agreement_template_-_dscsa_rfp.docx

MMCAP INFUSE XXXX

Vendor

XXXXX, 2020

Minnesota Department of Administration Office of State Procurement 50 Sherburne Avenue, Suite 112 Administration Building, St. Paul, MN 55155 Phone: 651.201.2420

[Insert Vendor’s Name] MMCAP Infuse Agreement: MMS2400XX Prepared on ________, 2024

PREFIX A

Definitions and Acronyms Are attached and incorporated into the Agreement

Definitions

1. 3T Data: refers to data elements as defined by the DSCSA, which include paragraphs 34-36, below.

2. Administrative Fee: Means three percent (3%) of all payments received by the Vendor for Services to Members.

3. Affiliate: Means a business entity that has a relationship with a second business entity if, directly or indirectly:

(A) One business entity controls, or has the power to control, the other business entity; or

(B) A third party controls, or has the power to control, both of the business entities.

4. Authorized: As defined by the DSCSA, authorized entities include:

(A) Manufacturers and Repackagers who have a valid registration under 21 U.S.C. § 360;

(B) Wholesale distributors with a valid license under State law or 21 U.S.C. § 360eee-2, in accordance with 21 U.S.C. § 360eee-1(a)(6), and who are compliant with all reporting requirements under 21 U.S.C. § 353(e);

(C) Third-party logistic providers with a valid license under State law or 21 U.S.C. § 360eee-3(a)(1), in accordance with 21 U.S.C. § 360eee-1(a)(7), and who are compliant with all reporting requirements under 21 U.S.C. § 360eee-3(b); and

(D) Dispensers with a valid State license.

5. Class of Trade: All Members are eligible for Contract Pricing.

6. Contract Pricing/Price (Pricing/Price): Means the price that the Vendor has agreed to provide the Services to MMCAP Infuse and its Membership as set forth on Attachment A and any subsequent amendment to this Agreement.

7. Days: (Not required to be capitalized) Unless otherwise specified in this Agreement, all references to days will be calendar days.

8. Dispenser: As defined by the DSCSA, a Dispenser means:

(A) A retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer Prescription Drugs, and the affiliated warehouses or distribution centers or such entities under common ownership and control that do not act as a wholesale distributor; and

(B) Does not include a person who dispenses only products to be used in animals in accordance with 21 U.S.C. § 360b(a)(5).

9. Disposition: means, with respect to a Product within the possession or control of an entity, the removal of such Product from the pharmaceutical Distribution supply chain, which may include disposal or return of the Product for disposal or other appropriate handling and other actions, such as retaining a sample of the Product for further additional physical examination or laboratory analysis of the Product by a Manufacturer or regulatory or law enforcement agency.

10. Distribute or Distribution: means the sale, purchase, trade, delivery, handling, storage, or receipt of a Product, and does not include the dispensing of a Product pursuant to a prescription executed in accordance with 21 U.S.C. § 353(b)(1) or the dispensing of a Product approved under 21 U.S.C. § 360b(b).

11. Drug Supply Chain Security Act (DSCSA): Title II of Public Law 113-54, H.R. 3204, and all associated provisions.

12. Exclusive Distributor: means the wholesale distributor that directly purchased the Product from the Manufacturer and is the sole distributor of that Manufacturer’s Product to a subsequent Repackager, wholesale distributor, or Dispenser.

13. Government Unit: Any entity as defined by Minnesota Statute 471.59.

14. Homogenous Case: means a sealed case containing only Product that has a single National Drug Code number belonging to a single lot.

15. Illegitimate Product: means a Product for which credible evidence shows that the Product is:

(A) Counterfeit, diverted, or stolen;

(B) Is intentionally adulterated such that the Product would result in serious adverse health consequences or death to humans;

(C) Is the subject of a fraudulent Transaction; or

(D) Appears otherwise unfit for Distribution such that the Product would be reasonably likely to result in serious adverse health consequences or death to humans.

16. Manufacturer: means, with respect to a Product—

(A) a person that holds an application approved under 21 U.S.C. § 355 of this title or a license issued under section 262 of title 42 for such Product, or if such Product is not the subject of an approved application or license, the person who manufactured the Product;

(B) a co-licensed partner of the person described in subparagraph (A) that obtains the Product directly from a person described in this subparagraph or subparagraph (A) or (C); or

(C) an affiliate of a person described in subparagraph (A) or (B) that receives the Product directly from a person described in this subparagraph or subparagraph (A) or (B).

17. Member: Means an MMCAP Infuse approved State or other Government Unit, including facilities (participating facilities) that has executed a Membership Application and Member Agreement with MMCAP Infuse. As a condition for purchasing under this Agreement, purchasers must be Members in good standing with MMCAP Infuse.

18. Membership: Means the joint power cooperative comprised of the MMCAP Infuse authorized States, Members, and other Government Units.

19. Onboarding Date: Means the Vendor must allow new Members to access to the Agreement within seven (7) days of notice by MMCAP Infuse and/or the completion of the required paperwork on Attachment D.

20. Order: Means the placement of a request for Services via the utilization of an Order Form

21. Order Form: Means the document or electronic platform Member utilizes to obtain Services.

22. Package:

(A) In general, the term “package” means the smallest individual saleable unit of Product for Distribution by a Manufacturer or Repackager that is intended by the Manufacturer for ultimate sale to the Dispenser of such Product.

(B) For purposes of this paragraph, an “individual saleable unit” is the smallest container of Product introduced into commerce by the Manufacturer or Repackager that is intended by the Manufacturer or Repackager for individual sale to a Dispenser.

23. Prescription Drug: The term “prescription drug” means a drug for human use subject to section 21 U.S.C. § 353(b)(1).

24. Product: means a Prescription Drug in a finished dosage form for administration to a patient without substantial further manufacturing, but for purposes of 21 U.S.C. § 360eee-1, does not include blood or blood components intended for transfusion, radioactive drugs or biological products (as defined in section 600.3(ee) of title 21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 2021 of title 42, imaging drugs, an intravenous product described in clause (xiv), (xv), or (xvi) of paragraph (24)(B), any medical gas (as defined in section 21 U.S.C. § 360ddd of this title), homeopathic drugs marketed in accordance with applicable guidance under this chapter, or a drug compounded in compliance with section 21 U.S.C. § 353a or 353b.

25. Product Identifier: means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the Product.

26. Quarantine: means the storage or identification of a Product, to prevent Distribution or transfer of the Product, in a physically separate area clearly identified for such use or through other procedures.

27. Repackager: means a person who owns or operates an establishment that repacks and relabels a Product or Package for:

(A) further sale; or

(B) Distribution without a further Transaction.

28. Services: means any service offered under this agreement that will assist Members in compliance with DSCSA and refer to the provision of an interoperable, secure electronic system for purposes of identifying and tracing a Product at the Package level through completion of the following requirements:

(A) The Transaction Information and the Transaction Statements as required under the DSCSA to be exchanged in a secure, interoperable, electronic manner in accordance with the standards established under the guidance issued pursuant to 21 U.S.C. 360eee-1(h)(3-5) including any revisions .

(B) The Transaction Information required under the DSCSA shall include the Product Identifier at the Package level for each Package included in the Transaction.

(C) Systems and processes for verification of Product at the Package level, including the standardized numerical identifier, shall be required in accordance with the standards established under the guidance issued pursuant to 21 U.S.C. 360eee-1(a)(2) and the guidance issued pursuant to paragraphs 21 U.S.C. 360eee-1(h)(2-4), including any revision of such guidance issued in accordance with paragraph (5) of such subsection, which may include the use of aggregation and inference as necessary.

(D) The systems and processes necessary to promptly respond with the Transaction Information and Transaction Statement for a Product upon a request by the Secretary of the Department of Health and Human Services (Secretary), or other appropriate Federal or State official, in the event of a recall or for the purposes of investigating a Suspect Product or an Illegitimate Product shall be required.

(E) The systems and processes necessary to promptly facilitate gathering the information necessary to produce the Transaction Information for each Transaction going back to the Manufacturer, as applicable, shall be required—

i. in the event of a request by the Secretary, or other appropriate Federal or State official, on account of a recall or for the purposes of investigating a Suspect Product or an Illegitimate Product; or

ii. in the event of a request by an Authorized Trading Partner, in a secure manner that ensures the protection of confidential commercial information and trade secrets, for purposes of investigating a Suspect Product or assisting the Secretary, or other appropriate Federal or State official, with a request described in clause (i).

(F) Each person accepting a saleable return shall have systems and processes in place to allow acceptance of such Product and may accept saleable returns only if such person can associate the saleable return Product with the Transaction Information and Transaction Statement associated with that Product.

29. Standardized Numerical Identifier: means a set of numbers or characters used to uniquely identify each Package or homogenous case that is composed of the National Drug Code that corresponds to the specific Product (including the particular Package configuration) combined with a unique alphanumeric serial number of up to 20 characters.

30. State: Means one of the recognized fifty (50) states of the United States of America.

31. Suspect Product: means a Product for which there is reason to believe that such Product—

(A) is potentially counterfeit, diverted, or stolen;

(B) is potentially intentionally adulterated such that the Product would result in serious adverse health consequences or death to humans;

(C) is potentially the subject of a fraudulent Transaction; or

(D) appears otherwise unfit for Distribution such that the Product would result in serious adverse health consequences or death to humans.

32. Trading Partner: means:

(A) a Manufacturer, Repackager, wholesale distributor, or Dispenser from whom a Manufacturer, Repackager, wholesale distributor, or Dispenser accepts direct ownership of a Product or to whom a Manufacturer, Repackager, wholesale distributor, or Dispenser transfers direct ownership of a Product; or

(B) a third party logistics provider from whom a Manufacturer, Repackager, wholesale distributor, or Dispenser accepts direct possession of a Product or to whom a Manufacturer, Repackager, wholesale distributor, or Dispenser transfers direct possession of a Product.

33. Transaction: In general, this means the transfer of a Product between persons in which a change of ownership occurs, with the following exemptions as noted in 21 U.S.C. § 360eee(24)(b).

34. Transaction History: means a statement in paper or electronic form, including the Transaction Information, for each prior Transaction going back to the Manufacturer of the Product.

35. Transaction Information: means

(A) The proprietary or established name or names of the Product;

(B) The strength and dosage form of the Product;

(C) The National Drug Code number of the Product;

(D) The container size;

(E) The number of containers;

(F) The lot number of the Product;

(G) The date of the Transaction;

(H) The date of the shipment, if more than 24 hours after the date of the Transaction;

(I) The business name and address of the person from whom ownership is being transferred; and

(J) The business name and address of the person to whom ownership is being transferred.

36. Transaction Statement: is a statement, in paper or electronic form, that the entity transferring ownership in a Transaction—

(A) is authorized as required under the Drug Supply Chain Security Act;

(B) received the Product from a person that is authorized as required under the Drug Supply Chain Security Act;

(C) received Transaction Information and a Transaction Statement from the prior owner of the Product, as required under 21 U.S.C. § 360eee–1;

(D) did not knowingly ship a Suspect or Illegitimate Product;

(E) had systems and processes in place to comply with verification requirements under 21 U.S.C. § 360eee–1;

(F) did not knowingly provide false Transaction Information; and

(G) did not knowingly alter the Transaction History.

37. Verification or Verify: means determining whether the Product Identifier affixed to, or imprinted upon, a Package or homogenous case, corresponds to the standardized numerical identifier or lot number and expiration date assigned to the Product by the Manufacturer or the Repackager, as applicable in accordance with 21 U.S.C. § 360eee-1.

AGREEMENT FOR MMCAP INFUSE NO. XXXXXXX

THIS Agreement (“Agreement”) is entered into as of the Effective Date by and between the State of Minnesota (“State”) acting through its Commissioner of Administration (“Minnesota”) on behalf of MMCAP Infuse (“MMCAP Infuse”) and ____________, a limited liability company/corporation with an address of __________________ (“Vendor”). Together, MMCAP Infuse and the Vendor will be referred to as “the Parties.”

Agreement Term:

1. Effective Date: _________, or the date MMCAP Infuse obtains all required signatures as required under Minnesota Statute, whichever is later.

2. Expiration Date: ________.

3. The Agreement Term may be extended upon mutual agreement of MMCAP Infuse and Vendor.

AGREEMENT COMPONENTS

The following components are the Agreement; all referenced Prefix and Attachments, are attached and incorporated into this Agreement.

1. Prefix A: Definitions

2. Attachment A: Pricing

3. Attachment B: Further Discounts

4. Attachment C: Scope of Services

5. Attachment D: Required Member Onboarding Forms (if applicable)

6. Attachment E: Reporting Requirements

7. Attachment F: MN Statutory Language

ARTICLE I

PRICING AND CHANGES

1.1 Notice to MMCAP Infuse. The Vendor must provide justification for all price increases. In the event the Vendor does not notify MMCAP Infuse of a price increase, the Vendor must honor the most recent previous Contract Price until such time as MMCAP Infuse receives notice of and approves the price increase.

1.2 Notices. All notices under this Article must be sent to: MMCAP_Infuse.Contracts@state.mn.us.

1.3 Pricing for Services. Pricing for Services are listed on Attachment A. The Vendor must maintain the same Pricing for Services, as listed in the initial Attachment A, with the exception of price reductions, for at least two (2) years from the Effective Date of the Agreement. The Vendor must provide justification for all requests for price increases.

A. Price Reductions. After the Effective Date, the Vendor may submit notices of price reductions to MMCAP Infuse. These price reductions will only take effect once but must notify MMCAP Infuse before they can take effect.

B. Price Increases in the First (2) Years: During the first two (2) years of the Agreement, price increase requests will only be approved if the following conditions are met: (i) at least sixty (60) days’ written notice; (ii) a force majeure condition, as denoted in Section 4.4, can be established; and (iii) the price increase request is approved by MMCAP Infuse.

C. Price Increases After the First Two (2) Years: Subsequent yearly price increases must be communicated by the Vendor to MMCAP Infuse with at least sixty (60) days’ written notice. Once Pricing is increased, the Vendor must wait one (1) year to increase Pricing. Any proposed increase cannot exceed two percent (2%) of the then-current Pricing.

Except as provided for in this Agreement, no fee, percentage, or other cost may be added to the Services purchased under this Agreement unless the fee, percentage, or cost is defined and approved in writing by MMCAP Infuse

1.4 Competitive Pricing for Services. If MMCAP Infuse determines or is informed that, during the Agreement Term, the Vendor is offering better Pricing and/or Services to another group purchasing organization or Government Unit, the Vendor will have ten (10) days to work with MMCAP Infuse to amend this Agreement to provide MMCAP Infuse the same Pricing and/or Services.

1.5 Member Fees. In the event a Member’s purchase of Services requires a fee, assessment, and/or additional costs above and beyond the Pricing in Attachment A, the Vendor must not absorb or pay those fees, assessments, and/or additional costs. Instead, the Vendor must add them to the Pricing and/or as an adjustment to the discounts provided to the applicable Member. The fees will be set aside and paid to the Member as detailed in a form provided and approved by MMCAP Infuse.

1.6 Value-Added Programs. Members must be offered any programs normally offered to the Vendor’s general customer base (e.g., rebates, tiered pricing, continuing education courses, marketing information, etc.) at the same or lower cost as that offered to the general customer base (Attachment B).

ARTICLE II

SERVICES AVAILABILITY

2.1 Scope of Services. The scope of the Services being provided to MMCAP Infuse and Membership are outlined on Attachment C.

2.2 Failure or Inability to Provide Services. If the Vendor either fails to or cannot provide the Services to a Member as set forth in this Agreement, the Member may obtain the same or equivalent Service through an alternate MMCAP Infuse Vendor. If an MMCAP Infuse Vendor cannot provide the Member with the Services required, the Member may obtain the Services on the open market, including retail, for the period in which the Vendor is unable to provide the Services. The Vendor will reimburse the Member for any accrued additional costs (including third-party fees) over and above the Pricing within the Agreement including additional set up fees the Member was required to pay in order to attain alternative services, via a credit to the Member within thirty (30) days of the receipt of the claim by the Vendor.

ARTICLE III

PAYMENT, ORDERS, AND DELIVERY

3.1 Conditions of Payment. As a condition for purchasing under this Agreement, purchasers must be Members in good standing with MMCAP Infuse. All Services provided by the Vendor under this Agreement must be performed to the satisfaction of MMCAP Infuse and the Member receiving the Services, as well as in accordance with all applicable federal, state, and local laws, ordinances, rules, and regulations. The Vendor will not receive payment for work found by MMCAP Infuse or a Member to be unsatisfactory or performed in violation of federal, state, or local law.

3.2 Payment Method. The Vendor will accept Electronic Funds Transfer (EFT), credit cards, purchasing cards (P-Card), or checks as payment methods and the Member will initiate this process with its financial institution.

3.3 Federal Funds. Payments under this Agreement may be made from federal funds. The Vendor is responsible for compliance with all federal requirements imposed on the acceptance of these funds and accepts full financial responsibility for any requirements imposed on the Vendor due to the Vendor’s failure to comply with federal requirements.

3.4 Orders. The Vendor may provide their own Order Form(s) for Members to use to place Orders. To the extent that the terms of any Order Form(s) conflict with the terms of this Agreement, the terms of this Agreement supersede. The Vendor agrees to invoice Members as established in this Agreement. Each Member will be responsible for payment to the Vendor for Services. MMCAP Infuse will not be liable for any Member’s unpaid invoice.

A. A Member’s use of Order Form(s) to obtaining Services from the Vendor constitutes a binding contract. All Services furnished to the Member will be subject to inspection and acceptance by the Member after delivery. No substitutions or cancellations are permitted without written approval of the Member. Back orders, failure to meet delivery requirements, or failure to meet specifications in the Order Form and/or the Agreement authorizes the ordering entity to cancel the Order in its entirety, or any portion of it, purchase Services elsewhere, as well as charge the Vendor for the resulting increase in costs and/or the administrative handling to the Vendor.

B. A Member may utilize the Order Form to create Orders that are repeatedly filled or invoiced on a recurring basis (standing orders).

C. Orders can be placed via:

3.5 Termination of Individual Orders. A Member may terminate, immediately or as identified by a Member, individual orders placed via Order Forms, in whole or in part, upon written notice to the Vendor if any of the following events occur:

A. The Member fails to receive funding, appropriations, or faces limitations around other expenditure authority, which result in insufficient funding levels to pay for Services to be purchased via the Order Form;

B. Federal and/or state laws, regulations, and/or guidelines are modified or interpreted in such a way that either the purchase of the Services for which an Order Form was submitted are prohibited, or the Member is prohibited from paying for the Services from the planned funding source; or C. The Vendor commits any material breach of this Agreement or an Order Form.

Upon receipt of written notice of termination of an Order, the Vendor will stop performance under the Order Form as directed by the Member. If a standing Order is terminated, the Member must pay the Vendor in accordance with the terms of this Agreement, for goods and Services delivered and accepted by the Member, in advance of the Order’s termination.

3.6 Jurisdiction and Venue of Orders. Upon completion of the Dispute Resolution process outlined in this Agreement, and only with the prior written consent of both MMCAP Infuse and the State of Minnesota Attorney General’s Office, a Member may bring a claim, action, suit, or proceeding against the Vendor. The Member’s request to MMCAP Infuse for consent to bring the claim, action, suit, or proceeding must identify the desired jurisdiction, venue, and governing law. As it applies to purchases made by a Member, nothing in the Agreement will be construed to deprive the Member of its sovereign immunity, or of any legal requirements, prohibitions, protections, exclusions, and/or limitations of liability applying to this Agreement or afforded by the Member’s law.

3.7 Delivery for Services. Delivery for Services will be in accordance with Attachment C and any Order Form utilized by the Vendor for Members.

3.8 Invoicing. The Vendor will submit an invoice to a Member for each Order placed by the Member.

A. Invoice Fields: At a minimum, the Vendor’s invoice will contain the following fields:

i. The ordering Member’s name and the Vendor-assigned account number for the Member;

ii. An invoice line number and the Member’s Order number (the Member must provide an Order number at the time of an Order for this to appear on the Vendor’s invoice);

iii. The “bill to” and “ship to” address, as applicable;

iv. The invoice date;

v. The unit price, quantity ordered, quantity shipped, extension (the unit price multiplied by the quantity shipped), and the total invoice price; and

vi. All applicable omit codes (e.g., manufacturer backorder, manufacturer discontinued, etc.).

B. Invoice Rounding: The Vendor agrees to round invoice totals down if the third digit after the decimal is four (4) or less. The Vendor agrees that any rounding of the invoice amounts will occur at the Member invoice unit price.

C. Invoice Disputes: A Member will notify the Vendor of any known dispute with an invoice within fifteen (15) days from the receipt of the invoice. If all, or a portion, of the disputed invoice is found to be in error, the Vendor shall issue a credit and/or adjust the original, disputed invoice amount appropriately, and provide a corrected invoice to the Member. Where the above is prohibited by a Member state’s applicable law(s), the Vendor shall comply with that state’s law(s) related to disputed invoices. The Vendor will make a good faith effort to resolve known disputes related to Agreement Pricing within thirty (30) days of notice of the dispute. This clause will in no way be deemed a limitation on the parties, as it relates to the future auditing and/or correction of invoices.

i. In the event that applicable state law mandates set-off by a Member, such set-off rights shall be exercised only to the extent expressly set forth in the applicable statute.

3.9 Payment Terms. To be negotiated.

3.10 Credits and Rebills. The Vendor will process credits and rebills as notifications are received from a Member. In the case of an invoice dispute, the Vendor will promptly issue credits/rebills, following the Dispute Resolution process set forth in this Agreement has been completed.

A. Vendor credits are valid until they are refunded or the Member’s account has used the credits as payment.

B. In the event of a facility closure, or other extreme event where the Member will not be making another purchase through the Vendor, the Member may cash out its credit(s).

C. If directed by a Member, a credit can be transferred from one account to another account.

D. The Vendor will take all commercially reasonable steps to ensure that credits that become available close to the end of the Member’s fiscal year and are activated for use by the Member no later than five (5) days before the end of the fiscal year.

E. The Vendor’s credit memo will contain, but is not limited to, the following information:

i. The original Order number and invoice number;

ii. An itemized listing of the Services affected;

iii. Any new invoices associated with the credit; and

iv. The net credit amount available to the Member.

3.11 Price Audits and Corrections. In the event of a Pricing error that is attributable to the Vendor, the Vendor agrees to process credit/rebills for the past twenty-four (24) calendar months. When either a Member or MMCAP Infuse discovers an error in Pricing, they will notify the Vendor.

ARTICLE IV

TERMINATION, CANCELLATION, AND REMEDIES

4.1 Cancellation. MMCAP Infuse may cancel this Agreement any time, without cause, upon thirty (30) days’ written notice to the Vendor. MMCAP Infuse is not obligated to pay for any Services that are provided after notice and the effective date of termination. However, the Vendor will be entitled to payment, determined on a pro rata basis, by Members who received satisfactorily performed Services, to the extent that funds are available.

4.2 Termination for Cause. Either Party may terminate this Agreement, at any time, on the basis that the other Party has breached this Agreement. The moving Party must provide written notice to the other Party, upon receipt of which, the Party has thirty (30) days to cure the defects. At the thirty (30) days, if the breaching Party has not cured the defects, the moving Party may terminate this Agreement after ten (10) subsequent days. MMCAP Infuse is not obligated to pay for any Services that are provided after notice and the effective date of termination. However, the Vendor will be entitled to payment, determined on a pro rata basis, by Members who received satisfactorily performed Services, to the extent that funds are available.

4.3 Termination for Insufficient Funding. MMCAP Infuse may immediately terminate the administration of this Agreement if it does not obtain funding from the Minnesota Legislature, or other funding source; or if funding cannot be continued at a level sufficient to allow for the payment of the Services covered here. Notice of termination must be sent by written or electronic mail to the Vendor. MMCAP Infuse is not obligated to pay for any Services that are provided after notice and the effective date of termination. However, the Vendor will be entitled to payment, as determined on a pro rata basis, by Members who received satisfactorily performed Services, to the extent that funds are available.

Minnesota will not be assessed any costs, fees, or other charges if the Agreement is terminated because of a decision by the Minnesota State Legislature, or other funding source, not to appropriate funds. MMCAP Infuse must provide the Vendor with notice of the lack of funding within a reasonable time of MMCAP Infuse receiving that notice.

A. For Orders made by a Member, the Vendor agrees to the applicable statutory terms of the applicable Member if the Member fails to receive funding, or appropriations, limitations or other expenditure authority at levels enough to pay for the Services.

4.4 Force Majeure. Neither Party will be considered in default in the performance of its’ obligations under the Agreement to the extent that performance of any such obligations is prevented or delayed by acts of God, war, riot or other catastrophes beyond the reasonable control of the Party. Force majeure will not apply to the extent that the act or occurrence could have been reasonably foreseen and reasonable action could have been taken to prevent the delay or failure to perform. A Party claiming excuse of performance under this provision must provide the other Party with prompt, written notice of the failure to perform, take all commercially reasonable efforts to mitigate the damages caused to all Parties, as well as take all necessary steps to bring about performance as soon as practicable.

4.5 Breach. In the event of a breach of this Agreement, MMCAP Infuse and Members reserve the right to pursue any other remedy available by law. The Vendor may be removed from Minnesota’s vendor list; suspended; or debarred from receiving a future contract for failure to comply with terms and conditions of the Agreement.

4.6 Failure to Perform. Upon failure to perform the below in the time and manner as set forth in this Agreement, the following fees shall be paid by the Vendor to MMCAP Infuse:

A. Reports. In the event that any report and/or data provided by the Vendor, pursuant to the terms of this Agreement, is not received according to schedule, contains incorrect data, incomplete data, no data, reflects more than a minor defect, or causes harm to MMCAP Infuse’s ability to conduct business or its governmental purpose, the Vendor will pay the following to MMCAP Infuse: $500/day, until resolved.

B. Late Administrative Fee Payments: Any late payments to MMCAP Infuse, and therefore the State, will be addressed as provided for in statute.

C. Notices and Signatures. If the Vendor fails to provide notice or signature as provided for in this Agreement, the Vendor will pay the following to MMCAP Infuse: $200/day, until resolved.

D. Class of Trade: In connection with this Agreement, if without pre-approval by MMCAP Infuse, the Vendor denies pricing to any class of trade, the Vendor will pay MMCAP Infuse: $200/per violation.

E. Adding and Removing Members. Every time the Vendor fails to meet the timeline requirements to add or remove a Member’s eligibility to purchase Services per this Agreement, the Vendor will pay MMCAP Infuse: $1,500/per violation.

F. Application of Fees. The application of the fees noted above will not excuse the Vendor’s performance obligations as set forth in this Agreement, nor will it waive any rights of MMCAP Infuse or Members to seek any and all available legal and equitable remedies. The Vendor acknowledges that the fees set forth above are not penalties, but rather are intended to seek to make MMCAP Infuse and Members whole for any failure of performance by the Vendor, as based upon good faith estimates as agreed to by the Parties.

4.7 Dispute Resolution. The Vendor and MMCAP Infuse will handle dispute resolution for unresolved issues using the following procedure:

A. Notification. The Parties shall promptly notify each other of any known dispute and work in good faith to resolve such dispute within thirty (30) days.

B. Escalation. If the Parties are unable to resolve the issue in a timely manner, as specified above, either MMCAP Infuse or the Vendor may escalate the resolution of the issue to a higher level of management. When escalated, a teleconference will be scheduled between MMCAP Infuse and the Vendor to review the dispute and develop a proposed resolution and plan of action.

C. Performance During Pending Dispute. Notwithstanding the existence of a dispute, the Vendor must continue, without delay, to carry out all responsibilities under the Agreement that are not affected by the dispute. If the Vendor fails to do so, any additional costs incurred by MMCAP Infuse and/or Members, as a result of such failure shall be borne by the Vendor.

D. No Waiver. This clause shall in no way limit or waive either party’s right to seek available legal or equitable remedies.

ARTICLE V

MEMBERSHIP

5.1 Onboard, Transition, and Implementation. If the Vendor requires additional paperwork for Members to acquire Services from the Vendor, the Vendor will work with MMCAP Infuse and Members to determine the appropriate steps and schedule for an onboard and transition. The Vendor’s documents and/or procedure for implementing and transitioning Members to this Agreement is set forth on Attachment D.

5.2 Membership Listing. MMCAP Infuse will provide the Vendor with a complete listing of the Membership. MMCAP Infuse reserves the right to add and remove Members during the Agreement Term.

A. New Members. The Vendor must allow new Members to access the Agreement by the Onboarding Date. MMCAP Infuse will provide the Vendor with online access to its Membership list, which is updated daily.

B. Removing Members. The Vendor must provide MMCAP Infuse with written notification that a Member will be removed, at least thirty (30) days prior to removing any Member. If MMCAP Infuse does not receive notification that a Member has been removed from Pricing, the Vendor will honor Pricing for the Member for thirty (30) days after MMCAP Infuse receives the written notice as required.

5.3 Membership Eligibility. Upon request, Vendor will send an electronic eligibility list identifying which Members are eligible for contract pricing to: MMCAP_Infuse.Contracts@state.mn.us.

5.4 Member Attachment. The Vendor will ensure Members are attached to the Agreement for all Service purchases made by a Member. Upon request of MMCAP Infuse, the Vendor must verify only the Membership has access to the Contract Pricing and Services. A Vendors failure to do may result in immediate termination.

5.5 Non-Solicitation. During the term of this Agreement, the Vendor will not solicit any Members or prospective Members to enter into or negotiate a separate contract or agreement for the same or substantially equivalent products and services as those offered in this Agreement, without MMCAP Infuse’s prior written consent. The Vendor is not prohibited from responding to a request for proposals issued by a Member that may include Services covered by this Agreement.

5.6 Member-Requested Participating Addendum (MPA). In order to use this Agreement, some Members will require jurisdiction-specific paperwork or contract language to establish a statewide contract for Members. The Vendor may be required to review an MMCAP Infuse MPA, as an addendum to this Agreement, to account for laws specific to a state or local jurisdiction. If these circumstances exist, the Vendor will work with MMCAP Infuse and the applicable Members to prepare an MPA to set forth the additional or altered terms and conditions. An MPA must clearly apply only to the requesting Member(s) and will not affect the rights of MMCAP Infuse, other States and/or its Members, nor will it modify, derogate, or otherwise diminish the rights and obligations set forth herein, except with regards to the applicable, named Member(s). When the specific terms are agreeable to the Vendor and the Member(s), the MPA will be presented by MMCAP Infuse to each Party for execution. No other mechanism of modifying or “attaching” terms to the Agreement is authorized. While Vendor is not required to agree to any additional terms, by not agreeing to the MPA, the Vendor may be precluded from doing business with that State/Member. No verbal or written instructions from States/Members to change any provision of this Agreement will be accepted by the Vendor without the prior approval of MMCAP Infuse.

ARTICLE VI

AGREEMENT MANAGEMENT

6.1 Primary Account Representative. The Vendor will assign a Primary Account Representative to MMCAP Infuse for this Agreement and must provide a minimum of seventy-two (72) hours notice to MMCAP Infuse if that person is reassigned. In the event that the Primary Account Representative is unresponsive or does not meet MMCAP Infuse’s needs, the Vendor will assign another Primary Account Representative upon MMCAP Infuse’s request. The Primary Account Representative will be responsible for:

A. Proper maintenance and management of the Agreement, including timely execution of all amendments.

B. Timely response to all MMCAP Infuse inquiries.

C. Performance of the business review as described in Paragraph 6.2.

D. Personnel Changes. Vendor will provide MMCAP Infuse with written advance notice of changes to the Primary Account Representative. In the event that an employee is removed pursuant to a written request from MMCAP Infuse, the Vendor will have ten (10) business days in which to fill the role with an acceptable employee.

6.2 Business Reviews. The Vendor will participate in at least one business review with MMCAP Infuse annually. The review will be at a time and location that is mutually agreeable to both the Vendor and MMCAP Infuse and, at a minimum address: a review of sales to Members, Pricing and Agreement Terms, Administrative Fees and reporting, industry updates, customer issues, and any other necessary information, as determined by MMCAP Infuse.

6.3

ARTICLE VII

WARRANTS, COVENANTS, AND DUTIES OF VENDOR

7.1 Covenant of Laws. The Vendor shall comply with all state and federal laws, as applicable to each Member, in the performance of this Agreement.

7.2 Required Licenses, Permits, and Registration. The Vendor shall have in place prior to the start of the Agreement, and must maintain for the life of the Agreement, all current licenses, permits and registrations required by state and federal agencies, specifically those required under the DSCSA. Vendor must make such documentation available upon request by MMCAP Infuse.

7.3 Debarment. The Vendor warrants and certifies that neither it nor its principals are presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from programs operated by the State of Minnesota, the United States federal government, or any Member; and that neither it nor any of its principals have been convicted of a criminal offense related to the subject of this Agreement. The Vendor further warrants that it will provide immediate written notice to MMCAP Infuse if at any time it learns that this certification was erroneous when submitted or becomes erroneous by reason of changed circumstances.

A. Certification regarding debarment, suspension, ineligibility, and voluntary exclusion: Federal money may potentially be used to pay for all or part of the work under the Agreement, therefore the Vendor certifies that it is in compliance with federal requirements on debarment, suspension, ineligibility and voluntary exclusion specified in the solicitation document implementing Executive Order 12549.

7.4 Indemnification. Pursuant to the Minnesota Constitution Article XI Section 1, MMCAP Infuse cannot indemnify the Vendor. Except for causes due to MMCAP Infuse’s or Members’ sole negligence, the Vendor will defend and hold harmless MMCAP Infuse, including MMCAP Infuse’s Members, agents, directors, employees, attorneys, and other representatives during and after this Agreement from and against all actual and potential claims relating to loss, liability, damage, costs and expenses (including attorneys’ fees and legal costs), causes of action, regulatory proceedings, suits, demands, or judgements relating to the Vendor’s:

A. Intentional, willful, or negligent acts or omissions;

B. Fraud and or deceit;

C. Actions that give rise to strict liability;

D. Breach of contract;

E. Breach of warranty;

F. Violations of federal, state, or local laws, orders, and/or policies;

G. Employees or subcontractors’ criminal and civil claims; and/or H. Failure to pay fees, charges, expenses, taxes, or other debts to third parties.

7.5 Antitrust. The Vendor hereby assigns to the State of Minnesota any and all claims for overcharges as to Services provided in connection with this Agreement resulting from antitrust violations that arise under the antitrust laws of the United States and the antitrust laws of the State of Minnesota, and/or the antitrust laws of any Member unless otherwise assigned directly to that Member by Vendor with MMCAP Infuse’s approval.

7.6 Business Interruption Plan. The Vendor must have an emergency preparedness and business interruption plan, which the Vendor will provide to MMCAP Infuse upon request. The Vendor’s emergency preparedness and business interruption plan must specify how the Vendor will ensure continued Services to Members during a regional/national disaster or other unforeseen circumstances. The plan must include, but is not limited to, the following:

A. Emergency customer support and centralized command and control centers;

B. Procedures for Members contacting Vendor employees;

C. Specifics as to how it will work with its Trading Partners and suppliers; and D. Specifics as to how it would work with government agencies and industry trade associations.

ARTICLE VIII

ADMINISTRATIVE FEE AND REPORTING

8.1 Administrative Fee. In consideration for the administrative support and other services provided by MMCAP Infuse in connection to this Agreement, the Vendor agrees to pay an Administrative Fee on all purchases of Services made by Members regardless as to the means by which a purchase of Services was made by a Member.

A. The Vendor must provide Administrative Fee data to MMCAP Infuse within ten (10) business days after the end of each calendar month. The Administrative Fee must be paid as soon as is reasonable after the end of each calendar month, but no later than thirty (30) calendar days after the end of the calendar month. The Vendor will submit a check payable to:

Financial Management & Reporting – MMCAP Infuse 50 Sherburne Avenue, Suite 309 St. Paul, MN 55155

B. The Vendor shall not be required to pay the Administrative Fees on tax amounts or services for which Vendor did not collect payment.

8.2 Reporting. The Vendor must submit a monthly (1) administrative fee data report and (2) sales data report that includes both direct (sales made direct from Vendor to Member) and indirect purchases (sales made through an Authorized Wholesaler). The monthly administrative fee data report must contain the fields detailed below and the sales data report requirements can be found on Attachment E. Vendor agrees that for indirect sales, sales data received from Authorized Wholesalers will be utilized to create the administration fee data report and if additional reports are needed to support creation of the administration fee data report, Vendor agrees to bear the cost of any special reporting that may be required by the Vendor in its relationship with the Authorized Wholesalers. All administrative fee data reports must be sent to: mmcap.infuse@state.mn.us at the end of each month, but no later than thirty (30) days after the end of the month. The Vendor will provide a dedicated person.

A. Administrative Fee Data Report fields:

i. MMCAP Infuse Assigned Authorized Wholesaler Number (As applicable)

ii. MMCAP Infuse Assigned Vendor Number

iii. Direct or Indirect Purchase Indicator (I=Indirect, D=Direct)

iv. Invoice Date (Point of Sale Date)

v. Invoice Number

vi. MMCAP Infuse Member

vii. Vendor’s Account Number for the MMCAP Infuse Member

viii. MMCAP Infuse Member DEA Number, if applicable

ix. MMCAP Infuse Member HIN Number, if applicable

x. MMCAP Infuse Member Address

xi. MMCAP Infuse Member City

xii. MMCAP Infuse Member State

xiii. Product’s NDC (Use all 11 digits (00076888888))

xiv. Product Name (e.g. Acetaminophen with Codeine, Acticin Cream 5%)

xv. Credit Indicator (C = credit)

xvi. Contracted Units (The number of units purchased on contract.)

xvii. MMCAP Infuse Contracted Unit Price

xviii. Administrative Fee Decimal Percentage (The contracted administrative fee percentage for the NDC number. Report as a decimal (e.g. 0.030))

xix. Vendor Contracted Sales (Contracted Units * Contracted Unit Price. Report in dollars) Administrative Fee Payment Amount (Administrative Fee Decimal Percentage * Vendor Contracted Sales. Report in dollars) B. Sales Data Usage Reports: Vendor will supply to MMCAP Infuse monthly sales data on or before the tenth (10th) day of the subsequent calendar month. The report must include Contracted Service dollar spend amount sorted in descending order and grouped by the Contracted Service category. Also, the report MUST include the information set forth on Attachment E.

ARTICLE IX

INTELLECTUAL PROPERTY

9.1 MMCAP Infuse Ownership. MMCAP Infuse owns all rights, title, and interest in MMCAP Infuse Member data, sales Transaction data, DEA/HIN information (subject to third-party rights), contract pricing, EDI Transaction data, reverse distribution data, and payment data, including copyrights and trade secrets contained therein. MMCAP Infuse grants to the Vendor an unlimited, non-revocable, nontransferable, fully paid license, for the term of this Agreement, to: (A) release state-specific data to a Member’s primary contact; (B) release any of the above data to product Manufacturers, when necessary for the performance of this Agreement or as required by the Vendor’s agreements with such product Manufacturers; (C) to release any of the above data to other MMCAP Infuse approved third parties, when necessary for the performance of this Agreement; (D) to provide Member purchase data to aggregators, including IMS and NDC Health, subject to the Vendor’s reasonable efforts to require such data aggregators to protect any identifiable data from discovery by another third party; and (E) to provide Member purchase data to other group purchasing organizations of which the Member is also a member, provided such data will not include MMCAP Infuse-identifiable data. Any MMCAP Infuse identifiable data provided hereunder to a third party must identify the data as MMCAP Infuse data and subject to Minnesota Statutes, Chapter 13. To the extent permitted by law, the Vendor hereby agrees that in the event that MMCAP Infuse or a Member request in writing that its purchase data be kept confidential, such data will not be provided to third party aggregators.

9.2 Vendor Ownership. The Vendor owns all rights, title, and interest to any aggregated data not identifiable as arising from this Agreement and any other intellectual property created for or presented to MMCAP Infuse. The Vendor grants to MMCAP Infuse an unlimited, non-revocable, non-transferable, fully paid, perpetual license, to use all intellectual property created for or presented to MMCAP Infuse under this Agreement.

9.3 Pre-Existing Intellectual Property. MMCAP Infuse and the Vendor will each retain ownership of, and all right and, title and interest in and to, their respective pre-existing intellectual property. The Vendor grants Minnesota a perpetual, irrevocable, non-exclusive, royalty free license for the Vendor’s pre-existing intellectual property that are incorporated in the products, materials, equipment, deliverables, or Services that are purchased through the Agreement. The aforementioned license is solely for use by Members, and their agents related to internal business or governmental purposes.

9.4 Vendor Obligations. The Vendor must perform all acts and take all steps necessary to ensure that all intellectual property rights created for MMCAP Infuse or Member are the sole property of MMCAP Infuse or Member, and that neither the Vendor nor its employees, agents, or subcontractors retain any interest in and to the works and documents. The Vendor represents and warrants that the works and documents do not and will not infringe upon any intellectual property rights of other persons or entities.

9.5 Intellectual Property Indemnification. The Vendor will indemnify; defend, to the extent permitted by the Attorney General; and hold harmless MMCAP Infuse, at the Vendor’s expense, from any action or claim brought against MMCAP Infuse to the extent that it is based on a claim of an infringement upon the intellectual property rights of others.