展品10.2
已從展示中排除了某些特定的信息，因爲這些信息既不是重要的（I），又屬於公司視爲私人或機密的類型（II）。
商業供應協議
本商業供貨協議（以下簡稱“協議”）於2024年10月21日由Hovione Farmaciência, S.A.（以下簡稱“生效日期。”）與其主要營業地點位於葡萄牙Sete Casas 2674-506 Loures的Hovione Portugal（以下簡稱“Hovione Portugal”）及Hovione, LLC.（以下簡稱“”）, 其註冊辦公地址位於美國新澤西州普林斯頓08543-5226號，202 Carnegia Center的Hovione NJ”）及其關聯公司（統稱“Hovione”），美國特拉華州公司，業務主要地點爲400 5th Ave., Suite 210, Waltham, MA 02451美國（“Ardelyx”）。Hovione和ardelyx均可在本文中稱爲“方”, and collectively as the “當事人”.
鑑於，ardelyx和Hovione是於2015年12月22日簽訂的主服務協議的一方，該協議規定Hovione履行對ardelyx的泰納帕諾產品進行噴霧乾燥和開發服務的義務（經修訂，包括所有附件和工作訂單）。開發協議”);
鑑於，各方希望根據原始製造地點（及其關聯公司中可能有一個或多個）在開發協議下開發和驗證的方式，在商業規模上爲ardelyx提供噴霧乾燥服務而訂立商業供應協議；
因此，鑑於前述情況和本協議中包含的契約，各方一致同意以下條款將規定本服務的履行：
1.定義。除非上下文另有規定，否則以下術語將具有以下所列各自的含義，這些術語的語法變體將具有相應的含義：
1.1.“供應不利事件”表示下列情況之一或多種：（i）Hovione無法[***]所需的[***]，或（ii）[***]命令停止爲產品提供製造服務的任何進一步執行。
1.2.“附屬公司「」表示直接或間接擁有某方的控制利益、受某方控制、或與某方共同受控的商業實體；在這裏“控制，「」表示通過持有股份或其他方式，合法確定選舉商業實體大多數董事（或等效管理人員）的權利；
1.3.“附加服務「」在第3.1節中有特定的含義;
1.4.“年度承諾”在第2.2節中指定的含義；
1.5.“應用程序接口「」表示原料藥物質通寧胺以鹼式形式存在；
1.6.“API報銷價格”指附錄3規定的每公斤API的報銷價格。
1.7.“是指與美國聯邦和州證券、稅收和其他適用法律、規則和法規、公司股票上市或報價的任何股票交易所或報價系統的適用規則以及授予獎項的任何外國國家或其他授予獎項的管轄區的適用法律和規則有關的股權獎項計劃的管理的要求。”指（i）就Hovione而言，指製造場地所在司法管轄區適用的所有法律；以及（ii）就ardelyx及ardelyx對產品使用而言，指領土內所有司法管轄區的適用法律；
1.8.“Ardelyx背景知識產權「」意味着由ardelyx擁有或代表所擁有並獨立於本協議之前或之後開發或取得的知識產權。ardelyx背景知識產權具體包括 [***];
1.9.“ardelyx的發明”在第13.3節中有指定的含義;
1.10.“ardelyx財產”在第8.3.2節中有指定含義；
1.11.“授權「」意味着任何對一方、製造業務、或產品領域（或其使用範圍）有管轄權的政府或監管機構、部門、證券交易所、機構或機構或任何外國的、聯邦的、州級的、省級的、縣級的或市級的法院、仲裁庭、局、委員會或其他類似機構。
1.12.“銀行系統”指第3.3(d)(ii)節中指定的含義;
1.13.“批次「單次運行製造活動」指在本《製造業-半導體活動》下製造的產品。爲明確起見，任何給定的製造活動可能包含單個批次或多個批次。
1.14.“綁定預測「」在5.1節中有特定含義；
1.15.“第十章
轉讓證券
第10.1節
交易
如果發行受託人證明，債券持有人可以交換並迅速交付發行受託人這樣的證明，無論是有欠款未償還，還是實質性週轉的時候，都可以在世界範圍範圍內經由源和債券市場交易。「工作日」指的是除星期六、星期日或是Hovione所在居住司法管轄區、ardelyx的居住司法管轄區，或是適用製造工地所在司法管轄區的法定假日外的一天；
1.16.“業務需求” 意味着ardelyx決定減少或停止生產產品，這與其業務策略或產品市場的重大變化有關，重點不在於禾菲安另有規定的任何違約或失職。 業務需求可能包括，例如，對執照安排或被許可人需求的重大變化，或者產品在特定領域市場需求的顯著減少。
1.17.“cGMPs” 指ICH Q7活性藥品原料製造良好生產指南中描述的原則，根據（i）美國聯邦法典第21章第210和211部分以及（ii）領土內任何其他監管機構發佈的相應藥品製造法律和指導方針。
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1.18.“商業上的合理努力就雙方在任何目標方面所付出的努力而言，「商業上合理、勤勉」的努力是指該方爲儘快完成類似目標通常會採取的商業上合理、勤勉的努力，並將考慮到該方對第三方的現有先前和衝突義務。
1.19.“元件「原材料」是指根據加工說明製造產品所需的所有原材料、配料、參考標準、雜質標記物和其他材料，除了原料藥。
1.20.“保密信息「」在第12節中有指定的含義；
1.21.“合同年份「」表示自生效日期起至首個週年的前一天止，並且在此後的每個連續十二（12）個月期間內在本條款期間內；
1.22.「[***]」具有第6.4節中指定的含義；
1.23.“不合格產品”在第6.2節中指定的含義;
1.24.“虧損「」的含義在第7.6.2節中指定；
1.25.“通過公司和各個承銷商通過代表的付款和證券的交付對於每批產品，"Hovione交貨日期"指的是在質量協議中確認或認證的計劃日期，並在收到正式訂單後由Hovione確認後可供裝運[***]。
1.26.“開發服務「藥品」指在開發協議項下，Hovione爲ardelyx提供的包括但不限於產品確認批量的製造在內的藥品研究或開發服務，無論是在生效日期之前還是之後以及在整個期限內；
1.27.“披露方「」在第12節中有指定的含義；
1.28.“設備“” 在第2.5節中有所指定;
1.29.“設備協議”在第2.5條中指定的含義；
1.30.“故障」指一方的 (a) [***]、(b) [***] 或 (c) [***]。
1.31.“「監管當局」指任何國家或超國家政府機構，包括美國食品藥品監督管理局（及其任何繼任實體）（以下簡稱「FDA」）在美國、歐洲藥品管理局（及其任何繼任實體）（以下簡稱「EMA」）或歐洲委員會（及其任何繼任實體，如適用）在歐盟、或日本內閣府健康福祉廳，或日本藥品醫療機器等級機構（或任何繼任者）（以下簡稱「MHLW」），在日本，英國藥物和保健品監管局（以下簡稱「MHRA」），或任何國家的任何衛生監管當局均為本文所述國家藥品的開發、商業化，以及進行監管審批負責的對應機構，包括但不限於HGRAC。“美國食品藥品監督管理局”代表美國食品和藥物管理局；
1.32.“FFDCA「」代表美國聯邦食品、藥品和化妝品法案，21 USC §§ 301等。
1.33.“最終發票” 在第8.3.2條款中有指定的含義；
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1.34.“堅定訂單”在第5.3節指定的意義中；
1.35.“預測“” 在第5.1條中有指定的含義；
1.36.“Hovione背景知識產權“”指Hovione擁有或控制的知識產權，並且獨立於本協議之外開發或取得，不論是在生效日期之前還是之後；為明確起見，Hovione背景知識產權特別 [***]
1.37.“霍維奧內發明」具有第 13.4 條所指明的含義；
1.38.“Hovione釋出“”在5.5節中有特定的含義；
1.39.“受益人”在第11.3節中有指定的意義；
1.40.“賠償人“”在第11.3節中已指定其涵義；
1.41.“初期期限“”在第8.1條中有特定的含義;
1.42.“知識產權「」代表專利、專利申請、配方、商標、商標申請、商號、發明、版權、工業設計、商楟和專業技術知識中的任何權利；
1.43.“發明” 意指任何創新、改進、發展、發現、計算機程序、裝置、交易秘密、方法、流程、技術或類似事項，無論是否以任何形式或媒體書面或其他方式固定，無論所涵蓋的媒體為何，亦無論是否可專利或可受版權保護；
1.44.“存貨「」代表在某一時間點，Hovione管理或控制的所有庫存，包括產品、API、元件、用於製造產品的中間產品以及在製品。
1.45.“[***]” 在第6.2條中指定了其含義；
1.46.“法律「法律」指所有法律（包括普通法）、法規、條例、規定、規則、附例、判決、法令或任何監管機構的命令；
1.47.“被許可人「」表示Ardelyx已與任何人就產品的營銷、銷售或分銷進行許可協議；
1.48.“虧損“”在第11.1节中指定了含义；
1.49.“製造業記錄“” 意味著，對於一批貨品的運輸，包括批次記錄、分析證書、符合證書、北交所/瘦肉/瘦香豬病證書和《質量協議》附錄D中指定的其他文件；
1.50.“製造業“製造業服務” 意指任何製造業服務的表現。
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1.51.“製造業服務”代表噴霧乾燥和品質控制、品質保證、穩定性測試、包裝和相關服務，用於產品的製造；
1.52.“製造業地點” 意味著位於葡萄牙Loures的設施（即“原始製造業地點”），以及美國新澤西州East Windsor的地點（即“新澤西州地點”），以及當事方同意將進行製造服務的任何其他Hovione地點；
1.53.“[***]”具有第3.3(d)條中指定的含義；
1.54.“終止通知書“”在第8.1條中有特定的含義;
1.55.“價錢「價格」指適用於交付給ardelyx的每公斤製成品價格，如所列出的 附錄1；以及（b）ardelyx要求的服務的單獨費用和費用，明確排除產品成本，可能受另外的書面工作訂單或書面協議的約束，該協議明確納入本協議的條款和條件；
1.56.“處理「製造」指反映於加工說明、規格和製造記錄中的產品製造過程。
1.57.“處理指示「製造服務之產品所需的文件化參數」指Hovione根據第3.2條不時更新的製造服務內容，包括：
(a)API和元件的品質控制測試方法;
(b)主批次、生產和控制記錄、製造說明、方向和流程;
(c)API、元件或產品有任何存儲要求嗎；及
(d)產品的品質控制測試方法，包裝指引以及運送要求；
1.58.“產品「」代表根據本協議製造的API的噴霧干燥形式；
1.59.“產品變更控制要求」具有第 3.2 節所述的含義；
1.60.“產品拒收” 的意義如第6.2條所規定;
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)根據設備協議的條款，在擴大規模（下文有定義）完成之前，儘管本協議中的任何相反規定，各方的年度承諾義務仍將保持在[***]，直至擴大規模完成，屆時[***]。
2.3.現有訂單至2024年，各方確認根據開發協議已經下達並接受了所有產品製造訂單。開發協議應控制在生效日期前交付的所有產品的製造，但在Hovione根據質量協議發佈之後，本協議的條款將控制與產品本身相關的使用、完整性和補救措施，包括但不限於第9.2.3節中規定的產品保證。此後，本協議將控制2024年已下訂單但尚未交付的任何產品製造訂單。
2.4.[***]。只要ardelyx在本協議的其他條款中基本遵守，包括但不限於，本協議下的年度承諾義務，Hovione在本期內不會在任何時間[***]，未經ardelyx明確書面同意。Hovione承認並同意，ardelyx可能授予或拒絕其同意[***]。
2.5.規模擴大各方承認，從2027年開始，年度承諾將超過[***]。 因此，各方已簽訂一份[***]，根據該協議，Hovione應購買、安裝、驗證和確認某些[***]設備用於[***]（以下簡稱“設備”) [***] (“設備協議），並參考其中的相關條款，根據其中Ardelyx同意向Hovione預付款和成功費用，總額高達[***]美元（美元[***]）作爲及時驗證和確認商業產品[***]的代價（以下簡稱“規模擴大”）。 爲明晰起見，任何驗證或確認批次（包括規模擴大所需的任何此類批次）應受發展協議（或各方之間可能達成的其他服務協議）約束，並且不算入供應失敗次數。
2.6.供應連續性在擴大規模之後，[***]。儘管前述，應ardelyx要求，Hovione將繼續向Hovione葡萄牙供應（i）Hovione葡萄牙從Hovione葡萄牙供應的年度承諾中的[***]（除非雙方另有約定）直到ardelyx的許可證持有人獲得Hovione NJ的監管批准，在此之後（ii）從Hovione葡萄牙提供的產品的協商一致量，至少足以在產品的適用監管備案中保留Hovione葡萄牙設施作爲備選供應商場所。ardelyx應採取商業上合理的努力 [***]。ardelyx和Hovione應合作促進爲此許可證持有人監管批准所需的信息交付。明確的是，在所有ardelyx許可證持有人批准Hovione NJ之後，上述款項（i）應終止，僅適用款項（ii）。
2.7.無獨家來源。根據第2.2節的規定，本協議的任何內容均不得禁止ardelyx從第三方購買tenapanor產品和服務，
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與任何第三方簽訂供應此類產品和服務的合同、製造自己的產品，或者爲產品供應合格的額外設施。
2.8.分包根據質量協議的合規性，Hovione可以在ardelyx的書面同意下聘請第三方執行與製造服務相關的服務（除了分包分析測試或穩定性儲存服務，這將不需要書面同意）（第三方分包商），前提是每個第三方分包商都遵守本協議的所有適用義務，並且，在適用的情況下遵守質量協議。如果第三方分包商違反本協議（或適用的質量協議），或者未能執行分包服務的任何部分，則Hovione將對ardelyx有責任，就好像Hovione直接違反、執行或未執行分包服務一樣。
2.9.基地設施Hovione將對每個製造地點進行資格驗證（並隨後維持符合適用法律和cGMP的資格），而這些操作不會產生任何費用。Hovione不會在未首先獲得Ardelyx的書面同意的情況下更改制造地點。除[***]外，如果Hovione提出並獲得Ardelyx同意有關將執行製造服務的製造地點的製造地點的任何更改，（a）如果此類更改是針對Ardelyx或其產品加工，則雙方應誠實進行談判，以確定爲此更改所需的任何驗證活動的成本以及由此帶來的收益的相應分配，就是這些建議的更改有助於改善製造服務的成本和/或效率的程度；（b）[***]。Hovione不會進行或允許任何對產品產生重大影響或實施任何對流程產生影響的製造地點的修改，包括但不限於未經Ardelyx事先書面同意而不得不合理推遲的加工說明或用於製造產品的設備的更改。
2.10.庫存報告霍維昂將在每月（至少）以及收到書面要求並在合理時間內的情況下，向ardelyx提供庫存的書面報告，報告形式由霍維昂的電子庫存管理平台生成，和/或書面週轉計數報告。此外，雙方一致同意的時間，每年一次，霍維昂應允許ardelyx合理查看存放所有庫存和相關記錄的位置，並查看定期管理這些庫存和記錄的人員，以便ardelyx對霍維昂掌控或掌管的所有庫存進行實際盤點。霍維昂將盡商業上合理的努力，確保其第三方承包商讓ardelyx獲得類似的訪問權限。如果霍維昂遇到元件供應問題，包括延遲或交付不符合要求的元件，將及時通知ardelyx。如果任何元件的採購交貨時間超出綁定預測時間範圍，或者霍維昂無法及時獲得需要製造的特定元件，雙方將善意協商對本協議做出適當修改，併合作減少或消除供應商的任何供應問題。
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2.11.包裝Hovione將安排並實施在每批產品的包裝桶上標記批號和有效日期。這些批號和有效日期將按照適用法律、cGMP標準(如果適用)的要求，並與規格一致地附在每個產品的運輸容器上。如適用，Hovione將執行關於批號/到期日期和序列號的在線電子驗證。如果Hovione在運輸容器上放置了與任何產品購買訂單中引用的Ardelyx批號不同的內部批號，Hovione將爲該產品批次相關的所有文件提供Ardelyx批號的交叉參考。
3.ardelyx的義務
3.1.付款。作爲製造服務的全部對價，Ardelyx將根據第4節向Hovione支付適用的價格。在期限內，根據雙方的共同協議，Ardelyx可以不時要求Hovione提供價格中未包含的額外服務，以支持產品的製造，但不包括任何受開發協議約束的開發服務（”其他服務”），由雙方正式授權的代表簽署的書面工作單中規定，並詳細說明了Hovione將提供的具體服務以及應提供的任何交付成果（每項，a”工作訂單”）。Hovione將根據本協議的條款（包括任何此類工作單中可能包含的對適用條款和條件的任何偏差）提供額外服務，並且此類附加服務應根據雙方在該工作單上可能達成的協議單獨收費。
3.2.變更控制請求ardelyx和Hovione將與有關文件（即「(變更控制請求」))合作，根據質量協議中規定的變更控制流程進行任何有關工藝指導書、規格或附屬文件的請求變更。經質量協議中指定的相關人員接受產品變更控制請求後，Hovione將向Ardelyx提供簽署日期的收據，表示Hovione已接受。應Hovione的要求，Ardelyx將提供由Ardelyx或代表Ardelyx提交給監管機構的原始文件的執行證據。Hovione將及時回應任何產品變更控制請求，並商業上合理、誠信地努力就所請求的變更條款及時達成一致（包括價格的任何變更），雙方將簽署反映製造服務和價格的此類變更的變更訂單（即「製造業-半導體」）Hovione同意及時並勤勉地審議並採取行動，以執行監管機構要求的任何變更。產品變更控制請求”）。修改訂單）。Hovione同意任何監管機構強制實施的變更將被視爲及時且勤勉地考慮和處理。
3.3.API供應.
(a)交貨時間。 ardelyx將承擔唯一費用並將API交付給製造站點[***]。 [***]的責任將包括從適用的海關機構和監管機構獲取API的放行。 除非另有約定
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寫信時，Ardelyx或Ardelyx的指定經紀人將是進口到製造場所的API的 「進口商」 或 「海關登記進口商」（或根據Ardelyx適用法律的理解是等效機構），Ardelyx負責遵守與該職位相關的適用法律（以及合規成本）。Ardelyx應至少在固定訂單所涵蓋產品的預定生產日期之前 [***] 將API交付給製造現場，其數量足以使Hovione能夠爲該固定訂單生產約定數量的產品。如果製造服務延遲是由Ardelyx未能向Hovione提供API而造成的，交貨期如前一句所述（”API 延遲”），那麼Hovione在與Ardelyx進行了真誠的協商，以確保儘量減少對雙方運營的干擾之後，將有權：（a）（i）重新分配原本爲此類製造業保留的資源，並根據適用製造場所的可用產能規劃重新安排此類製造的時間；（ii）採取商業上合理的努力來填補因此類API延遲而產生的任何閒置產能，以及（iii）與任何由此類 API 延遲導致的剩餘閒置容量，向Ardelyx 收取任何此類應付金額重新安排製造時間作爲對相應制造場所此類閒置產能的補償，或 (b) 延長產品的交付期限，前提是雙方同意爲相應制造場所分配資源中的任何空閒時間提供足夠的補償（如果適用）。如果任何此類延遲持續 [***] 或更長時間，締約方將開會討論如何解決問題，包括酌情討論成本和時間表的影響。
(b)存儲Hovione將根據產品安全數據表中包含的所有環保、健康和安全信息，處理、存儲和製造API。 Hovione將控制抵達製造現場的API的卸貨，並將這些API存儲在製造現場或其他雙方同意的存儲設施（視Ardelyx需要的任何資格限制而定）中，最多免費存儲[***]。 API將由Hovione代表Ardelyx按照本協議和與API相關的任何書面指示（包括如適用的任何安全數據表、安全操作說明和相關的健康和環境信息）進行持有。 API將始終是Ardelyx的財產。 Hovione收到的任何API都只能由Hovione用於爲Ardelyx執行製造服務。 Hovione將收集API樣本並將其交付給Ardelyx指定的第三方進行測試，以符合處理說明。
(c)損失風險API的損失風險在一切時候都將留給ardelyx，而不是在Hovione的監護下。[***]。儘管前述情況：
(i)Hovione將盡商業上合理的努力保持安全，並覈對所有API、元件和產品；
(ii)產品損失的風險將根據第5.5節的規定轉移到ardelyx。
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(iii)Hovione對因產品製造不當而導致API浪費的責任應按第6條規定。
(iv)根據第3.3(d)節中描述的銀行系統，應對[***]導致的API損失進行緩解。
(v)除了上文中與不合格產品和低產品產量有關的第(iii)和第(iv)款規定以外，以及根據第10條款的條款和根據3.3(d)的適用導致的任何調整，如果[***]，Hovione同意根據API報銷價格償還ardelyx公司任何因Hovione公司保管期間丟失或毀壞的其他API數量。
(vi)如果有要求，ardelyx將爲Hovione的保險公司提供合理的支持，以支付丟失或損壞的API的費用。
(d)收益銀行
(i)就每個製造工廠而言，在根據質量協議製造並交付給ardelyx的前十（10）批產品後，各方應就實際產品與API比例（“產品產量”）達成誠信協議。此後，Hovione應確保產品產量每年符合[***]（「[***]」）。各方承認並同意[***]中應包含各方同意的允許統計偏差，此偏差可能隨着製造更多產品批次並從這些製造中收集更多數據而在本協議期間變化。各方同意，截至生效日期，Hovione Portugal的產品產量爲[***]%，Hovione Portugal的[***]爲[***]%。[***]將按年修訂，同時根據第4.2節的更新年度定價，以合併根據本協議製造並交付給ardelyx的額外產品批次的數據。爲明確起見，各方同意[***]和年度修訂計算僅基於根據質量協議交付給ardelyx的產品批次，並不包括包含有次品產品的批次，無論這些次品產品是否已交付給ardelyx。
(ii)Hovione有權將超過[***]的產量抵銷低於[***]的產量或抵銷因產品不合格而導致的損失，之後才進行對Ardelyx的任何補償（“銀行系統”）。如果某批次的[***]未達到要求，Hovione將把損失計入銀行系統。
(iii)在每個日曆年結束後的90天內，Hovione將就實際年度產品產量與[***]進行年度調解，考慮到銀行系統的貸方和借方。如果該日曆年度的實際產品產量低於[***]，那麼Hovione將[***]。如果實際產品產量高於[***]，則超額部分將作爲下一年度的結餘。
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信貸將用於抵消未來產品收益不足或因產品不足而導致的損失。
3.5. 信息。 根據合適的要求，ardelyx將按照適用法律的規定，向Hovione提供Hovione在履行產品製造和本協議下其他責任方面合理要求的信息。
4.價格和價格調整
4.1. 定價製造和發佈產品的定價應按照原始製造地點規定的價格進行 附件1，根據本第4部分的規定進行調整。所有支付應以美元進行。關於在Hovione葡萄牙進行的製造費用，如果美元與歐元之間的匯率與參考匯率（如附錄2中定義）相比變動了[***]%或更多，則雙方同意根據附錄2的條款重新定義費用的價值。
4.2. 年度價格調整Hovione可以調整價格，自第一個完整年度後的每年1月1日生效，調整數值爲較大值的（a）[***]或者（b）[***]。對於本第4.2條下的所有價格調整，Hovione將交付給ardelyx[***]封函，說明調整後的定價將在下一年1月1日或之後訂購的產品生效，同時附上[***]。
4.3. 變動如果ardelyx要求對製造業-半導體服務範圍在第3.2節中所規定的任何更改，相應的變更訂單將規定隨着這些更改而必要的價格調整，這些調整將在執行此變更訂單時生效。
4.4. 稅收任何由政府機構徵收或根據本合約中Hovione和ardelyx之間擬議的交易所得的使用稅、銷售稅、消費稅、增值稅、關稅、檢驗或測試費用或任何其他性質的稅費或收費（不包括Hovione的所得稅），須由ardelyx支付，除了價格之外。如果Hovione被要求支付此類稅費或收費：(a)Hovione將及時按照適用法律進行支付，(b)Hovione將向ardelyx開具此類支付的發票，包括適用的付款憑證副本，(c)Ardelyx將就此類支付對Hovione作出賠償。Ardelyx可以在提交訂單時向Hovione提供免稅證明或其他可被徵稅的稅費或費用機構接受的文件，作爲此類支付的替代。
4.5. 爲實現價格降低而努力在本期內，Hovione和ardelyx同意共同努力開發一個旨在[***]的計劃，但該計劃不會涉及任何一方在未經對方書面同意的情況下產生資本或其他非常規成本。在成功的程度上，
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各方應就由此成本削減計劃帶來的成本節約分配進行誠信討論和談判。
5.購買產品
5.1.預測在生效日期後三十（30）天內，ardelyx將向Hovione提供一份產品成交量的書面預測，預測ardelyx預計在接下來的[***]中從Hovione訂購的產品數量（“預測”。每個預測的前[***]將對雙方具有約束力（“綁定預測”），其餘的[***]將是[其他]，可由雙方在預測中首次出現直至該月成爲約束性預測的整個期間的[其他]，或者由雙方另行約定（“非約束性預測”）。ardelyx將每季度至少提供一次更新的預測。在任何更新的預測部分超過年承諾的情況下，Hovione將善意考慮並盡一切合理努力來適應這種過度，但須遵守Hovione當時向其他客戶的約束性承諾。收到每份預測後[***]，Hovione應當書面接受或拒絕該預測，條件是[***]。如果Hovione拒絕了一份預測，它應將書面通知交給ardelyx [***]。如果沒有這樣的通知，[***]。
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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