IRO Systems Review. The IRO Systems Review shall be a review of systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of Taro relating to Pricing and Contracting Functions and other systems as described below. Where practical, Taro personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Taro in accordance with the preceding sentence. Specifically, the IRO shall review systems, processes, policies, and procedures of Taro associated with the following (hereafter “Reviewed Policies and Procedures”):
1. Taro’s systems (including any electronic systems), processes, policies, and procedures relating to Pricing and Contracting Functions. This review shall include an assessment of the following:
a. Xxxx’s organizational structure as it relates to Pricing and Contracting Functions, including:
i. The identification of those individuals, departments, or groups within Taro responsible for conducting market (and other) research relevant to setting prices and establishing pricing strategies and policies for Government Reimbursed Products, including the individuals, departments, or groups authorized to approve pricing terms and pricing strategies; and
ii. The identification of those individuals, departments, or groups within Taro responsible for bidding, negotiating, and contracting with customers or potential customers of Government Reimbursed Products, including the individuals, departments, or groups authorized to approve bids submitted to potential customers and contracts (including contract terms and changes in contract terms, including pricing terms) entered with customers;
b. the systems, processes, policies, and procedures that Taro uses or follows in connection with setting prices (including but not limited to suggested wholesale price (SWP), wholesale acquisition cost (WAC), and average wholesale price (AWP)) and establishing pricing strategies, including i) the information and factors to be considered in connection with setting prices and establishing pricing strategies; and ii) the types and sources of information (both internal and external) used to make decisions about prices and pricing strategies; and
c. the systems, processes, policies, and procedures that Taro uses or follows in connection with th...
IRO Systems Review. The Systems Review shall be a review of RMS's systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to Covered Functions. More specifically, the IRO shall review RMS's systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures):
1. RMS’s systems, policies, processes, and procedures relating to the materials and information that may be distributed by RMS sales representatives (including any contract sales force) about Government Reimbursed Products and the manner in which RMS sales representatives respond to requests for information about non-FDA approved (or “off-label”) uses of Government Reimbursed Products;
2. RMS’s systems, policies, processes, and procedures relating to the materials and information that may be distributed and the mechanisms through, and manner in which, RMS receives and responds to requests for information from an HCP or another individual or entity about off-label uses of Government Reimbursed Products; the form and content of information disseminated by RMS in response to such requests; and the internal review process for the information disseminated;
3. RMS’s systems, policies, processes, and procedures relating to the manner and circumstances under which RMS medical personnel interact with or participate in meetings or events with HCPs, HCIs, or payors (either alone or with RMS sales representatives) and the role of RMS medical personnel at such meetings or events, as well as how they handle responses to requests for information about off-label uses of Government Reimbursed Products;
4. RMS’s systems, policies, processes, and procedures relating to the materials and information that may be distributed or made available by RMS through social media and/or direct-to-consumer advertising;
5. RMS’s systems, policies, processes, and procedures relating to the development, implementation, and review of policies relating to the distribution of Government Reimbursed Products for evaluation purposes (Evaluation Product). This shall include a review of the bases upon, and circumstances under, which HCPs and HCIs belonging to specified medical specialties or types of clinical practice may receive Evaluation Product from RMS (including, separately, from sales representatives, or through other channels);
6. RMS’s systems, policies, processes, and procedures relating to consultant or other fee-for-service a...
IRO Systems Review. A. Description of Reviewed Policies and Procedures The Systems Review shall be a review of systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) of the J&J Pharmaceutical Affiliates relating to certain of the Covered Functions. Where practical, J&J Pharmaceutical Affiliates personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by the J&J Pharmaceutical Affiliates in accordance with the preceding sentence. Specifically, the IRO shall review systems, processes, policies, and procedures of the J&J Pharmaceutical Affiliates associated with the following (hereafter “Reviewed Policies and Procedures”):
1) the manner in which sales representatives and personnel from Medical Information and Services handle requests or inquiries relating to information about the uses of Government Reimbursed Products (including non-FDA-approved (i.e., off-label) uses of Government Reimbursed Products) and the dissemination of materials relating to the uses of these products. This review shall include:
a) the manner in which J&J Pharmaceutical Affiliate sales representatives handle requests for information about off- label uses of Government Reimbursed Products (i.e., by referring all such requests to relevant Medical Information and Services personnel);
b) the manner in which Medical Information and Services personnel, including those at the J&J Pharmaceutical Affiliate’s headquarters, handle and respond to requests for information about off-label uses of Government Reimbursed Products (including tracking the requests and using pre- approved materials for purposes of responding to the request);
c) the form and content of information and materials related to Government Reimbursed Products disseminated to HCPs and HCIs (as defined in Section II.C.2 of the CIA), , payers, and formulary decision-makers by the J&J Pharmaceutical Affiliates;
d) the systems, processes, policies, and procedures (including the Inquiries Database) of the J&J Pharmaceutical Affiliates to track requests to Medical Information and Services for information about off-label uses of products and responses to those requests;
e) the manner in which the J&J Pharmaceutical Affiliates collect and support information reported in any systems used to tra...
IRO Systems Review. The Systems Review shall be a review of Merit's systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to Covered Functions. More specifically, the IRO shall review Merit's systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”):
1. Merit’s systems, policies, processes, and procedures relating to the development, implementation, and compliant use of promotional materials used by sales representatives (including any contract sales force) and other Merit representatives who promote and sell Government Reimbursed Products;
2. Merit’s systems, policies, processes, and procedures relating to the development, implementation, and review of all policies for the distribution of Government Reimbursed Products for evaluation purposes (Evaluation Product). This shall include a review of the bases upon, and circumstances under, which HCPs and HCIs belonging to specified medical specialties or types of clinical practice may receive Evaluation Product from Merit (including, separately, from sales representatives, or through other channels);
3. Merit’s systems, policies, processes, and procedures relating to consultant or other fee-for-service arrangements entered into with HCPs or HCIs (including but not limited to speaker programs, speaker training programs, training and education services, product development activities, presentations, consultant task force meetings, advisory boards, ad hoc advisory activities, research and research-related activities, authorship activities, and any other financial engagement or arrangement with an HCP or HCI) and all events and expenses relating to such engagements or arrangements;
4. Merit’s systems, policies, processes, and procedures relating to agreements or arrangements with HCPs or HCIs for the purchase or licensing of intellectual property (including, but not limited to, patents, patent applications, and payment of royalties);
5. Merit’s systems, policies, processes, and procedures relating to programs by HCPs to educate sales representatives, including but not limited to presentations by HCPs at sales meetings, preceptorships, tutorials, and experience-based learning activities;
6. Merit’s systems, policies, processes, and procedures relating to the review and approval of, and payment for, travel and related expenses for HCPs including those in connection with an HCP’s participation in...
IRO Systems Review. The Systems Review shall be a review of Lundbeck’ systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to select Contribution and Assistance Related Functions. Where practical, Lundbeck personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Lundbeck pursuant to the preceding sentence. More specifically, the IRO shall review Lundbeck’ systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”):
1) Lundbeck’ systems, policies, processes, and procedures relating to arrangements and interactions with (including donations to and sponsorship of) independent third-party patient assistance programs (Independent Charity PAPs). This review shall include an assessment of the following:
x. Xxxxxxxx’ organizational structure as it relates to arrangements and interactions with Independent Charity PAPS, including:
i. the identification of those individuals, departments, or groups within Lundbeck that have responsibility for, or involvement with, such arrangements and interactions;
ii. the respective scope and nature of the responsibilities of each individual, department, or group with responsibility for, or involvement with, arrangements and interactions with Independent Charity PAPs; iii. the identification of those individuals, departments, or groups within Lundbeck (e.g., the commercial organization) that are precluded from involvement with arrangements and interactions with Independent Charity PAPs; and
IRO Systems Review. The Systems Review shall be a review of Amgen’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to Patient Assistance Related Functions and the Independent Charity PAP Review Program. Where practical, Amgen personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Amgen pursuant to the preceding sentence. More specifically, the IRO shall review Amgen’s systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”):
IRO Systems Review. The Systems Review shall be a review of United Therapeutics’ systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to select Contribution and Assistance Related Functions. Where practical, United Therapeutics personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by United Therapeutics pursuant to the preceding sentence. More specifically, the IRO shall review United Therapeutics’ systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”):
1) United Therapeutics’ systems, policies, processes, and procedures relating to arrangements and interactions with (including donations to and sponsorship of) independent third-party patient assistance programs (Independent Charity PAPs). This review shall include an assessment of the following:
a. United Therapeutics’ organizational structure as it relates to arrangements and interactions with Independent Charity PAPS, including:
i. the identification of those individuals, departments, or groups within United Therapeutics (e.g., the Compliance Officer, the Grants Committee, legal, compliance, medical affairs, executive level officers) that have responsibility for, or involvement with, such arrangements and interactions;
ii. the respective scope and nature of the responsibilities of each individual, department, or group with responsibility for, or involvement with, arrangements and interactions with Independent Charity PAPs;
iii. the identification of those individuals, departments, or groups within United Therapeutics (e.g., the commercial organization) that are precluded from involvement with arrangements and interactions with Independent Charity PAPs; and
iv. the manner by which the separation of Independent Charity PAP- related responsibilities from the commercial organization is enforced.
b. United Therapeutics’ written policies and procedures as they relate to arrangements and interactions with Independent Charity PAPs, including:
i. the criteria governing whether and under what circumstances United Therapeutics would donate to an Independent Charity PAP or any specific disease state fund of such a PAP;
ii. communications (including any limitations on such communications) bet...
IRO Systems Review. The Systems Review shall be a review of Life Spine’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to Covered Functions. Prior to the Systems Review, Life Spine shall certify to the IRO any activities listed below that it did not engage in during the applicable reporting period, and the IRO will not review systems related to activities Life Spine did not engage in. More specifically, the IRO shall review Life Spine’s systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”):
1. Life Spine’s systems, policies, processes, and procedures relating to conducting Covered Functions in compliance with all: (i) applicable Federal healthcare program requirements, including, but not limited to the Federal Anti-Kickback Statute (codified at 42 U.S.C. § 1320a-7b(b)) and the False Claims Act (codified at 31 U.S.C. §§ 3729-3733); and (ii) all applicable FDA requirements;
2. Life Spine’s systems, policies, processes, and procedures relating to the development, implementation, and compliant use of promotional materials used by sales representatives (including any contract sales force) and other Life Spine representatives who promote and sell Government Reimbursed Products;
3. Life Spine’s systems, policies, processes, and procedures relating to consultant or other fee-for-service arrangements entered into with HCPs or HCIs (including but not limited to speaker programs, speaker training programs, training and education services, product development activities, presentations, consultant task force meetings, advisory boards, ad hoc advisory activities, research and research-related activities, authorship activities, and any other financial engagement or arrangement with an HCP or HCI) and all events and expenses relating to such engagements or arrangements;
4. Life Spine’s systems, policies, processes, and procedures relating to agreements or arrangements with HCPs or HCIs for the purchase or licensing of intellectual property (including, but not limited to, patents, patent applications, and payment of royalties);
5. Life Spine’s systems, policies, processes, and procedures relating to programs by HCPs to educate sales representatives, including but not limited to presentations by HCPs at sales meetings, preceptorships, tutorials, and experience-based learning activities;
6. Life Spine’s systems, policies, processes, and proce...
IRO Systems Review. The Systems Review shall be a review of Jazz’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to select Contribution and Assistance Related Functions. Where practical, Jazz personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Jazz pursuant to the preceding sentence. More specifically, the IRO shall review Jazz’s systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”):
1) Jazz’s systems, policies, processes, and procedures relating to arrangements and interactions with (including donations to and sponsorship of) independent third-party patient assistance programs (Independent Charity PAPs). This review shall include an assessment of the following:
a. Jazz’s organizational structure as it relates to arrangements and interactions with Independent Charity PAPS, including: Jazz Pharmaceuticals plc CIA Appendix B i. the identification of those individuals, departments, or groups within Jazz (e.g., the Corporate Giving Executive Review Committee, Corporate Affairs, Finance, Legal and Compliance) that have responsibility for, or involvement with, such arrangements and interactions;
IRO Systems Review. The Covered Functions and RAMP Systems Review shall be a review of Daiichi’s systems, processes, policies, and procedures (including the controls on those systems, processes, policies, and procedures) relating to certain Covered Functions and its RAMP. Where practical, Daiichi personnel may compile documentation, schedule and organize interviews, and undertake other efforts to assist the IRO in performing the Systems Review. The IRO is not required to undertake a de novo review of the information gathered or activities undertaken by Daiichi pursuant to the preceding sentence. Specifically, the IRO shall review Daiichi’s systems, processes, policies, and procedures associated with the following (hereafter “Reviewed Policies and Procedures”):
1) Daiichi's systems, processes, polices, and procedures relating to incentive compensation for Relevant Covered Persons who are sales representatives and field- based managers of sales representatives, with regard to whether the systems, policies, processes, and procedures are designed to ensure that financial incentives do not inappropriately motivate such individuals to engage in the improper promotion, sales, and marketing of Daiichi’s products. This shall include a review of the bases upon which compensation is determined and the extent to which compensation is based on product performance. To the extent that Daiichi establishes different systems, processes, policies, or procedures relating to compensation for different products, the IRO shall review each type of compensation arrangement separately;
2) Daiichi’s systems, processes, policies, and procedures relating to the development and review of call plans (as described in Section III.B.3.h of the CIA). This shall include a review of the bases upon which HCPs and HCIs belonging to specified medical specialties are included in, or excluded from, the call plans based on, among other factors, expected utilization of products for FDA-approved uses or non-FDA-approved uses;
3) Daiichi’s systems, processes, policies, and procedures relating to sample distribution. This shall include a review of the bases upon, and circumstances under, which HCPs and HCIs belonging to specified medical specialties or types of clinical practice may receive samples from Daiichi (including, separately, from Daiichi sales representatives, from Medical Affairs, or through other channels). It shall also include a review of whether samples of Government Reimbursed Products are distributed by D...
