Common use of Project Specifications Clause in Contracts

Project Specifications. A. Start-Up Date and Term: • Project implementation (i.e., transfer of necessary currently available information resources) will start on or before October 1. • ATP suggests that the first month of the Project be dedicated to: • Deployment of resources (see Attachment A) • Specification of timeframes (see Attachment B) • Development of working processes • Review and agreement on topics for medical Letters (see Attachment C) • Provision of necessary RELIANT documents to ATP • The Project may operate through December 31, 2001, although it is anticipated that the medical letters initially specified for creation will be completed well in advance of this date. • Attached to this proposal is a Letter of Intent. Execution of the Letter of Intent is necessary for ATP to proceed with Project implementation. • Once the Letter of Intent is received by ATP and the scope of services is clearly defined, ATP will prepare an Addendum to the RELIANT MISS Service Agreement. B. Hours of Operation and Holidays: • Specification of the hours of operation and holidays is not required for the Medical Letter Writing Project. However, should RELIANT request accelerated turnaround of medical letters due to unforeseen events, then, as mutually agreed upon, ATP will invoice RELIANT at time and one-half hourly rates, or double-time where holidays apply. C. Staffing and Project • ATP Clinical Communications will use a cost-effective project management approach involving Medical Writers and Senior Medical Writers to draft the medical letters. An Editorial and Literature Search Coordinator may assist in conducting literature searches, editing documents, and ensuring the quality of all written material. Attachment A provides hourly rates for each type of staff. • The Director of Clinical Communications and/or the Executive Director of Medical Affairs at ATP will perform final document review. • Drafts will then be forwarded to individuals at RELIANT (to be designated) for review of clinical, regulatory, legal, and other issues. • RELIANT will notify ATP of any necessary changes to the draft medical letter; ATP will make required changes, as requested, and return the revised medical letter to RELIANT for review and final approval (processes and individuals to be determined) prior to its use by the MISS. • Although all medical letter writing will be conducted primarily by the Clinical Communications Medical Writing team, ATP will make every effort to utilize staff from the MISS, as appropriate and where possible, to create efficiencies and minimize costs. D. Technology

Project Specifications. A. Start-Up Date MEDPACE hereby agrees to perform Services for SPONSOR from time to time. The precise Services to be performed by MEDPACE shall be mutually agreed upon by the Parties and Term: • Project implementation set forth in one or more task orders (i.e.each a “Task Order”), transfer a form of necessary currently available which is attached hereto as Exhibit A; provided that MEDPACE may not unreasonably delay or withhold its approval of any Task Order. Each Task Order shall be signed by an authorized representative of each Party and attached hereto as an exhibit. Each Task Order shall include detailed information resources) will start on or before October 1. • ATP suggests that the first month concerning a given project, including a description of the specific services to be provided (“Scope of Work”), project milestones and target completion dates (“Project Schedule”), a detailed budget (“Project Budget”), and a schedule of payments related to the Project Schedule and the Project Budget (“Payment Schedule”). Each Task Order shall contain a Transfer of Obligations list (“Transfer of Obligations”) in conjunction with the relevant Task Order and consistent with the regulations set forth in 21 C.F.R. Section 312, Subpart D (Responsibilities of Sponsors and Investigators). Any responsibilities not specifically transferred in the Transfer of Obligations shall remain the regulatory responsibility of SPONSOR. B. MEDPACE shall conduct the Services in compliance with the terms and conditions of this Agreement and the relevant Task Order, MEDPACE SOPs and Policies, and applicable law. C. From time to time, SPONSOR may wish to enter into a Task Order with a MEDPACE Affiliate for Services under this Agreement (“Affiliate Task Order”), and such MEDPACE Affiliate may wish enter into the Affiliate Task Order with SPONSOR. Any such Affiliate Task Order must be dedicated to: • Deployment in writing and signed by the parties to the Affiliate Task Order, and each signatory to an Affiliate Task Order is solely responsible for all obligations it undertakes under the Affiliate Task Order. For the purposes of resources (see Attachment A) • Specification of timeframes (see Attachment B) • Development of working processes • Review and agreement on topics for medical Letters (see Attachment C) • Provision of necessary RELIANT documents to ATP • The Project may operate through December 31a particular Affiliate Task Order, 2001, although it is anticipated that the medical letters initially specified for creation Affiliate signing such Affiliate Task Order will be completed well deemed substituted for MEDPACE everywhere “MEDPACE” appears in advance of this date. • Attached to this proposal is a Letter of Intent. Execution of the Letter of Intent is necessary for ATP to proceed with Project implementation. • Once the Letter of Intent is received by ATP Agreement, and the scope of services is clearly defined, ATP term “Affiliate Task Order” will prepare an Addendum to the RELIANT MISS Service be deemed substituted for Task Order everywhere “Task Order” appears in this Agreement. B. Hours of Operation and Holidays: • Specification of the hours of operation and holidays is not required for the Medical Letter Writing Project. HoweverD. As used herein, should RELIANT request accelerated turnaround of medical letters due “Affiliate” means in relation to unforeseen eventsa Party, thenany entity, as mutually agreed upondirectly or indirectly, ATP will invoice RELIANT at time and one-half hourly ratescontrolling such Party, controlled by such Party, or double-time where holidays applyunder common control with such Party. C. Staffing and Project • ATP Clinical Communications will use a cost-effective project management approach involving Medical Writers and Senior Medical Writers to draft the medical letters. An Editorial and Literature Search Coordinator may assist in conducting literature searches, editing documents, and ensuring the quality of all written material. Attachment A provides hourly rates for each type of staff. • The Director of Clinical Communications and/or the Executive Director of Medical Affairs at ATP will perform final document review. • Drafts will then be forwarded to individuals at RELIANT (to be designated) for review of clinical, regulatory, legal, and other issues. • RELIANT will notify ATP of any necessary changes to the draft medical letter; ATP will make required changes, as requested, and return the revised medical letter to RELIANT for review and final approval (processes and individuals to be determined) prior to its use by the MISS. • Although all medical letter writing will be conducted primarily by the Clinical Communications Medical Writing team, ATP will make every effort to utilize staff from the MISS, as appropriate and where possible, to create efficiencies and minimize costs. D. Technology

Project Specifications. A. Start-Up Date MEDPACE hereby agrees to perform Services for SPONSOR from time to time. The precise Services to be performed by MEDPACE shall be mutually agreed upon by the Parties and Term: • Project implementation set forth in one or more task orders (i.e.each a “Task Order”), transfer a form of necessary currently available which is attached hereto as Exhibit A. Each Task Order shall be signed by an authorized representative of each Party and shall include detailed information resources) will start on or before October 1. • ATP suggests that the first month concerning a given project, including a description of the specific services to be provided (“Scope of Work”), project milestones and target completion dates (“Project be dedicated to: • Deployment Schedule”), the applicable protocol, a detailed budget (“Project Budget”), and a schedule of resources payments related to the Project Schedule and the Project Budget (see Attachment A“Payment Schedule”). Each Task Order shall contain a Transfer of Obligations list (“Transfer of Obligations”) • Specification in conjunction with the relevant Task Order and consistent with the regulations set forth in 21 C.F.R. Section 312, Subpart D (Responsibilities of timeframes (see Attachment B) • Development Sponsors and Investigators). Any responsibilities not specifically transferred in the Transfer of working processes • Review and agreement on topics for medical Letters (see Attachment C) • Provision Obligations shall remain the regulatory responsibility of necessary RELIANT documents to ATP • The Project may operate through December 31SPONSOR. B. Unless otherwise stated in the applicable Task Order, 2001, although it is anticipated that the medical letters initially specified for creation Services will be completed well conducted in advance compliance with MEDPACE SOPs and Policies, copies of this date. • Attached which have been or will be provided to this proposal is a Letter of Intent. Execution SPONSOR during the negotiation of the Letter relevant Task Order. C. From time to time, SPONSOR may wish to enter into a Task Order with a MEDPACE Affiliate for Services under this Agreement (“Affiliate Task Order”), and such MEDPACE Affiliate may wish enter into the Affiliate Task Order with SPONSOR. Any such Affiliate Task Order must be in writing and signed by the parties to the Affiliate Task Order, and each signatory to an Affiliate Task Order is solely responsible for all obligations it undertakes under the Affiliate Task Order. For the purposes of Intent is necessary a particular Affiliate Task Order, the Affiliate signing such Affiliate Task Order will be substituted for ATP to proceed with Project implementation. • Once the Letter of Intent is received by ATP MEDPACE everywhere it appears in this Agreement, and the scope of services is clearly defined, ATP term “Affiliate Task Order” will prepare an Addendum to the RELIANT MISS Service be substituted for Task Order everywhere it appears in this Agreement. B. Hours D. As used herein, “Affiliate” means in relation to a Party, any entity, directly or indirectly, controlling such Party, controlled by such Party, or under common control with such Party. For purposes of Operation and Holidays: • Specification this definition, “control” shall mean the possession, directly or indirectly, of the hours power to direct or cause the direction of operation and holidays is not required for the Medical Letter Writing Projectactivities, management or policies of such party, whether through the ownership of voting securities, by contract or otherwise. HoweverWithout limiting the foregoing, should RELIANT request accelerated turnaround control shall be presumed to exist when a person, organization or entity (i) owns or directly controls fifty percent (50%) or more of medical letters due to unforeseen events, then, as mutually agreed upon, ATP will invoice RELIANT at time and one-half hourly ratesthe outstanding voting stock or other ownership interest of the other organization or entity, or double-time where holidays apply(ii) possesses, directly or indirectly, the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the organization or other entity. C. Staffing and Project • ATP Clinical Communications will use a cost-effective project management approach involving Medical Writers and Senior Medical Writers to draft the medical letters. An Editorial and Literature Search Coordinator may assist in conducting literature searches, editing documents, and ensuring the quality of all written material. Attachment A provides hourly rates for each type of staff. • The Director of Clinical Communications and/or the Executive Director of Medical Affairs at ATP will perform final document review. • Drafts will then be forwarded to individuals at RELIANT (to be designated) for review of clinical, regulatory, legal, and other issues. • RELIANT will notify ATP of any necessary changes to the draft medical letter; ATP will make required changes, as requested, and return the revised medical letter to RELIANT for review and final approval (processes and individuals to be determined) prior to its use by the MISS. • Although all medical letter writing will be conducted primarily by the Clinical Communications Medical Writing team, ATP will make every effort to utilize staff from the MISS, as appropriate and where possible, to create efficiencies and minimize costs. D. Technology

Project Specifications. 1.1 MEDPACE hereby agrees to perform Services for SPONSOR from time to time. The precise Services to be performed by MEDPACE shall be mutually agreed upon by the Parties and set forth in one or more task orders (each a “Task Order”), a sample form of which is attached hereto as Exhibit A. Start-Up Date and Term: • Project implementation (i.e.Each Task Order shall be signed by an authorized representative of each Party, transfer of necessary currently available although neither Party is obligated to execute any Task Order. Each Task Order shall include detailed information resources) will start on or before October 1. • ATP suggests that the first month concerning a given project, including a description of the specific Services to be provided (“Scope of Work”), project milestones and target completion dates (“Project be dedicated to: • Deployment Schedule”), a detailed budget (“Project Budget”), and a schedule of resources (see Attachment A) • Specification of timeframes (see Attachment B) • Development of working processes • Review and agreement on topics for medical Letters (see Attachment C) • Provision of necessary RELIANT documents payments related to ATP • The the Project may operate through December 31, 2001, although it is anticipated that the medical letters initially specified for creation will be completed well in advance of this date. • Attached to this proposal is a Letter of Intent. Execution of the Letter of Intent is necessary for ATP to proceed with Project implementation. • Once the Letter of Intent is received by ATP Schedule and the scope Project Budget (“Payment Schedule”). A given Task Order may specifically identify the Key Employees (as defined below) assigned by MEDPACE to perform the specific Services under the Task Order. Each Task Order shall also contain a Transfer of services is clearly definedObligations list (“Transfer of Obligations”) in conjunction with the relevant Task Order and CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934. consistent with the regulations set forth in 21 C.F.R. Section 312, ATP will prepare an Addendum to Subpart D (Responsibilities of Sponsors and Investigators). Any responsibilities not specifically transferred in the RELIANT MISS Service AgreementTransfer of Obligations shall remain the regulatory responsibility of SPONSOR. B. Hours of Operation 1.2 MEDPACE and Holidays: • Specification of the hours of operation and holidays is not required for the Medical Letter Writing Project. However, should RELIANT request accelerated turnaround of medical letters due to unforeseen events, then, as mutually agreed upon, ATP will invoice RELIANT at time and one-half hourly rates, or double-time where holidays apply. C. Staffing and Project • ATP Clinical Communications will use a cost-effective project management approach involving Medical Writers and Senior Medical Writers to draft the medical letters. An Editorial and Literature Search Coordinator SPONSOR may assist in conducting literature searches, editing documents, and ensuring the quality of all written material. Attachment A provides hourly rates for each type of staff. • The Director of Clinical Communications and/or the Executive Director of Medical Affairs at ATP agree on certain key employees who will perform final document reviewServices under a Task Order (“Key Employees”), a list of whom shall be included in such Task Order. • Drafts will then be forwarded The Parties may from time to individuals at RELIANT (to be designated) for review time amend the list of clinical, regulatory, legal, and other issuesKey Employees under a Task Order by written agreement signed by authorized representatives of each Party. • RELIANT will notify ATP of any necessary changes to the draft medical letter; ATP will make required changes, as requested, and return the revised medical letter to RELIANT for review and final approval (processes and individuals to be determined) prior to its use by the MISS. • Although all medical letter writing will be conducted primarily by the Clinical Communications Medical Writing team, ATP will make every effort to utilize staff from the MISS, as appropriate and where possible, to create efficiencies and minimize costs[***]. D. Technology

Project Specifications. A. Start-Up Date MEDPACE hereby agrees to perform Services for SPONSOR from time to time. The precise Services to be performed by MEDPACE shall be mutually agreed upon by the Parties and Term: • Project implementation set forth in one or more task orders (i.e.each a “Task Order”), transfer a form of necessary currently available which is attached hereto as Exhibit A. Each Task Order shall be signed by an authorized representative of each Party and shall include detailed information resources) will start on or before October 1. • ATP suggests that the first month concerning a given project, including a description of the specific services to be provided (“Scope of Work”), project milestones and target completion dates (“Project be dedicated to: • Deployment Schedule”), a detailed budget (“Project Budget”), and a schedule of resources payments related to the Project Schedule and the Project Budget (see Attachment A“Payment Schedule”). Each Task Order shall contain a Transfer of Obligations list (“Transfer of Obligations”) • Specification in conjunction with the relevant Task Order and consistent with the regulations set forth in 21 C.F.R. Section 312, Subpart D (Responsibilities of timeframes (see Attachment B) • Development Sponsors and Investigators). Any responsibilities not specifically transferred in the Transfer of working processes • Review and agreement on topics for medical Letters (see Attachment C) • Provision Obligations shall remain the regulatory responsibility of necessary RELIANT documents to ATP • The Project may operate through December 31SPONSOR. B. Unless otherwise stated in the applicable Task Order, 2001, although it is anticipated that the medical letters initially specified for creation Services will be completed well conducted in advance compliance with MEDPACE SOPs and Policies. C. From time to time, SPONSOR may wish to enter into a Task Order with a MEDPACE Affiliate for Services under this Agreement (“Affiliate Task Order”), and such MEDPACE Affiliate may wish enter into the Affiliate Task Order with SPONSOR. Any such Affiliate Task Order must be in writing and signed by the parties to the Affiliate Task Order, and each signatory to an Affiliate Task Order is solely responsible for all obligations it undertakes under the Affiliate Task Order. For the purposes of a particular Affiliate Task Order, the Affiliate signing such Affiliate Task Order will be substituted for MEDPACE everywhere it appears in this date. • Attached to this proposal is a Letter of Intent. Execution of the Letter of Intent is necessary for ATP to proceed with Project implementation. • Once the Letter of Intent is received by ATP Agreement, and the scope of services is clearly defined, ATP term “Affiliate Task Order” will prepare an Addendum to the RELIANT MISS Service be substituted for Task Order everywhere it appears in this Agreement. B. Hours of Operation and Holidays: • Specification D. As used herein, “Affiliate” means in relation to a Party, any entity, directly or indirectly, controlling such Party, controlled by such Party, or under common control with such Party. E. As part of the hours of operation Services and holidays is not required as an accommodation to SPONSOR, MEDPACE may contract with third parties for the Medical Letter Writing Projectprovision of services not customarily performed or provided by MEDPACE (“Pre-funded Vendors”). HoweverWhile MEDPACE may contract with and/or facilitate the activities of such Pre-funded Vendors, should RELIANT request accelerated turnaround MEDPACE does not undertake by virtue of medical letters due to unforeseen eventsthis Agreement, thenthe relevant Task Order or such third party contract, as mutually agreed uponresponsibility for the Pre-funded Vendor’s business, ATP will invoice RELIANT at time and one-half hourly ratesprofessional conduct, performance, or doublebreaches by such Pre-time where holidays apply. C. Staffing funded Vendors. MEDPACE’s responsibility with respect to such Pre-funded Vendors shall be to coordinate the services of such Pre-funded Vendors and Project • ATP Clinical Communications will use to make payments after receipt of sufficient funds from SPONSOR (“Pre-funded Expenses”). If sufficient funds are not received from SPONSOR, payments to Pre-funded Vendors may be delayed. Pre - funded Expenses may include but are not limited to third party advance payments for investigator meetings, vendors, Study Site payments (“Study Site” shall mean the physical location at which a cost-effective project management approach involving Medical Writers and Senior Medical Writers to draft the medical letters. An Editorial and Literature Search Coordinator may assist in conducting literature searches, editing documentsparticular investigator conducts a study), and ensuring the quality of all written material. Attachment A provides hourly rates for each type of staff. • The Director of Clinical Communications and/or the Executive Director of Medical Affairs at ATP will perform final document review. • Drafts will then be forwarded any payments to individuals at RELIANT (to be designated) for review of clinicalinvestigators, regulatory, legalinstitutions, and other issuessite maintenance organizations for services performed that relate to a study. • RELIANT will notify ATP of any necessary changes In the event a Pre-funded Vendor requests indemnification with respect to the draft medical letter; ATP will make required changesservices performed under such Pre-funded Vendor’s contract, as requestedMEDPACE shall notify SPONSOR and SPONSOR shall, at its discretion, enter into an indemnification agreement directly with such Pre-funded Vendors. MEDPACE shall have no obligation with respect to the indemnity of a Pre-funded Vendors. The Parties acknowledge and return agree that any Pre-funded Vendors (including but not limited to investigators, institutions or site management organizations) paid with Pre-funded Expenses in connection with the revised medical letter to RELIANT for review and final approval (processes and individuals to performance of Services under this Agreement or any Task Order shall not be determined) prior to its use by considered the MISS. • Although all medical letter writing will be conducted primarily by the Clinical Communications Medical Writing teamagent, ATP will make every effort to utilize staff from the MISS, as appropriate and where possible, to create efficiencies and minimize costsemployee or subcontractor of MEDPACE. D. Technology

Project Specifications. A. Start-Up Date and Term: • Project implementation (i.e., transfer of necessary currently available information resources) will start on or before October 1. • ATP suggests that Medpace hereby agrees to perform Services for Sponsor from time to time in accordance with the first month of the Project be dedicated to: • Deployment of resources (see Attachment A) • Specification of timeframes (see Attachment B) • Development of working processes • Review and agreement on topics for medical Letters (see Attachment C) • Provision of necessary RELIANT documents to ATP • The Project may operate through December 31, 2001, although it is anticipated that the medical letters initially specified for creation will be completed well in advance terms of this dateAgreement. • Attached For the sake of clarity, the Services contemplated under this Agreement shall be provided on a non-exclusive basis and Sponsor reserves the right to this proposal is undertake all work on its own behalf or to obtain similar services from a Letter third party. Sponsor shall not be obligated to purchase any minimum or specific volume or dollar amount of Intent. Execution of the Letter of Intent is necessary for ATP to proceed with Project implementation. • Once the Letter of Intent is received by ATP and the scope of services is clearly defined, ATP will prepare an Addendum to the RELIANT MISS Service AgreementServices hereunder. B. Hours The precise Services to be performed by Medpace shall be mutually agreed upon by the Parties in writing and set forth in one or more task orders (each a “Task Order”), a form of Operation which is attached hereto as Exhibit A. Each Task Order shall be signed by an authorized representative of each Party and Holidays: • Specification shall include detailed information concerning a given project, including a description of the hours specific Services to be provided (“Scope of operation Work”), project milestones and holidays is not required for target completion dates (“Project Schedule”), a detailed budget (“Project Budget”), and a schedule of payments related to the Medical Letter Writing ProjectProject Schedule and the Project Budget (“Payment Schedule”). However, should RELIANT request accelerated turnaround of medical letters due to unforeseen events, thenThe Parties acknowledge and agree that Medpace may provide Services directly or through an Affiliate, as mutually agreed upondefined below. Each Task Order shall contain a Transfer of Obligations list (“Transfer of Obligations”) in conjunction with the relevant Task Order and consistent with the regulations set forth in 21 C.F.R. Section 312, ATP will invoice RELIANT at time Subpart D (Responsibilities of Sponsors and one-half hourly rates, or double-time where holidays applyInvestigators). Any responsibilities not specifically transferred to Medpace in the Transfer of Obligations shall remain the regulatory responsibility of Sponsor. Each Party shall provide such reasonable cooperation as the other may request in connection with the other Party’s compliance with the applicable provisions of Part 312. C. Staffing and Project • ATP Clinical Communications will use a cost-effective project management approach involving Medical Writers and Senior Medical Writers to draft Unless otherwise stated in the medical letters. An Editorial and Literature Search Coordinator may assist in conducting literature searchesapplicable Task Order, editing documents, and ensuring the quality of all written material. Attachment A provides hourly rates for each type of staff. • The Director of Clinical Communications and/or the Executive Director of Medical Affairs at ATP will perform final document review. • Drafts will then be forwarded to individuals at RELIANT (to be designated) for review of clinical, regulatory, legal, and other issues. • RELIANT will notify ATP of any necessary changes to the draft medical letter; ATP will make required changes, as requested, and return the revised medical letter to RELIANT for review and final approval (processes and individuals to be determined) prior to its use by the MISS. • Although all medical letter writing Services will be conducted primarily by the Clinical Communications Medical Writing team, ATP will make every effort to utilize staff from the MISS, as appropriate in compliance with Medpace Standard Operating Procedures (“SOPs”) and where possible, to create efficiencies and minimize costsPolicies. D. TechnologyFrom time to time, Sponsor may wish to enter into a Task Order with a Medpace Affiliate for Services under this Agreement (“Affiliate Task Order”), and such Medpace Affiliate may wish enter into the Affiliate Task Order with Sponsor. Any such Affiliate Task Order must be in writing and signed by the parties to the Affiliate Task Order, and each signatory to an Affiliate Task Order is solely responsible for all obligations it undertakes under the Affiliate Task Order. For the purposes of a particular Affiliate Task Order, the Affiliate signing such Affiliate Task Order will be substituted for Medpace everywhere it appears in this Agreement, and the term “Affiliate Task Order” will be substituted for Task Order everywhere it appears in this Agreement. Medpace shall be responsible for the compliance of its Affiliate with all of the terms and conditions applicable to Services performed under each Affiliate Task Order. E. As used herein, “Affiliate” means in relation to a Party, any entity, directly or indirectly, controlling such Party, controlled by such Party, or under common control with such Party. For purposes of this Agreement, “control”, whether used as a noun or a verb, means the possession, directly or indirectly, of the power to affirmatively direct, or affirmatively cause the direction of, the management and policies of an entity, whether through the ownership of voting securities, by contract, or otherwise.