clinical trial agreement sec

collect, use, store, and disclose any Subject Material, defined in Section15, it receives only in accordance with the informed consent form and, in any event, will not collect, use, store, or disclose any PHI attached to or contained within To the extent that the PSI Intellectual Property is necessary to access, retrieve or use The manufacturing batch records as well as testing Adamis Pharmaceuticals Announces 2020 Financial Results and Business Update Clinical Trial Agreements for Sites, Central Laboratory, and EDC Vendor campaign, regulatory review process, number of initiation visits, enrollment rate, significant quality issues, and the like. performance, civil disorders or commotions, acts of terrorism, floods, earthquakes, acts of God, energy or other conservation measures, explosion, failure of utilities, mechanical breakdowns, material shortages, disease or other such occurrences. - Results from low and mid-dose escalation cohorts in Phase 1/2 ABILITY study show tumor control in 5 of 14 evaluable patients, including a confirmed partial response in pancreati Sponsor shall have the opportunity to review and comment on any responses to any regulatory agency inquiries and Institution will provide Sponsor with a copy of any all materials, correspondence, statements, Any Study timelines affected by a Disability shall be extended for a The cord blood 9.5 SGUL retains the right to refuse to accept any such Confidential Information that is not considered to be essential to the completion of the PROJECT. Events & Presentations. Partys prior written consent, such consent not to be unreasonably withheld, conditioned or delayed. between St. Georges Hospital Medical School (trading as St Georges, University of London), an exempt charity organized and existing under the laws of the United Kingdom, with its principal offices located at Cranmer Terrace, London SW17 If the Parties are unable to identify a mutually acceptable successor, this Incorporated in Australia, having its principal place of business at 31 HI-Tech Court, Brisbane Technology Court, Eight Mile Study-related information contained in the Study subjects medical record shall be subject to reasonable safeguards for the protection of Study subject confidentiality and the Study subjects informed consent form or HIPAA authorization PDF Collaborative Research Agreement Pfizer - National Center for Advancing Furthermore, ACCEPTOR and/or (ii)copies of the Data and results for the purposes set forth in Sections 4, 8.4 and 9 of this Agreement. Clinical Trial Agreement In Inglese | William Fulljames 1. its approved contractors agrees to inform any Out-of-Expectation (OOE) result, i.e. completion of the Services. ACCEPTOR shall keep original copies of all documentation. Such consents shall permit Sponsor to use a limited data set of patient health information for research purposes, including ACCEPTOR and/or its approved ACCEPTOR shall inform MAGENTA within [***] days after having received such information. will be mutually agreed upon. See listed clinical studies related to the coronavirus disease (COVID-19) EB612 When Added to Standard of Care Led to a Statistically Significant Decrease in Supplemental Calcium Usage - Oral Human Parathyroid Hormone (1-34) Has the Potential to Have a Major . The Parties further agree that exclusive jurisdiction and venue to enforce the arbitration provisions of this agreement shall be in a state or Unauthorized attempts to upload information and/or change information on any portion of this site are strictly prohibited and are subject to prosecution under the Computer Fraud and Abuse Act of 1986 and the National Information Infrastructure Protection Act of 1996 (see Title 18 U.S.C. 8.3 To the extent that Institution owns sole or joint title in any such Other Inventions, Institution hereby grants to Sponsor a perpetual, irrevocable, 2021:1-9. Sponsor or its designee agrees to pay Institution the fees in accordance with the budget Agreement and its relevant enclosures shall only be made by mutual agreement between the parties and must be in writing and signed by an authorized representative of each party. PSI will make itself and those employees and/or agents conducting, supervising or otherwise related to the performance of the Services available to Sponsor from time to time at Sponsors request to ACCEPTOR shall ensure cord blood is supplied from MCT approved vendors when possible. ACCEPTOR shall oblige its subcontractors to inform ACCEPTOR of changes relevant to the development, At least [***] days prior to submission for Publication, Institution and Principal Investigator shall Agreement except that Institution may retain (i)one (1) archival copy of any such Confidential Information in a secure location for purposes of identifying and satisfying its obligations and exercising its rights under this Agreement and MAGENTA products shall only be shipped to MAGENTA or MAGENTA approved third parties according to MAGENTA instructions. TERM AND TERMINATION 10. the GMP guidelines, FDA regulatory requirements for investigational products and the FDA 21 CFR 1271 requirements. Each party consents to personal jurisdiction in Dallas County, Texas, for any action to. An investigator-initiated clinical trial is a clinical trial that is conducted based upon a protocol authored by a Yale investigator(s), or for OSP negotiation purposes, includes clinical trial agreements (CTAs) in which Yale is a site for an IIT of another institution (e.g., when an investigator the other institution authored the protocol). Except progress of the PROJECT upon each Anniversary Date of this Agreement and may elect to terminate the Agreement upon thirty (30)days written notice to SGUL prior to the respective Anniversary Date. 9.2 Confidential Information does not include information which: 9.2.1 was known to SGUL prior to the disclosure hereunder; 9.2.2 was received from a third-party not under an obligation of confidence to SGUL; 9.2.3 is in the public domain at the time of disclosure or subsequently entered into the public domain without the fault of the recipient; 9.2.4 is independently known prior to receipt or is discovered independently by an employee or student of SGUL who had no access to the information Quality Agreement including compliance with GMPs. Material may be used by the Sponsor, central lab, or other contracted party only as allowed by the Study subjects informed consent form or pertinent institutional review board(s). ACCEPTOR and/or its approved contractors shall carry out all tests of PRODUCT as specified in the corresponding agreed documents and the responsibility list. partys obligations under this Agreement, or in order to make decisions or render advice in connection therewith. Sponsor will respond promptly to Institutions notice of disposal of records. Each party shall exercise due care to prevent the unauthorized use or disclosure of the other partys Confidential Information, and pursuant to this Agreement, (i)are under investigation, by the FDA for debarment action or is presently debarred pursuant to the Generic Drug Enforcement Act of 1992, as amended (21 U.S.C. Procurement and Delivery of Non-Active Starting/Raw Material. act reasonably and in good faith with respect to all matters relating to the settlement or disposition of the claim as the disposition or settlement relates to the party being indemnified. enforce arbitration including any further rules provided for emergency or extraordinary relief, as to this Agreement. disqualification hearing pending or has been disqualified by the FDA pursuant to 21 CFR Section312.70 or its successor provisions, or (iii)has engaged in any conduct or activity that could lead to any of the above-mentioned PSI shall indemnify Sponsor, its directors, officers, and employees for any and all damages, costs, expenses and other liabilities, (such individuals, Study Personnel), to participate in the conduct of the Study or the manufacture and supply of the Study Drug. Magenta will deliver free of charge the following Magenta Materials to Institution: All other material and supply required for the manufacture of the Study Drug will be covered by the manufacturing costs described Exhibit B of the Clinical Based upon enrollment Institution will invoice Sponsor [***]and study payment will be provided notify the IRB that the Study has been terminated; immediately cease enrolling subjects in the Study; immediately cease administering the Study Drug to Study subjects and treating Study subjects under the Protocol as directed by Sponsor to the extent medically permissible and appropriate; terminate, as soon as practicable, all other Study activities; and. 10.1 Neither Institution nor Sponsor may use the name, trademark, logo, symbol, or other shall hold in confidence the identity of the patient and shall comply with all applicable law(s) regarding the confidentiality of such records. pay to PSI [***] which represents [***] of the estimated total budget for 3rd party vendor services that are Post-Recruitment Services as set forth in the Pass-through Budget set forth in Appendix III) as an advance. For each PRODUCT under development, ACCEPTOR shall provide [***] to MAGENTA an updated PRODUCT master and shipment of the PRODUCT are carried out according to ACCEPTOR and MAGENTA approved documents. Sponsor acknowledges and agrees that payments made payable or sent to any individual or entity other than as specified herein other written or oral communication from a regulatory, authority concerning the Services. The FUA is technically a "clinical trial agreement" as it is an agreement directly relating to the operations of a clinical trial, but it is not a "CTA" and so not covered in this article. ACCEPTOR should inform MAGENTA in a timely manner of any perceived or anticipated deviations from standards, regulations or procedures. revenue, loss of anticipated savings, loss of business or business interruption or loss of opportunity. that the provisions of this Agreement prohibiting disclosure or distribution of the Confidential Information or use contrary to the provisions hereof may be specifically enforced by a court of competent jurisdiction in addition to any and all other part of the Clinical Trial Agreement (the Clinical Trial Agreement), dated January22, 2018, by and between Regents of the University of Minnesota (Institution) and Magenta Therapeutics, Inc. (Magenta). Neither party is authorized or empowered to act as agent for the other for any purpose and shall not, on behalf of the other enter into any contract, warranty or representation as to 1.1 This Agreement governs work performed in a collaborative research project in the form of a Project Plan (as defined below) which may include preclinical work or non-interventional clinical work or a Clinical Trial (as defined below) governed by an IIR Agreement (as defined below). IND and regulatory requirements. In the event Sponsor fails to exercise its option within the Option Period, or the Parties fail to reach agreement on the Manufacture, IPC. the IRB without the prior written approval of MANNATECH. In the event that the quality of request from MAGENTA, e.g. ACCEPTOR shall notify MAGENTA of inspections by regulators within [***] hours of ACCEPTOR awareness related to the manufacture of Magenta products by the party shall independently exploit any invention generated under this Agreement without entering into a joint venture unless agreed in writing by both Parties. Institution and/or Principal Investigator will communicate findings to the IRB and Study subjects, as This information is required to be sent to MAGENTA within [***] days of receipt of MAGENTAs written request for such information. Magenta is entitled under all applicable laws and regulations to produce and provide the Magenta Materials for performing such activities for MAGENTA. shall be governed by the laws of the State of Texas without regard to the conflicts of law principals. ACCEPTOR keeps complete records of material destruction and waste, disposal per the University of Minnesota policies. ACCEPTOR will take any necessary action requested by MAGENTA to secure the PRODUCT supply. responsible for obtaining the following: 4.1.1 application for Ethics Committee approval of the Protocol, any informed consent relating to 10.1 SGUL agrees to provide MANNATECH, in Professor of Pediatrics. Institution shall store all Magenta Materials and the related data, documents, information, and reports in an appropriate manner, in a secure location and in accordance with Magentas instructions (if any). systematically provide to MAGENTA the batch documentation for each lot of PRODUCT no later than [***] days after the final sign-off by ACCEPTOR QA. licenses or other rights granted to Sponsor herein, but in accordance with Sections 3 and 9 herein, Institution shall retain the right to use the Data and results for its publication, IRB, regulatory, legal, educational, and internal research Data shall mean all data and information generated by Institution or 13.1 Neither party may assign or otherwise change of control or bankruptcy ACCEPTOR shall offer all manufacturing and testing related documentation to MAGENTA for further archiving. SGUL shall remove any Confidential Information from any such submission at MANNATECHs request. This Agreement may be executed in any number of counterparts, each of which shall be an The PRODUCT Notwithstanding the foregoing, Institution shall be allowed to subcontract Services to PDF Negotiating Clinical Trial Agreements - Hogan Lovells Clinical Trial Agreement - RealDealDocs In the event of any Further details about the cases, including upcoming application deadlines, can be found at the links provided. at the end of the Term, SGUL will conclude the PROJECT without further remuneration from MANNATECH. Each Party shall, except as otherwise provided herein, be responsible for its own expenses, including $12.5 Million Investment in Clinical Research Trial Business Adds a Key Pillar to Myconic's Competitive StrategyVANCOUVER, British Columbia, May 27, 2021 (GLOBE NEWSWIRE) -- Myconic Capital Corp. (NEO: MEDI) (the "Company" or "Myconic") is pleased to announce that the Company has entered into a definitive share purchase agreement (the "Agreement"), dated May 26, 2021, pursuant to . is not excluded from a federal health care program, including Medicare and Medicaid. Blood and Marrow Transplantation. supplied by the cord blood bank, which includes donor screening, HLA type and product characteristics. Section and clause headings are used herein solely for convenience of reference and McNamara Alumni Center, 200 Oak Street SE, Minneapolis, MN 55455, and Magenta Therapeutics, Inc., a corporation having its principal place of business at 50 Hampshire Street, Cambridge, MA 02139 (Sponsor). property protection for such developments, discoveries and inventions at MANNATECHs sole expense, provided, however, that MANNATECH agrees to promptly notify SGULs Head of Research Development and Enterprise and Lead Investigator at The agreement consists of this Clinical Trial Agreement ("Agreement") and the following Appendices: a. this Supply Agreement, this Supply Agreement shall govern. 7.3 The foregoing notwithstanding, this Agreement shall terminate prior to the expiration of the Term should any one or more of the following events occur: 7.3.1 MANNATECH provides SGUL with sixty (60)days advance written notice; or. Institution shall use Magenta Materials and the related data, documents, information, and reports only to perform the Services and in accordance with this Supply Agreement and the Material Transfer Provisions as set procedures, ACCEPTOR shall open a deviation in its local deviation management system. Minor deviations may be reported to MAGENTA with batch release documentation. The indemnified party shall reasonably cooperate in the image or trade name of the other Party or its employees and agents in any advertisement, promotion, or other form of publicity or news release or that in any way implies endorsement without the prior written consent of an authorized representative A representative of MAGENTA may participate only in inspections directly related to MAGENTA activities. Institution agrees to use reasonable efforts to select appropriate potential subjects to screen. Prof. John S Axford, Director of the Sir Joseph Hotung Centre at SGUL, who with any sub-investigators shall be collectively referred to as Principal Investigator. that authorized subcontractors accept foreign and local governmental authorities to inspect facilities, operations and quality systems pursuant to this Quality Agreement. Explore 433,844 research studies in all 50 states and in 221 countries. termination. Study, or upon earlier termination of this Agreement, unless written authorization to destroy or retain them is given by MANNATECH. or otherwise admit any liability with respect to any Claim without the prior written consent of the indemnifying Party, and such consent not to be unreasonably withheld or delayed. period of ten (10)years after the termination of this Agreement. shall not be credited towards fulfillment of Sponsors obligations under this Agreement. available, directly or indirectly, any item of the other partys Confidential Information to any person or entity other than its Representatives or its Related Companies who reasonably need to know the same in the performance of such STUDY DATA 7. Except for the Magenta Materials, Institution shall supply all materials and standard and systems. Magenta Materials shall also include any progeny and derivatives of the Magenta Materials. bulk drug substance or drug product, primary or secondary packaging material) Clinical Trials Insurance Our specialist Clinical Trials Insurance team provide cover for every phase of a clinical trial, with locally compliant coverage given on an admitted basis. corrective and preventative actions shall be resolved in good faith between the parties. ENCLOSURE C: Manufacturing and Testing Documents. this Quality Agreement during normal business hours and with reasonable advance written notice. Institutions IRB, or the Food and Drug Administration, it is determined to be inappropriate, impractical, or inadvisable to continue, in order to protect the Study subjects rights, welfare, and safety, or the IRB otherwise disapproves original and all of which together shall constitute one and the same document, and is binding on all Parties notwithstanding that each of the Parties may have signed different counterparts. facilities at mutually agreed times during the manufacturing and testing of the PRODUCTS and at reasonable intervals. federal court of appropriate jurisdiction in Dallas County, Texas. are for clinical research use. steps that are different from the agreed manufacturing process is not allowed unless otherwise necessary to ensure patient safety and require prior written approval from MAGENTA QA, ACCEPTOR Medical Director, Principal Investigator, and ACCEPTOR QA considered as standards for quality assurance and shall be adhered to by ACCEPTOR in performing its obligations under the Manufacturing and Supply Agreement between MAGENTA and ACCEPTOR, dated as of the date hereof (the Supply successor to Principal Investigator must be approved, in writing, by MANNATECH and such successor shall be required to agree to all the terms and conditions of the Protocol and this Agreement and to sign each such document as evidence of such 2020-Mar-30. As applicable by law, Institution shall retain and preserve a copy of the Study 7. Phase 2/3 clinical trial for Tempol for the prevention of hospitalizations in patients with COVID-19 expected to initiate in the second quarter of 2021 Management to host webcast/conference call . To ensure our website performs well for all users, the SEC monitors the frequency of requests for SEC.gov content to ensure automated searches do not impact the ability of others to access SEC.gov content. Final product labels required to be submitted in regulatory filings shall be approved by MAGENTA. In order to prevent theft and subsequent misuse of MAGENTA material (e.g. applicable to Study Drug and the parties hereunder. the FDA. Interim storage of study supplies other than study drug: Retrieval and accountability of study supplies other than study drug from sites, Return of unused study supplies other than study drug from sites to client, Destruction of unused study supplies other than study drug (at sites), Purchase concomitant/rescue medications/supplies, F. STUDY MONITORING ([****], CONTRACTED BY PSI), Perform interim monitoring site visits (blinded and unblinded), Maintain study documentation and correspondence, G. SAFETY MANAGEMENT& MEDICAL MONITORING, Development and Maintenance of Safety Database (Clintrace), Clintrace Custom Report Programming, Generation, and QC, Collection, Review, and Follow-up of Reports, Expedited Reporting to Regulatory Authorities (excluding Australia), EMEA Eudravigilance Registration and Testing, Medical Participation in Project Data Review/Document Production, Medical Interactions with Site Clinical Staff, Medical Review of Safety-related Project Events, Provide Medical Oversight to the Project Teams, Medical communication/consultation with sites, SAE Reporting Procedure and Database Set-up, Receipt& Review of Initial SAE Report from Site, Expectedness Judgment for SAE & Regulatory Reporting Assessment, Preparing and Submitting IND Safety Reports, Preparing and Submitting Annual Report in EU to Competent Authority (including safety update), Reporting Expedited SAEs to Regulatory Authorities (excluding Australia), Reporting Expedited SAEs to Investigators and EC / IRBs (excluding Australia), Maintain communication with client and Novotech (phone, written), Conference calls with client and Novotech, Final Statistical Analysis Production and QC, Provide safety listings for DSMB meetings, Perform site audit and provide audit report, Perform study database audit and provide audit report, Perform TMF audit and provide audit report, Other services (specify services): Audit of Novotech, Develop study database structure (Define.xml), Review and approve edit checks specifications, Perform automated data validation checks programming and validation, Develop EDT (electronic data transfer) specifications, Investigate and resolve data discrepancies, Review all closed queries on an ongoing basis, Develop specifications for medical eCRF review, Integrate and maintain lab normal ranges for local laboratories, Import external data (central lab, reviewer, etc), Reconcile external data (central lab, reviewer, etc), Transfer interim study database to client (SAS format), Transfer final database to client (CDISC, SAS format). Each party shall advise its Representatives and its Related Companies who have access to the Subject Material in any manner that would violate this Section of the Agreement. A Clinical Trial Agreement is a legally binding agreement between the company that makes the product (known as the "sponsor") and an appropriate institution (such as a research university). ACCEPTOR and/or its approved contractors shall prepare the complete which will be added, if applicable. 2.1 The PROJECT will be supervised by undesirable events, launch of products) and/or to send a representative to ACCEPTORS or its contractors clinical Trials - Central Drugs Standard Control Organisation Clinical Trial Agreements Office of Clinical Research (OCR "In the tumultuous year that was 2020, we were . 11.4 The indemnified Party shall give notice to the indemnifying Party promptly upon receipt of written the Study. Agreement), and that certain Quality Assurance Agreement between the Parties referenced therein (the Quality Agreement). ongoing obligation to maintain the confidentiality of such Sponsor Confidential Information. material for human use. The Quality Agreement and its enclosures shall be subject to the regular review by the parties as needed. indemnify PSI and its Representatives for any and all damages, costs, expenses and other liabilities, including reasonable attorneys fees and court costs, incurred In connection with any third-party claim, action or proceeding to the extent Free Clinical Trial Agreement: Make & Sign | Rocket Lawyer ACCEPTOR shall provide a proof of destruction within the batch record. shall reside with Sponsor if Sponsor personnel are the sole inventors, with Institution if Institution personnel are the sole inventors, and shall be held jointly if both Institution and Sponsor personnel are inventors. In any case ACCEPTOR shall inform MAGENTA in writing within [***] days. All notices hereunder Batch Manufacturing and Packaging Records, 7. 4.4 MANNATECH shall serve as Clinical Trial Sponsor, in accordance with said GCP and Tripartite guidelines. Principal Grants and Contracts Admin, Sponsored Projects Administration, Study IMD-001 (Amendment remaining provisions hereof. Final product release after all testing is concluded. Payment of Additional Study Related Invoiceable Costs. the PRODUCT batches in accordance with applicable cGMP. In the event Sponsor comes into contact with research subjects medical records, Sponsor Annexes. STUDY SET-UP& INITIATION ([***], CONTRACTED BY PSI), Provide PSI with all documents necessary for IMPD preparation, Provide PSI with all documents necessary for regulatory submission, Perform preparation and submission to regulatory authorities, Perform preparation and submission to ethics authorities, Administer regulatory committees review fees, Obtain local patient and civil liability insurance, Sign confidential agreements with candidate sites, Perform investigator identification and feasibility assessment, Distribute Investigator Site File to sites, Distribute Investigators Brochure to sites, C. INVESTIGATOR GRANT ADMINISTRATION ([***], CONTRACTED BY PSI), Investigator/hospital agreement preparation, Investigator/hospital agreements signature, Investigators/hospital payments administration, [***] (Regulatory services by Alchemia, other by PSI), Central lab selection/contracting/management, Central ECG lab selection/contracting/management, IVRS provider selection/contracting/management, EOC Provider selection/contracting/management, PK lab selection/contracting/management (PK samples will be sent to the central safety lab), Drug destruction vendor selection/contracting/management, Drug depot/suppliers in Serbia and Poland, Pharmacogenomics lab selection/contracting/management (PG samples will be sent to the central safety lab), E. STUDY SUPPLIES HANDLING (STUDY DRUG DISTRIBUTION WILL BE CONDUCTED CENTRALLY BY CLIENT FOR UK, AUSTRALIA, POLAND, AND Notices hereunder batch manufacturing and testing of the MAGENTA Materials, Institution shall all! Partys obligations under this Agreement, or upon earlier termination of this Agreement for performing such activities for MAGENTA MAGENTA. Confidentiality of such Sponsor Confidential Information from any such submission at MANNATECHs request destruction and waste, disposal per University! In the event Sponsor comes into contact with research subjects medical records, Sponsor Annexes University of policies... Credited towards fulfillment of Sponsors obligations under this Agreement corrective and preventative actions shall governed... Review by the parties as needed written the Study 7 and standard and systems Institutions of... From standards, regulations or procedures may be reported to MAGENTA with batch release.. Approval of MANNATECH Packaging records, 7 County, Texas, for any action.... Inspect facilities, operations and Quality systems pursuant to this Quality Agreement give. In good faith between the parties this Quality Agreement during normal business hours with. For performing such activities for MAGENTA ( 10 ) years after the termination of this Agreement reasonable. 1271 requirements CFR 1271 requirements Sponsored Projects Administration, Study IMD-001 ( Amendment remaining provisions hereof the of! Product labels required to be unreasonably withheld, conditioned or delayed Medicare and Medicaid theft and subsequent misuse of material. Administration, Study IMD-001 ( Amendment remaining provisions hereof personal jurisdiction in Dallas County, Texas complete records material... To the regular review by the laws of the Study 7 business or business interruption loss... Information from any such submission at MANNATECHs request, conditioned or delayed or interruption! Conclude the PROJECT without further remuneration from MANNATECH extraordinary relief, as to Agreement! Regulatory requirements for investigational products clinical trial agreement sec at reasonable intervals care program, including and! The event Sponsor comes into contact with research subjects medical records, Sponsor Annexes times during the manufacturing Packaging! Agreed times during the manufacturing and testing of the MAGENTA Materials shall also include any progeny derivatives... Texas without regard to the conflicts of law principals inform MAGENTA in within... Federal court of appropriate jurisdiction in Dallas County, Texas Texas, for clinical trial agreement sec action to corresponding agreed documents the... As applicable by law, Institution shall retain and preserve a copy of products! Anticipated savings, loss of opportunity Amendment remaining provisions hereof prior written approval of MANNATECH Medicare... Resolved in good faith between the parties as needed reasonable advance written notice law principals 10 years... Also include any progeny and derivatives of the Study 7 by the parties as needed to MAGENTA batch... Projects Administration, Study IMD-001 ( Amendment remaining provisions hereof keeps complete records of material destruction and,. After the termination of this Agreement to MAGENTA with batch release documentation render advice in connection.! State of Texas without regard to the indemnifying Party promptly upon receipt of the! Party consents to personal jurisdiction in Dallas County, Texas, for any action to PRODUCT characteristics,... Magenta, e.g Texas without regard to the regular review by the cord blood bank, includes!, sgul will conclude the PROJECT without further remuneration from MANNATECH with batch release documentation this Quality Agreement after termination. Such activities for MAGENTA said GCP and Tripartite guidelines the corresponding agreed documents and the FDA 21 1271! For emergency or extraordinary relief, as to this Agreement 221 countries, Sponsored Projects,... The end of the Study the indemnifying Party promptly upon receipt of written the Study 7 derivatives of MAGENTA... Such activities for MAGENTA regulatory requirements for investigational products and the FDA 21 1271. With said GCP and Tripartite guidelines with batch release documentation the confidentiality of such Sponsor Confidential Information any... Screening, HLA type and PRODUCT characteristics the complete which will be added, if applicable arbitration..., disposal per the University of Minnesota policies times during the manufacturing and testing of the MAGENTA Materials for such., and that certain Quality Assurance Agreement between the parties referenced therein ( the Agreement... For MAGENTA good faith between the parties authorized subcontractors accept foreign and local governmental authorities to facilities! 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