Common use of Introduction and definitions Clause in Contracts

Introduction and definitions. The Xxxxxx Xxxxxxx Xxxxxxx National Institute of Child Health and Human Development (NICHD), the RECIPIENT Organization (RECIPIENT) and the Principal Investigator (PI) hereby enter into this Research Materials Distribution Agreement (RMDA) as of the effective date specified on the final signature page. The Research Materials and Research Plan covered by this RMDA are: Information will be inserted from other parts of the request process Name of Clinical Study: < NATIONAL CHILDREN’S STUDY> Title of Research Plan: <TITLE OF RESEARCH PLAN> Research Materials Requested: <MATERIALS REQUESTED – DATA AND/OR BIOLOGICAL AND/OR ENVIRONMENTAL SAMPLES> Research Plan includes a Commercial Purpose <Y/N> Name of Principal Investigator (PI): < > Email of Principal Investigator (PI): < > Name of Other Approved Users at PI’s Institution: < > The Research Materials are provided through the NCS Vanguard Data and Sample Archive and Access System. The Center was established by the NICHD to develop and maintain the infrastructure necessary Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 0000 Xxxxxxxxx Xxxxx, XXX 0000, Xxxxxxxx, XX 00000-0000, ATTN: PRA (xxxx-xxxx). Do not return the completed form to this address. Privacy Act Notification: Information collected as part of the data use agreement, data request forms, and distribution agreement may be made public in part or in whole for tracking and reporting purposes. This Privacy Act Notification is provided pursuant to Public Law 93-579, Privacy Act of 1974, 5 U.S.C. Section 552a. Authority for the collection of the information requested comes from the authorities regarding the establishment of the National Institutes of Health, its general authority to conduct and fund research and to provide training assistance, and its general authority to maintain records in connection with these and its other functions (42 U.S.C. 203, 241, 289l-1 and 44 U.S.C. 3101), and Section 301 and 493 of the Public Health Service Act. These records will be maintained in accordance with the Privacy Act System of Record Notice 09-25-0156 09-25-0200 (xxxxx://xxx.xx.xxx.xxx/forms/Privacy%20Documents/PAfiles/0200.htm) covering “Clinical, Basic and Population- based Research Studies of the National Institutes of Health (NIH), HHS/NIH/OD.” The primary uses of this information are to document, track, and monitor and evaluate the submission of data from clinical, basic, and population-based research activities and to notify Submitters in the event a potential error in the dataset is identified or in the event of updates or other changes to the database. The Federal Privacy Act protects the confidentiality of the Submitter’s NIH records. The NIH will use the information collected for the purposes described above. In addition, the Act allows the release of some information in the Submitter’s records without the Submitter’s permission; for example, if it is requested by members of Congress or other authorized individuals. The information requested is voluntary, but necessary for obtaining access to data and samples in the NCS Archive. to facilitate and maximize access to Research Materials from NICHD-sponsored studies in accordance with NICHD approved procedures. The Research Materials were collected as part of the above clinical study; hereafter referred to as “STUDY.” They constitute a unique scientific resource and the NICHD is committed to making them available in a timely manner, on appropriate terms and conditions, to the largest possible number of qualified investigators who wish to analyze the materials in a secondary study designed to enhance the public health benefit of the original work. The RECIPIENT and PI acknowledge responsibility for ensuring the review of and agreement to the terms within this RMDA and the appropriate research use of the Research Materials, subject to applicable laws and regulations. The RECIPIENT and PI acknowledge that other researchers are entitled to access to the Research Materials on the same terms as RECIPIENT so that duplication of research may occur. RECIPIENT and XX also recognize that the STUDY Investigators have made a substantial long-term contribution in establishing the Research Materials and the NICHD encourages appropriate collaborative relationships by outside investigators with the STUDY Investigators and proper acknowledgement of their contributions. The NICHD believes that the confidentiality and privacy of the STUDY participants can best be assured by requiring all who are interested in accessing the Research materials to acknowledge their review of this RMDA and agree to adhere to its provisions. Violation of its confidentiality provisions could lead to legal action on the part of STUDY participants, their families, or the U.S. Government. Note: RECIPIENT requests access to NICHD Research Materials for its PI at its sole risk. For the purpose of this agreement

Introduction and definitions. The Xxxxxx Xxxxxxx Xxxxxxx National Heart, Lung, and Blood Institute of Child Health and Human Development (NICHDNHLBI), the RECIPIENT Organization (RECIPIENT) and the Principal Investigator (PI) hereby enter into this Research Materials Distribution Agreement (RMDA) as of the effective date specified on the final signature page. The Research Materials and Research Plan covered by this RMDA are: Information will be inserted from other parts of the request process Name of Clinical Study: < NATIONAL CHILDREN’S NAME OF PARENT STUDY> Title of Research Plan: <TITLE OF RESEARCH PLAN> Research Materials Requested: <MATERIALS REQUESTED – DATA AND/OR BIOLOGICAL AND/OR ENVIRONMENTAL SAMPLESBIOSPECIMENS> Research Plan includes a Commercial Purpose <Y/N> Name of Principal Investigator (PI): < > Email of Principal Investigator (PI): < > Name of Other Approved Users at PI’s Institution: < > The Research Materials are provided through the NCS Vanguard Biologic Specimen and Data and Sample Archive and Access SystemRepository Information Coordinating Center. The Center was established by the NICHD NHLBI to develop and maintain the infrastructure necessary Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 0000 Xxxxxxxxx Xxxxx, XXX 0000, Xxxxxxxx, XX 00000-0000, ATTN: PRA (xxxx-xxxx). Do not return the completed form to this address. Privacy Act Notification: Information collected as part of the data use agreement, data request forms, and distribution agreement may be made public in part or in whole for tracking and reporting purposes. This Privacy Act Notification is provided pursuant to Public Law 93-579, Privacy Act of 1974, 5 U.S.C. Section 552a. Authority for the collection of the information requested comes from the authorities regarding the establishment of the National Institutes of Health, its general authority to conduct and fund research and to provide training assistance, and its general authority to maintain records in connection with these and its other functions (42 U.S.C. 203, 241, 289l-1 and 44 U.S.C. 3101), and Section 301 and 493 of the Public Health Service Act. These records will be maintained in accordance with the Privacy Act System of Record Notice 09-25-0156 09-25-0200 (xxxxx://xxx.xx.xxx.xxx/forms/Privacy%20Documents/PAfiles/0200.htm) covering “Clinical, Basic and Population- based Research Studies of the National Institutes of Health (NIH), HHS/NIH/OD.” The primary uses of this information are to document, track, and monitor and evaluate the submission of data from clinical, basic, and population-based research activities and to notify Submitters in the event a potential error in the dataset is identified or in the event of updates or other changes to the database. The Federal Privacy Act protects the confidentiality of the Submitter’s NIH records. The NIH will use the information collected for the purposes described above. In addition, the Act allows the release of some information in the Submitter’s records without the Submitter’s permission; for example, if it is requested by members of Congress or other authorized individuals. The information requested is voluntary, but necessary for obtaining access to data and samples in the NCS Archive. to facilitate and maximize access to Research Materials from NICHDNHLBI-sponsored studies in accordance with NICHD NHLBI approved procedures. The Research Materials were collected as part of the above clinical study; hereafter referred to as “STUDY.” They constitute a unique scientific resource and the NICHD NHLBI is committed to making them available in a timely manner, on appropriate terms and conditions, to the largest possible number of qualified investigators who wish to analyze the materials in a secondary study designed to enhance the public health benefit of the original work. The RECIPIENT and PI acknowledge responsibility for ensuring the review of and agreement to the terms within this RMDA and the appropriate research use of the Research Materials, subject to applicable laws and regulations. The RECIPIENT and PI acknowledge that other researchers are entitled to access to the Research Materials on the same terms as RECIPIENT so that duplication of research may occur. RECIPIENT and XX also recognize that the STUDY Investigators have made a substantial long-long- term contribution in establishing the Research Materials and the NICHD NHLBI encourages appropriate collaborative relationships by outside investigators with the STUDY Investigators and proper acknowledgement of their contributions. The NICHD NHLBI believes that the confidentiality and privacy of the STUDY participants can best be assured by requiring all who are interested in accessing the Research materials to acknowledge their review of this RMDA and agree to adhere to its provisions. Violation of its confidentiality provisions could lead to legal action on the part of STUDY participants, their families, or the U.S. Government. Note: RECIPIENT requests access to NICHD NHLBI Research Materials for its PI at its sole risk. For the purpose of this agreement

Introduction and definitions. The Xxxxxx Xxxxxxx Xxxxxxx National Institute of Child Health and Human Development (NICHD), the RECIPIENT Organization (RECIPIENT) and the Principal Investigator (PI) hereby enter into this Research Materials Distribution Agreement (RMDA) as of the effective date specified on the final signature page. The Research Materials and Research Plan covered by this RMDA are: Information will be inserted from other parts of the request process Name of Clinical Study: < NATIONAL CHILDREN’S STUDY> Title of Research Plan: <TITLE OF RESEARCH PLAN> Research Materials Requested: <MATERIALS REQUESTED – DATA AND/OR BIOLOGICAL AND/OR ENVIRONMENTAL SAMPLES> Research Plan includes a Commercial Purpose <Y/N> Name of Principal Investigator (PI): < > Email of Principal Investigator (PI): < > Name of Other Approved Users at PI’s Institution: < > The Research Materials are provided through the NCS Vanguard Data and Sample Archive and Access System. The Center was established by the NICHD to develop and maintain the infrastructure necessary Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 0000 Xxxxxxxxx Xxxxx, XXX 0000, Xxxxxxxx, XX 00000-0000, ATTN: PRA (xxxx0925-xxxx0730). Do not return the completed form to this address. Privacy Act Notification: Information collected as part of the data use agreement, data request forms, and distribution agreement may be made public in part or in whole for tracking and reporting purposes. This Privacy Act Notification is provided pursuant to Public Law 93-579, Privacy Act of 1974, 5 U.S.C. Section 552a. Authority for the collection of the information requested comes from the authorities regarding the establishment of the National Institutes of Health, its general authority to conduct and fund research and to provide training assistance, and its general authority to maintain records in connection with these and its other functions (42 U.S.C. 203, 241, 289l-1 and 44 U.S.C. 3101), and Section 301 and 493 of the Public Health Service Act. These records will be maintained in accordance with the Privacy Act System of Record Notice 09-25-0156 09-25-0200 (xxxxx://xxx.xx.xxx.xxx/forms/Privacy%20Documents/PAfiles/0200.htm) covering “Clinical, Basic and Population- based Research Studies of the National Institutes of Health (NIH), HHS/NIH/OD.” The primary uses of this information are to document, track, and monitor and evaluate the submission of data from clinical, basic, and population-based research activities and to notify Submitters in the event a potential error in the dataset is identified or in the event of updates or other changes to the database. The Federal Privacy Act protects the confidentiality of the Submitter’s NIH records. The NIH will use the information collected for the purposes described above. In addition, the Act allows the release of some information in the Submitter’s records without the Submitter’s permission; for example, if it is requested by members of Congress or other authorized individuals. The information requested is voluntary, but necessary for obtaining access to data and samples in the NCS Archive. to facilitate and maximize access to Research Materials from NICHD-sponsored studies in accordance with NICHD approved procedures. The Research Materials were collected as part of the above clinical study; hereafter referred to as “STUDY.” They constitute a unique scientific resource and the NICHD is committed to making them available in a timely manner, on appropriate terms and conditions, to the largest possible number of qualified investigators who wish to analyze the materials in a secondary study designed to enhance the public health benefit of the original work. The RECIPIENT and PI acknowledge responsibility for ensuring the review of and agreement to the terms within this RMDA and the appropriate research use of the Research Materials, subject to applicable laws and regulations. The RECIPIENT and PI acknowledge that other researchers are entitled to access to the Research Materials on the same terms as RECIPIENT so that duplication of research may occur. RECIPIENT and XX also recognize that the STUDY Investigators have made a substantial long-term contribution in establishing the Research Materials and the NICHD encourages appropriate collaborative relationships by outside investigators with the STUDY Investigators and proper acknowledgement of their contributions. The NICHD believes that the confidentiality and privacy of the STUDY participants can best be assured by requiring all who are interested in accessing the Research materials to acknowledge their review of this RMDA and agree to adhere to its provisions. Violation of its confidentiality provisions could lead to legal action on the part of STUDY participants, their families, or the U.S. Government. Note: RECIPIENT requests access to NICHD Research Materials for its PI at its sole risk. For the purpose of this agreement

Introduction and definitions. The Xxxxxx Xxxxxxx Xxxxxxx National Institute of Child Health and Human Development (NICHD), the RECIPIENT Organization (RECIPIENT) and the Principal Investigator (PI) hereby enter into this Research Materials Distribution Agreement (RMDA) as of the effective date specified on the final signature page. The Research Materials and Research Plan covered by this RMDA are: Information will be inserted from other parts of the request process Name of Clinical Study: < NATIONAL CHILDREN’S STUDY> Title of Research Plan: <TITLE OF RESEARCH PLAN> Research Materials Requested: <MATERIALS REQUESTED – DATA AND/OR BIOLOGICAL AND/OR ENVIRONMENTAL SAMPLES> Research Plan includes a Commercial Purpose <Y/N> Name of Principal Investigator (PI): < > Email of Principal Investigator (PI): < > Name of Other Approved Users at PI’s Institution: < > The Research Materials are provided through the NCS Vanguard Data and Sample Archive and Access System. The Center was established by the NICHD to develop and maintain the infrastructure necessary Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 0000 Xxxxxxxxx Xxxxx, XXX 00007974, Xxxxxxxx, XX 00000-0000, ATTN: PRA (xxxx0925-xxxx0730). Do not return the completed form to this address. Privacy Act Notification: Information collected as part of the data use agreement, data request forms, and distribution agreement may be made public in part or in whole for tracking and reporting purposes. This Privacy Act Notification is provided pursuant to Public Law 93-579, Privacy Act of 1974, 5 U.S.C. Section 552a. Authority for the collection of the information requested comes from the authorities regarding the establishment of the National Institutes of Health, its general authority to conduct and fund research and to provide training assistance, and its general authority to maintain records in connection with these and its other functions (42 U.S.C. 203, 241, 289l-1 and 44 U.S.C. 3101), and Section 301 and 493 of the Public Health Service Act. These records will be maintained in accordance with the Privacy Act System of Record Notice 09-25-0156 09-25-0200 (xxxxx://xxx.xx.xxx.xxx/forms/Privacy%20Documents/PAfiles/0200.htm) covering “Clinical, Basic and Population- based Research Studies of the National Institutes of Health (NIH), HHS/NIH/OD.” The primary uses of this information are to document, track, and monitor and evaluate the submission of data from clinical, basic, and population-based research activities and to notify Submitters in the event a potential error in the dataset is identified or in the event of updates or other changes to the database. The Federal Privacy Act protects the confidentiality of the Submitter’s NIH records. The NIH will use the information collected for the purposes described above. In addition, the Act allows the release of some information in the Submitter’s records without the Submitter’s permission; for example, if it is requested by members of Congress or other authorized individuals. The information requested is voluntary, but necessary for obtaining access to data and samples in the NCS Archive. to facilitate and maximize access to Research Materials from NICHD-sponsored studies in accordance with NICHD approved procedures. The Research Materials were collected as part of the above clinical study; hereafter referred to as “STUDY.” They constitute a unique scientific resource and the NICHD is committed to making them available in a timely manner, on appropriate terms and conditions, to the largest possible number of qualified investigators who wish to analyze the materials in a secondary study designed to enhance the public health benefit of the original work. The RECIPIENT and PI acknowledge responsibility for ensuring the review of and agreement to the terms within this RMDA and the appropriate research use of the Research Materials, subject to applicable laws and regulations. The RECIPIENT and PI acknowledge that other researchers are entitled to access to the Research Materials on the same terms as RECIPIENT so that duplication of research may occur. RECIPIENT and XX PI also recognize that the STUDY Investigators have made a substantial long-term contribution in establishing the Research Materials and the NICHD encourages appropriate collaborative relationships by outside investigators with the STUDY Investigators and proper acknowledgement of their contributions. The NICHD believes that the confidentiality and privacy of the STUDY participants can best be assured by requiring all who are interested in accessing the Research materials to acknowledge their review of this RMDA and agree to adhere to its provisions. Violation of its confidentiality provisions could lead to legal action on the part of STUDY participants, their families, or the U.S. Government. Note: RECIPIENT requests access to NICHD Research Materials for its PI at its sole risk. For the purpose of this agreement