Representations and Undertakings. (a) [***] (b) Client represents that: (i) it recognizes that for Syneos Health to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Syneos Health with the necessary materials and assistance required to enable Syneos Health to perform the Services; (ii) the Services being provided by Syneos Health are in furtherance of Client’s program of marketing and promoting the Products and as such, Client is responsible for ensuring, and further, Client represents and warrants, that the Client’s program being implemented by Syneos Health pursuant to the terms hereof (but not the implementation thereof by Syneos Health), strictly adheres to all applicable state and federal statutes, laws, ordinances, and the rules and regulations of all governmental and regulatory authorities, including but not limited to, the Federal Food, Drug, and Cosmetic Act and the Prescription Drug Marketing Act; (iii) it shall ensure that none of its employees add, delete or modify claims of efficacy or safety of the Products, nor makes any changes (including but not limited to, underlining or otherwise highlighting any language or adding any notes thereto) in the Product Literature, during the training on the Products or during any communications with Syneos Health employees; (iv) it shall ensure that none of its employees working with the Project Team or in connection with the Services, directly or indirectly instruct any Syneos Health employee to pay, offer or authorize payment of anything of substantial value (either in the form of compensation, gift, contribution or otherwise) to any person or entity in a position to order, recommend or purchase the Products contrary to any law; and (v) neither it nor any of its employees directly or indirectly instruct any Syneos Health employee to make any representations or warranties relating to the Products that conflict, or are inconsistent with, applicable laws or the Food and Drug Administration approved labeling for the Products. (vi) Client shall: A. provide Syneos Health Project Team members with all Product Literature and arrange for the provision of Product samples (as applicable). B. inform Syneos Health promptly of any changes which Client believes are necessary or appropriate in the Product Literature or in information concerning the Products in order to be in compliance with all applicable federal and state law, regulations and administrative guidance. C. Arrange for a timely and appropriate response to any inquiry concerning a Product communicated to Syneos Health from any licensed practitioner and communicated by Syneos Health to Client.
Appears in 1 contract
Representations and Undertakings.
(a) [***]Alamo represents that:
(i) it, as well as the Reps employed by Alamo, shall perform the implementation of Clients’ detailing program in a professional, workmanlike manner consistent with industry standards and in conformance with that level of care and skill ordinarily exercised by other competent professional contract service organizations in similar circumstances and in accordance with those specifications and timelines which Alamo and Client agrees to (in writing) and which are not otherwise set forth herein or in the MSA. Alamo shall ensure that its employees or agents complete the Services in a timely manner and in accordance with the terms of this PA.
(ii) the Reps 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. Alamo shall only use and shall permit the Reps to only use the Product Literature provided by Client Alamo and the Reps shall not develop, create, or use any other promotional material or literature or alter Product Literature provided by Client. Alamo shall immediately cease the use of any Product Literature when instructed to do so (in writing) by Client_ Alamo shall use the Product Literature only for the purposes of this Agreement.
(iii) it shall not, and shall ensure that all Reps 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 Reps 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
(v) it shall ensure that each Rep shall promote, market and sell the Products in accordance with all applicable laws;
(b) Client represents individually that:
(i) it recognizes that for Syneos Health Alamo to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Syneos Health Alamo with the necessary materials and assistance required to enable Syneos Health Alamo to perform the Services; ;
(ii) the Services being provided by Syneos Health Alamo 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 Alamo pursuant to the terms hereof (but not the implementation thereof by Syneos HealthAlamo), strictly adheres to all applicable state and federal statutes, laws, ordinances, and the rules and regulations of all governmental and regulatory authorities, including but not limited to, the Federal Food, Drug, and Cosmetic Act and the Prescription Drug Marketing Act;
(iii) it shall ensure that none of its employees add, delete or modify claims of efficacy or safety of the Products, nor makes any changes (including but not limited to, underlining or otherwise highlighting any language or adding any notes thereto) in the Product Literature, during the training on the Products or during any communications with Syneos Health Alamo employees;
(iv) it shall ensure that none of its employees working with the Project Team or in connection with the Services, directly or indirectly instruct any Syneos Health Alamo 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 Alamo employee to make any representations or warranties relating to the Products that conflict, or are inconsistent with, with applicable laws or the Food and Drug Administration approved labeling for the Products. ; and
(vi) Alamo employees interacting with health care professionals shall deliver the approved sales presentation with appropriate fair balance at all times, including but not limited to leaving a copy of the Full Prescribing Information (“Package Insert”) at each sales call.
(vii) Client shall: :
A. provide Syneos Health Project Team members Reps with all approved Product Literature and arrange for the provision of Product samples (as applicable). Literature.
B. inform Syneos Health Alamo promptly of any changes which Client believes are necessary or appropriate in the Product Literature or in information concerning the Products in order to be in compliance with all applicable federal and state law, regulations and administrative guidance. .
C. Arrange for respond appropriately and in a timely and appropriate response manner to any inquiry concerning a Product communicated to Syneos Health Alamo from any licensed practitioner and communicated by Syneos Health Alamo to Client. .
Appears in 1 contract
Representations and Undertakings.
(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 represents, warrants and covenants that:: † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION
(i) it recognizes that for Syneos Health inVentiv to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Syneos Health inVentiv with the necessary materials and assistance required to enable Syneos Health inVentiv to perform the Services; ;
(ii) the Services being provided by Syneos Health are it will comply with Applicable Law in furtherance its marketing, promotion and sale 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 (leaving aside any acts or omissions of inVentiv or the Client’s program being implemented by Syneos Health pursuant to the terms hereof (but not the implementation thereof by Syneos HealthinVentiv Sales Representatives with respect thereto), strictly adheres to all applicable state and federal statutes, laws, ordinances, and the rules and regulations of all governmental and regulatory authorities, including but not limited to, the Federal Food, Drug, and Cosmetic Act and the Prescription Drug Marketing Act;
(iii) it shall ensure that none of its employees add, delete or modify claims of efficacy or safety of the Products, nor makes any changes (including but not limited to, underlining or otherwise highlighting any language or adding any notes thereto) in the Product Literature, Literature during the training on the Products or during any communications with Syneos Health 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 Syneos Health 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 and
(v) neither it nor any of its employees directly or indirectly instruct any Syneos Health inVentiv employee to make any representations or warranties relating to the Products that conflict, or are inconsistent with, applicable laws with Applicable Law or the Food and Drug Administration approved labeling for the Products. .
(vi) Client shall: :
A. provide Syneos Health Project Team members inVentiv Sales Representatives with all Product Literature and arrange for the provision of Product samples (as applicable). Literature.
B. inform Syneos Health inVentiv promptly of any changes which Client believes are necessary or appropriate 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 federal and state law, regulations and administrative guidance.
C. Arrange for a timely and appropriate response to any inquiry concerning a Product communicated to Syneos Health from any licensed practitioner and communicated by Syneos Health to Client. Applicable Law.
Appears in 1 contract
Sources: Project Agreement (Omeros Corp)
Representations and Undertakings.
(a) [***]Alamo represents that:
(i) it, as well as the Shared Reps employed by Alamo, shall perform the implementation of Clients’ detailing program in a professional, workmanlike manner consistent with industry standards and in conformance with that level- of care and skill ordinarily exercised by other competent professional contract service organizations in similar circumstances and in accordance with those specifications and timelines which Alamo and Clients agree to (in writing) and which are not otherwise set forth herein or in the MSA. Alamo shall ensure that its employees or agents complete the Services in a timely manner and in accordance with the terms of this PA.
(ii) the Shared Reps 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. Alamo shall only use and shall permit the Shared Reps to only use the Product Literature provided by Client. Alamo and the Shared Reps shall not develop, create, or use any other promotional material or literature or alter Product Literature provided by Client. Alamo shall immediately cease the use of any Product Literature when instructed to do so (in writing) by Client. Alamo shall use the Product Literature only for the purposes of this Agreement.
(iii) it shall not, and shall ensure that all Shared Reps shall not, directly or indirectly, 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 or purchase the Products contrary to any law;
(iv) it shall not, and shall ensure that all Shared Reps 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
(v) it shall ensure that each Shared Rep shall promote, market and sell the Products in accordance with all applicable laws;
(b) Client represents Clients represent individually that:
(i) it recognizes that for Syneos Health Alamo to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Syneos Health Alamo with the necessary materials and assistance required to enable Syneos Health Alamo to perform the Services; ;
(ii) the Services being provided by Syneos Health Alamo 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 Alamo pursuant to the terms hereof (but not the implementation thereof by Syneos HealthAlamo), strictly adheres to all applicable state and federal statutes, laws, ordinances, and the rules and regulations of all governmental and regulatory authorities, including but not limited to, the Federal Food, Drug, and Cosmetic Act and the Prescription Drug Marketing Act;
(iii) it shall ensure that none of its employees add, delete or modify claims of efficacy or safety of the Products, nor makes any changes (including but not limited to, underlining or otherwise highlighting any language or adding any notes thereto) in the Product Literature, during the training on the Products or during any communications with Syneos Health Alamo employees;
(iv) it shall ensure that none of its employees working with the Project Team or in connection with the Services, directly or indirectly instruct any Syneos Health Alamo 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 and
(v) neither it nor any of its employees directly or indirectly instruct any Syneos Health Alamo employee to make any representations or warranties relating to the Products that conflict, or are inconsistent with, with applicable laws or the Food and Drug Administration approved labeling for the Products. .
(vi) Client shall: :
A. provide Syneos Health Project Team members Shared Reps with all Product Literature and arrange for the provision of Product samples (as applicable). samples.
B. inform Syneos Health Alamo promptly of any changes which Client believes are necessary or appropriate in the Product Literature or in information concerning the Products in order to be in compliance with all applicable federal and state law, regulations and administrative guidance. .
C. Arrange for respond appropriately and in a timely and appropriate response manner to any inquiry concerning a Product communicated to Syneos Health Alamo from any licensed practitioner and communicated by Syneos Health Alamo to Client. Clients.
I. FIXED FEES
Appears in 1 contract
Representations and Undertakings.
(a) [***]
(b) Client represents that:
(i) it recognizes that for Syneos Health to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Syneos Health with the necessary materials and assistance required to enable Syneos Health to perform the Services;
(ii) the Services being provided by Syneos Health are in furtherance of Client’s program of marketing and promoting the Products and as such, Client is responsible for ensuring, and further, Client represents and warrants, that the Client’s program being implemented by Syneos Health pursuant to the terms hereof (but not the implementation thereof by Syneos Health), strictly adheres to all applicable state and federal statutes, laws, ordinances, and the rules and regulations of all governmental and regulatory authorities, including but not limited to, the Federal Food, Drug, and Cosmetic Act and the Prescription Drug Marketing Act;
(iii) it shall ensure that none of its employees add, delete or modify claims of efficacy or safety of the Products, nor makes any changes (including but not limited to, underlining or otherwise highlighting any language or adding any notes thereto) in the Product LiteratureClient 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 Project 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, with applicable laws or the Food and Drug Administration approved labeling for the Products.
(vi) Client shall:
A. provide Syneos Health Project Team members with all Product Literature and arrange for the provision of Product samples (as applicable).
B. inform Syneos Health promptly of any changes which Client believes are necessary or appropriate in the Product Literature or in information concerning the Products in order to be in compliance with all applicable federal and state law, regulations and administrative guidance.
C. Arrange for a timely and appropriate response to any inquiry concerning a Product communicated to Syneos Health from any licensed practitioner and communicated by Syneos Health to Client.
Appears in 1 contract
Representations and Undertakings.
(a) [***]Mission/Alamo represents that:
(i) it, as well as the Reps employed by Mission/Alamo, shall perform the implementation of Clients’ detailing program in a professional, workmanlike manner consistent with industry standards and in conformance with that level of care and skill ordinarily exercised by other competent professional contract service organizations in similar circumstances and in accordance with those specifications and timelines which Mission/Alamo and Client agrees to (in writing) and which are not otherwise set forth herein or in the MSA. Mission/Alamo shall ensure that its employees or agents complete the Services in a timely manner and in accordance with the terms of this PA.
(ii) the Reps 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. Mission/Alamo shall only use and shall permit the Reps to only use the Product Literature provided by Client. Mission/Alamo and the Reps shall not develop, create, or use any other promotional material or literature or alter Product Literature provided by Client. Mission/Alamo shall immediately cease the use of any Product Literature when instructed to do so (in writing) by Client. Mission/Alamo shall use the Product Literature only for the purposes of this Agreement.
(iii) it shall not, and shall ensure that all Reps 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 Reps 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
(v) it shall ensure that each Rep shall promote, market and sell the Products in accordance with all applicable laws;
(b) Client represents individually that:
(i) it recognizes that for Syneos Health Mission/Alamo to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Syneos Health Mission/Alamo with the necessary materials and assistance required to enable Syneos Health Mission/Alamo to perform the Services; ;
(ii) the Services being provided by Syneos Health Mission/Alamo 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 Mission/Alamo pursuant to the terms hereof (but not the implementation thereof by Syneos HealthMission/Alamo), strictly adheres to all applicable state and federal statutes, laws, ordinances, and the rules and regulations of all governmental and regulatory authorities, including but not limited to, the Federal Food, Drug, and Cosmetic Act and the Prescription Drug Marketing Act;
(iii) it shall ensure that none of its employees add, delete or modify claims of efficacy or safety of the Products, nor makes any changes (including but not limited to, underlining or otherwise highlighting any language or adding any notes thereto) in the Product Literature, during the training on the Products or during any communications with Syneos Health Mission/Alamo employees;
(iv) it shall ensure that none of its employees working with the Project Team or in connection with the Services, directly or indirectly instruct any Syneos Health Mission/Alamo 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 Mission/Alamo employee to make any representations or warranties relating to the Products that conflict, or are inconsistent with, with applicable laws or the Food and Drug Administration approved labeling for the Products. ; and
(vi) Mission/Alamo employees interacting with health care professionals shall deliver the approved sales presentation with appropriate fair balance at all times, including but not limited to leaving a copy of the Full Prescribing Information (“Package Insert”) at each sales call.
(vii) Client shall: :
A. provide Syneos Health Project Team members Reps with all approved Product Literature and arrange for the provision of Product samples (as applicable). Literature.
B. inform Syneos Health Mission/Alamo promptly of any changes which Client believes are necessary or appropriate in the Product Literature or in information concerning the Products in order to be in compliance with all applicable federal and state law, regulations and administrative guidance. .
C. Arrange for respond appropriately and in a timely and appropriate response manner to any inquiry concerning a Product communicated to Syneos Health Mission/Alamo from any licensed practitioner and communicated by Syneos Health Mission/Alamo to Client. .
Appears in 1 contract
Representations and Undertakings.
(a) [***]inVentiv represents that:
(i) it, as well as the inVentiv Sales Representatives, shall perform the Services in a professional, workmanlike manner consistent with industry standards and in conformance with that level of care and skill ordinarily exercised by other competent professional contract service organizations in similar circumstances and in accordance with 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 in a timely manner and in accordance with the terms of this Project Order;
(ii) the inVentiv Sales Representatives 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 only use and shall permit the inVentiv Sales Representatives to only use 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 set forth in this Project Order;
(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 FDA approved labeling for the Products;
(v) it shall ensure that each Sales Representative shall promote, market and sell the Products in accordance with all Applicable Laws; and
(vi) it shall ensure that all Project Team members sign the inVentiv Employment Agreement, attached hereto as Appendix 3, within five (5) business days of acceptance of inVentiv's offer of employment.
(b) Client represents that:
(i) it recognizes that for Syneos Health inVentiv to comply with its obligations hereunder, it inVentiv shall need the good faith cooperation of Client to provide Syneos Health inVentiv with the necessary materials and assistance required to enable Syneos Health inVentiv to perform the Services; ;
(ii) the Services being provided by Syneos Health inVentiv are in furtherance of Client’s '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 's program being implemented by Syneos Health inVentiv pursuant to the terms hereof (but not the implementation thereof by Syneos HealthinVentiv), 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 Actis in compliance with Applicable Law;
(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 employeesinVentiv employees unless such training materials approved by Client contain such highlighting;
(iv) it shall ensure that none of its employees working with the Project Team or in connection with the Services, directly or indirectly instruct instructs any Syneos Health 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 Syneos Health inVentiv employee to make any representations or warranties relating to the Products that conflict, or are inconsistent with, applicable laws with any Applicable Law or the Food and Drug Administration FDA approved labeling for the Products. ; and
(vi) Client shall:
A. provide Syneos Health Project Team members it shall ensure that Clients' Product Literature complies with all Product Literature and arrange for the provision of Product samples Applicable Law; and
(as applicable).
B. vii) it shall inform Syneos Health inVentiv 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 Applicable Law. EXHIBIT B COMPENSATION - FIXED FEES, PASS-THROUGH COSTS AND BILLING TERMS
I. FIXED FEES [***]
II. PASS-THROUGH COSTS [***] 11 ***Confidential Treatment Requested III. PERFORMANCE METRICS [*** ] IV. EARLY TERMINATION FEE [***] 12 ***Confidential Treatment Requested V. INVOICES; BILLING TERMS [***] 13 ***Confidential Treatment Requested APPENDIX 1 2012 PERFORMANCE METRICS 14 ***Confidential Treatment Requested APPENDIX 2 SAMPLING OF PRODUCTS TO TARGETS General inVentiv shall cause the inVentiv Sales Representatives to distribute samples of Products to [***] as part of the detailing activity of the inVentiv Sales Representatives, under a sampling program (the “Sampling Program”) in accordance with the terms of the Agreement. Any Sampling Program will be reviewed with and state lawapproved (in writing) by Client prior to implementation it being understood that any Sampling Program shall be Client's program and shall comply in all respect with all Laws. The program shall be implemented by inVentiv and inVentiv Sales Representatives in a manner that complies in all respects with all Laws. The Parties agree that Product samples shall not be considered an item of value. In connection with the foregoing, regulations and administrative guidanceClient expressly authorizes inVentiv to distribute the Product samples during the Term (or any Additional Term) of this Agreement.
C. Arrange If the Sampling Program to which this Exhibit is attached provides for a timely and appropriate response the distribution of samples by Client directly to any inquiry concerning a Product communicated to Syneos Health from any licensed practitioner and communicated by Syneos Health to Clientthe inVentiv Sales Representatives, Client shall be responsible for [***]. Client shall nonetheless [***] of the Products. Furthermore, Client shall at all times [***] of the Products.
Appears in 1 contract
Sources: Master Service Agreement (Amylin Pharmaceuticals Inc)
Representations and Undertakings. 1. The Service Provider hereby represents and warrants to each of the BRLMs and to the Company that it has the requisite power and authority to enter into this Agreement and it is not prohibited from acting as a public relations consultant or advertising agency or performing the services and obligations assumed by it under this Agreement by any provision of law, regulation or order of any court or governmental, legal, quasi-judicial, judicial, statutory, regulatory or administrative body. The execution, delivery and performance of this Agreement by the Service Provider do not and will not violate any applicable law or regulation, its constitutional documents, its obligations under any other business activity engaged, or any other assignment or instrument entered into by it with other parties or clients.
(a) [***]
(b) Client 2. The Service Provider undertakes and represents that:
(i) to the Company that it recognizes that for Syneos Health to has complied and shall comply with all requirements under the SEBI ICDR Regulations (including, in particular, Regulation 42 read with Schedule IX of the SEBI ICDR Regulation, annexed hereto in Annexure A), the Companies Act, all other applicable laws and the Publicity Memorandum in relation to the Offer and to the Advertisements and Publicity Materials prepared by the Service Provider.
3. The Service Provider hereby represents that this Agreement has been duly authorized, executed and delivered on their behalf and constitutes the legal, valid and binding obligation of the parties to the Agreement enforceable in accordance with its obligations hereunder, terms.
4. The Service Provider undertakes that it shall need act with utmost due diligence, care and skill while discharging its services under the good faith cooperation Agreement.
5. The Service Provider has not engaged and will not engage in any violations of Client to provide Syneos Health with applicable anti- corruption/bribery laws. Neither 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 Product Literature, during the training on the Products or during any communications with Syneos Health employees;
(iv) it shall ensure that none of its employees working with the Project Team or in connection with the Services, directly or indirectly instruct any Syneos Health employee to pay, offer or authorize payment of anything of substantial value (either in the form of compensation, gift, contribution or otherwise) to any person or entity in a position to order, recommend or purchase the Products contrary to any law; and
(v) neither it Service Provider nor any of its employees have engaged in or will engage in any activity, directly or indirectly, relating to the payment of any extraneous consideration / bribe / gratification or similar compensation to any of the employees of the Company for securing the arrangement set out in this Agreement.
6. Neither the Service Provider nor any of its employees have engaged in or will engage in any activity, directly or indirectly, which may be construed to be misuse or unauthorized use of the Company’s and/or each of the BRLMs logo, trademark, intellectual property and respective names.
7. Upon request by any of the BRLMs, the Service Provider will execute and deliver, and each of the BRLMs may rely on, a confirmation in the format annexed hereto in Annexure B, to the extent relevant and applicable, for purposes of providing a compliance certificate in accordance with the SEBI ICDR Regulations, in connection with press releases, Offer Advertisements and/or other Publicity Materials to SEBI.
8. The Service Provider represents that the amendments or corrections proposed to any Advertisement by the BRLMs, the legal counsel to the Company, the legal counsel to the BRLMs as to Indian law and the international legal counsel to the BRLMs will be incorporated in letter and spirit.
9. The Service Provider represents that there will be no impact on execution, delivery and performance of this Agreement by the Service Provider, due to the ongoing COVID-19 pandemic subject to applicable government (local, state or central) guidelines.
10. The Service Provider shall comply with the requirements of the SEBI ICDR Regulations, the Companies Act, 2013, and other applicable laws and undertakes not to directly or indirectly instruct induce others to carry out in any Syneos Health employee to make any representations or warranties relating to manner the Products that conflictpublicity which may be restricted under the SEBI ICDR Regulations, or are inconsistent with, other applicable laws or and the Food and Drug Administration approved labeling for the Products.
(vi) Client shall:
A. provide Syneos Health Project Team members with all Product Literature and arrange for the provision of Product samples (as applicable).
B. inform Syneos Health promptly of any changes which Client believes are necessary or appropriate in the Product Literature or in information concerning the Products in order to be in compliance with all applicable federal and state law, regulations and administrative guidance.
C. Arrange for a timely and appropriate response to any inquiry concerning a Product communicated to Syneos Health from any licensed practitioner and communicated by Syneos Health to Client. Publicity Memorandum.
Appears in 1 contract
Sources: Ad Agency Agreement
Representations and Undertakings.
(a) [***]Alamo represents that:
(i) it, as well as the Shared Reps employed by Alamo, shall perform the implementation of Clients’ detailing program in a professional, workmanlike manner consistent with industry standards and in conformance with that level of care and skill ordinarily exercised by other competent professional contract service organizations in similar circumstances and in accordance with those specifications and timelines which Alamo and Clients agree to (in writing) and which are not otherwise set forth herein or in the MSA. Alamo shall ensure that its employees or agents complete the Services in a timely manner and in accordance with the terms of this PA.
(ii) the Shared Reps 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. Alamo shall only use and shall permit the Shared Reps to only use the Product Literature provided by Client. Alamo and the Shared Reps shall not develop, create, or use any other promotional material or literature or alter Product Literature provided by Client. Alamo shall immediately cease the use of any Product Literature when instructed to do so (in writing) by Client. Alamo shall use the Product Literature only for the purposes of this Agreement.
(iii) it shall not, and shall ensure that all Shared Reps shall not, directly or indirectly, 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 or purchase the Products contrary to any law;
(iv) it shall not, and shall ensure that all Shared Reps 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
(v) it shall ensure that each Shared Rep shall promote, market and sell the Products in accordance with all applicable laws;
(b) Client represents Clients represent individually that:
(i) it recognizes that for Syneos Health Alamo to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Syneos Health Alamo with the necessary materials and assistance required to enable Syneos Health Alamo to perform the Services; ;
(ii) the Services being provided by Syneos Health Alamo 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 Alamo pursuant to the terms hereof (but not the implementation thereof by Syneos HealthAlamo), strictly adheres to all applicable state and federal statutes, laws, ordinances, and the rules and regulations of all governmental and regulatory authorities, including but not limited to, the Federal Food, Drug, and Cosmetic Act and the Prescription Drug Marketing Act;
(iii) it shall ensure that none of its employees add, delete or modify claims of efficacy or safety of the Products, nor makes any changes (including but not limited to, underlining or otherwise highlighting any language or adding any notes thereto) in the Product Literature, during the training on the Products or during any communications with Syneos Health Alamo employees;
(iv) it shall ensure that none of its employees working with the Project Team or in connection with the Services, directly or indirectly instruct any Syneos Health Alamo 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 and
(v) neither it nor any of its employees directly or indirectly instruct any Syneos Health Alamo employee to make any representations or warranties relating to the Products that conflict, or are inconsistent with, with applicable laws or the Food and Drug Administration approved labeling for the Products.
(vi) Client shall:
A. provide Syneos Health Project Team members with all Product Literature and arrange for the provision of Product samples (as applicable).
B. inform Syneos Health promptly of any changes which Client believes are necessary or appropriate in the Product Literature or in information concerning the Products in order to be in compliance with all applicable federal and state law, regulations and administrative guidance.
C. Arrange for a timely and appropriate response to any inquiry concerning a Product communicated to Syneos Health from any licensed practitioner and communicated by Syneos Health to Client. .
Appears in 1 contract
Representations and Undertakings.
(a) [***[ * ].
(b) Client represents that:
(i) it recognizes that for Syneos Health inVentiv to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Syneos Health inVentiv with the necessary materials and assistance required to enable Syneos Health inVentiv to perform the Services; ;
(ii) the Services being provided by Syneos Health inVentiv 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 inVentiv pursuant to the terms hereof (but not the implementation thereof by Syneos HealthinVentiv), 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 Actis in accordance with Applicable Law ;
(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 inVentiv employees;
(iv) it shall ensure that none of its employees working with the Project Team or in connection with the Services, directly or indirectly instruct any Syneos Health 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 [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(v) neither it nor any of its employees directly or indirectly instruct any Syneos Health inVentiv employee to make any representations or warranties relating to the Products that conflict, or are inconsistent with, with applicable laws or the Food and Drug Administration approved labeling for the Products. .
(vi) Client shall:
A. provide Syneos Health Project Team members inVentiv Account Managers with all Product Literature and arrange for the provision of Product samples (as applicable).
B. inform Syneos Health promptly of any changes which Client believes are necessary or appropriate in the Product Literature or in information concerning the Products in order to be in compliance with all applicable federal and state law, regulations and administrative guidance.
C. Arrange for a timely and appropriate response to any inquiry concerning a Product communicated to Syneos Health from any licensed practitioner and communicated by Syneos Health to Client. samples.
Appears in 1 contract
Representations and Undertakings.
(a) [***].
(b) Client represents that:
(i) it recognizes that for Syneos Health to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Syneos Health with the necessary materials and assistance required to enable Syneos Health to perform the Services;
(ii) the Services being provided by Syneos Health are in furtherance of Client’s program of marketing and promoting the Products and as such, Client is responsible for ensuring, and further, Client represents and warrants, that the Client’s program being implemented by Syneos Health pursuant to the terms hereof (but not the implementation thereof by Syneos Health), strictly adheres to all applicable state and federal statutes, laws, ordinances, and the rules and regulations of all governmental and regulatory authorities, including but not limited to, the Federal Food, Drug, and Cosmetic Act and the Prescription Drug Marketing Act;
(iii) it shall ensure that none of its employees add, delete or modify claims of efficacy or safety of the Products, nor makes any changes (including but not limited to, underlining or otherwise highlighting any language or adding any notes thereto) in the Product Literature, during the training on the Products or during any communications with Syneos Health employees;;
(iv) it shall ensure that none of its employees working with the Project 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
(v) neither it nor any of its employees directly or indirectly instruct any Syneos Health employee to make any representations or warranties relating to the Products that conflict, or are inconsistent with, applicable laws or the Food and Drug Administration approved labeling for the Products.
(vi) Client shall:
A. provide Syneos Health Project Team members with all Product Literature and arrange for the provision of Product samples (as applicable).
B. inform Syneos Health promptly of any changes which Client believes are necessary or appropriate in the Product Literature or in information concerning the Products in order to be in compliance with all applicable federal and state law, regulations and administrative guidance.
C. Arrange for a timely and appropriate response to any inquiry concerning a Product communicated to Syneos Health from any licensed practitioner and communicated by Syneos Health to Client.
Appears in 1 contract