Common use of Manufacture and Supply of Product Clause in Contracts

Manufacture and Supply of Product. (a) Alpharma will manufacture Product at Alpharma’s United States Food and Drug Administration (“FDA”) approved facilities in [***] in accordance with cGMP, the Product Specifications and the Quality Agreement and Applicable Law. ViroPharma shall be fully responsible for the safety and efficacy, and compliance with all Applicable Laws, in connection with the use (and the manner and method of use) of the Products in finished dosage form pharmaceutical products into which the Products are introduced by ViroPharma, except to the extent that any safety or efficacy problem is related to the manufacture of the Product. (b) Alpharma will notify ViroPharma of any changes, including but not limited to any change in the manufacturing process or Product specifications or control methods which are likely to alter the identity, purity, quality, potency or stability of the Product and which require a regulatory filing with the FDA. Alpharma will notify ViroPharma not less than ninety (90) days prior to implementation of any such change so that ViroPharma will have reasonable time to allow ViroPharma to update applicable regulatory filings and evaluate the effect on its finished product prior to receiving Product which incorporates the change. However, Alpharma will not notify ViroPharma of any Annual Reportable Changes before implementation. In the event that ViroPharma does not agree to accept Products with changes proposed by Alpharma pursuant to this subsection (b), ViroPharma shall promptly notify Alpharma in writing of that decision. The parties shall then attempt in good faith to resolve ViroPharma’s objections over a thirty (30) day period, failing which resolution ViroPharma shall have the right to terminate this Agreement with [***] written notice provided, however, that during this [***] termination period ViroPharma shall have the right to terminate this Agreement [***] Indicates material that has been omitted and for which confidential treatment has been requested. All such omitted material has been filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. immediately upon written notice if at any time during the [***] termination period Alpharma is unable to continue to supply to ViroPharma Product manufactured in accordance with the manufacturing process or Product specifications or control methods, as applicable, which were effective before the change implemented by Alpharma to which ViroPharma did not agree. (c) Notwithstanding anything to the contrary herein, it is acknowledged that commercial supply of Product manufactured at the [***] will not be commenced as of the Signature Date, as Product from the [***] is not registered with the FDA as a qualified source of Product for use in ViroPharma’s finished dosage form product containing the Product, and as the [***] has not yet been FDA inspected. (d) ViroPharma agrees to use commercially reasonable efforts to prepare and submit to the FDA the amendments to the regulatory documents for ViroPharma’s finished dosage form product containing the Product required for qualification of the [***] as source of Product as soon as practically possible and, using ViroPharma’s commercially reasonable efforts, no later than [***]. Alpharma agrees to use commercially reasonable efforts to assist and co-operate with ViroPharma in this respect as required to obtain such regulatory clearance including pre-approval inspections and technical assistance, and including making the relevant preparations for FDA inspection to take place in connection with ViroPharma’s qualification of the Product manufactured at the [***]. Each party will be responsible for its own costs associated with the qualification of the [***] as source of Product pursuant to this Section.

Manufacture and Supply of Product. (a) Alpharma will Upon final FDA regulatory approval granting Pentech the right to manufacture, sell and distribute the Product, Pentech hereby agrees to manufacture Product at Alpharma’s United States Food and Drug Administration (“FDA”) approved facilities in [***] in accordance with cGMP, or engage a subcontractor to manufacture the Product Specifications and exclusively for Pentech (the Quality Agreement and Applicable Law"Subcontractor"). ViroPharma shall be fully responsible Pentech hereby appoints Par for the safety Term and efficacyany Renewal Term of this Agreement as Pentech's exclusive distributor of the Product in the Territory. Pentech agrees that during the Term and any Renewal Term of this Agreement, all Product manufactured by or on behalf of Pentech shall not be supplied to any third party for distribution in the Territory. Par agrees to market, distribute, and compliance with sell the Product only in the Territory, subject to the terms and conditions of this Agreement. Par shall purchase exclusively from Pentech all Applicable Laws, of its requirements for the Product in connection with the use (and the manner and method of use) of the Products in finished dosage form pharmaceutical products into which the Products are introduced by ViroPharma, except Territory to the extent that any safety or efficacy problem Pentech is related able to, and does, supply them in accordance with this Agreement. Notwithstanding anything herein to the manufacture contrary, in the event that Par does not place a Firm Order for an aggregate quantity of capsules during the six-month period that commences on the Final Approval Date equal to what would represent ten percent (10%) of the Product. (b) Alpharma will notify ViroPharma of any changes, including but not limited to any change in the manufacturing process or Product specifications or control methods which are likely to alter the identity, purity, quality, potency or stability total market share for newly written prescriptions of the Product in its generic form only on the Final Approval Date, the exclusive right granted to Par in this Section 3.1 shall become a nonexclusive right and which require a regulatory filing with Pentech may use third parties to distribute and sell the FDAProduct in the Territory. Alpharma will notify ViroPharma not less than ninety (90) days prior to implementation For purposes of any such change so that ViroPharma will have reasonable time to allow ViroPharma to update applicable regulatory filings and evaluate this Section 3.1, market share of the effect on its finished product prior to receiving Product which incorporates the change. However, Alpharma will not notify ViroPharma of any Annual Reportable Changes before implementationshall be determined using data supplied by NDC Health Corporation. In the event that ViroPharma does Pentech shall fail or shall be unable to supply Par's reasonable requirements for any Product hereunder for a period exceeding thirty (30) days, Par may, in its discretion, elect to manufacture such Product, or cause such Product to be manufactured for Par. Par shall give Pentech not agree less than thirty (30) days notice of Par's intent to accept Products with changes proposed by Alpharma pursuant manufacture such Product, or cause such Product to this subsection (b)be manufactured for Par. If Pentech is able to demonstrate to Par, ViroPharma shall promptly notify Alpharma in writing of that decision. The parties shall then attempt in Par's reasonable good faith to resolve ViroPharma’s objections over a discretion, that it can meet Par's reasonable requirements within such thirty (30) day period, failing which resolution ViroPharma then Par shall have continue to procure its supply of the right to terminate this Agreement with [***] written notice provided, however, that during this [***] termination period ViroPharma shall have the right to terminate this Agreement [***] Indicates material that has been omitted and for which confidential treatment has been requestedProduct from Pentech. All such omitted material has been filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. immediately upon written notice if at any time during the [***] termination period Alpharma If Pentech is unable to continue demonstrate to Par, in Par's reasonable good faith discretion, that it can meet Par's reasonable requirements within such thirty (30) day period, then Par may manufacture such Product, or cause such Product to be manufactured for Par. Par may only manufacture such Product, or cause such Product to be manufactured for Par for as long as Pentech is unable to demonstrate to Par, in Par's reasonable good faith discretion, that it can supply the Product to ViroPharma Product manufactured in accordance with the manufacturing process or Product specifications or control methods, Par. As soon as applicable, which were effective before the change implemented by Alpharma to which ViroPharma did not agree. (c) Notwithstanding anything to the contrary herein, Pentech can demonstrate that it is acknowledged that commercial can supply of Product manufactured at the [***] will not be commenced as of the Signature Date, as Product from the [***] is not registered with the FDA as a qualified source of Product Par's reasonable requirements for use in ViroPharma’s finished dosage form product containing the Product, and as the [***] has not yet been FDA inspected. (d) ViroPharma agrees Par's right to use commercially reasonable efforts to prepare and submit to the FDA the amendments to the regulatory documents for ViroPharma’s finished dosage form product containing manufacture the Product required for qualification of the [***] as source of Product as soon as practically possible and, using ViroPharma’s commercially reasonable efforts, no later than [***]. Alpharma agrees to use commercially reasonable efforts to assist and co-operate with ViroPharma in this respect as required to obtain such regulatory clearance including pre-approval inspections and technical assistance, and including making the relevant preparations for FDA inspection to take place in connection with ViroPharma’s qualification of or cause the Product to be manufactured at the [***]. Each party will be responsible for its own costs associated with the qualification of the [***] as source of Product pursuant to this Sectioncease.

Manufacture and Supply of Product. (a) Alpharma Xellia will manufacture Product at AlpharmaXellia’s United States Food and Drug Administration (“FDA”) approved facilities in [***] * in accordance with cGMP, the Product Specifications and the Quality Agreement and Applicable Law. ViroPharma shall be fully responsible for the safety and efficacy, and compliance with all Applicable Laws, in connection with the use (and the manner and method of use) of the Products in finished dosage form pharmaceutical products into which the Products are introduced by ViroPharma, except to the extent that any safety or efficacy problem is related to the manufacture of the Product. (b) Alpharma Xellia will notify ViroPharma of any changes, including but not limited to any change in the manufacturing process or Product specifications or control methods which are likely to alter the identity, purity, quality, potency or stability of the Product and which require a regulatory filing with the FDA. Alpharma Xellia will notify ViroPharma not less than ninety (90) days prior to implementation of any such change so that ViroPharma will have reasonable time to allow ViroPharma to update applicable regulatory filings and evaluate the effect on its finished product prior to receiving Product which incorporates the change. However, Alpharma Xellia will not notify ViroPharma of any Annual Reportable Changes before implementation. In the event that ViroPharma does not agree to accept Products with changes proposed by Alpharma Xellia pursuant to this subsection (b), ViroPharma shall promptly notify Alpharma Xellia in writing of that decision. The parties shall then attempt in good faith to resolve ViroPharma’s objections over a thirty (30) day period, failing which resolution ViroPharma shall have the right to terminate this Agreement with [***] * written notice provided, however, that during this [***] * termination period ViroPharma shall have the right to terminate this Agreement [***] Indicates material that has been omitted and for which confidential treatment has been requested. All such omitted material has been filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. immediately upon written notice if at any time during the [***] * termination period Alpharma Xellia is unable to continue to supply to ViroPharma Product manufactured in accordance with the manufacturing process or Product specifications or control methods, as applicable, which were effective before the change implemented by Alpharma Xellia to which ViroPharma did not agree. (c) Notwithstanding anything to the contrary herein, it is acknowledged that commercial supply of Product manufactured at the [***] will not be commenced as of the Signature Date, as Product from the [***] is not registered with the FDA as a qualified source of Product for use in ViroPharma’s finished dosage form product containing the Product, and as the [***] has not yet been FDA inspected. (d) ViroPharma agrees to use commercially reasonable efforts to prepare and submit to the FDA the amendments to the regulatory documents for ViroPharma’s finished dosage form product containing the Product required for qualification of the [***] as source of Product as soon as practically possible and, using ViroPharma’s commercially reasonable efforts, no later than [***]. Alpharma agrees to use commercially reasonable efforts to assist and co-operate with ViroPharma in this respect as required to obtain such regulatory clearance including pre-approval inspections and technical assistance, and including making the relevant preparations for FDA inspection to take place in connection with ViroPharma’s qualification of the Product manufactured at the [***]. Each party will be responsible for its own costs associated with the qualification of the [***] as source of Product pursuant to this Section.

Manufacture and Supply of Product. 4.1. Sicor will Manufacture Product at the Sicor Facilities. The foregoing shall not preclude Sicor’s right to subcontract certain Manufacturing activities to qualified Affiliates or Third Parties at other sites and facilities pursuant to Section 2.4 hereof. For the purpose having two alternative sites available for the downstream chemistry processing of AP3 into Product to be supplied to ImmunoGen hereunder as contemplated in Appendix III of the Quality Agreement, Sicor agrees to have both of the Sicor Facilities qualified and utilizable for such purpose, in accordance with the relevant provisions the Quality Agreement. Furthermore, Sicor may otherwise propose to change the location from one of the Sicor Facilities to the other, or use any additional facility controlled by Sicor or its Affiliates for the Manufacture of Product, pursuant to the terms of the Quality Agreement and in any event only upon (a) Alpharma will manufacture Product providing ImmunoGen with written notice of such proposal at Alpharma’s United States Food and Drug Administration (“FDA”) approved facilities in least [***] in accordance with cGMPdays commencing any of the preparatory steps necessary to qualify such other facility for such activities, and (b) receiving ImmunoGen’s prior written consent, which consent will not be unreasonably withheld or delayed. The Parties agree that it will be reasonable for ImmunoGen to withhold such consent pending satisfactory completion by each of the Parties of their respective quality assurance audits and/or regulatory impact assessments of the new location or additional facility, as the case may be. Sicor will maintain, at its own expense, the Sicor Facilities (and any additional facility approved for use as described above) and all Equipment required for the Manufacture of Product Specifications in a state of repair and operating efficiency consistent with the Quality Agreement requirements of cGMP and Applicable Law. 4.2. ViroPharma shall be fully responsible for the safety and efficacy, and compliance with all Applicable Laws, in connection with the use (and the manner and method of use) of the Products in finished dosage form pharmaceutical products into which the Products are introduced by ViroPharma, except Any change or modification to the extent that Manufacturing Process or Specifications for any safety or efficacy problem is related to the manufacture of the Product. (b) Alpharma will notify ViroPharma of any changes, including but not limited to any change in the manufacturing process or Product specifications or control methods which are likely to alter the identity, purity, quality, potency or stability of the Product and which require a regulatory filing with the FDA. Alpharma will notify ViroPharma not less than ninety (90) days prior to implementation of any such change so that ViroPharma will have reasonable time to allow ViroPharma to update applicable regulatory filings and evaluate the effect on its finished product prior to receiving Product which incorporates the change. However, Alpharma will not notify ViroPharma of any Annual Reportable Changes before implementation. In the event that ViroPharma does not agree to accept Products with changes proposed by Alpharma pursuant to this subsection (b), ViroPharma shall promptly notify Alpharma in writing of that decision. The parties shall then attempt in good faith to resolve ViroPharma’s objections over a thirty (30) day period, failing which resolution ViroPharma shall have the right to terminate this Agreement with [***] written notice provided, however, that during this [***] termination period ViroPharma shall have the right to terminate this Agreement [***] Indicates material that has been omitted and for which confidential treatment has been requested. All such omitted material has been filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. immediately upon written notice if at any time during the [***] termination period Alpharma is unable to continue to supply to ViroPharma Product manufactured must be carried out in accordance with the manufacturing process or Product specifications or control methods, as provisions of the Quality Agreement (if applicable, which were effective before the change implemented by Alpharma to which ViroPharma did not agree). (c) Notwithstanding anything to 4.3. Sicor will take and retain, for such period and in such quantities as may be required by cGMP and the contrary hereinQuality Agreement, it is acknowledged that commercial supply samples of Product manufactured at the [***] will not be commenced as of the Signature Date, as Product from the [***] is not registered with the FDA as a qualified source of Product for use in ViroPharmaManufacturing Process produced under this Agreement. Further, Sicor will submit such samples to ImmunoGen, upon ImmunoGen’s finished dosage form product containing the Productwritten request. 4.4. Sicor will keep complete and accurate records, including, without limitation, reports, accounts, notes, data, and records of all information and results obtained from performance of the Manufacturing activities contemplated by this Agreement, including without limitation, all documents listed in section 5.2.2 of the Quality Agreement (such documents referred to as the [***] has “Records”). All Records will be will be treated by Sicor as ImmunoGen Confidential Information. Upon ImmunoGen’s request, Sicor will promptly provide ImmunoGen with copies of such Records. Sicor will not yet been FDA inspected. transfer, deliver or otherwise provide any such Records to any party other than ImmunoGen, without the prior written approval of ImmunoGen, provided that (da) ViroPharma agrees Sicor may provide the necessary parts of Records to use commercially reasonable efforts to prepare and submit any Regulatory Authority without ImmunoGen consent to the FDA the amendments to the regulatory documents for ViroPharma’s finished dosage form product containing the Product extent required for qualification of the [***] as source of Product as soon as practically possible andcompliance or abidance with Applicable Laws, using ViroPharma’s commercially reasonable efforts, no later than and (b) [***]. Alpharma agrees to use commercially reasonable efforts to assist While in the possession or control of Sicor, Records will be made available for inspection, examination and co-operate copying by or on behalf of ImmunoGen. All original Records of the Manufacture of Product hereunder will be retained and archived by Sicor in accordance with ViroPharma in this respect as required to obtain such regulatory clearance including pre-approval inspections cGMP and technical assistanceApplicable Law, and including making according to its applicable procedures. Sicor will not destroy the relevant preparations Records without first giving ImmunoGen written notice and the opportunity for FDA inspection ImmunoGen to take place in connection with ViroPharmareceive the Records at ImmunoGen’s qualification of the Product manufactured at the [***]. Each party will be responsible for its own costs associated with the qualification of the [***] as source of Product pursuant to this Sectionexpense.

Manufacture and Supply of Product. (a) Alpharma will manufacture AstraZeneca agrees to supply the Product at Alpharma’s United States Food to the Purchaser following the granting of Regulatory Approval and Drug Administration (“FDA”) approved facilities in [***] in accordance with cGMP, the terms and conditions of this Supply Agreement; the Purchaser agrees to pay the price for the Product Specifications in accordance with the terms and conditions of this Supply Agreement. AstraZeneca shall ensure that the volume of Product that is the subject of the Order shall be supplied to the Purchaser in accordance with the obligations under clause 5. AstraZeneca shall procure that it, its Affiliates and Subcontractors shall exercise the same level of effort, diligence and care in the Manufacture and supply of the Product to the Purchaser hereunder as AstraZeneca would exercise in carrying out the same or substantially similar services itself. AstraZeneca shall procure that the Product supplied under this Supply Agreement has been Manufactured (including being released) in compliance with Applicable Laws, Good Manufacturing Practice, Guidance, and the Quality applicable Regulatory Approval(s). AstraZeneca shall ensure that all Product supplied to the Purchaser (or its agent or designee) under this Supply Agreement shall, at the time of Delivery: be free of any identifiable Defects and Applicable Lawbe unadulterated; has, subject to AstraZeneca using Commercially Reasonable Efforts, a remaining shelf life that is no less than the Minimum Shelf Life; and be new and have not (i) previously left the control of AstraZeneca; (ii) been rejected or returned by any other entity, or (iii) been reprocessed or reworked; in each case of (i), (ii) and (iii) prior to their supply to the Purchaser under this Supply Agreement. ViroPharma AstraZeneca shall be fully solely responsible for the safety and efficacyManufacturing of the Product, and compliance with its supply of Product to the Purchaser hereunder. Such responsibilities shall include undertaking and coordinating all Manufacturing activities (including procuring all raw materials, equipment and services for the same), bulk holding stability studies, undertaking and validating manufacturing trials, validation activities (including, but not limited to, method, process and equipment cleaning validation), raw material and in-process testing, bulk finished product and stability (chemical and/or microbial) tests, and all other tests and certifications required by the Specification, Guidance, applicable Regulatory Approval(s) and Applicable Laws. Where and insofar as expressly stated in writing by the Purchaser to AstraZeneca, the Purchaser may appoint one or more Authorised Agents to act on the Purchaser’s behalf in relation to part or all of this Supply Agreement, including to receive one or more Deliveries of any Product (or part thereof). AstraZeneca shall work and co-operate reasonably with each Authorised Agent appointed by the Purchaser upon such notification. Nothing in this Supply Agreement shall amount to an exclusive purchasing obligation on the Purchaser or preclude or restrict the Purchaser from purchasing any products whatsoever from Third Parties, including any products that are complementary to, competitive to, equivalent to, or substitutable for the Product or that are indicated for use in the Field. Manufacturing Facilities And MATERIALS AstraZeneca either owns or operates the Facilities or has or will have a legally binding agreement in place at the time of Manufacture, in each case in order to use, or have used, the Facilities for the purposes of Manufacturing Product pursuant to this Supply Agreement and to ensure the supply and Delivery of Product in accordance with its terms. AstraZeneca represents to the Purchaser that, to AstraZeneca’s knowledge as at the Effective Date, the Facilities will be appropriate and sufficient for the Manufacture and Delivery of Conforming Product in the volumes that are the subject of the Order and in accordance with the terms of this Supply Agreement. AstraZeneca shall: keep, or procure the keeping of the Facilities in a state and condition that meets GMP, and is suitable and necessary for the successful Manufacture of the Product to enable AstraZeneca to comply with its obligations to supply the Product to the Purchaser in accordance with this Supply Agreement; and ensure that the Facilities have and will throughout the Term continue to hold all necessary Regulatory Approvals to operate and Manufacture Product for supply and Delivery under and in accordance with this Supply Agreement. ORDERING After the Effective Date, the Purchaser shall at any time as necessary submit to AstraZeneca a written order for demanded number of Doses of the Product (the “Order”), together with the Purchaser’s order number, VAT number, and invoice address. AstraZeneca shall accept the Order in writing, and the confirmed Order shall be binding upon the Parties and subject to the terms and conditions set out in this Supply Agreement. All other terms and conditions (including any terms and conditions which the Purchaser purports to apply under any order, specification or other document attached to any order form) are hereby excluded. DELIVERY Within thirty (30) days of receipt of Regulatory Approval, AstraZeneca shall provide Purchaser with a delivery schedule, setting forth the quantities and timing of Delivery of the Product, (the "Proposed Delivery Schedule"). AstraZeneca undertakes that it shall promptly update and refine such Proposed Delivery Schedule, from time to time, and notify the Purchaser of the same, to provide Purchaser its most accurate estimate, to AstraZeneca’s knowledge, of anticipated quantities and timing but in doing so shall use Commercially Reasonable Efforts to keep as close to the original version of the Proposed Delivery Schedule provided pursuant to this clause 5.1. Using Commercially Reasonable Efforts to deliver the same as soon as reasonably possible, and in any event not later than thirty (30) days prior to each anticipated Delivery, AstraZeneca shall provide a firm and final delivery schedule for each instalment ("Delivery Schedule") setting forth the quantities of Product for delivery in that instalment and the date for delivery of that instalment of Product within the Order. AstraZeneca shall: deliver the Product FCA (Incoterms 2020) at the Delivery Location ("Delivery") with Delivery being complete upon the Product being unloaded at the Delivery Location by AstraZeneca; and use Commercially Reasonable Efforts to ensure that the total volume of units set forth in the Order shall be delivered; it being understood that the Order may be delivered in multiple instalments. AstraZeneca shall not be in breach of its obligation to comply with the Delivery Schedule if: there is a material delay in AstraZeneca securing the Regulatory Approval for the Product in the Territory provided that (i) AstraZeneca, its Affiliates and Subcontractors used Commercially Reasonable Efforts in their respective activities to file for and secure the grant or issuance of the same; and (ii) delay was not caused by the breach of this Supply Agreement, or the negligence of, AstraZeneca, its Affiliates or Subcontractors; circumstances outside of AstraZeneca's reasonable control materially affect the Manufacture of the Product; there is any minor variance of dates of Delivery compared to the Delivery Schedule of up to five (5) Business Days due to the unpredictable nature of the Manufacturing of the Products, so long as such variance is notified to Purchaser as soon as reasonably practicable; or the Parties agree by mutual consent to vary the Delivery Schedule, provided however that AstraZeneca has and shall continue to use Commercially Reasonable Efforts to procure supply and Delivery of Conforming Product in accordance with the Delivery Schedule and failing that as soon as possible outside of the timelines set forth in the Delivery Schedule. AstraZeneca shall arrange for its nominated carrier to deliver the Product to the Delivery Location and shall give the Purchaser no less than five (5) Business Days' advance notice of the date of Delivery of the Product; provided, however, that such Delivery date shall not be earlier than the applicable date in the Delivery Schedule without the prior written consent of the Purchaser. Delivery shall be deemed complete when the Product has been unloaded at the Delivery Location. If the Purchaser cannot receive the Product within five (5) Business Days of AstraZeneca's written notice, the Purchaser shall notify AstraZeneca of the same and then prior to making a later Delivery AstraZeneca shall keep and store the same in accordance with the applicable storage guidelines and requirements for up to five (5) Business Days following the notified Delivery date at the Purchaser’s sole cost and expense (including the cost of any amounts required to insure the Product during such period). After such ten (10) Business Day period, AstraZeneca may continue to store such Product at the Purchaser’s cost if the Purchaser agrees to this. To the extent that either Party does not agree to continue to store the Product, AstraZeneca may sell the applicable Doses to a Third Party or destroy the applicable Doses at the cost of the Purchaser. The Purchaser shall reimburse AstraZeneca for all costs associated with distribution, storage, and destruction of the Product within XXX days of being invoiced therefor provided that AstraZeneca provides to the Purchaser specific evidence for such costs. All Deliveries of the Product supplied hereunder shall, at the time of Delivery or reasonably in advance of the Delivery of the Product, be accompanied by the documentation specified in Schedule 2 (the "Documentation"). Purchaser may, with AstraZeneca’s prior written consent and upon entry into a separate donation agreement, donate or transfer (“Donate”), at no profit to Purchaser, Product Delivered to the Purchaser that is in excess of its requirements to other countries, governments and charitable organisations (“Recipients”). Purchaser and Recipient shall be solely responsible for, at their sole cost and expense, obtaining any Regulatory Approvals, activities, consents or other requirements of any Governmental Authority which are necessary in connection with any Donation, as well as taking any actions required in connection with the use (foregoing. Purchaser shall ensure that any Donation is permitted by, and in compliance with, all Applicable Laws. AstraZeneca shall not be responsible for taking any action, and hereby disclaims any liability, in connection with, any Donation, and Purchaser hereby waives any claims or potential claims against AstraZeneca in connection with any Donation. RISK AND TITLE Risk of loss or damage and title to Products supplied under this Supply Agreement shall pass to the manner and method of use) Purchaser upon Delivery of the Products in finished dosage form pharmaceutical products into which the Products are introduced by ViroPharma, except Product to the extent that any safety or efficacy problem is related Purchaser pursuant to clause 5. Inspection and Rejection of Product Upon the manufacture later of the Product. (b) Alpharma will notify ViroPharma of any changes, including but not limited to any change in the manufacturing process or Product specifications or control methods which are likely to alter the identity, purity, quality, potency or stability Delivery of the Product and which require a regulatory filing with receipt of the FDA. Alpharma Documentation, the Purchaser will inspect the Product and review the Documentation, and notify ViroPharma not less than ninety AstraZeneca in writing (90within thirty (30) days prior of the Delivery of the Product and receipt of the Documentation) if it rejects the Product ("Rejected Product") due to implementation any Defect. AstraZeneca agrees that Purchaser may reject the portion, or if applicable, the whole, of any Delivery batch that would reasonably be expected to be Defective based on a reasonable sample of the Products taken indiscriminately from that Delivery batch that is found to have a Defect. Notwithstanding the above: if a Defect in the Product was not reasonably ascertainable from a visual inspection of the Product and review of the accompanying Documentation; or any Defect was a latent or hidden defect; then such change so that ViroPharma will have reasonable time to allow ViroPharma to update applicable regulatory filings and evaluate the effect on its finished product prior to receiving Product which incorporates the change. However, Alpharma will not notify ViroPharma of any Annual Reportable Changes before implementation. In the event that ViroPharma does not agree to accept Products with changes proposed by Alpharma pursuant to this subsection (b), ViroPharma shall promptly notify Alpharma in writing of that decision. The parties shall then attempt in good faith to resolve ViroPharma’s objections over a thirty (30) day periodperiod shall not apply, failing provided that the Purchaser notifies AstraZeneca in writing of its subsequent detection of the Defect prior to expiration of the shelf life and within twenty (20) Business Days of the time the Purchaser first becomes aware of a Defect in the applicable Product (which resolution ViroPharma may be prior to conducting root cause analysis) whereupon such Product shall have be deemed a Rejected Product. Should the right to terminate this Agreement with [***] written notice provided, however, that during this [***] termination period ViroPharma shall have the right to terminate this Agreement [***] Indicates material that has been omitted and for which confidential treatment has been requested. All such omitted material has been filed with the Securities and Exchange Commission Purchaser notify AstraZeneca pursuant to Rule 24b-2 under this clause 7.1, Purchaser shall make available samples of the Securities Exchange Act Rejected Product to AstraZeneca (or its nominated agent) for collection and testing. In the event of 1934a disagreement concerning whether Product has any Defect or is Conforming Product, AstraZeneca shall notify the Purchaser within fourteen (14) days of its receipt of the Purchaser’s notice of such Rejected Products. AstraZeneca and the Purchaser shall use their respective reasonable endeavours to resolve such disagreement as amendedpromptly as possible. immediately upon written notice if Either Party may submit a sample of the allegedly Defective Product for testing to an independent testing laboratory of recognised standing in the industry (to be mutually agreed and approved by the Parties acting in good faith) (“Laboratory”), to determine whether or not such Product was Defective or Conforming Product at any the time during of Delivery. The findings of the [***] termination period Alpharma Laboratory shall be final and binding on the Parties other than in the event of manifest error. The cost of the testing and evaluation by the Laboratory shall be borne by the Party against whom the Laboratory’s decision is unable to continue to supply to ViroPharma Product manufactured given. Remedies and Mitigation of Losses AstraZeneca acknowledges the critical importance that the Purchaser places on ensuring that Products are delivered free of Defect, in conformance with clauses 2.4 and 2.5, and in accordance with the manufacturing process Delivery Schedule. In respect of any Rejected Product for which the Parties are in agreement that the Product is Defective or the Laboratory has found to be Defective, provided that the Purchaser notifies AstraZeneca of such Defect in accordance with clause 7.1: AstraZeneca shall replace the Rejected Product specifications or control methodswith an identical quantity of Conforming Product at no additional cost to the Purchaser, as applicableupon the Parties agreeing on the Delivery Schedule for such replacement Product, which were effective before AstraZeneca shall use Commercially Reasonable Efforts to deliver on an expedited basis; and the change implemented Rejected Product shall be made available for collection and disposal by Alpharma to AstraZeneca, which ViroPharma did not agree. AstraZeneca shall collect in accordance with Applicable Law. AstraZeneca shall be responsible for (ci) Notwithstanding anything to the contrary herein, it is acknowledged that commercial supply cost of collection and disposal of Rejected Product manufactured at the [***] will not be commenced as and (ii) any of the Signature Date, as Product from the [***] is not registered with the FDA as a qualified source of Product for use in ViroPharma’s finished dosage form product containing the ProductPurchaser's reasonable, and as the [***] has not yet been FDA inspected. (d) ViroPharma agrees to use commercially reasonable efforts to prepare and submit to the FDA the amendments to the regulatory documents for ViroPharma’s finished dosage form product containing the Product required for qualification of the [***] as source of Product as soon as practically possible anddirect, using ViroPharma’s commercially reasonable efforts, no later than [***]. Alpharma agrees to use commercially reasonable efforts to assist and coout-operate with ViroPharma in this respect as required to obtain such regulatory clearance including preof-approval inspections and technical assistance, and including making the relevant preparations for FDA inspection to take place pocket expenses actually incurred by Purchaser in connection with ViroPharma’s qualification the storage, transportation and distribution of such Rejected Product after Delivery, provided that Purchaser shall use Commercially Reasonable Efforts to mitigate any such costs. Development and Information Requirements AstraZeneca shall itself and through its Affiliates be responsible at its sole cost and risk for the Development of the Product manufactured at and for filing with and prosecuting to grant or issuance a Regulatory Approval for the [***]Product in the Territory from the Licensing Authority for an indication in the Field. Each party will be responsible for its own costs associated with AstraZeneca shall ensure, and shall procure, the qualification Development of the [***] as source Product is undertaken (i) promptly, competently and in accordance with professional scientific standards; and (ii) using Commercially Reasonable Efforts to develop the Product to be a licensed medicine within the Territory for the Field. AstraZeneca shall inform the Purchaser in writing if it knows there to be any delay to, rejection of, or other issue jeopardising its grant or renewal of any Regulatory Approval required for or applicable to the Product in the Territory. PRICE AND CHARGES The price per Dose excluding VAT and delivery costs for Product is CZK XXXXXXX (the “Price”). The Parties acknowledge and agree that the Price applies to this Supply Agreement only and shall not impact the supply price for Product under any other supply arrangement. For clarity, the pricing set forth in clause 10.1 is on a per-Dose basis, and is not based on the Field of use. Prophylactic uses require one (1) Dose of Product pursuant to this Section.and therapeutic uses require two (2)