Document:

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Exhibit 10.1
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.
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PROJECT AGREEMENT
(DETAILING – FIELD TEAM AND TELESOLUTIONS)
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This Project Agreement (this “Project Agreement”) is made as of April 30, 2020 (the “Effective Date”) by and between inVentiv Commercial Services, LLC, a Syneos HealthTM group company, with an office located at 500 Atrium Drive, Somerset, NJ 08873 (“Syneos Health”) and Agile Therapeutics, Inc. with an  office located at 100 Poor Farm Road, Princeton, New Jersey 08540 (“Client”).  Client and Syneos Health may each be referred to herein as a “Party” and collectively, the “Parties”.
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RECITALS
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A.        Client and Syneos Health have entered into a Master Service Agreement dated as of October 11, 2017 (the “MSA”).
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B.         Client and Syneos Health desire to enter into this Project Agreement pursuant to which Syneos Health shall provide Syneos Health sales representatives, district managers and telesolutions agents to provide detailing services as set forth more fully in Exhibit A and B attached hereto.
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1.         Interpretation and Construction
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(a)        The Parties confirm that the MSA shall govern the relationship between the Parties.  Unless otherwise specifically set forth herein, in the event of a conflict or inconsistency between the terms and conditions set forth in the MSA and the terms and conditions set forth in this Project Agreement, the terms and conditions set forth in this Project Agreement shall take precedence, govern and control.
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(b)        The Parties hereby acknowledge that the terms set forth in the MSA are incorporated herein by reference, as if fully set forth at length therein.
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2.         The Services
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A description of the detailing services (the “Detailing Services”) is set forth on Exhibit A attached hereto and made a part hereof.  A description of sales operations, implementation and on-going services for the field and telesolutions team (the “Sales Operations Services”) is set forth on Exhibit A-1 attached hereto and made a part hereof. A description of the telesolutions services (the “Telesolutions Services”) is set forth on Exhibit B attached hereto and made a part hereof.  A description of the compliance services (the “Compliance Services”) is set forth on Exhibit C attached hereto and made a part hereof.  A description of the sample accountability services (the “SA Services”) is set forth on Exhibit D attached hereto and made a part hereof.  A description of the training services (the “Training Services”) is set forth on Exhibit E attached hereto and made a part hereof (the Training Services, Compliance Services, Sales Operations Services and, collectively with the Detailing Services, the “Services”).
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3.         The Term
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This Project Agreement shall be in effect as of the Effective Date and shall remain in effect until the second anniversary of the Deployment Date (as defined in Exhibit A), unless extended as provided herein (the “Term”) or unless earlier terminated as set forth below.  The period from the Effective Date through the day prior to the one year anniversary of the Deployment Date shall be referred to herein as “Year One,” and the period from the one year anniversary of the Deployment Date through the day prior to the second anniversary of the Deployment Date shall be referred to herein as “Year Two.”  The Term may be extended for additional periods of one (1) year (each an “Additional Term”) upon the mutual written agreement of the Parties not less than [***] before the end of the Term or any Additional Term.
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4.         Termination
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(a)        Notwithstanding Section 12(a)(iii) of the MSA, either Party may terminate this Project Agreement by providing the other Party with [***] prior written notice; provided, however, that such termination by Client may not occur [***], and if such termination by Client occurs [***], Client shall pay Syneos Health a termination fee based on the actual date of termination according to the following table schedule:
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(b)        In the case of termination of this Project Agreement by Client (except for termination by Client pursuant to Section 12(a) (ii),(iii) or (iv) of the MSA), a Scale Down, or at the end of the Term (or any Additional Term), Client shall (in addition to all other payment obligations under this Project Agreement) promptly pay (or if paid by Syneos Health, promptly reimburse) Syneos Health for: the amount due any lessor or rental agent of the fleet vehicles (“Fleet Vehicles”) and information technology equipment (i.e. laptops and iPads) (“IT Equipment”) leased or owned by Syneos Health and provided to members of the Sales Team (as defined in Exhibit A) or the Telesolutions Team (as defined in Exhibit B) (collectively, the “Project Team”), for any early termination of the lease or rental agreement.  Client may elect to:
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(i)         either, (i) transfer the IT Equipment to Client and pay an amount equal to the net book value (if any) of the IT Equipment on the books of Syneos Health at the time of the transfer event, or, (ii) dispose of the IT Equipment and pay Syneos Health the net loss on such IT Equipment. Net loss is calculated as the remaining net book value of such IT Equipment, plus any amounts due by Syneos Health in connection with the lease or rental termination and costs associated with the storage and disposal of said IT Equipment.
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(ii)       dispose of the Fleet Vehicles and pay Syneos Health the net loss on such Fleet Vehicles. Net loss is calculated the difference between the remaining net book value of such Fleet Vehicles and the actual net price received by Syneos Health for the disposal of such Fleet Vehicles, plus any amounts due by Syneos Health in connection with the lease or rental termination and costs associated with the transportation, storage, and disposal of said Fleet Vehicles.
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(c)        Notwithstanding Section 4(a) of this Project Agreement, Client may immediately terminate this Project Agreement upon prior written notice to Syneos Health, in the event that the United States Food and Drug Administration (the “FDA”)has caused the withdrawal from the market of the Product, and such withdrawal causes or will cause this Project Agreement and/or Client’s commercialization of the Product to no longer be commercially viable (such commercial viability to be mutually determined by the Parties in good faith); provided, however Client shall pay Syneos Health for all fees and expenses under this Project Agreement incurred through the effective date of such termination.
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(d)        In the event of a change of control, or assignment to a successor in interest in accordance with Section 14(b) of the Agreement, the assignee or successor in interest may terminate this Project Agreement by providing Syneos Health with [***] prior written notice; provided however, that if such termination by assignee or successor in interest occurs [***], assignee shall pay for all fees and noncancelable expenses under this Project Agreement incurred through the effective date of such termination and assignee shall pay a termination fee for each Sales Representative and Telesolutions Agent allocated hereunder in accordance with the below table schedule:
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5.         Conversion
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(a)        Notwithstanding Section 7 of the MSA, during the Term (or any Additional Term), Client may solicit, employ or retain the Syneos Health Sales Representative(s), DM(s) or Telesolutions Agent(s) performing Services hereunder (each a “Conversion”) upon [***] prior written notice to Syneos Health. In the event of a Conversion, Client may elect to either:
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(i)         backfill the position subject to such Conversion as to maintain the number of Syneos Health Sales Representatives and DMs as outlined in Exhibit A and Telesolutions Agent as outlined in Exhibit B and pay Syneos Health a recruitment fee for replacement/backfill per the table below; or
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(ii)       Scale Down the respective position pursuant to the terms of Section I(c)(ii) of Exhibit F and pay Syneos Health the Conversion Fee outlined in the below table based on the actual date of such Conversion.
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(iii)      The Parties shall meet to agree upon Project Team composition in the event of conversion.
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(b)        Client understands and agrees that Syneos Health cannot guarantee that the Syneos Health Sales Representative, DM or Telesolutions Agent will agree to participate in a Conversion.
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(c)        In the event Client implements a Conversion, the Parties agree that any and all training materials created by Syneos Health, without the use of any Client Confidential Information, and made available to the Syneos Health Sales Representative(s), DM(s) or Telesolutions Agent(s) will be immediately returned to Syneos Health, it being understood and agreed that the Syneos Health proprietary training modules constitute valuable and proprietary information of Syneos Health and are subject to the confidentiality obligations set forth in Section 6 of the MSA.  Within [***] of implementing a Conversion, Client shall return to Syneos Health any originals and copies of Syneos Health proprietary training modules, which had been in the possession of the converted Syneos Health Sales Representative, DM or
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Telesolutions Agent.
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6.         Fees
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Set forth on Exhibit F are the fees to be paid by Client to Syneos Health for the performance of the Services.
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WHEREFORE, the parties hereto have caused this Project Agreement to be executed by their duly authorized representatives on the day and year first above written.
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	AGILE THERAPEUTICS, INC.
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	INVENTIV COMMERCIAL SERVICES, LLC

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	By:
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	By:
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	Name:
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	Name:
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	Title:
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	Title:
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	Date: 
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	Date: 
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EXHIBIT A
THE DETAILING SERVICES
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Syneos Health will provide Client with a field force that shall consist of [***] full-time sales representatives (the “Representatives”) consisting of up to [***] senior representatives (the “SR. Reps” and collectively with the Representatives, the “Syneos Health Sales Representatives” or “Sales Representatives”) who shall detail Client’s Product by making Calls pursuant to a Call Plan on Targets in two waves of deployment as defined in the below table.
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The Sales Representatives will be managed by up to [***] district managers (the “DMs”) who will also be Syneos Health employees.  Syneos shall also provide [***] national sales director (the “NSD”).  The Sales Representatives, DMs and NSD may be referred to collectively herein as the “Sales 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 Wave One, the Telesolutions Agents, Sales Representatives, and the DMs.  The Fees associated with the Wave Two headcount shall be handled as a Scale Up pursuant to Section I(c)(i) of Exhibit F.  Syneos Health shall adjust the Fixed Monthly Fee prior to the initial fill of any Project Team member, pro-rated for any partial months, according to the Fixed Monthly Fee table outlined in Exhibit F, Section I(c)(i).
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In the event that the Parties desire to increase the type and / or number of Sales Team members providing Services under this Project Agreement they may do so by utilizing a Sales 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.
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I.          ADDITIONAL DEFINED TERMS
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(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).
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(b)        “Call Plan” means a plan jointly designed by Client and Syneos Health, which is intended to enhance the efficiency and effectiveness of the Sales 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 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
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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.
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(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.
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(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.
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(e)        “Product” shall mean Twirla®.
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(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.
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(g)        “Sales Team Hire Date” means the date the first Syneos Health Sales Representative is assigned to the Sales Team.
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(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
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(a)        Hire Status—Generally.  Upon completion and approval by the parties of the field alignment and profile (including approval of the final number of Sales Team members), Syneos Health will commence recruiting and hiring activities for the Sales 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 Sales Team members.
(ii)       Fleet Vehicles and fleet management services for the Sales Representatives include the following:
(1)        Coordination of department of motor vehicle (“DMV”) checks and confirmation of completion for all employees in Fleet Vehicles
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(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 Sales 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:
(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
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(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:
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(i)         Syneos Health shall be responsible for training members of the Sales Team pursuant to Exhibit E.
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(ii)       Client shall be responsible for training members of the Sales 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 Sales Team.
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(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.
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(e)  Syneos Health will be responsible for providing credit cards to any Syneos Health Sales 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.
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III.       PERFORMANCE
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If Client believes in good faith that the performance of any Syneos Health Sales Team member is unsatisfactory or is not in compliance with the provisions of this Project Agreement, 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 Sales 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
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any Syneos Health Sales Team member, Client may request the removal of such Syneos Health Sales Team member by promptly notifying Syneos Health in writing, and Syneos Health shall remove the Syneos Health Sales 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 Sales Team member has violated or is alleged to have violated any applicable law, regulation or policy.
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IV        CALLS AND TARGETS
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The Syneos Health Sales 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 Sales 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
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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
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In selecting Sales 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 Sales Team members.  Syneos Health shall not knowingly employ or otherwise retain, or permit to be retained as a Sales 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.
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VII.     BACKGROUND CHECKS
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Syneos Health shall be responsible for performing drug testing and background checks of all
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Sales Team members.  Syneos Health represents and warrants that it will complete or cause to be completed a thorough background check of all Sales 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:
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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);
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b.         is, so far as it is aware, an unfit or an improper individual for the performance of the Services;
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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.
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Syneos Health shall institute prompt corrective or disciplinary action against any Sales 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 Sales Team members under this Project Agreement.
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VIII.    REPRESENTATIONS AND UNDERTAKINGS
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(a)        [***].
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(b)        Client represents that:
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(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 necessary materials and assistance required to enable Syneos Health to perform the Services;
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(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;
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(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;
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(iv)       it shall ensure that none of its employees working with the Sales 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
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(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.
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(iv)       Client shall:
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A.        provide Syneos Health Sales Team members with all Product Literature and arrange for the provision of Product samples (as applicable).
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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.
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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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EXHIBIT A-1
FIELD OPERATIONS SERVICES (SALES TEAMS)
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
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;
(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;
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(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.);
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(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:
(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.
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(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
	[***]

	Testing
	[***]

	IC Administration
	[***]

	Training (Content/Delivery) 
	[***]

	Hardware/Help Desk
	[***]

​
3.2       Customer Relationship Management (“CRM”)
3.2.1    CRM; 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;
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(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.
3.2.2    CRM; Client Configuration Development and Implementation.  CRM implementation will be led using an agile development approach including the following deliverables:
	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.

​
3.2.3    Client 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);
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(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;
(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;
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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.
(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.
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(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).
​
3.4       Travel and Expense Management
3.4.1    Travel & 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;
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(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.
3.4.2    Travel & 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.

​
3.5       Transparency Reporting
3.5.1    Background.  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.
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3.5.2    Data 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;
(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
3.6.1    Generally.
(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.
3.6.2    Data 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;
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(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:
(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);
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(4)        Setup of integration between Veeva CRM and data warehouse, which allows roster, Territory hierarchy and Product management to be seamless (daily);
(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).
3.6.3    Assumptions.  The scope of the data management delivery and associated timelines for the Project assumes the following:
​
	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

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3.6.4    Non-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.
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).
3.7.2    Veeva 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
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(iv)       Call Plan Analysis Report can be found on the analytics tab.
(3)        Measure the impact of detailing and sampling on sales –
(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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	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
​
6.      All Dashboard elements are pictorials which aggregate data from an underlying report
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	Template Reports
	Base Assumptions
	Standard Frequency

		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
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12.    Account Demographics
a.     Target/Non-Target
b.     Account Type (practitioner, pharmacy, staff, etc.)
c.     Specialty
d.     Segmentation
e.     Custom Profile Attributes
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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

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

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	Template Reports
	Base Assumptions
	Standard Frequency

		3.      Comparison of sales data amongst the assigned span of control
	
	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

​
3.7.3    Custom 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
3.8.1    Generally.  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
(c)        Identification of uncovered white space geography.
3.8.2    Deliverables.
(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.
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3.8.3    Assumptions.
(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.
(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
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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.
3.9.2    Standard 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
(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;
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(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.
​
3.9.3    IC Plan Deliverables and Timelines.
(a)        Design Phase.
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	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

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	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.

​
(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)
·      Acknowledgement Portal Setup
·      Administration Portal Setup
·      Programming QC & Testing
·      Validation & QC of IC plan programming (independent of  Programming QC)
·      Minor changes (cosmetic, etc.)
	Maximum of 3 weeks after receipt of initial sales data file in final format

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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
	4 weeks after receipt of monthly sales data file
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	·      Eligibility; LOA; PIP; New Hire 
·      IC Portal Maintenance
·      Acknowledgment
·      Administration
	​

​
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 acknowledges that by engaging Syneos Health to perform incentive compensation management, Client is expressly consenting to the foregoing.
3.10     Field Support Services
3.10.1  Help 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
3.10.2  Asset 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.
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(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.
(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
3.11.1  Generally.  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)
3.11.2  Content.  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.
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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. 
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

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3.13     Quality Management and Assurance
3.13.1  Quality 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).
3.13.2  System 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.
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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.
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[Remainder of Page Intentionally Left Blank]
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EXHIBIT B
TELESOLUTIONS SERVICES
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Syneos Health will provide Agile with [***] full time telesolutions agents (the “Telesolutions Agents”) who shall detail Agile’s Product by making Calls pursuant to a Call Plan on Targets.  The Telesolutions Agents shall be managed by [***] shared Call Center Manager, allocated at [***] (the “CCM”).  The Telesolutions Agents and CCM may be referred to collectively herein as the “Telesolutions Team.”
​
In the event that the Parties desire to increase the type and / or number of Telesolutions Agents providing Services under this SOW 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 SOW other than those specific items set forth on the Request Form.
​
I.           DEFINITIONS
​
(a)        “Telesolutions Agent(s)” mean the full-time tele-solutions personnel who are Syneos Health employees hired, trained and assigned to provide the Telesolutions Services.
(b)        “Call” means the telecommunication-based discussion with an HCP (as defined in subsection (e) below).
(c)        “Call Plan” means a plan jointly designed by Client and Syneos Health, which is intended to enhance the efficiency and effectiveness of the Telesolutions Agents 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 according to the Standard Pricing Table outlined in Exhibit A-1, as agreed upon in writing, for the performance of such amendment or reconfiguration services.
(d)        “Client Material” means all Client provided written, printed or graphic material, intended for use by the Telesolutions Team including call script / guide, visual aids, file cards, literature, clinical studies, reprints, drug information updates and any other promotional support items that Client deems necessary or desirable.
(e)        “Go-Live Date” means the date of the first Call by a Telesolutions Agent.
(f)        “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 who are contacted by Agents or who contact Syneos Health via the assigned project toll free number with inquiries regarding the Client’s Product (as defined in subsection (g) below).
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(g)        “Product” shall mean Twirla®.
(h)        “Targets” means the HCPs who are identified by Client as potential prescription writers and/or customers for the Product as provided by Client to Syneos Health.
(i)         “Telesolutions Team Hire Date” shall mean the date that the first Telesolutions Agent is allocated to the Telesolutions Team.
II.        TELESOLUTIONS ACTIVITIES
Syneos Health shall be responsible for performing the following telesolutions activities as related to Agile’s Product:
​
(a)        Syneos Health will provide the following:
​
(i)         Third party data (phone number append, where applicable) purchased by Syneos Health in accordance with the business rules document will be billed to Agile as a pass-through expense.
​
(ii)       Standard Call activity reports will be provided to Agile on a weekly basis, focused on the Key Performance Indicators (the “KPIs”) determined for the project including successful qualification and scheduling metrics based on total target population provided.  The metrics and reporting layout will be defined, documented, and agreed upon during implementation in line with the business rules document.
​
(iii)      Coverage of up to [***] unique HCP Target records for the [***] Level 2 Telesolutions Agent
​
(iv)       Configuration of the Service Cloud CRM, including telephony integration.
​
1.   includes up to [***] question/answer survey configuration, email and SMS templates (each);
​
2.   AE process configuration using client specified form;
​
3.   call recording configuration (as determined applicable by client regulatory requirements); and
​
4.   call cycle configuration+IVR integration.
​
(v)        Development of an Agile approved Interactive Voice Response (IVR)/inbound Call flow which will facilitate automated transfers of callers to the appropriate team for handling, based on the reason for their Call.
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(vi)        Syneos Health will support inbound customer service for HCPs returning calls and looking for more information.  HCPs will be offered Product details and the opportunity to request the follow up Product information email.
​
(vii)     Documentation, configuration and implementation of the initiative level business rules document and data load of HCP, office and territory data.
​
(viii)    Setup of follow up email templates (up to a maximum of [***] forms) which can be triggered as follow up to a phone interaction, with opt-in from the recipient.
​
(ix)       Setup of follow up fax template (up to a maximum of [***] forms) which can be triggered as follow up to a phone interaction, with opt-in from the recipient. Faxing template will be configured to support DTP sampling, as needed, and will be integrated with requirements of the sample fulfillment vendor.
​
(x)        Updates to the target list and agent assignments on a quarterly basis.
​
(xi)       Integration with sample fulfillment vendor and mailhouse (distribution of any hard copy materials). Any additional fulfillment integration or vendors may require additional work effort and scope with incremental setup and ongoing support fees.
​
(xii)     Agile approval of call guide must be received at least [***] prior to beginning telesolutions outreach.
​
(xiii)    A training plan that incorporates all Syneos Health required training, including tele-solution standard operating procedures and system training.
​
(xiv)     Append phone numbers to entire universe at initial load – target HCP/ HCP office data needs to be provided [***] prior to the Go- Live Date if the phone append is required and [***] prior to go live if viable, current phone number data is included in the file.
​
(xv)      Load Target universe with unique physician identifier that will link the record back to Agile systems.
​
(xvi)     Standard Call activity reports will be provided to Agile on a weekly basis, focused on the KPIs determined for the project including successful qualification and scheduling metrics based on total target population provided.  The metrics and reporting layout will be defined, documented,
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and agreed upon during implementation in line with the business rules document.
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(xvii)   Agile will provide a direct contact that is responsible for development of HTML files that can be used to load to the CRM for email follow up communications.  The project assumes setup of up to [***] template emails with HTML files to be provided by third party.
​
(xviii)  Ongoing CRM Configuration modifications will be supported to provide continuous improvement of the program – including call outcome tags, detailed data capture requirements, call cycling plans.  Syneos team will provide up to [***] per month of Business Solutions design, CRM Configuration changes and Testing.
​
(xix)      Outbound Calls will consist of a touch point in [***] call cycles (each, a “Call Cycle”) over a twelve (12) month period, with up to [***] attempts per Call Cycle to reach a decision maker at each Target record, with the following assumptions.  The call prioritization and cycling to match this frequency will be configured in the Salesforce.com CRM.
​
1.         The number of Calls per day to a primary care office is approximately [***];
​
2.         The Total Office Call consists of messaging a clinical staff member (i.e., physician assistant(s) (PAs), nurse practitioner(s) (NPs), registered nurse(s) (RNs), medical assistant(s) (MAs), and certified medical assistant and registered nurse(s) (CMA and RNs);
​
(xx)      The goal will be to reach decision makers in the Target’s offices to drive awareness of the benefits and key features of the Product. Syneos Health will track data resulting from the discussions in a manner agreed to between the Parties. The program details are further described as follows:
​
1.    Outbound Calls to Targets in ‘whitespace’ (geographies which are not covered by a field-based representative) and/or territories with physical access restrictions, “low frequency” field covered Targets and other targets disseminated by Agile from time to time who have no field coverage.  Outbound Calls will focus on providing Product information, Product Literature, raising awareness of the benefits, key features and availability of the Product.
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III.        STATUS, TRAINING AND MEETINGS
(a)        Hire Status—Generally.  Upon completion and approval of the field alignment and profile, Syneos Health will commence recruiting and hiring activities for the Telesolutions Agent.  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 the Telesolutions Agent with the following:
(i)   Salary, benefits, and incentive compensation payments as agreed by Client.
(ii) Human resources management services 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
(i)   Human resources management services assume the following:
(8)        Timely completion of background vendor required information through its link for new hires
(9)         Information regarding vacation, and incentive compensation expectations are available for inclusion in the offer letters
(10)      Information technology hardware to include iPads and laptop computers (including sales force automation software) and printers.
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 (c)       Training - The training responsibilities of the Parties are as follows:
​
(i)         Syneos Health shall be responsible for training members of the Telesolutions Team concerning: Syneos Health human resource policies, procedures and administration and other applicable Syneos Health internal human resource and general compliance policies and procedures.
​
(ii)       Client shall be responsible for training members of the Telesolutions 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 Telesolutions Team.
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III.       PERFORMANCE
​
If Client believes in good faith that the performance of any Telesolutions Agent is unsatisfactory or is not in compliance with the provisions of this Project Agreement, 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 Telesolutions Agent 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 Telesolutions Agent, Client may request the removal of such Telesolutions Agent by promptly notifying Syneos Health in writing, and Syneos Health shall remove the Telesolutions Agent 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 Telesolutions Agent has violated or is alleged to have violated any applicable law, regulation or policy.
​
IV.        CALLS AND TARGETS
​
The Telesolutions Agent shall provide Client Material when making Calls as directed and approved by Client.  Client is solely responsible for the content, production and distribution (to the Telesolutions Agent) of the Client Material.  Each Telesolutions Agent 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 Telesolutions Agent calls.  Client shall permit Syneos Health to access and use all Targets, 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
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for the purpose of evaluating the performance of its Telesolutions 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
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In selecting the Telesolutions Agent, 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 Telesolutions Agents.  Syneos Health shall not knowingly employ or otherwise retain, or permit to be retained as an Telesolutions Agent, 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.
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VII.     BACKGROUND CHECKS
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Syneos Health shall be responsible for performing drug testing and background checks of all Telesolutions Agents.  Syneos Health represents and warrants that it will complete or cause to be completed a thorough background check of all Telesolutions Agents.  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 Telesolutions Agent:
​
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.
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Syneos Health shall institute prompt corrective or disciplinary action against any Telesolutions Agent who fails to meet the requirements set forth in this Exhibit B.  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 Telesolutions Agent under this Project Agreement.
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VIII.    REPRESENTATIONS AND UNDERTAKINGS
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(a)        [***]
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(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 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 Client Material, 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 Telesolutions 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.
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(iv)       Client shall:
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D.        provide Telesolutions Agents with all Client Material.
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E.         inform Syneos Health promptly of any changes which Client
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believes are necessary or appropriate in the Client Material or in information concerning the Products in order to be in compliance with all applicable federal and state law, regulations and administrative guidance.
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F.         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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[Remainder of Page Intentionally Left Blank]
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EXHIBIT C
COMMERCIAL COMPLIANCE SERVICES
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1.0       Executive Summary
This Exhibit C describes the work required for the initial implementation and ongoing services of the Selling Solutions Commercial Compliance Services.  Any changes to the assumptions, deliverables, or scope of work described in this document or any new work requests will follow the procedure set forth in Section 3.1.1(d) (Change Control Process) of Exhibit A-1.
​
2.0       Scope of Services
This Exhibit C defines the work related to the following service areas for the initial implementation and the ongoing services of the Selling Solutions Commercial Compliance teams within the following areas:
·     Compliance Services
·     Monitoring & Auditing
3.0       Compliance Services
Syneos Health will provide compliance services that comply with applicable laws and regulations and are aligned with the philosophy and requirements of OIG’s Compliance Program Guidance in correlation with the following activities.
3.1       Pre-Launch Activities
(a)        Initial interaction and fact finding with clients.
(b)        Development and consultation in regards to the implementation of client specific compliance business rules.
(c)        Creation of all training materials, (home study on Learning Management System) and live training modules.
(d)        Work with and post specific policies required by the client.
3.2       Launch Activities
(a)        Loading and testing of all on-line training to be conducted during home study, as well as assessments to test knowledge and competency.  All tracking and reporting of results from the training.
(b)        Live training to be conducted at launch meetings, POA’s at client site’s or in-house.
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3.3       Ongoing Activities
(a)        Training for all new hires/backfill for replacement personnel or expansions at client site’s or in-house.
(b)        Continual monitoring and updating if guidelines, laws, state requirements, or client business rules change during the course of the year.
(c)        Corporate Integrity Agreement (CIA) obligations, additional training requirements, debarment screening of personnel, and annual certification of personnel and reporting to the client.
(d)        Updates and assistance in supplying the necessary oversight and training at POA meetings during the year.
(e)        Compliance/Representative ride-along program to monitor the field personnel in regards to their compliance requirements as agreed to by the client (Optional).
3.4       Enforcement and Monitoring
(a)        Syneos Health adheres to an “Open Door Policy” and encourages employees to discuss issues and or concerns of misconduct with their manager or other senior personnel, Human Resources, or a member of the Compliance team.
(b)        Syneos Health maintains and also encourages and supports a 24 hour anonymous hotline 7 days a week if the person making the report requires or wishes to remain anonymous.
(c)        Syneos Health has an investigation process in place so as to ensure continuity in enforcement, and transparency with our personnel and clients so proper adjudication is achieved.
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4.0       Monitoring & Auditing
Syneos Health uses the industry standard T&E system, Concur, to capture all expense reimbursement and HCP meal spend.
The Compliance Monitoring & Auditing team will assume the following:
(a)        Standard Concur HCP expense fields and set-up are used for projects;
(b)        Post Manager Compliance Audit of expense reports that contain HCP meal spend for appropriateness and adherence to Client policy on Interactions with Healthcare Professionals; and
(c)        Ensure accountability for problem identification, oversight, follow-up, and resolution generated by the audit findings.
​
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EXHIBIT D
SAMPLE ACCOUNTABILITY SERVICES
​
1.0       Scope of Services
Syneos Health will provide management of third party sample accountability services (“SA”) in compliance with the Prescription Drug Marketing Act (PDMA) regulations for the field sales organization.
​
2.0       Sample Accountability Services
2.1       Implementation
Sample Accountability will be managed and monitored through a third party sample accountability vendor, through a PDMA compliant Inventory Management System. During the set up stages there will be requirements gathering, QA/validation, unit and integration testing with technical documentation prior to production deployment.
(a)        Development will include:
(1)        Interface to map from third party Sample Accountability system and Veeva CRM;
(2)        Qualification of the CRM/ Sample Accountability deployment with Client specific configuration;
(3)        Testing and documentation and validation of the system interfaces;
(4)        File layouts - formatting will be received in designated format;
(5)        Sample data extract for Annual Federal Reporting – Provided to Client in Syneos Health standard format;
(6)        Business Rules and Policy and Procedure Handbook development based on client’s specific rules;
(7)        Sample Accountability form development (PACF) utilized for disbursement corrections;
(8)        Signature verification letter development; and
(9)        Set up of individual representative files to store all Sample Accountability activity and documentation on training, storage locations and reconciliations
(10)      PDMA training – Initial training with documentation testing through Syneos Health LMS system
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(11)      Significant Loss Threshold (SLT) Analysis provided by a third party as required
(12)      Development of a 1-hour PDMA/Sample Accountability training slide deck (Client Specific) to be delivered to representatives through live training, either on site or via WebEx
​
2.2       On-Going Sample Accountability Services
Sample Accountability will assume monthly representative inventories will be taken with quarterly reconciliations. Quarterly reconciliations will monitor and compare inventory levels based on the representative’s transactional activity during the quarter. A standard suite of reports will be utilized throughout the quarter to monitor the representative’s activity and to detect areas of concern prior to the end of the quarter.
(a)        The quarterly reconciliation process will include:
(1)        Generation/emailing of Sample Inventory Reconciliation report to sales representatives based on field conducted inventory counts;
(2)        Representative assistance in reconciliation of inventory variances over established significant loss thresholds;
(3)        Reporting of sample reconciliation results to Client home office, based on the FDA reporting model of initial 5 day reporting and 30 day final reporting; and
(4)        Syneos Health’s Sample Management and Compliance Department (SM&C) oversight of the reconciliation process
2.3       General Sample Management Administration
(a)        Standard reports will be provided as agreed upon in the implementation phase of the project
(b)        Physician Signature Audit Service will include an agreed upon percentage of letters sent monthly to practitioners to verify signatures. This audit is to detect possible abuse with capturing fraudulent signatures. Negative responses are reported to Client as defined in the Client’s business rules
(c)        Tracking of PDMA and Sample Management Training – Files will be maintained for each representative
(d)        Field Audits – Random, For Cause, Closeouts and Annual
(e)        Sample Accountability Help Desk Support
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(f)        Ongoing PDMA/Sample Accountability training annually and as needed – New hire/retraining
(g)        Monitoring of non-compliant representatives through monthly trending reports
(h)        Maintenance/tracking of representative sample storage locations – Stored in representatives individual files
(i)         Maintenance of product name, description, lot numbers, expiry dates as pertains to Representative sampling activity
2.4       Additional Ad Hoc Services:
(a)        FDA and State reporting by third party Sample Accountability vendor
​
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​
EXHIBIT E
TRAINING SERVICES
​
5.0       Executive Summary
This Exhibit E describes the work required for the initial implementation and ongoing operation of the Training Services to support the Project Team by Syneos Health Learning Solutions
​
6.0       Scope of Services
​
Syneos Health will provide training services for the Syneos Health Field Team employees; to include, in addition to any Client-provided content, the following Syneos Health content:
o    Syneos Health Administrative Training
o    Syneos Health Technology & Operational Training
o    Syneos Health Policies
o    Selling Skills Training (customization to be scoped separately)
o    Fleet (as applicable)
o    Syneos Health University (Home Study e-Courses only)
o    Pharmaceutical Institute LLC; d/b/a Syneos Health Learning Solutions, Catalog of e-Courses), in the following categories:
·    Therapeutic Essentials (i.e., Disease State e-Courses)
·    Managed Markets Excellence (i.e., Market Access e-Courses)
·    Understanding Pharma (i.e., Industry Background e-Courses)
o    Skillsoft Business and Leadership Skills Catalog of e-Courses Only)
​
Syneos Health will leverage its internal Learning Management System (LMS) to consolidate the training curriculum and training records which allows for tracking and reporting of certification internally and to client.
​
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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

	Sales Team

	Sales Representatives
	[***]

	DMs
	[***]

	Telesolutions Team

	Telesolutions Agents
	[***]

​
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 Sales Team.
​
(ii)       Client shall pay Syneos Health an Implementation Fee of [***] associated with performance of the Services for the Telesolutions Agents.
​
(b)        Fixed Monthly Fees
(i)         Commencing on the Sales Team Hire Date, Client shall pay Syneos Health a Fixed Monthly Fee as follows:
​
​
	PERIOD
	SALES TEAM FIXED
MONTHLY FEE

	Year One
	[***]

	Year Two
	[***]

​
​
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​
(ii)       Commencing on the Telesolutions Team Hire Date, Client shall pay Syneos Health a Fixed Monthly Fee as follows:
​
	PERIOD
	TELESOLUTIONS 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, DM or Telesolutions Agent, 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 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, SR. Reps, Telesolutions Agents or DMs above the number outlined in Exhibit A and B (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 SR. Rep
	[***]

	Per Telesolutions Agent
	[***]

	Per DM
	[***]

​
​
	Position
	Fixed Monthly Fee
(Year One)
	Fixed Monthly
Fee
(Year Two)

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

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

	Per Telesolutions Agent
	[***]
	[***]

	Per DM
	[***]
	[***]

​
​
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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 and B (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:
​
	Position
	Fixed Monthly
Fee
(Year Two)

	Per Representative
	[***]

	Per SR. Rep
	[***]

	Per Telesolutions Agent
	[***]

	Per DM
	[***]

​
(iii)      The Parties shall meet to agree upon Project Team composition in the event of a Scale Up/Scale Down.
​
(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 SR. Rep
	[***]
	[***]

	Per Telesolutions Agent
	[***]
	[***]

	Per DM
	[***]
	[***]

​
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, DM and Telesolutions Agent 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, DMs or Telesolutions Agents (plus the applicable employer portion of taxes).  If any review shows that Syneos Health’s actual annual salary per Syneos Health Sales Representative, DMs or Telesolutions Agent 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, DMs or Telesolutions Agent is above the Annual Salary, then Syneos Health shall bill the difference to Client.
​
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​
(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 SR. Rep
	[***]
	[***]

	Per Telesolutions Agent
	[***]
	[***]

	Per DM
	[***]
	[***]

​
*Within the month a territory becomes vacant.
​
	Monthly Vacancy
Credit*
	Year One
	Year Two

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

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

	Per Telesolutions Agent
	[***]
	[***]

	Per DM
	[***]
	[***]

​
*Subsequent months of vacancy.
​
(f)        Backfill Recruiting
​
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.
​
​
	Position
	Backfill
Recruiting Fee

	Per Sales Representative
	[***]

	Per SR. Rep
	[***]

	Per Telesolutions Agent
	[***]

	Per DM
	[***]

​
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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.
​
	Position
	Monthly Fee
(Year One)
	Monthly Fee
(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 Telesolutions 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

	[***]

​
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, Telesolutions Agents and DMs (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
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​
-      Managers’ severance
-      Licensing and credentialing expenses
-      Shipping, freight, and postage of samples (if incurred)
-      Other expenses which have been approved by Client.
​
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.
​
V.        SERVICE CREDITS
​
Syneos Health shall issue to Client annual service credits of [***] per Syneos Health Sales Representative and Telesolutions Agent (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 and Telesolutions Agent 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.
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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 Sales Team Hire Date and Telesolutions Agent 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
​
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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​
ATTACHMENT 1
​
PROJECT TEAM MEMBER REQUEST FORM
​
This Request for Additional Project Team members is issued pursuant to the Master Services Agreement between Syneos Health Commercial Services, LLC (“Syneos Health”) and Agile Therapeutics, Inc. (“Client”) dated                and the Project Agreement issued thereunder dated _____________.
​
​
	​
​​

	​
​

	PART 1
	To be completed by Client
Attach any relevant, helpful information

	NUMBER AND TYPE OF PROJECT
TEAM PERSONNEL REQUESTED
	​

	​
TERRITORY LOCATION(S)
​
	​

	REQUESTED HIRE DATE
​
	​

	DEPLOYMENT DATE
	​

	​
AUTHORIZED CLIENT
REPRESENTATIVE SUBMITTING
REQUEST
​
​
	​
Signature: ____________________________________
Name:
Title:
Date:
Phone:
Fax:
​

	PART 2
	To Be Completed by Syneos Health
​

	​
NEW PROJECT TEAM MEMBER
DETAILS (the fees set forth below are
per Project Team member added):
​
Implementation Fee $_________
Added Fixed Monthly Fee: $_______
Target Start Date: __________
	​
Request is Accepted, and Recruitment shall begin
immediately upon Client approval of New Representative
Details:
​
____________________________________________
(sign and date)
Syneos Health Contact Person:
Phone:

	​
​
	​
New Project Team member accepted and customer
understands that recruiting will begin immediately:
​
(sign and date)
Client Contact Person:
Phone: 

​

Page 1Exhibit 10.2
​
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.
​
MASTER SERVICE AGREEMENT
​
This Master Service Agreement (this “Agreement”) is made as of October 11, 2017 (the “Effective Date”) by and between inVentiv Commercial Services, LLC, a New Jersey limited liability company with an office located at 500 Atrium Drive, Somerset, NJ 08873 (“inVentiv”) and Agile Therapeutics, Inc., a Delaware corporation with an office located at 101 Poor Farm Road, Princeton, New Jersey 08540 (“Client”).  Client and inVentiv may each be referred to herein as a “Party” and collectively, the “Parties”.
​
RECITALS
​
A.        inVentiv and its Affiliates (as defined herein) offer a wide range of services and offerings to clients in the pharmaceutical and biotechnology arena.
​
B.         Client hereby engages inVentiv, and inVentiv hereby accepts such engagement, to provide various types of services pursuant to the terms hereof and each separate project agreement in the form attached hereto as Exhibit A (each a “Project Agreement”) to be executed by the Parties.  Client and inVentiv shall enter into a Project Agreement for each program they wish to be governed by the terms and conditions of this Agreement.
​
1.         Interpretation and Construction
​
(a)        The Parties desire for the terms and conditions set forth in this Agreement to govern the relationship between the Parties.  Unless otherwise specifically set forth in a Project Agreement, in the event of a conflict or inconsistency between the terms and conditions set forth in this Agreement and the terms and conditions set forth in a Project Agreement, the terms and conditions set forth in this Agreement shall take precedence, govern and control.  Terms in a Project Agreement that supplement the terms of this Agreement will be read together with their related terms and not be deemed “conflicting”.
​
(b)        The Parties hereby acknowledge that the terms set forth in this Agreement shall be incorporated by reference into each Project Agreement, as if fully set forth at length therein.
​
(c)        The Parties acknowledge that in addition to inVentiv, certain of inVentiv’s Affiliates may provide certain services to Client and may directly enter into a Project Agreement with Client, subject to Client’s prior written consent, pursuant to which such inVentiv Affiliate shall provide certain services to Client, as set forth in detail in said executed Project Agreement.  The Parties acknowledge and agree that variation may exist in the form Project Agreement depending upon the inVentiv Affiliate and the nature and type of services provided.  In such event, the Project Agreement shall confirm that this Agreement shall govern the relationship between Client and the particular inVentiv Affiliate, and such parties agree to be bound by the terms set forth herein.  Client agrees that inVentiv acts solely on its own behalf and shall not be liable, or otherwise responsible, for the acts and/or omissions of any inVentiv Affiliate under any
​

1

​
circumstances in connection with any Project Agreement that is not signed by inVentiv.  Further, each inVentiv Affiliate acts solely on its own behalf and shall not be liable, or otherwise responsible, for the acts and/or omissions of inVentiv or any other inVentiv Affiliate under any circumstances in connection with this Agreement or any Project Agreement that is not signed by that inVentiv Affiliate.
​
(d)        As set forth above, 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.
​
2.         The Services
​
(a)        Client shall retain inVentiv to provide services as set forth in one or more Project Agreements (hereinafter the “Services”).
​
(b)        Client has no obligation to inVentiv for Services under this Agreement in the absence of an executed Project Agreement covering such Services.
​
(c)        Each Project Agreement shall allocate responsibility for project management and quality assurance activities necessary to perform the Services.  inVentiv will provide regular updates as to the progress of the Services at a frequency and in a manner designated by the Parties in the Project Agreement.
​
3.         Representations and Warranties of the Parties
​
(a)        inVentiv represents, warrants and covenants that:
​
(i)         it shall perform the Services in a professional, workmanlike manner, in accordance with good industry practice, in accordance with all applicable policies and procedures, and in accordance with those specifications, timelines, and any other qualitative or quantitative standards which inVentiv and Client agree to (in writing);
​
(ii)       it shall maintain in full force and effect all necessary licenses, permits, approvals (or waivers) and authorizations required by law to carry out its obligations under this Agreement and any Project Agreement;
​
(iii)      the execution, delivery and performance of this Agreement by inVentiv and the consummation of the transaction(s) contemplated hereby has been duly authorized by all requisite corporate action; that the Agreement constitutes the legal, valid, and binding obligation of inVentiv, enforceable in accordance with its terms (except to the extent enforcement is limited by bankruptcy, insolvency, reorganization or other laws affecting creditors’ rights generally and by general principles of equity); and that this Agreement and performance hereunder does not violate or constitute a breach under any organizational document of inVentiv or any contract,
​

2

​
other form of agreement, or judgment or order to which inVentiv is a party or by which it is bound;
​
(iv)       the personnel assigned to perform Services rendered under this Agreement and any Project Agreement shall be capable professionally and duly qualified to perform the Services hereunder and in each Project Agreement;
​
(v)        it is not a party to any agreement which would prevent it from fulfilling its obligations under this Agreement and any Project Agreement and that during the term of this Agreement and any Project Agreement, it will not enter into any agreement to provide services which would in any way prevent it from performing the Services;
​
(vi)       the Services shall be provided in compliance with all applicable statutes, federal and state laws, ordinances, rules or regulations of any governmental or regulatory authority including (but not limited to), as applicable, the OIG Compliance Program Guidance for Pharmaceutical Manufacturers, the PhRMA Code on Interactions with Healthcare Professionals, the Accreditation Council for Continuing Medical Education requirements for continuing medical education, the American Medical Association Ethical Guidelines on Gifts to Physicians from Industry, the Federal Food, Drug and Cosmetic Act (“FDCA”), the Medicare/Medicaid anti-kickback statute, the Prescription Drug Marketing Act (“PDMA”), the Health Insurance Portability and Accountability Act (“HIPAA”) and The Health Information Technology for Economic and Clinical Health (“HITECH”) Act, and similar state laws, rules and regulations (collectively, “Applicable Law”);
​
(viii)    any Services or work performed or Deliverables (defined below) provided under this Agreement or any Project Agreement, or any portion thereof, do not infringe, misappropriate, or otherwise violate any intellectual property rights of any third party;  and no third party has asserted or is asserting,  a claim of any of the foregoing.  However, the foregoing will not apply if the applicable infringement, misappropriation, or violation is caused by Client’s unauthorized use or modification of any work or Deliverables
​
(b)        Client represents, warrants and covenants that:
​
(i)         the execution, delivery and performance of this Agreement by Client and the consummation of the transaction(s) contemplated hereby has been duly authorized by all requisite corporate action; that the Agreement constitutes the legal, valid, and binding obligation of Client, enforceable in accordance with its terms (except to the extent enforcement is limited by bankruptcy, insolvency, reorganization or other laws affecting creditors’ rights generally and by general principles of equity); and that this Agreement and performance hereunder does not violate or constitute a breach under any organizational document of Client or any contract, other form of agreement, or judgment or order to which Client is a party or by which it is bound;
​
(ii)       Client shall apply the degree of skill and care necessary, and will act in good faith to provide inVentiv with the necessary materials, information, product training, and assistance required to enable inVentiv to perform the Services in compliance with all Applicable
​

3

​
Law.  Certain Client obligations and responsibilities unique to a specific Project Agreement shall be specified within that Project Agreement;
​
(iii)      Client shall ensure all content (product or otherwise), materials, documentation and information provided by it to inVentiv are in compliance with all Applicable Laws when provided or made available to inVentiv;
​
(iv)       Client shall provide any and all necessary training regarding the Client product(s) and shall be responsible for all costs and expenses of such training, including pre-approved inVentiv personnel travel, lodging, meals, and other reasonable miscellaneous expenses directly related to such training;
(v)        Client’s products shall be promoted under trademarks owned by or licensed to Client and are products which are either owned by Client and/or as to which Client has all lawful authority necessary to market and sell the products.  Client represents and warrants that its trademarks, trade names and trade dress do not infringe on any intellectual property or product marketing rights of any other person or entity.  Client further represents and warrants that the promotion of any Client product by inVentiv does not infringe on any intellectual property or product marketing rights of any other person or entity;
​
(vi)       Client is not a party to any agreement which would prevent it from fulfilling its obligations under this Agreement and any Project Agreement and that during the term of this Agreement and any Project Agreement, it will not enter into any agreement which would in any way prevent or restrict inVentiv from performing the Services; and
​
(vii)     Client is solely responsible for reviewing and approving all Client’s product promotional materials and literature created pursuant to or provided for use under this Agreement and/or Project Agreement and for ensuring all such materials comply with Applicable Law; and
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(viii)   Client shall notify inVentiv in the event it is subject to or becomes subject to a Federally Mandated Corporate Integrity Agreement (CIA) or other compliance obligations which require inVentiv to provide Client with data, training, analysis, oversight or certifications that are not contemplated by the Services described herein.  In such event, the Parties shall mutually agree on an appropriate allocation of costs and expenses associated with inVentiv's provision of such CIA related data, training, analysis, oversight or certifications not included in the scope of Services provided under this Agreement or any related Project Agreement.
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4.         Independent Contractors; inVentiv Personnel
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Except as may otherwise be provided in a Project Agreement:
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(a)        inVentiv and its directors, officers, employees, independent contractors, and any persons providing Services under the Agreement and any Project Agreement are at all times independent contractors with respect to Client.  Persons provided by inVentiv to perform Services shall not be deemed employees of Client.  Neither this Agreement nor the Services to be rendered hereunder
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shall for any purpose whatsoever or in any way or manner create any employer-employee relationship between inVentiv, its directors, officers, employees and any persons providing Services under the Agreement and Client.  inVentiv may utilize independent contractors in connection with its performance of the Services only with Client’s prior written approval; provided, further, that inVentiv will remain fully responsible for the conduct of its independent contractors.  For purposes of this Agreement, the parties agree that Client’s prior written consent is not required for inVentiv to use third party contractors in inVentiv’s general business operations and the underlying support services supporting such general business operations (for example, IT services and/or internal software, equipment, CRM, etc.) which may be used in the provision of Services.
(b)        inVentiv is, and at all times shall remain, solely responsible for the human resource and performance management functions of all inVentiv personnel provided to perform the Services.  inVentiv shall be solely responsible and liable for all disciplinary, probationary and termination actions taken by it, and for the formulation, content and dissemination of all employment policies and rules (including written disciplinary, probationary and termination policies) applicable to its employees, agents and contractors (individually, a “inVentiv Employee” and collectively, “inVentiv Employees”).
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(c)        inVentiv shall obtain and maintain worker’s compensation insurance and other insurances required for inVentiv Employees performing the Services and acknowledges that Client does not, and shall not obtain or maintain such insurances, all of which shall be inVentiv’s sole responsibility.
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(d)        Except as otherwise set out in this Agreement or in a Project Agreement, Client shall have no responsibility to inVentiv or any inVentiv Employee for any compensation, expense reimbursements or benefits (including, without limitation, vacation and holiday remuneration, healthcare coverage or insurance, life insurance, pension or profit-sharing benefits and disability benefits), payroll-related or withholding taxes, or any governmental charges or benefits (including, without limitation, unemployment and disability insurance contributions or benefits and workers compensation contributions or benefits) that may be imposed upon or be related to the performance by inVentiv or its employees, agents or contractors of the obligations under this Agreement or any Project Agreement, all of which shall be the sole responsibility of inVentiv.  To clarify, Client will not withhold any income tax or payroll tax of any kind on behalf of inVentiv.
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(e)       Any request by Client for removal of a inVentiv employee assigned to provide Service(s) shall be made in writing, supported by the Client’s reasons for requesting the removal and documentation of the inVentiv staff member’s actions and/or behavior that support the request.  All employment decisions regarding an inVentiv employee shall be made solely and exclusively by inVentiv and is subject to compliance at all times with inVentiv’s human resource policies and procedures.
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5.         inVentiv Compensation
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(a)        In consideration of the performance of the Services, Client shall pay inVentiv the
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fees, costs and expenses (collectively, the “Fees”) as set forth in each Project Agreement.  inVentiv shall bill Client as set forth in each Project Agreement and invoices shall be sent by inVentiv to Client on a monthly basis for the Fees for Services.
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(b)        In addition to the Fees set forth in a Project Agreement, certain necessary and reasonable expenses will be charged to Client on a pass-through basis.  These expenses will be billed to Client at actual cost incurred by inVentiv.  Pass-through costs specific to a particular Service shall be set forth in the applicable Project Agreement.
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(c)        Payments are due upon Client’s receipt of each applicable invoice from inVentiv.  If any invoice amount is not paid within [***] of Client’s receipt, inVentiv reserves the right, following [***] prior written notice, to impose a [***] on all amounts not paid when due.  In the event that a third party supplier of inVentiv requires expedited payment from inVentiv, Client will pay inVentiv for such expenses on the same terms that inVentiv is required to pay its third party supplier; provided, however, that inVentiv must provide Client with such terms in writing, and, whenever reasonably possible in advance, with as much notice as possible.
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(d)        Client may withhold payment of any invoiced amounts it may dispute in good faith; provided, however, that if there is an undisputed portion of the invoice, such payment must be made when due.  The Parties will work in good faith to resolve any such disputes, but in no event later than [***] from notice of the dispute.  During such good faith resolution period and subject to Section 12(a)(ii),  such billing disputes shall not be cause for non-performance under this Agreement or any Project Agreement.
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(e)        In the event Client will be issuing purchase orders for payment of inVentiv invoices, Client shall issue such purchase orders in a timely manner in accordance with the terms and conditions set forth herein.  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 Agreement provides the terms and conditions governing the relationship between the Parties.
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(f)        Taxes.    Upon mutual agreement of the Parties, inVentiv shall invoice Client and Client shall reimburse inVentiv for any taxes actually paid by inVentiv that are properly imposed upon inVentiv by any governmental agency as a result of this Agreement or any Project Agreement (excluding any taxes based on inVentiv’s income) that are the responsibility of the Client.  The Parties will cooperate to minimize mutual tax exposure.
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6.         Confidentiality
(a)        During the performance of the Services contemplated by this Agreement, each Party may learn confidential, proprietary, and/or trade secret information of the other Party (“Confidential Information”).   The Party disclosing Confidential Information shall be referred to as the “Disclosing Party” and the Party receiving Confidential Information shall be referred to as the “Receiving Party.”
(b)        Confidential Information means any information, unknown to the general public, which is disclosed, made available, or created by the Disclosing Party to the Receiving Party under this Agreement.   Confidential Information includes, without limitation, the terms set forth
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in this Agreement, technical, trade secret, commercial and financial information about either Party’s (i) research or development; (ii) marketing plans or techniques, contacts or customers; (iii) organization or operations; (iv) business development plans (i.e., licensing, supply, acquisitions, divestitures or combined marketing); (v) products, licenses, trademarks, patents, other types of intellectual property or any other contractual rights or interests (including without limitation processes, procedures and business practices involving trade secrets or special know-how), (vi) pricing and financial information, and (vii) in the case of inVentiv, the names and contact information (i.e. phone number, address and e-mail address) of the inVentiv Employees.
(c)        The Receiving Party shall neither use nor disclose Confidential Information received from the Disclosing Party for any purpose other than as specifically allowed by this Agreement.  Confidential Information disclosed to a Receiving Party will be held in confidence by the Receiving Party, using at least the same standard of care the Receiving Party uses with respect to its own information of a similar nature, but in no event less than a reasonable standard of care and will not be disclosed to others or used, except solely for the purposes agreed in this Agreement or any Project Agreement, without the prior written approval of the Disclosing Party.    Each party will advise its Permitted Representatives of the requirements of this Agreement and direct each of them to comply therewith.   Each party is responsible for any breach of this Agreement by its Permitted Representatives.  Receiving Party agrees to use the Confidential Information received hereunder solely for the purpose of this Agreement and any Project Agreement and further agrees to limit dissemination of Confidential Information to those of its Permitted Representatives who have a need to know for purposes of performing its obligations under this Agreement and each applicable Project Agreement and who are bound by an obligation (written or oral) of non-disclosure with Receiving Party.  Each party will maintain reasonable safeguards, policies and procedures to protect Confidential Information against unauthorized use, disclosure, alteration, or destruction.  As used herein, “Permitted Representatives” means a Party and its Affiliates and their respective officers, employees, directors, agents, third party vendors, independent contractors, consultants, counsel and advisors who need to know the Confidential Information for the purpose of performing obligations in connection with this Agreement or any Project Agreement.
(d)        Upon the expiration or termination of this Agreement and receipt of Disclosing Party’s written request, Receiving Party, at its option, shall promptly either (a) return to the Disclosing Party all tangible forms of Confidential Information in its possession, including any and all copies and/or derivatives of Confidential Information made by either Party or their employees as well as any writings, drawings, specifications, manuals or other printed or electronically stored material based on or derived from, Confidential Information, or (b) destroy Confidential Information in its possession and deliver to Disclosing Party a certification that such destruction has occurred; provided however, that Receiving Party may retain a copy of any information, including Confidential Information, that the Receiving Party reasonably believes is  required to comply with applicable laws or regulations or to effectuate the Purposes of this Agreement.   The Receiving Party shall not disclose to third parties any Confidential Information or any reports, recommendations, conclusions or other results of work under this Agreement or any Project Agreement without prior consent of an officer of the Disclosing Party.   The obligations set forth in this Section 6, including the obligations of confidentiality and non-use shall be continuing and shall survive the expiration or termination of this Agreement and the Project Agreement and will continue for a period of [***] from the date of such expiration or 
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termination.
(e)       The obligations of confidentiality and non-use set forth herein shall not apply to the following: (i) Confidential Information at or after such time that it is or becomes publicly available through no fault of the Receiving Party; (ii) Confidential Information that is already independently known to the Receiving Party without confidential or proprietary restriction, before disclosure, as shown by prior written records; (iii) Confidential Information at or after such time that it is disclosed to the Receiving Party by a third party with the legal right to do so, and (iv) solely with respect to the specific relevant process, order or request, Confidential Information required to be disclosed pursuant to judicial process (and only to the extent so required), court order or administrative request, provided that the Receiving Party shall so notify the Disclosing Party sufficiently prior to disclosing such Confidential Information as to permit the Disclosing Party to seek a protective order.
7.         Restrictions on Solicitation
Except as may otherwise be provided in a Project Agreement:
(a)        Neither Party may solicit the employees or independent contractors of the other Party to become employees of, or consultants to, such Party during the Term of this Agreement and any Project Agreement and for a [***] period following the termination of both this Agreement and any Project Agreement.  The provisions of this Section 7 shall not apply with respect to either Party’s employees or independent contractors who seek employment from the other Party on their own initiative, such as, but not limited to, in response to a general vacancy announcement or advertisement.
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(b)        Client agrees during the Term of this Agreement and for [***] thereafter not: (i) to provide any contact information (including name, address, phone number or e-mail address) of any inVentiv Employee to any third party which provides or proposes to provide Client with the same services being provided by inVentiv pursuant to a Project Agreement, or (ii) to assist actively in any other way such a third party in employing or retaining such inVentiv Employee.
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(c)        Each Party shall pay to the other Party (or cause the third party to pay to inVentiv, as the case may be, [***] for each employee of the other Party so employed or retained as liquidated damages for breach of Sections 7(a) or 7(b).).
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8.         Indemnification
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(a)        inVentiv shall indemnify and hold Client, its officers, directors and employees harmless from and defend them against any and all third party liabilities, losses, proceedings, suits, actions, damages, claims or expenses of any kind, including court costs and reasonable attorneys’ fees (collectively, “Losses”) which are caused by: (i) any fraudulent or negligent acts or omissions by or the willful misconduct of inVentiv, its directors, officers, or employees, or independent contractors, (ii) any material breach of this Agreement or any Project Agreement by inVentiv, its directors, officers, employees, or independent contractors, (iii) any breach of the representations, warranties, covenants, and agreements of inVentiv to Client set out in Section 3(a) and Section 6 above.
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(b)        Client shall indemnify and hold inVentiv, its officers, directors and employees harmless from and defend against any and all Losses which are caused by: (i) any negligent acts or omissions by or the willful misconduct of Client, its directors, officers or employees, (ii) any material breach of this Agreement or any Project Agreement by Client, its directors, officers or employees, (iii) any product liability claims relating to Client products, whether arising out of warranty, negligence, strict liability (including manufacturing, design, warning or instruction claims) or any other product based statutory claim, (iv) any intellectual property infringement claims relating to any trademarks owned by or licensed to Client, and (v) any breach of the representations, warranties, covenants, and agreements of Client to inVentiv set out in Section 3(b) and Section 6 above..
(c)        In case any action, proceeding or claim shall be brought against one of the Parties hereto (an “Indemnified Party”) based upon any of the above claims and in respect of which indemnity may be sought against the other Party hereto (the “Indemnifying Party”) such Indemnified Party shall promptly notify the Indemnifying Party in writing.  The failure by an Indemnified Party to notify the Indemnifying Party of such Claim shall not relieve the Indemnifying Party of responsibility under this Section, except to the extent such failure adversely prejudices the ability of the Indemnifying Party to defend such claim.  The Indemnifying Party at its expense, with counsel of its own choice, shall defend against, negotiate, settle or otherwise deal with any such claim, provided that the Indemnifying Party shall not enter into any settlement or compromise of any claim which could lead to liability or create any financial or other obligation on the part of the Indemnified Party without the Indemnified Party's prior written consent.  The Indemnified Party may participate in the defense of any claim with counsel of its own choice and at its own expense.  The parties agree to cooperate fully with each other in connection with the defense, negotiation or settlement of any such claims.  In the event that the Indemnifying Party does not undertake the defense, compromise or settlement of any claim, the Indemnified Party shall have the right to control the defense or settlement of such claim with counsel of its choosing.
(d)        Client shall reimburse inVentiv for all reasonable actual out-of-pocket expenses incurred by inVentiv in connection with responses to subpoenas and other similar legal orders issued to inVentiv in respect to Client’s product or the Services performed under this Agreement and the applicable Project Agreement. However, Client shall have no obligation to reimburse inVentiv for any such expenses (and to the extent paid by Client to inVentiv, shall be repaid by inVentiv to Client) arising out of, in connection with or otherwise relating to actions or omissions of inVentiv or its employees, independent contractors, officers, directors, and/or Affiliates that violate this Agreement, any Project Agreement, or Applicable Law.
9.         Limitation of Liability
(a)        Subject to Section 9(c) below, neither Party shall be liable to the other Party with respect to any subject matter of this Agreement or any Project Agreement under any contract, tort, negligence, strict liability, breach of warranty (express or implied) or other theory for any indirect, incidental, special, punitive, exemplary or consequential damages, nor for any loss of revenues or loss of profits, even if advised of the possibility of such damages.
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(b)        Subject to Section 9(c) below, each Party’s (including its Affiliates) liability, including for claims and Losses, arising out of the Services under a specific Project Agreement shall be limited to [***] (the “Liability Cap”).  If [***], the applicable Liability Cap will be [***].
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(c)        The limitations set out in Sections 9(a) and 9(b) above shall not apply:
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(i)         to the parties indemnification obligations set forth in Section 8 above; and
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(ii)       to any claims for liabilities, losses, proceedings, suits, actions, damages, claims or expenses of any kind, including court costs and reasonable attorneys’ fees caused by (A) the fraud, gross negligence or willful misconduct of a Party; (B) any violation, infringement or misappropriation of the other Party’s intellectual property rights; and (C) either Party’s breach of its confidentiality obligations set forth in Section 6 above.
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10.       Intellectual Property; Ownership
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(a)        Except as set forth in Sections 10(b) and 10(c) below, all documents, materials, reports and deliverables provided by inVentiv to Client pursuant hereto whether or not patentable, copyrightable, or susceptible to any other form of legal protection which are made, conceived, reduced to practice or authored by inVentiv, or inVentiv’s employees, independent contractors, representatives or agents (if any) as a result of the performance of Services, or which are derived from use or possession of Client’s Confidential Information (collectively, the “Deliverables”) shall be the sole and exclusive property of Client upon full payment of all sums due to inVentiv for each such Deliverable under this Agreement.  Notwithstanding the foregoing nothing in this Agreement or any Project Agreement shall be construed to give inVentiv any right, title or interest to any trademarks, patents or other pre-existing intellectual property of Client.  For the avoidance of doubt, but subject to Section 10(b) inVentiv will not have any right, title, or interest in any new inventions, developments or improvements inVentiv makes to Client intellectual property or creates using Client Confidential Information  during the course of performing under this Agreement and any Project Agreement.  Subject to Sections 10(b) and 10(c) below, each Deliverable constituting an original work shall be considered a work made for hire under applicable copyright laws. Subject to Section 10(b) and 10(c) below, inVentiv hereby assigns and agrees to assign to Client all right, title and interest in all worldwide intellectual property rights in the Deliverables, including without limitation, patents, copyrights, and trade secrets.  inVentiv agrees to cooperate, at Client’s expense, with reasonable all efforts on behalf of Client to identify and  perfect all intellectual property rights associated with the Deliverables.
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(b)        Notwithstanding anything to the contrary set forth herein, to the extent any Deliverable or work made for hire include inVentiv’s concepts, ideas, models, know-how, software, methodologies, technology, techniques, procedures, management tools, workshops, manuals, macros, data files, inventions, and other intellectual capital and property that inVentiv has developed, created or acquired prior to, in the course of, or independent of performing Services under this Agreement (the “inVentiv Materials”), inVentiv shall retain exclusive ownership in such inVentiv Materials.  Upon full payment of all sums due to inVentiv, inVentiv hereby grants Client a non-exclusive, non-transferable, royalty-free right and license, for Client 
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to use the inVentiv Materials solely in connection with its use of the Deliverables created by inVentiv in connection with the Services.  For the avoidance of doubt, the Parties agree that any source or object code, previously owned or licensed by inVentiv or created hereunder without the use of or reference to any Client Confidential Information, are not a part of the rights provided to Client and may be used by inVentiv on behalf of itself or any of its other clients.  Without limiting the foregoing, inVentiv may use such source or object code to create materials that have a substantially similar “look and feel” as the Deliverables for products or services that are directly competitive to products or services for which such Deliverables were created.  Provided that inVentiv de-identifies all personal data, Client, and Client product identifying information, inVentiv may use all project data for the purpose of evaluating its performance under this Agreement and for business development and analytics purposes.
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(c)        Without limiting the general rights of Client as provided in this Section 10, it is understood and agreed that certain promotional material or other Deliverables may contain the intellectual property of third parties pursuant to a license or other arrangement which permits Client to use such intellectual property only in connection with a specific project or campaign, and which would require additional payments for a different or extended use by Client.  inVentiv will provide prior written notification to Client of any material conditions or limitations relating to such approvals inVentiv has obtained as part of the approval process for specific projects and campaigns, and Client will be solely responsible for any fees or other charges associated with any use of such third party intellectual property outside the scope of the use contemplated by the applicable project.
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(d)        If a Deliverable or any portion of a Deliverable is found to infringe on the intellectual property rights of a third party, and provided the infringing portion does not arise from materials provided by Client, inVentiv shall, at no cost to the Client, (A) obtain the right for Client to continue use of the Deliverable; (B) replace or modify the Deliverable to be non-infringing and functionally and operationally equivalent to the applicable Deliverable; or (iii) remove the Deliverable, in which case, it will be inVentiv’s responsibility to find an alternative functionally equivalent solution to replace the Deliverable If none of the foregoing is possible within a commercially reasonable time, then Client shall have the immediate right to a refund of all Fees paid with respect to such infringing Deliverable.
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11.       Term
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The Agreement shall be in effect as of the Effective Date and shall remain in effect until the third anniversary of the Effective Date (the “Term”) or until such later date as may be set forth in a Project Agreement (it being understood that this Agreement will not terminate in the event the term set forth in a Project Agreement is longer than the term set forth herein).  The Parties may extend this Agreement for additional periods of one year each (each an “Additional Term”) by mutual written agreement of the Parties.
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12.       Termination
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(a)  Except as may otherwise be provided in any Project Agreement, this Agreement and any Project Agreement may be terminated by inVentiv or Client upon giving written notice as 
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follows:
(i)            by inVentiv, if any undisputed payment to inVentiv by Client is not made when due and such payment is not made within [***] from the date of written notice from inVentiv to Client of such nonpayment;
(ii)       by either Party, in the event that the other Party has committed a material breach of this Agreement and such breach has not been cured within [***] of receipt of written notice from the non-breaching Party of such breach (provided that, during the [***] cure period for termination due to breach, each Party will continue to perform its obligations under the Agreement);
(iii)      by Client, for its convenience, at any time, upon [***] prior written notice to inVentiv; or
(iv)       by either Party, in the event the other Party is either debarred from federal contracting or is a “Sanctioned Entity”.  For purposes hereof, a Sanctioned Entity is an entity that:
(A)       Is currently under indictment or prosecution for, or has been convicted (as defined in 42 C.F.R. § 1001.2) of:  (1) any offense related to the delivery of an item or service under the Medicare or Medicaid programs or any program funded under Title V or Title XX of the Social Security Act (the Maternal and Child Health Services Program or the Block grants to States for Social Services programs, respectively), (2) a criminal offense relating to neglect or abuse of patients in connection with the delivery of a health care item or service, (3) fraud, theft, embezzlement, or other financial misconduct in connection with the delivery of a health care item or service, (4) obstructing an investigation of any crime referred to in (1) through (3) above, or (5) unlawful manufacture, distribution, prescription, or dispensing of a controlled substance; or
(B)       Has been required to pay any civil monetary penalty regarding false, fraudulent, or impermissible claims under, or payments to induce a reduction or limitation of health care services to beneficiaries of, any state or federal health care program, or is currently the subject of any investigation or proceeding which may result in such payment; or
(C)       Has been excluded from participation in the Medicare, Medicaid, or Maternal and Child Health Services (Title V) program, or any program funded under the Block Grants to States for Social Services (Title II) program; or.
(b)        This Agreement and any Project Agreement shall terminate immediately without notice in the event that the other Party has: (i) become insolvent or has been dissolved or liquidated; (ii) filed or has filed against it, a petition in bankruptcy and such petition is not dismissed within thirty (30) days of the filing; (iii) makes a general assignment for the benefit of creditors; (iv) has a receiver appointed for a substantial portion of its assets; or (v) if this Agreement or any Affiliate Addendum or Project Agreement is deemed rejected pursuant to the provisions of Bankruptcy Code §365(d), as amended, in a case under Bankruptcy Code.
(c)        Upon the effective date of such termination, the Parties shall have no further 
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obligation to each other (other than those set forth in Sections 4, 6, 7, 8, 9, 10 12(d), 13, 14(a), 14(d)-14(f), 14(h), 14(k), and 14(hl)), except that Client shall pay the amounts set forth or provided for in any Project Agreement through the actual date of termination or completion of the Services being performed under all applicable Project Agreements.  For purposes of clarity, in the event this Agreement is terminated or expires prior to the completion of work under any Project Agreement, such Project Agreement shall continue through completion, and this Agreement shall continue to apply to the Project Agreement(s) in full force and effect through completion of such outstanding Services under such Affiliate Addendum and Project Agreement(s).
(d)        Client will pay for all fees and out-of-pocket expenses under this Agreement and all applicable Project Agreements incurred through the effective date of termination and any wind down period.  Client will be responsible for all reasonable non-cancelable commitments entered into by inVentiv on Client’s behalf and for reasonable wind down costs.  All expenses or commitments [***] and not set forth in a Project Agreement shall be pre-approved by Client.  Upon termination, to the extent applicable and as mutually agreed to by the Parties, inVentiv will give or otherwise transfer to Client, at Client’s expense, all property in inVentiv’s possession that belongs to and was paid for by Client (excluding archival copies thereof), provided that all invoices with respect to such property have been paid in full.
13.       Venue and Jurisdiction
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This Agreement shall be construed according to the laws of the State of New Jersey (without reference to any principles regarding conflicts of law) and any action brought by either inVentiv or Client in connection with this Agreement shall be brought in the state or federal courts located in the State of New Jersey.
14.       Miscellaneous
(a)        Insurance.  Each Party undertakes to maintain, as applicable, General Liability insurance of [***] per occurrence/[***] annual aggregate, Workers’ Compensation Statutory, Employer’s Liability insurance of [***], Automobile Liability insurance of [***] combined single limit each occurrence, Products/Completed Operations and Professional Errors and Omissions Liability insurance of [***] per occurrence/[***] annual aggregate.  In addition, Client shall carry Product Liability insurance each in the amount of at least [***].  Limits may be provided with Umbrella/Excess insurance.   Insurance companies must have an AM Best Rating of “A-/VII” or better, or an analogous rating by a similar organization if the insurance company is not a United States company.  Client’s indemnity shall not be capped by its insurance limits. Each Party shall name the other Party as an additional insured on all liability insurance coverage as their interests may appear. In addition, upon written request, each Party will provide the other with evidence of coverage complying with this Section 14. The Parties understand and agree that additional insurance requirements may be set forth in the Project Agreements
(b)       Assignment; Binding Effect.  Neither inVentiv nor Client may assign or transfer this Agreement or any Project Agreement or any of its rights, duties or obligations hereunder without the other Party’s prior written consent; provided, however, that either inVentiv or Client may assign or transfer its rights, duties and obligations as part of an acquisition or purchase of 
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inVentiv or Client, without the prior written consent of the other Party when: (i) such assignment is to a successor-in-interest to all or substantially all of the ownerships interest or business assets of such Party whether in a merger, sale of stock, sale of assets or other similar transaction;  (ii) the successor is a financially capable business entity; and (iii) the successor is not a competitor of the other Party.  Any permitted successor or assignee of this Agreement or any Project Agreement and the rights and/or obligations hereunder or thereunder, will in writing (satisfactory in form and substance) to the other Party, expressly assume this Agreement and any existing Project Agreement and the rights and obligations hereunder.  If such a writing is not received, any proposed assignment or transfer need not be recognized and shall be null and void.
(c)       Force Majeure.  Except for Client’s payment obligations, noncompliance with the obligations of this Agreement or any Project Agreement due to a state of force majeure, the laws or regulations of any government, regulatory or judicial authority, war, civil commotion, destruction of facilities and materials, fire, flood, earthquake or storm, shortage of materials, failure of public utilities or common carriers, and any other similar causes beyond the reasonable control of the applicable Party, shall not constitute a breach of contract.
(d)        Severability.  If any provision of this Agreement or any Project Agreement is finally declared or found to be illegal or unenforceable by a court of competent jurisdiction, both Parties shall be relieved of all obligations arising under such provision, but, if capable of performance, the remainder of this Agreement or such Project Agreement shall not be affected by such declaration or finding.
(e)        Entire Agreement; Amendment.   This Agreement, together with each applicable Project Agreement (including any attachments or exhibits hereunder or thereunder), contains all of the terms and conditions of the agreement between the Parties and constitutes the complete understanding of the Parties with respect thereto.  This Agreement and each Project Agreement supersedes all prior arrangements and understandings between the Parties related to the subject matter hereof.  No modification, extension or release from any provision hereof shall be affected by mutual agreement, acknowledgment, acceptance of contract documents, or otherwise, unless the same shall be in writing signed by the other Party and specifically described as an amendment or extension of this Agreement or any Project Agreement; provided, however, an email confirmation or other electronic confirmation accepting any modified terms shall be the same as if the Parties have signed in writing and shall be a valid enforceable agreement between the Parties.
(f)       Public Announcement.  The form and content of any public announcement to be made by one Party regarding this Agreement or any Project Agreement, or the subject matter contained herein, shall be subject to the prior written consent of the other Party (which consent may not be unreasonably withheld), except as may be, in the reasonable opinion of the disclosing Party’s legal counsel, required by Applicable Law, including the U.S. Securities Exchange Commission or any stock exchange upon which such Party’ securities are listed or to which application for listing has been submitted,  in which event the other Party shall endeavor to give the other Party reasonable advance notice, review and comment of any such disclosure, including a copy of the proposed redacted filings, if any.  Notwithstanding the above, either Party may, in connection with its general marketing materials and without the consent of the other Party, list the name of the other Party in a non-descriptive fashion in connection with its general marketing 
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materials; (ii) in a list of the names of other similarly situated third parties that such Party does business with; and (iii) in internal business communications, including communications to Affiliates.
(g)        Counterparts. This Agreement may be executed in any number of counterparts, each of which, when executed, shall be deemed to be an original and all of which together shall constitute one and the same document.  Electronically submitted signatures shall have the same force and effect of an original signature.
(h)        Notices. Any notices required or permitted under this Agreement shall be given in person or sent by first class, certified mail to:
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	To Client:
Address:
Agile Therapeutics, Inc.
101 Poor Farm Road
Princeton, NJ 08540
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	To inVentiv
Address:
inVentiv Commercial Services, LLC
500 Atrium Drive
Somerset, NJ 08873
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	Attention: Chairman and Chief Executive Officer
Fax:  609-683-1855
	Attention: President
Fax: 732-537-4999

	Copy To:
Agile Therapeutics, Inc.
101 Poor Farm Road
Princeton, NJ 08540
Attn: General Counsel
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	Copy To:
inVentiv Commercial Services, LLC
500 Atrium Drive
Somerset, NJ 08873
Attn: VCS General Counsel
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or to such other address or to such other person as may be designated by written notice given from time to time during the term of this Agreement by one Party to the other.
(i)         Cooperation.  Each of the Parties shall do, execute and perform and shall procure to be done and perform all such further acts deeds documents and things as the other Party may reasonably require from time to time to give full effect to the terms of this Agreement.
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(j)         Preparation.  Except as otherwise expressly provided in this Agreement, each Party shall pay its own expenses and costs incidental to the preparation of this Agreement and to the consummation of the transactions contemplated by this Agreement or each Project Agreement.
(k)        Waiver.
(i)         No delay or omission by either Party to exercise any right or power it has under this Agreement will impair or be construed as a waiver of such right or power.
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(ii)       A waiver by either Party of any breach or covenant will not be construed to be a waiver of any succeeding breach or any other covenant.
(iii)      No waiver to any provision of this Agreement or any Project Agreement (including any Exhibit or Schedule hereto or thereto), will be valid unless in writing and signed by an authorized representative of the Party against whom enforcement of such waiver is sought.
(l)         Interpretation.  This Agreement and each Project Agreement shall be governed by the following rules of construction, unless the context requires otherwise:  (i) any reference to a Section, Schedule, Exhibit, subsection, clause, subclause, or recital is a reference to a Section, Schedule, Exhibit, subsection, clause, subclause, or recital of this Agreement or the applicable Project Agreement; (ii) any reference to any statute shall be construed as including all statutory provisions consolidating, amending or replacing such statute; (iii) the terms “hereof,” “hereby,” “hereto,” “hereunder” and similar terms shall refer to this Agreement or applicable Project Agreement as a whole; (iv) the word “including” and words of similar import means “including, without limitation” and “including, but not limited to”; (v) the word “may” shall mean “has the right, but not the obligation to do something” and “may not” shall mean “does not have the right to do something”; (vi)          the headings contained herein are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement or any Project Agreement; (vii) any reference to “days” means calendar days unless otherwise stated as “Business Days”; (viii) all references to “dollars” or “$” refer to United States dollars; (ix) use of the singular includes the plural and vice versa; and (x) use of the masculine gender includes the feminine and neuter genders and vice versa.
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[SIGNATURE PAGE FOLLOWS]
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WHEREFORE, the Parties hereto have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
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	AGILE THERAPEUTICS, INC.
	    
	INVENTIV COMMERCIAL SERVICES, LLC

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	By:
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	By:
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	Title:
	Chairman and Chief Executive Officer
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	Title:
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Exhibit A
FORM OF PROJECT AGREEMENT
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This Project Agreement (the “Project Agreement”) made as of ________ ____, 20___ by and between [INVENTIV COMMERCIAL SERVICES, LLC, with its principal office located at 500 Atrium Drive, Somerset, New Jersey 08873 (“inVentiv”)] and Agile Therapeutics, Inc., a Delaware corporation with an office located at 100 Poor Farm Road, Princeton, New Jersey 08540 (“Client”).  Client and inVentiv may each be referred to herein as a “Party” and collectively, the “Parties”.
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RECITALS
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A.        Client and inVentiv have entered into a Master Services Agreement dated as of _________ ___, 2017 (the “Agreement”).
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B.         Client and inVentiv desire to enter into this Project Agreement (this “Project Agreement” or “PA”).
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1.         Interpretation and Construction
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(a)        The Parties confirm that the Master Service Agreement shall govern the relationship between the Parties.  Unless otherwise specifically set forth herein, in the event of a conflict or inconsistency between the terms and conditions set forth in the Master Service Agreement and the terms and conditions set forth in this Project Agreement, the terms and conditions set forth in the Master Service Agreement shall take precedence, govern and control.  Terms in a Project Agreement that supplement or refine the terms of this Agreement will be read together with their related terms and not be deemed “conflicting”.
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(b)        The Parties hereby acknowledge that the terms set forth in the Agreement are incorporated herein by reference, as if fully set forth at length herein.
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2.         The Services
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A detailed description of the services (the “Services”) is set forth on Exhibit A attached hereto.
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3.         Term and Termination
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[To be determined based on the Services and inVentiv Affiliate].
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4.         Fees
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Set forth on Exhibit B attached hereto is a summary of the cost and fees to be paid by Client to inVentiv for the performance of the Services.
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5.         [Miscellaneous]
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[Insert any additional contract terms and project requirements specific to the Services to be provided by inVentiv Affiliate].
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WHEREFORE, the parties hereto have caused this Project Agreement to be executed by their duly authorized representatives.
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	AGILE THERAPEUTICS, INC.
	    
	INVENTIV COMMERCIAL SERVICES, LLC

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	By:
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	By:
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	Title:
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	Title:
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EXHIBIT A
THE SERVICES
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EXHIBIT B
FEES AND COSTS

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