Heidi Gleason

 [Client= Buyer] [Master] Supply Agreement for Materials between (hereinafter referred to as “Client“) and […] (hereinafter referred to as “Supplier”) Recitals WHEREAS, This Supply Agreement for Materials (the “Agreement”) is entered into by and between Client (“Client”), and […] (“Supplier”). WHEREAS, Client is a global pharmaceutical company striving towards better health for patient worldwide through leading innovation in medicine. WHEREAS, Supplier has appropriate facilities and avails about know-how for the manufacturing and supply of pharmaceutical materials, to be used for solids, liqueds and other types of pharmaceutical products and medical devices. WHEREAS, Supplier is able to deliver to Client or its appointee pharmaceutical Materials (as defined hereinafter) according to the needs of Client. NOW THEREFORE, the Parties (as defined hereinafter) wish to enter into this Agreement and mutually agree as follows: Article 1 (Definitions) For the purposes of this Agreement, the following terms shall have the following meaning: “Affiliate” means any legal entity directly or indirectly controlled by, controlling, or other common control with a Party. The term "control" in this context means owning at least fifty percent (50%) of the voting shares or having the power to directly or indirectly direct the management or determine the policies of an entity. “Agreement” means this [Master] Supply Agreement for Materials. “Certificate of Analysis” means documentation containing a record of analytical testing data, provided and properly certified by a Qualified Person, stating and confirming that the material to which such documentation refers has been tested to, and complies with the relevant release specification for that material. “Certificate of Conformance” means the document provided by the Supplier and signed by a qualified person of the Supplier, or produced by a computer system which provides a degree of control equivalent to that given by a signature, which certifies that each batch of Material was produced and tested in compliance with all applicable laws, the terms and conditions of this Agreement, including the Material Specifications. “Change” means any change to the Materials including, without limitation, to the raw materials, manufacturing, manufacturing procedures, the in-process controls, the manufacturing equipment, changes to the facility and associated equipment and utilities, cleaning processes, analytical procedures, and quality control, as well as the storage conditions of the Materials. “Change of Ownership Notice” shall have the meaning set forth in “Change of Ownership Notice” shall have the meaning set forth in Article 12.6. “Confidential Information” shall mean any and all information of a Party hereto that may be submitted by or for such Party to the other Party, at any time and from time to time before and during the Term in relation to the subject matter covered by this Agreement, regardless of whether submitted in tangible (without limitation, written) form or in intangible form (without limitation, orally or electronically), which the Disclosing Party considers confidential and proprietary. “Defect(s) or “Defective Materials” shall have the meaning set forth in Article 5.2. “Disclosing Party” shall have the meaning set forth in Article 11.1. “Dispute” shall have the meaning set forth in Article 14.1. “Effective Date” shall have the meaning set forth in Article 12.1. “Force Majeure Event” shall have the meaning set forth in Article 15. “GMP” shall mean current guidelines and/or regulations regarding Good Manufacturing Practices as stipulated and revised from time to time by the competent health authorities of the European Union (EC guide to Good Manufacturing Practices for Medicinal Products). “Indemnified Party” shall have the meaning set fort in Article 10.3. “Indemnifying Party” shall have the meaning set fort in Article 10.3. “Initial Term” shall have the meaning set fort in Article 12.1. “Lead Time” shall mean the binding delivery dates for Materials as stipulated in Article 4.2 hereunder. “Losses of Supplier” shall have the meaning set forth in Article 10.2. “Losses of Client” shall have the meaning set forth in Article 10.1. “Manufacturing Location” shall have the meaning set forth in Article 2.2. “Materials” shall mean the materials, whether active pharmaceutical ingredients, excipients or packaging materials listed in Appendix C. “Materials Specifications” shall mean the specifications for the Materials, as listed in Appendix C. “Order(s)” shall have the meaning set forth in Article 4.2 hereunder. “Party” means either Client or Supplier, individually, as the context requires, and “Parties” meansClient and Supplier, collectively. “Quality Agreement” means that certain quality agreement attached to this Agreement as Appendix B. “Recall” shall have the meaning set forth in Article 5.4. “Receiving Party” shall have the meaning set forth in Article 11.1. “Renewal Term” shall have the meaning set fort in Article 12.1. “Rolling Forecast” shall have the meaning set forth in Article 3. “Supplier” means the Party as defined on pg. 1 of the Agreement. “Supply Price” shall have the meaning as set forth in Article 6.1 and Appendix A respectively. “Client” means the Party as defined on pg. 1 of the Agreement. “Term” shall have the meaning as set forth in Article 12.1. “Third Party” means any person or legal entity not being a Party or an Affiliate of a Party. “VAT” means, within the EU, such tax as may be levied in accordance with (but subject to derogations from) Directive 2006/112/EC and, outside the EU, value added tax or any form of consumption tax levied by a relevant tax authority, as well as all other forms of consumption taxes levied by the relevant tax authority on the purchase of a good or a service, including but not limited to sales tax and goods and services tax. Article 2 (Subject of the Agreement) 2.1 General Provision and Compliance with Laws. During the term of this Agreement, Supplier shall manufacture and supply the Materials in compliance with the GMP, (ii) this Agreement, including but not limited to the Quality Agreement, (iii) the Materials’ Specifications, (iii) further manufacturing standards if agreed by the Parties in writing, and (iv) all laws, rules and regulations, decrees and other ordinances issued by any governmental, state or authority relating to the subject matter of this Agreement. Supplier undertakes to Client that in the performance of this Agreement it complies with all laws, rules and regulations, decrees and other ordinances issued by any governmental, state or authority relating to the subject matter of this Agreement. 2.2 Manufacturing Facilities. Supplier shall be responsible that during the Term of this Agreement each of the facilities at […] in which the Materials are manufactured and handled by Supplier (the “Manufacturing Location”) complies with GMP. Upon request, Client shall be entitled to approve the Manufacturing Location prior the first delivery under this Agreement. Supplier shall not change the Manufacturing Location without prior written approval from Client. 2.3 Subcontracting. Supplier shall not subcontract any of its rights under this Agreement, whether in whole or in part, to an Affiliate of Supplier or to a Third Party without the prior written consent of Client. To the extent Supplier subcontracts all or part of its obligations pursuant to this Agreement to an Affiliate or a Third Party Supplier shall be solely responsible for the expenses of and shall be liable for the performance of any responsibilities delegated to any Affiliate or Third Party as if they had been performed or non-performed by Supplier. 2.4 Quality Audits. During the normal business hours and at least once per calender year, Client shall be entitled to perform quality audits of Supplier, the Manufacturing Location and Materials, including documentation as outlined more detailed in the provisions of the Quality Agreement. Further and if applicable, Supplier shall cause its subcontractors to grant Client access to all facilities and documentation related to the performance under this Agreement. Any audits shall be free of charge for Client. 2.5 Capacity and Resources. 2.5.1 Sufficent Resources. During the Term of this Agreement, Supplier agrees to use commercially reasonable efforts to allocate sufficient resources in order to meet Client's requirements for Materials in accordance with Articles 4 and 5. Furthermore, Supplier shall use commercially reasonable efforts to retain a buffer stock of substances and components used for the manufacturing of the Materials corresponding to Client’s requirements of the Materials for at least the subsequent […] months as indicated in Client’s Rolling Forecast in accordance with Article 4 or as otherwise agreed in writing by the Parties. 2.5.2 Sufficent Capacity. Supplier guarantees sufficient capacity at its facilities at the Manufacturing Location to manufacture and deliver per calendar year at least one hundred fifty percent (150%) of Client’s forecast requirements for Materials under Article 4.1. [Comment to Client: To be aligned with the Forecasts] However, for avoidance of doubts, except for the ordered quantities under Article 4.2 nothing in this Agreement shall be construed as a commitment by Client to purchase any quantity of Material. Article 3 (Master Effect) Supplier agrees that Client's Affiliates may request in writing the manufacturing and supply of Materials by Supplier. In such event, the terms and conditions under this Agreement shall be deemed to be agreed between the respective Client Affiliate and Supplier and, during the Term of this Agreement, the respecitve Client Affiliate shall be entitled to all rights and protections afforded Client under this Agreement. Any such Client‘ Affiliate shall execute a purchase order directly, in its own name and on its own behalf, provided that such purchase order specifically references this Agreement. Upon execution of a purchase order with Supplier, such Client’s Affiliates shall be substituted for “Client” for all purposes of this Agreement with respect to the relevant purchase order, including, but not limited to, payment of Supply Prices. General terms and conditions submitted together with the purchase order acceptance shall be expressly excluded. Unless otherwise set forth in the relevant purchase order, any notices or other communications required by or permitted to be given under this Agreement in relation to a purchase order signed by a Client’s Affiliate shall be sent to the Client’s Affiliate at its billing address in the purchase order. Upon termination or expiration of this Agreement and subject to Article 10,11, the relationship between the ordering Client Affiliate and Supplier shall likewise stand terminated or expired without need for any notice. Article 4 (Rolling Forecasts and Delivery) 14.1 Rolling Forecasts Effect. Within the first […] calendar days of each month, Client shall submit to Supplier its updated, non-binding written rolling forecast for Materials (the "Rolling Forecast"), showing Client's estimated requirements for Materials to be delivered by Supplier to Client or its appointee during the following […] months period. 4.2 Orders. Once each […] calendar month Client may submit to Supplier a binding order (each a “Order” or collectively the “Orders”) for Materials. Supplier shall indicate its acceptance of each Order within ten (10) Business Days of receipt thereof, following which no changes shall be made to the Order without the prior written consent of the other Party. In the event the Supplier fails to indicate such acceptance within such ten (10) Business Days, Client may deem that it has received Supplier’s acceptance. For the sake of clarity, to the extent the terms of any Order or acknowledgment are inconsistent with the terms of this Agreement, the terms of this Agreement shall prevail. The maximum lead-time for Supplier’s deliveries of Materials to Client or its appointee’s in accordance with this Article 4.2 shall be […] calendar days from the Order receipt by the Supplier (the “Lead Time”). 4.3 Warranty of Title. Supplier warrants that Materials to be supplied to Client are in his absolute property and none are subject of any option, right to aquire, assignment, mortgage, charge, lien or hypothecation or any other encumbrance whatsoever or the subject of any factoring arrangement, hire, purchase, conditional sale or credit sale agreement. 4.4 Terms of Delivery of Materials. Deliveries of Materials to Client or Client’s appointees shall be made [Place of delivery] [Pls. insert Incoterm] (ICC INCOTERMS 2010). 4.5 Accompanying Documentation. With each shipment of Materials, Supplier shall provide Client with the appropriate documentation, including but not limited to invoice, packing list, material used sheet, Certificate of Analysis, a Certicificate of Conformance and further documentation is required according to the Quality Agreement. 4.6 Delayed Delivery. If the Supplier fails to deliver the ordered Materials within the Lead Time and provided that (i) the delay was not caused by a breach of Client of its obligations according to this Agreement and/or (ii) the delay was not caused by circumstances related to a Force Majeure Event, Client shall have the right to demand from Supplier a penalty payment, not affecting any other rights Client may have hereunder or under the applicable law, of 1 % (one percent) of the net invoice value of Materials for each commenced calendar day of the delay, starting with the first calendar day following the Lead Time and ending with the calendar day in which the delivery has been made, always provided that the entire amount of the penalty for the delay of any quantity of Materials shall never exceed fifteen (15%) of the net invoice value of Materials. 4.7 Delivery Standard. Without limitation of any provision under this Agreement, for any calendar year during the Term, Supplier shall undertake its [….] efforts to deliver 99% (ninety-nine percent) of the ordered Material to Client or its nominees at the designated locations on time and complete. 4.8 Maximum Quantity. Subject to Article 2.5.2 of this Agreement, Supplier shall accept each Order(s) placed by Client, to the extent that such Order is up to one hundred […] percent (1[…]0%) of the immediately preceding […] Order (the “Maximum Quantity”). Article 5 (Warranty and Defective Materials) 5.1 Warranty. Supplier warrants that the Materials manufactured and supplied hereunder comply with the GMP, (ii) this Agreement, including but not limited to the Quality Agreement, (iii) the Materials’ Specifications, (iii) further manufacturing standards if agreed by the Parties in writing, and (iv) all laws, rules and regulations, decrees and other ordinances issued by any governmental, state or authority relating to the subject matter of this Agreement. To the extent that detailed designs have not been furnished by Client, the Materials are free from any design rights of Third Parties, and suitable for the purposes intended by Client. 5.2 Defective Materials and Incoming Inspection. The term “Defect(s)” or “Defective Materials” shall mean Materials not conforming to Supplier’s warranty pursuant to Article 5.1. Supplier’s warranties hereunder shall extend to any Defect(s) arising or manifesting itself within two (2) years after receipt of the respective Materials pursuant to Article 4.3. Upon receipt of the respective Materials, Client or Client’s appointee’s shall only make an incoming inspection if and to the extent set out for the receipt of Materials under the Quality Agreement and shall inform Supplier by written communication (letter, facsimile, e-mail) of any Defect(s). Such notice to be received by Supplier in case of Defect(s) revealed during the incoming inspection within forty (40) days after Material receipt. In all other cases notice shall be provided by Client within ten (10) days of discovery of Defect. Failure of Client to notify Supplier in the applicable time periods specified above shall constitute a waiver of any rights relating to such Defect(s). 5.3 Handling of Defective Materials. With respect to Defective Materials, Client, within its sole discretion and without waiving any rights or remedies provided by the applicable law, may require Supplier to correct or replace such Defective Materials at Supplier’s risk and expense or refund such portion of the Supply Price as elected by Client. Any Materials corrected or replaced shall be subject to the provisions of this Agreement in the same manner as those originally delivered hereunder. 5.4 Implementation and Administration of Recall. Any recall of any of Client’s pharmaceutical product(s), whether commercialized by Client, Client’s Affiliates or business partners, for Defect(s) of Materials (each a “Recall”), shall be implemented and administered by Client, its Affiliates or business partners in its sole discretion. The costs and expenses (including without limitation, costs and expenses related to transportation, storage, destruction, administration and management of the Recall) associated with any Recall shall be paid by the Party causing the failure of such Party to comply with its obligations hereunder. Article 6 (Commercial Set Up) 6.1 Supply Price. The initial Supply Price for each Material is set forth in Appendix  A and correlates to the delivery according to the INCOTERMS specified under Article 4.4. 6.2 Supply Price Adjustments. The Supply Prices in Appendix A shall be firm during the Term of this Agreement, except the Parties agreed on a Supply Price adjustment mechanism, to be attached under Appendix A (the “Supply Price Adjustment Mechanism”). 6.3 Further Commercial Terms. The terms set out in Appendix A shall apply. Article 7 (Changes) 7.1 Approval and Collaboration Requirement. Neither Party shall make any Changes without the prior written consent of the other Party. Supplier shall fully cooperate with Client on reasonable requests, regarding regulatory updates or information triggered by any Change. Without limitation of Article 7.1 first paragraph, Supplier shall promptly notify Client, without undue delay and in writing, if Supplier intends or should be required to make any Changes, whether due a request from a regulatory authority or otherwise. The implementation of Changes shall be further subject to the written approval of the regulatory authorities. Upon Client’s written request, Supplier shall keep a safety stock of the previous Material supplied at the time (without change) in sufficient quantity to satisfy Client’s estimated demand for a period of XXX months or the minimum regulatory timeline to avoid any supply disruption. 7.2 Costs. The costs for Changes, if (a) required by Supplier shall be borne by Supplier; (b) required by Client shall be borne by Client; and in both cases (i) and (ii) be mutually agreed based on reasonable market prices, in writing by the Parties. Notwithstanding the foregoing, in the event any Change are required by the applicable law or GMP, or are requested by any governmental authority, the costs shall be borne by Supplier unless Supplier clearly demonstrates that it would otherwise not be required to make such Change and the Change is necessary just for supplying the Materials to Client pursuant to this Agreement. If either Party reasonably demonstrates that Changes results in an increase or decrease of the production costs of the Materials, the Parties shall negotiate in good faith and agree upon a reasonable adjustment of the Supply Price in accordance with the Supply Price Adjustment Mechanism, if agreed under this Agreement. Article 8 (Intellectual Property) 8.1 General Principle. All Client patents and proprietary know-how and information, whether Confidential Information or not, of Client, and all labels, designs, trademarks, the trademark and company name Client, denominations, forms or wording, in particular the wording of packaging material, which pertain to the Materials, as well as the goodwill appertaining thereto, or connected directly or indirectly therewith, are, and shall at all times remain, the exclusive property of Client, its Affiliates, subsidiaries or licensors, as the case may be, and neither Supplier nor any Party claiming through it, nor any other person shall be entitled to or acquire any ownership, or title to, or interest in, the same. 8.2 Warranty Regarding Intellectual Property Rights. Without limitation of Article 5.1, Supplier represents and warrants to Client that, as of the Effective Date, Supplier owns or controls the relevant intellectual property rights and know-how necessary for manufacturing and supply of Materials without infringement of any Third Party intellectual property right. Supplier shall immediately inform Client about conflicting intellectual property rights of Third Parties as far as its performance of this Agreement is concerned. Article 9 (Information Duties and Supplier Standards) 9.1 Duty to Inform. Supplier shall keep Client fully informed of any notification or other information, whether received directly or indirectly, which might affect the marketability or safety of Materials or which might result in a Recall. 9.2 Compliance with Anti-Corruption Laws.  In performing this Agreement, Supplier and its employees and agents: (i) shall not offer to make, make, promise, authorize or accept any payment or giving anything of value, including but not limited to bribes, either directly or indirectly to any public official, regulatory authority or anyone else for the purpose of influencing, inducing or rewarding any act, omission or decision in order to secure an improper advantage, or obtain or retain business; and (ii) shall comply with all anti-corruption and anti-bribery applicable laws.  Supplier and its employees and agents shall not make any payment or provide any gift to a Third Party in connection with Suppliers performance of this Agreement except as may be expressly permitted in this Agreement without first identifying the intended third-party recipient to Client and obtaining Client’s prior written approval.  Supplier shall notify Client immediately upon becoming aware of any breach of Suppliers obligations under this subsection.  Supplier shall require each employee and agent of Supplier who will perform this Agreement to participate in any anti-corruption training reasonably required by Client. 9.3 Supplier Assistance; Notice of Government Inspection.  Supplier shall promptly comply with any request from Client for information and assistance to enable Client to ensure and confirm compliance with applicable laws.  Supplier shall immediately notify Client upon becoming aware of any governmental or regulatory review, audit or inspection of Supplier’s facilities, processes or products that might relate to this Agreement. 9.4 Supplier Code of Conduct.  Client is committed to responsible business practices and holds its Suppliers to similar expectations. Client is a signatory of the United Nations Global Compact (www.unglobalcompact.org). Client’s Supplier Code of Conduct supports Client’s commitment to uphold the UN Global Compact’s 10 universally accepted principles in the areas of human rights, labour, environment and anticorruption, as applied to Client’s supplier community. Supplier acknowledges receipt of Client’s Supplier Code of Conduct.  Client intends to evaluate its supplier’s fulfilment of the principles set forth in the Supplier Code of Conduct in connection with awarding business to and maintaining business with our suppliers.  Supplier agrees to cooperate with Client’s reasonable requests to records, facilities and personnel for review by Client or Client’s designated Third Party in order to permit Client to evaluate Supplier’s fulfilment of the principles set forth in the Supplier Code and to fulfil Client’s own obligations. Client expects Supplier to engage in good faith discussions regarding any areas in which the principles set forth in the Supplier Code of Conduct are not fulfilled, and actions Supplier will take to better fulfil the expectations set forth in the Supplier Code of Conduct.  Failure of Supplier to meet the expectations in the Supplier Code may affect Client’s willingness to award business to or maintain business with the Supplier. 9.5 Diversity.  Supplier acknowledges Client’s commitment to diversity, both for its own workforce, and within its supplier base through Client’s Supplier Diversity Program.  Client’s Supplier Diversity Program seeks to increase opportunities for small businesses and diverse businesses (businesses owned or operated by historically underutilized population groups, such as women, minorities, veterans,  persons with disabilities , persons representing a variety of sexual orientation or identity and others) to participate in Client’s contracts and subcontracts.  To that end, for any permitted subcontract under this Agreement, Supplier agrees to seek out and provide commercially reasonable opportunities for small and diverse businesses as described above to participate in such subcontracts to the extent consistent with the efficient performance of this Agreement.  Client invites and encourages small and diverse suppliers to identify them as part of the contracting process.  If Supplier is not a small or diverse business, Supplier agrees, upon the request of Client, to report spend with small and diverse businesses: (i) subcontracted under this Agreement, and/or (ii) generally (not directly for this Agreement).  In addition, Supplier agrees to provide information concerning its workforce diversity efforts to Client upon request. Article 10 (Indemnification. Liability and Insurance) 10.1 Indemnification of Client. Supplier hereby agrees to defend Client and its Affiliates and their respective directors, officers, employees and agents against any and all claims and suits of a Third Party and to indemnify and hold Client and its Affiliates and their respective directors, officers, employees and agents harmless from and against any and all losses, damages, costs, penalties, liabilities (including strict liabilities), judgments, amounts paid in settlement, fines and expenses (including court costs and reasonable fees of attorneys and other professionals) of a Third Party (individually and collectively, the “Losses of Client”) for bodily injury, personal injury, death and property (monetary) damage caused by (i) any breach by Supplier of its warranties or obligations under this Agreement, or (ii) negligent acts or omissions, reckless or wilful misconduct of Supplier or a person for which Supplier is legally responsible, provided, however, Supplier shall not be liable to Client if and to the extent, such Losses of Client are attributable to Client according to Article 10.2. 10.2 Indemnification of Supplier. Client hereby agrees to defend Supplier and its Affiliates and their respective directors, officers, employees and agents against any and all claims and suits of a Third Party and to indemnify and hold Supplier and its Affiliates and their respective directors, officers, employees and agents harmless from and against any and all losses, damages, costs, penalties, liabilities (including strict liabilities), judgments, amounts paid in settlement, fines and expenses (including court costs and reasonable fees of attorneys and other professionals) of a Third Party (individually and collectively, the “Losses of Supplier”) for bodily injury, personal injury, death and property (monetary) damage caused by (i) any breach by Client of its obligations or warranties under this Agreement, or (ii) negligent acts or omissions, reckless or wilful misconduct of Client or a person for which Client is legally responsible, provided, however, Client shall not be liable to Supplier if and to the extent, such Losses of Supplier are attributable to Supplier according to Article 10.1. 10.3 Indemnification Procedure. Any Party seeking to be indemnified hereunder (the “Indemnified Party”) shall provide prompt written notice to the other Party (the “Indemnifying Party”) no later than thirty (30) days after becoming aware of any actual claim in respect of which indemnification may be sought; provided, however, that the failure by the Indemnified Party to provide such prompt notice to the Indemnifying Party shall only be a bar to recovering Losses to the extent that the Indemnifying Party can demonstrate that it was actually prejudiced and directly damaged by such failure. In the event of any such actual or threatened Loss or claim therefor, each Party shall provide the other information and assistance as the other shall reasonably request for purposes of defense, and each Party shall receive from the other all necessary and reasonable cooperation in such defense, including, but not limited to, the services of employees of the other Party who are familiar with the transactions or occurrences out of which any such Loss may have arisen. The primary responsibility for defending any such Loss or claim shall be with the Indemnifying Party; provided, however, that the Indemnified Party shall have the right to participate in and with respect to the defense of any Loss with counsel of its own choosing, whose fees shall be borne by the Indemnified Party. The Indemnified Party shall not be entitled to settle any claim or agree to the entry of any judgment or other relief without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld or delayed. 10.4 Liability and General Limitation. Each Party shall compensate the respective other party for any damage suffered by the other Party due to such Party’s breach of its obligations or warranties under this Agreement. However, except for Supplier’s obligation to compensate Client pursuant to Articles 4.6 and 5.4, and except for each Party’s indemnification obligations pursuant to Articles 10.1 and 10.2, neither Party shall have any liability to the other Party or its Affiliates for any damages such as loss of profits, direct, indirect, consequential, exemplary, punitive or incidental damages arising out of or relating to this Agreement however caused and on any theory of liability (including negligence), whether or not a Party has been advised of the possibility of such damages, unless such damages have been caused by the gross negligence or willful misconduct of the other Party or any person for which such other Party is legally responsible. 10.5 Adequate Insurance. Both Parties will maintain liability insurance covering their respective risks as described above as are appropriate in accordance with applicable legal requirements, sound business practice and their respective contingent obligations under this Agreement. 10.6 Survival. The provisions of this Article 10 shall survive any termination of this Agreement. Article 11 (Confidentiality) 11.1 Confidentiality Obligations. Each Party (the “Receiving Party”) undertakes to maintain in confidence the Confidential Information received by the other Party (the “Disclosing Party”), not to disclose it or part of it to any Third Party without the prior written consent of the Disclosing Party and to use it only to perform its obligations under this Agreement during the term of this Agreement and for five (5) years thereafter, provided, however, Client may disclose Confidential Information to its Affiliates and business partners, to the extent necessary for the commercialization of its pharmaceutical product(s), for which Materials are employed, without prior written consent of the Supplier. The Receiving Party shall only disclose such Confidential Information to those of their respective employees, Affiliates and/or business partners who reasonably need to know such Confidential Information in order to apply such Confidential Information (only) for the purpose of this Agreement, provided, such employee’s, Affiliates, business partners are bound by confidentiality obligation not less strict then assumed by the Parties under this Agreement. 11.2 Exceptions of Confidentiality. Excepted from this confidentiality obligation shall be such Information: (i) which is in public domain at the time of disclosure; (ii) which is published or otherwise becomes part of the public domain through no fault of the Receiving Party; (iii) which was in the possession of the Receiving Party at the time of disclosure as shown by prior written records; (iv) which becomes available to the Receiving Party from a Third Party without duty of confidentiality; or (v) of which the Receiving Party can clearly and convincingly prove that it was independently developed by employees of the Receiving Party who had no access to the Confidential Information disclosed. The Receiving Party shall further be entitled to disclose to the European regulatory or legal authorities or other relevant regulatory authorities respectively courts, if the case may be, such part of Confidential Information received from the Disclosing Party that is required by law to be disclosed to such authorities. In this event, the Receiving Party shall (i) give the Disclosing Party promptly written notice of any such request as long as reasonably practical, and (ii) ask the receiving regulatory or legal authority to maintain confidentiality. 11.3 Survival. The provisions of this Article 11 shall survive any termination of this Agreement by five (5) years after end of the Term of this Agreement. Article 12 (Term, Termination and Obligations upon Termination) 12.1 Term and Termination. This Agreement shall be effective upon signing by both Parties (the “Effective Date”) and shall continue to be in force and effect until [insert relevant date here], unless terminated earlier in accordance with its terms (the “Initial Term”). Thereafter, the Agreement shall be automatically renewed for further periods of […] year(s) [month(s)] (each a “Renewal Term”) unless terminated by either Party by the end of the Initial Term or any Renewal Term with 12-24 months prior written notice. (Initial Term and Renewal Term, as applicable, collectively the “Term”.) 12.2 Either Party's Right to terminate for Cause. Either Party shall have the right to terminate this Agreement for cause in any of the following events: 12.2.1 Termination for Material Breach. This Agreement may be terminated by either Party, being the non-defaulting Party hereunder, at any time upon thirty (30) days prior written notice in the event that the other Party commits a material breach of this Agreement and such material breach, if curable, is not remedied to the other Party's reasonable satisfaction within the thirty (30) days period. For the sake of clarity, in case of non-curable material breach, the non-defaulting Party has the right to terminate this Agreement with immediate effect accordingly. 12.2.2Terminations for Insolvency. Each Party may terminate this Agreement, being the non-defaulting Party hereunder, with immediate effect upon notice in case the other Party becomes bankrupt or insolvent, terminates its business activities or is in a similar situation. 12.3 Termination in Case of Force Majeure Event. The Parties shall have the right to terminate this Agreement in accordance with Article 15 in case of Force Majeure Event. 12.4 Termination in Case of Safety Reasons. Client shall be entitled to terminate this Agreement with immediate effect by giving Supplier written notice for reasonable concerns as to the safety of Materials for Client’s pharmaceutical product(s). Such termination right may be exercised in the event that concerns as to the safety of Materials that prevent the use of them for Client’s pharmaceutical product(s) or cause the rejection of a regulatory approval, and which, within the reasonably exercised discretion of Client, render the commercialization of the respective pharmaceutical product(s) impossible. 12.5 Termination in Case of Manufacturing Stop. Client shall be entitled to terminate this Agreement at any time with no less than six (6) months prior written notice to Supplier if Client or its Affiliate(s) stop(s) the manufacturing of the pharmaceutical product(s) for which Materials have been purchased. 12.6 Termination in Case of Change of Ownership. Client may terminate this Agreement in accordance with this provision if ownership or control of Supplier is being transferred to a Third Party by purchase, merger, operation of law or otherwise, and if such transfer has within the reasonably exercised discretion of Client an adverse material impact on the interests of Client (i.e. if a competitor of Client acquires ownership or obtains control of Supplier). Supplier shall inform Client of such change of ownership or control without undue delay (the "Change of Ownership Notice"). Client may exercise its termination right for change of ownership or control within a period of two (2) months following receipt of the Supplier's Change of Ownership Notice. For the avoidance of doubt this Article 12.6 shall not apply to internal reorganisations of Supplier or its parent company. 12.7 Obligations Upon Termination. Upon Termination the Parties shall procedure as follows: 12.7.1 The Parties shall return Confidential Information received from the other Party without undue delay. 12.7.2 In case Client exercises its termination right pursuant to Articles 12.1 or 12.2.1 Supplier or the legal successor of Supplier shall be obliged to manufacture and supply Materials according to regulations of this Agreement for an additional period of up to nine (9) months after the termination of this Agreement upon Client’s written request. 12.7.3 Payments to be made by either Party under this Agreement shall be due on termination and payable within ninety (90) days after the date as of which the termination of this Agreement for any reason whatsoever becomes effective, provided that the amount may be calculated at that time; if this is not the case, such payments shall become due and payable as soon as the amount can be calculated accordingly. 12.8 Survival. The termination of this Agreement for any reason whatsoever shall be without prejudice to any obligations or rights on the part of either Party which have accrued prior to such termination, and shall not affect or prejudice any provision of this Agreement which is expressly (e.g. Indemnification and Insurance, Article 10; Confidentiality, Article 11); or by implication (e.g. warranties) provided to come into effect on, or continue in effect after, such termination. Article 13 (Notices) Except for the notices or communication to be given under Article 5 (for such a letter, fax or email shall be sufficent), any notice or other communication required or permitted to be given under this Agreement may be delivered personally or be sent by prepaid certified or registered post, courier, facsimile transmission (with receipt acknowledged or confirmed) addressed to the Party as follows: If to Supplier If to Client [TBD] Attention: [TBD] [TBD] [TBD] [TBD] Attention: [TBD] [TBD] [TBD] Facsimile: [TBD] Facsimile: [TBD] Any Party may change the address to which notice is to be given as provided herein by giving the other Party related written notification in advance. Article 14 (Dispute Resolution and Governing Law) 14.1 Disputes. In the event of any dispute, claim, question or disagreement arising out of or relating to this Agreement (a “Dispute”), the Parties shall use all reasonable efforts to settle such Dispute by amicable negotiations within a period of sixty (60) days of one Party giving notice of the Dispute to the other Party. 14.2 [Dispute Resolution]. Should the Parties not manage to settle the Dispute by amicable negotiations within the period of sixty (60) days, all Disputes shall be finally settled according to […]. 14.3 Governing Law. This Agreement shall be construed and enforced in accordance with the laws of [country], excluding its conflict of law provisions. If the English legal meaning differs from the German legal meaning of this Agreement and its terms, the German legal meaning shall prevail. The Parties explicitly exclude the application of the UNCITRAL Convention for the international sale of goods or any other uniform law for the formation of contracts for the international sale of goods and/or the international purchase of goods. Article 15 (Force Majeure) Neither Party shall be considered in default or be liable to the other Party for any delay in performance or non-performance caused by circumstances beyond the reasonable control of such Party, including but not limited to acts of God, explosion, fire, flood, war (whether declared or not) or general labour strike (each a “Force Majeure Event”). The Party so affected shall use its best efforts to avoid or remove such causes of non-performance and shall continue performance hereunder with the utmost dispatch whenever such causes are removed. If a Force Majeure Event occurs, the date(s) for performance of such obligation shall be postponed for as long as is made necessary by the Force Majeure Event, provided that if any Force Majeure Event continues for a period of or exceeding two (2) months, either Party shall have the right to terminate this Agreement by written notice to the other Party with immediate effect. Article 16 (Entire Agreement) 16.1 Entire Agreement. This Agreement is the entire agreement and understanding between the Parties respecting the subject matter hereof, and supersedes and replaces any and all other prior negotiations, correspondence, understandings and agreements relating to Materials, whether written or oral, between the Parties respecting the subject matter hereof. Any modification, amendment or supplement to this Agreement must be in writing and signed by authorised representatives. 16.2 Governing Agreement. The Preamble, the Appendices and the Quality Agreement to this Agreement form an integral and substantial part of this Agreement. In the event of any conflict between the provisions of the main body of this Agreement and its Appendices, the provisions of the main body shall prevail, except to the extent it has been expressly amended as set forth in the respective deed of amendment. Furthermore, in the event of conflict between the provisions of this Agreement and the Quality Agreement, the provisions of this Agreement shall prevail. 16.3 Standard Business Conditions. The standard business conditions of the Parties or its Affiliates are not content of this Agreement and are expressly excluded for any manufacturing and supply of Materials, even if they are used by the Parties in business connections. Article 17 (Severability) In the event of the invalidity, ineffectiveness or unenforceability of any provisions of this Agreement or if this Agreement containing any gaps, the Parties agree that such invalidity, ineffectiveness, unenforceability or gap shall not affect the validity, effectiveness, enforceability of the remaining provisions of this Agreement. The Parties will replace an invalid, ineffective or unenforceable provision or fill any gap with valid, effective and enforceable provisions which most closely approximate the purpose and economic effect of the invalid, ineffective or unenforceable provisions or, in case of a gap, the Parties' presumable intentions. In the event that the terms and conditions of this Agreement are materially altered as a result of the preceding sentences, the Parties shall renegotiate the terms and conditions of this Agreement in order to resolve any inequities. Article 18 (Assignment) This Agreement may not be assigned by either Party to a Third Party without the other Party’s prior written consent. However, Client shall be only entitled to assign this Agreement (i) to an Affiliate, or (ii) in connection with any merger or sale of all or substantially all of its products for which the Materials are used for, for (i) and (ii) without Supplier’s prior written consent. Article 19 (Headings) The heading references herein are for convenience purposes only, do not constitute a part of this Agreement and shall be deemed not to limit or affect any of the provisions hereof and their interpretation. The singular and plural numbers can be substituted for each other when the context requires such substitution. IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their duly authorized representatives. Appendices to this Agreement: Appendix "A":Commercial Set Up Appendix "B":Quality Agreement Appendix "C":Materials and Materials’ Specifications Appendix “D”: Equipment FURTHER ATTACHED: ALTERNATIVE WORDING: FOR CLIENT USE ONLY: DELETE PRIOR SENDING OUT TO PARTNER Appendix “A” Commercial Set Up 1. Details Regarding the Supply Price: 1.1 General Principle. Unless specifically otherwise determined in the Agreement, the Supply Price as determined under this Appendix A shall be the whole and entire compensation for Suppliers performance of this Agreement, including the Quality Agreement. For clarity, Supplier shall not be entitled to add (and shall be solely responsible for any additional) charges of any type, including shipping, packaging, labelling, stamp, customs and other duties, taxes (other than value-added tax),storage, insurance, boxing, overtime, and crating costs. Supplier shall provide all usual information and other input to enable Client to recover value-added tax. 2. Currency Fluctuation. [Comment to Client: Regularly to consider in case the contract partner is located in an Emerging Market; however; potentially less critical in this case if Client has to pay] 3. Shrinkage. Without limitation of Appendix A 1. Supplier shall be responsible for all expenses relating to its manufacturing losses and inventory losses. 4. Cost Savings. [Comment to Client: Cost saving clauses might an issue to be en forced, due to burden of prove. A guarantee (e.g. combined with German law) might be the strongest instrument, followed by the obligation to use best efforts. A pure obligation to save costs, will be hardly enforceable, however, might be honoured by certain suppliers in some cases.] Supplier shall use its best efforts to generate savings in the cost of the Materials. Cost savings shall be allocated as set forth in this Section. Alternative 1: Cost savings shall be applied to reduce the Supply Prices of the Materials. Alternative 2: Cost savings which (i) result from Materials or Material packaging modifications will be applied solely to reduce Supply Prices upon implementation. Supplier guarantees an annual aggregate minimum five (5) percent cost reduction in conversion cost and Supplier components employed in the manufacturing of Materials for each calendar year. The Parties agree to adjust the Supply Prices once per calendar year. The new Supply Prices, reflecting the guaranteed minimum five (5) percent cost reduction, will be determined no later than February 1 of each calendar year to take effect the following July 1 for the twelve (12) month period thereafter. The following will not count towards Supplier’s cost savings guarantee: (i) cost savings which are initiated by Client, and (iii) avoidance of future costs. Cost savings will only apply to the cost savings guarantee for one Contract Year and not to multiple Contract Years. Cost savings will be documented and reviewed [by …] on a quarterly basis. 5. Invoicing and Set Off. Supplier shall invoice Client upon delivery of the Materials, provided however, any claim for payment of Supply Price shall be set off against claims of Client according to Article 4.6. Consequently, Supplier shall invoice Client for the Supply Price minus the amount for the delayed delivery under Article 4.6, if applicable. Except for the duty to set off under this Appendix A (5.), Supplier shall not be entitled to set of or exercise a right of retention regarding any claims Client may have against Supplier. 6. Terms of Payment. Terms of payment shall be within ninety (90) calendar days following the date of receipt of an undisputed invoice. Ishall be issued in Euro and shall be paid to a bank account indicated by Supplier. 7. Taxes. Unless otherwise stated, any consideration payable under this Agreement shall be exclusive of VAT. If a Party makes a supply pursuant to this Agreement, and VAT is payable on that supply, the consideration for the supply (VAT exclusive consideration) is increased by an amount equal to the VAT exclusive consideration multiplied by the rate of VAT prevailing at the time the supply is made (additional VAT amount). VAT (if any) will become due and payable upon presentation of a valid VAT invoice (or, where there is no provision in the legislation for the jurisdiction concerned that a VAT invoice is required to be issued, a written demand containing such information as is customary in that jurisdiction). The Parties shall use commercially reasonable efforts to cooperate and coordinate with each other in completing and filing documents required under the provisions of any applicable laws (including tax treaties) in connection with the making of any required tax payment or withholding payment, in connection with a claim of exemption from, or entitlement to, a reduced or zero rate of withholding or in connection with any claim to a refund of or credit for any such payment. Note: Delete VAT language for US 8. Supply Price Per […] of Material Material Supply Price per […] 1. 2. 3. 9. Supply Price Adjustement Mechanism [Comment to Client: Not to be included as starting position] Appendix “B” Quality Agreement [pls. add] Appendix “C” Materials and Materials Specifications [pls. add] ALTERNATIVE WORDING: FOR CLIENT USE ONLY: DELETE PRIOR SENDING OUT TO PARTNER & ALIGNMENT WITH LEGAL NECESSARY Instead of 4.1/4.2 4.1 Rough Cut Capacity Planning. In the month of […] of the first calendar year and in the month of […] of all subsequent calendar years, Client agrees to submit to […] and, where relevant, update its best estimate rough cut capacity planning of its anticipated requirements of Materials for the subsequent […] period on which Supplier’s manufacturing capacity planning will be based. 4.2 Mid Term Forecast, Ordering, Lead Time. Promptly following the Effective Date, and within the first […] calendar days of each calendar month thereafter, Client shall submit to Supplier a non-binding rolling monthly forecast of the quantity of Materials which Client expects Supplier to supply during the succeeding […] months in the format of which is attached hereto as Schedule […] (the “Rolling Forecast”). The quantities indicated in the respective first […] months of each such Rolling Forecast shall be binding on Supplier and Client. Promptly following the Effective Date, or such other time agreed by the Parties in writing, Client may commence ordering Materials on the basis of the Rolling Forecast. Thereafter, before the […] calendar day of each calendar month, Client may place binding orders for Materials set out under the respective third month of the then applicable Rolling Forecast (Firm “Orders” or each a firm “Order”). Each Order may only be cancelled or modified if agreed in writing by the Parties. The maximum lead-time for Supplier’s deliveries of Materials to Client or its appointee’s in accordance with this Article 4.2 shall be […] calendar days from the Order receipt by the Supplier (the “Lead Time”).