32063-MMCAP RFP_Pharmaceutical Reverse Distribution .pdf

State of Minnesota

MMCAP INFUSE, OFFICE OF STATE

PROCUREMENT

Request for Proposals (RFP)

For Pharmaceutical Reverse Distribution

SPECIAL NOTICE: This is a request for proposal. It does not obligate the State of Minnesota or MMCAP Infuse to award a contract or complete the proposed program, and the State of Minnesota reserves the right to cancel this solicitation if it is considered in its best interest.

Minnesota’s Commitment to Diversity and Inclusion

The State of Minnesota is committed to diversity and inclusion in its public procurement process. The goal is to ensure that those providing goods and services to the State are representative of our Minnesota communities and include businesses owned by minorities, women, veterans, and those with substantial physical disabilities. Creating broader opportunities for historically under-represented groups provides for additional options and greater competition in the marketplace, creates stronger relationships and engagement within our communities, and fosters economic development and equality.

To further this commitment, the Department of Administration operates a program for Minnesota-based small businesses owned by minorities, women, veterans, and those with substantial physical disabilities. For additional information on this program, or to determine eligibility, please call 651-296-2600 or go to www.mn.gov/admin/oep.

http://www.mn.gov/admin/oep

Request for Proposals for Pharmaceutical Reverse Distribution

Proposal Due Date: November 9, 2022 by 2 pm Central Time

RFP Release date September 27, 2022 Cutoff Date for Questions October 14, 2022, 2 pm Central Time Final RFP Answers Posted October 21, 2022 Proposal Due Date November, 9, 2022 2 pm Central time Contract Effective Date Negotiable

SECTION 1 – INSTRUCTIONS TO RESPONDERS

Steps for Completing Your Response

Follow the steps below to complete your response to this RFP:

Step 1: Read the solicitation document and ask questions, if any

Step 2: Write your response Step 3: Sign and submit your response

Incomplete Submittals

A proposal must be submitted along with any required additional documents.

Incomplete proposals that materially deviate from the required format and content may be rejected.

STEP 1 – READ THE SOLICITATION DOCUMENT & ASK QUESTIONS, IF ANY

How to Ask Questions

Questions must be emailed to MMCAP_Infuse.RFP@state.mn.us by October 12,2022 at 2 pm Central Time.

Questions will be responded to, via an addendum to this RFP, in batches as they arrive and will not be attributed to the asking entity. Similar questions may be combined with a single answer.

Other personnel are not authorized to answer questions regarding this RFP.

STEP 2 – WRITE YOUR RESPONSE

Request for Proposals

(RFP)

In Section 3, insert your response to the questions as asked or provide content as requested.

By signing this response, your firm is making a legal, binding offer for a contract to provide services to the State of Minnesota.

STEP 3 – SIGN & SUBMIT YOUR RESPONSE

Documents making up a complete proposal

Vendor Response Form Section 3 Proposed Scope of Work and Services (SOW) (submitted in

Microsoft Word or PDF) Section 3 Cost Proposal (in a separate document from the product/service proposal) (submitted in Microsoft Excel or PDF) Section 4 Exhibit A Standard Contract Sample Exceptions (submitted in

Microsoft Word) Exhibit B Certification Regarding Lobbying (submitted in PDF) Exhibit C Workforce Certificate Form (submitted in PDF) Required business applications or forms to do business with

Responder If applicable, Exhibit D, Veteran Owned Preference (submitted in

PDF)

mailto:MMCAP_Infuse.RFP@state.mn.us

Where to Send Your Response

Email your responses to MMCAP_Infuse.RFP@state.mn.us with “[Company] Pharmaceutical Reverse Distribution RFP Response” in the Subject line.

If your email is larger than the maximum allowed size, send your response in multiple emails. Use “[Company] Pharmaceutical Reverse Distribution RFP Response Part [1…N] of [N]” in the Subject line.

Mailed responses cannot be accepted at this time.

Faxed responses will not be accepted.

Response Submission Deadline

Must be received not later November 9, 2022, at 2pm Central Time as indicated by a notation made by the email timestamp. Late proposals will not be considered. All costs incurred in responding to this RFP will be borne by the responder.

mailto:MMCAP_Infuse.RFP@state.mn.us

SECTION 2 – RFP PROJECT INFORMATION

1. Description of Project

MMCAP Infuse (MMCAP Infuse) is a governmental cooperative serving thousands of state and local government facilities across the United States. MMCAP Infuse is operated by the State of Minnesota (State) Department of Administration’s Office of State Procurement (OSP) and is governed by Minnesota laws and procurement policies.

MMCAP Infuse Members are state agencies and political subdivisions throughout the United States. For more information on MMCAP Infuse and its membership, visit www.infuse-mn.gov. Membership is available to government-operated facilities, and the extent to which a Member participates in the program is voluntary.

Members include but are not limited to the following classes of trade: correctional facilities, psychiatric treatment facilities, public hospitals, school/college/university student health systems, public health, long term care facilities, skilled nursing facilities, and clinics.

MMCAP Infuse currently has three (3) awarded vendors for pharmaceutical reverse distribution processing. In the last fiscal year, MMCAP Infuse had approximately 700 Members accessing contracted returned good Agreements for approximately $22 million in annual return credit value.

MMCAP Infuse is issuing this RFP to establish contract(s) with qualified national suppliers that provide services that meet all regulatory requirements, provide easily auditable pharmaceutical reverse distribution processing services of Members, maximize pharmaceutical credits from manufacturers, minimize fees, and reduce resources required by MMCAP Infuse Member facilities to process expired and non-usable pharmaceuticals.

This RFP cannot be used as a means for the Responder and Member to enter into their own standalone agreement and is not intended to produce a pharmaceutical waste disposal contract or pharmaceutical hazardous waste disposal contract.

2. Sample Tasks

Responders are expected to provide all participating MMCAP Infuse Member facilities with the option to utilize the following services as part of a comprehensive pharmaceutical reverse distribution program:

• Process reverse distribution credits through MMCAP Infuse contracted pharmaceutical wholesalers (Currently AmerisourceBergen, Cardinal Health, and Morris & Dickson);

• Obtain maximum credit from manufacturers for returned products;

• Process unusable controlled substances according to all applicable federal and state regulatory guidelines;

• Process potentially creditable hazardous pharmaceutical product according to all applicable federal and state regulatory guidelines while properly disposing of product if determined to be non-creditable;

• Process non-hazardous pharmaceutical waste not eligible for credit in accordance with all applicable federal, state and local regulatory guidelines;

• Provide timely, transparent reports in order to track and audit individual returned products to the appropriate credits earned and distributed;

• Maximize the amount of credit returned to Members as a pharmaceutical wholesaler credit as compared to a check to the facility;

• Provide users with a secure online portal to access reports, certificates of destruction, invoices and credits in a timely fashion for each account the Member maintains; and http://www.infuse-mn.gov/

• Maintain, for the term of the contract, all required regulatory licenses, permits, registrations, and insurance required to provide these contracted services and comply with all applicable local, state, and federal laws

3. Agreement Duration It is anticipated that MMCAP Infuse will enter into contracts for an initial two (2) year term, with an option to extend three (3) additional years in increments determined by MMCAP Infuse.

4. Minimum Qualifications Required (Pass/Fail) All proposals received by the deadline above will be evaluated. Proposals will first be evaluated to determine whether these minimum qualifications have been met.

A. Responder must have been in business for a minimum of five years B. Responder must perform, at minimum, either on-site and/or off-site services within all 50 states of the United States of America

5. Response Evaluation

Responses will first be reviewed to confirm compliance with the minimum qualifications identified above.

Responses that meet all the minimum qualifications will be further evaluated in accordance with the following:

Factors Percentage Narrative (Scored) Criteria 60% Agree to admin fee of 3% outlined in Exhibit A (General Requirements)

5%

Agree to the data fields as outlined in Exhibit A (General Requirements)

5%

Cost Proposal 30%

Preferences 6% Minnesota Certified Targeted Group/Economically Disadvantaged Preference 6% Veteran-owned Preference Minnesota Resident Vendor Preference

Responses will be evaluated by a team of MMCAP Infuse staff, MMCAP Infuse advisory board members, and/or staff from Members. Each evaluator will read all proposals that have passed all the minimum qualifications.

MMCAP Infuse reserves the right to require a demonstration of capabilities and/or ordering systems via in-person meetings, webinar, or other such mechanism.

Any award that may result from this solicitation will be based upon the total accumulated points as established in the solicitation. MMCAP Infuse reserves the right to award this solicitation to a single Responder, or to multiple Responders, whichever is in the best interest of the State and MMCAP Infuse, providing each Responder is in compliance with all terms and conditions of the solicitation. MMCAP Infuse reserves the right to accept all or part of an offer, to reject all offers, to cancel the solicitation, or to re-issue the solicitation, whichever is in the best interest of the State and MMCAP Infuse. If a Responder with an active contract with MMCAP Infuse is an awarded bid as a result of this RFP, MMCAP Infuse reserves the right to amend the active contract to include the scope of this RFP rather than issue a brand-new document.

6. Additional MMCAP Infuse Rights Reserved/Pre-Proposal Meeting/Background Checks/Budget

a. reject any and all responses received;

b. waive or modify any informalities, irregularities, or inconsistencies in the responses received;

c. negotiate with the highest scoring Responder[s];

d. terminate negotiations and select the next response providing the best value for the State;

e. Short list the highest scoring Responders;

f. Require Responders to conduct presentations, demonstrations, or submit samples;

g. Award by item (including category, location, etc.), by groups of items, or all items, therefore, the

Responder is encouraged to offer a response for all items

h. Award by location

i. Interview key personnel or references; and

j. Request a best and final offer from one or more Responders.

7. Alterations or Additions to the State’s General Terms

If you wish to take an exception to the State’s General Terms (see Exhibit A), please indicate that below and attach any appropriate documentation.

☐None

☐See attached document detailing proposed alterations and/or additions to the State’s General Terms. By signing, I acknowledge that the above-named responder accepts, without qualification, all terms and conditions stated in this solicitation (including the sample contract) except those clearly outlined as exceptions above.

Signature: ____________________________________________________

Printed Name: _________________________________________________

Title: ________________________________

Date:________________________________

SECTION 3 – VENDOR RESPONSE

INSTRUCTIONS: Fill in the information requested below.

1. Responder’s Contact Information

Company’s Full Legal Name:

Business Address:

Company Website:

Federal Employer Identification Number:

Primary Contact Person’s Name:

Title:

Telephone Number:

E-Mail Address:

Alternate Contact Person:

Title:

Telephone Number:

E-Mail Address:

Admin Fee Contact Person:

Telephone Number:

E-Mail Address:

Membership Contact Person:

Telephone Number:

E-Mail Address:

2. Pass/Fail Criteria

Does Responder comply with each term?

Yes No Term Responder must have been in business for a minimum of five years

Responder must perform on-site and/or off-site services within all 50 states of the

US

Responders that have not completed each section will not be further considered.

3. Administrative Fee.

In consideration for the administrative support and other services provided by MMCAP Infuse, the Responder agrees to pay an Administrative Fee of three percent (3%) on all purchases of products and services.

- Does Responder comply with the item below?

Yes No Term Responder agrees to pay an Administrative Fee of three percent (3%) on all purchases of products and services

4. Administrative Fee Data Report Fields.

The MMCAP Infuse standard data fields and interpretation for use by the contract(s) resulting from this RFP are attached as Exhibit E. These data fields allow for reporting of drug costs as well as the costs of contracted services within reverse distribution. The intent of the monthly data files are to (1) provide a basis for Administrative Fee payments, (2) to assess overall value from the contract; and (3) provide stakeholders with actual usage volume and spending on their contract with the Responder. MMCAP Infuse will never request patient-identifiable data.

Does Responder comply with the item below?

Yes No Term

Responder agrees to provide the minimum Administrative Fee Report fields as identified in Exhibit E

5. Narrative Questions

Provide a detailed description of Responder’s proposed services. At a minimum, the following must be included in the proposal. Any pricing information submitted in this section may be grounds for disqualification;

if pricing is submitted in this section, it will not have a bearing on points received for a Cost Proposal.

1. Experience

a. Provide a brief overview of Responder’s reverse distribution processing business. Include information on operating location (offices and processing facilities), the history of the company, years in business within reverse distribution processing, the current economic conditions of the Responder, and describe history working with government facilities.

b. List the staff member(s) who will be responsible for managing the contract with MMCAP Infuse and describe their qualifications and experience managing contracts.

c. Identify the team(s) that will be responsible for working directly with the Members by providing a map of the assigned regions for each local representative. Describe their roles in providing customer service and when issues will be escalated to other teams/individuals. Explain your ability to assign a dedicated service representative to an individual facility.

d. Many of the Member facilities are secure government facilities (i.e. correctional facilities, psychiatric hospitals). Describe the qualifications, training, and screening of on-site service representatives.

e. Describe how subcontracts or subcontractors are used at any point in the return goods processing.

2. Services

a. Service Types:

i. Provide a detailed description of the types of services provided with an on-site service visit.

1. How will outdates will be addressed in active stock? (i.e. Will product be pulled only once it is past its expiration date or up to six months prior to expiration? Will every bottle be examined or only the first in the row?)

2. What are the requirements of the Member prior to, during, and after the on-site visit? Describe the anticipated timeline for an on-site visit after Member requests such a service.

3. List the states that are NOT eligible for On-site service

ii. Provide a detailed description of the types of services provided with an off-site service visit.

1. Include samples of all documents currently required to ship pharmaceutical products for return. Will the Responder provide paid shipping labels for return?

Does the vendor have an online tool for scanning in product prior to shipping?

2. Describe how multiple packages in the same return shipment will be processed and documented.

3. List the states that are NOT eligible for off-site options.

4. List any service limitations (e.g., location or types of facilities serviced, types of returns accepted, minimum credit value, minimum on-site service schedule, etc.)

b. Account set up and activation:

1. Provide a description of the account set up process and activation. You must address at a minimum in your response

- required paperwork

- process steps

- timeline needed to establish a fully operational account.

2. How will the Responder ensure MMCAP Infuse Members are properly identified and attached to the MMCAP Infuse contract for billing and reporting purposes?

3. Describe how current customers would be transitioned to the MMCAP Infuse contract.

4. How will the Responder promote the contract to MMCAP Infuse membership if a contract is awarded?

5. What expectations does the Responder have of MMCAP Infuse to grow contract utilization among its Members?

6. Describe the training available to Members for determining products to be returned, proper shipping procedures including DEA 222 form completion and retention, maximizing return credit, web portal in-service, and any additional applicable training to support the Contract

c. Holding procedure for in-dated product:

1. Provide a detailed description of Responder’s process and timeline for maximizing credit for returned product that has not yet expired.

2. How are returned products that are in-date reported to the Responder’s web portal so that Members can track the process?

3. What mechanism is in place to ensure product is processed at the appropriate time and does not age out at Responder’s processing facility?

4. How does Responder provide Members with manufacturer-specific information to help them understand the optimal time to return product to obtain maximum credit?

d. Credit Process:

1. Provide a detailed description of Responder’s process for obtaining credit from manufacturers.

2. Which pharmaceutical wholesalers can provide credit to the Member through a wholesaler credit?

3. What is the average timeframe for the Member to receive an initial wholesaler credit for an expired product?

4. If wholesaler credit is not an option, what is the timeframe for the member to receive a manufacturer’s check for an expired product being returned?

5. How are Member credit disputes handled?

6. What pharmaceutical wholesalers are you currently affiliated with to allow processing of reverse distribution credits?

7. Describe the process used to ensure product does not “age out” while in the batch process.

8. What is the average number of days for Responder to complete the batch process?

What is the fastest and slowest turnaround for Responder to complete a batch process?

9. How many days, on average, does it take for Members to receive about 75% of their credit?

10. After how many months will a return be considered closed out? What determines when the return is no longer expected to receive any additional credit?

11. Provide a detailed description of how the estimated return value is determined.

What is the process when the estimated return value is different from the actual credit received by the manufacturer? How do you quantify your accuracy in provided estimated return value and the actual credit received?

12. Provide a detailed description of Responder’s Instant Credit program, whereby members receive an up-front credit percentage in lieu of tracking the return process over long periods of time.

- Provide the credit calculation process, timeline, payment mechanism, and participating wholesalers.

- What manufacturers are not eligible for this service and how will those credits be issued to a Member?

13. If Responder employs an alternate credit process model, provide a detailed description, including the fee calculation process, payment mechanism, wholesalers that participate, and average number of days for Members to receive credit.

e. Manufacturer Information:

1. How many manufacturers does Responder have direct pharmaceutical reverse distribution processing agreements? Of those agreements, how many are exclusive agreements?

2. For which manufacturers must Responder process through another reverse distributor to receive credit?

3. Provide a detailed description of the process to maintain and update manufacturers’ return policies. Are the return policies available to a Member upon request and for auditing purposes? How would a Member obtain manufacturer creditable product lists for reference?

f. Web Portal

1. Provide a detailed description of the web portal capabilities, including details regarding processing returns; tracking credits, non-creditable products, and products in holding; auditing; and reconciling each item in a return.

2. What is the timeline for Members to view reports on the portal once a product has been returned?

3. How often do maintenance updates occur on the web portal and how are these proactively communicated to customers?

4. Is the portal capable of aggregating reports for multiple accounts or multiple facilities?

5. Does the portal allow report generation by drug category and date range?

6. Is a designated MMCAP Infuse staff member eligible to have access to view portal at the Member level to view all Member return information?

7. Describe how Responder’s data systems are protected against cyber-attack, ransomware, and other malicious threats that may impact Members.

8. Provide sample documentation of all available reports from the portal, and include whether they will be available in PDF and/or Excel formal. The reports should include, at a minimum: date product is received, the estimated return value, actual product credit value received by item and vendor, date credit is posted, non-creditable reason codes, and explanation of fees deducted from credit value.

g. Unique Returns

1. Describe the process for returning and receiving credit for recalled items.

2. How does Responder differentiate and process 340B products (if it differs from the standard process)? How does Responder ensure accuracy when the product file changes quarterly?

3. How will Responder process expired stockpiled/emergency preparedness drugs for returns? Describe the return process if it differs from the standard process and how would Responder help an MMCAP Member if the expired emergency preparedness stockpiles have no return value?

h. Managing Accounts

1. If a Member manages multiple drug inventories, how will Responder manage account invoicing and fees?

2. How does Responder set up Member accounts with 340B and non-340B purchases to ensure inventory and reporting are not comingled?

3. Describe the Responder’s typical communication with Members. How often are policy, web portal, or manufacturer updates communicated to Members and what detail is provided?

i. Pharmaceutical Waste

1. Will Responder accept non-credit worthy product (i.e., unused blister packs with patient identifiers) from Members?

2. Will Responder accept repackaged product or product out of the manufacturer packaging?

3. Is there a limit to the amount of pharmaceutical waste a Member may return?

4. Propose a solution to legally and appropriately dispose of a Member’s non-creditable, non-hazardous pharmaceutical waste.

5. If hazardous waste is unknowingly or accidentally sent to the Responder, from a state where Resource Conservation and Recovery Act (RCRA) laws prohibit shipping certain types of hazardous waste, how will it be addressed?

j. Differentiation:

1. Provide specific examples of what differentiates Responder from its competitors.

2. In the past two years, what has been Responder’s greatest success? Please limit responses to 250 words lor less

SECTION 4 – COST PROPOSAL

Follow the instructions below when completing your cost proposal. Your cost proposal must be submitted in a separate file in the email. No cost information should be provided in Section 3.

Responder must submit a cost proposal that details the proposed cost structure to Members. The following is the preferred format for cost proposals, but innovative approaches will also be considered:

1. Complete and submit all applicable pricing information via an attached Excel document titled

“Pharmaceutical Reverse Distribution Cost Proposal Worksheet.” Extend prices to two decimal places only and do NOT add sales tax or service tax to the proposed price. Pricing must be available for all MMCAP Infuse members regardless of size and class of trade. If pricing will differ based on single or multiple contract awards, provide both pricing models for consideration.

The cost proposal must include the following:

A. Completion of the Cost Proposal Worksheet (Tab 1) B. Provide a sample return (Tab 2-4) that demonstrates the complete reverse distribution of a product from product pickup (onsite) and/or product arrival (off-site) to the final credit return to the member.

Please include all fees that are included from your Cost Proposal Worksheet. Multiple sample returns may be provided if Responder proposes different credit value options.

Proposals will be evaluated on “best value,” meaning the cost proposal will not be opened by the review committee until after the qualifications are scored.

http://www.mmd.admin.state.mn.us/xls/MMCAPInfuse/32063PharmaceuticalReverseDistributionCostProposal.xlsx

SECTION 5 – RESPONDER CERTIFICATIONS

Responder must check each box to certify to the conditions required under this RFP. Please note that some certifications may require the submission of additional information. Sign below to finalize response.

1. Required

☐ I have read and am aware of the State’s General Requirements as attached as Exhibit A.

☐ I have COMPLETED and ATTACHED:

☐ Exhibit B - Certification Regarding Lobbying.

☐ Exhibit C - Workforce Certificate

☐ That I am the Responder (if the Responder is an individual), a partner in the company (if the Responder is a partnership), or an officer or employee of the responding corporation having authority to sign on its behalf (if the Responder is a corporation).

☐ That the proposal submitted in response to the RFP has been arrived at by the Responder independently and has been submitted without collusion with and without any agreement, understanding or planned common course of action with, any other Responder of materials, supplies, equipment, or services described in the RFP, designed to limit fair and open competition.

☐ That the contents of the proposal have not been communicated by the Responder or its employees or agents to any person not an employee or agent of the Responder and will not be communicated to any such persons prior to the official opening of the proposals.

☐That I am fully informed regarding the accuracy of the statements made in the proposal.

2. If Applicable

☐ I am a certified veteran-owned business, in accordance with Minn. Stat. § 16C.16, subd. 6a and § 16C.19 (d). Please Complete Exhibit D

By signing here, I warrant that the information provided in this proposal is true, correct, and reliable for purposes of evaluation for potential contract award. The submission of inaccurate or misleading information may be grounds for disqualification from contract award and may subject me/my company to suspension or debarment proceedings, as well as other remedies available to the State, by law.

Signature Title Date

EXHIBIT A

General Requirements

Conflicts of Interest

Responder must provide a list of all entities with which it has relationships that create, or appear to create, a conflict of interest with the work that is contemplated in this request for proposals. This includes any conflict of interests the Responder may have with a Member. The list should indicate the name of the entity, the relationship, and a discussion of the conflict.

Organizational Conflicts of Interest

To the best of Responder’s knowledge and belief, and except as otherwise disclosed, there are no relevant facts or circumstances which could give rise to organizational conflicts of interest. An organizational conflict of interest exists when, because of existing or planned activities or because of relationships with other persons, A. vendor is unable or potentially unable to render impartial assistance or advice to the State;

B. the vendor’s objectivity in performing the contract work is or might be otherwise impaired; or C. the vendor has an unfair competitive advantage.

If after award, an organizational conflict of interest is discovered, an immediate and full disclosure in writing must be made to the State’s Chief Procurement Officer which must include a description of the action which the contractor has taken or proposes to take to avoid or mitigate such conflicts. If an organization conflict of interest is determined to exist, the State may, at its discretion, cancel the contract. In the event the Contractor was aware of an organizational conflict of interest prior to the award of the contract and did not disclose the conflict to OSP, the State may terminate the contract for default. Organizational conflicts of interest terms apply to any subcontractors for this work.

Proposal Contents The information provided is true, correct, and reliable for purposes of evaluation for potential contract award.

The submission of inaccurate or misleading information may be grounds for disqualification from the award as well as subject the Responder to suspension or debarment proceedings as well as other remedies available by law.

Responses are Nonpublic during Evaluation Process All materials submitted in response to this Solicitation will become property of the State. During the evaluation process, all information concerning the responses submitted will remain private or nonpublic and will not be disclosed to anyone whose official duties do not require such knowledge. Responses are private or nonpublic data until the completion of the evaluation process as defined by Minn. Stat. § 13.591. The completion of the evaluation process is defined as the State having completed negotiating a contract with the selected responder. The State will notify all responders in writing of the evaluation results.

The State will not consider the prices submitted by the Responder to be proprietary or trade secret materials.

Notwithstanding the above, if the State contracting party is part of the judicial branch, the release of data shall be in accordance with the Rules of Public Access to Records of the Judicial Branch promulgated by the Minnesota Supreme Court as the same may be amended from time to time.

Contingency Fees Prohibited Pursuant to Minnesota Statutes Section 10A.06, no person may act as or employ a lobbyist for compensation that is dependent upon the result or outcome of any legislation or administrative action.

Administrative Fee.

In consideration for the administrative support and other services provided by MMCAP Infuse, the Responder agrees to pay an Administrative Fee of three percent (3%) on all purchases of products and services.

Administrative Fee Data Report Fields.

The MMCAP Infuse standard data fields and interpretation for use by the contract(s) resulting from this RFP are attached as Exhibit E. These data fields allow for reporting of drug costs as well as the costs of contracted services within reverse distribution. The intent of the monthly data files are to (1) provide a basis for Administrative Fee payments, (2) to assess overall value from the contract; and (3) provide stakeholders with actual usage volume and spending on their contract with the Responder. MMCAP Infuse will never request patient-identifiable data.

Reimbursements

Reimbursement for travel and subsistence expenses actually and necessarily incurred by the contractor as a result of the contract will be in no greater amount than provided in the current "Commissioner’s Plan” promulgated by the commissioner of Minnesota Management and Budget will not be made for travel and subsistence expenses incurred outside Minnesota unless it has received the State’s prior written approval for out of state travel. Minnesota will be considered the home state for determining whether travel is out of state.

Targeted Group, Economically Disadvantaged Business, Veteran-Owned and Individual Preference.

Unless a greater preference is applicable and allowed by law, in accordance with Minn. Stat. § 16C.16, businesses that are eligible and certified by the State as targeted group (TG) businesses, economically disadvantaged (ED) businesses, and veteran-owned businesses will receive points equal to 6% percent of the total points available as preference.

For TG/ED/VO certification and eligibility information visit the Office of Equity in Procurement website at https://mn.gov/admin/business/vendor-info/oep/ or call the Division’s Helpline at 651.296.2600.

Work Force Certification For all contracts estimated to be in excess of $100,000, responders are required to complete the attached Affirmative Action Data page and return it with the response. As required by Minnesota Rule 5000.3600, “It is hereby agreed between the parties that Minnesota Statute § 363A.36 and Minnesota Rule 5000.3400 -

5000.3600 are incorporated into any contract between these parties based upon this specification or any modification of it. A copy of Minnesota Statute § 363A.36 and Minnesota Rule 5000.3400 - 5000.3600 are available upon request from the contracting agency.”

Non-Collusion Certification.

A. The Proposal has been arrived at by the Responder independently and has been submitted without collusion and without any agreement, understanding or planned common course of action with any other vendor designed to limit fair or open competition; and

B. The contents of the Response have not been communicated by the Responder or its employees or agents to any person not an employee or agent of the Responder and will not be communicated to any other individual prior to the due date and time of this Solicitation. Any evidence of collusion among Responders in any form designed to defeat competitive responses will be reported to the MMCAP Infuse for investigation and appropriate action.

Certification Regarding Lobbying

For State of Minnesota Contracts and Grants over $100,000, the undersigned certifies, to the best of his or her knowledge and belief that:

A. No Federal appropriated funds have been paid or will be paid, by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or employee of any agency, a member of https://mn.gov/admin/business/vendor-info/oep/

Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with the awarding of any Federal contract, the making of any Federal grant, the making of any Federal loan, the entering into of any cooperative agreement, and the extension, continuation, renewal, amendment, or modification of any Federal contract, grant, loan, or cooperative agreement.

B. If any funds other than Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this Federal contract, grant, loan, or cooperative agreement, the undersigned shall complete and submit Standard Form-LLL, Disclosure Form to Report Lobbying in accordance with its instructions.

C. The undersigned shall require that the language of this certification be included in the award documents for all sub-awards at all tiers (including subcontracts, sub-grants, and contracts under grants, loans and cooperative agreements) and that all sub-recipients shall certify and disclose accordingly.

This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into and is a prerequisite for making or entering into this transaction imposed by 31 U.S.C. 1352. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure.

Insurance Requirements

1. Notice. The Responder is required to submit Certificates of Insurance acceptable to MMCAP Infuse as evidence of insurance coverage requirements prior to commencing work under an awarded contract.

Responder will not commence work under a contract until they have obtained all the insurance described below and MMCAP Infuse has approved such insurance. Responder shall maintain such insurance in force and effect throughout the term of a contract. The failure of MMCAP Infuse to obtain a Certificate of Insurance, for the policies required under a contract or renewals thereof, or failure of the insurance company to notify MMCAP Infuse of the cancellation of policies required under and awarded contract shall not constitute a waiver by MMCAP Infuse to the Responder to provide such insurance. MMCAP Infuse reserves the right to immediately terminate a contract if the Responder is not in compliance with the insurance requirements and retains all rights to pursue any legal remedies against the Responder.

All insurance policies must be open to inspection by MMCAP Infuse and copies of policies must be submitted to MMCAP Infuse. The Responder’s insurance company(ies) waives its right to assert the immunity of the State of Minnesota as a defense to any claims made under said insurance.

2. Additional Insurance Conditions.

A. Responder’s policy(ies) shall be primary insurance to any other valid and collectible insurance available to MMCAP Infuse with respect to any claim arising out of Responder’s performance under this Agreement;

B. If Responder receives a cancellation notice from an insurance carrier affording coverage herein, Responder agrees to notify MMCAP Infuse within five (5) business days with a copy of the cancellation notice, unless Responder’s policy(ies) contain a provision that coverage afforded under the policy(ies) will not be cancelled without at least thirty (30) days advance written notice to MMCAP Infuse;

C. Responder is responsible for payment of Agreement related insurance premiums and deductibles;

D. If Responder is self-insured, a Certificate of Self-Insurance must be attached;

E. Responder’s policy(ies) shall include legal defense fees in addition to its liability policy limits;

F. Responder’s insurance companies must either (1) have an AM Best rating of A- (minus) and a

Financial Size Category of VII or better, and be authorized to do business in the State of Minnesota or (2) be domiciled in the State of Minnesota and have a Certificate of Authority/Compliance from the Minnesota Department of Commerce if they are not rated by AM Best; and

G. An Umbrella or Excess Liability insurance policy may be used to supplement the Responder’s policy limits to satisfy the full policy limits required by the Agreement.

3. Responder is required to maintain and furnish satisfactory evidence of the following insurance policies:

A. Workers’ Compensation Insurance: Except as provided below, Responder must provide

Workers’ Compensation insurance for all its employees and, in case any Responder is subcontracted, Contractor will require the subcontractor to provide Workers’ Compensation insurance in accordance with the statutory requirements of the State of Minnesota, including Coverage B, Employer’s Liability. Insurance minimum limits are as follows:

$100,000 – Bodily Injury by Disease per employee $500,000 – Bodily Injury by Disease aggregate $100,000 – Bodily Injury by Accident

If Minnesota Statute 176.041 exempts Responder from Workers’ Compensation insurance or if the Responder has no employees in the State of Minnesota, Responder must provide a written statement, signed by an authorized representative, indicating the qualifying exemption that excludes Responder from the Minnesota Workers’ Compensation requirements.

If during the course of the contract the Responder becomes eligible for Workers’ Compensation, the responder must comply with the Workers’ Compensation Insurance requirements herein and provide the State of Minnesota with a certificate of insurance.

B. Commercial General Liability Insurance: Responder is required to maintain insurance protecting it from claims for damages for bodily injury, including sickness or disease, death, and for care and loss of services as well as from claims for property damage, including loss of use which may arise from operations under the contract whether the operations are by the Responder or by a subcontractor or by anyone directly or indirectly employed by the Responder under the contract. Insurance minimum limits are as follows:

$5,000,000 – per occurrence $5,000,000 – annual aggregate $5,000,000 – annual aggregate – Products/Completed Operations

The following coverages shall be included:

Premises and Operations Bodily Injury and Property Damage Personal and Advertising Injury Blanket Contractual Liability Products and Completed Operations Liability Other; if applicable, please list__________________________________ State of Minnesota named as an Additional Insured, to the extent permitted by law

C. Commercial Automobile Liability Insurance: Responder is required to maintain insurance protecting it from claims for damages for bodily injury as well as from claims for property damage resulting from the ownership, operation, maintenance or use of all owned, hired, and non-owned autos which may arise from operations under this contract, and in case any work is subcontracted the Responder will require the subcontractor to maintain Commercial Automobile Liability insurance. Insurance minimum limits are as follows:

$2,000,000 – per occurrence Combined Single limit for Bodily Injury and Property Damage

In addition, the following coverages should be included:

Owned, Hired, and Non-owned Automobile

D. Network Security and Privacy Liability Insurance, Including Ransomware (or equivalent):

Responder will maintain insurance to cover claims which may arise from failure of Responder’s security resulting in, but not limited to, computer attacks, unauthorized access, disclosure of not public data including but not limited to confidential or private information, transmission of a computer virus or denial of service. Insurance minimum limits are as follows:

i. $2,000,000 – per occurrence

ii. $2,000,000 – annual aggregate

E. Professional/ Technical, Errors and Omissions, and or Miscellaneous Liability Insurance: This policy will provide coverage for all claims the Responder may become legally obligated to pay resulting from any actual or alleged negligent act, error, or omission related to the Responder’s services required under the Agreement. Insurance minimum limits are as follows:

i. $2,000,000 – per occurrence

ii. $2,000,000 – annual aggregate

E-Verify Certification (In accordance with Minn. Stat. §16C.075)

By submission of a proposal for services in excess of $50,000, Responder certifies that as of the date of services performed on behalf of the State, Responder and all its subcontractors will have implemented or be in the process of implementing the federal E-Verify program for all newly hired employees in the United States who will perform work on behalf of the State. In the event of contract award, Responder shall be responsible for collecting all subcontractor certifications and may do so utilizing the E-Verify Subcontractor Certification Form available at http://www.mmd.admin.state.mn.us/doc/EverifySubCertForm.doc. All subcontractor certifications must be kept on file with Responder and made available to the State upon request.

Certification of Nondiscrimination (In accordance with Minn. Stat. § 16C.053)

The following term applies to any contract for which the value, including all extensions, is $50,000 or more:

Responder certifies it does not engage in and has no present plans to engage in discrimination against Israel, or against persons or entities doing business in Israel, when making decisions related to the operation of the vendor's business. For purposes of this section, "discrimination" includes but is not limited to engaging in refusals to deal, terminating business activities, or other actions that are intended to limit commercial relations with Israel, or persons or entities doing business in Israel, when such actions are taken in a manner that in any way discriminates on the basis of nationality or national origin and is not based on a valid business reason.

Diverse Spend Reporting

If the total value of the awarded contract may exceed $500,000 in the State, including all extension options, the Vendor must track and report, on a quarterly basis, the amount paid to diverse businesses both: (A) directly to subcontractors performing under the Agreement, and (B) indirectly to diverse businesses that provide supplies/services to your company (in proportion to the revenue from the awarded contract compared to your company’s overall revenue). When this applies, you will be set up in a free portal to help report the Tier 2 diverse spend, and the requirement continues as long as the contract is in effect.

http://www.mmd.admin.state.mn.us/doc/EverifySubCertForm.doc

EXHIBIT B

CERTIFICATION REGARDING LOBBYING

The undersigned certifies, to the best of his or her knowledge and belief that:

(1) No Federal appropriated funds have been paid or will be paid, by or on behalf of the undersigned, to any person for influencing or attempting to influence an officer or employee of any agency, a member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with the awarding of any Federal contract, the making of any Federal grant, the making of any Federal loan, the entering into of any cooperative agreement, and the extension, continuation, renewal, amendment, or modification of any Federal contract, grant, loan, or cooperative agreement.

(2) If any funds other than Federal appropriated funds have been paid or will be paid to any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with this Federal contract, grant, loan, or cooperative agreement, the undersigned shall complete and submit Standard Form-LLL, Disclosure Form to Report Lobbying in accordance with its instructions.

(3) The undersigned shall require that the language of this certification be included in the award documents for all subawards at all tiers (including subcontracts, subgrants, and contracts under grants, loans and cooperative agreements) and that all subrecipients shall certify and disclose accordingly.

This certification is a material representation of fact upon which reliance was placed when this transaction was made or entered into. Submission of this certification is a prerequisite for making or entering into this transaction imposed by 31 U.S.C. 1352. Any person who fails to file the required certification shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure.

Organization Name

Name and Title of Official Signing for Organization

By:_______________________________________

Signature of Official

Date

Exhibit C

STATE OF MINNESOTA – WORKFORCE CERTIFICATE INFORMATION

Information required for ALL bids or proposals that could exceed $100,000

Complete Box A or B of this form, and sign and return it with your bid or proposal. A Workforce Certificate or exemption from the Minnesota Department of Human Rights (MDHR) is required to execute a contract in excess of $100,000 under Minn. Stat. §363A.36.

Signature By signing this statement, I certify that the information provided is accurate and that I am authorized to sign on behalf of the company.

Name of Company Authorized Signature

Date Printed Name

Phone Number Title

For assistance with this form, contact:

Minnesota Department of Human Rights

Web: http://mn.gov/mdhr/ Toll Free: 1-800-657-3704 Email: compliance.mdhr@state.mn.us MN Relay: 711/ 1-800-627-3529

Rev. 7/21

BOX A – COMPANIES that have employed 40 or more full-time employees in this state or a state where the business has its primary place of business on any single working day during the previous 12 months, check one option below:

Attached is our current Workforce Certificate issued by the Minnesota Department of Human Rights (MDHR).

Attached is confirmation that MDHR received our application for a Minnesota Workforce Certificate on

(date).

☐ Our company does not yet have a Workforce Certificate, but we acknowledge that a Workforce Certificate is required before a contract in excess of $100,000 can be executed with the State of Minnesota or other covered entities.

BOX B – EXEMPT COMPANIES that have not employed 40 or more full-time employees on a single working day in Minnesota or any state where it has its primary place of business during the previous 12 months, check option below if applicable:

We attest to MDHR that we are exempt. If our company is awarded a contract, upon request, we will submit to MDHR within 5 business days after the contract is fully signed, the names of our employees during the previous 12 months, the date of separation, if applicable, and the state in which the persons were employed.

Send to compliance.MDHR@state.mn.us.

http://mn.gov/mdhr/ mailto:compliance.mdhr@state.mn.us mailto:compliance.MDHR@state.mn.us

EXHIBIT D

STATE OF MINNESOTA

VETERAN-OWNED PREFERENCE FORM

Unless a greater preference is applicable and allowed by law, in accordance with Minn. Stat. §16C.16, subd. 6a, the state will award a 6% preference on state procurement to certified small businesses that are majority owned and operated by veterans.

Veteran-Owned Preference Requirements - See Minn. Stat. § 16C.19(d):

1) The business has been certified by the Office of Equity in…