Exhibit A - Sample Agreement Terms and Conditions.docx
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- Solicitation number
- S-10700-00005546
- Issued by
- Oregon
About this file
This document is an exhibit containing the terms and conditions for an agreement between the Minnesota Department of Administration Office of State Procurement (MMCAP Infuse) and a vendor. The agreement covers the provision of pharmaceutical and over-the-counter (OTC) products to MMCAP Infuse's membership, which includes approved states, government units, and other entities that have executed a membership agreement. The agreement term is from the effective date to the expiration date, with the potential for extension upon mutual agreement.
The agreement outlines pricing structures, including fixed pricing, non-fixed pricing, and wholesale acquisition cost (WAC) minus pricing. It also covers requirements for product availability, recalls, backorders, failure to supply, and administrative fee reporting. The agreement includes provisions for termination, dispute resolution, membership onboarding, and vendor compliance with applicable laws and regulations. Vendors must maintain appropriate licenses, permits, and registrations, and comply with good manufacturing practices.
View the file
Other files
| File | Type | Posted |
|---|---|---|
| Studio Carts.pdf | ||
| MMCAP Infuse RFP Submission Instructions_Pharma_and_OTC.pdf | ||
| 2023 Rx OTC Addendum 1.pdf | ||
| 32145_MMCAPInfusePharmaceuticalandOTCProd. - 2023 ePro.pdf | ||
| Exhibit C.xlsx | XLSX spreadsheet |
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Text version
MMSXXX
Vendor
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 Legal Name] MMCAP Infuse Agreement: MMSXXXX Prepared on Month Date, Year
PREFIX A
Definitions and Acronyms Are attached and incorporated into the Agreement
Definitions
1. Administrative Fee: Means three percent (3%) of Contract Pricing for Products or as listed on Attachment A, which will supersede Prefix A.
2. Agreement: Means the resulting agreement that is reached between MMCAP Infuse and the Vendor.
3. Authorized Wholesaler(s): Cardinal Health, Inc., AmerisourceBergen Drug Corporation, and Morris & Dickson Corp, LLC.
4. Class of Trade: All Members are eligible for Contract Pricing.
5. Contract Pricing: Means the price that the Vendor has agreed to provide the Products to MMCAP Infuse and its Membership as set forth on Attachment A and any subsequent amendment to this Agreement.
A. Fixed Pricing: Means Vendor cannot increase the Contract Pricing for the Products identified on Attachment A or any subsequent amendment to this Agreement during the Agreement Term.
B. Non-Fixed Pricing: Means all Products identified as such on Attachment A or any subsequent amendment to this Agreement.
C. Wholesale Acquisition Cost (WAC) Minus - a percentage or dollar amount off WAC that changes by providing MMCAP Infuse prior written notice of the price change along with the new WAC and contract price.
6. Days: (Not required to be capitalized) Unless otherwise specified in this Agreement, all references to days will be calendar days.
7. Failure to Supply (FTS): Means when the Vendor could not fulfill a combined direct and/or wholesaler purchase volume of one hundred fifty percent (150%) of the Members’ previous quarter’s volume.
8. Government Unit: Any entity as defined by Minnesota Statute 471.59.
9. Member: Means an approved MMCAP Infuse State or other Government Unit that has executed a membership application and Member agreement with MMCAP Infuse.
10. Membership: Means the joint power cooperative comprised of MMCAP Infuse authorized States, Members, and other Government Units.
11. 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 C.
12. Products: Means all products offered by the Vendor in this Agreement, which are identified in Attachment A.
13. State: Means one of the recognized fifty (50) states of the United States of America.
AGREEMENT FOR MMCAP INFUSE NO. XXXXXXX
THIS Agreement is entered into as of the Effective Date by and between the State of Minnesota 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”).
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: Products and Pricing
3. Attachment B: Further Discounts (if applicable)
4. Attachment C: Required Member Onboarding Forms (if applicable)
5. Attachment D: MN Statutory Language
ARTICLE I
PRICING AND CHANGES
1.1 Notices. All notices under this Article must be sent to: MMCAP_Infuse.Contracts@state.mn.us.
1.2 Pricing Structure: Pricing for Products are listed on Attachment A and will remain in effect during the Agreement Term.
1.3 Fixed Pricing. Vendor must hold pricing firm for at least one (1) year from the Effective Date. Each time the Contract Pricing is changed, the Vendor must wait one (1) year from the change date to amend any pricing again.
A. Price Reductions. After the Effective Date, Vendor may submit to MMCAP Infuse price reductions but must notify MMCAP Infuse before they can take effect.
B. Price Increases. Price increases will only be accepted with (i) at least thirty (30) days’ written notice; (ii) a force majeure condition can be established; (iii) and is approved by MMCAP Infuse. Except as provided for in this Agreement, no fee, percentage, or other cost may be added to the products purchased under this Agreement unless the fee, percentage, or cost is defined and approved in writing by MMCAP Infuse.
1.4 Non-Fixed Pricing. All Non-Fixed Pricing requires notice of increases be submitted to MMCAP Infuse at least thirty (30) / sixty (60)/ ninety (90) days before the requested increases may take effect. Vendor cannot increase prices until one hundred twenty (120) calendar days after the Effective Date of the Agreement. In the event of any price reductions, Vendor will advise MMCAP Infuse as set forth on Paragraph 1.3(A).
1.5 Wholesale Acquisition Cost (WAC) Minus Percentage or Dollar Pricing. If specifically noted on Attachment A that the prices are a percentage or price off WAC, the price may be changed by providing MMCAP Infuse at least five (5) business days’ prior written notice of the price change along with the new WAC and pricing. Notices of WAC increases must be sent to MMCAP Infuse. In the event Vendor does not notify MMCAP Infuse of a WAC increase, Vendor must honor wholesalers’ chargebacks for the most recent previous pricing until such time as MMCAP Infuse receives notice of the WAC increase.
1.6 Notice to MMCAP Infuse: Vendor must provide justification for all price increases. In the event Vendor does not notify MMCAP Infuse of a price increase, Vendor must honor wholesalers’ chargebacks for the most recent previous Contract Price until such time as MMCAP Infuse receives notice of and approves the price increase.
1.7 Notice to Authorized Wholesalers. The Vendor must notify any and all Authorized Wholesalers of price changes. If Vendor fails to send price notification(s), Vendor agrees to honor all chargebacks at the lower Contract Pricing until such time the Authorized Wholesalers receive notice of and approves the price change. Vendor must confirm with MMCAP Infuse that price changes have been sent to the Authorized Wholesalers.
1.8 Competitive Pricing. If MMCAP Infuse is made aware and determines during the Agreement Term Vendor is offering better Contract Pricing and/or Products to another group purchasing organization or Government Unit, Vendor will have ten (10) days to work with MMCAP Infuse to amend this Agreement to provide MMCAP Infuse the same Contract Pricing and/or Products.
1.9 Vendor’s Right of First Refusal on Equivalent Products. If an equivalent product’s market price is less than the Contract Pricing, MMCAP Infuse will provide five (5) days to the Vendor to match the price. If the Vendor does not match the price or fails to respond, MMCAP Infuse reserves the right to dual award or re-award the Product(s).
A. In the event Vendor increases the Contract Pricing, MMCAP Infuse reserves the right to obtain quotes from other vendors and to dual or re-award a Product to the vendor offering the best value.
B. For Vendor to receive right of first refusal on a post one hundred eighty (180) day new generic, the new generic must be a Product on this Agreement at least one-hundred fifty (150) consecutive days before the expiration of the one-hundred eighty (180) day exclusivity period; failure to do so waives Vendor’s right of first refusal.
C. If Vendor submits an offer for a Product currently awarded to another vendor, each vendor will be permitted one best and final offer. If a Product is challenged by another vendor, each vendor will be provided one best and final offer.
1.10 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.
1.11 Product Dating. All Products supplied to Authorized Wholesalers must have an expiration date of at least one (1) year from the date of manufacture and have a least a six (6) month shelf life from the date of acceptance of the Product by the Authorized Wholesaler.
1.12 Annual Bid Cycle. Vendor will be required to submit Contract Pricing on an annual basis. Products may be awarded to other contract holders during this annual cycle. In the event Vendor loses all Products on its contract during an annual cycle, it will not lose its Vendor status with MMCAP Infuse and is eligible to resubmit products and pricing during the next annual cycle. MMCAP Infuse reserves the right to open its RFP process to new suppliers during the annual cycle.
A. Bid Roll. Vendor must report its Products to the Authorized Wholesalers no later than forty-five (45) days prior to the start of the next annual cycle. Changes to the Contract will be managed per Paragraph 1.13.
B. No Contract Pricing increases can become effective until one hundred twenty (120) calendar days after the effective date of the awards resulting from the annual bid cycle.
1.13 Changes. Any changes to this Agreement, including but not limited to product additions/deletions, price changes, NDC changes, changes to terms and conditions, etc., must be made in writing as an amendment and must be fully executed by the effective date of the amendment. With the exception of changes to Contract Pricing which are subject to Paragraph 1.7, Vendor must send confirmation of amendment changes, including but not limited to additions/deletions, NDC changes, Product removals, etc., to the Authorized Wholesalers within two (2) business days of the time that documentation of the change is received by the Vendor from MMCAP Infuse. If MMCAP Infuse’s Authorized Wholesalers do not receive the notification(s), Vendor agrees to honor all chargebacks at the Contract Pricing from the effective date indicated on the amendment. Vendor-generated Product offers and notifications may be used as amendments to Attachment A by submitting to MMCAP Infuse a letter on Vendor’s letterhead with the following elements (Offer Letter):
A. Offer Date B. MMCAP Infuse Contract Number C. Action (e.g., addition, deletion, price change, NDC conversion) D. NDC Number E. Product Description F. Packaging G. Most recent previous Contract Price H. New Contract Price I. Pricing Type J. Effective Date K. Signature of an individual authorized to bind Vendor’s change to contract.
Upon written acceptance by MMCAP Infuse, Offer Letter will automatically amend Attachment A of this Agreement. If MMCAP Infuse indicates that aspects of the Offer Letter conflict with Agreement at that time, Paragraph 10.5 will apply to any subsequent conflicts and/or issues that may arise subsequently. If MMCAP Infuse executes the Offer Letter and provides counters, the Vendor has fifteen (15) days to object to MMCAP Infuse’s counters before they are deemed as accepted by Vendor. In the event the Vendor is unwilling or unable to provide offers in this format, MMCAP Infuse will draft all amendments. Vendor must countersign the amendments drafted by MMCAP Infuse to be incorporated into the Agreement. Amendments must be countersigned by the Vendor by the earlier of the following (A): fifteen (15) days; or (B) the Expiration Date.
ARTICLE II
SUPPLYING AND AVAILABILITY
2.1 Authorized Wholesaler Requirements. Vendor will notify the Authorized Wholesalers of the initial Products and Contract Pricing and any subsequent changes.
A. All sales of Products to Members must be through the Authorized Wholesalers unless previously authorized in writing by MMCAP Infuse. Direct sales to Members without written authority may result in immediate termination of this Agreement at the sole discretion of MMCAP Infuse.
B. Vendor must establish and maintain chargeback agreement(s) with the Authorized Wholesalers.
C. Vendor must notify MMCAP Infuse immediately of any issues (e.g., failure to negotiate terms, etc.) with Authorized Wholesalers that could affect the Contract Products’ availability. Notices must be sent to: MMCAP_Infuse.Contracts@state.mn.us.
2.2 Dual/Multi Award. MMCAP Infuse reserves the right to dual or multi award Products based on the following: family awards, product formulations, (e.g., alcohol free/sugar free, flavor, product, size), packaging type based on facility need (e.g., non-metal tubes for correctional facilities, etc.), drugs not carried by Authorized Wholesalers, drugs not eligible for reimbursement by Medicaid, look-alike/sound-alike products, products with tall-man lettering, products with unit-of-use barcoding, unit dose products, products that do not have an NDC listed in First DataBank Inc., specific products requested by Members, recall situations, product availability and shortages, quality concerns, failure to supply situations, and in situations that are in the best interest of MMCAP Infuse and its Members.
2.3 First DataBank, Inc. All prescription Products must have an 11-digit NDC code that is registered with First DataBank, Inc., unless such designation is expressly waived by MMCAP Infuse.
A. If NDC codes are not applicable (e.g., OTC products), Vendor must use the product’s UPC number to create an 11-digit number by adding a zero to the sixth position (e.g., 5-5 [99999-99999] becomes 5-4-2 [99999-0999-99]). If the Product does not have an NDC number or a UPC code, Vendor must use its product number with leading zeroes (e.g., product #90024 = 00000-0900-24).
B. Vendor must report Products to Authorized Wholesalers using only these approved formats.
2.4 Product Removal or Discontinuation. With the exception of a recall, if the Vendor assigns, discontinues, or removes a Product during the Agreement, Vendor must provide written notice to MMCAP Infuse and Authorized Wholesaler at least sixty (60) days prior. If the Vendor removes a Product, Vendor will honor Contract Pricing until the Authorized Wholesalers’ inventories are depleted or a mutually agreed upon removal date. If inventory is depleted prior to the end of the sixty (60) day period, Paragraph 2.9 will apply; removal of Products on backorder or shortage will be subject to Paragraph 2.9.
2.5 Price Audits and Corrections. In the event of a Contract Pricing error that is attributable to the Vendor, Vendor agrees to accept credit/rebills for the past twelve (12) calendar months. When MMCAP Infuse discovers an error in pricing, it will notify Vendor.
2.6 Product Recalls. Vendor will supply a copy of its returned goods/credit policy to MMCAP Infuse and/or Authorized Wholesalers upon request.
2.7 Returned Goods/Credits. The Vendor will supply a copy of its returned goods/credit policy to MMCAP Infuse and/or Authorized Wholesalers upon request.
2.8 Backorders. Vendor must provide written notice of all Product backorders expected to last longer than thirty (30) calendar days and/or inability to supply situations to MMCAP Infuse within twenty-four (24) hours of the knowledge of the situation. Notices must include the reason(s) for and the expected duration of the issue. Notices must be sent to: MMCAP_Infuse.Contracts@state.mn.us.
2.9 Failure to Supply (FTS). It is the responsibility of the Vendor to maintain sufficient inventory levels for all Products to meet the foreseeable needs of the Members. Provided Vendor was responsible for the FTS as opposed to an Authorized Wholesaler or force majeure, the Vendor agrees to utilize the following process in the event of a FTS:
A. Member may purchase an alternate equivalent generic product on the open market for the period in which the Vendor is unable to provide the Product. If the cost for the alternative is higher, the Vendor will be liable for any excess cost over the Contract Pricing.
B. Reimbursement: Members will submit the following information to the Vendor for each Product that reimbursement is expected:
i. Name, Address, City, State, and Zip
ii. DEA or HIN
iii. Point of contact for reimbursement (including telephone number and e-mail address)
iv. Product NDC number, description
v. MMCAP Infuse Contract Price
vi. Authorized Wholesaler Name, Address, City, State, Zip
vii. Authorized Wholesaler account number
viii. Authorized Wholesaler distribution service fee
ix. Alternate NDC
x. Alternate NDC manufacturer
xi. Alternate NDC purchase price
xii. Alternate NDC quantity purchased
xiii. Alternate NDC date purchased
xiv. Amount due
xv. Reason (e.g., brief description, such as Manufacturer Backorder)
xvi. A copy of the invoice showing the purchase of an equivalent generic product from the alternate source.
C. Vendor must pay claims directly to the Authorized Wholesaler within thirty (30) days of receipt of a claim as described above. A detailed payment of claim report must be provided with payment to the Member.
D. Vendor will not be liable for FTS if Vendor can prove that its inability to supply any Product was not due to its acts or omissions. Vendor must provide written documentation to MMCAP Infuse, demonstrating there were adequate stock levels at Vendor’s warehouse, Authorized Wholesaler order patterns that show inconsistency, and Authorized Wholesaler order information that includes order date and ship date, for the relevant time period.
E. Vendor will be responsible for payment of FTS claims for one hundred eighty (180) calendar days unless the Vendor has provided MMCAP Infuse with at least one hundred eighty (180) calendar days’ advanced written notice of the intent to remove said Product(s) from production and discontinue distribution in the U.S. market. Vendor will remain responsible for all FTS claims during the notice period.
F. In the event MMCAP Infuse chooses to process FTS claims on behalf of the Member, Vendor will receive thirty (30) days’ advanced written notice. Vendor agrees to accept electronic claims from MMCAP Infuse, any MMCAP Infuse contracted FTS claims system vendor, and/or the Member. All FTS payments made to MMCAP Infuse must be separate from Administrative Fee payments and must be clearly identified as such.
ARTICLE III
TERMINATION, CANCELLATION, AND REMEDIES
3.1 Cancellation. MMCAP Infuse may cancel this Agreement any time, without cause, upon thirty (30) days’ written notice to the Vendor.
3.2 Termination for Cause. Either party may terminate this Agreement at any time on the basis the other party breached this Agreement. The moving party must provide written notice to the other party, which upon, the receiving party has thirty (30) days to cure the defects. Upon thirty (30) days, the breaching party has not cured the defects, the moving party may terminate this Agreement after ten (10) subsequent days.
3.3 Termination for Insufficient Funding. MMCAP Infuse may immediately terminate 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 Products covered here. Termination must be by written or electronic mail notice to the Vendor. MMCAP Infuse is not obligated to pay for any Products that are provided after notice and effective date of termination. However, the vendor will be entitled to payment, determined on a pro rata basis, for Products satisfactorily performed 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 the decision of the Minnesota Legislature, or other funding source, not to appropriate funds. MMCAP Infuse must provide the Vendor notice of the lack of funding within a reasonable time of MMCAP Infuse receiving that notice.
A. For orders made by a Member, 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 Products.
3.4 Force Majeure. Parties will not be considered in default in the performance of its obligations in 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 a 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 prompt written notice of the failure to perform, take commercially reasonable efforts to mitigate the damages caused to all parties, and take all necessary steps to bring about performance as soon as practicable.
3.5 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. Vendors may be removed from the Minnesota’s vendors list; suspended; or debarred from receiving a contract for failure to comply with terms and conditions of the Agreement.
3.6 Failure to Perform. Upon failure to perform the following items in the time and manner as set forth herein, the following fees shall be paid by Vendor:
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, or no data, or is more than a minor defect or causes harm to MMCAP Infuse’s ability to conduct business or its governmental purpose, Vendor will pay the following to MMCAP Infuse: $500/day, until resolved.
B. Late Administrative Fee Payments: As provided for in statute for late payments to the State of Minnesota.
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 the Vendor denies pricing to any class of trade that has not been pre-approved by MMCAP Infuse, Vendor will pay MMCAP Infuse $200/per violation.
E. Adding and Removing Members. Every time the Vendor fails to meet the timeline requirements in this Agreement to add or remove a Member’s eligibility to purchase Products, Vendor will pay MMCAP Infuse $1,500/per violation.
F. Application of Fees. The application of the amounts herein shall not excuse 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. Vendor acknowledges that the fees set forth above are not penalties, but rather 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.
3.7 Dispute Resolution. Vendor and MMCAP Infuse will handle dispute resolution for unresolved issues using the following procedure.
A. Notification. 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 parties are unable to resolve the issue in a timely manner, as specified above, either MMCAP Infuse or 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 while Dispute is Pending. Notwithstanding the existence of a dispute, the Vendor must continue without delay to carry out all of their responsibilities under the Agreement that are not affected by the dispute. If the Vendor fails to continue without delay to perform its responsibilities under the Agreement, in the accomplishment of all undisputed work, any additional costs incurred by MMCAP Infuse and/or Members as a result of such failure to proceed 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 IV
MEMBERSHIP
4.1 Onboard, Transition, and Implementation. If the Vendor requires additional paperwork for Members to acquire the Products, Vendor will work with MMCAP Infuse and Members to determine the appropriate steps and schedule for an onboard and transition. Vendor’s documents and/or procedure for implementing and transitioning Members to this Agreement is set forth on Attachment C.
4.2 Membership Listing. MMCAP Infuse will provide Vendor 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 Vendor with online access to its Membership list, which is updated daily. MMCAP Infuse will send Vendor a monthly e-mail with instructions on how to obtain the Membership list.
B. Removing Members. Vendor must provide MMCAP Infuse written notification at least thirty (30) days prior to removing any Member. If MMCAP Infuse does not receive notification that a Member has been removed from Contract Pricing, Vendor will honor Contract Pricing for the Member for thirty (30) days after MMCAP Infuse receives the written notice.
4.3 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.
A. If the Vendor has eligibility requirements, Vendor must provide MMCAP Infuse access to Vendor’s online contract and eligibility management system in addition to providing MMCAP Infuse the algorithm it uses to categorize a Member’s class of trade.
4.4 Non-Solicitation. During the term of this Agreement, 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 offered in this Agreement without MMCAP Infuse’s prior written consent. Vendor is not prohibited from responding to a request for proposals issued by a Member that may include Products and services covered by this Agreement.
4.5 DEA License/HIN. Unless the Member purchases a controlled substance, the Vendor may not require that a Member have a Drug Enforcement Administration number assigned to it in order to be eligible for Contract Pricing. The Vendor may require a Health Industry Number from Member.
4.6 Product Use. All items acquired by Members under this Agreement are purchased for consumption in traditional governmental functions and not for the purpose of competing against private enterprise.
ARTICLE V
AGREEMENT MANAGEMENT
5.1 Primary Account Representative. Vendor will assign a primary account representative to MMCAP Infuse for this Agreement and must provide a minimum of seventy-two (72) hours advanced 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 5.2.
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.
5.2 Business Reviews. Vendor will perform at least one business review with MMCAP Infuse annually. The review will be at a time and location that is mutually agreeable to Vendor and MMCAP Infuse and at a minimum it will address: a review of sales to members, pricing and contract terms, administrative fees and reporting, supply issues, customer issues, and any other necessary information.
ARTICLE VI
WARRANTS, COVENANTS, AND DUTIES OF VENDOR
6.1 Covenant of Laws. Vendor shall comply with all state and federal laws, as applicable to each Member, in the performance of this Agreement.
6.2 Required Licenses, Permits, and Registration. 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. Vendor must make such documentation available upon request by MMCAP Infuse.
6.3 FDA-Certified Drug Application. The Vendor acknowledges that each Product has, if required by law, an FDA-certified New Drug Application, an Abbreviated New Drug Application, or a Biologics License Application on file and accepts the liability with which such application confers. The Vendor guarantees to furnish Products that have not been adulterated or misbranded within the meaning of the Federal Food, Drug and Cosmetic Act, or any regulation of the Federal Food and Drug Administration, or as required by each member state’s Board of Pharmacy.
6.4 cGMP Vendor certifies that it is in compliance with the Food and Drug Administration’s current “Good Manufacturing Practices” (cGMP) and the current United States Food, Drug, and Cosmetic Act. If the Vendor receives a 483 or similar type warning letter for any Product, it must be provided to MMCAP Infuse within ten (10) days of receipt by Vendor.
6.5 Debarment. 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 has not been convicted of a criminal offense related to the subject of this Agreement. 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 will be used or may potentially be used to pay for all or part of the work under the Agreement, therefore 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.
6.6 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, 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 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.
6.7 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.
ARTICLE VII
ADMINISTRATIVE FEE
7.1 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 Products made by Members with the Vendor through an Authorized Wholesaler.
A. 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. Vendor shall not be required to pay the Administrative Fees on tax amounts, returns, or other shipments for which Vendor did not collect payment.
7.2 Reporting. Vendor must provide Administrative Fee data to MMCAP Infuse within thirty (30) business days after the end of each calendar month. The Vendor must submit a monthly Administrative Fee 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. Vendor agrees that for indirect sales, chargeback or 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.
A. Administrative Fee Data Report fields:
i. MMCAP Infuse Assigned Authorized Wholesaler Number (Cardinal=0301, AmerisourceBergen=0401, Morris & Dickson=0701)
ii. MMCAP Infuse Assigned Manufacturer 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 Name
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)
ARTICLE VIII
INTELLECTUAL PROPERTY
8.1 MMCAP Infuse Ownership. MMCAP Infuse owns all rights, title, and interest in MMCAP Infuse customer 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 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 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 IQVIA and NDC Health, subject to 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, Vendor hereby agrees that in the event that MMCAP Infuse or a Member requests in writing that its purchase data be kept confidential, such data will not be provided to third party aggregators.
8.2 Vendor Ownership. 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. 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.
8.3 Pre-Existing Intellectual Property. MMCAP Infuse and 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 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 an internal business or governmental purposes.
8.4 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 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.
8.5 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. The Vendor will be responsible for payment of any and all such claims, demands, obligations, liabilities, costs, and damages, including but not limited to, attorney fees. If such a claim or action arises, or in the Vendor’s or MMCAP Infuse’s opinion is likely to arise, the Vendor must, at MMCAP Infuse’s discretion, either procure for MMCAP Infuse the right or license to use the intellectual property rights at issue or replace or modify the allegedly infringing works or documents as necessary and appropriate to obviate the infringement claim. This remedy of MMCAP Infuse will be in addition to and not exclusive of other remedies provided by law.
8.6 Publicity and Endorsement. Any publicity regarding the subject matter of this Agreement must identify MMCAP Infuse as a sponsoring or endorsing agency and must not be released without prior written approval from MMCAP Infuse. For purposes of this provision, publicity includes notices, informational pamphlets, press releases, research, reports, signs, and similar public notices prepared by or for the Vendor individually or jointly with others, or any subcontractors, with respect to the program, publications, or services provided resulting from this Agreement.
A. Marketing. Any direct advertising, marketing, or direct offers with Members must be approved by MMCAP Infuse. Violation of this may be cause for immediate cancellation of this Agreement and/or MMCAP Infuse may reject any proposal submitted by the Vendor in any subsequent solicitations for awards.
B. Endorsement. The Vendor must not claim that MMCAP Infuse, the State of Minnesota, or any Member State endorses its products or services.
ARTICLE IX
INSURANCE
9.1 Notice. The Vendor is required to submit Certificates of Insurance acceptable to MMCAP Infuse as evidence of insurance coverage requirements prior to commencing work under the Agreement. Vendor will not commence work under the Agreement until they have obtained all the insurance described below and MMCAP Infuse has approved such insurance. Vendor shall maintain such insurance in force and effect throughout the term of the Agreement. The failure of MMCAP Infuse to obtain a Certificate of Insurance, for the policies required under this Agreement or renewals thereof, or failure of the insurance company to notify MMCAP Infuse of the cancellation of policies required under this Agreement shall not constitute a waiver by MMCAP Infuse to the Vendor to provide such insurance. MMCAP Infuse reserves the right to immediately terminate the Agreement if the Vendor is not in compliance with the insurance requirements and retains all rights to pursue any legal remedies against the Vendor. All insurance policies must be open to inspection by MMCAP Infuse and copies of policies must be submitted to MMCAP Infuse. The Vendor’s insurance company(ies) waives its right to assert the immunity of the State as a defense to any claims made under said insurance.
9.2 Additional Insurance Conditions.
A. Vendor’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 Vendor’s performance under this Agreement;
B. If Vendor receives a cancellation notice from an insurance carrier affording coverage herein, Vendor agrees to notify MMCAP Infuse within five (5) business days with a copy of the cancellation notice, unless Vendor’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. Vendor is responsible for payment of Agreement related insurance premiums and deductibles;
D. If Vendor is self-insured, a Certificate of Self-Insurance must be attached;
E. Vendor’s policy(ies) shall include legal defense fees in addition to its liability policy limits;
F. Vendor’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 Vendor’s policy limits to satisfy the full policy limits required by the Agreement.
9.3 Coverage. Vendor is required to maintain and furnish satisfactory evidence of the following insurance policies:
A. Workers’ Compensation Insurance: Except as provided below, Vendor must provide Workers’ Compensation insurance for all its employees and, in case any work is subcontracted, Vendor 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:
i. $100,000 – Bodily Injury by Disease per employee
ii. $500,000 – Bodily Injury by Disease aggregate
iii. $100,000 – Bodily Injury by Accident If Minnesota Statute 176.041 exempts Vendor from Workers’ Compensation insurance or if the Vendor has no employees in the State of Minnesota, Vendor must provide a written statement, signed by an authorized representative, indicating the qualifying exemption that excludes Vendor from the Minnesota Workers’ Compensation requirements. If during the course of the Agreement the Vendor becomes eligible for Workers’ Compensation statutory requirements, the Vendor must comply with the Workers’ Compensation Insurance requirements herein and provide MMCAP Infuse with a certificate of insurance.
B. Commercial General Liability Insurance: Vendor 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 Agreement whether the operations are by the Vendor or by a subcontractor or by anyone directly or indirectly employed by the Vendor under the Agreement. Insurance minimum limits are as follows:
i. $5,000,000 – per occurrence
ii. $5,000,000 – annual aggregate
iii. $5,000,000 – annual aggregate – Products/Completed Operations
iv. The following coverages shall be included:
a. Premises and Operations Bodily Injury and Property Damage
b. Personal and Advertising Injury
c. Blanket Contractual Liability
d. Products and Completed Operations Liability
e. Other; if applicable, please list__________________________________
f. MMCAP Infuse named as an Additional Insured, to the extent permitted by law C. Network Security and Privacy Liability Insurance, Including Ransomware (or equivalent): Vendor will maintain insurance to cover claims which may arise from failure of Vendor’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 D. Professional/ Technical, Errors and Omissions, and or Miscellaneous Liability Insurance: This policy will provide coverage for all claims the Vendor may become legally obligated to pay resulting from any actual or alleged negligent act, error, or omission related to the Vendor’s services required under the Agreement. Insurance minimum limits are as follows:
i. $2,000,000 – per occurrence
ii. $2,000,000 – annual aggregate
ARTICLE X
GENERAL TERMS
10.1 Notices. If one party is required to provide legal notice or notice under the terms of the Agreement to the other, such notice will be in writing and will be effective upon dispatch. Delivery shall be by certified United States mail, or by email. Either party must notify the other of a change in address for notification purposes.
10.2 Audits. Under Minn. Stat. § 16C.05, subd. 5, the Vendor’s books, records, documents, and accounting procedures and practices relevant to this Agreement are subject to examination by Minnesota, MMCAP Infuse, and/or the Minnesota Auditor or Legislative Auditor, as appropriate, for a minimum of six (6) years from the end of this Agreement. This clause extends to the Membership as it relates to business conducted with and sales a Member.
A. Invoice and Pricing Audit. MMCAP Infuse and Members served by this Agreement may periodically audit validity of invoice pricing. Such audits may be conducted only during ordinary business hours and upon reasonable notice.
B. Costs. Vendor, MMCAP Infuse, and Members shall each be responsible for its own costs associated with any audit, including costs related to the production of records and/or other documents requested by the other party.
10.3 Assignment. The Vendor may neither assign nor transfer any rights or obligations under this Agreement without the prior consent of MMCAP Infuse and a fully executed assignment agreement.
10.4 Amendments. Any amendment to this Agreement must be in writing and will not be effective until it has been executed and approved by the same parties who executed and approved this Agreement, or their successors in office.
10.5 Order of Precedence. Vendor agrees that applicable federal and state law will supersede this Agreement, however this Agreement will take precedence over all other the terms, covenants, conditions, commitments, stipulations, order forms, website use of terms, Offer Letters, and other legal documents MMCAP Infuse, Vendor, and/or Member may use in the performance of this Agreement. If the provisions of this Agreement are inconsistent, or are modified, diminished, or derogated with any of the terms and provisions of the aforementioned legal documents in this Paragraph, this Agreement will supersede and govern. MMCAP Infuse does not agree to or bound by any additional terms and conditions between the Vendor and Member.
10.6 Counterparts and Electronic Signature. The Agreement cannot be executed in counterparts and will not be enforceable until MMCAP Infuse has obtained all required signatures. If requested by MMCAP Infuse and Vendor expressly agree to conduct transactions under the Agreement by electronic means (including, without limitation, with respect to execution, delivery, storage, and transfer of this Agreement by electronic means and to the enforceability of this electronic agreement). MMCAP Infuse will be deemed to have control of the authoritative copy for the electronic transferable record, in each case regardless of whether applicable law recognizes electronic transferable records or control of electronic transferable records and regardless of whether this Agreement is an electronic record or transferable record.
10.7 Severability. If any provision of the Agreement, including items incorporated by reference, is found to be illegal, unenforceable, or void, then both MMCAP Infuse and the Vendor will be relieved of all obligations arising under such provisions. If the remainder of the Agreement is capable of performance, it will not be affected by such declaration or finding and will be fully performed.
10.8 Waiver. If either party fails to enforce any provision of this Agreement, that failure does not waive the provision or its right to enforce it.
10.9 Governing Law,…
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