こんな契約を締結する役人は脅威を恐れてまたは賄賂で迎合した犯罪者の一味だ
Pfizer Draft 1.6.2021 CONFIDENTIAL 1 MANUFACTURING AND SUPPLY AGREEMENT BY AND AMONG PFIZER EXPORT B.V., ALBANIA MINISTRY OF HEALTH AND SOCIAL PROTECTION MINISTER OF STATE FOR RECONSTRUCTION AND INSTITUTE OF PUBLIC HEALTH
CONFIDENTIAL 2
-
DEFINITIONS. 1
-
SUPPLY OF PRODUCT7
2.1 Agreement to Supply. 7
2.2 Capacity. .8
2.3 Purchase Orders. .8
2.4 Delivery Schedule..8 2.5 Product Shortages. .9 2.6 Delivery Delays. ..10 2.7 Product Handling. 10 2.8 Title to Product, Risk of Loss. 11 3. PRICE AND PAYMENT. .12 3.1 Purchase Price.12 3.2 Invoices and Payment. 12 3.3 Method of Payment.13 3.4 Taxes13 4. MANUFACTURING STANDARDS AND QUALITY ASSURANCE14 4.1 Manufacturing Standards.14 4.2 Legal and Regulatory Filings and Requests14 4.3 Quality Tests and Checks.15 4.4 Rejection of Product; Disposal of Rejected Shipments. 15 4.5 Maintenance and Retention of Records. ..16 4.6 Diversion Issues16 4.7 Recalls.17 5. REPRESENTATIONS & WARRANTIES. 17 5.1 Mutual Representations and Warranties..17 5.2 Warranties of Pfizer. 18 5.3 Anti-Bribery/Anti-Corruption and Global Trade Controls18 5.4 No Other Warranty. 19 5.5 Purchaser Acknowledgement..19 6. TERM; TERMINATION..19 6.1 Term of Agreement.20 6.2 Termination for Cause. .20 6.3 Mutual Termination Rights.20 6.4 Termination in Event of Insolvency. ..21
CONFIDENTIAL 3 6.5 Effect of Termination..21 7. INTELLECTUAL PROPERTY21 8. INDEMNIFICATION. .22 8.1 Indemnification by Purchaser .22 8.2 Assumption of Defense by Purchaser.22 8.3 Participation Rights.22 8.4 Assumption of Defense.22 8.5 Privileges and Immunities23 8.6 Costs23 9. INSURANCE AND LIABILITY..23 9.1 Insurance..23 9.2 Limits on Liability. .23 9.3 Excluded Liability24 9.4 Waiver of Sovereign Immunity 24 9.5 Conditions Precedent to Supply25 9.6 Condition Precedent…25 10. CONFIDENTIAL INFORMATION25 10.1 Non-Use and Non-Disclosure.25 10.2 Recipient Precautions..26 10.3 Return of Confidential Information. 27 10.4 Survival.27 11. NOTICES.27 12. MISCELLANEOUS. 28 12.1 Negotiations of Dispute. ..28 12.2 Arbitration29 12.3 Purchasers Obligations29 12.4 Publicity. ..29 12.5 Governing Law. 30 12.6 Third Party Rights30 12.7 Relationship of the Parties. .30 12.8 Assignment; Binding Effect..30 12.9
Force Majeure. .31 12.10 Severability. ..31 12.11 Non-Waiver; Remedies.31
CONFIDENTIAL 4 12.12 Further Documents..31 12.13 Forms. .31 12.14 Headings. .32 12.15 Counterparts32 12.16 Electronic Delivery and Storage. .32 12.17 Entire Agreement; Amendments..32 12.18 Rule of Construction32 12.19 English Language.32 12.20 Legal Costs..33
CONFIDENTIAL 1 MANUFACTURING AND SUPPLY AGREEMENT THIS MANUFACTURING AND SUPPLY AGREEMENT effective as of the date of the last signature below (the “Effective Date”) is made by and among Pfizer Export B.V., a company established under the laws of the Netherlands with its registered office at Rivium Westlaan 142, 2909LD Capelle aan den Ijssel, the Netherlands (hereinafter “Pfizer”) and Albania Ministry of Health and Social Protection, acting on its own behalf and on behalf of the Republic of Albania with offices at Kavaja St 25, Tirana 1001 (“MOH”), Albanian Minister of State for Reconstruction,acting on its own behalf and on behalf of the Republic of Albania with offices at Boulevard “Dëshmorët e Kombit”, Tirana 1001 (MOR) and Institute of Public Health, acting on its own behalf and on behalf of the Republic of Albania with offices at Rr. Aleksander Moisiu, nr. 80, Tirana, 1001 (“IPH”) (MOH,MORand IPH, individually and collectively referred to hereinafter as “Purchaser”). Purchaser and Pfizer may be referred to herein individually as a “Party” or collectively as the “Parties”. WHEREAS, Pfizer Inc. (“Pfizer US”) and BioNTech SE, a company organized and existing under the laws of Germany (“BioNTech”), are collaborating to develop a vaccine to address the global COVID-19 pandemic; WHEREAS, subject to clinical success, Pfizer US and BioNTech shall be responsible for all requirements of the processes of approval of the clinical trials and the marketing authorization of the Product; WHEREAS, Purchaser desires to purchase the Product for use in Albania, and subject to clinical success and regulatory approval, Pfizer desires to manufacture and supply such Product to Purchaser; and WHEREAS, the Parties are willing to carry out the foregoing pursuant to the terms and conditions set forth in this Agreement. NOW, THEREFORE, in consideration of these premises and the covenants and agreements set forth herein, the sufficiency of which is hereby acknowledged and agreed, and intending to be legally bound thereby, the Parties hereby agree as follows: 1. DEFINITIONS. As used in this Agreement, the following terms shall have the meanings set forth below. 1.1 “Adjusted Delivery Schedule” shall have the meaning set forth in Section 2.4(e). 1.2 “Advance Payment” shall have the meaning set forth in Section 3.2(a). 1.3 “Affiliate(s)” means, with respect to each Party or, if applicable, BioNTech, any corporation, firm, partnership or other entity or Person which directly or indirectly controls or is controlled by or is under common control with the named Party, including without limitation Pfizer US, or, if applicable, BioNTech. For purposes of this definition, “control” (including, with correlative meaning, the terms “controlled by” and “under common
CONFIDENTIAL 2 control with”) shall be presumed to exist if one of the following conditions is met: (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors of such corporate entity or any direct or indirect parent of such corporate entity, and (b) in the case of noncorporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of such non-corporate entities. 1.4 “Agreement” means this Manufacturing and Supply Agreement and all Attachments hereto as the same may be amended, amended and restated, supplemented or otherwise replaced from time to time. 1.5 “Allocation” shall have the meaning set forth in Section 2.5(a). 1.6 “Authorization” means the Conditional Approval or Marketing Authorization. 1.7 “BioNTech” shall have the meaning set forth in the recitals. 1.8 “Business Day” means any day other than Saturday, Sunday or a public holiday in New York, New York or Tirana, Albania. 1.9 “Commercially Reasonable Efforts” means with respect to the efforts to be expended by Pfizer to achieve the relevant objective, the activities and degree of effort that a similarly situated party (with respect to size, resources and assets) in the pharmaceutical industry would use to accomplish a similar objective in its own commercial interests under similar circumstances and considering the relevant risks, uncertainties, limitations and challenges of the development, manufacture, commercialization and distribution of a novel COVID19 vaccine product, taking into account the following factors: actual and potential issues of safety and efficacy, novelty, product profile, the proprietary position, the then current competitive environment for such Product, the likely timing of the Product’s entry into the market, the regulatory environment and status of the Product, compliance with Laws, past performance of the Product and other similar products, the ability to produce or obtain adequate supply of the Product or any components or materials used in the manufacture of the Product and other relevant scientific, technical, operational and commercial factors, in each case as measured by the facts and circumstances at the time such efforts are due. 1.10 “Conditional Approval” means a conditional marketing authorization (“CMA”) or emergency use authorization (“EUA”) for the Product granted (a) by (i) the United States Food and Drug Administration (the federal agency of the United States Department of Health and Human Services) (“FDA”) (in the case of an EUA) or (ii) the European Commission (in the case of a CMA) and (b) via an appropriate regulatory mechanism by the (i) National Agency of Medicines and Medical Equipment (“NAM”) or (ii) the Minister of Health and Social Protection that allows the Product to be placed on the market in Albania (“Albanian Conditional Approval”). 1.11 “Confidential Information” means all confidential or proprietary information, other than Exempt Information, in any form, directly or indirectly disclosed to Recipient or its
CONFIDENTIAL 3 Representatives by or on behalf of the Disclosing Party pursuant to this Agreement, regardless of the manner in which such information is disclosed, delivered, furnished, learned, or observed, either marked “Confidential” or, if oral, declared to be confidential when disclosed and confirmed in writing within thirty (30) days of disclosure. Confidential Information includes, without limitation, the terms and conditions of this Agreement. Failure to mark Confidential Information disclosed in writing hereunder as “Confidential” shall not cause the information to be considered non-confidential, with the burden on the Disclosing Party to prove such information clearly should have been known by a reasonable person with expertise on the subject matter, based on the nature of the information and the circumstances of its disclosure, to be Confidential Information, provided that the Disclosing Party has otherwise made good faith efforts to clearly mark Confidential Information as such. 1.12 “Contracted Doses” shall have the meaning set forth in Section 2.3(a). 1.13 “Current Good Manufacturing Practices” or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product. 1.14 “Delivery Price” shall have the meaning set forth in Section 3.2(b). 1.15 “Delivery Schedule” shall have the meaning set forth in Section 2.4(d). 1.16 “Delivery Specifications” shall have the meaning set forth in Section 2.4(d). 1.17 “Disclosing Party” means the Party or any of its Affiliates that discloses, or causes to be disclosed, Confidential Information to the other Party or any of its Affiliates. 1.18 “Effective Date” shall have the meaning set forth in the preamble. 1.19 “Exempt Information” means information that: (a) the Recipient or any of its Representatives lawfully possessed, as demonstrated by competent proof, before the Disclosing Party disclosed such information under this Agreement; or (b) was already generally available and in the public domain at the time of disclosure, or becomes public (other than as a result of breach of this Agreement by the Recipient or its Representatives); (c) the Recipient or any of its Representatives lawfully obtains from a Person not in breach of any confidentiality obligation (or other prohibition from disclosing the information) to the Disclosing Party with respect to such information (and Recipient has made reasonable enquiry with respect thereto); or (d) the Recipient evidences to the reasonable satisfaction of the Disclosing Party is independently developed by or on behalf of the Recipient or its Representatives without the use of, reference to, aid from, or reliance on, the Confidential Information. In clarification of the foregoing, a general disclosure in the public domain will not cause more specific (but related) information to be deemed Exempt Information under one of the above exceptions; similarly, a combination of several pieces of information, which individually would be deemed Exempt Information, will not be deemed Exempt Information unless the combination itself is in the public domain, independently
CONFIDENTIAL 4 developed by the Recipient or its Representatives or otherwise lawfully in the possession of the Recipient or any of its Representatives. 1.20 “Facilities” means Pfizer’s manufacturing sites in Kalamazoo (Michigan) and Puurs, Belgium and BioNTech’s two manufacturing sites, in Mainz and Idar Oberstein in Germany or such other manufacturing site used in connection with the manufacture of the Product supplied by Pfizer hereunder. 1.21 “Force Majeure Event” shall have the meaning set forth in Section 12.9. 1.22 “Forms” shall have the meaning set forth in Section 12.13. 1.23 “Government” means all levels and subdivisions of government (i.e., local, regional, national, provincial, federal, administrative, legislative, or executive) of Albania. 1.24 “ICC” shall have the meaning set forth in Section 12.2. 1.25 “Indemnified Claims” shall have the meaning set forth in Section 8.2. 1.26 “Indemnitees” shall have the meaning set forth in Section 8.1. 1.27 “Intellectual Property” means (a) any processes, trade secrets, inventions, industrial models, designs, methodologies, drawings, discoveries, result, materials, formulae, procedures, techniques, clinical data or technical or other information or data, manufacturing, engineering and technical drawings, including proprietary rights in any of the foregoing, and (b) registered trademarks, trade mark applications, unregistered marks, trade dress, copyrights, know-how, patents, patent applications, and any and all provisionals, divisions, continuations, continuations in part, extensions, substitutions, renewals, registrations, revalidations, reissues or additions, including certificates of supplementary protection, of or to any of the aforesaid patents and patent applications, and all foreign counterparts of any, or to any, of the aforesaid patents and patent applications. 1.28 “Labelling and Packaging Specifications” shall have the meaning set forth in Section 2.4(e). 1.29 “Latent Defect” means a defect causing the Product to not conform to the applicable Specifications that Purchaser can show was present at the time of Pfizer’s delivery of the Product to Purchaser and which could not have been detected by Purchaser, its designee, or their Personnel at delivery through diligent inspection. 1.30 “Law/s” means, collectively, all applicable national and local laws, common laws, statutes, ordinances, codes, rules, regulations, orders, decrees or other pronouncements of any government, administrative or judicial authority having the effect of law. 1.31 “Losses” shall have the meaning set forth in Section 8.1. 1.32 “Marketing Authorization” means the marketing authorization, or such other permission having similar effect, in respect of the Product granted by both (a) (i) the FDA, or (ii)
CONFIDENTIAL 5 European Commission, and (b) (i) NAM or (ii) the Minister of Health and Social Protection from time to time, that allows the Product to be placed on the market in such country or territory according to Law. 1.33 “Non-Complying Product” shall have the meaning set forth in Section 4.4(a). 1.34 “Party” or “Parties” shall have the meaning set forth in the preamble. 1.35 “Person” means any natural person, entity, corporation, general partnership, limited partnership, limited liability partnership, joint venture or similar entity or organization, joint stock company, proprietorship, other business organization, trust, union, association or Government. 1.36 “Personnel” means all Affiliates, subcontractors, or other third parties, and employees and agents of each of them, used by a Party in the performance of services or obligations or in connection with this Agreement. 1.37 “Pfizer” shall have the meaning set forth in the preamble. 1.38 “Pfizer US” shall have the meaning set forth in the preamble. 1.39 “Point of Delivery” shall have the meaning set forth in Section 2.8(a). 1.40 “Price” shall have the meaning set forth in Section 3.1. 1.41 “Privileges and Immunities” means any privileges, immunities, or legislation in Albania, including, without limitation, no-fault vaccine compensation programs, pandemic insurance programs, immunities from suit or liability, or any protections, defenses, or limitations-of-liability (whether statutory, regulatory, common law or otherwise), existing or future, that may separately protect Indemnitees from Losses. 1.42 “Product” means all vaccines manufactured, in whole or in part, or supplied, directly or indirectly, by or on behalf of Pfizer or BioNTech or any of their Affiliates pursuant to this Agreement that are intended for the prevention of the human disease COVID-19 or any other human disease, in each case which is caused by any of the virus SARS-CoV-2, and/or any or all related strains, mutations, modifications or derivatives of the foregoing. 1.43 “Product Materials” means all packaging materials and components needed for delivery of the Product. 1.44 “Purchase Order” means a written or electronic order form submitted by Purchaser to Pfizer in accordance with the terms of this Agreement authorizing the manufacture and supply of the Product, in substantially the form attached as Attachment G (as may be updated from time to time by Pfizer upon notice to Purchaser). 1.45 “Purchaser” shall have the meaning set forth in the preamble. 1.46 “Recipient” means the Party who receives Confidential Information from the other Party.
CONFIDENTIAL 6 1.47 “Records” means books, documents, and other data, of all matters relating to performance of obligations under this Agreement. 1.48 “Representatives” means, with respect to Recipient, its Affiliates and its and their respective directors, officers, and employees, agents, contractors, consultants, advisors and representatives who (a) are subject to an obligation of confidentiality protecting the Confidential Information on terms no less restrictive than those contained in this Agreement; and (b) have a need to know the Confidential Information in connection with this Agreement. 1.49 “Specifications” means the material specifications for the manufacture, processing, packaging, labeling, testing and testing procedures, shipping, storage and supply of the Product as will be set out in Attachment A following the Effective Date (and in any event before supply in accordance with the agreed Delivery Schedule), and as such specifications may be amended, supplemented or otherwise modified by Pfizer and communicated to Purchaser. 1.50 “Taxes” shall have the meaning set forth in Section 3.4. 1.51 “Term”, with respect to this Agreement, shall have the meaning set forth in Section 6.1. 1.52 “Third Party Beneficiary” or “Third Party Beneficiaries” shall have the meaning set forth in Section 12.6(a). 1.53 “USD” means the lawful currency of the United States of America. 1.54 “Vaccine” shall include (a) all vaccines manufactured, in whole or in part, or supplied, directly or indirectly, by or on behalf of Pfizer or BioNTech or any of their Affiliates pursuant to this Agreement that are intended for the prevention of the human disease COVID-19 or any other human disease, in each case which is caused by any of the virus SARS-CoV-2, and/or any or all related strains, mutations, modifications or derivatives of the foregoing, (b) any device, technology, or product used in the administration of or to enhance the use or effect of, such vaccine, or (c) any component or constituent material of (a) or (b). 1.55 “VAT” means Value Added Tax. Except where the context expressly requires otherwise, (a) the use of any gender herein shall be deemed to encompass references to either or both genders, and the use of the singular shall be deemed to include the plural (and vice versa), (b) the words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation”, (c) the word “will” shall be construed to have the same meaning and effect as the word “shall”, (d) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (e) any reference herein to any person shall be construed to include the person’s successors
CONFIDENTIAL 7 and assigns, (f) the words “herein”, “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (g) all references herein to Sections or Attachments shall be construed to refer to Sections or Attachments of this Agreement, and references to this Agreement include all Attachments hereto, (h) the word “notice” means notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement, (i) references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof and (j) the term “or” shall be interpreted in the inclusive sense commonly associated with the term “and/or”. 2. SUPPLY OF PRODUCT. 2.1 Agreement to Supply. (a) During the Term, Pfizer shall use Commercially Reasonable Efforts to supply or have supplied the Product to Purchaser, and Purchaser shall purchase the Product, subject to and in accordance with the terms and conditions of this Agreement. (b) Purchaser acknowledges and agrees that (i) Pfizer’s efforts to develop and manufacture the Product are aspirational in nature and subject to significant risks and uncertainties, and (ii) the fact that any other drug or vaccine to prevent, treat or cure COVID-19 infection is successfully developed or granted authorization earlier than the granting of Authorization for the Product shall not change the current situation of urgent needs for prevention of the spread of the COVID-19 infection that poses serious threats to and harmful effects on the lives and health of the general public. (c) Notwithstanding the efforts and any estimated dates set forth in the Delivery Schedule, the Parties recognize that the Product has completed Phase 2b/3 clinical trials and that, despite the efforts of Pfizer in research, and development and manufacturing, the Product may not be successful due to technical, clinical, regulatory, manufacturing, shipping, storage, or other challenges or failures. (d) Accordingly, Pfizer and its Affiliates shall have no liability for any failure by Pfizer or its Affiliates to develop or obtain Authorization of the Product in accordance with the estimated dates described in this Agreement. Even if the Product is successfully developed and obtains Authorization, Pfizer shall have no liability for any failure to deliver doses in accordance with any estimated delivery dates set forth herein (other than as expressly set out in this Agreement), nor shall any such failure give Purchaser any right to cancel orders for any quantities of Product. (e) Pfizer shall keep Purchaser apprised of the progress of the material development of the Product and shall provide Purchaser with such information regarding that development as Purchaser reasonably requests.
CONFIDENTIAL 8 2.2 Capacity. Pfizer shall use Commercially Reasonable Efforts to build or obtain manufacturing capacity to be capable of manufacturing and supplying the Product to Purchaser in accordance with the provisions of this Agreement. 2.3 Purchase Orders. (a) Upon receipt of Approval set forth in Section 9.6, Purchaser shall submit to Pfizer a legally binding and irrevocable Purchase Order(s) for four hundred ninety-nine thousand five hundred ninety (499,590) doses (“Contracted Doses”) of the Product. (b) The Purchase Order shall be provided together with Purchaser’s order number, VAT number, and invoice address. Pfizer shall accept the Purchase Order conforming to the terms set forth in this Agreement in writing, and the confirmed Purchase Order shall be binding upon the Parties and subject to the terms and conditions set out in this Agreement. 2.4 Delivery Schedule. (a) Pfizer shall deliver the Product Carriage and Insurance Paid (“CIP”) Incoterms 2020. (b) The Parties shall reasonably agree, in writing, to the location(s) (including number of locations) for delivery of shipments of Product (“Place(s) of Destination”) as soon as reasonably practicable following the Effective Date; provided that: (i) each Place of Destination meets the requirements set forth in Attachment D, (ii) all agreed upon Place(s) of Destination shall be agreed in writing by the Parties at least eight (8) weeks prior to shipment of the Product, (iii) the Place(s) of Destination are serviced by a contracted transportation carrier of Pfizer (“Shipping Agent”), and (iv) each Place of Destination is an authorized location to receive the Product, evidence of which shall be presented to Pfizer on Purchaser’s official letterhead, or other official format acceptable to Pfizer, and Purchaser shall provide any additional information, as requested by Pfizer in advance of delivery, to verify such authorization. In case the Parties do not agree on the Place(s) of Destination within the abovementioned timeline, Pfizer shall have the right to revise the Delivery Schedule. Pfizer shall have the ability, acting reasonably, to restrict the number of Places of Destination where shipments of Product shall be delivered. However, the Parties agree that: (a) title to the Products and risk of loss or damage shall pass to Purchaser at the Point of Delivery as defined under Section 2.8(a) of this Agreement, and (b) Purchaser shall have full liability and responsibility for any further transportation and distribution following delivery to Place(s) of Destination that is not a point of use of the Product, including but not limited to ensuring compliance with Attachment D.
CONFIDENTIAL 9 (c) Each shipment of Product shall have a minimum volume of 195 vials. (d) Pfizer may deliver the Product by separate installments and shall use Commercially Reasonable Efforts to meet the delivery schedule set out in Attachment B (the “Delivery Schedule”), provided that no Product shall be shipped until Authorization is received and Purchaser is compliant with, to Pfizer’s satisfaction, the conditions set forth in Section 9.5. All deliveries shall be accompanied by the documentation specified in Attachment C (which may be updated from time to time by Pfizer upon notice to Purchaser), and shall be in accordance with, and subject to, the delivery specifications to be set forth in Attachment D (which shall be populated following the Effective Date, but in any event before supply in line with the agreed Delivery Schedule, and as may be updated from time to time by Pfizer upon notice to Purchaser) (“Delivery Specifications”). (e) The Product shall be labelled and packaged in accordance with the packaging specifications to be set forth in Attachment E (which shall be populated following the Effective Date, but in any event before supply in line with the agreed Delivery Schedule, and as may be updated from time to time by Pfizer upon notice to Purchaser) (“Labelling and Packaging Specifications”). For clarity, Purchaser shall be solely liable for compliance with local labelling requirements, including without limitation, any local language translation requirements. (f) If an Authorization is granted after March 31, 2021 but before June 30, 2021, then the Delivery Schedule will be revised to add the period of time between March 31, 2021 and the date of the Authorization (“Adjusted Delivery Schedule”). In the event that the Authorization is granted prior to March 31, 2021, Pfizer has no obligation to accelerate shipment of Product. (g) If Authorization is received by March 31, 2021, but Pfizer is unable to deliver any Contracted Doses for technical or other reasons from the Facilities intended to produce the Contracted Doses under this Agreement, Pfizer agrees to use Commercially Reasonable Efforts to obtain supply of the Product from another location, subject to availability of supply. (h) If Authorization is received by March 31, 2021, but by September 30, 2021, Pfizer is unable to manufacture or deliver any Contracted Doses for technical or other reasons from any Facilities, Pfizer will have no obligation to deliver against the Delivery Schedule, Adjusted Delivery Schedule or a Purchase Order. 2.5 Product Shortages. (a) If Authorization is received but there is insufficient supply to deliver the full number of Contracted Doses on the Delivery Schedule (including the Adjusted Delivery Schedule), including to the extent any shortage is due to a requirement of Pfizer to divert available supply of the Product to another market, Pfizer shall work collaboratively to provide notice (and manage any communications associated with any Product shortages). Following receipt of such notification, Purchaser shall
CONFIDENTIAL 10 execute any instructions set out in the notice in a timely fashion (and in no event longer than 24 hours). Subject to the foregoing, including any requirement by Pfizer to divert Product to another market, Pfizer shall decide on necessary adjustments to the number of Contracted Doses and Delivery Schedule due to the Purchaser to reflect such shortages based on principles to be determined by Pfizer under the then existing circumstances (“Allocation”) which shall be set out in such notice. Purchaser shall be deemed to agree to any revision. (b) Purchaser hereby waives all rights and remedies that it may have at Law, in equity or otherwise, arising from or relating to: (i) any failure by Pfizer to develop or obtain Authorization of the Product in accordance with the estimated dates described in this Agreement; or (ii) any failure by Pfizer to deliver the Contracted Doses in accordance with the Delivery Schedule. In the event of an inconsistency between the provisions of this Section 2.5 (Product Shortages) and those of other sections of this Agreement, the provisions of this Section 2.5 (Product Shortages) shall control and supersede over those of other sections of this Agreement to the extent of such inconsistency. 2.6 Delivery Delays. Under no circumstances will Pfizer be subject to or liable for any late delivery penalties. 2.7 Product Handling. (a) Pfizer shall use Commercially Reasonable Efforts to assure the Product is manufactured in accordance with material Specifications and cGMP. (b) Upon delivery of Product to Purchaser at the Place(s) of Destination and, to the extent applicable, for any onward distribution and/or transportation to a Place of Destination that is not a point of use of the Product, Purchaser shall store and handle the Product in the manner set forth in the Specifications, instructions on Attachment D and the instructions provided by Pfizer to ensure stability and integrity of the Product. (c) For the avoidance of doubt, Purchaser shall bear all expenses for use of the Product upon transfer from Pfizer at the Place(s) of Destination, including, but not limited to, those for storage of the Product and distribution and administration of the Product (if applicable) in Albania. (d) Purchaser shall be solely responsible and liable for the proper storage, handling, distribution, transportation, administration, use and disposal of the Product in Albania following delivery of the Product to Purchaser or its designee at the Place(s) of Destination. Without prejudice to the generality of the foregoing, Purchaser shall ensure that: (a) recipients of the Product shall follow the return and disposal instructions in Attachment F (which may be updated from time to time by Pfizer upon notice to Purchaser) when disposing of open and unused Product and its packaging components; and (b) such return and disposal complies with Laws