The Treaty itself with Fiser: THIS IS REAL WORLD EPIDEMIOLOGICAL EVIDENCE COSAL AGREEMENT
⏳ ተ𐍂𐌉ଓ𐌵𑀉ꤕ Ⴝ𐌳𐍅Ⴝ🎙
1 page, the date of the initial contract has been removed. Why remove the date? Unless it's before the "pandemic." Paragraph 1.2 "Global Trade Control Laws" means the U.S. Export Administration Regulations; the U.S. International Traffic in Arms Regulations; the U.S. economic sanctions rules and regulations implemented under statutory authority and/or the President's Executive Orders and administered by the U.S.
Note: "Global Trade Control Laws" mean U.S. Export Regulations; these are the U.S. Rules on International Arms Trade; ...
THIS COOPERATION AGREEMENT WITH REAL EPIDEMIOLOGICAL EVIDENCE
January 6, 2021 (present "Agreement") between the Israeli Ministry of Health, which is in force
on behalf of and on behalf of the State of Israel ("MoH") and Pfizer Inc., Delaware Corporation
(along with its affiliates, PFIZER) (each, "The Party" and, together, "Parties").
WHAT, PFIZER and BioNTech SE, a company established and existing in accordance with the law
Germany is collaborating on the development of a vaccine against the global COVID-19 pandemic; and WARNING that the parties had previously entered into a confidential production and supply agreement.
Agreement from the Treasury Department for Foreign Assets Control; Regulations of the Council of the European Union (EU)
Export controls, including No. 428/2009, 267/2012; Other E.U. Council Sanctions Resolutions, as implemented in the EU by Member States; United Nations sanctions policy; all relevant rules and
Legislative tools created in accordance with any of the above; other relevant economic sanctions, exports and imports
control laws, as well as other laws, regulations, laws, orders and requirements imposed by the relevant
government agency.
(the Manufacturing and Supply Agreement), under which the Ministry of Health
agreed to buy the Product (as defined below) and PFIZER agreed to manufacture and supply the product in accordance with the terms of the Manufacturing and Supply Agreement and subject to
certain preconditions, including, among other things, certain regulatory approvals and availability; And
WHAT under section 2.1 (f) of the Manufacturing and Supply Agreements, the Parties agreed
cooperate on a reasonable basis to share information and data related to distribution, administration
And use the product, including to track its benefits; and WHATER PFIZER has received certain conditional approvals for the product, including
Rule 29 (a) (9) Israel Pharmacists Regulations (medical drugs) 1986, as amended and
Similar permits for use in emergencies in other jurisdictions; and WHAT Parties agree that from a public health perspective it would be very useful to track pandemic data in a real context for assessment
whether the protection of collective immunity is observed during the deployment of the drug vaccination program.
SO, taking into account the preconditions, reciprocal agreements contained in this document, as well as for obtaining other useful and valuable remuneration, obtaining and adequacy
which are hereby recognized, Parties intending to take on legal obligations hereby agree on the following:
1. DEFINITIONS
The following terms have meanings assigned to them for all purposes of the Agreement.
1.1 "Affiliate" means for each Party or, if applicable, BioNTech, any corporation, firm, partnership or other legal or natural person who directly or indirectly controls or is controlled or controlled
party or under its general control, including, among other things, Pfizer US, or if
applicable, BioNTech. For the purposes of this definition, "control" (including, with the appropriate value,
the terms "controlled" and "under general control c") are assumed to exist if one of the following conditions is met: (a) in the case of legal entities, direct or indirect property is at least fifty per cent
(50%) shares or shares that have the right to vote on the election of the directors of such a legal entity or
any direct or indirect parent company of such a legal entity, and (b) in the case of non-corporate entities, direct or
indirect possession of at least fifty per cent (50 per cent) share in capital with the power to manage
the management and policies of such non-corporate organizations.
1.2 "Global Trade Control Laws" mean U.S. Export Management Rules; U.S. rules on international arms trade; U.S. economic sanctions are enforced in accordance with the law and/or presidential decree and is administered by the United States.
1.3 "Identifiable medical information" means medical information in accordance with the definition of the term in
Israel's Patient Rights Act, which contains details to identify a person without cross-referencing
additional information or health information that does not contain identification information
but it can lead to identification by reasonable means or other information available to the general public.
1.4 "Intellectual property" means worldwide any (a) patents, patent applications (including, among other things, separation, continuation, partial continuation and re-examination of the application) and any updates, extensions or reissues;
(b) Trademarks, service marks, regardless of unregistered, copyright and registration or applications for registration of copyright related rights
with author's works, including author's, non-property and masks;
(c) Designs, algorithms and
Other industrial property rights;
(d) computer software, including, among other things, source code, operating systems and specifications, documentation and other written materials related to them;
(e) trade secrets rights;
(f) Data
(g) other ideas, inventions (patentable or generic), methods, research information and knowledge;as; Treasury Department for Foreign Assets Control; Regulations of the Council of the European Union (EU)
Export controls, including No. 428/2009, 267/2012; other E.U. Council sanctions regulations like
implemented in the EU by member states; United Nations sanctions policy; all relevant rules and
Legislative tools created in accordance with any of the above; other relevant economic sanctions, exports and imports
control laws, as well as other laws, regulations, laws, orders and requirements imposed by the relevant
government agency.
Item 1.4 Intellectual Property, (h)
(h) reagents, kits, chips, micromatrixes, devices, devices used for genetic tests, compositions, methods, markers and direct treatment;
(i) other intellectual and industrial property rights
of any kind and character, whether they are the result of a law, contract, license or
It's different. And
(j) Registration, applications, extensions, extensions, extensions, separations or reissues are valid now or in the future (including, among other things, any rights in any of the above).
1.5 "Pfizer Data" refers to aggregated product information in other jurisdictions around the world, which may include scientific information, safety and efficacy information collected by PFIZER, depending on whether
useful for achieving the project goals, which will be provided to PFIZER by the Ministry of Health in accordance with applicable legal requirements and on the basis of a reasonable definition of PFIZER.
1.6 "Product" means all vaccines produced in full or in part, or delivered directly or
indirectly, PFIZER or BioNTech, or on their behalf or on their behalf in accordance with the Manufacturing and Supply Agreement, which are designed to prevent human disease COVID-19 or any other human disease, in each case caused by any SARS-CoV-2 virus and/or any or all related strains, mutations, modifications or derivatives from the above.
1.7 "Project" refers to the analysis of real-world epidemiological data on COVID-19 conducted by Parties using data collected during the Ministry of Health's product vaccination programme, as described in Section 2 and Appendix A to this Agreement, including its components and additions to it, developed and implemented by Parties in accordance with the terms of this Agreement.
1.8 "Project Data" refers to any anonymized data provided by the Ministry of Health to PFIZER as part of the Project.
1.9 "Regulatory Requirements" Requirements of all applicable national, regional and
local laws and regulations, court orders and consent decrees, as well as all requirements, guidance, policies and orders of all government agencies or agencies with jurisdiction over each Party and their
relevant staff and agents in relation to activities carried out under this Agreement. Normative
Requirements include, among other things:
(a) Israel's Patient Rights Act 1996, as amended;
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(b) Privacy Protection Act, Israel, 1981, as amended,
(c) Israel's Health Ordinance, 1940, as amended
(d) The Office of Pharmacists of Israel (medical drugs), 1986, as amended,
(e) Israel's Freedom of Information Act, 1998, as amended,
(f) ant-bribery anti-corruption laws abroad, 1977, as amended,
(g) and international trade control laws.
1.10 "Party (persons) with limited access" means any individual or legal person on any of the following points:
List of suspended and convicted by the U.S. government, list of excluded parties HHS OIG; FDA OIG exemption list: any similar disqualification lists, licensing restrictions, disciplinary sanctions, or enforcement action against scientists, medical professionals or research professionals in accordance with Israeli, U.S. or any jurisdiction. 1.11 "Collateral Circumstances" means: (i) epidemiological reports from Israel prepared by the Ministry of Health: (ii) analyses created by one of the Parties, independently or jointly with the other Party, related to the project data: and (iii) any epidemiological reports from Israel, which relates to the Product provided by Pizer.
1.12 "Term" As defined in section 4.1. 2.
Project
2.1 The goal of the project. To measure and analyze epidemiological data obtained from the introduction of the product to determine whether collective immunity is achieved after reaching a certain percentage of vaccination coverage in Israel.
2.2 Principles of Cooperation. The parties agree that the project aims to obtain and analyse epidemiological and population-level vaccine efficacy data, vital for public health purposes, which can be used to develop technical recommendations for vaccines worldwide. The project's data are aimed at helping to stop the global COVID-19 epidemic for the benefit of all patients inside and outside Israel. The project will be based on modern medical literature and guidelines adopted by respected medical organizations. In order to carry out the Project and measure the impact of products at the population level, the Ministry of Health relies on the receipt of doses of Products in accordance with the terms of the Manufacturing and Supply Agreement, which can be amended from time to time, as well as on the speed at which PFIZER products are delivered to maintain a level of vaccination sufficient to achieve collective immunity and disease data as soon as possible, and must be approved by the two parties. Nothing in this Agreement can change or in any way change the terms of the Manufacturing and Supply Agreement. In the event of a conflict between the terms of the Production and Supply Agreement and the present Manufacturing and Supply Agreement, the terms of the Production and Supply Agreement will prevail.
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2.3 Collaboration Management.
During the Term, if the Parties do not agree on a different frequency, the Parties will meet weekly via video conferencing/teleconference at a convenient time for both parties to review and discuss the status of the project's development and implementation. The composition of the project team is determined by the Parties. Each Party is responsible for its costs associated with any meetings.
3. FUNDING / CONTRIBUTIONS OF PARTIES
Funding for this Agreement is not provided. The project data are collected by the Ministry of Health on a regular basis for epidemiological, logistical and control purposes to monitor the status of the pandemic and vaccination, including the data detailed in Annex A. To maintain the viability and relevance of the project, the Ministry of Health will do everything possible to ensure the timeliness of reporting to PFIZER in accordance with Annex B.
Both Parties recognize that the viability and success of the Project depends on the number and volume of vaccinations in Israel.
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The Ministry of Health will ensure the rapid distribution, deployment and use of the Product, complying with all storage requirements and ensuring patient safety, while ensuring timely and accurate collection of epidemiological data in accordance with applicable regulatory requirements. PFIZER will work with the Ministry of Health on the project to provide, subject to PFIZER assessment, qualified PFIZER counterparts infectious diseases, respiratory diseases, vaccines, epidemiology, infectious disease modeling, data analysis and public health, as well as providing Pfizer data to the Ministry of Health, in accordance with applicable legal requirements and on the basis of PFIZER's reasonable definition. technical knowledge and expertise in the subject area of the Ministry of Health will provide Pfizer with aggregated data on the project, and the parties will jointly analyze such data for the project. The Ministry of Health reserves the right to continue to publicly analyze and report public health data collected by the Ministry of Health, as well as information on the safety and efficacy of products. The Ministry of Health and Pfizer will jointly report in materials for publication in peer-reviewed scientific or medical journals about the results of the project. PFIZER will provide the Ministry of Health with the results of the analysis of the project conducted by PFIZER or its consultant.
4. TERM AND TERMINATION
4.1 Deadline. This Agreement and the Obligations of the Parties to it take effect from the moment of its implementation, remain in force until the completion of the Project, if not terminated earlier in accordance with the provisions of Section 4.2 ("Term").
4.2 Cessation events.
This Agreement terminates the first time any of the following events (each, the "Cessation event"):
4.2.1 Expiration Date; 4.2.2 The written consent of the Parties to the termination of this Agreement;
4.2.3 if PFIZER or the Ministry of Health find the project scientifically useless;
4.2.4 in the event of a disaster, such as a serious patient safety issue with the Product as a result of the recall of a Product requiring the early termination of the Project;
4.2.5 In the event of a significant violation of this Agreement by a Party claiming such a violation and sending written notification to the other Party, and the Party does not eliminate the violation
Within 30 (thirty) days of written notification;
4.2.6 either (i) any law, rule or ordinance to which amendments are made or made public, or any new interpretation of any law, rule or ruling or (ii) of any legal action,
including any investigation initiated by the government against
any of the Parties or their Affiliates who, in the case of (i) or (ii),
(x) it can reasonably be expected that they will have a significant adverse impact on the ability to meet their obligations under this Agreement or (y) makes THE FREE or
the material obligations of the other Party under this Agreement;
provided, however, that at least 30 days' notice of the termination of the other Party and made a reasonable effort to work with the other Party to change the
this Agreement, in order to preserve its primary purpose while at the same time creating the effect of the event specified in paragraphs (i) or (ii) of this Section 4.2 (d) does not cause significant harm to the terminating party or any of its affiliates;
4.2.7 Any Party may terminate this Agreement if the other Party violates any of the
Statements and guarantees contained in this Agreement.
4.3 Consequences of termination.
Except in the cases mentioned in the following proposal, the termination of this Agreement under section 4.2 must
to terminate all obligations of the Parties under this Agreement (or with respect to a separate Draft Treaty
terminated if applicable), except for previously accrued liabilities. Sections 5, 6, 7 and 8 remain in force after the termination of this Agreement. To avoid any doubt, Pfizer is not required to return or destroy the project's data or results, including after this Agreement has expired.
PRIVACY
5.1 "Confidential information" means, except for deleted information (defined below), any
and any information, whatever form it is presented in, and
(a) refers to the business/operations of the Party
or their plan, technology, research, finances or any other confidential or official information that PFIZER or the Ministry of Health may disclose through their employees or consultants in accordance with this Agreement to other Partners;
(b) is or contains identifiable medical information;
(c) Pfizer data; Or
(d) Project or results, unless such data or project results, in the case of data or project results prepared or collected by the Ministry of Health,
are considered public health data. "Released information" means the information that the receiving Party can
Demonstrate that (a) was in legal possession until the disclosure was made; (b) is or becomes public
knowledge is not the fault, inaction or other actions of the host party; (c) received from a third party and has a legal right to own such information and has no obligation to respect confidentiality
Revealing side; or (d) was independently assembled or developed by the host Party or for it without
breach of the terms of this Agreement. The Ministry of Health has the right to publicly disclose this Agreement, subject to reasonable editing of any confidential information at the approval of the Parties.
5.2 Parties and each of their employees, agents, subcontractors, affiliates and others
Representatives ("Representatives") must not disclose any confidential information to any third party within or after the expiration of this Agreement without the approval of the disclosure party; or (b) use
Confidential information for its own benefit or benefit, except in the implementation of this Agreement.
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Each Party must protect the Confidential information of the other Party with the same degree of caution as its own confidential information of this kind, with an equally reasonable degree of caution. No identifiable medical information will be passed between the Parties, and the Ministry of Health must provide the project data exclusively in an anonymous form provided by the Ministry of Health in accordance with regulatory requirements, so that the project data cannot be reasonably used for re-identification. If the identified medical information is inadvertently transmitted by any of the Parties, it is treated as Confidential information by the host, immediately returned to the disclosure party and destroyed by the host. If a Party requires, in accordance with applicable law, regulation or legal process, to disclose any confidential information to another Party, such a receiving Party shall be: (a) immediately notified by the disclosure Party so that the disclosed Party can request a protective order or other relevant remedy and cooperate with the disclosure Party in such efforts at the expense of the disclosure party. (b) to disclose only the part of Confidential information that her legal adviser believes she should disclose and (c)
5.3 Make every reasonable effort to gain confidence that such Confidential information will be handled confidentially.
5.4. Any and all written Confidential information obtained by the Party under this Agreement must be returned to the disclosure party along with all copies of the Party or must be destroyed upon request and by the disclosure party's choice.
5.5 The Ministry of Health will store and safely maintain the project data at its own expense during the period defined by the current laws and regulations of Israel, but not less than fifteen (15) years after the termination of the Agreement ("Storage period"). 6. COMPENSATION; LIMITING LOSSES AND LIABILITY
The fun is closed.
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7. STATEMENTS AND GUARANTEES
7.1. Each Party enters into a treaty, declares and guarantees to the other Party that such a Party has full RIGHT, the authority to conclude this Agreement, and there is nothing to prevent it from fulfilling its obligations under the terms of the agreement;
7.2 Each Party agrees, states and ensures that, if this Agreement and the Project is implemented, it will take all actions necessary and appropriate to ensure compliance
(a) The terms of this Agreement, including any applicable Project plans and other annexes to this document, and
(b) regulatory requirements.
Each Party guarantees and undertakes that it has obtained all necessary regulatory approvals and permits required by law to transmit or obtain project data, as a matter of course, and that no legislation prevents the implementation of this Agreement. The Ministry of Health determined that the Project does not require the approval of the IRB or the Privacy Board.
7.3 Each Party undertakes that all materials, work products and documentation are created in accordance with the
this Agreement should not infringe any patents, copyrights or other intellectual property rights by a third party.
7.4 Each Party, in concluding the contract, states and guarantees to the other Party that it is not prohibited by any applicable body, including under Subsections 306 (a) or (b) of the Federal Food and Drug Administration, and the Cosmetic Products Act, as amended, is not included in the U.S. Government's Suspended and Suspended List; HHS OIG
List of excluded parties; or any similar disqualification lists, licensing restrictions, disciplinary sanctions or
coercive measures against scientists, health care providers or researchers under the laws of Israel, the United States or any other jurisdiction, and they have not used and will not use in any capacity any service
individuals or entities, including any individuals, agents, employees, subcontractors, clients, healthcare
service providers, hospitals, pharmacies, clinics and any other interested parties directly or indirectly involved in activities under this Agreement, which has been prohibited by any such applicable authority in relation to this Agreement. Such a Party immediately notifies other Parties if it, subcontractors or any of their staff are disqualified or excluded during the duration of this Agreement. Such a Party recognizes that such a suspension is the basis for the termination of the Agreement of other Parties for a good reason.
7.5 Each Party states and ensures that the services provided under this Agreement will not indeed include advising or promoting a business relationship or other activity that violates
applicable law. Each Party also states and guarantees that it will not and will not be in the future directly
or indirectly offer or pay, or authorize an offer or payment of any money or anything of value in an attempt
influence any government official or any other person so that Pfizer may improperly obtain or retain
business or receiving an improper commercial advantage, and will not accept or accept in the future,
such a payment. Each party also states and ensures that the Ministry of Health has been provided with a copy
Pfizer's International Principles against Bribery and Corruption (attached to this document as Annex C) and will be brought to the attention of all persons acting on its behalf in connection with the Project, including
agents or subcontractors
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Despite any period of correction outlined herein, the Parties recognize that the designation as a Restricted Party is the basis for the immediate termination of this Agreement, in full or in part, by another Party, for a reason, without a period of correction.
Parties must include this and all of the aforementioned provisions of the Global Trade Control Act, as well as the relevant definitions in any contract or agreement required to comply with or relate to the implementation of the discount agreement under this Agreement.
7.8 PFIZER will not use Project Data for any purpose or in any way that does not improve health, public health, or discriminates against insurance or employment, or has other non-compliant social purposes, and (ii) perform or enforce any manner or action that may lead to the disclosure or identification of individual patients' data in relation to project data, including the deanymization or (re-identification) of the project data.
7.9 The Ministry of Health guarantees, assures and undertakes to obtain all necessary regulatory approvals and permits required by law to transfer and grant a license for project data.
8. PROPERTY
8.1. Each Party owns the relevant intellectual property, created or developed outside of this cooperation and up to the date of this Agreement, as well as all modifications, improvements or changes in or in such pre-existing Intellectual Property (the above is referred to as the Intellectual Property Party). For the avoidance of doubt, the project data (but not Pfizer data) belongs to the Ministry of Health or the relevant health organization, and their transfer does not affect the rights in them, except for licenses granted under this Agreement.
8.2 Unless otherwise stipulated in this Agreement, any Intellectual Property jointly developed by the Ministry of Health and PFIZER ("Joint Intellectual Property") will be jointly owned by the Ministry of Health and PFIZER.
In the relationship between PFIZER and the Ministry of Health, PFIZER owns all rights, titles and interests in relation to the Product, including any intellectual property of the project included in or useful to the product, except for public health data collected by the Ministry of Health.
Painted lines8.4 PFIZER has the right to use the project data for research and development purposes, for submission to the competent authorities, in research, publications (subject to the provisions of Section 9) and other legitimate business purposes.
9. PUBLICATIONS AND PUBLICATIONS
9.1 Publications.
9.1.1 PFIZER and the Ministry of Health will jointly prepare and publish the results in the form of materials for publication in peer-reviewed scientific or medical journals. Nothing in this Agreement prevents the Ministry of Health from continuing to disseminate project data or other data collected by the MoH other than the results of achieving the project's goal,
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