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) Clients represent individually that: (i) it recognizes that for Alamo to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Alamo with the necessary materials and assistance required to enable Alamo to perform the Services; (ii) the Services being provided by 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 Alamo pursuant to the terms hereof (but not the implementation thereof by 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 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 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 Alamo 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.
Appears in 1 contract
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) Clients represent individually Client represents that:
(i) it recognizes that for Alamo Syneos Health to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Alamo Syneos Health with the necessary materials and assistance required to enable Alamo Syneos Health to perform the Services;;
(ii) the Services being provided by Alamo 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 Alamo Syneos Health pursuant to the terms hereof (but not the implementation thereof by AlamoSyneos 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 Alamo 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 Alamo 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; andand
(v) neither it nor any of its employees directly or indirectly instruct any Alamo 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) 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 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 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. 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) Clients represent Client represents individually that:
(i) it recognizes that for Alamo to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Alamo with the necessary materials and assistance required to enable Alamo to perform the Services;
(ii) the Services being provided by 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 Alamo pursuant to the terms hereof (but not the implementation thereof by 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 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 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 Alamo 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; 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 Reps with all approved Product Literature.
B. inform 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. respond appropriately and in a timely manner to any inquiry concerning a Product communicated to Alamo from any licensed practitioner and communicated by Alamo to Client.
Appears in 1 contract
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) Clients represent individually Client represents that:
(i) it recognizes that for Alamo inVentiv to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Alamo inVentiv with the necessary materials and assistance required to enable Alamo inVentiv to perform the Services;
(ii) the Services being provided by Alamo 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 Alamo inVentiv pursuant to the terms hereof (but not the implementation thereof by AlamoinVentiv), 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 Alamo 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 Alamo 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; andand [ * ] = 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 Alamo inVentiv 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 inVentiv Account Managers with all Product Literature and Product samples.
Appears in 1 contract
Representations and Undertakings. (a) Mission/Alamo represents that:
(i) it, as well as the Shared 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 Clients agree 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 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. Mission/Alamo shall only use and shall permit the Shared Reps to only use the Product Literature provided by Client. Mission/Alamo and the Shared 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 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) Clients represent Client represents individually that:
(i) it recognizes that for Mission/Alamo to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Mission/Alamo with the necessary materials and assistance required to enable Mission/Alamo to perform the Services;
(ii) the Services being provided by 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 Mission/Alamo pursuant to the terms hereof (but not the implementation thereof by Mission/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 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 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 Mission/Alamo 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; 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 Reps with all approved Product Literature.
B. inform 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. respond appropriately and in a timely manner to any inquiry concerning a Product communicated to Mission/Alamo from any licensed practitioner and communicated by Mission/Alamo to Client.
Appears in 1 contract
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) Clients represent individually Client represents that:
(i) it recognizes that for Alamo Syneos Health to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Alamo Syneos Health with the necessary materials and assistance required to enable Alamo Syneos Health to perform the Services;;
(ii) the Services being provided by Alamo 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 Alamo Syneos Health pursuant to the terms hereof (but not the implementation thereof by AlamoSyneos 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 Alamo 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 Alamo 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; andand
(v) neither it nor any of its employees directly or indirectly instruct any Alamo 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..
Appears in 1 contract
Representations and Undertakings. (a) Alamo inVentiv represents that:
(i) it, as well as the Shared Reps employed by AlamoinVentiv Sales Representatives, shall perform the implementation of Clients’ detailing program 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 Alamo inVentiv and Clients Client agree to (in writing) and which are not otherwise set forth herein or in the MSA. Alamo inVentiv shall ensure that its employees or agents complete the Services in a timely manner and in accordance with the terms of this PA.Project Order;
(ii) the Shared Reps 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. Alamo inVentiv shall only use and shall permit the Shared Reps inVentiv Sales Representatives to only use the Product Literature provided by Client. Alamo inVentiv and the Shared Reps inVentiv Sales Representatives shall not develop, create, or use any other promotional material or literature or alter Product Literature provided by Client. Alamo inVentiv shall immediately cease the use of any Product Literature when instructed to do so (in writing) by Client. Alamo inVentiv shall use the Product Literature only for the purposes of set forth in this Agreement.Project Order;
(iii) it shall not, and shall ensure that all Shared Reps Sales Representatives 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 Sales Representatives shall not, directly or indirectly, make any representations or warranties relating to the Products that conflict, conflict or are inconsistent with the Food and Drug Administration FDA approved labeling for the Products; and;
(v) it shall ensure that each Shared Rep Sales Representative shall promote, market and sell the Products in accordance with all applicable laws;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) Clients represent individually Client represents that:
(i) it recognizes that for Alamo inVentiv to comply with its obligations hereunder, it inVentiv shall need the good faith cooperation of Client to provide Alamo inVentiv with the necessary materials and assistance required to enable Alamo inVentiv to perform the Services;
(ii) the Services being provided by Alamo 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 Alamo inVentiv pursuant to the terms hereof (but not the implementation thereof by AlamoinVentiv), 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 Alamo 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 Alamo 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 Alamo inVentiv employee to make any representations or warranties relating to the Products that conflict, or are inconsistent with applicable laws any Applicable Law or the Food and Drug Administration FDA approved labeling for the Products; and
(vi) it shall ensure that Clients' Product Literature complies with all Applicable Law; and
(vii) it shall inform inVentiv promptly of any changes which Client believes are necessary or appropriate in the Product Literature or information concerning the Products in order to be in compliance with all 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 approved (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, Client expressly authorizes inVentiv to distribute the Product samples during the Term (or any Additional Term) of this Agreement. If the Sampling Program to which this Exhibit is attached provides for the distribution of samples by Client directly to the 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
Samples: Master Service Agreement (Amylin Pharmaceuticals Inc)
Representations and Undertakings. (a) Alamo represents inVentiv represents, warrants and covenants that:
(i) it, as well as the Shared Reps employed by AlamoinVentiv Sales Representatives, shall perform the implementation of Clients’ Client’s detailing program in a professional, workmanlike professional 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 this PA, the MSA, and those specifications and timelines which Alamo inVentiv and Clients Client agree to (in writing) and which are not otherwise set forth herein or in the MSA. Alamo 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 Shared Reps 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. Alamo shall only use inVentiv shall, and shall permit the Shared Reps to inVentiv Sales Representatives to, use only use the Product Literature provided by Client. Alamo inVentiv and the Shared Reps inVentiv Sales Representatives shall not develop, create, or use any other promotional material or literature or alter Product Literature provided by Client. Alamo inVentiv shall immediately cease the use of any Product Literature when instructed to do so (in writing) by Client. Alamo inVentiv shall use the Product Literature only for the purposes of this Agreement.;
(iii) it shall not, and shall ensure that all Shared Reps Sales Representatives 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 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, 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 Shared Rep Sales Representative shall promote, market and sell the Products in accordance with all applicable laws;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) Clients represent individually Client 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 Alamo inVentiv to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Alamo inVentiv with the necessary materials and assistance required to enable Alamo inVentiv to perform the Services;
(ii) the Services being provided by Alamo 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 Alamo pursuant to the terms hereof (but not the implementation thereof by AlamoinVentiv 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 Alamo 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 Alamo 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 Alamo inVentiv employee to make any representations or warranties relating to the Products that conflict, or are inconsistent with applicable laws 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.
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Samples: 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 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) Clients represent individually that:
(i) it recognizes that for Alamo to comply with its obligations hereunder, it shall need the good faith cooperation of Client to provide Alamo with the necessary materials and assistance required to enable Alamo to perform the Services;
(ii) the Services being provided by 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 Alamo pursuant to the terms hereof (but not the implementation thereof by 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 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 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 Alamo 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 Shared Reps with all Product Literature and Product samples.
B. inform 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. respond appropriately and in a timely manner to any inquiry concerning a Product communicated to Alamo from any licensed practitioner and communicated by Alamo to Clients.
I. FIXED FEES
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