CONFIDENTIAL 26 Purchaser shall protect any Confidential Information pursuant to this Agreement on the bases of applicable provisions of public procurement and/or information right Laws in Albania for the protection of confidential information, trade secrets, industrial property rights. Each Recipient shall not use or disclose such Confidential Information except as permitted by this Agreement. Each Recipient shall safeguard the confidential and proprietary nature of the Disclosing Party’s Confidential Information with at least the same degree of care as it holds its own confidential or proprietary information of like kind, which shall be no less than a reasonable degree of care. The Recipient and its Representatives may use, copy, and make extracts of the Disclosing Party’s Confidential Information only in connection with fulfilling its obligations under this Agreement and, without limiting the foregoing, shall not use the Confidential Information for the benefit of the Recipient or any of its Representatives, or for the benefit of any other Person. In the event that Recipient becomes aware of any breach of the obligations contained in this Section 10 (Confidential Information) by it or its Representatives, Recipient shall promptly notify the Disclosing Party in writing of such breach and all facts known to Recipient regarding same. In addition, if Recipient is required to disclose the Disclosing Party’s Confidential Information in connection with any court order, statute or Government directive or requirement under any Law, Recipient shall give the Disclosing Party notice of such request, as soon as practicable, before such Confidential Information is disclosed so that the Disclosing Party may seek an appropriate protective order or other remedy, or waive compliance with the relevant provisions of this Agreement. If the Disclosing Party seeks a protective order or other remedy, Recipient shall promptly cooperate with and reasonably assist the Disclosing Party (at the Disclosing Party’s cost) in such efforts. If the Disclosing Party fails to obtain a protective order or waives compliance with the relevant provisions of this Agreement, Recipient shall disclose only that portion of Confidential Information which its legal counsel determines it is required to disclose. Neither this Agreement nor the performance by a Party hereunder shall transfer to the Recipient any proprietary right, title, interest or claim in or to any of the Disclosing Party’s Confidential Information (including, but not limited to, any Intellectual Property rights subsisting therein) or be construed as granting a license in its Confidential Information. Notwithstanding the foregoing, in all cases, (a) Purchaser may not disclose any of the financial or indemnification provisions contained in this Agreement, including, without limitation, the price per dose of Product or refundability of the Advance Payment or any information that could reasonably ascertain the price per dose of Product, without the prior written consent of Pfizer, and (b) Pfizer may disclose (i) Confidential Information to its Affiliates and BioNTech without prior written consent of Purchaser, and (ii) upon foreign government request, financial information relating to this Agreement, including cost per dose. 10.2 Recipient Precautions. In order to comply with the obligations contained in this Section 10 (Confidential Information), Recipient shall take at least the following precautions: (a) Recipient shall exercise all reasonable efforts to prevent unauthorized employees and unauthorized third parties from gaining access to Confidential Information (and in no event less than reasonable care); (b) Recipient shall disclose Confidential Information only to such of its Representatives who have a need to know such Confidential Information to fulfill its
CONFIDENTIAL 27 obligations under this Agreement; provided, however, before any disclosure of Confidential Information, Recipient shall bind its Representatives receiving such Confidential Information to a written agreement of confidentiality at least as restrictive as this Agreement; and (c) prior to any disclosure, Recipient shall instruct its Representatives of the confidential nature of, and to maintain the confidentiality of, the Confidential Information. Recipient shall be responsible for all actions of its Representatives, including, without limitation, any breach of the terms hereof, regardless of whether or not such Representatives remain employed or in contractual privity with the Recipient. 10.3 Return of Confidential Information. Upon the written request of the Disclosing Party, Recipient shall promptly return or, at the Recipient’s option, delete or destroy all Confidential Information of the Disclosing Party (including, without limitation, all copies in whatever medium provided to, or made by, such recipient); provided, however, that, subject to the terms of this Agreement, (i) Recipient shall be entitled to retain one archival copy of such Confidential Information for purposes of determining its obligations under this Agreement; and (ii) Recipient shall not be required to destroy any computer files stored securely by the Recipients or its Affiliates that are created during automatic system back up, or retained for legal purposes by the legal division of the Recipient and its Affiliates, provided that such retained Confidential Information shall remain subject to the terms of this Agreement. Notwithstanding Recipient’s return or destruction of Confidential Information, Recipient shall continue to be bound by its obligation of confidentiality and non-use under this Agreement. 10.4 Survival. The provisions of this Section 10 (Confidential Information) shall survive the termination or expiration of the this Agreement for a period of ten (10) years, except with respect to any information that constitutes a trade secret (as defined under Law), in which case the Recipient of such information will continue to be bound by its obligations under this Section 10 (Confidential Information) for so long as such information continues to constitute a trade secret, but in no event for a period of less than the ten (10)-year period specified above. 11. NOTICES. Any notice required to be given hereunder shall be in writing and deemed to have been sufficiently given, (a) when delivered in person, (b) on the next Business Day after mailing by overnight courier service, or, where overnight courier service is unavailable, by other expedited delivery provided by a recognized express courier, or (c) when delivered via e-mail, provided the original is delivered via one of the preceding methods on or prior to the fifth (5th) Business Day after transmission of the e-mail, to the addresses specified below. Each notice shall specify the name and date of and parties to this Agreement. If to Purchaser: Institute of Public Health Aleksander Moisiu, nr. 80
CONFIDENTIAL 28 Tirana, Albania 1001 Email: ishp@shendetesia.gov.al If to MOH: [Insert Purchaser notice information] If to MOR Insert Purchaser notice information If to Pfizer: PFIZER EXPORT B.V. Rivium Westlaan 142, 2909LD Capelle aan den Ijssel, The Netherlands Attn: Andrew Richmond Email: Andrew.Richmond@Pfizer.com With a copy (which shall not constitute notice) to: Pfizer SRB d.o.o. Tresnjinog cveta 1/VI 11070 Novi Beograd Serbia Attn: Mila Zrnic Email: Mila.Zrnic@Pfizer.com With a copy (which shall not constitute notice) to: Pfizer Inc. 235 East 42nd Street New York, NY 10017 Attention: General Counsel LegalNotice@Pfizer.com A Party may, by notice to the other Parties, change the addresses and names given above. 12. MISCELLANEOUS. 12.1 Negotiations of Dispute. Prior to commencing any arbitration with respect to any controversy, claim, counterclaim, dispute, difference or misunderstanding arising out of or relating to the interpretation or application of any term or provisions of this Agreement, a Party shall provide written notice to the other Parties of the existence of such dispute. The Parties shall for a period of thirty (30) days following such notice enter into good faith discussions and negotiations in an attempt to resolve such dispute. If, by the end of such thirty (30) day period, unless such period is extended by mutual written agreement of the Parties, the Parties have been unable to resolve such dispute, a Party may initiate arbitration in accordance with the procedures set forth in Section 12.2 (Arbitration). The procedures specified in this Section 12.1 (Negotiations of Dispute) are a precondition to the initiation of arbitration by a Party, in connection with disputes between the Parties arising from or related to this Agreement or a Purchase Order; provided, however, that a Party may seek a preliminary injunction or other preliminary judicial relief, without attempting to resolve such dispute as provided in this Section 12.1 (Negotiations of Dispute), if in its judgment such action is necessary to avoid irreparable harm. The Parties expressly and irrevocably submit to the jurisdiction of the courts of New York, New York, U.S.A., for any such injunctive relief. Further, the requirement to attempt to resolve a dispute in accordance with this Section 12.1 (Negotiations of Dispute) does not affect a Party’s right to terminate this Agreement as
CONFIDENTIAL 29 provided in Section 6 hereof, and a Party shall not be required to follow these procedures prior to terminating the Agreement. The failure of a Party to participate in good faith discussions and negotiations in an attempt to resolve such dispute shall not delay the date by which another Party may initiate arbitration under this Section 12.1 (Negotiations of Dispute). 12.2 Arbitration. Any dispute, controversy, or claim arising out of, relating to, or in connection with this Agreement, including with respect to the formation, applicability, breach, termination, validity or enforceability thereof, or relating to arbitrability or the scope and application of this Section 12.2 (Arbitration), shall be finally resolved by arbitration. The arbitration shall be conducted by three arbitrators, in accordance with the Rules of Arbitration of the International Chamber of Commerce (“ICC”). The claimant shall nominate an arbitrator in its request for arbitration. The respondent shall nominate an arbitrator within thirty (30) days of the receipt of the request for arbitration. The two (2) arbitrators nominated by the Parties shall nominate a third arbitrator, in consultation with the Parties, within thirty (30) days after the confirmation of the later-nominated arbitrator. The third arbitrator shall act as chair of the tribunal. If any of the three (3) arbitrators are not nominated within the time prescribed above, then the ICC shall appoint the arbitrator(s). The seat of the arbitration shall be New York, New York, U.S.A. and it shall be conducted in the English language. . The Parties undertake to maintain confidentiality as to the existence of the arbitration proceedings and as to all submissions, correspondence and evidence relating to the arbitration proceedings. This provision shall survive the termination of the arbitral proceedings. The costs of the arbitration, including, without limitation, the Parties’ reasonable legal fees, shall be borne by the unsuccessful Party or Parties. However, the arbitral tribunal may apportion such costs between the Parties if it determines that apportionment is reasonable, taking into account the circumstances of the case. The arbitration award shall be final and binding on the Parties, and the parties undertake to carry out any award without delay. Judgment upon the award may be entered by any court having jurisdiction of the award or having jurisdiction over the relevant party or its assets. 12.3 Purchasers Obligations. MOH, MOR and IPH are defined collectively herein as Purchaser; provided, however, that any references herein to “Purchaser”, or similar references, shall be construed as a reference to each MOH, MOR and IPH. MOH, MOR and IPH shall be jointly and severally liable for all of the obligations of Purchaser under this Agreement. Each of MOH, MOR and IPH, individually, hereby acknowledge and agree that all of the representations, warranties, covenants, obligations, conditions, agreements and other terms contained in this Agreement shall be applicable to and shall be binding upon and measured and enforceable individually against each of MOH,MOR and IPH. 12.4 Publicity. A Party shall not use the name, trade name, service marks, trademarks, trade dress or logos of the other Parties in publicity releases, advertising or any other publication, without the other Parties’ prior written consent in each instance.
CONFIDENTIAL 30 12.5 Governing Law. All disputes shall be governed by the Laws of the State of New York, USA, without regard to conflict of Law principles other than Section 5-1401 of the New York General Obligations Law, except that any dispute regarding the arbitrability or the scope and application of this Section shall be governed by the Federal Arbitration Act of the United States. 12.6 Third Party Rights. (a) Purchaser agrees the applicable rights granted or provided to Pfizer under this Agreement are also granted or provided to Pfizer’s Affiliates or to BioNTech to the extent that those rights relate to such Affiliates or BioNTech, including but not limited to the indemnification in Section 8(a) (each a “Third Party Beneficiary” and together the “Third Party Beneficiaries”). Each Third Party Beneficiary shall be entitled to enforce the terms of this Agreement; provided that, to the extent permissible by Law and where reasonably practicable, any claims, demands or actions from any Third Party Beneficiary shall be brought by Pfizer itself on behalf of the relevant Third Party Beneficiary. (b) Any Losses suffered by a Third Party Beneficiary will not be treated as being indirect solely because it has been suffered by a Third Party Beneficiary and not by Pfizer directly. 12.7 Relationship of the Parties. The relationship hereby established between Purchaser and Pfizer is solely that of independent contractors. No Party has authority to act or make any agreements or representations on behalf of the other Parties. This Agreement is not intended to create, and shall not be construed as creating, between Pfizer and Purchaser, the relationship of principal and agent, employer and employee, joint venturers, co-partners, or any other such relationship, the existence of which is expressly denied. 12.8 Assignment; Binding Effect. Neither Purchaser nor Pfizer shall assign any of its rights or delegate or subcontract any of its duties and obligations under this Agreement without the prior written consent of the other Parties, which may be withheld at such Party’s discretion, provided that Pfizer, without Purchaser’s consent, may assign, delegate or subcontract any of its duties and obligations under this Agreement to an Affiliate of Pfizer, BioNTech or an Affiliate of BioNTech. Any such attempted assignment of rights or delegation or subcontracting of duties without the required prior written consent of the other Parties shall be void and ineffective. Any such assignment, delegation or subcontracting consented to by a Party in writing shall not relieve the other Parties of their responsibilities and liabilities hereunder and such assigning Party shall remain liable to other Parties for the conduct and performance of each permitted assignee, delegate and subcontractor hereunder. This Agreement shall apply to, inure to the benefit of and be binding upon the Parties hereto and
CONFIDENTIAL 31 their respective successors and permitted assigns. The Parties agree that this Agreement is not intended by a Party to give any benefits, rights, privileges, actions or remedies to any Person or entity, partnership, firm or corporation as a Third Party Beneficiary or otherwise under any theory of Law. 12.9 Force Majeure. Each Party shall not be liable for any failure to perform or any delays in performance, and each Party shall not be deemed to be in breach or default of its obligations set forth in this Agreement, if, to the extent and for so long as, such failure or delay is due to any causes that are beyond its reasonable control and not to its acts or omissions, including, without limitation, such causes as acts of God, natural disasters, flood, severe storm, earthquake, civil disturbance, lockout, riot, embargo, acts of Government (other than Purchaser), war (whether or not declared), acts of terrorism, the impact on a Party of an outbreak of any disease or an epidemic or pandemic or other similar causes (“Force Majeure Event”). Failure or inability to pay shall not be a basis for a Force Majeure Event under this Agreement. In the event of a Force Majeure Event, the Party prevented from or delayed in performing shall promptly give notice to the other Parties and shall use Commercially Reasonable Efforts to avoid or minimize the delay. 12.10 Severability. If and solely to the extent that any court or tribunal of competent jurisdiction holds any provision of this Agreement to be unenforceable in a final non-appealable order, such unenforceable provision shall be stricken and the remainder of this Agreement shall not be affected thereby. In such event, the Parties shall in good faith attempt to replace any unenforceable provision of this Agreement with a provision that is enforceable and that comes as close as possible to expressing the intention of the original provision. 12.11 Non-Waiver; Remedies. A waiver by any Party of any term or condition of this Agreement in any instance shall not be deemed or construed to be a waiver of such term or condition for the future, or of any subsequent breach thereof. All remedies specified in this Agreement shall be cumulative and in addition to any other remedies provided at Law or in equity. 12.12 Further Documents. Each Party hereto agrees to execute such further documents and take such further steps as may be reasonably necessary or desirable to effectuate the purposes of this Agreement. 12.13 Forms. The Parties recognize that, during the Term, a Purchase Order acknowledgment form or similar routine document (collectively, “Forms”) may be used to implement or administer provisions of this Agreement. The Parties agree that the terms of this Agreement shall prevail in the event of any conflict between terms of this Agreement and the terms of such
CONFIDENTIAL 32 Forms, and any additional or different terms contained in such Forms shall not apply to this Agreement. 12.14 Headings. Headings of Sections or other parts of this Agreement are included herein for convenience of reference only and shall not constitute a part of this Agreement or change the meaning of this Agreement. 12.15 Counterparts. This Agreement may be executed in three or more counterparts, each of which shall constitute an original and all of which together shall constitute one and the same agreement, and shall become effective when signed by all of the Parties hereto and delivered to the other Parties in accordance with the means set forth in Section 11 (Notices) or by reliable electronic means (with receipt electronically confirmed). 12.16 Electronic Delivery and Storage. Delivery of a signed Agreement by reliable electronic means, including facsimile or email (with receipt electronically confirmed), shall be an effective method of delivery of the executed Agreement. This Agreement may be stored by electronic means and either an original or an electronically stored copy of this Agreement can be used for all purposes, including in any proceeding to enforce the rights or obligations of the Parties to this Agreement. 12.17 Entire Agreement; Amendments. This Agreement, together with any attachments and amendments (and as such attachments may be amended, amended and restated or replaced from time to time), which are hereby incorporated by reference, constitute the entire agreement of the Parties with respect to its subject matter and merges and supersedes all prior discussions and writings with respect to thereto. Except as otherwise set out herein; no modification or alteration of this Agreement shall be binding upon the Parties unless contained in a writing signed by a duly authorized agent for each respective Party and specifically referring hereto or thereto. 12.18 Rule of Construction. The Parties have participated jointly in the negotiation and drafting of this Agreement. In the event that an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the Parties and no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of the authorship of any of the provisions of this Agreement. 12.19 English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into
CONFIDENTIAL 33 any other language shall not be an official version thereof, and in the event of any conflict in interpretation between the English version and such translation, the English version shall control. 12.20 Legal Costs. Each Party will bear its own legal costs in preparing and concluding this Agreement. [signature on following page]
CONFIDENTIAL 1 IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly executed and delivered as of the date first written above. PFIZER EXPORT B.V. By: Name: Title: Date: ALBANIA MINISTRY OF HEALTH AND SOCIAL PROTECTION By: Name: Title: Date: AGREED AND ACKNOWLEDGED by MINISTEROF STATE FOR RECONSTRUCTION By: Name: Title: Date: INSTITUTE OF PUBLIC HEALTH By: Name: Title:
CONFIDENTIAL 1 Attachment A - Specifications [To be inserted following the Effective Date (and in any event before supply in line with the agreed Delivery Schedule)]
CONFIDENTIAL 2 [Attachment B - Delivery Schedule and Price] Supply Period January 2021 February 2021 Q3 -Q4 2021 Total Doses 10,530 30,420 458,640 499,590 Price per dose USD 12 USD 12 USD 12
CONFIDENTIAL 3 Attachment C- Delivery Documentation Documentation and Delivery Notes Thermal Shipper Documentation It is currently envisaged that the following will be provided with each shipment of the Products: 1. Emergency Use Authorization (EUA) Fact Sheets/Leaflets – Five (5) fact sheets folded 3x2” in a plastic bag 2. Pfizer Brochure – One (1) per thermal shipper container containing product storage and handling information including: - Dry Ice Handling Insert - Safety Data Sheet (SDS) for Dry Ice - Return instructions for GPS loggers and thermal shipping system - A stand-alone SDS for Dry Ice - Blank label – purpose of the blank label: for carriers to mark out the dry ice label to indicate that the thermal shipper containers are empty (not containing dry ice) 3. Return Shipping Label – One (1) 4. Outbound Shipping Label – One (1), standard label on thermal shipper 5. Contents Label – One (1) label on inside flap, picking label details how many carton trays are in thermal shipper Proof of Delivery Documentation Currently, Pfizer intends to use the carrier delivery signal as proof of delivery. Proof of delivery document that can be accessed online based on track and trace number. See UPS example* below: *The above proof of delivery image is an example only.
CONFIDENTIAL 4 Attachment D – Delivery Specification Product Delivery, Storage & Handling Specifications Shipments will arrive in a long-distance thermal shipping container as provided by Pfizer in accordance with the Labelling and Packaging Specifications set forth in Attachment E (“Thermal Shipper”). At this time, the minimum package in any shipment shall be one (1) tray with 195 vials or 1170 doses of Product. Purchaser ensures that at the expected time of arrival at the Place(s) of Destination, a dedicated person will be available to receive the Product, sign acceptance for delivery, and, immediately, no later than 24 hours of delivery, switch off the temperature logger located in the Thermal Shipper, and: (a) transfer the Product to: (i) a -75 oC (+/- 15 oC) ultra-low temperature (“ULT”) freezer; or (ii) a 2-8 oC refrigerator; or (b) maintain the Product with sufficient supply of dry ice in accordance with the protocols for re-icing set forth below with such initial re-icing to occur no later than 24 hours from signature of acceptance of delivery. Purchaser acknowledges the following stability timelines as of the Effective Date: • The Product has a shelf-life of up to 6 months when stored at a constant -75 oC (+/- 15 oC) • The Thermal Shipper can be used as temporary storage for up to 30 days, as long as dry ice is replenished upon receipt and at least every five (5) days per Pfizer’s guidelines. • The Product has an effective life of up to 5 days when stored at refrigerator temperatures 2-8°C • Once the Product is defrosted and reconstituted it can be retained for up to 6 hours at standard ambient room temperatures (19-25°C) Any further shipment or distribution of the Product by Purchaser from the Place(s) of Destination shall be through a certified shipping service, or use of its own logistics system, that will ensure next day delivery from the Place(s) of Destination to point of use of the Product; and Purchaser shall be liable for ensuring continual compliance with the cold chain requirements for any further distribution following delivery to a Place of Destination that is not a point of use of the Product. In all cases, Purchaser shall ensure that all Product is transported in (a) the Thermal Shipper with re-icing performed in accordance with the Protocols for re-icing set forth below, or (b) an alternate shipper purchaser by Purchaser, in each case in a manner to maintain the temperature requirements set forth herein. All costs associated with receiving, handling, storing and further delivery of the Product shall be the responsibility of Purchaser, and Purchaser shall ensure that all locations where any Product is delivered by, or on behalf of Purchaser, shall comply with the requirements set forth in this Attachment D and shall meet the standards set forth herein.
CONFIDENTIAL 5 Protocols for Unpacking Product and Re-icing: See Exhibits 1 and 2 of Attachment D Requirements of Delivery Location: 1. EUA, Pre-approval, Post-approval vaccination points with -75 oC (+/- 15 oC) ULT freezer 2. EUA, Pre-approval, Post-approval vaccination points with sufficient access and supply of dry-ice 3. EUA, Pre-approval, Post-approval vaccination points with 2-8 oC refrigerator
CONFIDENTIAL 6 Attachment D – Delivery Specification Exhibit 1 – Unpacking and Re-icing: Thermal Shipper A
CONFIDENTIAL 7 Attachment D – Delivery Specification Exhibit 2 – Unpacking and Re-icing: Thermal Shipper B
CONFIDENTIAL 8 Vaccine Preparation & Administration Instructions Removing the Vials to Thaw • From storage, remove 1 vial for every 6 recipients according to planned vaccinations schedule. • Vials may be stored in the refrigerator for 5 days (120 hours). Diluting the Vaccine • Obtain 0.9% Sodium Chloride Injection, for use as a diluent. Do not use any alternate diluents. • Dilute the thawed vial by adding 1.8 mL of 0.9% Sodium Chloride Injection into the vial. • Ensure vial pressure is equalized by withdrawing 1.8 mL air into the empty diluent syringe before removing the needle from the vial. Preparing the Dose • Draw up 0.3 mL of the diluted dosing solution into a new sterile dosing syringe with a needle appropriate for intramuscular injection. • For each additional dose, use a new sterile syringe and needle and ensure the vial stopper is cleansed with antiseptic before each withdrawal. Vaccine Administration • Diluted vials must be used within 6 hours from the time of dilution and stored between 2-25 °C (35-77°F). • A single 30 mcg/0.3 mL dose is followed by a second dose 21 days later.
CONFIDENTIAL 9 Attachment E – Labelling and Packaging Specifications Product Labelling Specifications Product labels for primary, secondary and tertiary packaging will be shared closer to country regulatory filings. It is currently envisaged that the following will be part of the initial product artwork: Primary Packaging (Vial): • Linear barcode: Scans as the Global Trade Item Number (GTIN) that includes the humanreadable National Drug Code (NDC) number. Secondary Packaging (Carton Tray): • Linear barcode: Scans as the GTIN number that includes the human-readable NDC number. • QR code: When scanned, this code links to a landing page where a copy of the Fact Sheets for the Healthcare Provider, patient/recipient, and Emergency Use Authorization Product Insert (i.e. eleaflet) will be available. • 2D GS1 DataMatrix: Scan of the 2D code will include the GTIN number, lot and expiry information. Product Packaging Specifications Primary Packaging • 2 mL type 1 glass preservative free multi-dose vial (MDV) • MDV has 0.45 mL frozen liquid drug product • 6 doses per vial Secondary Packaging “Single Tray” • Single tray holds 195 vials • 1170 doses per tray • Tray (white box) dimensions: 229 X 229 x 40 mm Tertiary Container: Thermal Shipper (Softbox) • Minimum 1 tray (1170 doses) or up to 5 trays (max 5850) stacked in a payload area of the shipper • Payload carton submerged in 23 Kg of dry ice pellets (9 mm – 16 mm pellets) • Thermal shipper dimensions: o Internal Dimensions: 245mm X 245mm X 241mm o External Dimensions: 400mm X 400mm X 560mm
CONFIDENTIAL 10 Attachment F – Return and Disposal of Product Materials A. Return “Logistics Delivery Equipment” refers to the long-distance thermal shipping container (“Thermal Shipper”) used for shipping and the temperature data logger/monitoring device attached to such Thermal Shipper. Once dry ice is no longer needed, open the Logistics Delivery Equipment and leave it at room temperature in a well-ventilated area. The dry ice will readily sublime from a solid to a gas. DO NOT leave dry ice unattended. Store the empty Logistics Delivery Equipment until return in an appropriate clean and secure location to protect and maintain the functionality of the equipment (e.g., do not store outside under uncontrolled conditions, exposed to weather, exposed to pests, etc.). Return of the Logistics Delivery Equipment to be undertaken within 30 days following delivery of the Product at the Place(s) of Destination. Instructions and logistics for return will be provided on the interior of the Thermal Shipper and will also be available on Pfizer’s website. In the event that either: (a) the Logistics Delivery Equipment (or any part thereof), is not (i) delivered to the return carrier within 30 days following delivery of the Product or (ii) received by Pfizer within five (5) days following the date of Purchaser’s return shipment of such Logistics Delivery Equipment; or (b) the Logistics Delivery Equipment (or any part thereof), is damaged in any way (determined in Pfizer’s sole discretion), Pfizer shall be entitled to charge Purchaser $450 (exclusive of VAT) per Thermal Shipper and temperature data logger/monitoring device; which Purchaser shall pay within 30 days of the date of any invoice for such amount(s). Purchaser acknowledges that such amount represents a reasonable pre-estimate of replacement cost such Logistics Delivery Equipment as a result of Purchaser’s default, act or omission. B. Disposal “Primary Container Units” refers to the vials that contain the Product. Destruction of the Primary Container Units that have been opened or are unused must take place at a facility appropriately licensed to handle and destroy pharmaceutical waste, medical waste, and/or hazardous waste, and destruction must be by means of grinding or incineration. “Secondary Cartons” refers to the immediate boxes that contain the vials of Product. Secondary Cartons must be defaced and destroyed in accordance with local clinical dosing facility waste management services, and Secondary Cartons may not be disposed of in routine household waste collection or recycling centers.
CONFIDENTIAL 11 Attachment G – Form of Purchase Order [To be inserted following the Effective Date (and in any event before supply in line with the agreed Delivery Schedule)]
CONFIDENTIAL 12 Attachment H- Customs Clearance Documentation and waivers PART 1 SAMPLE 1. Shipping Document/Airway Bill “AWB” 2. Commercial Invoice 3. Packing List 4. Copy of the Certificate of Origin 5. Copy of the Certificate of Analysis “COA” 6. Copy of Export Declaration. During the Term of the Agreement: • Any other documents not included in the above-mentioned list of documents, including but not limited to import permits, will be waived by the Purchaser or any other Government authority. • Any notarization, legalization and/or certification of the above-mentioned list of documents will be waived by the Purchaser or any other Government authority. • Any required analysis to release any of the shipments upon arrival at the Point of Delivery will be waived by the Purchaser or any other Government authority. PART II • Any other documents not included in the global Pfizer dossier for Pfizer BioNTech Covid 19 Vaccine registration, will be waived by the Purchaser or any other Government authority. • Any notarization, legalization and/or certification of the documents required for issuing the Marketing Authorization in Albania, will be waived by the Purchaser or any other relevant Government authority (e.g. GMPs, CPP, etc). • Any required analysis to issue the Marketing Authorization in Albania, will be waived by the Purchaser or any other relevant Government authority (e.g. registration samples and reference standards).
CONFIDENTIAL 13 Attachment I – Normative Act, dated 31.12.2020.
CONFIDENTIAL 14 Attachment J - Approval and Ratification of Agreement by Law of Parliament of Normative Act