33180 RFP Medical Repackaging Srvs.pdf

State of Minnesota

MMCAP INFUSE,

OFFICE OF STATE PROCUREMENT

REQUEST FOR PROPOSAL

Medication Repackaging Services

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 Medication Repackaging Services

Proposal Due Date: August 2, 2023 by 2pm Central Time

RFP Release date July 12, 2023 Cutoff Date for Questions July 19, 2023, 2 pm Central Time Final RFP Answers Posted July 25, 2023 Proposal Due Date August 2, 2023, 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 July 19, 2023, at 2pm 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

Section 3:

Responder’s Contact Information Pass/Fail Criteria Administrative Fee Reporting & Data Technical Proposal

Section 4:

Exhibit B: Cost Proposal (submitted in a separate document from the technical proposal) (submitted in Microsoft Excel or PDF) Section 5:

Exhibit A State’s General Requirements (read and acknowledge in section 2, question 7)

Exhibit B Certification Regarding Lobbying (submit in PDF) Exhibit C Workforce Certificate Form (submit in PDF) If applicable, Exhibit D, Veteran Owned Preference (submit in PDF)

Exhibit E Reporting Requirements (read and acknowledge in Section 3, question 4)

Where to Send Responses

• Email your responses to MMCAP_Infuse.RFP@state.mn.us with “[Company Name] Medical Repackaging Services RFP Response” in the Subject line. If your email is larger than the maximum allowed size, send your response in multiple emails. Use “[Company Name] Medical Repacking Services RFP Response Part [#] of [#]” in the Subject line.

• Mailed SAMPLES of repackaged product should be sent to:

MMCAP Infuse – State of Minnesota Medication Repackaging Services RFP Response 50 Sherburne Avenue #112 St. Paul, MN 55155

• Faxed responses will not be accepted

Response Submission Deadline

Must be received no later than August 2, 2023, 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.

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 (Members or Membership) are state agencies and political subdivisions throughout the United States. 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. For more information on MMCAP Infuse and its membership, visit www.infuse-mn.gov.

MMCAP Infuse currently has 50+ members using repackaging contracts across all regions of the United States with sales totaling over $500,000 annually.

MMCAP Infuse is looking for qualified Responders that offer repackaging services, (i.e., repackaging into blister cards, physician-dispensing packaging, unit-dose syringes, etc.). MMCAP Infuse is requesting proposals for Medication Repackaging Services to be provided to the entire membership. Responses to this RFP will be used to establish contract(s) that will comply with all regulatory requirements related to repackaging services. Responder should be able to demonstrate knowledge and commitment to providing high quality products with prompt delivery and customer service.

2. Desired Capabilities

A. Provide pass-through billing with MMCAP Infuse authorized wholesalers (Authorized

Wholesalers) (currently AmerisourceBergen, Cardinal Health, and Morris & Dickson) B. Provide repackaging service for oral solids, liquids, and topical products into unit dose products C. Provide repackaging services for hazardous drugs that fall under NIOSH guidelines to aid members in USP<800> compliance D. Provide timely customer service and support Member inquiries as needed E. Integrate and offer services that are relevant to meet the needs of the dynamic pharmaceutical landscape F. Generate accurate and timely data used for reporting of sales and administrative fee’s G. Offer a competitive pricing structure H. Proven comprehension of the pharmaceutical industry and well versed in the overall government procurement process

3. Agreement Duration It is anticipated that MMCAP Infuse will enter into agreements for an initial two (2) year term with an option to extend in increments determined by MMCAP Infuse, in compliance with Minnesota law.

http://www.infuse-mn.gov/

4. Minimum Qualification 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. Proposals were received on or before the due date and time specified in this RFP B. Responder is accredited with the National Association of Boards of Pharmacy Drug Distributor

Accreditation (formerly Verified-Accredited Wholesale Distributor) C. Responder must be able to receive product(s) used for repackaging directly from a pharmaceutical wholesaler D. Responder must have been in business a minimum of 5 years

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 3% Administrative Fee 5% Reporting Data 5% Technical Response:

Experience & Background 5% Regulatory Requirements 10% Customer Service, Ordering, Shipping & Payment 15% Services Offered 30% Cost Proposal 30%

Preferences 12% Minnesota Certified Targeted Group/Economically Disadvantaged Preference 12% 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 Proposals received on or before the due date and time specified in this RFP Responder is accredited with the National Association of Boards of Pharmacy

(NABP) Drug Distributor Accreditation (formerly Verified-Accredited Wholesale Distributor)

Responder must be able to receive product(s) used for repackaging directly from a pharmaceutical wholesaler

Responder must have been in business a minimum of 5 years

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 Members’ purchase of products and services.

Does Responder comply with term below?

Yes No Term

Responder agrees to pay Administrative Fee of three percent (3%) on all purchases of products and services

4. Reporting & Data

The MMCAP Infuse standard data fields and interpretation for use by the contract(s) resulting from this RFP are attached as Exhibit E Reporting Requirements. These data fields ensure proper reporting of data required for overall value of the contract and allow for the collection of Administrative Fee’s.

Does Responder comply with term below?

Yes No Term

Responder agrees to provide the minimum Sales Data fields as outlined in Exhibit E

5. Technical Proposal

Experience and Background

1. Provide a brief history of Responder’s organization, including any subsidiary businesses Responder is associated with. Indicate the length of time Responder has been in the repackaging business.

2. Which of the MMCAP Infuse Authorized Wholesaler(s) does Responder have a relationship with?

Describe the contract capabilities of each of those relationships.

3. What is the address of the location where repackaging services will be performed? Where are

Responder’s customer service center(s) located? How does the repackaging team and customer service team interface with one another?

4. List the date of initial NABP accreditation (formerly VAWD) and the most recent recertification.

5. What license(s) does Responder hold to provide repackaging services (i.e., repackager, wholesaler, manufacturer, etc.)? How does this align with Responder’s business model?

6. Describe any geographic or class of trade limitations that would limit Responder from providing service to any Member.

Regulatory Requirements

Responder should be able to meet all regulatory requirements to provide repackaged medications including but not limited to the Federal Drug Administration (FDA), Drug Enforcement Agency (DEA) and all applicable state regulations.

7. Describe how Responder complies with FDA, DEA, state, and national regulations.

8. Describe how the Drug Supply Chain Security Act (DSCSA) is integrated into your processes? Are you a registered trading partner in all states for which you do business in?

9. Via what media does Responder provide transactional information (TI) and transactional statements

(TS)?

10. Does Responder have capacity to store data, securely and with portal access? Is this storage outsourced? If yes, who is your outsourced vendor(s)?

11. Describe Responder’s quality assurance program as it pertains to Current Good Manufacturing Practices (cGMP).

12. Describe Responder’s procedures to maintain a clean environment for repackaging medications and minimizing cross-contamination.

13. Has Responder received a citation or warning letter from the FDA, state Board of Pharmacy, or other regulatory body in the last 3 years? If yes, include information regarding the findings and how Responder corrected the situation.

14. Describe how regulatory changes will be communicated to MMCAP Infuse and its Members to ensure all parties are kept informed of changes that may affect them.

15. Describe Responder’s procedure for managing and repackaging controlled substances.

16. How does Responder ensure allergen prone medications (i.e., penicillin and sulfa based products) avoid cross contamination?

17. Describe Responder’s procedure for managing hazardous medications, both form a RCRA and USP

<800> perspective?

Customer Service

18. What hours are Responder’s customer service representatives available to MMCAP Infuse Members?

How will Responder ensure customer service needs are addressed for Members across all time zones (including for Hawaii and Alaska)?

19. Will Responder have dedicated staff to manage the MMCAP Infuse agreement and to work directly with MMCAP Infuse Members?

20. Describe Responder’s dispute resolution process?

21. In today’s tight labor market, how will Responder ensure they have an appropriate number of qualified staff to ensure top notch service with minimal delays?

Ordering

22. Explain the process of how an MMCAP Infuse Member will order repackaging services? List all methods for placing orders (e.g., fax, online, phone).

23. What are the ordering minimums?

24. What is Responders policy on short-dated product? What is the minimum date a product can have for Responder to repackage?

25. Include a copy of any documents needed for account setup. How long does it take for a Member to get a new account set up?

26. Does Responder offer emergency (expedited) orders? If so, is there an extra fee associated and what is the expected timeframe for expedited delivery?

27. With all of the supply chain issues in the last few years, how has Responder adjusted supply orders and developed redundancies to ensure adequate supply of repackaging materials are available?

28. Does Responder accept returns under any circumstances? If so, what is Responder’s return policy?

Shipping and Payment

29. List all available shipping options and the contracted couriers/providers used. If more than one courier is used, how does Responder determine which to use? How long have each of these couriers been contracted with Responder?

30. What is the typical turnaround time for a standard order? What has been the average turnaround time in the last 3 months? In the last 12 months?

31. How are deliveries accounted for and assured to be received at the correct location within a facility?

(e.g., carrier tracking numbers, signatures required for delivery)

32. How are orders for multiple products handled? Will product be shipped in one delivery to save on shipping costs, or will it be shipped separately as product is ready?

33. What process is used to ensure a controlled temperature during shipping?

34. How does Responder handle delayed shipments? How is this communicated to the Member? Is there a mechanism for an order to be updated/cancelled due to a delay?

35. Is shipping included in the cost of repackaging? All specific amounts should only be included in the cost proposal (section 4).

36. What type of product insurance is provided on standard orders? How can additional insurance be provided on high-cost medications?

37. How will damaged shipments be handled? How quickly can replacement product be received by the

Member?

38. What forms of payment are accepted (e.g., P-card, purchase order) and are there are any additional fees associated with a specific payment form? What are the expected payment terms? Are there any prompt pay, recurring order, volume-base, or other discounts available to Members?

39. Provide a sample of Responder’s invoice. Is it customizable? Will a printed invoice be included in each order?

Services Offered

40. Explain Responder’s standard operating procedure for repackaging, bar coding and labeling products including, but not limited to controlled substances, creams/ointments, semi-toxic agents, liquids, and oral solids.

41. Please describe your current expiration dating process when repackaging a commercially available product.

42. Describe Responder’s assignment process for lot numbers.

43. If an original bottle contains 1000 tablets and is being repackaged into 30-count bingo cards, explain the process of how the leftover product will be managed. Is there a threshold for when leftover product would be returned to the Member?

44. There are instances in which Members need specialized repackaging services. Some student health members might be operating under a physician dispensing model, where pre-packaged pharmaceuticals are dispensed under the supervision of a physician (as opposed to a pharmacy, where they are dispensed under the supervision of a pharmacist). Does Responder offer any repackaging services that cater to this model? How could your repackaging services be tailored to fulfill the physician-dispensing need of a Member? If this is offered, please clearly indicate so on the cost proposal.

45. Describe Responder’s procedure for managing recalls, including notification to Members?

46. Provide a list of products Responder will not repackage. Describe Responder’s process when product is received that cannot be repackaged?

47. Provide a list of hazardous drugs as outlined in USP<800> that Responder will repackage. Are there any hazardous medications Responder will NOT repackage and explain why?

48. Describe how Responder’s packaging and labeling will integrate with Member’s pharmacy software, automation cabinets and/or carousels.

49. What types of barcoding is offered (i.e., 2D, linear, etc.)? What is the scan ability rate of barcoded products? What is the remedy process for barcoded product that does not scan?

50. What options or solutions can Responder offer to assist Members in shortage situations? How quickly can Responder react to major market shifts in the need for unit dose products?

51. What steps has Responder taken to incorporate recyclable and environmentally friendly material into the repackaging process or to reduce waste?

52. Describe Responder’s quality assurance review process. What is Responder’s error rate for the last year?

53. Prior to the RFP due date, Responder should send samples of packaging, labels, bar codes and any other packaging material that will be used for repackaging obligations. Please send in sets of 4 (i.e., 4 bingo cards, 4 bottles, 4 labels, etc.)

Send to:

MMCAP Infuse – State of Minnesota Medication Repackaging Services RFP Response 50 Sherburne Avenue #112

St. Paul, MN 55155

54. Is Responder able to participate in strategic stockpiling for Emergency Preparedness bids for the private or public sector? Common requests would require repackaging Ciprofloxacin 500mg tablets and/or Doxycycline Hyclate 20mg tablets into 20 count bottles. If so, how would the expiration date be calculated to ensure maximum dating? Would there be any limitations or requirements to this type of repackaging need?

55. Which of the MMCAP Infuse Authorized Wholesalers does Responder offer pass-through billing for?

What is required of the Member in this process? What is required of the Authorized Wholesaler?

56. List any additional service offerings not identified in this proposal that might improve the results of this project.

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. Any additional fees proposed MUST be included on the cost proposal. Fees/costs that are not included on the cost proposal will NOT be considered during contract negotiations if Responder is awarded a contract. 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.

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.

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 12% 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 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.

https://mn.gov/admin/business/vendor-info/oep/

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

Workforce and Equal Pay Declarations Page Rev. 11/7/2022

Workforce and Equal Pay Declaration Page

This form is required for all businesses executing government contracts under the following:

Select one:

Businesses executing a contract with State or Metropolitan agencies in excess of $100,000 (Workforce Certificate) and if applicable $500,000 (Equal Pay Certificate) Businesses executing a contract with University of Minnesota for general obligation bond funded capital projects in excess of $100,000 (Workforce Certificate) and if applicable $500,000 (Equal Pay Certificate) Businesses executing a contract with Political Subdivisions for general obligation bond funded capital projects in excess of $250,000 (Workforce Certificate) and if applicable $1,000,000 (Equal Pay Certificate)

Select all that apply:

We are a Certificate holder:

Workforce Certificate under the name: _________________________________________________________ Equal Pay Certificate under the name: __________________________________________________________

We are applying/have applied for the following certificate(s):

Workforce Certificate Application date (MM/DD/YYYY): ____________________ Equal Pay Certificate Application date (MM/DD/YYYY): ____________________

We have not applied for one or both certificates:

Our Company does not yet have a Workforce Certificate or Equal Pay Certificate. We acknowledge that a Workforce and, if applicable, Equal Pay Certificate, or approved exemption by MDHR is required before a contract can be executed.

We are Exempt:

We attest to MDHR that we have not employed 40 or more employees on a single day during the prior 12 months in Minnesota or the state in where we have our primary place of business. MDHR may request the names of our employees during the previous 12 months, the date of separation, if applicable, and the current employment status and count.

Business Information

Vendor/Supplier ID Business Name Name of Contracting Agency

Authorized Signatory Name Title Date

Signature Email Phone

For assistance with this form, email the Minnesota Department of Human Rights Compliance.MDHR@state.mn.us

(If applicable)

Not applicable - MMCAP Infuse WESA exemption memo dated Dec, 17, 2018

Not applicable - MMCAP Infuse WESA exemption memo dated Dec, 17, 2018

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 Commissioner of Administration will award up to a 12% 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 Procurement (OEP) as being a veteran-owned or service-disabled veteran-owned small business.

or

2) The principal place of business is in Minnesota AND the US Small Business Administration verifies the business as being a veteran-owned or service-disabled veteran-owned small business under Public Law 109- 461 and Code of Federal Regulations, title 13, part 128.

Statutory requirements and appropriate documentation must be met by the solicitation response due date and time to be awarded the veteran-owned preference. For Bids, the preference applies only to the first $2,000,000.

Claim the Preference By signing below I confirm that:

My company is claiming the veteran-owned preference afforded by Minn. Stat. § 16C.16, subd. 6a. By making this claim, I verify that:

• The business has been certified by the Office of Equity in Procurement (OEP) as being a veteran-owned or service-disabled veteran-owned small business.

or

• My company’s principal place of business is in Minnesota and the US Small Business Administration verifies my company as being a veteran-owned or service-disabled veteran-owned small business.

Name of Company: _____________________________ Date: ________________________________

Authorized Signature: _____________________________ Telephone: ________________________________

Printed Name: _____________________________ Title: ______________________________________

Sign and return this form with your solicitation response to claim the veteran-owned preference.

EXCEL COLUMN Required Data Field Full Name for Sales Data Report A MMCAP Infuse-assigned Member ID B MMCAP Infuse Member Name C Vendor Distribution Center Code D Vendor-assigned Account Number for MMCAP Infuse Member E Invoice Number F Invoice Line Number G Purchase Order Number H Invoice Date (MM/DD/YYYY) I Buyer Name/ Buyer ID J SKU/ Item Number

K NDC

L Label Name/ Product Description M Unit Dose N Pack Size O Unit P Case Size Q Dose R Strength S Route T Unit Price (99999.9999) U Quantity Ordered (99999.9999) V Quantity Shipped (99999.9999) W Extended Price (99999.9999) X Type of Transaction Y Bill to Address 1 Z Bill to City AA Bill to State AB Bill to Zip AC Ship to Address 1 AD Ship to City AE Ship to State AF Ship to Zip AG Service Fee AH MMCAP Infuse Contract Number AI Admin Fee AJ Credit Indicator AK MMCAP Infuse Assigned Wholesaler Code AL Manufacture Name AM Class of Trade AN 340B Purchase AO Category AP Manufacture Part Number AQ List Price AR UNSPSC Code AS UNSPSC Description AT Order Date AU NDCRepack

AV GLN

AW GTIN

EXHIBIT E

Reporting Requirements