CONFIDENTIAL 11 regarding pharmaceutical waste, medical waste, or hazardous waste, as appropriate. Attachment F provides the ability for Pfizer to charge Purchaser for the cost of such packaging components, without limiting any other remedies available to Pfizer, in the event that Purchaser fails to comply with the return requirement set forth in Attachment F. (e) Purchaser shall be responsible for and shall ensure that any equipment used to deliver the Product, for example the shipper(s) and monitoring device(s), are stored in an appropriate clean and secure location to protect and maintain the functionality of such equipment (in controlled conditions, with no exposure to weather or pests, etc). Within thirty (30) days of delivery of the Product at the Place(s) of Destination, subject to Section 4.4(b), Purchaser shall organize safe return of all such equipment, including the shipper and monitoring device, in accordance with Pfizer’s instructions. (f) Pfizer may provide Safety Data Sheets and other information to Purchaser to assist Purchaser to develop processes and procedures, including training, to handle the Product and Product Materials in a safe manner and in compliance with Laws, including occupational health and safety Laws. Purchaser represents and warrants that Purchaser has and shall ensure that all recipients of the Product and Product Materials have the requisite expertise to develop and implement appropriate procedures and training programs to enable proper handling of the Product and Product Materials in a safe and lawful manner. 2.8 Title to Product, Risk of Loss. (a) Title to the Product, and risk of loss or damage shall pass to, Purchaser at the first point of entry in Albania at any airport in Albania, before customs clearance (the “Point of Delivery”). Pfizer reserves the right to change any supply or Point of Delivery by giving Purchaser adequate notice as acceptable under the Laws, taking into account to change the point of delivery in one of the neighboring states of the Republic of Albania. Prices are quoted on CIP Place(s) of Destination basis in effect at the time and Point of Delivery. For purposes of this Agreement, the terms CIP shall have the meaning ascribed thereto in INCOTERMS 2020 as published by the ICC, Paris, France. (b) Purchaser shall be the sole importer of the Products in front of the relevant customs authorities in Albania (“Importer of Record”) and shall be responsible to obtain, where applicable, at its own risk and expense, any import license or other official authorization and carry out all customs formalities for the import of the Products in Albania. Purchaser shall also be responsible to pay, where applicable, all duties, taxes and other charges, as well as the costs of carrying out customs formalities payable upon import of the Products. Given the nature of the Product, Purchaser undertakes to support the Shipping Agent to swiftly clear the Products from the relevant customs authorities within one (1) Business Day from the arrival of the Product at the Point of Delivery; any delay in such clearance process might affect the overall shelf-life of the Products. Subject to Pfizer’s prior written approval, the
CONFIDENTIAL 12 Purchaser can request and procure any such customs clearance services from the Shipping Agent. The Purchaser confirms that the required documents for customs clearance of the Products are indicated in Attachment H Part 1 of this Agreement. (c) Without prejudice to the generality of the foregoing, following the transfer of title to and risk of the Product to Purchaser at the Point of Delivery as defined under Section 2.8(a), Purchaser shall be fully responsible for and liable in relation to any Product wastage, and for ensuring appropriate disposal in accordance with Sections 2.7(d) and 2.7(e). For absolute clarity, even though Pfizer will support in the transportation of the Product from the Point of Delivery to the Place(s) of Destination through the Shipping Agent, Pfizer will not be liable for any risks of loss or damage to the Product after the Point of Delivery, including without limitation, temperature excursions, theft, or damages of any kind to the Product. (d) Without prejudice to Section 4.4, Purchaser acknowledges that Pfizer will not, in any circumstances, accept any returns of Product (or any dose). In particular, following receipt of the Product in accordance with this Section 2.8, no Product returns may take place under any circumstances (inclusive of future changes in stock, expired Products, changes in Product allocation, delivery, demand or new product launch). 3. PRICE AND PAYMENT. 3.1 Purchase Price. Purchaser shall purchase the Product from Pfizer at the price per dose set out in Attachment B, excluding VAT (the “Price”) and in accordance with the terms of this Agreement. The Price shall include all of Pfizer’s internal costs associated with the manufacturing and delivery of the Product to the Place(s) of Destination in accordance with this Agreement. For clarity, the Price shall be exclusive of the costs described in Section 2.8(b). The Price shall be firm for the Term. 3.2 Invoices and Payment. (a) In partial consideration of the Contracted Doses, Purchaser shall pay an upfront payment of $2,997,540 USD (calculated as $12.00USD/dose multiplied by 249,795 of the Contracted Doses) within thirty (30) days of receipt of an invoice from Pfizer issued upon Purchaser’s receipt of Approval set forth in Section 9.6 (the “Advance Payment”); provided, however, that Pfizer shall have no obligation to ship or deliver Product until receipt of the Advance Payment. All amounts due hereunder shall be converted to EUR which shall be determined based on the exchange rate used by The Wall Street Journal, Eastern U.S. Edition, one (1) Business Day prior to the date of this Agreement. (b) Pfizer shall invoice Purchaser for the Price for the remaining 249,795 of the Contracted Doses at least sixty (60) days in advance of each delivery pursuant to Section 2.4 (Delivery Schedule) (the “Delivery Price”) payable in accordance with
CONFIDENTIAL 13 the terms of Section 3.3(a). All such amounts shall be due prior to delivery of the volume of anticipated doses to be delivered in such delivery. (c) Invoices shall be provided to ishp@shendetesia.gov.al, Institute of Public Health, Aleksander Moisiu, nr. 80, Tirana, Albania 1001. Pfizer shall include the following information on all invoices: the Purchase Order number and billing address; and shall also include, where applicable, the type description, part number (if any) and number of Contracted Doses delivered; the delivery date; the actual date of shipment; the Price; any applicable taxes or other charges provided for in the Purchase Order; and the ship-to destination. 3.3 Method of Payment. (a) Purchaser shall pay all undisputed (in good faith) amounts due in EUR within thirty (30) days from the date of the invoice. Payment shall be remitted by wire transfer in immediately available funds to a bank and account designated by Pfizer. Any payment which falls due on a date which is not a Business Day may be made on the next succeeding Business Day. Any dispute by Purchaser of an invoice shall be provided to Pfizer in writing (along with substantiating documentation and a reasonably detailed description of the dispute) within ten (10) days from the date of such invoice. Purchaser will be deemed to have accepted all invoices for which Pfizer does not receive timely notification of disputes, and shall pay all undisputed amounts due under such invoices within the period set forth in this Section 3.3(a). The Parties shall seek to resolve all such disputes expeditiously and in good faith. (b) Any amount required to be paid by a Party hereunder which is not paid on the date due shall bear interest, to the extent permitted by law, at the higher of (a) the rate applied by the European Central Bank for its main refinancing operations in euros (the reference rate) plus five points (or such centralized bank reference rate set forth in the Vaccine Order Form) and (b) 2%. The reference rate is the rate in force, as published in the C series of the Official Journal of the European Union, on the first day of the month in which the payment period ends. Such interest shall be computed on the basis of a year of three hundred sixty (360) days for the actual number of days payment is delinquent. In addition to all other remedies available under this Agreement or at Law, if Purchaser fails to pay any undisputed amounts when due under this Agreement, Pfizer may (i) suspend the delivery of the Product or (ii) terminate this Agreement. (c) Purchaser shall not, and acknowledges that it will have no right, under this Agreement, any Purchase Order, any other agreement, document or Law, to withhold, offset, recoup or debit any amounts owed (or to become due and owing) to Pfizer, whether under this Agreement or otherwise, against any other amount owed (or to become due and owing) to it by Pfizer or a Pfizer Affiliate. 3.4 Taxes. It is understood and agreed between the Parties that any payments made and other
CONFIDENTIAL 14 consideration provided under this Agreement are exclusive of any VAT or similar tax and all other taxes which are incurred as a result of manufacturing and supplying the Product (including, without limitation, custom duties, levies and charges and all local taxes) (“Taxes”), which shall be added thereon as applicable. Where Taxes are properly chargeable on a payment made or consideration provided under this Agreement, the Party making the payment or providing the consideration will pay the amount of Taxes in accordance with the laws and regulations of the country in which the Taxes are chargeable. In the event any payments made pursuant to this Agreement become subject to withholding Taxes under the laws or regulation of any jurisdiction, the Party making such payment shall deduct and withhold the amount of such Taxes for the account of the payee to the extent required by Law and such amounts payable to the payee shall be reduced by the amount of Taxes deducted and withheld. Any such withholding Taxes required under Law to be paid or withheld shall be an expense of, and borne solely by, the payee. 4. MANUFACTURING STANDARDS AND QUALITY ASSURANCE. 4.1 Manufacturing Standards. Pfizer shall manufacture and supply the Product in material accordance with the Specifications and cGMP. Such Specifications may be revised through written notification by Pfizer to Purchaser to conform to the Authorization or changes to the manufacturing or distribution of the Product. 4.2 Legal and Regulatory Filings and Requests. (a) Pfizer shall (a) comply with all regulatory or government licenses and permits, and (b) comply with all cGMP with respect to its manufacturing and packaging processes, the Facilities or otherwise, to permit the performance of its obligations hereunder. Notwithstanding the foregoing, Pfizer shall use Commercially Reasonable Efforts to obtain the Authorization provided that the Purchaser shall waive, to the extent applicable, all the requirements set out in Attachment H Part 2 of this Agreement in respect of the issue of the Authorization. (b) Pfizer shall ensure that all Product is properly labelled and packaged in accordance with the applicable Authorization, Specifications and material cGMP standards. For clarity, Purchaser shall be solely liable for compliance with local labelling requirements, including without limitation, any local language translation requirements. (c) Prior to delivery, Pfizer shall comply with all conditions (in the relevant timescales) set out in the Authorization; provided, however, that Purchaser shall grant, or obtain on Pfizer’s behalf, all exemptions, exceptions, and waivers of country specific requirements for the Product granted or permitted by the Government authority (including but not limited to serialization, applicable laboratory or quality testing and/or marketing information form submission and approval), which requirements,
CONFIDENTIAL 15 absent an exemption, exception or waiver, would prevent Pfizer from supplying and releasing the Product in Albania upon receipt of the Authorization. (d) In the event that a third party is the applicant or holder of the Authorization, any obligation on Pfizer under this Agreement shall be taken as a requirement on Pfizer to use Commercially Reasonable Efforts to procure the compliance of such third party Authorization applicant or holder with such obligations to the extent necessary to ensure the relevant obligation is fully met. (e) Due to the current pandemic situation and the fact that any anticipated Authorization will be initially under an emergency use authorization, and the Parties agreement that Pfizer will only supply the Purchaser directly, the Purchaser agrees to the below conditions and, as a condition precedent to supply of the Product, will issue, or make any other Government authority to issue, any necessary approvals to ensure enforceability of the same: (i) During the Term, Pfizer will not be required by the Purchaser or any other Government authority to appoint a local agent, distributor, or any responsible Person, including without limitation, for purposes of selling or supplying the Product or applying for the Albanian Conditional Approval, unless Pfizer decides otherwise at a later stage to appoint a local agent or distributor. For the avoidance of doubt, Purchaser also agrees that (i) Pfizer or any of its Affiliates will be the entity applying and submitting any regulatory files required for issuance of Albanian Conditional Approval, and (ii) Albanian Conditional Approval will be issued under Pfizer’s or any of its Affiliates name. (ii) During the Term, Pfizer will not be required by the Purchaser or any other Government authority to submit a price reference certificate for purposes of applying for Albanian Conditional Approval or otherwise. 4.3 Quality Tests and Checks. Pfizer shall perform all bulk holding stability, manufacturing trials, validation (including, but not limited to, method, process and equipment cleaning validation), raw material, inprocess, bulk finished product and stability (chemical or microbial) tests or checks required to assure the quality of the Product and tests or checks required by the Specifications and cGMP. 4.4 Rejection of Product; Disposal of Rejected Shipments. (a) Purchaser may reject any Product that does not materially conform to Specifications or cGMP (“Non-Complying Product”) by providing written notice of rejection to Pfizer and the delivery carrier and setting out detailed reasons for such rejection: (i) immediately (and in no event more than 24 hours) upon delivery at the Point of Delivery; (ii) immediately and in any event within 24 hours of delivery at the Place(s) of Destination of such Non-Complying Product to Purchaser; or (iii)
CONFIDENTIAL 16 immediately and in no event more than 24 hours upon its first knowledge of a Latent Defect. In the event notice is not provided within 24 hours from delivery, the Product shall have been deemed accepted. Pfizer shall respond to any rejection and notice of Non-Complying Product from Purchaser in a timely manner. For clarity, Purchaser shall not be entitled to reject any Product based on service complaints unless a Product does not materially conform to Specifications or cGMP. (b) Pfizer shall conduct an analysis of the causes of any such quality-related complaint, and shall report to Purchaser on any corrective action taken. If Pfizer’s inspection and testing reveals, to Pfizer’s reasonable satisfaction, that such items of the Product are Non-Complying Product and that any such non-conformity or defect has not been caused or contributed to by any abuse, misuse, neglect, negligence, accident, improper testing, improper storage, improper handling, abnormal physical stress, abnormal environmental conditions or use contrary to any instructions issued by Pfizer, Pfizer shall use Commercially Reasonable Efforts to replace such NonComplying Product as soon as practicable at no additional charge to Purchaser. In such circumstances, Pfizer will further arrange for reverse logistics for Product collection and manage the destruction of the Non-Complying Product. Until collection, Purchaser shall store and maintain the relevant Non-Complying Product in appropriately secure locations and in accordance with the manufacturers’ specifications. Notwithstanding any other provision of this Agreement, this Section 4.4(b) contains Purchaser’s sole and exclusive remedy for Non-Complying Product. The provisions of this Section 4.4 (Rejection of Product; Disposal of Rejected Shipments) shall survive termination or expiration of this Agreement. 4.5 Maintenance and Retention of Records. (a) Each Party shall maintain detailed Records with respect to its activities under this Agreement as required by Laws. (b) Purchaser will maintain a quality system for receipt, inspection, storage, traceability to further delivery points, and recall activities. If Purchaser does not have a quality system for the activities defined, Pfizer may share details of a proposed quality system for Purchaser’s compliance. 4.6 Diversion Issues. All Product delivered to Purchaser shall be: (a) stored securely by Purchaser; and (b) distributed by Purchaser only in Albania in a secure manner appropriate to the transportation route and destination, in each case (a) and (b) to guard against and deter theft, diversion, tampering, substitution (with, for example, counterfeits) resale or export out of Albania, and to protect and preserve the integrity and efficacy of the Product. Purchaser shall promptly notify Pfizer by email1 within 48 hours (with follow up in writing in line with the notice provisions of this Agreement) if at any time Purchaser believes that any of the Product has been stolen, diverted, tampered with, substituted, or otherwise 1Note to Draft: To include quality/diversion notice contact information.
CONFIDENTIAL 17 subjected to abuse, misuse, neglect, negligence, accident, improper testing, improper storage, improper handling, abnormal physical stress, abnormal environmental conditions or use contrary to any instructions issued by Pfizer. The notice shall provide all information relating to the Product diversion, including, but not limited to, detailed information including the date, time, location, number, batch number(s), expiration date, circumstances, and contact person(s) information. Purchaser shall cooperate with Pfizer or its designee, upon Pfizer’s request, to cooperate in connection with such Product diversion. 4.7 Recalls. Purchaser shall be responsible for all costs of any recall or market withdrawal of the Product in Albania, including, without limitation, reasonable costs incurred by or on behalf of Pfizer and its Affiliates or BioNTech and its Affiliates, except to the extent that such recall or market withdrawal results from willful misconduct (being a wrongful act, willingly and knowingly committed without legal or factual justification, with the intent to cause the harmful effects) on the part of, Pfizer or any of its Affiliates or any of their respective Personnel, in which event Pfizer will be responsible solely for: (a) any reasonable and documented out of pocket expenses directly incurred by Purchaser to third parties in implementing such recall or market withdrawal; and (b) replacing, at Pfizer’s expense, the Product which has to be recalled. 5. REPRESENTATIONS & WARRANTIES. 5.1 Mutual Representations and Warranties. Pfizer and Purchaser each represents and warrants to each other the following: (a) Organization and Authority. It has full right, power and authority to enter into this Agreement and to perform its respective obligations under this Agreement, including, in the case of Purchaser, that all necessary authorizations and approvals have been obtained by Purchaser to authorize entering into this Agreement and its performance of all of its obligations contained herein, that Purchaser is entering into this Agreement pursuant to the Normative Act of the Albanian Council of Ministers no. 38 dated December 31, 2020 “On the approval of agreement for the manufacturing and supply by and between Pfizer Export B.V. and the Ministry of Health and Social Protection, Minister of State for Reconstruction and the Institute of Public Health, and the authorization of procedure for the anticovid-19 vaccination of the population”, a true and correct copy of which is attached hereto as Appendix H (the “Normative Act”), that this Agreement is exempt from the application of all Albanian Public Procurement Laws and each of the terms and conditions of this Agreement are fully enforceable, that the budgetary allocation set forth in Article 4 of the Normative Act in no respect limits Purchaser’s funding or other obligations under this Agreement, including the indemnification obligations set forth in Article 8, that Purchaser has the authority to bind the Republic of Albania and that Purchaser has exercised that authority to bind the Republic of Albania as to each of the provisions and terms and conditions set forth in this Agreement;
CONFIDENTIAL 18 (b) No Conflicts or Violations. The execution and delivery of this Agreement by such Party and the performance of such Party’s obligations hereunder (i) do not conflict with or violate any Laws existing as of the Effective Date, or upon date of Approval, and applicable to such Party and (ii) do not conflict with, violate, breach or constitute a default under, and are not prohibited or materially restricted by, any contractual obligations of such Party existing as of the Effective Date, or upon date of Approval; and (c) Valid Execution. Such Party is duly authorized to execute and deliver this Agreement, and the Person executing this Agreement on behalf of such Party is duly authorized to execute and bind such Party to the terms set forth herein. 5.2 Warranties of Pfizer. Pfizer warrants to Purchaser that: (a) At the time of delivery, the Product (except for any non-compliance or failure to meet the relevant standard or requirement that could not be reasonably discovered given the state of medical, scientific or technical knowledge at the time when Pfizer delivered the Product): (i) complies in a material manner with the relevant Specifications; and (ii) has been manufactured in material accordance with current Good Manufacturing Practices. (b) Subject to Pfizer’s disclaimer of non-infringement of Intellectual Property rights of a third party (at Section 5.4(a) and (b) below), it has good title to the Product delivered to Purchaser pursuant to this Agreement and shall pass such title to Purchaser free and clear of any security interests, liens, or other encumbrances. (c) The execution, delivery and performance of this Agreement by Pfizer will not violate any agreement or instrument to which Pfizer is a party. 5.3 Anti-Bribery/Anti-Corruption and Global Trade Controls. (a) The Parties represent and warrant that, beyond the mutual consideration set forth in this Agreement, neither they nor their agents have provided or requested, or will provide or request, any additional incentive or benefit to or from another Party or its agents to induce a Party to enter this Agreement or perform any part of this Agreement. (b) Pfizer has not made, and will not make, in the performance of this Agreement directly or indirectly any payment, offer, promise, or authorization of payment of money or anything of value to a Government official, political party, candidate for political office, or any other Person, and has not sought and will not seek improperly or corruptly to influence any Government official, political party,
CONFIDENTIAL 19 candidate for political office, or any other Person, in order to gain an improper business advantage. (c) The Parties will comply with applicable economic sanctions, import, and export control laws, regulations, and orders in the performance of this Agreement. (d) Activities performed under this Agreement will not involve Restricted Parties (defined as the list of sanctioned parties maintained by the United Nations; the Specially Designated Nationals List and the Sectoral Sanctions Identifications List, as administered by the U.S. Department of the Treasury Office of Foreign Assets Control; the U.S. Denied Persons List, the U.S. Entity List, and the U.S. Unverified List, all administered by the U.S. Department of Commerce; the entities subject to restrictive measures and the Consolidated List of Persons, Groups and Entities Subject to E.U. Financial Sanctions, as implemented by the E.U. Common Foreign & Security Policy; and similar lists of restricted parties maintained by relevant governmental entities). (e) Notwithstanding any other provision of this Agreement, Pfizer shall not be required to take or refrain from taking any action prohibited or penalized under the laws of the United States or any applicable non-United States jurisdiction, including, without limitation, the antiboycott laws administered by the U.S. Commerce and Treasury Departments. 5.4 No Other Warranty. Except to the extent set out expressly in this Agreement, all conditions, warranties or other terms which might have effect between the Parties or be implied or incorporated into this Agreement (whether by statute, common law or otherwise) are hereby excluded to the fullest extent permitted by Laws. Without prejudice to the general nature of the previous sentence, unless this Agreement specifically states otherwise and to the maximum extent permitted by Law, Pfizer expressly disclaims any representations or warranties with respect to the Product, including, but not limited to, any representation, warranties or undertaking as to (a) non-infringement of Intellectual Property rights of any third party, (b) that there is no requirement to obtain a license of third party Intellectual Property rights to enable the use or receipt of the Product, (c) merchantability, or (d) fitness for a particular purpose. 5.5 Purchaser Acknowledgement. Purchaser acknowledges that the Vaccine and materials related to the Vaccine, and their components and constituent materials are being rapidly developed due to the emergency circumstances of the COVID-19 pandemic and will continue to be studied after provision of the Vaccine to Purchaser under this Agreement. Purchaser further acknowledges that the long-term effects and efficacy of the Vaccine are not currently known and that there may be adverse effects of the Vaccine that are not currently known. Further, to the extent applicable, Purchaser acknowledges that the Product shall not be serialized. 6. TERM; TERMINATION.
CONFIDENTIAL 20 6.1 Term of Agreement. This Agreement shall commence on the Effective Date and shall continue until delivery of the Contracted Doses of the Product under the accepted Purchase Order, unless extended or terminated pursuant to this Section 6 (Term; Termination), or the mutual written agreement of the Parties, or pursuant to Section 9.6 (“Term”). 6.2 Termination for Cause. a) Pfizer may terminate this Agreement immediately upon written notice to Purchaser in the event of a material breach by the Purchaser of any term of this Agreement, which breach remains uncured for thirty (30) days following written notice to Purchaser of such material breach. b) Purchaser may terminate this Agreement immediately upon written notice to Pfizer in the event of a material breach by Pfizer of any term of this Agreement, which breach remains uncured for thirty (30) days following written notice to Pfizer of such material breach. c) Notwithstanding the foregoing, if such material breach, by its nature, cannot be cured, the terminating Party may terminate this Agreement immediately upon written notice to the other Parties. In the event that this Agreement is terminated by Pfizer under this Section 6.2, Purchaser shall pay within thirty (30) days of the date of notice of termination of this Agreement the full Price for all Contracted Doses less amounts already paid to Pfizer as of such date. 6.3 Mutual Termination Rights. (a) In the event: (i) the Product does not obtain Authorization by the EC by June 30, 2021, (ii) Pfizer has supplied to Purchaser no doses of Product by December 31, 2021, subject to the extensions set forth in Section 2.4 (Delivery Schedule), or (iii) Pfizer is unable to supply all of the Contracted Doses by December 31, 2022, then a Party may terminate this Agreement upon written notice to the other Parties. Purchaser may invoice Pfizer for a refund of fifty percent (50%) of the Advance Payment for the initial 249,795 Contracted Doses not delivered (as determined ratably for the doses not delivered) except for cases where the cause of the termination is mainly or solely attributable to Purchaser. In the event this Agreement is terminated pursuant to this Section 6.3(a), the return of fifty percent (50%) Advance Payment shall be Purchaser’s sole and exclusive remedy for the failure to deliver any Contracted Doses. (b) If the Authorization is received on or before June 30, 2021 but there is insufficient supply to deliver the full number of Contracted Doses by December 31, 2022, fifty percent (50%) of the Advance Payment for the initial 249,795 Contracted Doses not delivered (as determined ratably for the doses not delivered) will be refunded to Purchaser except for cases where such event is mainly or solely attributable to Purchaser. In such case and this Agreement is terminated, the return of Advance
CONFIDENTIAL 21 Payment for amounts not delivered shall be Purchaser’s sole and exclusive remedy for the Contracted Doses, or portion thereof, that were not delivered to Purchaser. For absolute clarity, there shall be no refund for the Contracted Doses delivered. 6.4 Termination in Event of Insolvency. In the event that Pfizer: (a) becomes insolvent, or institutes or has instituted against it a petition for bankruptcy or is adjudicated bankrupt; or (b) executes a bill of sale, deed of trust, or a general assignment for the benefit of creditors; or (c) is dissolved or transfers a substantial portion of its assets to a third party (excluding any of Pfizer’s Affiliates); or (d) has a receiver appointed for the benefit of its creditors, or has a receiver appointed on account of insolvency; then Pfizer shall immediately notify Purchaser of such event and Purchaser shall be entitled to terminate this Agreement. 6.5 Effect of Termination. (a) Upon expiry or termination of this Agreement for any reason: (i) Purchaser shall pay any sums owed to Pfizer pursuant to this Agreement within thirty (30) days of the date of invoice for the same; and (ii) each Party shall use Commercially Reasonable Efforts to mitigate both (1) the damages that would otherwise be recoverable from the other pursuant to this Agreement, and (2) any costs, fees, expenses or losses that may be incurred by a Party, or for which a Party may be responsible, under this Agreement, by taking appropriate and reasonable actions to reduce or limit the amount of such damages, costs, fees, expenses or losses. (b) The termination or expiration of this Agreement shall not affect the survival and continuing validity of Sections 2.1(b)-(d), 2.5(b), 2.6, 2.7(b)-(e), 2.8, 3.1, 3.3, 3.4, 4.4, 4.5, 4.6, 4.7, 5.4, 5.5, 6.2 (last sentence), 6.5, 9.2, 9.3, 9.4, 9.5, 9.6, and Articles 1, 7, 8, 10, 11 and 12 or of any other provision which is expressly or by implication intended to continue in force after such termination or expiration. (c) Expiry or termination of this Agreement for any reason shall be without prejudice to a Party’s other rights and remedies or to any accrued rights and liabilities as the date of such expiry or termination; provided that (i) Pfizer shall have no liability for any failure by Pfizer to develop or obtain Authorization of the Product in accordance with the estimated dates described in this Agreement and (ii) even if the Product is successfully developed and Pfizer obtains Authorization, Pfizer shall have no liability for any failure to deliver Contracted Doses in accordance with any estimated delivery dates set forth herein. 7. INTELLECTUAL PROPERTY. Pfizer US will be the sole owner of all Intellectual Property it generates during the development, manufacture, and supply of the Product or otherwise related to the Product.
CONFIDENTIAL 22 No Party will gain any rights of ownership to or use of any property or Intellectual Property owned by the other Parties (whether by virtue of this Agreement, by implication or otherwise). 8. INDEMNIFICATION. 8.1 Indemnification by Purchaser. Purchaser hereby agrees to indemnify, defend and hold harmless Pfizer, BioNTech, each of their Affiliates, contractors, sub-contractors, licensors, licensees, sub-licensees, distributors, contract manufacturers, services providers, clinical trial researchers, third parties to whom Pfizer or BioNTech or any of their respective Affiliates may directly or indirectly owe an indemnity based on the research, development, manufacture, distribution, commercialization or use of the Vaccine, and each of the officers, directors, employees and other agents and representatives, and the respective predecessors, successors and assigns of any of the foregoing (“Indemnitees”), from and against any and all suits, claims, actions, demands, losses, damages, liabilities, settlements, penalties, fines, costs and expenses (including, without limitation, reasonable attorneys’ fees and other expenses of an investigation or litigation), whether sounding in contract, tort, intellectual property, or any other theory, and whether legal, statutory, equitable or otherwise (collectively, “Losses”) arising out of, relating to, or resulting from the Vaccine, including but not limited to any stage of design, development, investigation, formulation, testing, clinical testing, manufacture, labeling, packaging, transport, storage, distribution, marketing, promotion, sale, purchase, licensing, donation, dispensing, prescribing, administration, provision, or use of the Vaccine. 8.2 Assumption of Defense by Purchaser. The Indemnitee(s) shall notify Purchaser of Losses for which it is seeking indemnification pursuant hereto (“Indemnified Claims”). Upon such notification, Purchaser shall promptly assume conduct and control of the defense of such Indemnified Claims on behalf of the Indemnitee with counsel acceptable to Indemnitee(s), whether or not the Indemnified Claim is rightfully brought; provided, however, that Purchaser shall provide advance notice in writing of any proposed compromise or settlement of any Indemnified Claim and in no event may Purchaser compromise or settle any Indemnified Claim without Indemnitee(s)’s prior written consent, such consent not to be unreasonably withheld. Indemnitee(s) shall reasonably cooperate with Purchaser in the defense of the Indemnified Claims. 8.3 Participation Rights. Each Indemnitee shall have the right to retain its own counsel and to participate in Purchaser’s defense of any Indemnified Claim, at its own cost and expense except as set forth below. A failure by the Indemnitee(s) to give notice or timely notice or to offer to tender the defense of the action or suit pursuant to this Section 8.3 (Participation Rights) shall not limit the obligation of Purchaser under this Section 8 (Indemnification), except and only to the extent Purchaser is actually prejudiced thereby. 8.4 Assumption of Defense. Notwithstanding the foregoing and without prejudice to Section 12.6, Pfizer, directly or through any of its Affiliates or through BioNTech, may elect to assume control of the defense of an Indemnified Claim (a) within thirty (30) days of Indemnitee’s notice to Purchaser of the Indemnified Claim or (b) at any time if, in Pfizer’s sole discretion: (i) Purchaser fails to timely assume the defense of or reasonably defend
such Indemnified Claim(s) in good faith to the satisfaction of Pfizer (or Pfizer’s Affiliates and BioNTech); or (ii) Pfizer believes (or any of Pfizer’s Affiliates or BioNTech believe) in good faith that a bona fide conflict exists between Indemnitee(s) and Purchaser with respect to an Indemnified Claim hereunder. Upon written notice of such election, Pfizer shall have the right to assume control of such defense (directly or through either one of its Affiliates or BioNTech), and Purchaser shall pay (as incurred and on demand), all Losses, including, without limitation, the reasonable attorneys’ fees and other expenses incurred by Indemnitee(s), in connection with the Indemnified Claim. In all events, Purchaser shall cooperate with Indemnitee(s) in the defense, settlement or compromise of the Indemnified Claim. 8.5 Privileges and Immunities. Purchaser acknowledges that its indemnification obligations under this Agreement are (a) expressly in addition to, and not limited by, any Privileges and Immunities, and (b) do not waive or relinquish Indemnitees’ rights to any Privileges and Immunities. 8.6 Costs. Costs and expenses, including, without limitation, fees and disbursements of counsel, incurred by the Indemnitee(s) in connection with any Indemnified Claim shall be reimbursed on a quarterly basis by Purchaser, without prejudice to Purchaser’s right to refund in the event that Purchaser is ultimately held in a final, non-appealable judgment or award to be not obligated to indemnify the Indemnitee(s). 9. INSURANCE AND LIABILITY. 9.1 Insurance. During the Term, Pfizer or its Affiliates shall self-insure or procure and maintain such types and amounts of general liability insurance to cover liabilities related to its activities under this Agreement as is normal and customary in the pharmaceutical industry generally for companies that are similarly situated and providing similar manufacturing and supply services. For absolute clarity, this shall not include, nor constitute, product liability insurance to cover any third party/patients claims and such general liability insurance shall be without prejudice to Purchaser’s indemnification obligation as set out in this Agreement. 9.2 Limits on Liability. (a) Subject to the exclusions set forth in Section 9.3, in no circumstances shall (i) a Party be liable to the other Parties or its Affiliates, whether arising in tort (including, without limitation, negligence), contract or otherwise, for any indirect, special, consequential, incidental or punitive damages, whether in contract, warranty, tort, negligence, strict liability or otherwise arising out of or relating to this Agreement, the transactions contemplated therein or any breach thereof (whether or not reasonably foreseeable and even if the first Party had been advised of the possibility of another Party incurring such loss or type of loss), and (ii) in the case of Pfizer and its Affiliates, in no event shall Pfizer be liable to Purchaser for any direct damages except to the extent such direct damages were a result of a material breach of a representation or warranty by Pfizer under this Agreement that directly and
solely caused the damage. In no instance shall Pfizer and its Affiliates be liable to Purchaser (whether arising in warranty, tort (including, without limitation, negligence), contract, strict liability or otherwise) for any liabilities of Purchaser to any third party, including, without limitation, through contribution, indemnity, or for any claim for which Purchaser would have to indemnify Pfizer if that claim were brought directly against Pfizer. (b) The aggregate liability of Pfizer and its Affiliates (whether arising in warranty, tort (including, without limitation, negligence), contract, strict liability or otherwise) arising out of, under or in connection with this Agreement shall not exceed a sum equivalent to one hundred percent (100%) of the total Price actually received by Pfizer under this Agreement for the Contracted Doses. 9.3 Excluded Liability. Nothing in this Agreement excludes or limits the liability of a Party for: (i) fraud or fraudulent misrepresentation; (ii) any breach of Section 10 (Confidential Information); (iii) in the case of Purchaser, the indemnity given by it under Section 8 (Indemnification); or (iv) in the case of Purchaser, failure to pay the Price for the Product or any other sums properly owing to Pfizer under this Agreement. 9.4 Waiver of Sovereign Immunity. Purchaser, on behalf of itself and the Republic of Albania, expressly and irrevocably waives any right of immunity which either it or its assets may have or acquire in the future (whether characterized as sovereign immunity or any other type of immunity) in respect of any arbitration pursuant to Section 12.2 (Arbitration) or any other legal procedure initiated to confirm or enforce any arbitral decision, order or award, or any settlement in connection with any arbitration pursuant to Section 12.2 (Arbitration), whether in Albania or any other foreign jurisdiction, including but not limited to immunity against service of process, immunity of jurisdiction, or immunity against any judgment rendered by a court or tribunal, immunity against order to enforce the judgment, and immunity against precautionary seizure of any of its assets. Purchaser expressly and irrevocably submits to the jurisdiction of the courts of New York, or any other court of competent jurisdiction, for the purposes of enforcing any arbitral decision, order or award, or any settlement in connection with any arbitration pursuant to Section 12.2 and represents and warrants that the person signing this Agreement on its behalf has actual authority to submit to such jurisdiction. Purchaser also expressly and irrevocably waives the application of any Law in any jurisdiction that may otherwise limit or cap its obligation to pay damages arising from or in connection with any Indemnified Claims and represents and warrants that this Agreement and any Indemnified Claims arising hereunder are not subject to the Albanian Public Procurement Laws. Purchaser represents and warrants that the person signing this Agreement on its behalf has actual authority to waive such immunity and bind
CONFIDENTIAL 25 Purchaser and the Republic of Albania to the limitations of liability and liability waivers set forth herein. 9.5 Conditions Precedent to Supply. Purchaser represents that it has and will continue to have adequate statutory or regulatory authority and adequate funding appropriation to undertake and completely fulfil the indemnification obligations and provide adequate protection to Pfizer and all Indemnitees from liability for claims and all Losses arising out of or in connection with the Vaccine or its use. Purchaser hereby covenants and acknowledges and agrees that a condition precedent for the supply of the Product hereunder requires that Purchaser shall implement and maintain in effect such statutory or regulatory requirements or funding appropriation sufficient to meet its obligations in this Agreement prior to supply of the Product by Pfizer and thereafter shall maintain such statutory and regulatory requirement and funding appropriation, each as applicable, for so long as necessary to meet all of Purchaser’s obligations under this Agreement, including, without limitation, any such obligations that, pursuant to Section 6.5, survive expiration or termination of this Agreement. For clarity, the sufficiency of such statutory or regulatory requirements or funding appropriation shall be in Pfizer’s sole discretion. Purchaser acknowledges that Pfizer’s supply of Product hereunder is in reliance (without any duty of investigation or confirmation by or on behalf of Pfizer or its Affiliates), inter alia, on Purchaser’s representations and covenants under this Section 9.5, Purchaser implementing and maintaining in effect the requirements and funding appropriation described in this Section 9.5 and the other representations and warranties made by Purchaser under this Agreement. 9.6 Condition Precedent. Purchaser further covenants and acknowledges and agrees that a condition precedent to the effectiveness of this Agreement requires that the Normative Act, and the entry into this Agreement thereunder, be ratified by a law of the Albanian parliament in accordance with Albanian law within ten (10) days of the Effective Date (the “Approval”). Purchaser shall notify Pfizer immediately upon issuance of such Approval and provide a copy of such Approval to Pfizer. A true and correct copy of such Approval shall be attached hereto as Attachment J. Purchaser acknowledges that such Approval is a material term of this Agreement and that Pfizer is entering into this Agreement in reliance thereon. In the event that such Approval is not obtained within the time period prescribed above, this Agreement shall automatically terminate. In such event, Pfizer shall have no liability to Purchaser, and Pfizer shall have no obligation to amend, restate, modify or enter into a new agreement with Purchaser for supply of the Product. For clarity, the provisions of Section 6.5 shall apply upon termination of this Agreement pursuant to this Section 9.6. 10. CONFIDENTIAL INFORMATION. 10.1 Non-Use and Non-Disclosure. Each Recipient shall, and shall cause its Representatives which have access to the Disclosing Party’s Confidential Information to, maintain in strict confidence, and shall not disclose to any third party, all Confidential Information observed by or disclosed to it by or on behalf of the Disclosing Party pursuant to this Agreement. In particular, the