展品10.2
已从展示中排除了某些特定的信息，因为这些信息既不是重要的（I），又属于公司视为私人或机密的类型（II）。
商业供应协议
本商业供货协议（以下简称“协议”）于2024年10月21日由Hovione Farmaciência, S.A.（以下简称“生效日期。”）与其主要营业地点位于葡萄牙Sete Casas 2674-506 Loures的Hovione Portugal（以下简称“Hovione Portugal”）及Hovione, LLC.（以下简称“”）, 其注册办公地址位于美国新泽西州普林斯顿08543-5226号，202 Carnegia Center的Hovione NJ”）及其关联公司（统称“Hovione”），美国特拉华州公司，业务主要地点为400 5th Ave., Suite 210, Waltham, MA 02451美国（“Ardelyx”）。Hovione和ardelyx均可在本文中称为“方”, and collectively as the “当事人”.
鉴于，ardelyx和Hovione是于2015年12月22日签订的主服务协议的一方，该协议规定Hovione履行对ardelyx的泰纳帕诺产品进行喷雾干燥和开发服务的义务（经修订，包括所有附件和工作订单）。开发协议”);
鉴于，各方希望根据原始制造地点（及其关联公司中可能有一个或多个）在开发协议下开发和验证的方式，在商业规模上为ardelyx提供喷雾干燥服务而订立商业供应协议；
因此，鉴于前述情况和本协议中包含的契约，各方一致同意以下条款将规定本服务的履行：
1.定义。除非上下文另有规定，否则以下术语将具有以下所列各自的含义，这些术语的语法变体将具有相应的含义：
1.1.“供应不利事件”表示下列情况之一或多种：（i）Hovione无法[***]所需的[***]，或（ii）[***]命令停止为产品提供制造服务的任何进一步执行。
1.2.“附属公司“”表示直接或间接拥有某方的控制利益、受某方控制、或与某方共同受控的商业实体；在这里“控制，“”表示通过持有股份或其他方式，合法确定选举商业实体大多数董事（或等效管理人员）的权利；
1.3.“附加服务“”在第3.1节中有特定的含义;
1.4.“年度承诺”在第2.2节中指定的含义；
1.5.“应用程序接口“”表示原料药物质通宁胺以碱式形式存在；
1.6.“API报销价格”指附录3规定的每公斤API的报销价格。
1.7.“是指与美国联邦和州证券、税收和其他适用法律、规则和法规、公司股票上市或报价的任何股票交易所或报价系统的适用规则以及授予奖项的任何外国国家或其他授予奖项的管辖区的适用法律和规则有关的股权奖项计划的管理的要求。”指（i）就Hovione而言，指制造场地所在司法管辖区适用的所有法律；以及（ii）就ardelyx及ardelyx对产品使用而言，指领土内所有司法管辖区的适用法律；
1.8.“Ardelyx背景知识产权“”意味着由ardelyx拥有或代表所拥有并独立于本协议之前或之后开发或取得的知识产权。ardelyx背景知识产权具体包括 [***];
1.9.“ardelyx的发明”在第13.3节中有指定的含义;
1.10.“ardelyx财产”在第8.3.2节中有指定含义；
1.11.“授权“”意味着任何对一方、制造业务、或产品领域（或其使用范围）有管辖权的政府或监管机构、部门、证券交易所、机构或机构或任何外国的、联邦的、州级的、省级的、县级的或市级的法院、仲裁庭、局、委员会或其他类似机构。
1.12.“银行系统”指第3.3(d)(ii)节中指定的含义;
1.13.“批次“单次运行制造活动”指在本《制造业-半导体活动》下制造的产品。为明确起见，任何给定的制造活动可能包含单个批次或多个批次。
1.14.“绑定预测“”在5.1节中有特定含义；
1.15.“第十章
转让证券
第10.1节
交易
如果发行受托人证明，债券持有人可以交换并迅速交付发行受托人这样的证明，无论是有欠款未偿还，还是实质性周转的时候，都可以在世界范围范围内经由源和债券市场交易。“工作日”指的是除星期六、星期日或是Hovione所在居住司法管辖区、ardelyx的居住司法管辖区，或是适用制造工地所在司法管辖区的法定假日外的一天；
1.16.“业务需求” 意味着ardelyx决定减少或停止生产产品，这与其业务策略或产品市场的重大变化有关，重点不在于禾菲安另有规定的任何违约或失职。 业务需求可能包括，例如，对执照安排或被许可人需求的重大变化，或者产品在特定领域市场需求的显著减少。
1.17.“cGMPs” 指ICH Q7活性药品原料制造良好生产指南中描述的原则，根据（i）美国联邦法典第21章第210和211部分以及（ii）领土内任何其他监管机构发布的相应药品制造法律和指导方针。
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1.18.“商业上的合理努力就双方在任何目标方面所付出的努力而言，“商业上合理、勤勉”的努力是指该方为尽快完成类似目标通常会采取的商业上合理、勤勉的努力，并将考虑到该方对第三方的现有先前和冲突义务。
1.19.“元件“原材料”是指根据加工说明制造产品所需的所有原材料、配料、参考标准、杂质标记物和其他材料，除了原料药。
1.20.“保密信息“”在第12节中有指定的含义；
1.21.“合同年份“”表示自生效日期起至首个周年的前一天止，并且在此后的每个连续十二（12）个月期间内在本条款期间内；
1.22.“[***]”具有第6.4节中指定的含义；
1.23.“不合格产品”在第6.2节中指定的含义;
1.24.“亏损“”的含义在第7.6.2节中指定；
1.25.“通过公司和各个承销商通过代表的付款和证券的交付对于每批产品，"Hovione交货日期"指的是在质量协议中确认或认证的计划日期，并在收到正式订单后由Hovione确认后可供装运[***]。
1.26.“开发服务“药品”指在开发协议项下，Hovione为ardelyx提供的包括但不限于产品确认批量的制造在内的药品研究或开发服务，无论是在生效日期之前还是之后以及在整个期限内；
1.27.“披露方“”在第12节中有指定的含义；
1.28.“设备“” 在第2.5节中有所指定;
1.29.“设备协议”在第2.5条中指定的含义；
1.30.“故障」指一方的 (a) [***]、(b) [***] 或 (c) [***]。
1.31.“「监管当局」指任何国家或超国家政府机构，包括美国食品药品监督管理局（及其任何继任实体）（以下简称「FDA」）在美国、欧洲药品管理局（及其任何继任实体）（以下简称「EMA」）或欧洲委员会（及其任何继任实体，如适用）在欧盟、或日本内阁府健康福祉厅，或日本药品医疗机器等级机构（或任何继任者）（以下简称「MHLW」），在日本，英国药物和保健品监管局（以下简称「MHRA」），或任何国家的任何卫生监管当局均为本文所述国家药品的开发、商业化，以及进行监管审批负责的对应机构，包括但不限于HGRAC。“美国食品药品监督管理局”代表美国食品和药物管理局；
1.32.“FFDCA「」代表美国联邦食品、药品和化妆品法案，21 USC §§ 301等。
1.33.“最终发票” 在第8.3.2条款中有指定的含义；
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1.34.“坚定订单”在第5.3节指定的意义中；
1.35.“预测“” 在第5.1条中有指定的含义；
1.36.“Hovione背景知识产权“”指Hovione拥有或控制的知识产权，并且独立于本协议之外开发或取得，不论是在生效日期之前还是之后；为明确起见，Hovione背景知识产权特别 [***]
1.37.“霍维奥内发明」具有第 13.4 条所指明的含义；
1.38.“Hovione释出“”在5.5节中有特定的含义；
1.39.“受益人”在第11.3节中有指定的意义；
1.40.“赔偿人“”在第11.3节中已指定其涵义；
1.41.“初期期限“”在第8.1条中有特定的含义;
1.42.“知识产权「」代表专利、专利申请、配方、商标、商标申请、商号、发明、版权、工业设计、商楟和专业技术知识中的任何权利；
1.43.“发明” 意指任何创新、改进、发展、发现、计算机程序、装置、交易秘密、方法、流程、技术或类似事项，无论是否以任何形式或媒体书面或其他方式固定，无论所涵盖的媒体为何，亦无论是否可专利或可受版权保护；
1.44.“存货「」代表在某一时间点，Hovione管理或控制的所有库存，包括产品、API、元件、用于制造产品的中间产品以及在制品。
1.45.“[***]” 在第6.2条中指定了其含义；
1.46.“法律「法律」指所有法律（包括普通法）、法规、条例、规定、规则、附例、判决、法令或任何监管机构的命令；
1.47.“被许可人「」表示Ardelyx已与任何人就产品的营销、销售或分销进行许可协议；
1.48.“亏损“”在第11.1节中指定了含义；
1.49.“制造业记录“” 意味著，对于一批货品的运输，包括批次记录、分析证书、符合证书、北交所/瘦肉/瘦香猪病证书和《质量协议》附录D中指定的其他文件；
1.50.“制造业“制造业服务” 意指任何制造业服务的表现。
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1.51.“制造业服务”代表喷雾干燥和品质控制、品质保证、稳定性测试、包装和相关服务，用于产品的制造；
1.52.“制造业地点” 意味著位于葡萄牙Loures的设施（即“原始制造业地点”），以及美国新泽西州East Windsor的地点（即“新泽西州地点”），以及当事方同意将进行制造服务的任何其他Hovione地点；
1.53.“[***]”具有第3.3(d)条中指定的含义；
1.54.“终止通知书“”在第8.1条中有特定的含义;
1.55.“价钱「价格」指适用于交付给ardelyx的每公斤制成品价格，如所列出的 附录1；以及（b）ardelyx要求的服务的单独费用和费用，明确排除产品成本，可能受另外的书面工作订单或书面协议的约束，该协议明确纳入本协议的条款和条件；
1.56.“处理「制造」指反映于加工说明、规格和制造记录中的产品制造过程。
1.57.“处理指示「制造服务之产品所需的文件化参数」指Hovione根据第3.2条不时更新的制造服务内容，包括：
(a)API和元件的品质控制测试方法;
(b)主批次、生产和控制记录、制造说明、方向和流程;
(c)API、元件或产品有任何存储要求吗；及
(d)产品的品质控制测试方法，包装指引以及运送要求；
1.58.“产品「」代表根据本协议制造的API的喷雾干燥形式；
1.59.“产品变更控制要求」具有第 3.2 节所述的含义；
1.60.“产品拒收” 的意义如第6.2条所规定;
1.61.“Product Yield” has the meaning specified in Section 3.3(d);
1.62.“Purchase Order” has the meaning specified in Section 5.2;
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1.63.“Quality Agreement” means the Quality Agreement between Ardelyx and Hovione Portugal, dated November 16, 2018, as amended from time to time;
1.64.“Recall” has the meaning specified in Section 6.7;
1.65.“Recipient” has the meaning specified in Section 12.1;
1.66.“Regulatory Approval” has the meaning specified in Section 7.6.1;
1.67.“Regulatory Authority” means the FDA and any other foreign regulatory agencies competent to grant marketing approvals for pharmaceutical or biopharmaceutical products, including the Products, in the Territory;
1.68.“Representative” means a Party’s director, officer, employee, advisor, agent, consultant, subcontractor or service partner;
1.69.“Scale-Up” has the meaning specified in Section 2.5;
1.70.“Specifications” means the requirements and standards for the Product as set forth in Appendix B to the Quality Agreement;
1.71.“Supply Failure” means (a) Hovione’s Manufacture of [***] Batches of Deficient Product, or (b) with respect to Product scheduled for Delivery pursuant to Firm Orders during [***], a failure by Hovione to deliver to Ardelyx or its designee at least [***] within [***] of the applicable scheduled Delivery Dates, absent [***], provided, however, that in the case of [***]. A Supply Failure may result from [***]. The Parties acknowledge that [***].
1.72.“Term” means the Initial Term and any and all renewal terms applicable under Section 8.1;
1.73.“Territory” means [***];
1.74.“Third Party Claim” has the meaning specified in Section 11.1;
1.75.“Third Party Subcontractors” has the meaning specified in Section 2.8;
1.76.“Third Party Rights” means the Intellectual Property of any third party;
1.77.“Work Order” has the meaning set forth in Section 3.1 and
1.78.“Year” means in the first year of this Agreement, the time from the Effective Date up to and including December 31 of the same calendar year, and after that will mean a calendar year, except for in the case of the calendar year in which this Agreement is terminated or expires, in which case the Year will be the date beginning on January 1 of that Year and ending on the date of the effective termination of this Agreement.
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2.Manufacturing Services
2.1.Performance Standard. Hovione shall perform the Manufacturing Services in accordance with the Processing Instructions and supply Product manufactured in accordance with the Specifications, for the Price, in accordance with the material provisions of the Quality Agreement, Applicable Law, cGMP and the prevailing industry standards and practices for the performance of similar services. Subject to the preceding sentence, Hovione will convert API and Components into Product, and provide supportive Manufacturing Services such as quality assurance (for example quality controls, analytical testing, and stability programs). From time to time during the Term and by mutual agreement between the Parties, Ardelyx may request any other related Manufacturing Services, excluding any Development Services which shall be subject to the Development Agreement, and such additional Manufacturing Services shall be charged separately as may be agreed by and between the Parties.
2.2.Annual Commitment.
(a)Conditional upon Ardelyx’s timely payments as required in accordance with the Equipment Agreement and beginning in Year 2024, subject to Sections 6.3 and 6.5 and the other terms of this Agreement, Ardelyx will place Purchase Orders (as defined below) in accordance with Section 5.2 for, and Hovione will manufacture for Ardelyx, Product for delivery by the scheduled Delivery Dates specified in the accepted Purchase Order in accordance with this Agreement, in the following minimum quantities (the “Annual Commitment”):
2024 [***]
2025 [***]
2026 [***]
2027 [***]
2028 to end of the Term [***]
For the avoidance of doubt, the Delivery Dates set out in the relevant Purchase Orders shall be the applicable dates for determination of Ardelyx’s satisfaction of the Annual Commitment.
(b)The Annual Commitment may be adjusted by mutual agreement of the Parties pursuant to Section 2.6 below. For clarity, in the event of failure to order the Annual Commitment absent Supply Failure, Adverse Supply Events (subject to the applicable limitations of Section 6.5.3), or mutually agreed Manufacturing reductions, Hovione may on December 31st of the relevant Year charge Ardelyx the respective shortfall between the Annual Commitment for such Year and the orders for Product actually placed by Ardelyx and with the Delivery Dates (set out in the relevant Purchase Orders) in such Year.
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(c)根据设备协议的条款，在扩大规模（下文有定义）完成之前，尽管本协议中的任何相反规定，各方的年度承诺义务仍将保持在[***]，直至扩大规模完成，届时[***]。
2.3.现有订单至2024年，各方确认根据开发协议已经下达并接受了所有产品制造订单。开发协议应控制在生效日期前交付的所有产品的制造，但在Hovione根据质量协议发布之后，本协议的条款将控制与产品本身相关的使用、完整性和补救措施，包括但不限于第9.2.3节中规定的产品保证。此后，本协议将控制2024年已下订单但尚未交付的任何产品制造订单。
2.4.[***]。只要ardelyx在本协议的其他条款中基本遵守，包括但不限于，本协议下的年度承诺义务，Hovione在本期内不会在任何时间[***]，未经ardelyx明确书面同意。Hovione承认并同意，ardelyx可能授予或拒绝其同意[***]。
2.5.规模扩大各方承认，从2027年开始，年度承诺将超过[***]。 因此，各方已签订一份[***]，根据该协议，Hovione应购买、安装、验证和确认某些[***]设备用于[***]（以下简称“设备”) [***] (“设备协议），并参考其中的相关条款，根据其中Ardelyx同意向Hovione预付款和成功费用，总额高达[***]美元（美元[***]）作为及时验证和确认商业产品[***]的代价（以下简称“规模扩大”）。 为明晰起见，任何验证或确认批次（包括规模扩大所需的任何此类批次）应受发展协议（或各方之间可能达成的其他服务协议）约束，并且不算入供应失败次数。
2.6.供应连续性在扩大规模之后，[***]。尽管前述，应ardelyx要求，Hovione将继续向Hovione葡萄牙供应（i）Hovione葡萄牙从Hovione葡萄牙供应的年度承诺中的[***]（除非双方另有约定）直到ardelyx的许可证持有人获得Hovione NJ的监管批准，在此之后（ii）从Hovione葡萄牙提供的产品的协商一致量，至少足以在产品的适用监管备案中保留Hovione葡萄牙设施作为备选供应商场所。ardelyx应采取商业上合理的努力 [***]。ardelyx和Hovione应合作促进为此许可证持有人监管批准所需的信息交付。明确的是，在所有ardelyx许可证持有人批准Hovione NJ之后，上述款项（i）应终止，仅适用款项（ii）。
2.7.无独家来源。根据第2.2节的规定，本协议的任何内容均不得禁止ardelyx从第三方购买tenapanor产品和服务，
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与任何第三方签订供应此类产品和服务的合同、制造自己的产品，或者为产品供应合格的额外设施。
2.8.分包根据质量协议的合规性，Hovione可以在ardelyx的书面同意下聘请第三方执行与制造服务相关的服务（除了分包分析测试或稳定性储存服务，这将不需要书面同意）（第三方分包商），前提是每个第三方分包商都遵守本协议的所有适用义务，并且，在适用的情况下遵守质量协议。如果第三方分包商违反本协议（或适用的质量协议），或者未能执行分包服务的任何部分，则Hovione将对ardelyx有责任，就好像Hovione直接违反、执行或未执行分包服务一样。
2.9.基地设施Hovione将对每个制造地点进行资格验证（并随后维持符合适用法律和cGMP的资格），而这些操作不会产生任何费用。Hovione不会在未首先获得Ardelyx的书面同意的情况下更改制造地点。除[***]外，如果Hovione提出并获得Ardelyx同意有关将执行制造服务的制造地点的制造地点的任何更改，（a）如果此类更改是针对Ardelyx或其产品加工，则双方应诚实进行谈判，以确定为此更改所需的任何验证活动的成本以及由此带来的收益的相应分配，就是这些建议的更改有助于改善制造服务的成本和/或效率的程度；（b）[***]。Hovione不会进行或允许任何对产品产生重大影响或实施任何对流程产生影响的制造地点的修改，包括但不限于未经Ardelyx事先书面同意而不得不合理推迟的加工说明或用于制造产品的设备的更改。
2.10.库存报告霍维昂将在每月（至少）以及收到书面要求并在合理时间内的情况下，向ardelyx提供库存的书面报告，报告形式由霍维昂的电子库存管理平台生成，和/或书面周转计数报告。此外，双方一致同意的时间，每年一次，霍维昂应允许ardelyx合理查看存放所有库存和相关记录的位置，并查看定期管理这些库存和记录的人员，以便ardelyx对霍维昂掌控或掌管的所有库存进行实际盘点。霍维昂将尽商业上合理的努力，确保其第三方承包商让ardelyx获得类似的访问权限。如果霍维昂遇到元件供应问题，包括延迟或交付不符合要求的元件，将及时通知ardelyx。如果任何元件的采购交货时间超出绑定预测时间范围，或者霍维昂无法及时获得需要制造的特定元件，双方将善意协商对本协议做出适当修改，并合作减少或消除供应商的任何供应问题。
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2.11.包装Hovione将安排并实施在每批产品的包装桶上标记批号和有效日期。这些批号和有效日期将按照适用法律、cGMP标准(如果适用)的要求，并与规格一致地附在每个产品的运输容器上。如适用，Hovione将执行关于批号/到期日期和序列号的在线电子验证。如果Hovione在运输容器上放置了与任何产品购买订单中引用的Ardelyx批号不同的内部批号，Hovione将为该产品批次相关的所有文件提供Ardelyx批号的交叉参考。
3.ardelyx的义务
3.1.付款。作为制造服务的全部对价，Ardelyx将根据第4节向Hovione支付适用的价格。在期限内，根据双方的共同协议，Ardelyx可以不时要求Hovione提供价格中未包含的额外服务，以支持产品的制造，但不包括任何受开发协议约束的开发服务（”其他服务”），由双方正式授权的代表签署的书面工作单中规定，并详细说明了Hovione将提供的具体服务以及应提供的任何交付成果（每项，a”工作订单”）。Hovione将根据本协议的条款（包括任何此类工作单中可能包含的对适用条款和条件的任何偏差）提供额外服务，并且此类附加服务应根据双方在该工作单上可能达成的协议单独收费。
3.2.变更控制请求ardelyx和Hovione将与有关文件（即“(变更控制请求”))合作，根据质量协议中规定的变更控制流程进行任何有关工艺指导书、规格或附属文件的请求变更。经质量协议中指定的相关人员接受产品变更控制请求后，Hovione将向Ardelyx提供签署日期的收据，表示Hovione已接受。应Hovione的要求，Ardelyx将提供由Ardelyx或代表Ardelyx提交给监管机构的原始文件的执行证据。Hovione将及时回应任何产品变更控制请求，并商业上合理、诚信地努力就所请求的变更条款及时达成一致（包括价格的任何变更），双方将签署反映制造服务和价格的此类变更的变更订单（即“制造业-半导体”）Hovione同意及时并勤勉地审议并采取行动，以执行监管机构要求的任何变更。产品变更控制请求”）。修改订单）。Hovione同意任何监管机构强制实施的变更将被视为及时且勤勉地考虑和处理。
3.3.API供应.
(a)交货时间。 ardelyx将承担唯一费用并将API交付给制造站点[***]。 [***]的责任将包括从适用的海关机构和监管机构获取API的放行。 除非另有约定
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写信时，Ardelyx或Ardelyx的指定经纪人将是进口到制造场所的API的 “进口商” 或 “海关登记进口商”（或根据Ardelyx适用法律的理解是等效机构），Ardelyx负责遵守与该职位相关的适用法律（以及合规成本）。Ardelyx应至少在固定订单所涵盖产品的预定生产日期之前 [***] 将API交付给制造现场，其数量足以使Hovione能够为该固定订单生产约定数量的产品。如果制造服务延迟是由Ardelyx未能向Hovione提供API而造成的，交货期如前一句所述（”API 延迟”），那么Hovione在与Ardelyx进行了真诚的协商，以确保尽量减少对双方运营的干扰之后，将有权：（a）（i）重新分配原本为此类制造业保留的资源，并根据适用制造场所的可用产能规划重新安排此类制造的时间；（ii）采取商业上合理的努力来填补因此类API延迟而产生的任何闲置产能，以及（iii）与任何由此类 API 延迟导致的剩余闲置容量，向Ardelyx 收取任何此类应付金额重新安排制造时间作为对相应制造场所此类闲置产能的补偿，或 (b) 延长产品的交付期限，前提是双方同意为相应制造场所分配资源中的任何空闲时间提供足够的补偿（如果适用）。如果任何此类延迟持续 [***] 或更长时间，缔约方将开会讨论如何解决问题，包括酌情讨论成本和时间表的影响。
(b)存储Hovione将根据产品安全数据表中包含的所有环保、健康和安全信息，处理、存储和制造API。 Hovione将控制抵达制造现场的API的卸货，并将这些API存储在制造现场或其他双方同意的存储设施（视Ardelyx需要的任何资格限制而定）中，最多免费存储[***]。 API将由Hovione代表Ardelyx按照本协议和与API相关的任何书面指示（包括如适用的任何安全数据表、安全操作说明和相关的健康和环境信息）进行持有。 API将始终是Ardelyx的财产。 Hovione收到的任何API都只能由Hovione用于为Ardelyx执行制造服务。 Hovione将收集API样本并将其交付给Ardelyx指定的第三方进行测试，以符合处理说明。
(c)损失风险API的损失风险在一切时候都将留给ardelyx，而不是在Hovione的监护下。[***]。尽管前述情况：
(i)Hovione将尽商业上合理的努力保持安全，并核对所有API、元件和产品；
(ii)产品损失的风险将根据第5.5节的规定转移到ardelyx。
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(iii)Hovione对因产品制造不当而导致API浪费的责任应按第6条规定。
(iv)根据第3.3(d)节中描述的银行系统，应对[***]导致的API损失进行缓解。
(v)除了上文中与不合格产品和低产品产量有关的第(iii)和第(iv)款规定以外，以及根据第10条款的条款和根据3.3(d)的适用导致的任何调整，如果[***]，Hovione同意根据API报销价格偿还ardelyx公司任何因Hovione公司保管期间丢失或毁坏的其他API数量。
(vi)如果有要求，ardelyx将为Hovione的保险公司提供合理的支持，以支付丢失或损坏的API的费用。
(d)收益银行
(i)就每个制造工厂而言，在根据质量协议制造并交付给ardelyx的前十（10）批产品后，各方应就实际产品与API比例（“产品产量”）达成诚信协议。此后，Hovione应确保产品产量每年符合[***]（“[***]”）。各方承认并同意[***]中应包含各方同意的允许统计偏差，此偏差可能随着制造更多产品批次并从这些制造中收集更多数据而在本协议期间变化。各方同意，截至生效日期，Hovione Portugal的产品产量为[***]%，Hovione Portugal的[***]为[***]%。[***]将按年修订，同时根据第4.2节的更新年度定价，以合并根据本协议制造并交付给ardelyx的额外产品批次的数据。为明确起见，各方同意[***]和年度修订计算仅基于根据质量协议交付给ardelyx的产品批次，并不包括包含有次品产品的批次，无论这些次品产品是否已交付给ardelyx。
(ii)Hovione有权将超过[***]的产量抵销低于[***]的产量或抵销因产品不合格而导致的损失，之后才进行对Ardelyx的任何补偿（“银行系统”）。如果某批次的[***]未达到要求，Hovione将把损失计入银行系统。
(iii)在每个日历年结束后的90天内，Hovione将就实际年度产品产量与[***]进行年度调解，考虑到银行系统的贷方和借方。如果该日历年度的实际产品产量低于[***]，那么Hovione将[***]。如果实际产品产量高于[***]，则超额部分将作为下一年度的结余。
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信贷将用于抵消未来产品收益不足或因产品不足而导致的损失。
3.5. 信息。 根据合适的要求，ardelyx将按照适用法律的规定，向Hovione提供Hovione在履行产品制造和本协议下其他责任方面合理要求的信息。
4.价格和价格调整
4.1. 定价制造和发布产品的定价应按照原始制造地点规定的价格进行 附件1，根据本第4部分的规定进行调整。所有支付应以美元进行。关于在Hovione葡萄牙进行的制造费用，如果美元与欧元之间的汇率与参考汇率（如附录2中定义）相比变动了[***]%或更多，则双方同意根据附录2的条款重新定义费用的价值。
4.2. 年度价格调整Hovione可以调整价格，自第一个完整年度后的每年1月1日生效，调整数值为较大值的（a）[***]或者（b）[***]。对于本第4.2条下的所有价格调整，Hovione将交付给ardelyx[***]封函，说明调整后的定价将在下一年1月1日或之后订购的产品生效，同时附上[***]。
4.3. 变动如果ardelyx要求对制造业-半导体服务范围在第3.2节中所规定的任何更改，相应的变更订单将规定随着这些更改而必要的价格调整，这些调整将在执行此变更订单时生效。
4.4. 税收任何由政府机构征收或根据本合约中Hovione和ardelyx之间拟议的交易所得的使用税、销售税、消费税、增值税、关税、检验或测试费用或任何其他性质的税费或收费（不包括Hovione的所得税），须由ardelyx支付，除了价格之外。如果Hovione被要求支付此类税费或收费：(a)Hovione将及时按照适用法律进行支付，(b)Hovione将向ardelyx开具此类支付的发票，包括适用的付款凭证副本，(c)Ardelyx将就此类支付对Hovione作出赔偿。Ardelyx可以在提交订单时向Hovione提供免税证明或其他可被征税的税费或费用机构接受的文件，作为此类支付的替代。
4.5. 为实现价格降低而努力在本期内，Hovione和ardelyx同意共同努力开发一个旨在[***]的计划，但该计划不会涉及任何一方在未经对方书面同意的情况下产生资本或其他非常规成本。在成功的程度上，
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各方应就由此成本削减计划带来的成本节约分配进行诚信讨论和谈判。
5.购买产品
5.1.预测在生效日期后三十（30）天内，ardelyx将向Hovione提供一份产品成交量的书面预测，预测ardelyx预计在接下来的[***]中从Hovione订购的产品数量（“预测”。每个预测的前[***]将对双方具有约束力（“绑定预测”），其余的[***]将是[其他]，可由双方在预测中首次出现直至该月成为约束性预测的整个期间的[其他]，或者由双方另行约定（“非约束性预测”）。ardelyx将每季度至少提供一次更新的预测。在任何更新的预测部分超过年承诺的情况下，Hovione将善意考虑并尽一切合理努力来适应这种过度，但须遵守Hovione当时向其他客户的约束性承诺。收到每份预测后[***]，Hovione应当书面接受或拒绝该预测，条件是[***]。如果Hovione拒绝了一份预测，它应将书面通知交给ardelyx [***]。如果没有这样的通知，[***]。
5.2.Capacity; Order Placement. In respect of Year 2025, and each Year throughout the remainder of the Term, Ardelyx shall deliver purchase orders quarterly that specify the order quantities and requested delivery dates for the Product in accordance with this Agreement (each a “Purchase Order”). Ardelyx shall purchase Product in an amount at least equal to the Annual Commitment for each Year and otherwise consistent with the Binding Forecast. Hovione shall use Commercially Reasonable Efforts to accommodate any Ardelyx requests to manufacture and deliver volumes of Product which exceed the Binding Forecast (“Excess Product”), but Hovione expressly reserves the right to accept or reject any requests to supply Excess Product. Unless otherwise expressly agreed between the Parties, Ardelyx agrees that it has no right of reservation over the Equipment or any other equipment of Hovione. Each Purchase Order shall (i) specify order quantities consistent with the then current Forecast, (ii) meet the Annual Commitment, and (iii) specify the Purchase Order number and requested Delivery Dates for the Product (not less than [***] from the date of the relevant Purchase Order, and otherwise in accordance with the minimum number of Batches per Hovione Release as set forth in Section 5.5). All Purchase Orders for Product submitted by Ardelyx during the Term will be subject to and will comply with the terms of this Agreement even if the Purchase Order does not expressly make reference to this Agreement.
5.3.Acceptance of Purchase Orders. Hovione shall accept any Purchase Order which does not exceed the Binding Forecast and is properly submitted by Ardelyx in accordance with this Agreement, including in respect of the Delivery Dates stipulated in the relevant Purchase Order, and otherwise in compliance with Section 5.1 and Section 5.2 herein. Hovione may not reject a Purchase Order unless for reasons constituting Force Majeure or [***]. A Purchase Order submitted by Ardelyx and not properly rejected by
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Hovione within [***] will be binding on the parties (a “Firm Order”). Promptly following acceptance of each Firm Order, Hovione will deliver to Ardelyx a copy of its campaign production schedule, after which either party may request a change to the Delivery Date in the Firm Order, and the parties will negotiate in good faith to agree on an alternative Delivery Date. If the parties cannot agree, the original Delivery Date set out in the relevant Firm Order will apply. The original Delivery Date shall in any event be the relevant date for purposes of KPI calculation described in Section 7.1.
5.4.Inventory Management. Hovione will handle and store the Inventory in accordance with this Agreement, any safety data sheets, safe handling instructions and health and environmental information associated therewith and customary industry standards. If any Components have a shelf life or other expiry dating, Hovione will use the Components in manufacturing Product on a first-in, first-out basis to retain shelf life.
5.5.Delivery, Shipping and Storage. Hovione shall release Product together with its issuance of a Certificate of Analysis (as defined in the Quality Agreement) and the Manufacturing Records for the applicable Batch in writing. If Ardelyx identifies any deficiency with the Manufacturing Records it should provide prompt notice to Hovione which shall occur no later than [***] after receipt of the complete Certificate of Analysis and the completed Manufacturing Records. The [***] period set forth in the preceding sentence shall be tolled until Hovione has delivered the complete Manufacturing Records (i.e. the time between the notice from Ardelyx of a deficient Manufacturing Batch and the date of reissuance of the complete Manufacturing Records to Ardelyx will not be included in calculating the [***] period set forth above). Hovione shall retain copies of the Manufacturing Records for such period set forth in the Quality Agreement. Upon Ardelyx’s approval of the Manufacturing Records of at least [***] Batches, Hovione shall make available for Delivery the respective Batches of Product to Ardelyx or its designee in accordance with the Quality Agreement (“Hovione Release”). For clarity Hovione Release shall only occur with multiple Batches with a minimum threshold of three (3) Batches as set forth above, unless Hovione in its absolute discretion decides to act otherwise. Delivery of Product and any other materials will be [***] from Hovione’s Manufacturing Site on the relevant Delivery Date. [***] is responsible for taking delivery of Product at Hovione’s Manufacturing Site with its carrier of choice. [***]. All shipping instructions of Ardelyx will be accompanied by the name and address of the recipient and the shipping date and any costs and insurance associated with shipping will be borne by Ardelyx. Ardelyx will arrange for insurance and will select the freight carrier used by Hovione to ship Product and may monitor Hovione’s shipping and freight activity under this Agreement. Should Ardelyx require special handling, packaging or services not set forth in the Specifications or Processing Instructions (other than for confirmatory testing required by downstream manufacturers), then the cost of such special handling, packaging or services will be borne entirely by Ardelyx at Hovione’s prevailing rates. Ardelyx will use Commercially Reasonable Efforts to take delivery of all Product within [***] after the Delivery Date. Thereafter, Hovione will store Product for up to [***], subject to storage fees at Hovione’s prevailing rates.
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5.6.Invoices and Payment. Hovione will issue and deliver its invoice for each delivery of Product upon the applicable Hovione Release as set forth in Section 5.5, by email to [***]. Hovione will also submit to Ardelyx, with each shipment of Product, a duplicate copy of the invoice covering the shipment. Each invoice will, to the extent applicable, identify the applicable Ardelyx Purchase Order number, Product name and quantity, unit price, freight charges, and the total amount to be paid by Ardelyx. Ardelyx will pay all undisputed invoices within thirty (30) days of the delivery of the invoice. If any portion of an invoice is disputed, Ardelyx will pay Hovione for the undisputed amount and the parties will use good faith efforts to reconcile the disputed amount as soon as practicable. Hovione shall not suspend Manufacturing Services, withhold Product, or otherwise delay or stop providing services in connection with any such good faith dispute. In the event any undisputed payment is not made on time for three consecutive invoices, Hovione will be entitled, in addition to its other rights and remedies, to (a) charge interest on the unpaid amount at the rate of one and one half percent (1.5%) per month of the unpaid undisputed balance per month or the maximum amount allowed by law; and (b) if such non-payment persists for six consecutive undisputed invoices, to cease work and stop deliveries until such payment, including any interest, is made.
6.Product Rejection and Recalls
6.1.Acceptance. Within [***] following Ardelyx’s receipt of the Product and approved Manufacturing Records, Ardelyx shall provide Hovione with written notice of its acceptance or rejection of the Product. If Ardelyx fails to provide Hovione with written notice within such [***] period, the Product will be deemed to be accepted by Ardelyx.
6.2.Rejection. Ardelyx may reject any Product (a “Product Rejection”) for any portion of any Batch of Product for which Hovione did not [***] or where the Product otherwise fails to [***] (“Deficient Product”). Any rejection notice issued shall state in reasonably sufficient detail the [***]. Ardelyx shall have the right to, and Hovione may require that Ardelyx, return any rejected Product to Hovione at [***]’s cost. With respect to Product Rejection relating to Deficient Product that (i) [***] (“[***]”), Ardelyx will in all cases give written notice within [***] after the Delivery Date of the Product. For clarity, Hovione shall only be liable for Product Rejection as expressly set forth in Section 6.4.
6.3.Determination of Deficiency. The basis for a Product Rejection by Ardelyx shall be conclusive unless Hovione notifies Ardelyx via email or otherwise in writing within [***] of its receipt of the rejection notice that it disagrees with the basis for rejection. In the event Hovione and Ardelyx are unable to agree as to whether the Product has been appropriately rejected, [***]. The conclusion of such mutually [***] shall be binding for both Parties.
6.4.Replacement Product. In the event that any Product is appropriately rejected and unless Hovione can show with sufficient evidence that (i) [***] (collectively “[***]”) or (ii) Deficient Product is otherwise due to Ardelyx’s Fault, then Hovione shall promptly [***]. If the Parties determine that replacement can not be done through reprocessing or
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reworking, Hovione shall promptly, at Ardelyx’s election following good faith consultation with Hovione, either:
6.4.1.Use Commercially Reasonable Efforts to replace such Deficient Product, if [***], provided that the acceptance procedures described above shall be repeated for any replacement Product. Costs for such replacement Product shall be as follows:
6.4.1.1.Manufacturing Services Costs. Unless Hovione can show with sufficient evidence that (i) [***] or (ii) Deficient Product is otherwise due to Ardelyx’s Fault, Hovione will [***];
6.4.1.2.API Costs. Unless Ardelyx can provide sufficient evidence that the failure in the Deficient Product is due to Hovione’s Fault, Ardelyx shall pay [***]; or
6.4.2.Credit such amounts as follows:
6.4.2.1.Manufacturing Services Costs. Credit [***]% of [***] unless Hovione can show with sufficient evidence that the Deficient Product is due to [***]; and
6.4.2.2.API Costs. If Ardelyx can provide sufficient evidence that the failure in the Deficient Product is due to Hovione Fault, credit [***]% of [***] in respect of such Deficient Product Batch(es).
6.4.3.Subject to Section 10.3, the remedies set forth in Section 6.4.1 and Section 6.4.2 are Ardelyx’s sole remedies under this Agreement with respect to Deficient Product.
6.5.Supply Failure.
6.5.1.Remedies for Supply Failure. Hovione shall work diligently to avoid Supply Failure during the Term. In the event of a Supply Failure, Ardelyx may in its sole discretion do one or more of the following: (a) [***], (b) [***]. To the extent such Supply Failure was due to [***], for clarity excluding any Supply Failure resulting from Deficient Product to the extent Hovione is not liable for such Deficient Product under Section 6.2, and notwithstanding Section 5.1, Ardelyx may (i) adjust its Forecast as reasonably required by Ardelyx to account for the Supply Failure and its impact on forecasted market demands and (ii) adjust any outstanding Binding Forecast not yet Manufactured, including any payment obligations associated therewith, without any further liability on Ardelyx’s part, and (iii) [***].
6.5.2.Annual Commitment. In addition to the remedies set forth in Section 6.5.1, if Hovione fails to deliver at least [***] percent ([***]%) of the total aggregate quantity of Product placed under all Firm Orders in any given Year (provide such quantities are equal or above the Annual Commitment), within [***] after the last Delivery Date
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scheduled for each respective Firm Order for [***] within the Term (“Firm Order Failure”), then Ardelyx shall [***] until such time as Hovione has delivered at least [***], without Firm Order Failure, after which the [***]. The remedies contained in this Section 6.5 for a Supply Failure will be in addition to the rights of indemnification contained in Section 11.1 and any other rights and remedies available under this Agreement to Ardelyx.
6.5.3.Adverse Supply Events. If there is an Adverse Supply Event that Hovione does not remediate so that it can perform the Manufacturing Services in accordance with the Processing Instructions and manufacture Product in accordance with this Agreement within [***], Ardelyx may [***]. To the extent such Adverse Supply Event was due to Hovione’s Fault, Ardelyx may in its discretion do any of the following (i) [***] or (ii) [***]. In the event an Adverse Supply Event is due to Hovione being unable to comply with a change in the Processing Instructions or Specifications that is required by the FDA or other United States Regulatory Agency, (a) the Parties shall discuss in good faith [***], and (b) [***]. The existence of an Adverse Supply Event will not exonerate or otherwise relieve either Party of any liability for breach of any independent obligation contained in this Agreement.
6.6.Processing Holds and Cancellation Fees. Notwithstanding anything to the contrary herein, Ardelyx may at any time instruct Hovione to suspend Manufacture of the Product on [***] days’ written notice following [***] (a “Processing Hold”) so that the Parties can confer to discuss the underlying cause(s). Hovione shall not commence Processing during such notice period but may complete Batches that have already commenced Processing on the date such notice was delivered. Within [***] days after initiation of a Processing Hold, the Parties shall negotiate in good faith any changes or remedies appropriate under the circumstances in respect of the applicable Firm Order, impacted Forecast, Annual Commitment and/or Pricing. The Processing Hold shall expire upon execution of a written instrument reflecting the foregoing mutually agreed changes and/or remedies, provided that if the Parties fail to reach agreement within [***]) days after initiation of the Processing Hold, then:
6.6.1.To the extent that Ardelyx instructs Hovione to remain in a Processing Hold, Ardelyx shall pay for Facility idle time (“Idle Time”), including any Idle Time incurred within [***] after a Processing Hold, at an annualized rate of [***] during such period of Processing Hold;
6.6.2.Ardelyx shall have a right to terminate this Agreement in the event of a Processing Hold, effective on the [***] anniversary of the notice of termination issued in accordance with this Section, subject to payment, at Ardelyx’s discretion, of one of the following: (A) Annual Commitment for the remainder of such truncated Term (or the reduced Annual Commitment in accordance with Section 6.5.1(iii) if applicable), provided, however, Hovione shall use Commercially Reasonable Efforts to reallocate any resources liberated in connection with such termination to other projects, and to the extent successful in reallocating the resources previously reserved for Ardelyx, reduce or waive any corresponding payment obligations of Ardelyx; or (B) non-refundable yearly fees for the
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remainder of such truncated Term, but without further Annual Commitment obligations, as follows: (i) [***] percent ([***]%) of the Idle Time fees due for the period between the notice of termination and [***]; (ii) [***] percent ([***]%) of the Idle Time fees due for the period between [***] and [***]; and (iii) [***] percent ([***]%) of the Idle Time fees due for the period between [***] and [***]. Ardelyx shall determine in its notice of termination its choice between items (A) and (B) above; and
6.6.3.A Processing Hold may be lifted by mutual agreement following Ardelyx’s written notice to Hovione accompanied by an updated Forecast and a new Firm Order, subject to delivery of any Idle Time payments due in respect of such Processing Hold. Hovione shall agree to any such lifting of a Processing Hold unless it reasonably determines that further Processing would be unlawful or technically impossible. Commencing on the first Hovione Release of non-Deficient Product under such new Firm Order, (a) the Annual Commitment shall be reinstated to the level set forth in Section 2.2, prorated for the remainder of the applicable Year and (b) Ardelyx’s right of termination under Section 6.6.2 shall expire in respect of the lifted Processing Hold. For clarity, such termination right shall be available for any subsequent Processing Hold, subject to the terms of this Section 6.6.
6.6.4.In either option (A) or (B) as set forth in Section 6.6.2, starting from the receipt of a notice of termination following a Processing Hold in accordance with Section 6.6.2, Hovione shall have the right to reallocate resources liberated through any Processing Hold to other projects and in option (A) shall reduce or waive the respective fees as set forth in Section 6.6.2. Any credits or other payments due to Ardelyx under this Agreement shall be issued within [***].
6.7.Product Recalls and Returns.
6.7.1.Records and Notice. The parties will each maintain records, in accordance with cGMP and each Party’s standard operating procedures, and otherwise as reasonably necessary to permit a Recall of any Product delivered to Ardelyx or customers of Ardelyx. Each party will promptly notify the other of any information which might affect the marketability, safety or effectiveness of the Product or which might result in the Recall or seizure of the Product in accordance with the Quality Agreement. The decision to initiate a Recall or to take some other corrective action, if any, will be [***]. “Recall” will mean any action: (i) by Ardelyx to recover title to or possession of quantities of the Product sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Product from the market); (ii) by any Regulatory Authority to detain or destroy any of the Product; or (iii) by either party to refrain from selling or shipping quantities of the Product to third parties which would be subject to a Recall if sold or shipped.
6.7.2.Recalls. If: (i) any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled; or (ii) a court of competent jurisdiction orders a Recall; or (iii) Ardelyx determines that any Product should be Recalled, then Hovione will [***]. Ardelyx
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will bear all expenses of any Recall and Hovione’s assistance unless and to the extent such Recall directly results from Hovione’s gross negligence or willful misconduct.
6.7.3.Recalled Product. To the extent that a Recall directly results from Hovione Hovione’s gross negligence or willful misconduct , Hovione will, subject to the limitations set forth in Section 10, be [***]. Ardelyx may adjust its Forecast as reasonably required by Ardelyx to account for the Recall and its impact on forecasted market demands.
6.8.Disposition of Deficient Product. Ardelyx will not dispose of any damaged, returned, or Deficient Product for which it intends to assert a Product Rejection against Hovione without Hovione’s prior written authorization to do so. Hovione may instruct Ardelyx to return the Product to Hovione. Hovione will [***].
7.Co-operation and Regulatory Affairs
7.1.Governance. Each Party will without delay upon execution of this Agreement appoint one of its employees to be a relationship manager responsible for liaison between the Parties. The relationship managers will meet on a frequency agreed between the Parties to review the current status of the business relationship, including, but not limited to, review of key performance indicators such as API delivery, on-time delivery of Product, right first time, and satisfaction of the Annual Commitment (“KPIs”), and manage any issues that have arisen.
7.2.Governmental Agencies. The Parties will consult each other in relation to regulatory communications directly relating to the Product in accordance with the Quality Agreement. To the fullest extent permitted under Applicable Laws (in relation to Ardelyx’s use of the Product) and cGMP, Ardelyx shall have sole authority and responsibility for communicating with any Regulatory Authority responsible for granting Regulatory Approval for the Product and any other relevant Authority regarding the Product. Hovione will provide to Ardelyx, its Affiliates and Licensees with reasonable assistance as Ardelyx may request in order to assist with obtaining Regulatory Approval for Products, subject to reimbursement of Hovione’s reasonable expenses incurred in connection therewith.
7.3.Governmental Inspections and Requests. Hovione will promptly advise Ardelyx if an authorized agent of any Regulatory Authority intends to inspect a Manufacturing Site, to the extent such inspection is directly related to the Product or could reasonably be expected to impact the Manufacture of the Product. Hovione will promptly furnish Ardelyx a copy of any report or notice issued by the Regulatory Authority (including, without limitation, any Form 483s or warning letters) (redacted to the extent containing information that is not relevant to the Manufacturing Services or the Product). To the extent the inspection is announced and is directly related to the Product, Hovione will promptly inform Ardelyx and, to the extent permitted by the applicable Regulatory Authority, Parties will discuss in good faith an appropriate scope for Ardelyx agents and representatives to be present at the Manufacturing Site on the date and time of such Regulatory Authority inspection. Hovione shall in any event [***].
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7.4.Records. Hovione will keep complete and accurate books, records, test and laboratory data, reports and other information relating to the manufacture, testing, and shipping of the Product (including, without limitation, all manufacturing and packaging Batch records), and retain samples of the Product as are necessary to comply with manufacturing regulatory requirements applicable to Hovione, Applicable Laws and cGMP. Copies of the records and samples will be retained as and for the period specified in the Quality Agreement provided, however, that Hovione may exclude or redact from such Records any confidential or proprietary information of third parties or any Hovione Background IP that Hovione regards as trade secrets. The Parties acknowledge and agree that the Manufacturing Records constitute Confidential Information of Ardelyx.
7.5.Audits. In accordance with the frequency and parameters set forth in the Quality Agreement ([***]), Hovione will give Ardelyx and its Licensees (if so requested by Ardelyx, and who cannot be competitors of Hovione and who are subject to confidentiality obligations no less restrictive than those set forth in this Agreement) reasonable access at agreed times to the areas of the Manufacturing Site in which the Product is manufactured, stored, handled, or shipped and to the personnel that regularly perform these activities, to permit Ardelyx and its Licensees to verify that the Manufacturing Services are being performed in accordance with the Processing Instructions, the Specifications, this Agreement, cGMPs and Applicable Laws. Ardelyx’s and its Licensees’ employees and representatives will at all times comply with Hovione’s rules, regulations and SOPs relating to inspections and visits to the Facility, and Ardelyx shall be responsible for compliance with this Agreement by its and its Licensees’ representatives on Hovione’s premises. Hovione will use Commercially Reasonable Efforts to enable that its Third Party Subcontractors permit Ardelyx and its Licensees similar audit rights to those set forth in this Section 7.5 and to the extent unsuccessful shall make its own audit reports for such Subcontractors available for review by Ardelyx and its Licensees in the course of an audit in accordance with this Section 7.5.
7.6.Regulatory Filings.
7.6.1.Regulatory Authority Documentation. Ardelyx will provide copies of all relevant documents relating to Regulatory Authority approval for the commercial manufacture of the Product (“Regulatory Approval”) to Hovione on request. Hovione will review and verify the accuracy of these documents in accordance with the Quality Agreement. Ardelyx shall refrain from submitting Regulatory Approvals specifically referring to Hovione or its Affiliates or the Manufacturing Services until approved by Hovione (this approval not to be unreasonably withheld or delayed).
7.6.2.Deficiencies. If Hovione reasonably determines that any regulatory information pertaining to the Manufacturing Services or the Manufacturing Site given by Ardelyx is inaccurate or deficient in any manner whatsoever (the “Deficiencies”), Hovione will notify Ardelyx promptly in writing of the Deficiencies. The Parties will each use commercially reasonable efforts and act in good faith to have the Deficiencies resolved prior to the date of filing of the relevant application and in any event before any pre-
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approval inspection or before the Product is placed on the market if a pre-approval inspection is not performed.
7.6.3.Pharmacovigilance. If requested by either Party, Hovione and Ardelyx will use Commercially Reasonable Efforts to negotiate in good faith a process and procedure for sharing adverse event information received by Hovione. Hovione will provide Ardelyx with any information received by it regarding any adverse events and/or quality complaints in connection with the use of the Product to Ardelyx Pharmacovigilance within [***].
7.7.Release. Nothing in this Agreement will remove or limit the authority of the relevant quality function (as specified by the Quality Agreement) to determine whether the Product will be released for sale or distribution.
8.Term and Termination
8.1.Initial Term. This Agreement will become effective as of the Effective Date and will continue until December 31, 2030 (the “Initial Term”), unless terminated earlier by one of the Parties in accordance with this Agreement. Thereafter, this Agreement will automatically renew for successive terms of two Years until terminated in accordance with this Agreement. The Initial Term together with all successive renewal terms shall together be referred to herein as the “Term”. In the event that a Party elects to exercise a right of termination afforded it in accordance with the provisions of Section 8.2, such Party shall provide the other Party with a written notice (a “Notice of Termination”).
8.2.Termination.
8.2.1.Termination due to Legitimate Business Needs.
8.2.1.1.Initial Term. No earlier than [***] years from Effective Date, Ardelyx may terminate this Agreement for Business Need effective during the Initial Term, provided that such notice shall not be effective until [***] months after delivery of the Notice of Termination and that Parties shall negotiate in good faith a winding down of Annual Commitment to release capacity from the Equipment.
8.2.1.2.Renewal Term. Either Party may terminate this Agreement for convenience effective after expiration of the Initial Term, provided that such termination shall be effective (i) [***] months after delivery of a Notice of Termination by Ardelyx, or (ii) [***] months after delivery of a Notice of Termination by Hovione.
8.2.2.Termination for Cause. Either Party may terminate this Agreement by providing a Notice of Termination for breach if the other Party has failed to remedy a material breach of this Agreement within [***] days (the “Remediation Period”) following receipt of a written notice of the breach from the aggrieved Party that expressly states that it is a ‘notice of breach’ under this Section 8.2.2 (a “Breach Notice”). Each Party will ensure that any Breach Notice delivered by it to the other Party will not contain any reference to a
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Notice of Termination, or otherwise express any intent to terminate this Agreement, until that Party may properly submit a Notice of Termination for breach in accordance with this Section 8.2.2. The aggrieved Party’s right to terminate this Agreement under this Section 8.2.2 may only be exercised for [***] days following the expiry of the Remediation Period (where the breach has not been remedied) and if the termination right is not exercised during this period then the aggrieved Party will be considered to have waived the breach described in the Breach Notice.
8.2.3.Termination for Regulatory Action. Ardelyx may terminate this Agreement effective [***] days after delivery of a Notice of Termination for regulatory action if any Regulatory Authority takes any legal action or procedure that prevents Ardelyx from selling the Product in the United States and such market interruption is reasonably expected to last at least [***].
8.2.4.Termination for Product Issue. Ardelyx may terminate this Agreement effective [***] days after delivery of a Notice of Termination for Product issue if a [***] notifies Hovione or Ardelyx [***] that there is a significant regulatory deficiency of Hovione related to the performance of the Manufacturing Services at the Manufacturing Site therefore resulting in an Adverse Supply Event in accordance with Section 1.1(ii) and Hovione is not able to satisfy its obligations under this Agreement through Manufacture at an alternative approved Manufacturing Site, and the deficiency is not remedied to the satisfaction of the Regulatory Authority within [***] days of the notice.
8.2.5.Supply Failure. Ardelyx may terminate this Agreement effective [***] after the delivery of a Notice of Termination for Supply Failure arising due to Hovione’s Fault if there have been more than [***] Supply Failures in [***] or more than [***] Supply Failures in [***].
8.2.6.Force Majeure. Either Party may terminate this Agreement under Section 14.5 (Force Majeure) in accordance with the terms thereof.
8.3.Obligations in Connection with Termination. If this Agreement is terminated for any reason, then:
8.3.1.Firm Orders and Outstanding Credit. Following the delivery of a Notice of Termination by either Party in accordance with the provisions of Section 8.2 of this Agreement (except in the case of a Notice of Termination delivered for cause by Hovione pursuant to Section 8.2.2 or 8.2.6), Hovione shall continue to supply Product in accordance with the Binding Forecast and any Firm Orders until the effective date of the termination set forth in the Notice of Termination unless unlawful. To the extent there is any outstanding credit or amounts due from Hovione to Ardelyx hereunder, including any credit due in accordance with Section 3.3(d) after termination of the Agreement and delivery of the final Batch of Product as set forth in this Section 8.2.1, Hovione shall reimburse such amounts to Ardelyx within [***] days after the effective date of termination.
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8.3.2.Inventory; Payment. At least [***] days prior to the effective date of termination or expiration of this Agreement, Hovione will deliver to Ardelyx a written accounting of all Inventory and any other moveable property owned by Ardelyx that is in Hovione’s possession or control (“Ardelyx Property”), including quantities, identification information, location, and such other relevant information as may be reasonably requested by Ardelyx. The Parties shall cooperate in good faith to finalize such accounting, whereupon Ardelyx shall be entitled to take delivery of any Components that it desires to receive, and Hovione shall deliver to Ardelyx an invoice for (i) all undelivered Product Manufactured under a Firm Order (subject to the acceptance provisions of Section 6), at the Price in effect at the time the Firm Order was placed, (ii) all Components identified by Ardelyx for delivery, which shall be invoiced at Hovione’s cost plus a [***]% administration fee and without additional mark-up, and (iii) any Annual Commitment payment obligations due pursuant to Section 2.2(b) in respect of the Term, as truncated by such termination (the “Final Invoice”). Subject to resolution of any disputed portion of the Final Invoice, Ardelyx shall pay the Final Invoice and take delivery of the Ardelyx Property within [***] days after receipt of the Final Invoice. If Ardelyx asks Hovione to destroy any Ardelyx Property, Hovione will arrange for such destruction, at Ardelyx’s cost, in accordance with Applicable Laws and cGMP. Hovione acknowledges and agrees that, following payment of the Final Invoice, Ardelyx shall have no further payment obligations under this Agreement.
8.4.Survival. Except as otherwise set forth herein, the termination or expiration of this Agreement will not affect any prior outstanding obligations or payments due, nor will it prejudice any other rights or remedies that the Parties may have under this Agreement. The obligations and responsibilities of the Parties under Sections 6, 7, 8.3-8.4 and 10-14 shall survive any termination or expiration of this Agreement, as well as any other provisions that are by implication or otherwise intended to survive. Where Hovione has agreed to provide stability services beyond the final supply of Product, the relevant provisions of this Agreement related to stability services will survive for the agreed duration of those stability services.
9.Representations, Warranties and Covenants
9.1.Mutual Representations.
9.1.1.Authority. Each party covenants, represents, and warrants that it has the full right and authority to enter into this Agreement and that it is not aware of any impediment that would inhibit its ability to perform its obligations under this Agreement.
9.1.2.Sanctions. Neither Ardelyx nor Hovione, nor any of their respective Affiliates, nor to the best knowledge of each Party, any of its directors, officers or representatives, is an individual or entity that is, or is owned or controlled by an individual or entity that is the subject of any sanctions administered or enforced by the U.S. Department of Treasury’s Office of Foreign Assets Control, the United Nations Security Council, the European Union, Her Majesty’s Treasury, or other relevant sanctions authority
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in the Territory. Breach of this Section 9.1.2 shall be considered a material breach of this Agreement and, notwithstanding anything to the contrary herein, to the extent either Party reasonably determines the breach by the other Party of this Section 9.1.2, the non-breaching Party shall be able to terminate this Agreement for cause and with immediate effect.
9.2.Manufacturer Warranties. Hovione covenants, represents, and warrants to Ardelyx as follows:
9.2.1.Compliance. Hovione will perform the Manufacturing Services in accordance with this Agreement, the Processing Instructions, cGMPs and Applicable Laws.
9.2.2.Non-Infringement. To the best of Hovione’s knowledge, the Hovione Intellectual Property used by Hovione to perform the Manufacturing Services (i) is Hovione’s or its Affiliate’s unencumbered property or is otherwise licensed to Hovione, (ii) may be lawfully used by Hovione, and (iii) does not infringe and will not infringe any Third Party Rights.
9.2.3.Product. Upon delivery to Ardelyx or its designee, the Product will: (i) have been manufactured in accordance with the Processing Instructions and all cGMPs, (ii) meet the Specifications and conform to the Manufacturing Records, and (iii) [***] (collectively, the “Product Warranties”).
9.2.4.Custody. Hovione will at all times use commercially reasonable measures to protect all Inventory in its possession or control from theft, damage, loss or misuse.
9.2.5.No Debarment. Hovione will not in the performance of its obligations under this Agreement, to the best of its knowledge, use the services of any person who is debarred or suspended under 21 U.S.C. §335. To the best of its knowledge, Hovione does not currently have, and it will not hire, as an officer or an employee any person who has been convicted of a felony under Applicable Laws.
9.2.6.Notice. Hovione will promptly notify Ardelyx if at any time during the Term if it becomes aware that any of the foregoing representations and warranties has been breached or is untrue.
9.3.Ardelyx Warranties. Ardelyx represents and warrants to Hovione that:
9.3.1.To the best of Ardelyx’s knowledge, the use of Ardelyx Background IP (other than Background IP generated by Hovione in performance of the Development Agreement) as contemplated in the Manufacturing Services will not infringe the intellectual property rights of any Third Party and Ardelyx will promptly notify Hovione in writing should it become aware of any claims asserting such infringement.
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9.3.2.Upon delivery to Hovione, the Ardelyx Materials will comply with the applicable specifications, and have been manufactured in accordance with cGMP (if applicable).
9.3.3.Ardelyx will comply with all Applicable Laws in its use of the Product.
9.3.4. Ardelyx will not release any Batch of Product for commercial sale if Ardelyx does not hold all necessary Regulatory Approvals to market and sell the Product.
9.4.Disclaimer of Implied Warranties. EXCEPT AS EXPRESSLY SET OUT IN THIS AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY, REPRESENTATION OR CONDITION OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW.
10.Limitations on Liability
10.1.Product Rejection claims. Subject to Section 10.3, and except for any claim for expenses related to a Recall under Section 6.7.1, the remedies described in Section 6.4 will be Ardelyx’s sole remedy for Deficient Product.
10.2.Consequential Damages. Subject to Section 10.3, under no circumstances whatsoever will either Party be liable to the other for any consequential, special, punitive or other indirect liability, damage, costs, penalty, or expense of any kind incurred by the other party of an indirect or consequential nature, regardless of any notice of the possibility of these damages PROVIDED, HOWEVER, THAT THIS LIMITATION WILL NOT APPLY TO DAMAGES RESULTING FROM BREACHES BY A PARTY OF ITS DUTY OF CONFIDENTIALITY AND NON-USE IMPOSED UNDER SECTION 12.
10.3.Limitation of Liability. Subject to Section 10.4, Hovione’s liability for Losses arising from any single event under this Agreement (including without limitation any such event arising from Manufacturing) will be limited to [***]; the total liability of Hovione for Losses under this Agreement during [***] is limited to the lesser of (i) [***] US Dollars ($[***]) or (ii) the amount paid by Ardelyx under this Agreement and/or the Development Agreement during [***]; and, in any case, the total aggregate liability of Hovione for Losses under this Agreement is limited to [***] US Dollars ($[***]).
10.4.Exclusions. Nothing contained in this Agreement will act to exclude or limit either Party’s (i) liabilities arising from failure to meet the confidentiality obligations under Section 12, (ii) liabilities arising from a Party’s gross negligence or willful misconduct, or (iii) liability for personal injury or death caused by the negligence of either party or fraudulent misrepresentation. In addition, nothing contained in this Agreement will act to limit or exclude Hovione’s or Ardelyx’s performance obligations or liabilities under Section 6.4.1.1.
11.Indemnification.
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11.1.Hovione Indemnity. Hovione agrees to defend and indemnify Ardelyx, its officers and employees, against all losses, damages, costs, claims, demands, subpoenas, judgments and liability (“Losses”) asserted against or incurred by them in connection with any legal action or claim brought by third parties (“Third Party Claims”) to the extent the Third Party Claim is the direct result of (a) a breach of [***], or (b) Hovione’s [***] in performing this Agreement except, in each case, to the extent Ardelyx is obligated to indemnify Hovione under Section 11.2.
11.2.Ardelyx Indemnity. Ardelyx agrees to defend and indemnify Hovione, its officers and employees, against all Losses asserted against or incurred by them in connection with any Third Party Claim to the extent the Third Party Claim is the result of (a) the manufacturing (insofar as it relates to Ardelyx’s obligations pursuant to this Agreement or the Development Agreement), packaging, marketing, distribution, import, use or sale by Ardelyx or its Licensees of the Product (including without limitation any claim of infringement of any patent or trademark or the unauthorized use of a trade secret and any product liability claims), (b) a breach of [***], or (c) Ardelyx’s [***] in performing this Agreement; except, in each case, to the extent Ardelyx is obligated to indemnify Hovione under Section 11.1.
11.3.Indemnity Procedure. A Party that intends to claim indemnification under Section 11.1 or Section 11.2 (the “Indemnitee”) will notify the other Party (the “Indemnitor”) promptly in writing of the applicable Third Party Claim, provided that the failure to give timely notice to the Indemnitor will not release the Indemnitor from any liability to the Indemnitee except to the extent the Indemnitor is actually prejudiced thereby. The Indemnitor will have the right, by notice to the Indemnitee, to assume the defense of the action or claim within fifteen (15) days after the Indemnitor’s receipt of notice of the action or claim with counsel of the Indemnitor’s choice and at the sole cost of the Indemnitor. If the Indemnitor assumes the defense, the Indemnitee may participate therein through counsel of its choice, but at the sole cost of the Indemnitee. The Party not assuming the defense of the claim will give reasonable assistance to the Party assuming the defense, and all reasonable out-of-pocket costs of this assistance will be for the account of the Indemnitor. No claim will be settled other than by the Party defending the claim, and then only with the consent of the other Party which will not be unreasonably withheld or delayed. The Indemnitee will have no obligation to consent to any settlement of any action or claim which imposes on the Indemnitee any liability or obligation which cannot be assumed and performed in full by the Indemnitor, and the Indemnitee will have no right to withhold its consent to any settlement of any action or claim if the settlement involves only the payment of money by the Indemnitor or its insurer.
12.Confidentiality
12.1.Definition. “Confidential Information” means any and all non-public scientific, technical, financial or business information, including without limitation any third-party confidential information, that is furnished or made available by or on behalf of one Party or its Affiliates (the “Discloser”) to the other or its Affiliates (the “Recipient”),
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on or after the Effective Date, whether in writing, orally, visually ((including, without limitation, video, streaming or picture) or through physical inspection, subject to the exceptions in this Section 12.1. The term “Confidential Information” does not include information that (a) is publicly known at the Effective Date or later becomes publicly known under circumstances involving no breach of this Agreement, (b) is lawfully and in good faith disclosed to the Recipient without an obligation of confidence by a third party who is not subject to a confidentiality obligation to the Discloser, (c) is independently developed by the Recipient without use of or reliance on the Discloser’s Confidential Information, as evidenced by its written records; or (d) by a mutual written agreement by the Parties, is released from confidential status. Subject to the foregoing exceptions in this Sections 12.1, Ardelyx Confidential Information includes the Manufacturing Records, Specifications and Processing Instructions, and Hovione Confidential Information includes Hovione Background IP, Hovione Inventions and Incorporated Hovione IP. This Agreement constitutes the Confidential Information of both Parties.
12.2.Restriction. Discloser shall use commercially reasonable efforts to mark any Hovione Confidential Information “Confidential” or otherwise identify it as Confidential Information at the time of disclosure. Notwithstanding the foregoing, all information provided by one Party to the other, regardless of being marked or identified as confidential, shall be considered Confidential Information if it would be apparent to a reasonable person familiar with the Discloser’s industry that such information is of a confidential or proprietary nature.
12.3.Confidentiality Obligation. The Discloser shall be the sole owner of its Confidential Information. Recipient will keep confidential and protect the confidentiality of Confidential Information and will not disclose or use any Confidential Information except with the Recipient’s written permission or as permitted under this Agreement. Recipient will protect the Confidential Information disclosed to it by using reasonable precautions to prevent the unauthorized disclosure, dissemination or use of the Confidential Information, which precautions will not be less than those exercised by Recipient for its own confidential or proprietary Confidential Information of a similar nature. Recipient may disclose Confidential Information to its Representatives who need to know such Confidential Information in order to perform Recipient’s obligations or exercise Recipient’s rights hereunder, and who are legally or contractually bound to protect the confidentiality of such Confidential Information under terms no less stringent than those set forth in this Section 12. Specifically, Ardelyx may disclose [***] to its Representatives in order to exercise its rights under the license grants set forth in Section 13.6.2 and such right shall survive termination of this Agreement, and Ardelyx shall have the right to disclose [***]. Each Party, in its capacity as a Recipient, will be liable for the acts and failures to act by its respective Representatives for the improper use, disclosure, distribution, protection or handling of the Confidential Information of the Discloser as the actions or failures were committed directly by the Recipient.
12.4.Permitted Disclosure. Recipient may disclose Confidential Information of the Discloser to the extent required, as advised by counsel, in response to a valid order of a
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court or other governmental body, or as required by law, regulation or stock exchange rule applicable to it; provided that, to the extent lawful, the Recipient will (a) advise the Discloser in advance of the disclosure and (b) limit the required disclosure to the extent practicable and permissible by the order, law, regulation or stock exchange rule and any other applicable law, and (c) reasonably cooperate with the Discloser, if requested, in seeking an appropriate protective order or other remedy, and (d) otherwise continue to perform its obligations under this Section 12 with respect to information so disclosed. If any public disclosure is required by law, the Parties will consult concerning the form of announcement prior to the public disclosure being made.
12.5.Return of Confidential Information. Upon the written request of the Discloser or termination of the Agreement pursuant to Section 8, the Recipient will promptly return or destroy the Confidential Information of the Discloser, as directed by the Discloser, except for one copy which may be maintained by the Recipient in the sole and exclusive custody of its legal department to be held for the sole purpose of assessing compliance with the terms of this Agreement. The retained copy will remain subject to all confidentiality provisions contained in this Agreement. During the Term, Ardelyx will not unreasonably require the return or destruction of Confidential Information that is necessary or useful for Hovione to perform the Manufacturing Services. Hovione will not unreasonably require the return of Confidential Information that is necessary for Ardelyx to exercise its rights under this Agreement, and, specifically, to exercise its rights as granted by Section 13 (Intellectual Property).
12.6.Remedies. The Parties acknowledge that monetary damages may not be sufficient to remedy a breach by either Party of this Section 12 and therefore agree that the non-breaching Party will be entitled to seek specific performance, injunctive or other equitable relief in any court of competent jurisdiction (notwithstanding Section 14.13) to prevent breaches of this Section 12 and to specifically enforce Section 12 in addition to any other remedies available at law or in equity. These remedies will not be the exclusive remedies for breach of this Section 12 but will be in addition to any and all other remedies available at law or in equity.
12.7.Survival. The obligations contained in this Section 12 will survive any termination of this Agreement for seven years from the last day of the Term.
13.Intellectual Property
13.1.Development Agreement. All inventions and other Intellectual Property arising from performance of Development Services, including without limitation project reports, final reports and Manufacturing Records, shall be owned in accordance with, and otherwise subject to, the terms and conditions of the Development Agreement.
13.2.Background IP. Ardelyx shall solely own all Ardelyx Background IP and Hovione shall solely own all Hovione Background IP (collectively, “Background IP”). For
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clarity the Process for Manufacture of the Product, as of the Effective Date, constitutes Ardelyx Background IP.
13.3.Ardelyx Inventions. Ardelyx shall solely own all Inventions arising from [***] (collectively, “Ardelyx Inventions”). Hovione hereby assigns to Ardelyx, and agrees to assign to Ardelyx, all right, title and interest in and to the Ardelyx Inventions.
13.4.Hovione Inventions. As between the Parties, Hovione shall solely own all Inventions arising from [***] that do not constitute Ardelyx Inventions (collectively, “Hovione Inventions”). Hovione shall [***]. Each Party will be solely responsible for the costs of filing, prosecution, and maintenance of patents and patent applications on its own Inventions.
13.5.Incorporated Hovione Background IP. Prior to Hovione’s use of Background IP in a manner which could result in the incorporation of, embodiment within, or reference to, any such Hovione Background IP in the Product or Process, Hovione shall first (i) provide Ardelyx with a written description of any such Hovione Background IP proposed to be so used or incorporated and (ii) obtain Ardelyx’s prior written consent to proceed to use the Hovione Background IP in the manner so described, whereupon the Parties shall promptly negotiate commercially reasonable terms for, and Hovione shall grant to Ardelyx, a license to practice all such Hovione Background IP in accordance with the terms and conditions as negotiated between the Parties and prior to incorporation thereof.
13.6.Licenses.
13.6.1.License under Ardelyx Background IP. For the Term of this Agreement, Ardelyx hereby grants to each of Hovione Portugal and Hovione NJ a non-exclusive, paid-up, royalty-free, non-transferable license to use Ardelyx Background IP and Ardelyx Inventions solely and specifically as needed in order to perform the Manufacturing Services for Ardelyx in accordance with this Agreement. The foregoing license does not extend to [***] absent separate written consent by Ardelyx in each case.
13.6.2.License under Incorporated Hovione IP. In addition to any license(s) negotiated pursuant to Section 13.5, [***] (collectively, the “Incorporated Hovione IP”), Hovione hereby [***]. With respect to any license to practice Hovione Incorporated IP hereunder or to any license(s) negotiated pursuant to Section 13.5, Ardelyx will be solely responsible for the actions of any third party to which Ardelyx sublicenses its rights to Incorporated Hovione IP and will indemnify and hold harmless Hovione against all costs, expenses, damages, or losses of any nature arising out of such sublicensee’s use of Incorporated Hovione IP, including, but not limited to, any use of such Incorporated Hovione IP outside the bounds of Ardelyx’s license under this Section. Ardelyx will cause any such sublicensee to be bound by, and to comply with, (a) the limitations on Ardelyx’s use of the Incorporated Hovione IP under the license granted in this Section, and (b)
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confidentiality requirements relating to the Incorporated Hovione IP that are no less strict than those contained in this Agreement.
13.7.Ardelyx Affiliates and Licensees. Notwithstanding any license granted by Ardelyx to its Licensees or Affiliates, during the Term Hovione agrees not to [***] without Ardelyx’s express written instruction or consent, which may be granted or withheld in Ardelyx’s sole discretion.
13.8.No Additional Rights. Except as expressly set out in this Agreement, neither Party has, nor will it acquire, any interest in any of the other Party’s Intellectual Property unless otherwise expressly agreed to in writing. Neither Party will use any Intellectual Property of the other Party, except as specifically authorized by the other Party in writing or as required for the performance of its obligations or exercise of its rights under this Agreement.
14.Miscellaneous
14.1.Insurance. Each Party will maintain commercial general liability insurance, including blanket contractual liability insurance covering the obligations of that Party under this Agreement through the term of this Agreement and for a period of [***] after that. This insurance will have policy limits of not less than: (i) $[***] for each occurrence for personal injury or property damage liability; and (ii) $[***] in the aggregate per annum for product and completed operations liability. If requested each Party will give the other a certificate of insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date, and the limits of liability. The insurance certificate will further provide for a minimum of thirty (30) days’ written notice to the insured of a cancellation of, or material change in, the insurance.
14.2.No Agency or Partnership. The Parties are independent contractors and this Agreement does not create between the Parties any other relationship such as, by way of example only, that of employer and employee, principal and agent, joint-venturers, co-partners, or any similar relationship, the existence of which is expressly denied by the Parties.
14.3.No Waiver. Neither Party’s failure to require the other Party to comply with any provision of this Agreement will be considered a waiver of the provision or any other provision of this Agreement, with the exception of Section 8.2.1 of this Agreement.
14.4.Assignment. Ardelyx may assign this Agreement to an Affiliate or to any successor in interest to all or substantially all of Ardelyx’s business to which this Agreement relates. Hovione may assign this Agreement: (i) to any of its Affiliates or (ii) to a successor to or purchaser of all or substantially all of its business, if (I) performance of activities hereunder remains at the Manufacturing Sites, (II) the FDA registration number for the Manufacturing Sites do not change and (III) the assignee executes an agreement with Ardelyx whereby it agrees to be bound by the obligations of this Agreement owed to
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Ardelyx. Neither Party may otherwise assign this Agreement or any of its associated rights or obligations hereunder without the written consent of the other Party, and any assignment in violation of this Agreement will be void.
14.5.Force Majeure. Neither Party will be liable for the failure to perform its obligations under this Agreement if the failure is caused by an event beyond that Party’s reasonable control, including, but not limited to, strikes or other labor disturbances, lockouts, riots, quarantines, communicable disease outbreaks, wars, acts of terrorism, cyber-attacks, fires, floods, storms, interruption of or delay in transportation, defective equipment, lack of or inability to obtain fuel, power or components, or compliance with any order, regulation, or enforcement decision of any Authority (a “Force Majeure Event”). A Party claiming a right to excused performance under this Section 14.5 will promptly notify the other Party in writing of the extent of its inability to perform, which notice will specify the event beyond its reasonable control that prevents the performance, and will use Commercially Reasonable Efforts to mitigate the contingency and recommence its performance of the obligation as soon as commercially practicable. If a Force Majeure Event causes a partial but not complete inability to perform its obligations under this Agreement, that Party will perform to the maximum extent it is able to. If a Force Majeure Event results in a partial reduction in manufacturing capacity at a Hovione NJ or Hovione Portugal, as applicable: (a) to the extent reasonably practical, Hovione will supply Ardelyx from another Hovione site, (b) Hovione will otherwise use Commercially Reasonable Efforts to [***], and (c) Ardelyx may [***]; and (d) within [***] after the occurrence of a Force Majeure Event which results in a partial reduction in manufacturing capacity at a Hovione NJ or Hovione Portugal, Ardelyx may in its discretion do any of the following: (i) [***] to the extent fulfilment thereof by Hovione is impacted by the Force Majeure Event, without any further liability on Ardelyx’s part, including [***], and/or (ii) [***]. If a Force Majeure Event claimed by one Party is not resolved within [***], then (A) the other Party may terminate this Agreement on written notice or (B) on the other Party’s written request, the Parties shall negotiate in good faith adequate consequences of such Force Majeure Event, including if appropriate a reduction of the Annual Commitment.
14.6.Notices. Any notice, approval, instruction or other written communication required or permitted under this Agreement will be sufficient if made or given to the other Party by personal delivery or confirmed receipt email or by sending the same by first class mail, postage prepaid, return receipt requested, to the respective addresses or email addresses set out below:
If to Ardelyx:
Ardelyx, Inc.
400 5th Ave., Suite 210
Waltham, MA 02451 USA
Attention: [***]
With a copy to: [***]
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If to Hovione:
Hovione LLC
40 Lake Drive
East Windsor, NJ 08520, USA
Attention: [***]
With a copy to: [***]
With a copy to: [***]
or to any other address given to the other Party in accordance with the terms of this Section 14.6. Notices or written communications made or given by personal delivery, national courier or email will be considered to have been sufficiently made or given upon confirmation of receipt.
14.7.Interpretation. The division of this Agreement into Sections, Subsections, and Appendices, and the insertion of headings, are for convenience of reference only and will not affect the interpretation of this Agreement. Unless otherwise indicated, any reference in this Agreement to a Section or Appendix refers to the specified Section or Appendix to this Agreement. In this Agreement, the term “this Agreement” and similar expressions refer to this Agreement as a whole and not to any particular part, Section or Appendix of this Agreement. Except as otherwise expressly stated or unless the context otherwise requires, all references to the singular will include the plural and vice versa. All monetary amounts stated in this Agreement are in United States Dollars ($).
14.8.Severability. If any provision of this Agreement is determined by a court of competent jurisdiction to be invalid, illegal, or unenforceable in any respect, that determination will not impair or affect the validity, legality, or enforceability of the remaining provisions, because each provision is separate, severable, and distinct.
14.9.Entire Agreement. This Agreement, together with its Appendices, [***] and the Quality Agreement constitutes the full, complete, final and integrated agreement between the Parties relating to the subject matter of the Agreement and supersedes all previous written or oral negotiations, commitments, representations, agreements, transactions, or understandings concerning the subject matter of this Agreement (for clarity excluding Development Services subject to the Development Agreement). The basis of the Parties’ agreement is set out expressly and they have not been induced by or relied on any statement or representation that is not set out in this Agreement. Any modification, amendment, or supplement to this Agreement must be in writing and signed by authorized representatives of both Parties. In case of conflict among terms, the following order of precedence shall apply: (i) the Quality Agreement shall prevail with respect to matters of Product quality, (ii) [***] will prevail with respect to matters of Equipment and Scale Up, and (iii) this Agreement shall prevail with respect to all other matters.
14.10.No Third Party Benefit or Right. Nothing in this Agreement will confer or be construed as conferring on any third party any benefit or the right to enforce any express or implied term of this Agreement (except that Ardelyx Licensees may enforce their rights
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under Section 7.5). The rights of the Parties to terminate, rescind or agree any variation, waiver or settlement under this Agreement are not subject to the consent of any other person.
14.11.Execution in Counterparts. This Agreement may be executed in two or more counterparts, by original or electronic (including “pdf”) signature, each of which will be considered an original, but all of which together will constitute one and the same instrument.
14.12.Use of Name. Neither Party may use the other Party’s name, trademarks or logo or any variations of them, alone or with any other word or words, without the prior written consent of the other Party, unless required in connection with a Regulatory Approval or any communications with a Regulatory Authority.
14.13.Governing Law. This Agreement and any dispute or claim (including non-contractual disputes or claims) arising out of or in connection with it or its subject matter or formation are governed by the laws of the State of New York, United States of America, without regard to any conflicts-of-law principle that directs the application to another jurisdiction’s law. Both parties hereby submit to the exclusive jurisdiction of: (i) [***] or (ii) [***]. The Parties expressly agree that the UN Convention on Contracts for the International Sale of Goods will not apply to this Agreement.
14.14.Dispute Resolution.
14.14.1.Both Parties understand and appreciate that their long-term mutual interest shall be best served by effecting a rapid and fair resolution of any claims or disputes which may arise out of services performed under this contract or from any dispute concerning contract terms. Therefore, both Parties agree to use Commercially Reasonable Efforts to resolve all such disputes as rapidly as practicable on a fair and equitable basis. Toward this end both Parties agree to develop and follow a process for presenting, rapidly assessing, and settling claims on a fair and equitable basis.
14.14.2.If any dispute or claim arising under this Agreement cannot be readily resolved by the Parties pursuant to the process described in Section 14.14.1, the Parties agree to refer the matter to a panel consisting of one (1) senior executive employed by each Party who is not directly involved in the claim or dispute for review and resolution. A copy of the contract terms, agreed upon facts (and areas of disagreement), and concise summary of the basis for each side’s contentions shall be provided to both such senior executives who shall review the same, confer, and attempt to reach a mutual resolution of the issue.
14.14.3.If within [***] days after a dispute or claim has been escalated in accordance with Section 14.14.2, the matter has not been resolved utilizing the process set forth in this Section, and the Parties are unwilling to accept the non-binding decision of the panel, any Party may seek resolution of said dispute in accordance with Section 14.13.
* * *
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This Agreement is signed by the authorized representatives of the parties on the dates shown below and will take effect from the Effective Date.
ARDELYX, INC. | |||||
By: /s/ Thierry Bilbault Name: Thierry Bilbault Title: Sr VP Technical Operations Date:10/25/2024 | |||||
HOVIONE, LLC. | HOVIONE, LLC. | ||||
By: /s/ Jean-Luc Herbeaux Name: Jean-Luc Herbeaux Title: Chief Executive Officer Date: 10/23/2024 | By: /s/ Marco Gil Name: Marco Gil Title: Sr VP Sales & Marketing Date: 10/25/2024 | ||||
HOVIONE FARMACIENCIA, S.A. | HOVIONE FARMACIENCIA, S.A. | ||||
By: /s/ Jean-Luc Herbeaux Name: Jean-Luc Herbeaux Title: Chief Executive Officer Date: 10/23/2024 | By: /s/ Marco Gil Name: Marco Gil Title: Sr VP Sales & Marketing Date: 10/25/2024 | ||||
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Appendix 1
PRICING
[***]
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Appendix 2
EXCHANGE RATE CLAUSE
[***]
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Appendix 3
API REIMBURSEMENT PRICE
[***]
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