Exhibit 10.13
​
Information in this exhibit identified by [***] is confidential and has been excluded pursuant to Item 601(b)(10)(iv) of Regulation S-K because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.
​
FIRST AMENDMENT TO
PROJECT AGREEMENT
(DETAILING – FIELD TEAM AND TELESOLUTIONS)
​
This First Amendment (the “Amendment”) dated June 1, 2020 (the “Effective Date”) is made by and between inVentiv Commercial Services, LLC, a Syneos Health® group company, with an office at 500 Atrium Drive, Somerset, N.J. 08873 (“Syneos Health”) and Agile Therapeutics, Inc. with an  office located at 100 Poor Farm Road, Princeton, New Jersey 08540 (the “Client”).  Syneos Health and Client may each be referred to herein as a “Party” and, collectively, as the “Parties.”
​
W I T N E S S E T H:
​
WHEREAS, Syneos Health and Client are parties to a Project Agreement (Detailing – Field Team and Telesolutions) made as of April 30, 2020 (the “Agreement”); and
​
WHEREAS, Syneos Health and Client desire to amend the Agreement as set forth herein.
​
NOW THEREFORE, in consideration of the premises and other good and valuable consideration, the receipt and adequacy of which is hereby acknowledged, it is agreed as follows:
​
1.   Except as provided in this Amendment, the terms and conditions set forth in the Agreement shall remain unaffected by execution of this Amendment.  To the extent any provisions or terms set forth in this Amendment conflict with the terms set forth in the Agreement, the terms set forth in this Amendment shall govern and control.  Terms not otherwise defined herein, shall have the meanings set forth in the Agreement.
​
2.The Sales Team in Exhibit A, “Detailing Services,” is hereby deleted in its  entirety and replaced with the Amended and Restated Exhibit A attached hereto and made a part hereof.
​
3.Exhibit B, “Telesolutions Services,” is hereby deleted in its entirety and any and all references to “Telesolutions Agents” or “Telesolutions Team” are likewise deleted in their entirety.
​
4.All references to “Wave Two” are hereby deleted in their entirety.
​
5.Exhibit A-1, “Field Operations Services,” is hereby deleted in its entirety and replaced with the Amended and Restated Exhibit A-1 attached hereto and made a part hereof.
​
6.   Exhibit F, “Compensation – Fixed Fees, Variable Fees and Pass-through Costs,” is hereby deleted in its entirety and replaced with the Amended and Restated Exhibit F attached hereto and made a part hereof.
​
7.   This Amendment may be executed simultaneously in multiple counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the
​

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	Amendment – v050114
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same instrument.  Execution and delivery of this Amendment by exchange of facsimile copies or via pdf file bearing the facsimile signature of a party hereto shall constitute a valid and binding execution and delivery of this Amendment by such party.  Such facsimile copies and/or pdf versions shall constitute enforceable original documents.
​
8.   The terms of this Amendment are intended by the Parties to be the final expression of their agreement with respect to the subject matter hereof and may not be contradicted by evidence of any prior or contemporaneous agreement.  The Parties further intend that this Amendment constitute the complete and exclusive statement of its terms and shall supersede any prior agreement with respect to the subject matter hereof.
​
WHEREFORE, the parties hereto have caused this Amendment to be executed by their duly authorized representatives.
​
	AGILE THERAPEUTICS, INC.


	​


	INVENTIV COMMMERCIAL SERVICES, LLC



	​
	​
	​

	By: 
	/s/ Al Altomari
	​
	By: 
	/s/ Todd Tomasoski

	​
	​
	​

	Name: 
	Al Altomari
	​
	Name: 
	Todd Tomasoski

	​
	​
	​

	Title: 
	Chairman and CEO
	​
	Title: 
	Vice President, Global Deal Management

	​
	​
	​

	Date: 
	11/24/2020
	​
	Date: 
	12/9/2020



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AMENDED AND RESTATED
EXHIBIT A
THE DETAILING SERVICES
​
Syneos Health will provide Client with a field force that shall consist of up [***] full-time sales representatives (the “Representatives”) and [***] regional sales representatives (the “RS Reps” and collectively with the Representatives, the “Syneos Health Sales Representatives” or “Sales Representatives”).  The Sales Representatives shall detail the Client’s Product by making calls pursuant to a Call Plan on Targets.  The Sales Representatives will be managed by up to [***] regional sales managers (the “RSMs”) who will also be Syneos Health employees.  Syneos shall also provide [***] national sales director (the “NSD”).  The Sales Representatives, RSMs and NSD may be referred to collectively herein as the “Project Team”.
​
For purposes of clarity, the Implementation Fees and Fixed Monthly Fees outlined in Section I(a) and (b) of Exhibit F includes the headcount for the Project Team as set forth in the table below.
​
	

	


	Position
	Headcount

	Project Team

	Representatives
	[***]

	RS Reps
	[***]

	RSM
	[***]

	NSD
	[***]



​
In the event that the Parties desire to increase the type and / or number of Project Team members providing Services under this Project Agreement they may do so by utilizing a Project Team Member Request Form (the “Request Form”) in a format that is substantially similar to the one attached hereto as Attachment 1.  The details set forth in the Request Form shall be mutually agreed upon by the Parties.  For clarification, the Request Form may not be used in those situations where it is the intent of the Parties to amend terms and conditions of this Project Agreement other than those specific items set forth on the Request Form.
​
I.ADDITIONAL DEFINED TERMS
​
(a)“Call” means the activity undertaken by a Sales Representative to detail the Product, further described as a face-to-face presentation by a in Sales Representative to a Target and will include providing the Product Literature (as directed by Client).
​
(b)“Call Plan” means a plan jointly designed by Client and Syneos Health, which is intended to enhance the efficiency and effectiveness of the Project Team in making Calls.  The Call Plan will be maintained by Syneos Health at its offices with a copy of such Call Plan maintained by Client at its offices, and may be amended or reconfigured from time to time solely at Client’s written request (limited quarterly updates are included in the current fee) with Client paying Syneos Health a fee pursuant to the Standard Pricing Table outlined in Exhibit A-1, Section 3.1.1(d)(5), as agreed upon in writing, for the performance of such amendment or reconfiguration services.  Client may add products to the call plan, which may be either products
​

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owned by the Client or those for which the client has entered into a co-promotion agreement without having an impact on the monthly fees.  If a Call Plan requires amending or reconfiguration a Change of Scope document would be executed by both Parties and the Standard Pricing Table see Exhibit A, Section 3.1.1(d)(5) would apply as applicable.
​
(c)“Deployment Date” means the date of the first Call by a Syneos Health Sales Representative, which is anticipated by the Parties to be on or about [***].  Notwithstanding the date set forth herein, the Deployment Date will be the actual date of the first Call by a Syneos Health Sales Representative.
​
(d)“Healthcare Professional” or “HCP” means a person, other than an individual patient, including, without limitation, any medical or health care professional or entity in a position to purchase, lease, recommend, use, influence or arrange for the purchase or lease of, or prescribe the Products with whom Syneos Health Sales Representatives come in contact with in connection with providing the Services hereunder.
​
(e) “Product” shall mean Twirla®.
​
(f)“Product Literature” shall mean promotional, informative and other written information concerning the Product.  All Product Literature shall be prepared and provided by Client.  The Syneos Health Sales Representatives shall utilize the Product Literature when making Calls.
​
(g)“Project Team member Hire Date” means the date the first Syneos Health Sales Representative is assigned to the Project Team.
​
(h)“Targets” mean the licensed practitioners who are identified by Client as potential prescription writers and/or customers for the Product as provided by Client to Syneos Health.
​
II.HIRE STATUS, FLEET, TRAINING AND MEETINGS
​
(a)Hire Status—Generally.  Upon completion and approval by the parties of the field alignment and profile (including approval of the final number of Project Team members), Syneos Health will commence recruiting and hiring activities for the Project Team members.  In the event that Syneos Health receives notification to commence recruiting and hiring activities with respect to a position or territory, and that position or territory is subsequently cancelled by Client at any time after [***] from the date of such notification, then Client shall pay a cancellation fee to Syneos Health in the amount of [***] for each such cancelled position or territory.
(b)Hire Status—Provisioning.  Syneos Health shall provide following:
		(i)
	Salary, benefits, and incentive compensation as agreed by Client to the Project Team members.


(ii)Fleet Vehicles and fleet management services for the Sales
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Representatives include the following:
(1)Coordination of department of motor vehicle (“DMV”) checks and confirmation of completion for all employees in Fleet Vehicles
(2)Management of vendor involvement for accidents, fuel cards, and insurance
(3)Coordination of delivery of bridge rentals or Fleet Vehicles dependent upon background and DMV check completion, timeline of deployment and vehicle availability
(4)Recommendations for snow belt vehicles as applicable for project
(5)Ordering new vehicles or transfer of existing surplus vehicles dependent upon team size, availability and Client budget
(6)Timely pick-up of fleet vehicles through third-party vendor for terminations and leaves of absence (“LOAs”) as appropriate
(iii)The above stated fleet management services shall assume the following:
(1)Timely notification of territory and district locations for vehicle placement
(iv)Human resources management services for the Project Team to include, but not be limited to, the following:
(1)Creation, distribution, and tracking of offer letters and onboarding documents
(2)Distribution of emails from background and drug screening vendors to complete required data for background screening and drug screen
(3)Tracking of background and drug screening results (follow-up may be required)
(4)New hire orientation
(5)Works with project lead coordination on investigations of policy non-compliance, background and other performance issues
(6)Coordination with leave and benefits administration as required
(7)Delivery of termination notices, participation in notification calls regarding downsizing and conversions
(v)Human resources management services assume the following:
​

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(1)Timely completion of background vendor required information through its link for new hires
(2)Information regarding vacation,  incentive compensation, expectations are available for inclusion in the offer letters
(vi)Information technology hardware for the Sales Representatives to include iPads and laptop computers (including sales force automation software) and printers.
(vii)CRM and operational support for the Sales Representatives as further described in Exhibit A-1.
 (c)Training - The training responsibilities of the Parties are as follows:
​
(i) Syneos Health shall be responsible for training members of the Project Team pursuant to Exhibit E.
​
(ii)Client shall be responsible for training members of the Project Team concerning all Product specific information including Product complaint handling procedures, applicable specific Client health care compliance policies and Client customer service policies and procedures, orientation to Client’s business, compliance with Applicable Law, and adverse event reporting policies and procedures.  The Parties agree to work together to mutually determine if, when, and at what cost additional training shall be provided to members of the Project Team.
​
(d)All expenses associated with Plan of Action (POA) meetings and national training meetings shall be pre-approved by Client and be paid for by Client as a pass-through expense or direct billed to Client.
​
(e)Syneos Health will be responsible for providing credit cards to any Syneos Health Project Team member as requested by Client who establishes credit-worthiness in accordance with standards established by Syneos Health’s corporate credit card provider.  Client and Syneos Health shall establish appropriate limitations on the amount of available credit.  In the event a Syneos Health Sales Representative is unable to establish credit worthiness, Client shall determine if it nevertheless desires to have a credit card issued to such Syneos Health Sales Representative.  All credit card expenses shall be submitted and processed through the Syneos Health expense reimbursement system.  In the event of a default on a credit card invoice by any Syneos Health Sales Representative (i.e., the expenses/receipts are not input into the Concur system), Client shall nevertheless reimburse Syneos Health for all business related expenses properly incurred by such field personnel in accordance with the Project Agreement which are substantiated through credit card statement documentation, and not otherwise entered in the expense management system.
​
III.PERFORMANCE
​
If Client believes in good faith that the performance of any Syneos Health Project Team member is unsatisfactory or is not in compliance with the provisions of this Project Agreement,
​

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Client shall notify Syneos Health and Syneos Health shall promptly address the performance or conduct of such person in accordance with its internal human resource policies.  In the event that Client determines in good faith that a Syneos Health Project Team member has violated any applicable law, regulation or policy, Client shall notify Syneos Health in writing.  Syneos Health shall promptly address the issue and take all reasonable and appropriate action (including but not limited to termination of such employee).  No such action shall be contrary to Syneos Health’s internal human resource policies and procedures, provided such human resource policies and procedures are in compliance with all Applicable Laws.  If, despite any foregoing action by Syneos Health, Client is still reasonably unsatisfied with the performance of any Syneos Health Project Team member, Client may request the removal of such Syneos Health Project Team member by promptly notifying Syneos Health in writing, and Syneos Health shall remove the Syneos Health Project Team member from the provision of Services hereunder.  Any action taken pursuant to this Section III will be in accordance with Syneos Health’s internal human resource policies and procedure and the Applicable Laws governing employees.  Syneos Health shall promptly notify Client if it becomes aware that any Project Team member has violated or is alleged to have violated any applicable law, regulation or policy.
​
IVCALLS AND TARGETS
​
The Syneos Health Project Team shall provide Product Literature and Product samples (as needed) when making Calls as directed and approved by Client.  Client is solely responsible for the content, production and distribution (to the Syneos Health Sales Representatives) of the Product Literature.  Each Syneos Health Sales Representative shall record information concerning each Call, including but not limited to Product sample distribution, and concerning the profile of each individual Target (or other physician called upon) on whom the Syneos Health Sales Representative calls.  Client shall permit Syneos Health to access and use all Target, sales and Call-related data that supports or is associated with the Services that are performed in accordance with this Project Agreement (the “Data”).  The Data shall be used by Syneos Health for the purpose of evaluating the performance of its Project Team members; and, provided that Syneos Health de-identifies all Client and Product specific components of the Data, for business development and analytics purposes.
V.THE PRODUCTS
​
The Product shall be promoted by Syneos Health under trademarks owned by or licensed to Client and are Products which Client has all lawful authority necessary to market and sell the Products in all geographic areas where the Products are to be promoted under this Project Agreement.  This Project Agreement does not constitute a grant to Syneos Health of any property right or interest in the Products or the trademarks owned by or licensed to Client.  Syneos Health recognizes the validity of and the title of Client to all its owned or licensed trademarks, trade names and trade dress in any country in connection with the Products, whether registered or not.  Client represents to Syneos Health that neither those trademarks, trade names and trade address nor the promotion of the Products by Syneos Health infringes on any intellectual property right of any other person or entity.
​
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VI.HIRING PROFILE
​
In selecting Project Team members, Syneos Health will use the preferred hiring profile approved by Client.  Syneos Health will take reasonable steps to confirm the accuracy of information concerning background and experience received from applicants for positions of Project Team members.  Syneos Health shall not knowingly employ or otherwise retain, or permit to be retained as a Project Team member, a practicing physician or a person affiliated on a professional level with or employed by any physician, physician practice or other healthcare professional or provider or a person who is in a position to unduly influence the purchase of the Products.
​
VII.BACKGROUND CHECKS
​
Syneos Health shall be responsible for performing drug testing and background checks of all Project Team members.  Syneos Health represents and warrants that it will complete or cause to be completed a thorough background check of all Project Team members.  This will include, Criminal Check, Social Security Check, Drug Screen, Motor Vehicle Record Check, Education Check, Past Employer Check.  Syneos Health further represents and warrants that it will perform or cause to be performed background checks to confirm that no Sales Representative:
​
a.is an excluded person on the Office of Inspector General’s List of Excluded Individuals/Entities and is not on the General Services Administration Excluded Parties List (as of the date the background check is performed);
​
b.is, so far as it is aware, an unfit or an improper individual for the performance of the Services;
​
c.is, so far as it is aware, engaged in any fraudulent or unlawful activity, or other inappropriate conduct as measured by the other requirements of this Project Agreement.
​
Syneos Health shall institute prompt corrective or disciplinary action against any Project Team member who fails to meet the requirements set forth in this Exhibit A.  Syneos Health further agrees to cooperate and comply with all investigations by or on behalf of Client with respect to wrongdoing, or alleged or suspected wrongdoing, in respect of any obligations of Syneos Health or any Project Team members under this Project Agreement.
​
VIII.REPRESENTATIONS AND UNDERTAKINGS
​
		(a)
	[***]


​
(b)Client represents that:
​
(i)it recognizes that for Syneos Health to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Syneos Health with the
​

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necessary materials and assistance required to enable Syneos Health to perform the Services;
​
(ii)the Services being provided by Syneos Health are in furtherance of Client’s program of marketing and promoting the Products and as such, Client is responsible for ensuring, and further, Client represents and warrants, that the Client’s program being implemented by Syneos Health pursuant to the terms hereof (but not the implementation thereof by Syneos Health), strictly adheres to all applicable state and federal statutes, laws, ordinances, and the rules and regulations of all governmental and regulatory authorities, including but not limited to, the Federal Food, Drug, and Cosmetic Act and the Prescription Drug Marketing Act;
​
(iii)it shall ensure that none of its employees add, delete or modify claims of efficacy or safety of the Products, nor makes any changes (including but not limited to, underlining or otherwise highlighting any language or adding any notes thereto) in the Product Literature, during the training on the Products or during any communications with Syneos Health employees;
​
(iv)it shall ensure that none of its employees working with the Project Team or in connection with the Services, directly or indirectly instruct any Syneos Health employee to pay, offer or authorize payment of anything of substantial value (either in the form of compensation, gift, contribution or otherwise) to any person or entity in a position to order, recommend or purchase the Products contrary to any law; and
​
(v)neither it nor any of its employees directly or indirectly instruct any Syneos Health employee to make any representations or warranties relating to the Products that conflict, or are inconsistent with, applicable laws or the Food and Drug Administration approved labeling for the Products.
​
(vi)Client shall:
​
A.provide Syneos Health Project Team members with all Product Literature and arrange for the provision of Product samples (as applicable).
​
B.inform Syneos Health promptly of any changes which Client believes are necessary or appropriate in the Product Literature or in information concerning the Products in order to be in compliance with all applicable federal and state law, regulations and administrative guidance.
​
C.Arrange for a timely and appropriate response to any inquiry concerning a Product communicated to Syneos Health from any licensed practitioner and communicated by Syneos Health to Client.
​
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AMENDMENT AND RESTATED
EXHIBIT A-1
FIELD OPERATIONS SERVICES
	1.0
	Executive Summary


This Exhibit A-1 describes the scope of work, deliverables, and assumptions for field operations initial implementation and ongoing annual support for the Project (as defined in Section 3.1.1(a)).  Any changes to the assumptions, deliverables, or scope of work described in this Exhibit A-1, or any new work request(s), will follow Section 3.1.1(d), Change Control Process of this Exhibit A-1.
	2.0
	Scope of Services


The following service areas are part of field operations initial implementation and ongoing annual support:
		·
	Operations Management


		·
	Customer Relationship Management (CRM)


		·
	Customer Master Source Data & Validation


		·
	Travel and Expense Management


		·
	Transparency Reporting


		·
	Data Management


		·
	Analytics and Reporting


		·
	Targeting, Alignment and Call Plan Administration


		·
	Incentive Compensation Management


		·
	Field Support Services


		·
	Technology Training Services


		·
	LMS System Support


		·
	Quality Management and Assurance


		·
	Field Trigger Email with Veeva Engage


	3.0
	Scope of Work Definition


		3.1
	Operations Management


		3.1.1
	As part of operations management, Syneos Health will provide the following:


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(a)Project Management.  Syneos Health will provide a fully integrated project management approach for the implementation of the operations services (the “Project”) including the following:
​
(1)Leadership of Project kick-off meeting to include review of scope, timelines, and assumptions for each functional area, Sales Team member introduction, and status reporting formats and meetings.
​
(2)Integration of all Project activity, timelines, and deliverables across all functional areas into a consolidated Project schedule.
​
(3)Leadership, facilitation, and documentation of all meetings, including meeting notes and action items.
​
(4)Management of the Project schedule including task management, escalation of issues, risk identification, and interdependencies through Project documentation including:
​
(i)Issue tracker;
(ii)Milestone tracker; and
(iii)Action item tracker.
​
(5)Project status meetings and Project status reporting, including weekly status reports and plan reviews with the Client.
​
(6)Project close-out and lessons learned session to include any information that can be applied to the ongoing operational support of the Client after the initial implementation is complete.
​
(7)Project management implementation deliverables including the following:
​
(i)Weekly implementation schedule identifying Project activities and target completion dates.
(ii)Weekly implementation log of risks, actions, issues, and key decisions (“RAID”).
​
(b)Technical Operations Management.  Technical operations Project implementation deliverables include the following:
​
(1)Ongoing communication plan;
​
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(2)Technical operations deliverables document identifying standard deliverables and key business rules – delivered within six (6) weeks of the first day in the field;
​
(3)Monthly technical operations status report;
​
(4)Monthly operation leadership meeting and supporting documents; and
​
(5)Quarterly business review meeting and supporting documents.
​
(c)Field Administrative Management.  Syneos Health will oversee all field administrative tasks, including the following activities:
​
(1)Field Administrative Management—Implementation.
(i)Project set up and roster management using Syneos Health’s proprietary master roster system;
(ii)Onboarding of new hires, including all aspects of administrative systems and processes (e.g., travel, CRM system, business cards, welcome memo, conference call accounts, fleet coordination, credentialing, licensure);
(iii)Meeting planning logistics for national and POA meetings;
(iv)Venue sourcing, hotel sourcing/booking, meal and events arrangements, ground transportation set up, flight arrangements, travel letter development, and budget tracking for national and POA meetings;
(v)One (1) resource for on-site meeting support available, as needed;
(vi)Training development and coordination;
		·
	Identify and coordinate Syneos Health/Client courses for LMS upload


		·
	Coordinate presenters/training schedules & agendas


		·
	LMS course completion monitoring


		·
	Post launch mastery training plan development


(vii)Team Expense Travel and Budget Policy development.
​
(2)Field Administrative Management—Ongoing Support.
​
(i)Roster management and distribution;
​

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(ii)Continuation of meeting planning logistics, as described above, either with Client vendor(s) or as a stand-alone offering;
(iii)Monitoring Project parameters and managing eligibility and payout of incentive compensation and awards within approved Project guidelines;
(iv)Coordinate, route, track, and report operational initiatives, questions, or directives across all of the internal administrative departments, as well as external vendors and Client home office;
(v)Review of monthly invoicing and budgets for adherence to Project P&L;
(vi)Coordination with sample management and fulfillment vendor (if applicable);
(vii)Coordination with Syneos Health compliance on HCP expense monitoring and reporting;
(viii)Onboarding of backfill new hires to include all aspects of administrative systems and processes;
(ix)Coordination of communication to the field;
(x)Ad hoc reporting (e.g., turnover/vacancy reports, budget tracker);
(xi)Monthly field employee roster audits; and
(xii)Payroll processing;
(xiii)Review and ensure all field expense reporting is completed, to include HCP reporting;
(xiv)Field communication to include the following for the team conference call:
​
		·
	FAQ development with HR and business lead


		·
	Communication script


		·
	Project exit check list and acknowledgement


(xv)Monitor return of Syneos Health property;
(xvi)Monitor return of Client property (i.e., samples, marketing materials, etc.);
(xvii)Coordination with fleet department on return of vehicle (if applicable); and
(xviii)Deactivations of all Project specific accounts (i.e., conference call/WebEx, etc.).
​
(d)Change Control Process.  During the Term of this Project Agreement, the Parties may mutually agree to alter the Field Operations Services outlined in this Exhibit A-1.  Such changes will be addressed as follows:
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(1)Assess the impact of scope changes on Project schedules, resources and pricing;
​
(2)Provide a formal vehicle for approval to proceed with any changes to the Project Agreement;
​
(3)Provide a Project audit record of all material changes to the original Project Agreement; and
​
(4)If requirements arise that are outside the scope of this Exhibit A-1, a Change of Scope document (or an amendment to the Project Agreement, as applicable) will be submitted for Client approval following the below process:
​
(i)Client requests additional requirements for new functionality or deliverables outside the scope of work provided herein.
(ii)Syneos Health reviews change, meets with Client and internal team members to understand and scope Client expectations regarding business need, timelines, and other deliverable expectations.
(iii)Syneos Health provides Change of Scope (or Amendment or new Project Agreement, as applicable) document, which outlines work effort, timeline and pricing impacts of the change.  Pricing will be determined based on standard rates provided below.
(iv)Client accepts proposal and signs Change of Scope (or Amendment or new Project Agreement, as applicable) document which authorizes work to begin on the change request.
​
(5)Standard Pricing Table.
​
	

	


	Role
	Price/HR

	Software Development
	[***]

	CRM Configuration
	[***]

	Data Management
	[***]

	Alignment/Call Planning
	[***]

	Incentive Comp Modeling/Design
	[***]

	Analytics & Reporting
	[***]

	Project Management/Business Analysis/Solution Design
	[***]



​
​

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	​


	​



	Role
	Price/HR

	Testing
	[***]

	IC Administration
	[***]

	Training (Content/Delivery) 
	[***]

	Hardware/Help Desk
	[***]



​
		3.2
	Customer Relationship Management (“CRM”)


3.2.1CRM; Client Configuration and Available Functionality.  Syneos Health will provide a CRM application.  Additionally, within its CRM application, Syneos Health will set-up a single, Client-specific, dedicated CRM environment configured specifically to the Client’s business rules (the “Client Configuration”).  The core functionalities within the Client Configuration are as follows, and will be configured by Syneos Health upon selection by Client:
(a)Customer profile management across account types (individuals and organizations);
(b)Call recording, reporting, and loading of Call plans;
(c)Closed-Loop Marketing (“CLM”), loading and presentation of digital media as part of integrated call record;
(d)Sample management and recording of samples and physician signature capture as part of integrated call record, including Prescription Drug Marketing Act (PDMA), CFR Part 11 Validation, if requested by Client;
(e)Medical Inquiry Request Form (“MIRF”) including physician signature capture;
(f)Field Coaching Report (FCR) configuration;
(g)Pre-established reports and dashboards to enable field and field management performance (online only); and
(h)iPad/online platform options including online/home office PC, field tablet PC, and iPad to support mobility needs and improved customer interaction.
3.2.2CRM; Client Configuration Development and Implementation.  CRM implementation will be led using an agile development approach including the following deliverables:
​

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	Project Deliverable
	Definition

	Initial Requirements
	Demonstration of the Client Configuration; and discussion of Client needs and business environment to support the general usage and end-user experience; will include accounts, functions, Call types, products, customer profile maintenance, etc.  

	Alpha Review
	First iteration of the Client configuration based on requirements gathered in the Initial Requirements session.  Detailed demonstration of the Client Configuration for more in-depth review of Client requirements.

	Configuration Requirements Document (“CRD”)
	After the Alpha Review, Syneos Health will provide the Client with a draft CRD document which summarizes all end-user system requirements taken from both the Initial Requirements and Alpha Review sessions.  The CRD will form a basis for the final Client Configuration specifications, risk assessment, testing, training, and validation (if applicable).  

	Beta Review
	The final phase of the Client requirements will be a Beta Review, which will allow for any changes to the Client Configuration system requirements for final testing and production readiness.  

	CRD Sign-Off
	Any changes or additions to the Client Configuration requirements during the Beta Review will be incorporated into the final CRD and submitted to the Client after the Beta Review session for final approval and signature.



​
3.2.3Client Configuration Assumptions.  The scope of the Client Configuration CRM delivery and associated timelines for the Project assumes the following:
(a)Necessary Client members are available for the Initial Requirements, Alpha Review, and Beta Review meetings (each typically 3 hours), based on the weeks assumed in the agreed upon Project plan (Alpha Review/Beta Review may be done via WebEx);
(b)Sign-off of documentation within 5 days of delivery by necessary Client members;
(c)No customization of code outside of CRM provided configuration capabilities;
(d)Use of standard MIRF functionality and data extracts to medical information;
(e)Client Configuration/CRM does not include Adverse Events/Pharmacovigilance (“AE”) reporting or recording.   An alert is setup in the CRM system to remind field users of the appropriate number/process to communicate to HCPs;
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(f)Linking to company or external web-based systems within CRM tab structure;
(g)Access to Syneos Health Veeva Vault for Client approved content including:  CLM presentations and approved email templates.  Alternatively, Syneos Health Veeva Vault may be setup to attach directly to Client internal Veeva Vault system in cases where Client is using Veeva Vault for internal Medical, Legal, Review (“MLR”).  Syneos Health Veeva Vault is not used for internal Client MLR usage, only for field delivery of approved content;
(h)Sample management functionality, if required, and data feeds for sample shipments, SLN validation, and sample product information as determined by Client requirements;
(i)Inclusion of sales data within standard Veeva reporting functionality (online only);
(j)Field Coaching Report originates from manager, not representative, including data entry only.  Form will not be pre-populated with any data from any source;
(k)Call history within the Sales Force Automation (“SFA”) system not to exceed 15 months (5 Quarters) without purchasing additional data storage from Salesforce.com;
(l)External access for Client home office administrators can be granted with change control processes in place to ensure integrity of Syneos Health production environment, with additional license costs as dictated by home office license pricing in contract; and
(m)Ongoing support for CRM system including tier 2/technical support for escalated calls from field support desk, and home office support needs;
		3.3
	Customer Master Source Data and Validation


		3.3.1
	Veeva Network and Veeva OpenData Validation.


(a)Syneos Health shall provide a near real-time customer validation process leveraging the integration of Veeva Network and Veeva OpenData.  This combination gives direct access to Veeva OpenData for adding and changing of HCP and HCO data, which allows for field users to search, add, and immediately pull-down HCPs/HCOs industry standard identifiers and compliance information, such as SLN and DEA, upon adding the new prescriber, as opposed to waiting the standard 2-3 weeks for weekly data exports and validation.
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(b)Client and Syneos Health’s targeting and alignment team will also have access to Veeva OpenData for sales or marketing research, such as to identify initial target universe, ongoing target adjustments, new product or market evaluations, etc.
(c)The Veeva Network service includes the following:
(1)Configuration and support for utilizing Veeva OpenData and the Veeva Network to allow for this Customer Master Data solution to control the universe in the CRM system and to provide for data stewardship services via Veeva OpenData provided controls.
(2)Data change requests can be submitted by field users to the Veeva OpenData data stewards, which increases efficiency and decreases timelines associated with routine action request processing for universe changes discovered by the field.
(3)The Veeva Network account search will allow for the field to search the Veeva OpenData Customer Master Data for any HCP or HCO that meets the search criteria, and provides the ability to add that HCP or HCO to their Veeva CRM territory.  The information included is pre-validated by Veeva OpenData so an eligible HCP can be sampled immediately. Additionally, all valid address information known for that account will be brought down with the HCP or HCO selected.
		(d)
	The Veeva OpenData service includes access to the following data set:


(1) Licensed field and home office users have access to entire customer universe (HCPs, HCOs, addresses, affiliations) in the Veeva OpenData customer universe.
(2)Usage of compliance data scrub – for industry standard identifiers SLN, NPI, DEA #s for initial and ongoing data validation.
(3)Usage of data hygiene scrub – for HCP demographic data such as address, specialty etc. for initial data validation.
(4)Access to email address data is not included in standard offering but may be available on a per record basis for marketing initiatives as needed and is recommended for usage if Client is implementing enhanced approved email functionality (not included in base CRM license).
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		3.4
	Travel and Expense Management


3.4.1Travel & Expense Set-Up and Ongoing Services.  Syneos Health shall leverage its then current travel and expense (“T&E”) management system application (and solution provider) (collectively, the “T&E Management Solution”), currently Concur, for capture and reimbursement of all expenses incurred by Syneos Health employees recruited for the Client’s Project, and for HCP data capture necessary for transparency reporting. The T&E Management Solution assumes the following:
(a)Required Client members are identified and available for requirements gathering;
(b)Client’s requirements align with the standard baseline Concur configuration, (i.e. able to utilize existing expense types, approval workflow, etc., without customization);
(c)Completion of Configuration Request document for Project set-up based on Client spend limits and business rules;
(d)Acceptance of Syneos Health universe for HCP selection utilizing Medpro Concur Connect;
(e)Ongoing support for Concur T&E management system including tier 2/technical support for escalated calls from field support desk;
(f)Changes to or additional audit rules may be requested post-deployment;
(g)On-going roster management as teams expand or re-align (including territory and manager changes);
(h)Information on areas such as Amex cards, mileage rates, report approvers, etc. are communicated and decided on at onset of implementation based on Client business rules;
(i)T&E management system setup and support is only provided for Syneos Health employees. If any Client employees are supported, Client will be responsible for the deployment of the T&E management system and capture of any HCP meal spend, etc. for the Client employees;
(j)Coordination of Learning Management System (“LMS”) Project set-up and communication of system access and viewing of Concur module to new hires/end users;
(k)Inclusion of Expense Management in Technology Training sessions; and
(l)Tracking of completed Concur module review in LMS per user.
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3.4.2Travel & Expense Deliverables.  The T&E management system application work stream will be managed by the Operations Manager, the Concur system subject matter expert, and the compliance lead, and will include the following deliverables:
​
	​


	​



	Project Deliverable
	Definition

	T&E Guidelines
	General Syneos Health guidelines provided to assist the Client in developing their T&E program; this can be reviewed and modified by Client as required.

	Compliance Business Rules Document
	Detailed document describing all compliance business rules associated with the Client Project.  A draft will be provided with Syneos Health’s base business rules and guidance with review and modifications as needed, and approval by Syneos Health and Client.

	ERD (Expense Requirements Document)
	Detailed document describing standard Concur functionality and Client-specific business rules based on requirements gathering and configuration request.
Following internal review, final document will be reviewed and approved by Syneos Health and Client.

	Training Documentation
	Training documentation provided to field users and management with guidance on T&E management system application and compliance business rules and usage.



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		3.5
	Transparency Reporting


3.5.1Background.  H.R. 3590, Section 6002: “Transparency Reports and Reporting of Physician Ownership or Investment Interests,” also referred to as the “National Physician Payment Transparency Program” a/k/a the “OPEN PAYMENTS” or “Sunshine Act” and H.R. 3590, Section 6004: “Prescription Drug Sample Transparency,” requires certain data collection and reporting regarding  payments or transfers of value and drug sample distribution  to physicians.
3.5.2Data Management.  Syneos Health will provide the following data management services to Client:
(a)Regular reports of HCP-related meal expenses in Syneos Health’s standard format;
(b)Regular reports Syneos Health’s standard format of items of value non-sample items left with HCPs;
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(c)Syneos Health will run full-cycle system testing and support UAT testing; and
(d)All reports will be clearly defined in terms of layout, content and delivery in the Data Requirements Document.
Syneos Health will work with Client in the data requirements process to confirm the file format, data elements, file delivery process and frequency to meet Client specifications for transparency reporting and Client System Integration.  Syneos Health’s Monitoring and Auditing processes for transparency reporting is detailed in Exhibit C, below.
		3.6
	Data Management


3.6.1Generally.
(a)Syneos Health will provide data loads and data integration services for standard data imports and exports.  Data management services includes data flowing to and from the Veeva CRM application, including Client data sources, third parties (i.e. sales data), or service partners.  The data management team will work with the Veeva CRM, and analytics and reporting tools, to ensure that all Client business rules and data requirements are understood and planned for in the overall implementation plan.
(b)A full description of all data files and formats for data interfaces will be provided in the Data Requirements Document (“DRD”), which will be included as part of the Project Plan with necessary approvals from the Client and Project leads.  The DRD will also include a Production Schedule, for ongoing data management services.
3.6.2Data Loads, Imports and Extracts—Standard.   The Project assumes use of standard data loads and file formats for all initial and ongoing data support as provided below:
(a)Standard initial data loads shall use agreed upon Syneos Health/Client formats including:
(1)Territory hierarchy;
(2)Customer universe, alignments, and Targets/Call plans;
(3)Product information; and
(4)Call history (if required).
(b)Standard reoccurring data imports shall be conducted at set frequencies and in agreed upon formats within five (5) business days of receipt as needed for the following:
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(1)Prescriber/account sales data (weekly & monthly);
(2)Prescriber payer data (weekly & monthly);
(3)Call Plan/Targets (quarterly); and
(4)Customer universe updates—validation responses (weekly).
(c)Standard reoccurring data extracts shall be provided at set frequencies to either home office or third-party vendors as needed for processing to include:
(1)Call/activity data (weekly or monthly – Syneos Health to provide within 5 business days from the end of the cycle);
(2)Medical inquiries (daily);
(3)Sample activity (weekly or monthly – Syneos Health to provide within 5 business days from the end of the cycle);
(4)Extracts supporting Transparency Reporting in Section 3.5 (monthly or quarterly);
(i)DME Spend data from Concur;
(ii)Items of value, open payments reports;
(iii)Hand-carry sample reports for ACA 6004 (Knipper clients only); and
(5)Customer Universe Validation Requests (weekly – Syneos Health to provide within 5 business days from the end of the cycle).
(d)Standard data maintenance services will be provided for the ongoing support of the systems and data at fixed frequencies as defined below to include:
(1)State license validation process to reduce field impact in sampling (weekly);
(2)PDRP flagging on accounts (monthly);
(3)Routine merging of accounts (quarterly);
(4)Setup of integration between Veeva CRM and data warehouse, which allows roster, Territory hierarchy and Product management to be seamless (daily);
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(5)Processing of action requests (Client data changes) (quarterly);
(6)Time off Territory and holiday updates (monthly);
(7)Ongoing maintenance of sales and payer data (weekly or monthly based on sales data provider availability);
(8)Training database setup and management (quarterly);
(9)Tier 2/technical support for data issues routed from the Field Support Desk (daily);
(10)Customer sales data extracts for IC (as defined in Section 3.10) processing (monthly); and
(11)Customer sales data and Call/activity extracts for A&R processing (monthly).
3.6.3Assumptions.  The scope of the data management delivery and associated timelines for the Project assumes the following:
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	​


	​



	Project Deliverable
	Definition

	Initial Requirements
	Discussion of client needs regarding data loads, extracts, and imports and finalization of Project plan and scope based on SOW assumptions and change management process  

	Third Party Agreements (TPA)
	Syneos Health will secure, in coordination with Client, any rights and licenses that Syneos Health needs from external vendors such as sales data companies which require TPA for data services to be provided

	DRD (Data Requirements Document)
	Syneos Health will provide the Client with a DRD document which summarizes all data loads, imports, and extracts, as well as any business rules, frequencies, and formats associated with the data services to be provided as part of implementation and ongoing data management services, the DRD draft will be reviewed, modified as needed, and signed by the Client to confirm Project deliverables

	Test Files
	The Client or third parties will provide needed test files in specified formats and agreed dates in the Project plan based on the implementation schedule

	Final Production Files
	The Client or third parties will provide final production files in specified formats and agreed dates in the Project plan based on the implementation schedule



​
3.6.4Non-Standard; Changes.  Any additional data feeds not included in the standards as defined above, or changes to data exchanges or maintenance subsequent to the approved DRD will follow the change control process and rate schedule set forth in Sections 3.1 and 3.1.1(d) respectively.

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		3.7
	Analytics and Reporting


		3.7.1
	Veeva CRM Dashboard Reporting.


(a)Reporting Generally; User Types.  The Project assumes general field activity reporting will be provided in the Veeva CRM Dashboard Reporting environment utilizing Syneos Health’s pre-configured reporting tools to optimize field performance and implementation setup time. Syneos Health reporting will be provided for the following user types aggregated based on the user type’s span of control:
(1)Representative (Territory level);
(2)Field Management (regional level); and
(3)Home Office (national level).
3.7.2Veeva Report Configuration and Templates.
(a)Syneos Health will configure the reporting tools to include Client specific fields and terminology, where applicable, within Veeva and SalesForce.com guidelines. Veeva requirements, development, and deployment will follow the requirements and format as provided in the Veeva CRD as stated in Section 3.2, and may include the following: field activity, including the following: Call activity, Call plan adherence, sample activity, CLM utilization, synchronization monitoring, manager exceptions, and/or administration.
(b)Report Templates.  The Veeva template field reporting package is designed to drive sales behavior in the following ways:
(1)  Evaluation of prescriber sales for pre-Call planning from account summary report;
(2)Measure that the most valuable drivers of sales were detailed and sampled in accordance with the recommended Call plan - account/physician –
(i)Average Calls per day –reviews Call activity against Target or segmentation;
(ii)Reach and frequency can be found on analytics tab;
(iii)Call plan information can be found on the Call plan tab; and
(iv)Call Plan Analysis Report can be found on the analytics tab.
(3)Measure the impact of detailing and sampling on sales –
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(i)Effort vs. results report can be found on the analytics tab.
(4)Examine the landscape for the product to identify top sales accounts and potential –
(i)Territory sales analysis—reviews trends in Client Product and competitive landscape; can be found on analytics tab;
(ii)Territory payer analysis –examines payer information; can be found on analytics tab; and
(iii)Territory comparison report—compares sales performance at the Territory level for all territories within span of control; can be found on analytics tab.
(5)Report Template Table.
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	​


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	Template Reports
	Base Assumptions
	Standard Frequency

	Account Summary 
	Prescriber based product level prescription data
	At same frequency as sales data (aka prescription data) delivery to Client 

	Activity/ Administrative
	1.

Reviews key territory and/or district performance indicators with drill down details for:




a.

Interactions




b.

Detailing




c.

Sampling



2.

Review key territory and/or district administrative metrics with drill down details



3.

Any information collected within a check box or drop down list into the Veeva systems can be aggregated into a dashboard element.



4.

Text box information can be rolled into a report but not the dashboard.



5.

Dashboards can have up to 20 measurement elements



	Real time as of last synchronization and refresh



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	Template Reports
	Base Assumptions
	Standard Frequency

	​
	6.

All Dashboard elements are pictorials which aggregate data from an underlying report



7.

All pictorials are flexible but limited to two dimensions



8.

Color selection is not an option



9.

Filters can be applied to comparable data



10.

Reports can be filtered by user level (Field, Management, Home Office)



11.

Other Reportable Activity:




a.

System Utilization




b.

Pending Interaction (Exception/incomplete information)




c.

Time off Territory




d.

Synchronization Reports




e.

Interaction by Date and Time




f.

Field Action Requests



12.

Account Demographics




a.

Target/Non-Target




b.

Account Type (practitioner, pharmacy, staff, etc.)




c.

Specialty




d.

Segmentation




e.

Custom Profile Attributes



13.

Closed Loop Marketing (CLM)




a.

Slide Utilization as % of Calls




b.

View Duration




c.

Ranking of Slides by View count and Average Duration




d.

Viewer Reaction (Positive, Neutral, Negative)



	​

	Reach and Frequency
	Adapted to specific activity measurements and goals within set up matrix (calls, targets only, reach, frequency, sample distribution)
	Real Time as of last synchronization and refresh



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	Template Reports
	Base Assumptions
	Standard Frequency

	Average Calls Per Day 
	Average Calls Per Day versus goal
	Real Time as of last synchronization and refresh

	Territory Sales Analysis
	1.

Adapted to specific product/market definition



2.

Monthly prescriber-based product level prescription data; Up to 3 promoted products



	At same frequency as sales data (aka prescription data) delivery to Client

	Territory Comparison (Mgmt. supplement)
	1.

Adapted to specific product/market definition



2.

Monthly prescriber-based product level prescription data; Up to 3 promoted products



3.

Comparison of sales data amongst the assigned span of control



	At same frequency as sales data (aka prescription data) delivery to Client

	Territory Payer Analysis
	1.

Monthly payer-based product level prescription data



2.

Analysis of the prescriber payer



3.

Top payers



4.

Comparison of payer market products



	At same frequency as sales data (aka prescription data) delivery to Client

	Effort vs. Results aka Impact Report
	1.

Adapted to specific product/market definition



2.

Up to 3 promoted products



3.

Monthly prescriber-based product level prescription data



	At same frequency as sales data (aka prescription data) delivery to Client



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3.7.3Custom Analysis & Insights.
Additional work-effort will require work estimates and Change of Scope as detailed in Section 3.1.1(d), to be coordinated by the PM.
		3.8
	Targeting, Alignment and Call Plan Administration


3.8.1Generally.  Syneos Health will provide targeting and sales force alignment services for optimization of key targets. The goal of these services is to:
(a)Optimize geographic coverage on the most valuable Targets while balancing Territory workload;
(b)Target list generation based on business-specific workload parameters including the incorporation of any segmentation, detailing and frequency provided; and

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(c)Identification of uncovered white space geography.
3.8.2Deliverables.
(a)Metropolitan Statistical Area (MSA) overview;
(b)Alignment summary including coverage of top targets;
(c)Uncovered geography summary;
(d)Mapping at territory, district and national levels;
(e)Zip-Terr;
(f)Span of control; and
(g)Target list.
3.8.3Assumptions.
(a)The scope assumes the following:
(1)Alignment will be created utilizing Syneos Health’s preferred alignment software;
(2)Territory workload parameters and Project assumptions are agreed upon before work starts;
(3)All third-party agreements are signed off on before work starts;
(4)If third-party data purchased by Syneos Health will be passed through to Client;
(5)Client will supply physician level universe which will include best address.  Any workload specific data points will be mutually agreed upon by the Parties (i.e., Rx, Deciles, etc.);
(6)One (1) per-deployment interactive alignment session for the field managers for minor geographic tweaks; and
(7)Quarterly Target or Call plan updates will be managed through the Veeva Action Request process, with timing provided for call plan updates that represent [***] changes in territories, geographies or segmentation.   This will be done for alignment and Target updates each quarter, with District Manager/Sales Management reviews, per the agreed upon process between Client and Syneos Health.    Additional work-effort will require work estimates and Change of Scope as detailed in Section 3.1.1(d), to be coordinated by the PM.
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(b)Items not included in the assumptions:
(1)Major realignments or re-targeting exceeding [***] changes in territories, geography, or segmentation such as new Target strategy, expansions, or down-sizing; and
(2)Additional mapping and data analysis.
		3.9
	Incentive Compensation Management


		3.9.1
	Generally.  Syneos Health incentive compensation management will design and /or implement an annual incentive compensation (“IC”) plan and administer quarterly payouts.  Syneos Health IC personnel will facilitate an IC assessment meeting to ascertain scope of work, IC plan parameters, data availability, budget, IC plan goals and incentive compensation culture. Sessions will be led by Syneos Health IC employees experienced in the discipline of IC plan design and field performance measurements.  The assessment sessions are strategically structured to aid in the IC plan design, consisting of metrics aligned to business strategy. After the IC plan design has been approved by the parties, the Syneos Health incentive compensation department will implement, manage and administer IC plan.


3.9.2Standard IC Services are inclusive of the following:
(a)Post the launch year, which will include at least one full year from the date of launch, a single annual IC plan for each Client team (i.e. Sales and Sales Managers) for the covered field employees, with no more than two (2) Plan Updates (as defined herein) per year.  A “Plan Update” is defined as a change, which does not alter the IC plan structure thus resulting in an amendment to the IC plan.  Changes to IC plan structure, which require a new set of modeling, design work, and/or plan communication documentation are considered a “New Plan,” and may be subject to a separate Statement of Work (“SOW”).
(b)The components of an IC plan will include the following:
(1)Plan concept presentation deck;
(2)Formal plan document with electronic signature;
(i)Inclusive of:
		·
	Plan design measurements


		·
	Business rules


		·
	Data crediting


		·
	Calculations


		·
	Participation rules


		·
	Terms and Conditions


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(ii)IC Plan document will be reviewed by the following:
		·
	Syneos Health Sales Leadership


		·
	Syneos Health Human Resources


		·
	Syneos Health Corporate Compensation


		·
	Syneos Health Authorized Legal


(3)Monthly spreadsheet (“IC Grid”) of calculated results (dependent on data availability and IC plan design);
(4)Monthly field scorecards (dependent on data availability and IC plan design);
(5)Quarterly payout administration in accordance with the Syneos Health payroll calendar;
(6)A single contest/special performance for field force per year to include:
(i)Contest Concept Presentation Deck;
(ii)Formal Plan Document with electronic signature;
(iii)Single payout administration in accordance with the Syneos Health payroll calendar; and
(iv)Single contest grid and/or scorecard of contest results.
(7)A single annual President’s Club contest/trip to include:
(i)Results published in conjunction with the monthly IC reporting process.
(8)Additional services and changes will be subject to the Change Control Process and subject to an amendment.
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3.9.3IC Plan Deliverables and Timelines.
(a)Design Phase.
​
	Category
	Description
	Duration/Timeline

	IC Plan Meeting(s)
	Initial Meeting to discuss:

●
Corporate Philosophy



●
Sales Goals/Objectives



●
Sales/Marketing Strategy



●
Business Rules



●
Data Inputs



●
Eligibility Requirements



	1 day – initial meeting; subsequent follow-up meetings may be held to discuss pending topics or matters requiring further discussion from initial meeting.
Maximum timeline 3 weeks

	IC Modeling
	Based on inputs derived from initial IC meeting(s), Syneos Health will create/provide IC deck illustrating:

●
Recommended IC plan(s)



●
Payout Scenarios/Distribution



	●
1 week to provide recommendation


●
1 week for feedback/follow-up


●
Additional time may be needed if data is required for modeling




	Field Communication
	IC Plan communication includes:

●
PowerPoint deck (Management Team & Sales force)



●
Word/PDF document (for IC plan participants/acknowledgement)



	3 weeks (maximum) once IC plan has been finalized.



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(b)Implementation Phase.
​
	​


	​


	​



	Category
	Description
	Duration/Timeline

	IC Plan Programming
	
●
Data Process Setup



●
SQL Programming



●
User Interface Setup



●
Report/Scorecard Programming



●
KPI/MBO Programming (if applicable)



	Maximum of 3 weeks after receipt of initial sales data file in final format



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	Category
	Description
	Duration/Timeline

	​
	
●
Acknowledgement Portal Setup



●
Administration Portal Setup



●
Programming QC & Testing



●
Validation & QC of IC plan programming (independent of  Programming QC)



●
Minor changes (cosmetic, etc.)



	​



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(c)Maintenance/Management Phase.
​
	​


	​


	​



	Category
	Description
	Duration/Timeline

	Plan Administration
	IC plan processing

●
Report Generation




o
Payout Grid/Summary



o
Scorecard



o
Management Summary




●
IC plan QC



●
Report Distribution



●
Roster Management



●
Eligibility; LOA; PIP; New Hire



●
IC Portal Maintenance



●
Acknowledgment



●
Administration



	4 weeks after receipt of monthly sales data file



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As IC is a passthrough expense to Client, Syneos Health encourages Client input on IC plan design.  In instances where Client has given input into the IC plan design or when Syneos Health implements an IC plan design created by Client, Client acknowledges and agrees that it shall use best efforts to timely approve such IC plan design.  The foregoing notwithstanding, in the event field force goals, dependent data, Client requested input, and/or plan documentation are not approved by Client and/or acknowledged by the field force within forty-five (45) calendar days into the then current IC plan period, Syneos Health reserves the right to implement either the IC plan which was utilized in the prior IC period or an Syneos Health standard best practice IC plan, and Client
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acknowledges that by engaging Syneos Health to perform incentive compensation management, Client is expressly consenting to the foregoing.
		3.10
	Field Support Services


3.10.1Help Desk.  The Syneos Health field support service desk supports Syneos Health systems and operational processes for field user readiness and performance.
(a)Field support service desk hours are Monday through Friday, 8am-10pm, Eastern Standard Time
(b)Standard Syneos Health metrics and KPIs for call and ticket resolution
(c)Field Support can be reached via telephone or via email
(d)Knowledge base will be supplied for field support service desk based on Client business rules and system configuration
(e)Standard monthly reporting will be provided along with post-rollout daily monitoring reporting for 2 weeks following each field deployment
3.10.2Asset Management.
(a)Syneos Health will provide asset management services ranging from hardware procurement, to configuration and deployment, and includes tracking IT assets throughout the life of the Project.  Syneos Health maintains a suite of standard Windows images and custom images available as needed.  Client hardware is asset tagged, scanned and secured in a locked area with restricted access for designated IT personnel.
(b)Standard hardware platform includes:
(1)Field laptop with carrying case
(2)Apple iPad with cover
(3)Printer
(c)Users are given Syneos Health-hosted email boxes with the option to configure with Client-like domains/addresses to give the look and feel of a Client employee.
(d)All Client launches include a [***] spare pool of hardware to be used as replacements in the event of breakage or theft/loss.  Repairs/replacements are shipped out to the end-users within 48 hours of receipt of broken hardware.
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(e)Passcode-protected iPads are deployed using our mobile device management software with remote-wipe capabilities for added security.  App packaging and deployment capabilities are available.  For clients opting for iPads with data plans, we can activate with one of the major carriers prior to shipment and then maintain that data plan throughout the life of the contract.
		3.11
	Technology Training Services


3.11.1Generally.  Syneos Health will provide technology training services for the Sales Team.  The technology training services format follows Syneos Health’s core training content and facilitation approach.  Training delivery assumes the following structure:
(a)Pre-learning home study training (e-modules)
(b)Face-to-face training (up to 1 day)
(c)Post-training mastery (up to 2 hours WebEx)
3.11.2Content.  The training content will include key Syneos Health supported field hardware and applications including the following topics: iPad basics, Concur T&E, HCP Spend Capture, Veeva CRM, Veeva Analytics & Dashboards, and Customer Maintenance. New hire training will be delivered using the same content developed for implementation and offered at the frequency of one class per quarter, with the preferred Client format of either WebEx or face-to-face delivery.   Additional training is offered as needed following the Change of Scope process in Section 3.1.1(d) of this Exhibit A-1.
		3.12
	Learning Management System (LMS)


Syneos Health will supply Client with our standard LMS system for the delivery and tracking of all online training.  Standard LMS reporting will be provided to internal Syneos Health leadership and Client for communication of training completion and verification of required compliance training.   The LMS can contain a combination of Syneos Health and Client-created content to enable its use across all product, selling skills, soft skills, and compliance training and service as a central repository for all training records.
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Standard LMS Service Levels are indicated in the below table:
​
	Standard SLA Agreement - Content Load*

	Task/Request
	Timeline

	Simple PDF Load
	1-2 days

	Simple SCORM Load
	2-4 days

	Simple Assessment
	2-3 days

	Registrations/Assignments for existing activities and users
	24 hours

	Add Additional users (upon notice)
	End of next business day

	Transcripts
	24 hours

	Complex Assessment
	3-5 days

	Complex Course with Assessment
	5-7 days

	High Stakes/Large Assessment
	5-7 days



​
		3.13
	Quality Management and Assurance


3.13.1Quality Management System (QMS).  All Client implementations are managed via an approved set of Standard Operating Procedures (SOPs) which are part of Syneos Health’s Quality Management System (QMS) under the Head of Quality Assurance. Key processes such as project governance, document control, CRM implementation and training are required for assigned operations personnel.  Other SOPs such as Change Control, security and access control, asset provisioning, and CRM end-user training are additional required training for implementation teams, which are also delivered and tracked within Syneos Health’s Learning Management System (LMS).
3.13.2System Validation (Sampling Only).  When required by sampling, formal Computer System Validation (CSV) is conducted by professional validation resources following Syneos Health’s System Validation SOP. The work is driven by the approved Configuration Requirements Document (CRD), and includes a Validation Plan, Operational Qualification, Performance Qualification, Test Evidence (typically screen shots), Deviation Reports, Traceability Matrix and a Validation Summary Report.
		3.14
	Field Trigger Email with Veeva Engage


		3.14.1
	Field Trigger Email with Veeva Engage. Syneos Health will provide field-trigger email follow-up to HCPs to reinforce key messages in the Call and distribute the Prescribing Information.  Syneos Health leverages Veeva’s approved email capabilities to ensure compliance and a controlled environment to protect the integrity of the HCP communication.  Approved content for email templates may be stored in the Syneos Health Veeva Vault or the Client’s internal Veeva Vault (if applicable) and linked with the CRM Client Configuration. The solution will also include Veeva Engage to deliver built in virtual voice and video capabilities in a single solution for the field teams.


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	4.0
	Operations Services Termination and Data/System Conversion


Syneos Health will retain all documented business requirements, system configurations, and data collected during the term of the Project Agreement.  If the Client wishes to convert the field team pursuant to the Project Agreement, Client may have the option to continue on with Syneos Health-provided operations services to limit the disruption of field operations and leverage custom built systems, business rules and data integration. In such a case, a separate agreement will be established to confirm the scope and fees for any stand-alone operations services required.  Alternatively, the parties may agree to convert the pre-built CRM configuration utilized for Client, for a fee mutually agreed to by the parties, to cover the migration of data, requirements documentation, and transfer of CRM configuration ownership, training on Client configuration settings and administration, as well as the Project management of the operations conversion, all to ensure a successful migration.  Additionally, if the Client does not want to migrate the Syneos Health CRM configuration, the option may be made for Syneos Health to transfer Client data, business rules documentation, current data production schedules, and custom reporting formats for a fee mutually agreed to by the parties.  If Syneos Health provides any migration or materials, Client is solely responsible for the system knowledge and performance post-conversion.  Syneos Health may provide additional services based on the standard rates provided in the Change Control 3.1.1(d) of this Exhibit A-1.
[Remainder of Page Intentionally Left Blank]
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AMENDMENT AND RESTATED
EXHIBIT F
COMPENSATION - FIXED FEES, VARIABLE FEES AND PASS-THROUGH COSTS
I.FIXED FEES
The Fixed Fees provided in this Exhibit F are based on per position headcount as follows:
​
	Position
	Headcount

	Project Team

	Sales Representatives
	[***]

	RS Reps
	[***]

	RSM
	[***]

	NSD
	[***]



​
The Fixed Fees will be proportionally modified based on the final headcount.
​
		(a)	Implementation Fee

​
(i)Client has paid, or shall pay, [***] pursuant to the Initial Service Agreement (the “ISA”) by and between Client and Syneos Health dated as of March 30, 2020, which will be applied as a credit against the Implementation Fee invoice.
​
(ii)Client shall pay Syneos Health an Implementation Fee of [***] associated with performance of the Services for the Project Team.
​
		(b)	Fixed Monthly Fees

​
(i)Commencing on the Project Team Hire Date, Client shall pay Syneos Health a Fixed Monthly Fee as follows:
​
	PERIOD
	PROJECT TEAM FIXED MONTHLY FEE

	Year One
	[***]

	Year Two
	[***]



​
Syneos Health shall adjust the Fixed Monthly Fee prior to the initial fill of any Syneos Health Sales Representative or RSM, prorated for any partial months, according to the Fixed Monthly Fee table outlined in subsection (c)(i), below.
​
The Implementation Fee and/or Fixed Monthly Fee set forth above are based upon the assumptions set forth in the recruitment/training timeline agrees to by the Parties.  In the event that the assumptions set forth in the recruitment/training timeline are changed, the
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Implementation Fee and/or Fixed Monthly Fee shall be re-calculated and agreed-upon by the Parties.
​
(c)Scale Up/Down
​
(i)Client may increase the number of Representatives, RS Reps, or RSMs above the number outlined in Exhibit A (a “Scale Up”) upon written notification to Syneos Health. In the event of a Scale Up, Client shall pay to Syneos Health an additional Implementation Fee and Fixed Monthly Fee as follows:
​
	Position
	Implementation Fee

	Per Representative
	[***]

	Per RS Rep
	[***]

	Per RSM
	[***]



​
			Fixed Monthly 

	​
	Fixed Monthly Fee
	Fee

	Position
	(Year One)
	(Year Two)

	Per Representative
	[***]
	[***]

	Per RS Rep
	[***]
	[***]

	Per RSM
	[***]
	[***]



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(ii)Client may decrease the number of Representatives, SR. Reps, Telesolutions Agents or DMs below the number outlined in Exhibit A (a “Scale Down”) upon [***] prior written notice to Syneos Health; provided, however, that the Client may not perform a Scale Down prior to the [***] anniversary of the Deployment Date.  In the event of a Scale Down, Syneos Health shall reduce the Fixed Monthly Fee as follows:
​
	​
	Fixed Monthly 

	​
	Fee

	Position
	(Year Two)

	Per Representative
	[***]

	Per RS Rep
	[***]

	Per RSM
	[***]



​
(iii)The Parties shall meet to agree upon Project Team composition in the event of a Scale Up/Scale Down.
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(d)Salary Reconciliation
​
The parties agree that the Fixed Monthly Fees set forth in Section I(b), above, are based on the annual salary per the below table (the “Annual Salary”).
​
	Position
	Salary
	Salary

		(Year One)
	(Year Two)

	Per Representative
	[***]
	[***]

	Per RS Rep
	[***]
	[***]

	Per RSM
	[***]
	[***]



​
Syneos Health and Client will reconcile actual salaries and payroll taxes at [***] (pricing assumption), excluding incentive compensation, measured by actual days worked, for each Syneos Health Sales Representative and RSM in such calendar month against an amount equal to the appropriate percentage of the Annual Salary.  The parties agree that the Annual Salary does not include incentive compensation for the Syneos Health Sales Representatives or RSM (plus the applicable employer portion of taxes).  If any review shows that Syneos Health’s actual annual salary per Syneos Health Sales Representative or RSM is below the Annual Salary, then Syneos Health shall issue a credit for the entire amount of such difference to Client.  If any review shows that Syneos Health’s actual salary per Syneos Health Sales Representative or RSM is above the Annual Salary, then Syneos Health shall bill the difference to Client.
​
(e)Vacancy Credit
​
Syneos Health agrees to fill vacant territories as requested by Client.  Syneos Health will continue to invoice Client the amounts set forth above as Fixed Monthly Fee during any such vacancy period.  Syneos Health will provide a monthly credit to Client, prorated for the number of business days per month that a territory is vacant, for each vacant territory, including leaves of absence lasting longer than [***], until such territory is filled, as set forth in the following table:
​
	Monthly Vacancy
	​
	​

	Credit*
	Year One
	Year Two

	Per Representative
	[***]
	[***]

	Per RS Rep
	[***]
	[***]

	Per RSM
	[***]
	[***]



​
		*
	Within the month a territory becomes vacant.


​
	Monthly Vacancy
	​
	​

	Credit*
	Year One
	Year Two

	Per Representative
	[***]
	[***]

	Per SR. Rep
	[***]
	[***]

	Per RSM
	[***]
	[***]



​
		*
	Subsequent months of vacancy.



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(f)Backfill Recruiting
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Client agrees to pay Syneos Health a fee, per the table below, for recruiting and onboarding costs associated with any backfill for a vacant territory, provided that Client shall only pay such fee in the event that such territory becomes vacant [***] after the applicable hire date.
​
	​
	Backfill

	Position
	Recruiting Fee

	Per Sales Representative
	[***]

	Per RS Rep
	[***]

	Per RSM
	[***]



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II.VARIABLE FEES
(i)Client shall pay Syneos Health the following monthly fees per Client employee receiving operations support (Veeva and LMS Licenses) commencing on the date a Client employee is provided such support.
​
	​
	Monthly Fee
	Monthly Fee

	Position
	(Year One)
	(Year Two)

	Veeva License Only Per Client User
	[***]
	[***]

	LMS License Only Per Client User
	[***]
	[***]



​
(ii)Client shall pay Syneos Health an annual fee of [***] for each Client employee to have access to a list of Client programs on the LMS System (same environment as the Syneos Health Project Team – i.e., no customization per view set-up) commencing on the date a Client employee is provided such support.
​
(iii)Syneos Health shall invoice Client the following Variable Fees associated with the Project Team as incurred.
​
	Additional Services


	Variable Fee



	Phone Append Access (up to 13,000 Records)


	[***]



	Phone Append Access, per Record (After 13,000 Records)


	[***]



	Phone Append Transfer (up to 650 Records)


	[***]



	Phone Append Transfer, per Record (After 650 Records)


	[***]



	Outbound Fax, per page


	[***]



	E-mail, each


	[***]





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III.PASS-THROUGH COSTS
In addition to the Fixed Fees, certain expenses will be charged to Client on a pass-through basis.  These expenses will be billed to Client at actual cost.  Pass-through costs include:
​
		-	Incentive compensation payments for the Syneos Health Sales Representatives, RSMs and NSD(plus applicable employer portion of taxes at [***])

		-	Travel expenses (e.g. transportation, lodging, meals etc.)

		-	Costs for all meetings, including but not limited to POA Meetings

		-	Marketing expenses and costs (e.g. Lunch & Learns, etc.)

		-	Sales TRx data and any third party data acquisition expenses

		-	Syneos Health Sales Representative product storage units

		-	Data plan overages

		-	Interview expenses (including turnover recruiting)

		-	Business cards

		-	Managers’ severance

		-	Licensing and credentialing expenses

		-	Shipping, freight, and postage of samples (if incurred)

		-	Other expenses which have been approved by Client

		-	Costs associated with Project Team Protective Equipment (PPE)

​
IV.INCENTIVE FEES
​
(a) Included in the Fixed Monthly Fees (set forth in Section I(b)(i), above) is Syneos Health’s management fee, a portion of which (the “Incentive Fee”) is subject to Syneos Health’s achievement of certain performance objectives (the “Performance Objectives”) which will be mutually agreed upon by the Parties.
​
(b)The monthly Incentive Fee for the annual period from the Deployment Date through the end of Year One is equal to [***] and the monthly Incentive Fee during Year Two is equal to [***].
​
(c)In the event of a Scale Up or Scale Down, the monthly Incentive Fee shall be adjusted by [***] per Syneos Health Sales Representative from the Deployment Date through the end of Year One, and [***] per Syneos Health Sales Representative during Year Two.
​
(d)In the event of termination of this Project Agreement by the Client, effective as of the date of notification of such termination from the Client, the Performance Objectives shall no longer be applicable and the outstanding incentive fees will be earned at [***]; unless Project Agreement is terminated due to material breach by Syneos Health in accordance with Section 12(ii) of the MSA.
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V.SERVICE CREDITS
​
Syneos Health shall issue to Client annual service credits of [***] per Syneos Health Sales Representative (estimated to be [***] in Year One and [***] in Year Two).  Credits shall be earned at a rate of [***] per month per Syneos Health Sales Representative territory, for which a fee has been paid, commencing on the Deployment Date. Client may use all expected credits at any time during the Term and shall repay Syneos Health at the end of the Term for any credits used, but never accrued. The service credits shall be used to purchase additional services from Syneos Health’s Affiliates. The term Affiliate means, with respect to any entity, any other entity directly or indirectly, through one or more intermediaries, controlling, controlled by or under common control with such entity.  As used in this definition, the term “control” (including “controlled by” or “under common control with”) means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of an entity, whether through ownership of voting securities, as trustee, by contract or otherwise. For purposes of clarity, Client shall not be permitted to apply the credits against any of the fees or costs associated with Services provided under this Work Order or any others services provided by Syneos Health, it being understood that the credits are applicable only for services provided by a Syneos Health Affiliate. The credits shall be valid until expiration or termination of this Work Order. Syneos Health shall not provide any form of refund, rebate or any other form of monetary incentive to Client in lieu of the credits.
​
VI.INVOICES; BILLING TERMS
​
The Implementation Fees outlined in Section I(a), above, shall be invoiced to Client upon execution of the Project Agreement.  [***] of Sales Team Fixed Monthly Fee and [***] of Agents Fixed Monthly Fee (the “Advanced Fees”) shall be paid by Client to Syneos Health which will be invoiced to the Client [***] prior to the sales representative hire date.  The Advanced Fees shall be held as a deposit and credited to Client upon expiration or termination of the Project Agreement. Thereafter, commencing on the Project Team Hire Date, Client will be billed monthly in advance the amounts stated above as the Fixed Monthly Fees.  Pass-through Costs will be billed to Client at actual cost as incurred by Syneos Health.
Invoices are due in accordance with Section 5 of the MSA.  All invoices shall include the following:
​
		-	A/P Email

		-	A/P Telephone

		-	A/P Mailing Address

		-	A/P E-invoice System

		-	Other Contacts to be Included on Submission of Invoice

		-	Accountant

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Payment to Syneos Health may be made by the following method:
​
		-
	ACH Payment (Preferred Method)


[***]
ACH # [***]
Account # [***]
​
Advice transmittals should be directed to [***].
​
In the event Client will be issuing purchase orders for payment of Syneos Health invoices, Client shall issue such purchase orders within [***] following the execution of this Project Agreement.  A purchase order shall include the following:
​
		-
	PO Number


		-
	PO Contact Name


		-
	PO Contact E-mail


		-
	PO Contact Telephone


Purchase Orders should be directed to [***].
​
The Parties understand and agree that all terms and conditions set forth in a purchase order are null and void, it being understood and agreed that this Project Agreement provides the terms and conditions governing the relationship between the Parties.

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