Risk Assessment and Mitigation Process Sample Clauses

Risk Assessment and Mitigation Process. Within 120 days after the Effective Date, Indivior shall develop and implement a centralized annual risk assessment and mitigation process to identify and address risks associated with Indivior’s compliance with Federal health care program requirements and FDA requirements, including risks associated with the sales, marketing, and promotion of Government Reimbursed Products. The Compliance Committee shall be responsible for implementation and oversight of the risk assessment and mitigation process. The Risk Assessment and Mitigation Process (RAMP) shall require compliance, legal, and business unit leaders, at least annually, to: (1) evaluate and identify emerging risks (e.g., new products or activities) and assess relevant, material changes to previously identified RAMP risk areas, (2) prioritize, develop, update (as relevant), and implement specific risk mitigation plans related to the identified, prioritized risks, (3) implement the risk mitigation plans (which may include compliance auditing and monitoring activities), and
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Risk Assessment and Mitigation Process. Within 120 days after the Effective Date, Jazz shall develop and implement a centralized annual risk assessment and internal review process to identify and address risks associated with each of Jazz’s Government Reimbursed Products and with applicable Federal health care program requirements. The risk assessment and internal review process shall require compliance, legal, and department leaders, at least annually, to: (1) identify and prioritize risks associated with each Government Reimbursed Product, including risks associated with the sales, marketing, and promotion of such products and risks associated with Jazz’s operation of any patient assistance program and the company’s arrangements and interactions with any Independent Charity PAPs, (2) develop audit work plans related to the identified risk areas, (3) implement the audit work plans, (4) develop corrective action plans in response to the results of any internal audits performed, and (5) track the implementation of the corrective action plans in order to assess the effectiveness of such plans. Jazz shall maintain the risk assessment and internal review process for the term of the CIA.
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Risk Assessment and Mitigation Process. Within 120 days after the Effective Date, United Therapeutics shall develop and implement a centralized annual risk assessment and internal review process to identify and address risks associated with each of United Therapeutics’ Government Reimbursed Products and with applicable Federal health care program requirements. The risk assessment and internal review process shall require compliance, legal, and department leaders, at least annually, to: (1) identify and prioritize risks associated with each Government Reimbursed Product, including risks associated with the sales, marketing, and promotion of such products and risks associated with United Therapeutics’ operation of any patient assistance program and the company’s arrangements and interactions with any Independent Charity PAPs, (2) develop internal audit work plans related to the identified risk areas, (3) implement the internal audit work plans, (4) develop corrective action plans in response to the results of any internal audits performed, and (5) track the implementation of the corrective action plans in order to assess the effectiveness of such plans. United Therapeutics shall maintain the risk assessment and internal review process for the term of the CIA.
Sample 1
Risk Assessment and Mitigation Process. Within 90 days after the Effective Date, DaVita shall develop a standardized, centralized process to allow DaVita Dialysis’s in-house or outside legal counsel, compliance, and leaders of the relevant functions to: (1) identify and assess the risks associated with DaVita Dialysis’s compliance with Federal health care program requirements, the False Claims Act, and the Anti-Kickback Statute; and (2) determine what steps, if any, DaVita Dialysis should take to mitigate the identified risks. DaVita shall maintain the Risk Assessment and Mitigation Process for the duration of the CIA. DaVita HealthCare Partners Inc. Corporate Integrity Agreement
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Risk Assessment and Mitigation Process. Prior to the Effective Date of the CIA, Baxano Surgical implemented an Enterprise Risk Management (ERM) process. Within 120 days after the Effective Date, Baxano Surgical shall modify the ERM process as necessary to meet the requirements of the CIA and Appendix C by developing a standardized, centralized process to allow Baxano Surgical in-house or outside legal counsel, compliance, and other personnel to identify and assess risks associated with the marketing and promotion of Government Reimbursed Products, and to devise and implement specific measures to mitigate the identified risks. This process shall focus on the risks associated with Government Reimbursed Products, including the areas of: safety, marketing, sales, promotion issues (including the risk of off-label promotion), reimbursement, and healthcare compliance risks. Based on the outcomes of the risk identification and assessment process, Baxano Surgical in-house or outside legal counsel, compliance and other personnel shall centrally develop and implement specific plans designed to mitigate or reduce the identified risks. The IRO review of the ERM process is described in more detail in Appendix C. Baxano Surgical shall maintain the ERM process for the duration of the CIA.
Sample 1
Risk Assessment and Mitigation Process. Within 90 days after CPT Publication, EGS shall develop a standardized, centralized process to allow EGS in-house or outside legal counsel, compliance, and leaders of the relevant departments and functions to identify and assess risks associated with the sale, marketing, detailing, advertising, and promotion of Government Reimbursed Products, and to devise and implement specific measures to mitigate identified risks. This process shall focus on risks associated with Government Reimbursed Products, including, but not limited to, Promotional Functions and Advice Functions, related to compliance with Federal health care program requirements, the False Claims Act, and the Federal anti-kickback statute. EGS shall maintain the Risk Assessment and Mitigation Process for the duration of the CIA. The IRO shall perform a review of the effectiveness of the Risk Assessment and Mitigation Process at the OIG’s request.
Sample 1
Risk Assessment and Mitigation Process. Within 120 days after the Effective Date, Daiichi shall implement a standardized, centralized annual risk assessment and mitigation process (RAMP) as further described in this Section III.D and Appendix B. The RAMP shall require compliance, legal and business unit leaders, at least annually, to evaluate and identify risks associated with each Government Reimbursed Product, including risks associated with the sales, marketing, and promotion of such products. Based on the outcomes of the risk-identification component of the RAMP, Daiichi legal, compliance and other personnel shall centrally develop and implement specific plans designed to mitigate or reduce the identified risks. The risk mitigation plans shall be developed annually and a plan shall be developed for each Government Reimbursed Product. Daiichi shall implement the risk mitigation plans and shall track the implementation of the mitigation plans. The RAMP shall be reviewed by the IRO, and the IRO review of the process is described in more detail in Appendix B. Daiichi shall maintain the RAMP for the duration of the CIA.
Sample 1
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Risk Assessment and Mitigation Process. Within 120 days after the Effective Date, Aegerion shall implement a centralized annual risk assessment and mitigation process (RAMP) as further described in this Section III.D and Appendix B. The RAMP shall require compliance, legal and business unit leaders, at least annually, to evaluate and identify risks associated with Aegerion’s participation in Federal health care programs and the risks associated with each Government Reimbursed Product, including risks associated with the sales, marketing, and promotion of such products. Based on the outcomes of the risk-identification component of the RAMP, Aegerion legal, compliance and other personnel shall centrally develop and implement specific plans designed to mitigate or reduce the identified risks. The risk mitigation plans shall be developed annually and a plan shall be developed for each Government Reimbursed Product. Aegerion shall implement the risk mitigation plans and shall track the implementation of the mitigation plans. The RAMP shall be reviewed by the IRO, and the IRO review of the process is described in more detail in Appendix B. Aegerion shall maintain the RAMP for the duration of the CIA.
Sample 1
Risk Assessment and Mitigation Process. Within 120 days after the Effective Date, IHS shall develop and implement a centralized annual risk assessment and mitigation process to identify and address risks associated with Arrangements (as defined in Section III.C.1, above). The risk assessment and mitigation process should include: (1) a process for identifying and prioritizing risks;
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Related to Risk Assessment and Mitigation Process

  • Data Protection Impact Assessment and Prior Consultation Processor shall provide reasonable assistance to the Company with any data protection impact assessments, and prior consultations with Supervising Authorities or other competent data privacy authorities, which Company reasonably considers to be required by article 35 or 36 of the GDPR or equivalent provisions of any other Data Protection Law, in each case solely in relation to Processing of Company Personal Data by, and taking into account the nature of the Processing and information available to, the Contracted Processors.

  • Risk Assessment An assessment of any risks inherent in the work requirements and actions to mitigate these risks.

  • Conformity Assessment Procedures 1. Each Party shall give positive consideration to accepting the results of conformity assessment procedures of other Parties, even where those procedures differ from its own, provided it is satisfied that those procedures offer an assurance of conformity with applicable technical regulations or standards equivalent to its own procedures. 2. Each Party shall seek to enhance the acceptance of the results of conformity assessment procedures conducted in the territories of other Parties with a view to increasing efficiency, avoiding duplication and ensuring cost effectiveness of the conformity assessments. In this regard, each Party may choose, depending on the situation of the Party and the specific sectors involved, a broad range of approaches. These may include but are not limited to: (a) recognition by a Party of the results of conformity assessments performed in the territory of another Party; (b) recognition of co-operative arrangements between accreditation bodies in the territories of the Parties; (c) mutual recognition of conformity assessment procedures conducted by bodies located in the territory of each Party; (d) accreditation of conformity assessment bodies in the territory of another Party; (e) use of existing regional and international multilateral recognition agreements and arrangements; (f) designating conformity assessment bodies located in the territory of another Party to perform conformity assessment; and (g) suppliers’ declaration of conformity. 3. Each Party shall exchange information with other Parties on its experience in the development and application of the approaches in Paragraph 2(a) to (g) and other appropriate approaches with a view to facilitating the acceptance of the results of conformity assessment procedures. 4. A Party shall, upon request of another Party, explain its reasons for not accepting the results of any conformity assessment procedure performed in the territory of that other Party.

  • Data Protection Impact Assessment If, pursuant to Data Protection Law, Customer (or its Controllers) are required to perform a data protection impact assessment or prior consultation with a regulator, at Customer’s request, SAP will provide such documents as are generally available for the Cloud Service (for example, this DPA, the Agreement, audit reports or certifications). Any additional assistance shall be mutually agreed between the Parties.

  • Evaluation Process ‌ A. The immediate supervisor will meet with an employee at the start of their review period to discuss performance expectations. The employee will receive copies of their performance expectations as well as notification of any modifications made during the review period. Employee work performance will be evaluated during probationary, trial service and transition review periods and at least annually thereafter. Notification will be given to a probationary or trial service employee whose work performance is determined to be unsatisfactory. B. The supervisor will discuss the evaluation with the employee. The employee will have the opportunity to provide feedback on the evaluation. The discussion may include such topics as: 1. Reviewing the employee’s performance; 2. Identifying ways the employee may improve their performance; 3. Updating the employee’s position description, if necessary; 4. Identifying performance goals and expectations for the next appraisal period; and 5. Identifying employee training and development needs. C. The performance evaluation process will include, but not be limited to, a written performance evaluation on forms used by the Employer, the employee’s signature acknowledging receipt of the forms, and any comments by the employee. A copy of the performance evaluation will be provided to the employee at the time of the review. A copy of the final performance evaluation, including any employee or reviewer comments, will be provided to the employee. The original performance evaluation forms, including the employee’s comments, will be maintained in the employee’s personnel file. D. If an employee disagrees with their performance evaluation, the employee has the right to attach a rebuttal. E. The performance evaluation process is subject to the grievance procedure in Article 30. The specific content of a performance evaluation is not subject to the grievance procedure. F. Performance evaluations will not be used to initiate personnel actions such as transfer, promotion, or discipline.

  • Risk Assessments a. Risk Assessment - DST shall, at least annually, perform risk assessments that are designed to identify material threats (both internal and external) against Fund Data, the likelihood of those threats Schedule 10.2 p.2 occurring and the impact of those threats upon DST organization to evaluate and analyze the appropriate level of information security safeguards (“Risk Assessments”). b. Risk Mitigation - DST shall use commercially reasonable efforts to manage, control and remediate threats identified in the Risk Assessments that it believes are likely to result in material unauthorized access, copying, use, processing, disclosure, alteration, transfer, loss or destruction of Fund Data, consistent with the Objective, and commensurate with the sensitivity of the Fund Data and the complexity and scope of the activities of DST pursuant to the Agreement. c. Security Controls Testing - DST shall, on approximately an annual basis, engage an independent external party to conduct a review (including information security) of DST’s systems that are related to the provision of services. DST shall have a process to review and evaluate high risk findings resulting from this testing.

  • Periodic Risk Assessment Provider further acknowledges and agrees to conduct periodic risk assessments and remediate any identified security and privacy vulnerabilities in a timely manner.

  • Diagnostic Assessment 6.3.1 Boards shall provide a list of pre-approved assessment tools consistent with their Board improvement plan for student achievement and which is compliant with Ministry of Education PPM (PPM 155: Diagnostic Assessment in Support of Student Learning, date of issue January 7, 2013). 6.3.2 Teachers shall use their professional judgment to determine which assessment and/or evaluation tool(s) from the Board list of preapproved assessment tools is applicable, for which student(s), as well as the frequency and timing of the tool. In order to inform their instruction, teachers must utilize diagnostic assessment during the school year.

  • Search, Enquiry, Investigation, Examination And Verification a. The Property is sold on an “as is where is basis” subject to all the necessary inspection, search (including but not limited to the status of title), enquiry (including but not limited to the terms of consent to transfer and/or assignment and outstanding charges), investigation, examination and verification of which the Purchaser is already advised to conduct prior to the auction and which the Purchaser warrants to the Assignee has been conducted by the Purchaser’s independent legal advisors at the time of execution of the Memorandum. b. The intending bidder or the Purchaser is responsible at own costs and expenses to make and shall be deemed to have carried out own search, enquiry, investigation, examination and verification on all liabilities and encumbrances affecting the Property, the title particulars as well as the accuracy and correctness of the particulars and information provided. c. The Purchaser shall be deemed to purchase the Property in all respects subject thereto and shall also be deemed to have full knowledge of the state and condition of the Property regardless of whether or not the said search, enquiry, investigation, examination and verification have been conducted. d. The Purchaser shall be deemed to have read, understood and accepted these Conditions of Sale prior to the auction and to have knowledge of all matters which would have been disclosed thereby and the Purchaser expressly warrants to the Assignee that the Purchaser has sought independent legal advice on all matters pertaining to this sale and has been advised by his/her/its independent legal advisor of the effect of all the Conditions of Sale. e. Neither the Assignee nor the Auctioneer shall be required or bound to inform the Purchaser of any such matters whether known to them or not and the Purchaser shall raise no enquiry, requisition or objection thereon or thereto.

  • COMPLAINT AND GRIEVANCE PROCEDURE 9.01 Where a difference arises between the parties relating to the interpretation, application or administration of this Agreement, including any questions as to whether a matter is arbitrable, or where an allegation is made that this Agreement has been violated or whenever an employee who has completed the required probationary period and has been accepted by the Employer for employment in the permanent service, claims that he/she has been disciplined or discharged without reasonable cause, such difference, allegation or claim being hereinafter referred to as the grievance, the grievance procedure set forth below shall apply. 9.02 The Association shall name, appoint or otherwise select a Grievance Committee of no more than three (3) who shall be members of the Association and shall have reached at least the rank of First Class Fire Fighter and other advisors as deemed necessary at the expense of the Association. The Employer shall recognize and deal with the Grievance committee with respect to any matter or dispute which properly arises from a breach of the Collective Agreement from time to time during its term. This committee shall suffer no loss as a result of their attendance at such grievance meetings, hearings, etc. 9.03 No grievance will be considered where the circumstances giving rise to it occurred or originated more than ten (10) full working days before the submission of the grievance. Step 1 - An employee having a grievance will take the matter up through their Association representative. The President or designate shall contact Fire Management to seek a resolution. Step 2 - If the grievance is not settled within five (5) working days, the Association shall submit the matter in writing to the Fire Chief or designate within five (5) working days of receiving the reply from Step 1. The Fire Chief or designate shall render the written decision to the Association within five (5) working days after receiving the written grievance. In the context of this Article a working day shall be deemed to be Monday to Friday excluding designated holidays. Step 3 - If the reply of the Fire Chief is not acceptable to the Association the grievance may be referred to the Chief Administrative Officer (CAO) or the Director of Human Resources within five (5) working days of the written decision of the Fire Chief. The CAO or the Director of Human Resources, who together with the Fire Chief and any other advisors deemed necessary, shall meet with the Association Representatives within 5 working days to consider the grievance. Within five (5) working days of the aforesaid, the CAO or the Director of Human Resources will render a written reply to the employee and the Association. Step 4 - If no resolve is reached at Step 3, the matter shall be submitted to arbitration. Notice shall be given within 5 business days. The parties agree that, for the purposes of this collective agreement the words of the expedited arbitration provisions of the Labour Relations Act, 1995 as amended (Section 49), will be deemed to have been incorporated into this collective agreement. Accordingly and notwithstanding any other provisions of this article (the grievance/arbitration provisions); either party may refer a grievance to expedited arbitration in accordance with the provisions of Section 49. The parties further agree that neither party will raise any jurisdictional or other objection to the application of Section 49 to a grievance under this collective agreement as it pertains to the right to an expedited arbitration. Either party is entitled however, to raise any objection, with the arbitrator with respect to whether the provisions of Section 49 have been properly utilized in respect of any specific grievance (e.g. objections with respect to time limits etc.). Such an appointment by the Minister of Labour or his or her designate will be determined to be a joint appointment in accordance with Section 53(3) of the Fire Protection and Prevention Act. 9.04 Extensions to the time limits in 9.03 may not be unreasonably withheld. 9.05 The employee in all steps of the grievance procedure shall be confined to the grievance and redress sought as set forth in the written grievance initially filed as provided.

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