PROJECT AGREEMENT (DETAILING AND SALES OPERATION SERVICES)

A.    Client and inVentiv have entered into a Master Service Agreement dated as of May 12, 2014 (the “MSA”).

B.    Client and inVentiv desire to enter into this Project Agreement (the “PA” or “Project Agreement”) pursuant to which inVentiv shall provide a field force of inVentiv sales representatives to provide detailing services and shall provide sales operation services as set forth more fully in Exhibits A and B attached hereto.

    

The Parties confirm that the MSA shall govern the relationship between the Parties, and this Project Agreement shall be subject to the terms of the MSA. Unless otherwise expressly 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 PA, the terms and conditions set forth in the MSA shall take precedence, govern and control. Unless otherwise expressly provided herein (including in any exhibits), capitalized terms used in this Project Agreement have the meanings set forth in the Master Service Agreement.

2.    The Services

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 is set forth on Exhibit B attached hereto and made a part hereof (the “Sales Operations Services” and, collectively with the Detailing Services, the “Services”).

3.    The Term

This Project Agreement shall be in effect as of the Effective Date and shall remain in effect until the second (2^nd) anniversary of the Deployment Date (as defined in Exhibit A) (the time from the Effective Date through such second anniversary, the “Initial Term”), unless extended as provided herein. The period from the Deployment Date until the day prior to the one (1) year anniversary of the Deployment Date shall be referred to herein as “Year One” and the period from the one (1) year anniversary of the Deployment Date through the day prior to the

two (2) year anniversary of the Deployment Date shall be referred to herein as “Year Two”. The term of this Project Agreement 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 ninety (90) days before the end of the Initial Term or any Additional Term (the Initial Term plus any Additional Term(s) collectively, the “Term”).

4.    Termination

(a)    Subject to Section 4(b) below, either Party may terminate this Project Agreement in accordance with Section 12 of the MSA.

(b)    Notwithstanding Section 12(a)(v) of the MSA, Client may terminate this Project Agreement in its sole discretion only by providing the other Party with at least ninety (90) days’ prior written notice; provided, however, that the actual termination date may not occur prior to the eighteen (18) month anniversary of the Deployment Date.

(c)    Client may terminate this Project Agreement upon thirty (30) days’ prior written notice if any of the following events take place: (i) the Product is withdrawn from the market for any reason, or any competent regulatory agency acts to prevent or materially restrict the sale of the Product, such as by governmental seizure or restraining order; (ii) the Product is not approved by the FDA by the Product’s PDUFA date of May 30, 2014; or (iii) the Product is determined to be [†], such [†] or the [†]; provided, however, that if Client terminates this Project Agreement in accordance with this Section 4(b), then Client shall pay inVentiv for the actual cost of all reasonable non-cancellable expenses incurred by inVentiv up to the termination date.

(d)    Client may terminate this Project Agreement upon thirty (30) days’ prior written notice if inVentiv fails to reach the milestones and/or deliver the deliverables specified in the Project Plan by the scheduled Deployment Date and such failure is not cured within the notice period, provided, however, that any such failure shall be excused for the duration and to the extent that such failure was caused by Client’s delay in performing its obligations under this Project Agreement.

(e)    Client may terminate this Project Agreement upon thirty (30) days’ prior written notice if the inVentiv Sales Representatives fail to achieve the performance standards to be mutually agreed by the Parties within six (6) months following the Deployment Date (such standards, as may be amended from time to time by written agreement of the Parties, “Detailing Services Performance Standards”) and such failure is not cured within the notice -period.

(f)    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), or at the end of the Term (or any Additional Term) or in the event Client conducts a Selective Conversion or Block Conversion (as set forth in Section 5 below), Client shall (in addition to all other payment obligations under this Agreement accrued by the effective date of such termination or Conversion) (A) promptly pay (or if paid by inVentiv, promptly reimburse) inVentiv for the amount due any lessor or rental agent of the equipment (e.g. laptop computers, iPads, fleet

automobiles) (collectively, the “Equipment”)) leased or owned by inVentiv and provided to the relevant members of the Project Team (i.e., in the event of termination, all members of the Project Team or in the event of a Conversion, the inVentiv Sales Representative(s) so Converted), for any early termination of the lease or rental agreement for the applicable Equipment, (B) in the event such Equipment is owned by inVentiv, transfer such Equipment to Client and pay an amount equal to the net book value (if any) of such Equipment on the books of inVentiv at the time of the transfer event, or in the event such Equipment is subject to a lease or finance lease, such Equipment may be transferred to Client (subject to the last sentence of this Section 4 (f)) and Client shall assume the responsibility for all further payments due (including costs associated with the transfer), or (C) pay inVentiv the net loss to inVentiv (or, in the case of a net gain to inVentiv, inVentiv shall pay Client the net gain) on such Equipment determined by the difference between the net book value of such Equipment and the actual net price received by inVentiv for the disposal of such Equipment, plus any amounts due by inVentiv in connection with the lease or rental termination and costs associated with the storage and disposal of such Equipment. For clarity, with regards to leased fleet automobiles, all realized and unrealized gains or losses will be combined to determine such net gain or loss. Any proposed transfer of Equipment to Client shall be subject to Client establishing its own relationship and credit with the entity that inVentiv contracted with to lease or rent such Equipment.

5.    Conversion (Selective Hiring and Block Conversion)

(a)    Notwithstanding Section 7 of the MSA, during the Term and after the Deployment Date, Client may solicit, employ or retain one or more inVentiv Sales Representatives performing Services hereunder (a “Selective Hiring”). Client shall give forty-five (45) days’ prior written notice to inVentiv of any Selective Hiring. Should there be Selective Hiring by Client, inVentiv will backfill the respective position so as to maintain the previously agreed upon number of inVentiv Sales Representatives performing Services hereunder. In the event Client wishes to implement a Selective Hiring during the Term, Client shall pay inVentiv [†] as a recruitment fee for each replacement/backfill inVentiv Sales Representative.

(b)    Notwithstanding Section 7 of the MSA, Client may solicit, employ or retain one or more inVentiv Sales Representatives performing Services hereunder and inVentiv shall not backfill the respective position (a “Block Conversion”) provided that: (i) such hiring may not occur prior to the eighteen (18) month anniversary of the Deployment Date (as defined in Exhibit A) and (ii) Client provides at least forty-five (45) days’ prior written notice to inVentiv of any Block Conversion. In the event Client wishes to implement a Block Conversion, Client shall pay inVentiv a Conversion fee based upon the date of the actual Block Conversion, in accordance with the following table, and in lieu of any payment under Section 7(c) of the MSA:

(c)    Client understands and agrees that inVentiv cannot guaranty that any inVentiv Sales Representative will agree to participate in a Selective Hiring or Block Conversion. In the event a Sales Representative does not agree to participate in a Selective Hiring or Block Conversion, Client will have no payment obligation to inVentiv under this Section 5 with respect to such Sales Representative.

(d)    In the event Client implements a Selective Hiring or Block Conversion, the Parties agree that any inVentiv proprietary training materials made available to the inVentiv Sales Representatives will be immediately returned to inVentiv, it being understood and agreed that the inVentiv proprietary training modules constitutes valuable and proprietary information of inVentiv and is subject to the confidentiality obligations set forth in Section 6 of the MSA. For clarity, such inVentiv proprietary training materials excludes any materials provided by Client, any Product-specific materials, or other materials created for Client or Client’s Product by inVentiv in the course of performing services under this Project Agreement or any other Project Agreement under the MSA. Within fifteen (15) days of implementing a Selective Hiring or Block Conversion, Client shall use commercially reasonable efforts to return to inVentiv any originals and copies of such inVentiv proprietary training modules which had been in possession of the converted inVentiv Sales Representatives.

(e)    In the event Client conducts a Selective Hiring or Block Conversion (collectively, a “Conversion”) and the converted inVentiv Sales Representative had been provided with use of a fleet automobile leased, rented or owned by inVentiv and Client wishes to commence an arrangement with the fleet vendor to assume such cars (and all associated costs and liabilities) under Client’s name, the converted inVentiv Sales Representative may only to continue to have access to such automobile following the Conversion if Client either: (i) registers the fleet automobile under its name; or (ii) ensures that inVentiv remains named as an additional insured under Client's automobile insurance policies until such time as the vehicle is registered in Client’s name (which shall occur no later than three (3) months following the Conversion). The Parties understand and agree that it is solely Client’s obligation to ensure one of the above actions are taken and Client shall be responsible for indemnifying, defending and holding inVentiv harmless for all damages resulting from Client’s failure to take such action. The Parties further agree that on the effective date of the Conversion, Client shall destroy the inVentiv insurance card(s) in the fleet vehicle(s) of the converted inVentiv Sales Representative.

6.    Return of Client Materials

Except as set forth in Section 5, if any inVentiv Sales Representative leaves the employ of inVentiv or ceases to perform Services (including in connection with the expiration or termination of this Project Agreement), inVentiv shall use commercially reasonable efforts to retrieve from such person all materials provided by Client, any Product-specific materials, or other materials created for Client or Client’s Product by inVentiv in the course of performing Services under this Project Agreement (or any other Project Agreement under the MSA), and shall provide such materials to the replacement inVentiv Sales Representative, or, if there is no such replacement (including in the case of expiration or termination of this Project Agreement), return the materials to Client within fifteen (15) business days.

 

Set forth on Exhibit C are the costs and fees to be paid by Client to inVentiv for the performance of the Services.

WHEREFORE, the parties hereto have caused this PA to be executed by their duly authorized representatives on the day and year first above written.

inVentiv will provide Client with a field force that shall consist of twenty (20) full-time sales representatives (the “inVentiv Sales Representatives” or “Sales Representatives”) who shall detail Client’s Product by making Calls pursuant to a Call Plan on Targets. The inVentiv Sales Representatives shall be managed by one (1) shared National Business Director (“NBD”) and one (1) shared Operations Manager (“OM”) each of whom shall also be inVentiv employees. The inVentiv Sales Representatives, the NBD and the OM may be collectively referred to herein as the “Project Team”.

In the event that the Parties desire to increase the type and / or number of Project Team members providing Services under this Project Agreement they may do so by utilizing a Project Team Member Request Form (the “Request Form”) in a format that is substantially similar to the one attached hereto as Exhibit A – 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.

In connection with the promotion of Client’s Product, inVentiv shall provide the Client with following Detailing Services.

(a)    “Adverse Event” means the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to the Product, whether or not considered causally related to the Product, the exacerbation of any pre-existing condition(s) occurring during the use of the Product, or any other adverse experience or adverse drug experience described in the FDA’s Investigational New Drug safety reporting and New Drug Application postmarketing reporting regulations, 21 C.F.R. 312.32 and 314.80, respectively, as they may be amended from time to time. For purposes of this Project Agreement, “undesirable medical condition” shall include symptoms (e.g., nausea, chest pain), signs (e.g., tachycardia, enlarged liver) or the abnormal results of an investigation (e.g., laboratory findings, electrocardiogram), including unfavorable side effects, toxicity, injury, overdose, sensitivity reactions or failure of the Product to exhibit its expected pharmacologic/biologic effect.

(b)    “Call” means the activity undertaken by an inVentiv Sales Representative to detail the Product, further described as a face-to-face presentation by an inVentiv Sales Representative to a Target and will include providing the Target with Product Literature as directed by Client.

(c)    “Call Plan” means a plan designed by Client, which is intended to enhance the efficiency and effectiveness of the inVentiv Sales Representatives in making Calls. The Call Plan will be maintained by inVentiv at its offices with a copy of such Call Plan maintained by client at its offices, and may be amended or reconfigured once per calendar quarter by Client.

(d)    “Deployment Date” means the date of the first Call which is anticipated by the Parties to be on or about August 4, 2014. The actual Deployment Date will take precedence over the date specified herein.

(e)    “inVentiv Sales Representative” or “Sales Representative” means an individual employed by (or, if applicable, an independent contractor to) inVentiv who is engaged under this Project Agreement to detail the Products.

(f)    “Minimum Detailing Standards” means the minimum standards for detailing by an individual Sales Representative under this Project Agreement, such standards to be decided upon by the Parties within six (6) months following the Deployment Date.

(g)    “Product” shall mean Omidria (phenylephrine-ketorolac ophthalmic injection) 1%/0.25% or other Client products added to this Project Agreement with the mutual written consent of the Parties.

(h)    “Product Literature” shall mean promotional, informative and other written information concerning the Product. All Product Literature shall be prepared and provided by Client.

(i)    “Product Quality Complaint” means any and all manufacturing or packaging-related complaints related to the Product, including (a) any complaint involving the possible failure of the Product to meet any of the specifications for the Product; (b) any dissatisfaction with the design, package or labeling of the Product; or (c) any Adverse Event that may involve the quality of the Product, including lack of effect, infection or request for testing.

(j)    “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 inVentiv.

(a)    inVentiv will recruit and hire the full-time inVentiv Sales Representatives and assign the necessary the shared resources to Client’s project. A complete description of the sourcing, screening and recruiting services is attached hereto as Exhibit A-2. The Client shall notify inVentiv in writing of the date on which inVentiv may commence such hiring, such date to be selected in Client’s sole discretion (the “Hiring Start Date”) For clarity, inVentiv shall not hire any member of the Project Team until the Hiring Start Date.

inVentiv shall provide the inVentiv Sales Representatives with salary, benefits, fleet automobiles (e.g. Chevrolet Malibu, Chevrolet Equinox (snow belt territories) or similar model), iPads, laptop computers, sales force automation software, printers and bonus as agreed by the Client and as set forth in Exhibit C, Section II, Pass-Through Costs. inVentiv shall provide the NBD and OM with salary, benefits, iPads, laptop computers, sales force automation software and printers as needed to perform their respective duties under this Project Agreement.

(b)    Training - The training responsibilities of the Parties are as follows:

(i)     inVentiv shall be responsible for training members of the Project Team concerning: selling skills, inVentiv human resource policies, procedures and administration and other applicable inVentiv internal human resource and general compliance policies and procedures, prior to the Deployment Date (or, in the case of inVentiv Sales Representatives hired after the Deployment Date, prior to their deployment).

(ii)    Client shall be responsible for training members of the Project Team concerning all Product specific information including Product Quality 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, prior to the Deployment Date (or, in the case of inVentiv Sales Representatives hired after the Deployment Date, prior to their deployment).

(iii)    The Parties agree to work together to mutually determine if, when, and at what cost additional training shall be provided to members of the Project Team, provided that, at Client’s request and expense, inVentiv will perform any follow-up or refresher training on a schedule to be mutually agreed upon by the Parties.

(vi)    inVentiv shall maintain during the Term and for a period of three (3) years thereafter, records of any training it conducts under this Project Agreement.

(c)    Exclusivity. The inVentiv Sales Representatives shall be solely and exclusively used for the Detailing Services as set forth herein, and shall not, during the Term, market, promote or sell any pharmaceutical product other than the Product. In addition, during the Term, the National Business Director and Operations Manager shall not participate in (including through the coordination or supervision of other teams of sales representatives) the marketing, promotion or selling of any product for an Identified Competitor. Upon any breach of this Section II(c), Client may, in addition to any other rights or remedies to which Client may be entitled in law or equity, terminate this Project Agreement by providing thirty (30) days’ written notice of termination to inVentiv specifying such breach, provided that the termination shall not become effective if inVentiv cures such breach within such thirty-day period.

If Client believes in good faith that the performance of any inVentiv Sales Representative is unsatisfactory or is not in compliance with the provisions of this Agreement, Client shall notify inVentiv and inVentiv 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 an inVentiv Sales Representative has violated any Applicable Law or policy, Client shall notify inVentiv (in writing). inVentiv shall promptly address the issue and take all reasonable and appropriate action (including but not limited to termination of such employee) consistent with inVentiv’s internal human resource policies and procedures, which in the case of

any failure to meet the Minimum Detailing Standards or for any violation of Applicable Law or policy, shall include at a minimum reassigning such inVentiv Sales Representative so that such person no longer performs Detailing Services or any other services for Client.

 

The inVentiv Sales Representatives shall provide information to the Target about the Product when making Calls as directed by Client. Client is solely responsible for the content, production and distribution (to the inVentiv Sales representatives) of the Product Literature, and the inVentiv Sales Representatives shall utilize only such Product Literature when making Calls. Each inVentiv Sales Representative shall record information concerning each Call and concerning the profile of each individual Target (or other physician called upon) on whom the inVentiv Sales Representative calls. To the extent not prohibited by any third-party agreement, and subject to the Parties’ obtaining any necessary licenses or rights from third-parties, Client shall permit inVentiv 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 Agreement (the “Data”). The Data shall be used by inVentiv for the purpose of evaluating the performance of its Project Team members and, provided that inVentiv de-identifies all Client and Product specific components of the Data, for business development and analytics purposes, provided, however, that inVentiv shall not use any such Data in connection with any such activities associated with or directed at any third party without the prior written consent of Client.

For the avoidance of doubt, all such Data, as well as any data stored on behalf of the Client by inVentiv in accordance with this Project Agreement, shall, as between the Parties, be owned solely and exclusively by Client.

To the extent permitted by applicable law, Client shall be permitted to coach Sales Representatives on effective selling strategies for the Products, evaluate and recommend actions to improve the Call Plan to conform to Minimum Detailing Standards, participate in “ride alongs” with Sales Representatives when making Calls, and train Sales Representatives about the Products and requisite medical background information.

(a) Requests for Medical Information.

(i)    Client shall have the exclusive right to respond to all questions or requests for information made to inVentiv or its Sales Representatives by any medical professionals or any other person or entity about the Product, if such questions or requests (i) warrant a response beyond the understanding or knowledge of the Sales Representative or (ii) are beyond the scope of the Product labels and inserts or Product Literature (a “Medical Information Request”).

(ii)    inVentiv shall promptly communicate to Client, or any third-party vendor designated by Client to process such information, all Medical Information Requests received by inVentiv or the inVentiv Sales Representatives. If Client designates such a third-party vendor or

changes such third-party vendor (which Client may do from time to time in its sole discretion), it shall notify inVentiv in writing of the name and contact information for such new vendor.

(b) Regulatory Reporting.

(i)    Client shall be solely responsible for making all reports, submissions and responses to Agencies concerning the Product, including reporting Adverse Events and Field Alerts, as required by Applicable Law. In addition, Client shall be solely responsible for (A) taking all actions and conducting all communication with all third parties with respect to all Product Quality Complaints, including complaints related to tampering or contamination, and (B) investigating all Product Quality Complaints, Adverse Events, and Field Alerts with respect to the Product. inVentiv shall, at Client’s expense, cooperate with all of Client’s reasonable requests and use its diligent efforts to assist Client in connection with (x) preparing any and all such reports for any relevant governmental or regulatory authority, (y) preparing and disseminating all such communications to third parties, and (z) investigating and responding to any Product Quality Complaint or Adverse Event.

(ii)    inVentiv shall provide notice to Client within two (2) business days from the time it becomes aware of an Adverse Event associated with the use of the Product (whether or not the reported effect is (A) described in the full prescribing information or the published literature with respect to the Product or (B) determined to be attributable to the Product) or any information in or coming into its possession or control concerning such Adverse Event by providing notice to Client or any third-party vendor designated by Client to process such information. If Client designates such a third-party vendor or changes such third-party vendor (which Client may do from time to time in its sole discretion), it will notify inVentiv in writing of the name and contact information for such new vendor.

(iii)    inVentiv shall provide notice to Client within two (2) business days of the time it becomes aware of (A) any information that might necessitate the filing by Client of a field alert report, as required under 21 C.F.R. § 314.81(b)(1) (a “Field Alert”), as such regulation may be amended from time to time or (B) any Product Quality Complaint associated with use of the Product, in each case ((A) or (B)), by providing notice to Client or any third-party vendor designated by Client to process such information. If Client designates such a third-party vendor or changes such third-party vendor (which Client may do from time to time in its sole discretion), it will notify inVentiv in writing of the name and contact information for such new vendor.

(iv)    inVentiv shall put in place procedures and protocols that shall be actively monitored by inVentiv to ensure that all relevant information regarding the matters referred to in this Section V that come to the attention of any member of the Project Team is promptly conveyed to Client so that Client can comply with applicable reporting requirements. As to any Adverse Event of which the Project Team is made aware, inVentiv and the Project Team shall not make any statement or give any opinion (written or verbal) to any person or entity that could reasonably be construed as an admission of fault on Client’s part or a promise that Client will compensate any person or entity with respect thereto.

(a)    The Product shall be promoted by inVentiv 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 PA. This Agreement does not constitute a grant to inVentiv of any property right or interest in the Products or the trademarks owned by or licensed to Client. inVentiv 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 inVentiv that to its knowledge, neither those trademarks, trade names and trade dress nor the promotion of the Products by inVentiv infringes on any intellectual property right of any other person or entity.

(b)    Client shall have the sole right and responsibility of establishing or modifying the terms and conditions of sale of Products. Client shall be exclusively responsible for accepting and filling purchase orders, billing, and returns with respect to the Product. If inVentiv or any inVentiv Sales Representative receives an order or a request to order a Product, it shall, within one (1) business days, forward such order or request to Client for acceptance or rejection, which acceptance or rejection shall be at Client’s sole discretion.

VII.    HIRING PROFILE

In selecting Sales Representatives, inVentiv shall use the preferred hiring profile approved by Client as set forth below and shall provide the sourcing, screening and recruiting services identified in Exhibit A-2. inVentiv shall use diligent efforts to hire Sales Representatives in accordance with the preferred hiring profile and to confirm the accuracy of information concerning background and experience received from applicants for positions of Sales Representatives. inVentiv shall not knowingly employ or otherwise retain, or permit to be retained as a Sales Representative, 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 or whose employment or retention for this purpose is otherwise prohibited by Applicable Law.

Must have:

4 year college degree

Outside sales experience

Dedication to full time employment (no employment or income-producing activities outside of inVentiv)

Clearance on all pre-employment screening

Ability to attend required training programs

Ability to participate in minimal overnight travel

Most preferable to least preferable:

[†] experience

[†] experience

[†] experience

[†]

[†] experience

Desired:

Professional image and conduct

Intelligence

Analytical/business oriented

Persuasive

Organized and high planning aptitude

Goal/objective oriented

High degree of personal motivation and drive

Honest

Oral & written communication skills.

inVentiv shall be responsible for performing drug testing and background checks of all Sales Representatives. inVentiv represents and warrants that it will complete or cause to be completed a thorough background check of all Sales Representatives. This will include the following: criminal check, Social Security check, drug screen, motor vehicle record check, education check, and past employer check. inVentiv further represents and warrants that it will perform or cause to be performed background checks to confirm that no Sales Representative:

(a).    is an excluded person on the Office of Inspector General’s List of Excluded Individuals/Entities and is not on the General Services Administration Excluded Parties List (as of the date the background check is performed);

(b).    is, so far as it is aware, an unfit or an improper individual for the performance of the Services;

(c).    is, so far as it is aware, engaged in any fraudulent or unlawful activity, or other inappropriate conduct as measured by the other requirements of this Agreement.

inVentiv further covenants to provide prompt written notice to Client in the event it becomes aware that any Sales Representative falls within any of the categories set forth in this Section VIII(a)-(c). inVentiv shall institute prompt corrective or disciplinary action against any Sales Representative who fails to meet the requirements set forth in this Exhibit A. inVentiv 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 inVentiv or any Sales Representative under this Agreement.

(a)    inVentiv represents, warrants and covenants that:

(i)    it, as well as the inVentiv Sales Representatives, shall perform the implementation of Client’s detailing program in a professional manner consistent with industry standards and with that level of care and skill ordinarily exercised by other competent professional contract service organizations in similar circumstances and in accordance with this PA, the MSA, and those specifications and timelines which inVentiv and Client agree to (in writing) and which are not otherwise set forth herein or in the MSA. inVentiv shall ensure that its employees or agents complete the Services (including those in Exhibit B) in a timely manner and in accordance with the terms of this PA;

    (ii)    the inVentiv Sales Representatives shall make only those statements and claims regarding the Product, including as to safety and efficacy, that are consistent with the labeling of the Product, the inserts for the Product, and the Product Literature, and shall not add, delete or modify claims of efficacy or safety of the Products, nor make any changes (including but not limited to, underlining or otherwise highlighting any language or adding any notes thereto) in the Product Literature. inVentiv shall, and shall permit the inVentiv Sales Representatives to, use only the Product Literature provided by Client. inVentiv and the inVentiv Sales Representatives shall not develop, create, or use any other promotional material or literature or alter Product Literature provided by Client. inVentiv shall immediately cease the use of any Product Literature when instructed to do so (in writing) by Client. inVentiv shall use the Product Literature only for the purposes of this Agreement;

(iii)    it shall not, and shall ensure that all Sales Representatives shall not, directly or indirectly, pay, offer or authorize payment of anything of value (either in the form of compensation, gift, contribution or otherwise) to any person or entity in a position to order or purchase the Products contrary to any law;

(iv)    it shall not, and shall ensure that all Sales Representatives shall not, directly or indirectly, make any representations or warranties relating to the Products that conflict, or are inconsistent with the Food and Drug Administration approved labeling for the Products, and shall not make any untrue or misleading statements or comments about the Products, Client, any employees of Client, any competitors of Client, or other products;

(v)    it shall ensure that each Sales Representative shall promote, market and sell the Products in accordance with Applicable Law; and

(vi)    it shall ensure that any Data used by or on behalf of inVentiv in accordance with Section IV of this Exhibit A is properly de-identified before such use and such use is otherwise in compliance with Applicable Law.

(b)    Client represents, warrants and covenants that:

(i)    it recognizes that for inVentiv to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide inVentiv with the necessary materials and assistance required to enable inVentiv to perform the Services;

(ii)     it will comply with Applicable Law in its marketing, promotion and sale of the Products (leaving aside any acts or omissions of inVentiv or the inVentiv Sales Representatives with respect thereto);

(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 inVentiv employees, provided, however, that in no event shall Client be prohibited from making changes to the Product Literature that Client believes are necessary or appropriate and in compliance with Applicable Law;

(iv)    it shall ensure that none of its employees working with the Project Team or in connection with the Services, directly or indirectly instruct any inVentiv 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 inVentiv employee to make any representations or warranties relating to the Products that conflict, or are inconsistent with Applicable Law or the Food and Drug Administration approved labeling for the Products.

(vi)    Client shall:

A.    provide inVentiv Sales Representatives with all Product Literature.

B.    inform inVentiv promptly of any changes in the Product Literature or in information concerning the Products which Client believes are necessary or appropriate in order to be in compliance with all Applicable Law.

C.    as permitted under Applicable Law, respond appropriately and in a timely manner to any inquiry concerning a Product communicated to inVentiv from any licensed practitioner and communicated by inVentiv to Client.

This Request for Additional Project Team members is issued pursuant to the Master Services Agreement between Ventiv Commercial Services, LLC (“inVentiv”) and (“Client”) dated         and the Project Agreement issued thereunder dated _____________.

This Exhibit B describes the work required for the initial implementation and ongoing operation of the Sales Operations Services to support the Project Team, which will initially include twenty (20) inVentiv Sales Representatives. Any changes to the assumptions, deliverables, or scope of work described in this document or any new work requests will follow Section 4.0, Change Control Process, of this document.

This Exhibit B defines the work related to the following service areas for the initial implementation and ongoing operation of the Sales Operation Services within the following areas:

Without limiting any obligations of inVentiv as set forth herein, inVentiv shall perform all activities assigned to it under the applicable Project Plan and shall use commercially reasonable efforts to perform such activities in accordance with any applicable time periods, milestones and deadlines set forth in such Project Plan.

inVentiv has developed a project implementation methodology based upon industry best practices into the most efficient process and method for conducting and managing projects.

The inVentiv project team will approach this engagement with the following perspectives in mind:

inVentiv will provide a fully integrated project management approach for the implementation of the Sales Support Services and hereinafter referred to as the “Project”. The Project will be managed by a dedicated project manager (“Project Manager”) who will be responsible for the following:

The Project Manager will be assigned to Client during the implementation period, including the preparation and delivery of the kick-off meeting through the completion of the Project close-out and lessons learned. After the implementation period is over and field users are deployed, the operational support of the client will be provided by the shared Operations Manager with support provided as needed by the Project Manager.

inVentiv will provide a fully functioning CRM application utilizing our proprietary, pre-configured build, referred to as the inVentiv General Development Org or “GDO”, of Veeva CRM software, an industry leader in providing cloud-based CRM applications to the Life Sciences industry. The CRM Services include those supported within the inVentiv Health GDO including:

The CRM implementation will be led using an Agile development approach including the following deliverables:

The scope of the CRM delivery and associated timelines for the Project assumes the following:

System, not to include any Adverse Events reporting or recording.

inVentiv will provide data loads and data integration services for all needed 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 very closely with the CRM and analytics & reporting tools to ensure that all customer business rules and data requirements are properly understood and planned for in the overall implementation plan. This Project assumes typical data loads and ongoing data support as provided below:

A full description of all data files and interfaces will be provided in the Data Requirements Document (“DRD”), which will be included as part of the Project Plan with necessary approvals from Client project leads.

Data interfaces typically include the following:

Initial data loads using agreed upon inVentiv/Client formats including:

Reoccurring data imports at set frequencies and in agreed upon formats for ongoing Customer and Territory management including:

Reoccurring data extracts provided at set frequencies to either home office or third party vendors as needed for processing including:

Standard Data Management services will be provided for the ongoing maintenance of the systems and data including:

The scope of the Data Management delivery and associated timelines for the project assumes the following:

inVentiv shall maintain all data in the Veeva CRM system relating to the Detailing Services for a minimum of fifteen (15) months, and at Client’s request and expense, shall store such data for longer periods.

Promptly upon the expiration or termination of this Project Agreement, inVentiv shall return, or cause to be returned, in a format reasonably acceptable to inVentiv, any data stored in the Veeva CRM system.

The project assumes general field activity reporting will be provided in the Veeva CRM Reporting environment utilizing inVentiv’s pre-configured reporting tools to optimize field performance and implementation setup time. inVentiv will configure the template reporting tools to include client specific fields and terminology where applicable within Veeva and SalesForce.com guidelines.

After initial implementation, configuration and approval of alpha/beta reviews, inVentiv will provide documents, in the form of Business Requirements Documentation

(“BRD”) and Reporting Requirements Document (“RRD”). These documents will be signed by both Client and inVentiv to ensure coordination and agreement on the overall requirements. Any additional dashboards will be assessed and scoped based on Client needs following the specified Change Management process implemented by inVentiv.

Veeva reporting can be implemented for the following:

The Veeva template field reporting package is designed to drive sales behavior in the following ways:

While there is a suite of reports included in the Veeva offering, the reporting department is designed to create and publish ad hoc (one time) and custom (scheduled) reporting. These reports are scoped for time and resources and the fees are agreed to

prior to any work being performed. Included in the Veeva offering are the following time period reports prepared at Territory level and rolled in summary to the district, regional and national level unless noted otherwise:

inVentiv will provide Targeting and sales force alignment services for optimization of key customers. These services will produce the following:

Deliverables including:

The scope assumes the following:

•    Alignment will be created utilizing inVentiv’s preferred alignment software

•    Territory Workload parameters and project assumptions are agreed upon before work starts

•    All Third Party Agreements are signed off on before work starts

•    Third Party Data purchased by inVentiv will be passed through to Client

workload specific data points (Rx, Deciles, etc.)

Items not included in these assumptions:

3.6    Incentive Compensation

inVentiv will facilitate incentive compensation requirement /assessment meetings with the Client to establish plan parameters, data availability, budget, assess plan goals and bonus culture of Client. Additionally inVentiv will create a formal IC plan (“IC Plan”), subject to approval by Client in its sole discretion. Upon approval of the IC Plan by Client, such IC Plan will be distributed to the field force for signature and electronic validation of plan acceptance. The plan documentation will outline the plan payment components as well as terms and conditions for participation in the plan. IC results data will be calculated based on monthly data provided by Client. inVentiv will develop scorecards to document the field performance to the approved plan. Typically, field forces are paid bonus on a quarterly cycle which commences post the receipt of sales data for the final month of the quarter. Client will be provided with territory level results which aggregate to the national level. This allows for budget analysis, accrual processing and approval of results findings or adjustments to plan in the event of major windfalls or shortfalls outside the field control. Post concurrence of the performance results, inVentiv will process IC payouts through the inVentiv payroll system.

    inVentiv will develop and administer the incentive compensation (“IC”) plan through the following phases:

    Plan Design:

    Implementation & Programming:

Deliverables and timelines are provided in the tables following:

inVentiv will provide Fleet services for the Client project. The Fleet activities will be managed by a Fleet Analyst who will be responsible for the following:

The associated timelines for the project assumes the following:

inVentiv will provide HR services for the project to support the recruiting and ongoing field management requirements. The HR activities will be managed by an HR Manager who will be responsible for the following:

The timelines for the project assumes the following:

3.7.3 Field Operations Management

    The Operations Manager will be assigned and work with the Project Manager during the implementation period. Post-deployment, the Operations Manager will assume the day-to-day management of the project and will be responsible for the following:

The associated timelines for the project assumes the following:

inVentiv leverages the industry standard T&E system, Concur, for capturing of all expense management for reimbursement for and HCP data capture for inVentiv Employees for the Project. The Expense Management Solution will assume the following:

•    Standard Concur expense fields and set-up are used for project

•    Full-cycle testing of the DME File Delivery Process

•    Inclusion of Expense Management in Technology Training sessions (Manager/Rep)

•    Tracking of completed Concur module review in LMS per user

inVentiv will work closely with client in the Data Requirements process to confirm the file format, data elements, and file delivery process and frequency to meet Client specifications for Transparency Reporting and Client System Integration.

The inVentiv Field Service Desk supports inVentiv Systems and Operational processes, to ensure field user readiness and performance.

inVentiv will provide full asset management services ranging from hardware procurement to configuration and deployment and includes tracking IT assets throughout the life of the project. inVentiv 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.

Our standard hardware platform includes:

Users are given inVentiv-hosted email boxes with the option to configure with client-like domains/addresses to give the look and feel of a Client employee.

inVentiv shall use commercially reasonable efforts to ship Repairs/replacements of broken, stolen or lost hardware one business day after receiving notification of such breakage, theft or loss.

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.

inVentiv will provide training services for the inVentiv Sales Representatives including the development of a comprehensive training program and certification of all inVentiv field employees for the client project across the following areas and sources:

inVentiv will leverage an internal Learning Management System (LMS) to consolidate all training curriculum and training records and allow tracking and reporting of certification internally and to client.

All Client implementations are managed via an approved set of Standard Operating Procedures (SOPs) which are part of inVentiv Health’s Quality Management System (QMS) under the Director of Quality Assurance. Key processes such as Change Control, CRM Implementations of Third Party Applications and Training are required training for Sales Operations personnel. Other SOPs such as Security and Access Control, System Development Life Cycle, Asset Provisioning and CRM End-User Training are additional required training for implementation teams delivered and tracked within inVentiv’s Learning Management System.

Formal System Validation is conducted by professional validation resources following inVentiv Health’s System Validation SOP. The work is driven by the approved Business Requirements Document (BRD), and includes a Validation Plan, Operational Qualification, Performance Qualification, Test Evidence (typically screen shots), Deviation Reports, Traceability Matrix and a Validation Summary Report.

Resources, or a member of the Compliance team

Throughout the development of a business solution, additional knowledge is gained and situations and underlying assumptions change. A key component of the project management process is to identify the changes and make informed decisions, especially with regard to functionality, schedule and cost.

    

The change control process enables inVentiv and its customer to maintain a shared vision for the project. The objectives of change control are to:

If requirements arise that are outside the scope of this proposal, a Change of Scope document will be submitted for client approval following the below process:

Standard Pricing Table:

(a)    Implementation Fee

Client shall pay inVentiv $307,922 for implementation fee associated with performance of the Services.

(b)    Fixed Monthly Fee

Commencing on the date of hire of the first Project Team member Client shall pay inVentiv a Fixed Monthly Fee as follows:

For clarity, the Implementation Fee and Fixed Monthly Fee shall be the total compensation paid by Client to inVentiv for performing the Services. Unless expressly set forth herein, including in Section II of this Exhibit C, inVentiv shall be responsible for any costs associated with performing the Services.

(c)    Salary Reconciliation

The parties agree that the Fixed Monthly Fees set forth in Section I (b), above, are based on the annual salary per inVentiv Sales Representative of $[†] in Year One and $[†] in Year Two (the “Annual Salary”). When calculated on a quarterly basis such salary shall be $[†] in Year One and $[†] for Year Two (the “Quarterly Salary”). inVentiv will reconcile such salaries (excluding incentive compensation) on a calendar quarter basis as follows: for each inVentiv Sales Representative, the applicable Quarterly Salary shall be multiplied by the ratio of (A) the aggregate actual days worked (as determined in accordance with inVentiv human resources policies then in effect) by such inVentiv Sales Representative in such calendar quarter to (B) the total working days in such calendar quarter (as determined in accordance with inVentiv human resources policies then in effect) (each a “Calculated Quarterly Salary”). The Parties agree that the Quarterly Salary does not include bonuses for the inVentiv Sales Representatives (or the applicable employer portion of taxes) for such calendar quarter. If such reconciliation shows that the inVentiv’s Calculated Quarterly Salary is below the Quarterly Salary for such Sales Representative, then inVentiv shall issue a credit (or, in the case of the final quarter of the Term,

a payment) for the entire amount of such difference to Client within thirty (30) days of the close of such calendar quarter. If such reconciliation shows that inVentiv’s Calculated Quarterly Salary is above the Quarterly Salary for such Sales Representative, then inVentiv shall bill the difference to Client. For clarity, any credits arising from a vacancy (whether such vacancy occurs before or after the Deployment Date) or for any Block Conversion will be calculated in accordance with Section I(d) below.

(d)    Vacancy Credit; Block Conversion Credit

inVentiv agrees to fill vacant territories as requested by Client.  inVentiv will continue to invoice Client the amounts set forth above as Fixed Monthly Fee during any such vacancy period.  inVentiv 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 that is vacant for a period of time that exceeds one (1) month, until such territory is filled, as set forth in the table below.

In addition, if Client exercises its rights to a Block Conversion in accordance with Section 5(b) of the Project Agreement, inVentiv will provide a monthly credit to Client for such Sales Representative(s) for the remainder of the Term, prorated for the month in which such Conversion takes place for the number of business days per month that such position has been Converted, as set forth in the table below.

In addition to the Fixed Fees and subject to the terms and conditions of the MSA and PA, including the remainder of this Section II, certain expenses will be charged to Client on a pass-through basis. These expenses will be billed to Client at actual cost. The categories of permissible pass-through costs are as follows:

-     Project Team member travel expenses (e.g. transportation, lodging, meals, etc.)

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

-     Marketing and entertainment costs

-     Sales TRx data and any third party data acquisition expenses

−    Interview expenses

−    Travel expenses for inVentiv recruiters

−    Licensing and credentialing expenses

−    Other expenses which have been approved by Client.

All meetings for which inVentiv may seek reimbursement shall be held only at Client’s

request, and all marketing costs are to be agreed-upon by the Parties. Any travel and entertainment expenses shall be subject to inVentiv’s travel and entertainment policies and procedures. Without the prior written approval of Client, Client shall not be responsible for reimbursement for any travel or entertainment expenses in excess of or in violation of any applicable inVentiv travel and entertainment policies and procedures reviewed and approved by Client.

The Implementation Fee shall be paid in full on or before June 30, 2014. Up to but not exceeding one (1) month of Fixed Monthly Fee shall be invoiced to Client by inVentiv upon the Deployment Date, provided, however, that inVentiv shall, unless such amount has been credited to Client against subsequent Fixed Monthly Fees owed to Client, repay to Client any such amount paid to inVentiv by Client upon the termination or expiration of this Agreement. Commencing in the month of the Deployment Date, Client will be billed monthly on the first day of the month the amount stated above as the Fixed Monthly Fee. For purposes of clarity, the intent is that inVentiv should receive payment of the Fixed Monthly Fee on the first day of the month for which the payment applies (e.g., payment received June 1 for June activities), and in no event shall Client be charged a Fixed Monthly Fee more than once for a given month. Pass-through Costs will be billed to Client at actual cost as incurred by inVentiv.

Except as set forth in the preceding paragraph, payments are due within thirty (30) days of Client’s receipt of each applicable invoice from inVentiv. If an invoice is not paid within thirty (30) days of Client’s receipt, inVentiv reserves the right to impose a finance charge of the lesser of 1.0% (calculated on a monthly basis) or the maximum amount permitted by law of all amounts due.

During the Term and for a period of three (3) years thereafter, inVentiv shall keep and maintain complete and accurate records regarding matters relevant to payment of fees or other compensation under this Project Agreement (including records of the number of days worked by inVentiv Sales Representatives, pass-through costs, bonus compensation or incentive compensation). Upon Client’s request and at Client’s expense, inVentiv shall permit an independent certified public accounting firm selected by Client and reasonably acceptable to inVentiv to have access during normal business hours to inVentiv’s records as necessary to determine the correctness and completeness of such records and the amounts paid in accordance with such records. Such audit shall not take place more than twice a year. If such audit concludes that additional payments were owed or that excess payments were made during such period, the owing Party shall pay the additional payments or the receiving Party shall reimburse such excess payments, within sixty (60) days after the date on which such accounting firm’s written report is delivered to the Parties. Each Party shall cooperate with such accounting firm’s investigation, and the results of any investigation under this Section IV shall be made available to both Parties and be deemed the confidential information of both Parties, with both Parties the Disclosing Party and Receiving Party with respect thereto. Notwithstanding the foregoing, if any

such audit discloses a variance to the detriment of Client of more than [†] percent ([†]%) from the amount of the original payment calculation, inVentiv shall bear the reasonable and documented cost of such audit.