase at the prices herein provided, any Product for which Purchase Orders have been or are required to be placed at the time of expiration or termination in accordance with a then-current [***] Rolling Forecast or Capacity Reservation and, at the purchase Prices thereof, any and all Inventory ordered as contemplated in or permitted under this Master Commercial Supply Agreement or such Product Schedule; and (vi) each Party shall return to the other Party any and all documentation (including copies thereof) constituting confidential information of the other Party and/or any of its Affiliates under the applicable Confidentiality Agreement, provided, however, that, subject to Section 11(2), a Party may retain such documentation (and Vetter may cause Vetter Pharma to retain such limited quantity of the Product, MoonLake Materials and Sourced Materials, all sufficient for two (2) analyses) as may be necessary for proper record keeping (including Section 11(2)(ii)) in satisfaction of Legal Requirements. MoonLake shall be responsible and liable to Vetter for any amounts related to, based upon or arising out of such expiry or termination, including for an orderly cessation of the Manufacture and any related activities, as well as such other amounts accruing prior to termination; provided, however, any and all expenditures scheduled under the Manufacture not actually made, due to such termination, shall be deducted from any of the foregoing amounts.
(7) Survival. The following provisions of this Master Commercial Supply Agreement shall survive termination and expiry hereof and any expiry and termination of an Product Schedule hereunder: Section 8(6) (Consequences), this Section 8(7), Article 9 (Intellectual Property), Article 10 (Indemnification, Liability and Limitations), Section 11(1)(i) (Insurance of MoonLake), Section 11(2) (Confidentiality), and Sections 11(4) (Conflicts) through 11(18) (Governing Law).
ARTICLE 9: INTELLECTUAL PROPERTY
(1) Background IP. Each Party and/or any of its Affiliates shall own and continue to own all of its Background IP and, except as herein provided, neither a Party nor any third party shall as a result of this Master Commercial Supply Agreement or any Product Schedule acquire any right, title or interest in or to such Background IP.
(2) Developments.
(i) Any Developments that (a) are related to a Product and/or the API, including without limitation its formulation, and not generally applicable to any other active pharmaceutical ingredient, bulk drug substance or bulk drug solution or other material or product and (b) which do not incorporate any of Vetter’s Confidential Information or Vetter’s Background IP shall be solely owned by MoonLake, and Vetter agrees to assign and hereby assigns to MoonLake any and all rights anywhere in the world that may have been created under this Master Commercial Supply Agreement or any Product Schedule with respect thereto.
(ii) Any Developments that (a) are not related to a Product and/or the API, including without limitation its formulation, and generally applicable to any other pharmaceutical ingredient, bulk drug substance, bulk drug solution or other material or product and (b) do not incorporate MoonLake’s
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Confidential Information or MoonLake’s Background IP shall solely be owned by Vetter, and MoonLake agrees to assign and hereby assigns to Vetter any and all rights anywhere in the world that have been created under this Master Commercial Supply Agreement or any Product Schedule with respect thereto.
(iii) For clarification, since MoonLake wishes and Vetter agrees to avoid any Development to become jointly between the Parties owned IP, the determination of ownership of a certain Development shall always be made in favor of either MoonLake or Vetter and in accordance with the rules provided in (i) and (ii). In the event, that a determination of ownership of a Development to one Party in accordance with (i) and (ii) is not possible, both Parties shall discuss [***] whether the spirit of the Development is rather API related, in such case MoonLake shall become the owner, or rather related to production, then Vetter shall become the owner, each with the consequences set forth in (i) and (ii).
(3) Licenses. MoonLake hereby grants to Vetter (and/or any of its Affiliates, as may be reasonably required and subject to the provisions hereof) a temporary (for the duration of this Master Commercial Supply Agreement and the applicable Product Schedule hereunder), worldwide, royalty-free, fully paid up, non-exclusive and non-transferable license under MoonLake’s Background IP and any other Intellectual Property under its ownership or control, but only to the extent needed for, and solely for the purpose of, Vetter’s and/or its Affiliates’ use thereof of in the performance of their respective duties and obligations under this Master Commercial Supply Agreement and any Product Schedule hereunder. Furthermore, MoonLake acknowledges that Vetter and/or its Affiliates may, while performing the Services under the Master Commercial Supply Agreement and any Product Schedules hereunder, unavoidably acquire information, experience and skills, including some derived from MoonLake IP disclosed to Vetter or its Affiliates, which become an inextricable part of its general knowledge and non-separable, in recognition of which MoonLake hereby also grants to Vetter and/or its Affiliates a perpetual, irrevocable, worldwide, royalty-free, fully paid up, non-exclusive and non-transferable license under such MoonLake IP to use such knowledge as part of Vetter’s or its Affiliates’ general knowledge generally applied within the due and ordinary course of Vetter’s and its Affiliate’s business (i.e. contract manufacturing), including for providing services to other clients, without (i) disclosing MoonLake Confidential Information. Notwithstanding anything to the contrary in this Agreement, MoonLake does not grant, and has not granted, to Vetter and/or any of its Affiliates any license or right relating to the API.
(4) No Other Licenses. Except as provided for in this Article 9, nothing in this Master Commercial Supply Agreement or any Product Schedule hereunder shall be construed as a grant of license or covenant under, a waiver of rights in, or a transfer of ownership of, any Intellectual Property owned or controlled by a Party, either expressly or by implication.
ARTICLE 10: INDEMNIFICATION, LIABILITY AND LIMITATIONS
(1) Indemnification of MoonLake by Vetter. Vetter shall indemnify and hold harmless and/or, upon MoonLake’s request, defend MoonLake Indemnitees from and against any Costs that arise out of or result from
(i) any third party claim that any Manufacturing process owned or controlled by Vetter or its Affiliates, and used under this Master Commercial Supply Agreement or any Product Schedule hereunder, infringes another’s Intellectual Property under the patent or intellectual property laws of
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the United States and/or the European Union (but subject in any such cases to a maximum aggregate indemnification amount of [***] during the Product Schedule Term);
(ii) any third party product liability claim, producer liability claim or tort claim for personal injury (but subject in such cases to a maximum aggregate indemnification amount of [***] during the Product Schedule Term), and in both events (i) and (ii) if and to the extent such Costs have been caused by negligent or willful failure of Vetter or a Vetter Indemnitee to Manufacture and/or supply Product in accordance with the terms of this Agreement, and are not attributable to third parties (other than Vetter Affiliates, Vetter Subcontractors or any other subcontractors of Vetter) and/or the negligence or willful misconduct of MoonLake Indemnitees. Any such Vetter indemnification obligation is subject to the limitations of this Article generally and reduced by any obligations of indemnification owed by MoonLake pursuant to Section 10(2); and
(iii) the negligence or willful misconduct of a Vetter Indemnitee, subject to the limitations set forth in this Article.
(2) Indemnification of Vetter by MoonLake. MoonLake shall indemnify and hold harmless and/or, upon Vetter’s request, defend Vetter Indemnitees from and against any Costs that arise out of or result from
(i) any third party claim that a third party’s Intellectual Property is infringed by any MoonLake Materials, Sourced Materials, Intellectual Property and information or other deliverable received from or on behalf of MoonLake and used by Vetter or Vetter Indemnitees under this Master Commercial Supply Agreement or any other Product Schedule and/or the Product;
(ii) the negligence or willful misconduct of a MoonLake Indemnitee;
(iii) any third party claim in connection with any Assistance rendered and any actions undertaken by a Vetter Indemnitee in compliance with this Master Commercial Supply Agreement or any Product Schedule hereunder, the Process Specifications, MoonLake Product Information and/or a direction by or on behalf of a MoonLake Indemnitee or MoonLake designee;
(iv) any use of Materials supplied or approved by a MoonLake Indemnitee and/or use of any information or other deliverable received by or on behalf of MoonLake in compliance with this Master Commercial Supply Agreement or any Product Schedule hereunder, the Quality Agreement, Process Specifications, and/or a direction by or on behalf of a MoonLake Indemnitee or MoonLake designee;
(v) any breach by a MoonLake Indemnitee of this Master Commercial Supply Agreement or any Product Schedule hereunder; or
(vi) any third party claim arising from the distribution, sale or use of a Product which, upon delivery by Vetter (excluding sample shipments, quarantine shipments and similar kinds of delivery of Product not yet released by Vetter), conformed to, and was Manufactured in accordance with, the requirements of this Agreement, including the Process Specifications; Except, in each of the above-mentioned cases, to the extent that any such Costs are attributable to the negligence or willful misconduct of Vetter Indemnitees.
(3) [***]
(4) Cooperation. Each Party agrees to notify the other within [***] of receipt of any claim made for which the other Party might be liable under this Article 10, as the case may be. Subject to the rights of any insurer, the indemnifying Party shall have the right, but not the obligation, to defend, negotiate and settle such claim. The indemnified Party shall be entitled to participate in the defense of such matter and to employ counsel at its expense to assist therein, provided, however, that if the
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indemnifying Party elects to defend the indemnified Party, the indemnifying Party shall have final decision-making authority regarding all aspects of the defense of any claim. The Party seeking indemnification shall provide the indemnifying Party with such information and assistance as the indemnifying Party may reasonably request, at the expense of the indemnifying Party. Neither Party shall be responsible under or bound by any settlement of any claim or suit made without its [***] consent, provided, however, that the indemnified Party shall not unreasonably withhold, condition or delay such consent. If a settlement contains an absolute waiver of liability for the indemnified Party, and each Party has acted in compliance with the requirements of this Section 10(4), then the indemnified Party’s consent shall be deemed given. The foregoing notwithstanding, neither Party shall agree to settle any claim on such terms or conditions as would impair the other Party’s ability or right to research, develop, manufacture, market, sell or otherwise use the Product, or as would impair Vetter’s ability, right or obligation to perform its obligations under this Master Commercial Supply Agreement, any Product Schedule hereunder or its ability to provide services of a similar nature to other MoonLake’s.
(5) Vetter Liability Limitations. [***]
(i) [***]
(ii) [***]
(iii) [***]
(iv) Maximum Liability. All other provisions of this Master Commercial Supply Agreement notwithstanding, and except for the indemnification obligations of the foregoing subsection 10(1)(ii) (for product liability) as to which the respective maximum indemnification amount is specified individually, Vetter’s annual aggregate liability and indemnity obligations to MoonLake, regardless of the legal grounds, for any Costs arising from or in connection with the Master Commercial Supply Agreement and any Product Schedule hereunder, shall not exceed the Vetter Maximum Liability Cap.
For the avoidance of doubt, any Vetter liability under this Section is subject to the limitations of this Article generally and Vetter shall be liable in unlimited amounts, for itself and any other Vetter Indemnitee, if Costs are incurred as a consequence of willful misconduct by a Vetter Indemnitee.
(6) Assertion. All claims under this Master Commercial Supply Agreement and in any Product Schedule hereunder shall be brought within [***] after the cause of action incurred or shall be deemed waived, if not otherwise agreed in this Master Commercial Supply Agreement.
(7) No warranty. Neither Vetter nor any of its Affiliates makes or has made any representation, warranty or covenant, whether written or oral, direct, implied or statutory, other than the covenant under German law as stipulated in this Agreement, and hereby expressly disclaims any other representation, warranty, covenant or agreement, written or oral, direct, implied or statutory, including but not limited to warranties of merchantability, quality or fitness for a particular purpose.
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(8) Other limitation. No Affiliate of Vetter shall incur any liability in connection with this Master Commercial Supply Agreement or an Product Schedule hereunder, and MoonLake shall seek payment or other remedy solely from Vetter in accordance with this Master Commercial Supply Agreement and not from any Vetter Affiliate. Vetter shall not be liable for errors, defects or shortcomings in the Process Specifications provided or approved by MoonLake, in the Materials, third party services provided by other parties than Vetter, Vetter Affiliates and/or Vetter Subcontractors, or in any instruction or direction expressly given to Vetter by MoonLake in writing (e-mail being sufficient).
(9) Special Damages Excluded. In no event shall a Party or its Affiliates be responsible to the other Party for any reason whatsoever, including but not limited to any liability under this Agreement or an indemnification obligation under this Article 10, for loss of profits, loss of goodwill, loss of business, delay in or cancellation, interruption or suspension of any Product supply, or for any indirect, incidental, exemplary, punitive, special or consequential damages, provided, however, the foregoing shall not apply to breaches of the confidentiality provisions in this Master Commercial Supply Agreement.
ARTICLE 11: MISCELLANEOUS.
(1) Insurance. During the Product Schedule Term of any Product Schedule hereunder and for a period of at least [***] thereafter:
(i) MoonLake shall carry with a reputable insurance company a policy of insurance for product liability claims with a per-occurrence limit of at least [***] (or the equivalent thereof in U.S. Dollars) or such higher amount as may be required by applicable law in any of the jurisdictions of Product use. Such policy shall name each Vetter Indemnitee as an additional insured thereunder. MoonLake shall, at Vetter’s request, provide Vetter with a copy of the certificate for such policy, and shall immediately inform Vetter in the event that such policy is cancelled or rendered void, or if coverage thereunder fails to meet the above standards.
(ii) Vetter shall carry with a reputable insurance company a policy of insurance for product liability claims (to the extent [***] or, if otherwise, shall self-insure and remain personally responsible and liable for such coverage) in an aggregate amount of [***], which coverage shall include (namely be reduced by) attorneys’ fees and/or court fees. Either Party’s violation of this Section 11(1) shall be deemed a material breach of the applicable Product Schedule and the Master Commercial Supply Agreement.
(2) Confidentiality, Press. The provisions of the Confidentiality Agreement regarding the Parties obligations of confidentiality and limited use shall apply to any Confidential Information disclosed in connection with this Master Commercial Supply Agreement or any Product Schedule hereunder (including any Confidential Information which have already been disclosed prior to the effective date of the Master Commercial Supply Agreement or any Product Schedule related to the Product or the Services), and shall remain in full force and effect during the Product Schedule Term of any Product Schedule hereunder and for a period of [***] thereafter. For clarity purposes only, (i) data storage in a third party cloud system or maintenance/structural work on the IT-system or landscape by third parties shall not be deemed a disclosure of information to a third party, provided that such storage/activities are subject to industry standard data security, data privacy and confidentiality obligations,
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and (ii) backups may be maintained provided that such backups are generated automatically from time to time, are not generally accessible and remain subject to the confidentiality and non-use obligations. Neither Party shall issue a press release or make a public statement of any type that mentions the other Party, unless the other Party provides [***] approval of such press release or public statement.
(3) Assignments. Unless expressly provided for herein, neither Party shall be permitted to assign or transfer any of its rights and obligations under this Master Commercial Supply Agreement or any Product Schedule hereunder without the [***] consent of the other Party, subject to the following exceptions:
(i) Each Party may assign or transfer any such rights (and, for the avoidance of doubt, to grant of security interests in the same) to any of its Affiliates and
(ii) Each Party may assign or transfer any such rights and obligations, (and including, for the avoidance of doubt, granting of security interests in the same) to lenders, shareholders, investors or financial underwriters, in both cases (i) and (ii) so long as such assignment or transfer does not impair or materially diminish the assigning Party`s ability to perform its obligations under this Master Commercial Supply Agreement or any Product Schedule hereunder, provided, however, that the assigning Party shall not be relieved, by action of such assignment or transfer of rights, of any of its obligations hereunder, and the assignee shall, in addition to the assignor, assume confidentiality obligations to the same extent as set forth in this Master Commercial Supply Agreement and accepted by the assignor.
(iii) MoonLake may assign this Master Commercial Supply Agreement or any Product Schedule hereunder, and all rights and obligations hereunder or thereunder, to a successor in connection with a merger, consolidation or the sale of all or substantially all of MoonLake’s business to which this Master Commercial Supply Agreement or such Product Schedule relates, provided, however, that (a) MoonLake shall provide [***] notice to Vetter of any such assignment, merger, consolidation or sale, (b) MoonLake shall not be released of obligations already accrued including confidentiality obligations which, for the sake of clarity, shall be assumed by such successor in addition to being retained by MoonLake, and (c) such successor shall have agreed in writing to be bound by this Master Commercial Supply Agreement or such Product Schedule and have the financial capacity (at least commensurate with that of MoonLake as of the Product Schedule Effective Date) to perform the obligations to be assumed by such assignee.
(4) Conflicts. In the event of a conflict between the terms of this Master Commercial Supply Agreement (excluding Annex 2) or any Product Schedule hereunder, and those of an associated Quality Agreement, the terms of such Quality Agreement shall exclusively govern and control with respect to all technical, pharmaceutical and/or quality-related aspects of the Services, and the terms hereof (excluding Annex 2) or of any Product Schedule hereunder shall exclusively govern and control with respect to all other matters. In the event of a conflict between this Master Commercial Supply Agreement and those of an Product Schedule made hereunder, the terms of the Master Commercial Supply Agreement shall exclusively govern and control. No term of an Product Schedule shall be deemed to change or replace a term of this Master Commercial Supply Agreement, unless such Product Schedule (i) expressly states that such change or replacement is intended and (ii) specifically references the Article or Section hereof in which the subject term is found.
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(5) Amendments. Any amendment or alteration to this Master Commercial Supply Agreement, specifically including this Section, or to any Product Schedule hereunder, or of any other attachment to any of the above, shall take effect only by a written document signed and duly executed.
(6) Notices. All legal notices and other legal communication hereunder or under any Product Schedule hereunder shall be in writing and addressed to the other Party at its address first written above, or to such other address as may be stated in a Party’s written notice provided under this Section, and shall be deemed duly given upon receipt when such receipt is on a Business Day during normal business hours of the recipient and, otherwise, on the next Business Day.
(7) Force Majeure. No Party shall be responsible or liable to the other Party and/or any of its representatives, and no breach shall be deemed to have occurred, for failure or delay in performing any obligation or for other non-performance if such failure, delay or other non-performance is caused by or arises from Force Majeure. A Party shall be under no obligation to settle a strike, labor stoppage, lockout, or any other labor trouble by entering into any agreement to settle any thereof, and such matter shall continue to be deemed Force Majeure until settled to the satisfaction of the affected Party. Any and all of the foregoing shall also apply to a Party to the extent that an Affiliate of such Party or Vetter Subcontractor is performing or providing any service or work in connection with the obligations of a Party. A Party claiming Force Majeure shall notify the other Party specifying the cause and probable duration of the failure, delay or other non-performance. Neither Vetter nor any of its Affiliates shall be under any obligation to fulfill any Purchase Order which has been, or should have been scheduled to be performed during a time period of Force Majeure, provided, however, that a Party so affected shall undertake every reasonable effort to fulfill its contractual obligations to the extent reasonably possible under the circumstances.
To the extent that any such event is threatened or has already commenced at the time of execution of this Master Commercial Supply Agreement or any Product Schedule hereunder, the Parties (i) shall be deemed to be equally informed as to the current scope of such event and its potential impact on the subject matter hereof, (ii) acknowledge that the future course of such event and the extent of its impact (“Future Developments”) are unknowable and cannot be foreseen, and (iii) agree that such Future Developments shall, prior threat or commencement of the event notwithstanding, themselves be regarded as Force Majeure events excusing a Party’s failure of or delay in performance, subject in any case to the above obligations of timely notice and estimate of effect and duration, mitigation and/or recommencement.
(8) No Waiver. Any failure by either Party to request performance or non-performance by the other Party and/or any of its Affiliates, or to claim a breach of this Master Commercial Supply Agreement or any Product Schedule hereunder, shall neither be construed as a waiver of any right under this Master Commercial Supply Agreement or such Product Schedule, nor affect any subsequent failure to request performance or non-performance or to claim a breach, nor affect the effectiveness, the validity and/or the enforceability of this Master Commercial Supply Agreement or any Product Schedule hereunder or any part thereof, nor prejudice or preclude such Party with respect to any subsequent action. Any request for performance or non-performance by either Party and/or any of its Affiliates or claim of a breach of this Master Commercial Supply Agreement or any Product Schedule hereunder shall be effective, valid and enforceable only if such request or claim is reduced to writing.
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(9) Debarment. Neither Party nor any of their Affiliates shall be debarred by the FDA, nor shall they knowingly employ or use the services of any individual or organization (including subcontractors) who are debarred.
(10) Compliance. Each Party shall ensure
(i) not to misuse any payment made under this Master Commercial Supply Agreement and/or any Product Schedule hereunder in any manner that constitutes a criminal offence or otherwise constitutes a material violation of any applicable Legal Requirements or any way that could have an adverse effect on the other Party and/or its Affiliates; and
(ii) compliance with and Legal Requirements, including any anticorruption and antitrust laws; and
(iii) compliance of its Affiliates, designees, subcontractors and suppliers with this Section; and
(iv) that it has effective compliance programs, policies and procedures to address relevant risk areas associated with the pharmaceutical industry (“Code of Conduct”) in place. Each Party adheres at all times to its Code of Conduct
(for MoonLake set out at: https://ir.moonlaketx.com/static-files/77430771-4421-47b8-9b1a-daa3394fe441
and for Vetter set out at: https://www.vetter-pharma.com/media/content/Downloads/ Unternehmen/2025_Vetter_Code_of_Conduct_EN.pdf)
Each Party shall immediately notify the other Party of any possible violation of this Section and of any initiation of investigation by public authorities against itself or its Affiliates relating to any subject matter covered by this Section. A violation of this Section 11(10) shall be deemed a material breach of this Master Commercial Supply Agreement and/or any Product Schedule hereunder, provided however, a Party shall already be allowed to terminate the respective contract if there reasonable suspicion that the other Party or its Affiliates are involved in any matter which could be considered a criminal offense.
(11) Relationship. Each of the Parties and their respective Affiliates are independent parties and independent contractors, and nothing herein creates a partnership, agency, employment, joint venture or similar relationship between any of them.
(12) Severability. If a provision of this Master Commercial Supply Agreement or any Product Schedule hereunder is held void, invalid or unenforceable, it shall be replaced constructively by a mutually agreed provision that is effective, valid and enforceable and consistent with the lawful purposes manifest in or determinable from the remainder of this Master Commercial Supply Agreement and/or such Product Schedule as a whole. Any matter not initially or fully addressed in this Master Commercial Supply Agreement or any Product Schedule hereunder shall be resolved by incorporating into the same such reasonable provisions as are necessary to complete this Master Commercial Supply Agreement or such Product Schedule in a manner which accomplishes to the maximum extent possible such lawful purposes and intentions. The effectiveness, validity and enforceability of this Master Commercial Supply Agreement or any Product Schedule hereunder shall remain, independent of any provision which might be or has become void, invalid or unenforceable unless constructive replacement thereof is not possible and, in the absence of such provision, this Master Commercial Supply Agreement or such Product Schedule would not reasonably have been entered into.
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(13) United Nations Convention. The United Nations Convention on Contracts for the International Sale of Goods shall have no application to, and shall be of no force and effect with respect to, the matters set forth or contemplated in this Master Commercial Supply Agreement or any Product Schedule hereunder.
(14) Entire Agreement. This Master Commercial Supply Agreement, the Product Schedule executed hereunder, the Quality Agreement and the Confidentiality Agreement, as amended and together with any attachments thereto (whether Annexes, Exhibit or Appendices), constitute the entire agreement with respect to the matters set forth or contemplated in this Master Commercial Supply Agreement and such Product Schedule, and supersedes in any and all respects any prior proposal, quotation, negotiation, conversation, discussion, agreement or other communication concerning such matters, the purported terms and conditions of any of which shall be null and void. The terms of this Master Commercial Supply Agreement and the Quality Agreement (being an Annex hereto or an Exhibit to the Product Schedule) form an integral part of each agreement made hereunder, including any Product Schedule, and shall have the same force and effect as if expressly set forth therein. Any reference to this Master Commercial Supply Agreement includes its Annexes and the Confidentiality Agreement, and any breach thereof or the breach of an Product Schedule shall be deemed a breach of this Master Commercial Supply Agreement.
(15) Execution. This Master Commercial Supply Agreement (except Annex 2 )and any Product Schedule hereunder, and any amendments or addenda thereto, may be executed in counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument. Execution may be carried out conventionally (by handwritten ink signature of all counterparts) or electronically (with e‑signature by all Parties using the DocuSign® electronic signature system ). Documents executed conventionally may be exchanged by (i) physical delivery of signed originals or (ii) electronic transmission of scanned or other images of the same, with physical delivery of the signed originals to follow; the Parties intend such transmitted images to have the same meaning, validity and enforceability as original documents bearing a handwritten signature, and a Party receiving a document so signed may rely upon it as if the original had been received. Documents executed electronically shall be deemed fully executed and legally binding upon all Parties' completion of the DocuSign® protocol, and the Parties hereby acknowledge their intent to be so bound, provided, however, that the Parties hereby reject use of the DocuSign® Electronic Record and Signature Disclosure or any similar DocuSign-generated collateral agreement ("ERSD") and further jointly agree that, in the event such ERSD is used and consent thereto is needed for completion of the electronic signature process, all provisions thereof are hereby anticipatorily repudiated and shall be void, inapplicable and unenforceable as between the Parties, even if consented to.
(16) Interpretation. Any titles or headings, of Articles or Sections or otherwise, are for convenience and reference only and shall not be relied upon in the construction hereof. Any meaning or interpretation of legal terms contained or referred to in this Master Commercial Supply Agreement, and any Product Schedule hereunder and its associated documents shall be defined and interpreted solely in accordance with the governing law specified in Section 11(18) below, irrespective of any other meanings or interpretations under any other source or body of law. In this Master Commercial Supply Agreement and in any Product Schedule hereunder, the words "herein", "hereunder" and similar words refer to this Master Commercial Supply Agreement as a whole; terms
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used in the plural include the singular, and vice versa, unless the context requires otherwise; the words "including", "include" and variations thereof are deemed to be followed by "without limitation"; reference to a document, including this Master Commercial Supply Agreement, also refers to any Annex, Exhibit, Appendix or other attachment thereto; and reference to any regulatory authority includes any successor thereto.
(17) Disputes. Each Party’s sole remedy for any dispute, controversy or claim arising out of, relating to or in connection with this Master Commercial Supply Agreement and any Product Schedule hereunder shall be binding arbitration under the Rules. The arbitration shall be adjudicated by [***] arbitrators appointed in accordance with the Rules. The Parties agree that (i) such arbitration shall be conducted exclusively in Zürich, Switzerland; (ii) all arbitral proceedings (including, but not limited to, their existence, content and results) shall be kept confidential by all persons involved (including, but not limited to, the Parties and any Affiliates, witnesses, experts and adjudicators); and (iii) the language used in the arbitral proceedings shall be English, provided, however, that annexes to any procedural document may also be provided in German.
(18) Governing Law. This Master Commercial Supply Agreement (including any applicable Quality Agreement) and any Product Schedule entered into hereunder, any Confidentiality Agreement or other agreement incorporated herein by reference, and any amendments to any of the above, and all terms and provisions of the same, shall be construed, enforced and governed exclusively by and according to the substantive laws of Switzerland, without reference to any conflict-of-laws-rules or any then-current rules on general terms and conditions. Further, United Nations Convention is excluded as set out in Section 11 (13).
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IN WITNESS WHEREOF, and intending to be bound hereby, each of the Parties has caused this Master Commercial Supply Agreement to be executed by its duly authorized representatives at the place(s) and on the date(s) set forth below, with effect as of the Effective Date.