CN-680000-ME214-A3.pdf

AHCA CONTRACT NO. MED214

AMENDMENT NO. 3

AHCA Contract No. MED214, Amendment No. 3, Page 1 of 1 April 2020

THIS CONTRACT, entered into between the STATE OF FLORIDA, AGENCY FOR HEALTH CARE ADMINISTRATION, hereinafter referred to as the "Agency," and LIFE SCIENCE LOGISTICS, LLC, hereinafter referred to as the "Vendor," is hereby amended as follows.

1. In accordance with Standard Contract, Section I., THE VENDOR HEREBY AGREES, Sub-Section W., Requirements of Section 287.058, Florida Statutes, Item 6., which provides for renewal of this Contract for a period that may not exceed three (3) years or the original term of this Contract, whichever is longer, both Parties hereby agree to exercise the renewal option for a period of three (3) years, beginning July 1, 2023.

Therefore, Standard Contract, Section I, THE VENDOR HEREBY AGREES, Sub- Section W., Requirements of Section 287.058, Florida Statutes, Item 5., is hereby amended to read as follows:

5. This Contract shall begin upon execution by both Parties or December 29, 2020, (whichever is later) and end on June 30, 2026, inclusive.

2. Attachment I-A, Scope of Services, is hereby deleted in its entirety and replaced with Attachment I-B, Scope of Services – Update: February 1, 2023, attached hereto and made a part of this Contract. All references in this Contract to Attachment I-A, Scope of Services, shall hereinafter refer to Attachment I-B, Scope of Services – Update: February 1, 2023.

All provisions not in conflict with this Amendment are still in effect and are to be performed at the level specified in this Contract.

This Amendment and all its attachments are hereby made a part of this Contract.

This Amendment cannot be executed unless all previous Amendments to this Contract have been fully executed.

IN WITNESS WHEREOF, the Parties hereto have caused this fifty-four (54) page Amendment to be executed by their officials thereunto duly authorized. This Amendment is not valid until signed and dated by both Parties.

LIFESCIENCE LOGISTICS, LLC STATE OF FLORIDA, AGENCY FOR

HEALTH CARE ADMINISTRATION

SIGNED

BY:

SIGNED

BY:

NAME: NAME:

TITLE: TITLE:

DATE: DATE:

List of Attachments included as part of this Amendment:

Specify Type Number Description Attachment I-B Scope of Services – Update February 1, 2023 (53

Pages)

DocuSign Envelope ID: 2221988C-F7E5-4997-99A3-C6DABA101D01

David Cheetham

CEO

12/21/2022

Simone Marstiller

Secretary

12/22/2022

ATTACHMENT I-B

SCOPE OF SERVICES

Update February 1, 2023

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 1 of 47

AHCA Form 2100-0003 (Rev. OCT 16)

Table of Contents

I. Service(s) to be Provided

A. Background

B. Overview/Purpose

II. Manner of Service(s) Provision:

A. Services Provided by the Agency

B. Services Provided by the Vendor

C. Deliverables

D. Reporting

1. General Reporting Requirements

2. Monthly Reporting

3. Annual Reporting

4. Adverse Event Reporting

5. FDA Quarterly Reports

6. Ad Hoc Analysis and Reports

E. Monitoring

III. Method of Payment:

A. Invoicing

B. Late Invoicing

C. Financial Consequences as Liquidated Damages

IV. Financial Requirements

A. General Provisions

V. Attorney’s Fees

VI. Legal Action Notification

VII. Failure to Implement Contract Requirements

VIII. Damages for Failure to Meet Contract Requirements

IX. Corrective Action Plan (CAP)

X. Performance Bond

XI. Contract Transition

XII. System Functionality

XIII. Information Technology

XIV. Disaster Recovery

XV. Agency Contract Management

XVI. Disputes

XVII. Definitions and Acronyms

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 2 of 47

I. Service(s) to be Provided

A. Background

During the 2019 Florida Legislative session, Governor Ron DeSantis signed into law House Bill 19/Senate Bill 1528 that creates section (§) 381.02035, Florida Statutes (F.S.)

establishing the Canadian Prescription Drug Importation Program (Program) within the Agency for Health Care Administration (Agency). The law requires the Agency to contract with a vendor that will assist with overseeing the importation of specific prescription drugs from eligible Canadian suppliers. Eligible importers are limited to pharmacists or wholesalers providing services to individuals on behalf of State programs including pharmacies enrolled in Florida Medicaid, pharmacies or wholesalers employed or contracted with the Department of Corrections, county health departments, developmental disability centers, and treatment facilities as defined in s. 394.455, F.S.

Consistent with the requirements in the Medicare Modernization Act of 2003 (21 United States Code (U.S.C.) § 384), the law defines the prescription drugs that are eligible for importation, including those that are excluded (e.g., controlled substances, biologic drugs, etc.).

B. Overview/Purpose

The purpose of this contract is to specify requirements for a Vendor to provide services necessary for the implementation, operation, and management of the Program.

The Vendor shall perform duties as specified in this Contract and in accordance with all applicable State (Chapter 499, F.S. and Chapter 61N, F.A.C.) and federal (Title II of the Drug Quality Security Act (DQSA) (Pub. L. No. 113-54), the Federal Drug Supply Chain Security Act (DSCSA)) rules and statutes.

The Agency will retain ultimate responsibility for ensuring that the Vendor operates consistently with all federal rules and regulations related to the importation of prescription drugs. The Agency will maintain active oversight and monitoring functions over Vendor operations and will actively collaborate with DHHS and DOH to ensure success under the Program.

II. Manner of Service(s) Provision:

A. Services Provided by the Agency

The Agency will provide the following information and services:

1. Establishing standards and requirements to ensure receipt of complete and accurate data for program administration.

2. Establishing Vendor requirements for receiving orders and invoicing state agencies that will purchase imported prescription drugs under the Program.

3. Providing information related to federal and State requirements related to the provision of services under this Contract and expectations of the Vendor.

4. Collaborate with the Vendor on identifying prescription drugs eligible for importation that yield the highest potential for cost savings.

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 3 of 47

5. Monitoring and evaluating the Vendor’s compliance with the requirements of this

Contract. The Agency reserves the right to request additional information in support of monitoring the Vendor’s performance to ensure compliance with the requirements of this Contract.

6. Executing inter-agency agreements with other State agencies that will receive imported prescription drugs to determine quantities needed of each drug and delivery locations for prescription drug shipments.

7. Reviewing all deliverables submitted by the Vendor in a timely manner. The Agency reserves the right to approve, deny, or require revision to any submitted deliverables.

8. Determining whether the Vendor has violated a contractual obligation and assessing liquidated damages or monetary sanctions, when necessary.

9. Providing contract management of this Contract in good faith, with the best interest of the State and persons it serves being the prime consideration. The Agency shall make all clarification of policy and contractual requirements as needed or as requested by the Vendor. The Vendor may seek a formal interpretation of the Contract from the Agency by submitting a written request to the Agency’s Deputy Secretary for Medicaid at the following mailing address:

Deputy Secretary for Medicaid Agency for Health Care Administration Prescription Drug Importation Request for Contract Interpretation, Mail Stop 8 2727 Mahan Drive, MS#8 Tallahassee, FL 32308

10. Performing at least one (1) on-site readiness review of the Vendor during the implementation of this Contract. The readiness review process shall include additional on-site and virtual meetings as needed and required by the Agency.

11. Meeting with the Vendor in person or virtually after execution of this Contract to discuss the Vendor’s proposed implementation plan, anticipated time frames, and to determine information and other resources needed to complete the final implementation plan.

12. Ensuring that the Vendor has the necessary data and information from the State agencies involved in the Program to fulfill the requirements of this Contract.

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AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 4 of 47

B. Services Provided by the Vendor

The Vendor shall facilitate the implementation, management, and operational duties of importing prescription drugs into Florida from Canadian Suppliers. The Vendor, at a minimum, shall be responsible for the following:

1. General Responsibilities

a. The Vendor shall:

1) Comply with all State and federal laws related to the importation of prescription drugs from Canada, including the federal Title II of the DSCSA; § 381.02035, F.S.; Chapter 499, F.S.; and Chapter 61N-1, Florida Administrative Code (F.A.C.).

2) Be licensed, minimally, as a prescription drug wholesale distributor through the Florida Department of Business and Professional Regulation (DBPR).

3) Ensure that Canadian prescription drugs purchased and imported under the Program have equivalents manufactured by a United States (U.S.) Food and Drug Administration (FDA) approved manufacturer.

4) Purchase eligible prescription drugs from Canadian suppliers as approved by the Agency.

5) Make available publicly registration data connected with drug labeler codes to identify FDA-approved manufacturers for qualifying prescription drugs.

6) Submit pre-import requests to the FDA as required by Title 21

CFR § 251.5.

7) Ensure that imported prescription drugs enter into the U.S.

through a U.S. customs and border patrol free trade zone.

8) Establish a process for distributing imported prescription drugs and receiving orders and delivery information from State agencies that will receive imported prescription drugs.

9) Identify and enter into agreements with Canadian suppliers and manufacturers that are in full compliance with relevant Canadian federal and provincial laws and regulations and who have agreed to export drugs at prices that will provide cost savings to the State.

10) Be responsible for directly reimbursing the Canadian manufacturer(s) or Canadian wholesaler(s) for imported prescription drugs. Copies of remittance notifications must be made available to the Agency upon request.

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11) Assume ownership and liability of imported prescription drugs until ownership and custody of the imported prescription drugs are in the possession of the State.

12) Contract with a qualifying laboratory(s) that has ISO 17025 accreditation to perform statutorily required testing on selected samples of imported prescription drugs to verify authenticity.

13) Maintain documentation that sample testing of the prescription drugs occurred at a qualified laboratory, as required by 21 U.S.C.

384.

14) Maintain documentation that the imported prescription drug is approved for marketing in the United States, has not been adulterated or misbranded, and meets all labeling requirements under state and federal law.

15) Lease or purchase a facility in Florida that has adequate space, security, and environmental conditions necessary for the storage of imported prescription drugs.

16) Ship and distribute imported prescription drugs from the Canadian manufacturer(s) or wholesaler(s) to the receiving State agency(s) or its designee(s).

17) Maintain additional information and documentation from Canadian suppliers as specified in § 381.02035, F.S.

18) Assist the Agency in the preparation of an annual legislative report on the efficacy of the Program.

19) Complete quarterly reports required for submission to the U.S.

FDA in accordance with Title 21 CFR § 251.19.

20) Acknowledge all Agency inquiries within twenty-four (24) hours and respond to them on the next business day. Responses due on a weekend or State holiday shall be submitted to the Agency no later than the next business day.

21) Meet with Agency staff both face-to-face and via conference call throughout the term of this Contract period concerning any issues as needed and required to fulfill the responsibilities of this Contract.

22) Develop, manage, maintain, and modify an electronic system and database specific to the requirements of this Contract.

23) Support the exchange of data with necessary partners, as approved by the Agency, in the required formats as is necessary to support this Contract.

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 6 of 47

24) Develop, deliver, and comply with all reporting requirements established by the Agency, including ad hoc reporting, as applicable, at no additional cost to the Agency. Reports due on a weekend or State holiday shall be submitted to the Agency no later than the next business day.

25) Create and deliver an implementation plan within ten (10) calendar days of the execution of this contract.

26) Provide outreach and communication to other state agencies regarding use of the online platform for ordering and invoicing prescription drugs purchased under the Program as approved and directed by the Agency.

27) Deliver training to pharmacies, Agency staff, and other state agencies as identified in this Contract or otherwise directed by the Agency.

28) Provide for any equipment necessary for the operation and distribution of imported prescription drugs necessary for the performance of duties specified in this Contract at a location within the State of Florida.

29) Provide sufficient qualified staff to meet the requirements of this

30) Maintain Agency-approved procedures for all aspects of the work performed under this Contract.

31) Maintain a structured complaint process that includes tracking and escalation of issues. The Vendor shall develop a performance dashboard for this process, as specified and approved by the

32) Develop and submit internal quality control (IQC) assurances that ensure appropriate administration of Vendor responsibilities specified under this Contract.

33) Obtain approval from the Agency prior to any delegation of responsibilities related to this Contract.

34) Submit all policies and procedures to the Agency in accordance with an Agency-approved implementation plan and as otherwise specified in this Contract.

b. If the Vendor fails to comply with the requirements of this Contract, the

Vendor may be subject to liquidated damages and/or sanctions pursuant to Section IV., Method of Payment, Sub-Section D., Financial Consequences as Liquidated Damages, and as outlined in Exhibit A-1, Deliverables and Associated Payments.

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 7 of 47

2. General Requirements

a. The Vendor shall perform duties related to the importation of prescription drugs as described in this Contract.

b. The Vendor shall perform the following duties:

1) Purchase and import prescription drugs from Canada on behalf of the following Florida State agencies: the Agency and its Medicaid managed care plans, the Agency for Persons with Disabilities (APD), the Department of Children and Families (DCF) mental health treatment facilities, the Department of Corrections (DOC), and the Department of Health (DOH) county health departments.

2) Serve as an intermediary between the Canadian Supplier or manufacturers and the State.

c. The Vendor shall maintain all required and current licenses, permits, and/or registrations in good standing for the duration of this Contract. The Agency reserves the right to sanction or terminate the Vendor if the Vendor is found by its regulating body to be in violation of Florida laws or rules or if the Vendor receives disciplinary action.

3. Eligible Canadian Supplier

a. The Vendor shall perform the following duties:

1) Identify an eligible Canadian Supplier(s) or manufacturer(s) that is in compliance with relevant Canadian federal and provincial laws, received eligible prescription drugs from an FDA-approved manufacturer, and can obtain the eligible prescription drugs to be imported under the Program.

2) Negotiate and execute agreements with an eligible Canadian

Supplier(s) or manufacturer(s), who has agreed to sell prescription drugs under the Program. The Vendor shall ensure that each agreement has been reviewed and approved by the Agency prior to execution with the Canadian Supplier(s).

3) Provide the Agency with copies of all agreements negotiated with

Canadian Supplier(s) within ten (10) days of their signing by the Vendor and Supplier or manufacturer. The Vendor must submit any modifications or changes to these agreements to the Agency upon completion of these changes.

4) Ensure that the Canadian Supplier or manufacturer provides the

Vendor with all of the following for each batch of imported prescription drugs:

(a) Proprietary or established product name;

(b) Formulation;

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 8 of 47

(c) Strength and dosage;

(d) Container size;

(e) Number of containers;

(f) Lot number of product;

(g) Serial identifier for each package and homogenous case or product;

(h) Dates of shipment and transaction;

(i) Business names and addresses of the Canadian Supplier and importer;

(j) Business name and addresses of person associated with importer and foreign seller from whom ownership is being transferred; and

(k) Canadian drug identification number.

5) Be responsible for directly reimbursing the Canadian Supplier for imported prescription drugs.

b. The Agency shall make all payments associated with this Contract in accordance with the Performance Standards and Liquidated Damages (Table 2-B) and Payment Schedule (Table 4-B) listed in this Contract.

4. Prescription Drugs Eligible for Importation

1) Collaborate with the State to identify the list of prescription drugs that can be imported under the Program.

2) Collaborate with the Agency to ensure that the listed prescription drugs have the highest potential for cost savings to the State.

3) Provide the Agency with the actual amount(s) paid to Canadian supplier(s) or manufacturer(s) for prescription drug(s) imported under this Program and maintain a process for updating the Agency with information on the entry of lower-priced products into the market.

4) Report to the Agency any price changes and product additions or deletions within five (5) business days of the manufacturer price change or manufacturer product addition(s) or deletion(s).

5) Ensure all products designated for importation to the U.S.

maintain the same formulation as FDA-approved products.

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 9 of 47

6) Import prescription drugs that are not “donated or otherwise supplied at no charge by the manufacturer of the prescription drug to a charitable or humanitarian organization (including the United Nations and affiliates) or to a government of a foreign country.”

See 21 U.S.C. § 384(i).

7) Ensure that imported prescription drugs are manufactured by a facility designated by the FDA as an approved facility and be an FDA-registered manufacturer.

8) Ensure that prohibited prescription drugs (as defined in federal law

(21 U.S.C. § 384(a)(3)) are not imported under the Program.

9) Exclude generic products if the importation of the products would violate U.S. patent laws applicable to U.S.-branded products.

10) Ensure that eligible prescription drugs are initially purchased either from an FDA-approved manufacturer or from their authorized distributors, and that secondary and unauthorized products do not enter the Program supply chain.

11) Submit Section 804 Pre-Import Requests to a U.S. Customs and

Border Patrol port of entry or to the U.S. Customs and Border Patrol’s Automated Commercial Environment system at least thirty (30) calendar days prior to the scheduled date of arrival of an imported prescription drug shipment.

12) On a quarterly basis, provide the Agency with an updated list of prescription drugs eligible for importation that have the highest potential for cost savings to the State, including prescription drugs for which there are shortages, specialty prescription drugs, and high-volume prescription drugs.

5. Ownership and Liability

a. The Vendor shall assume ownership for imported prescription drugs under this Program upon the transfer of title(s) from the Canadian Supplier(s) or manufacturer(s) and delivery to its facility in the U.S.

b. The Vendor shall obtain and maintain insurance for imported prescription drugs due to loss, theft, security breach, accident, contamination, adulteration, mis-delivery, or other factors that have direct responsibility for the reduction of the quantity and quality, as applicable, at all points of in the chain of custody, including:

1) While the imported prescription drugs are in the Vendor’s or its delegate’s possession. Such policy must cover at a minimum ($5,000,000.00) per occurrence and ($10,000,000.00) annual aggregate.

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 10 of 47

2) While imported prescription drugs are in transit either from the Canadian manufacturer or wholesaler to the Vendor’s facility or from the Vendor’s facility to the ordering state agency or its designee. Such policy must cover at a minimum ($2,000,000.00) per occurrence and ($4,000,000.00) annual aggregate.

All amounts are in U.S. currency.

6. Wholesaler and Distribution Requirements

a. The Vendor shall be responsible for the importation and storage of imported prescription drugs under the Program.

b. The Vendor shall comply with all applicable State and federal regulations related to the storage and distribution of prescription drugs.

c. The Vendor shall submit an application within thirty (30) days of the execution of this Contract for a Florida Prescription Drug Wholesale Distributor license and shall not initiate distribution operations in Florida until license is obtained.

d. The Vendor shall purchase or lease (for a minimum of twelve (12) months with the option to renew) a facility in Florida that meets the FDA (Title 21 CFR § 205) and state (Chapter 499, F.S.) requirements for the storage of prescription drugs within sixty (60) calendar days of the execution of this Contract. This facility shall meet the following requirements:

1) Be geographically situated to allow for the timely delivery of

2) Be clean and maintain cleanliness standards sufficient to prevent contamination of imported prescription drugs.

3) Have adequate space and environmental conditions available for the safe storage of imported prescription drugs.

4) Have sufficient space that can be environmentally controlled (i.e., refrigerated) to prevent degradation and maintain potency of

5) Have areas designated for the quarantine of imported prescription drugs in accordance with Section 499.0121(5), F.S.

6) Have secure loading and unloading areas appropriate for vehicles used for the shipping and transportation of imported prescription drugs.

7) Have security measures sufficient to prevent theft, tampering, or damages to imported prescription drugs.

e. The Vendor shall ensure that its facility located in Florida is staffed and fully operational on or before May 15, 2021.

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 11 of 47

f. The Vendor shall ensure daily environmental conditions related to temperature, and humidity are tracked in the storage facility through conducting minimum twice-daily recordings and controls.

g. The Vendor shall ensure that the space in its storage facility designated for the Program is not allocated for other purposes or clients.

h. The Vendor shall ensure it does not distribute drugs with a shelf life expiration date of less than six (6) months.

i. The Vendor shall have written policies and procedures for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. The Vendor shall make all policies and procedures available to the Agency upon request.

j. The Vendor shall develop and maintain a written procedure whereby the oldest approved stock of a prescription drug product is distributed first.

The procedure may permit deviation from this requirement if the deviation is temporary.

k. The Vendor shall develop and maintain a written procedure to prepare for, protect against, and handle any crisis that affects security or operation of any facility if a strike, fire, flood, or other natural disaster, or a local, State, or national emergency occurs.

7. Ordering and Invoicing

a. The Vendor shall establish an electronic online system to receive orders from State agencies for eligible prescription drugs under the Program.

The Vendor shall ensure that the system allows for the immediate receipt of orders and needs to capture the following information:

1) Name of product and product description (e.g., active pharmaceutical ingredients);

2) Quantity needed of the imported prescription drugs;

3) Strength and dosage;

4) Imported prescription drug form (e.g., tablet);

5) NDC number of each product;

6) Identity of requester; and,

7) Billing and shipping addresses.

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 12 of 47

b. Upon the receipt of an order(s), the Vendor shall notify the requestor within twenty-four (24) hours whether the order can be completely or partially fulfilled.

c. The Vendor shall have a system in place to receive orders via telephone in the event its electronic system is unavailable to take orders.

d. The Vendor shall only process orders for prescription drugs imported under the Program received from State agencies or individuals or entities designated by a State agency.

e. The Vendor shall have a process or mechanism for verifying that orders originated from a State agency or its authorized designee.

f. The Vendor shall have a process and mechanism in place for invoicing each State agency for imported prescription drug orders. The Vendor invoices shall include the following:

1) Date order was placed;

2) NDC number of each product;

3) Product name and product description;

4) Quantity(s) ordered;

5) Strength and dosage;

6) Imported prescription drug form;

7) FDA-approved U.S. and Canadian manufacturer(s);

8) FDA-approved U.S. equivalent(s) prescription drug(s);

9) Payment amount due;

10) Requestor billing and shipping addresses; and,

11) Vendor’s billing address and method for payment.

The Vendor shall ensure the Agency has access to all invoices sent to State agencies for purchases under the Program.

g. The Vendor shall make staff available to provide technical assistance via telephone with the ordering and invoicing process from 8:00 AM (EST) to 5:00 PM (EST), Mondays through Fridays, excluding State holidays.

h. The Vendor shall process and ensure shipping of all complete orders received prior to 2:00 PM (EST) on the following business day. Orders received after 2:00 PM (EST) will be shipped on the second business day following the date of the order.

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i. If the Vendor is unable to completely fill an order, it shall notify the requesting State agency or its designee within twenty-four (24) hours of receiving the order.

j. If the Vendor is unable to fill an order within the timeframe specified in

Part II.B.10.i (Shipping and Delivery) and has not provided notice to the requester within twenty-four (24) hours of receipt of the order, it shall assume responsibility for obtaining the prescription drugs from an FDA-approved U.S. manufacturer. The Vendor cannot invoice the State for the difference in price between the imported prescription drug’s cost and that of the U.S. FDA-approved equivalent prescription drug.

8. Purchasing Imported Prescription Drugs

a. The Agency will be responsible for making payments to the Vendor for the cost of imported prescription drugs purchased on behalf of each State agency or its designee.

b. Each state agency or its designee will be responsible for placing orders with the Vendor for the purchase of imported prescription drugs.

c. The Vendor shall purchase prescription drugs from a Canadian

Supplier(s) or manufacturer(s) in bulk and maintain at least a ninety (90)-day supply of imported prescription drugs at its facility in Florida. Inventory exceeding a ninety (90)-day supply require written approval by the Agency at least fifteen (15) days in advance.

d. The Vendor shall not charge state agencies or their designees any additional fees, percentages, or cost increases beyond the markup percentage specified in this Contract on imported prescription drugs under this program, except for fees for emergency orders.

e. The Vendor, when purchasing prescription drugs on behalf of the State, shall ensure sufficient quantity to account for the loss of product due to testing. The additional quantity for any single order shall not exceed two percent (2%).

f. In the event that the Vendor purchases the prescription drug at a lower cost than invoiced to the Agency, the Vendor will refund the difference or issue a credit toward a future purchase of imported prescription drugs as determined by the Agency.

g. In the event that the Vendor can only purchase the prescription drug(s) at a higher cost than invoiced to the Agency, the Vendor will notify the Agency within twenty-four (24) hours of determining the error and provide the Agency the option of paying the additional amount or receive a full refund or credit toward a future purchase of imported prescription drugs.

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9. Shipping and Delivery

a. The Vendor shall be responsible for the shipping of imported prescription drugs purchased under the Program from their point of origin in Canada to the delivery to their respective State agency(s) or designated recipient(s). The Vendor may delegate this responsibility to a subcontractor or commercial shipping entity with Agency approval.

b. If the Vendor does not perform shipping of imported prescription drugs, the Vendor shall identify its subcontractor or commercial shipping entity within thirty (30) calendar days of the execution of this Contract.

c. The Vendor shall only use its own vehicles or an Agency-approved subcontractor or commercial shipping provider for the transportation of

d. The Vendor shall coordinate with the Agency, DOH, DCF, APD, and DOC or their designee(s) to identify the specific locations for the delivery of

e. The Vendor shall ensure the safe transportation of all imported prescription drugs in accordance with Section 499.0121(12), F.S. by requiring the following for its vehicles or those of its subcontractor or selected commercial shipping provider:

1) Security measures sufficient to prevent theft, tampering, or damages to imported prescription drugs;

2) Maintaining environmental conditions as recommended by the manufacturer to prevent degradation and maintain potency;

3) Maintaining cleanliness standards to prevent contamination of imported prescription drugs; and

4) Processes to prevent mis-delivery or loss of imported prescription

f. The Vendor shall ensure that its shipping provider can track packages and provide estimated times of delivery.

g. The Vendor shall ensure that its shipping provider obtains delivery confirmations from its shipping provider for orders of imported prescription

h. The Vendor or its shipping provider shall have a process for addressing mis-deliveries or lost shipments that could cause a delay resulting in a shortage of the ordered prescription drug(s).

i. The Vendor shall ensure that ninety-eight percent (98%) of all orders for an imported prescription drug(s) are shipped from the Vendor’s facility in Florida within seventy-two (72) hours of receiving the order.

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10. Pricing Requirements

a. The Vendor shall negotiate prices with a Canadian Supplier(s) or manufacturer(s) for prescription drugs that render substantial savings to the State.

b. The Vendor shall be responsible for ensuring that prices for imported prescription drugs adhere to the following:

1) Provide a cost savings for all prescription drugs purchased across the Program in comparison to what the State paid in Calendar Year 2020 for same quantities, strengths, dosages, and forms of the FDA-approved equivalent prescription drugs. This percentage includes any markup from the Vendor added to the prices and is based on amounts after all rebates, discounts, and reductions.

2) Cost comparison(s) used to demonstrate savings between the imported prescription drug(s) shall be between an imported brand-name drug(s) and FDA-approved equivalent brand-name drug(s) or a generic imported drug(s) and generic FDA-approved drug(s).

3) Cost comparison(s) used to demonstrate savings shall be between prescription drugs that meet the following requirements:

(a) Have the same active pharmaceutical ingredient(s); and,

(b) Have the same quantities of active pharmaceutical ingredient(s).

c. The Vendor shall report a pricing change by the Canadian manufacturer(s) to the Agency within three (3) business days of its occurrence(s).

11. Supply Chain Quality Assurance

1) Establish and maintain a quality assurance system for ensuring compliance with the federal DSCSA, federal Food, Drug, and Cosmetic Act (FDCA), § 381.02035, F.S., and Chapter 61N-1, F.A.C.

2) Implement supply chain standards for Canadian manufacturers and wholesalers to ensure that prescription drugs manufactured outside of Canada are commercially exported to Canada by the manufacturer(s) and labeled for the Canadian market and sold directly to the Canadian Supplier.

3) Establish processes and procedures delineating the responsibilities of all parties within the pharmaceutical supply chain, delegation of responsibilities, authorization for release of products, inspection and certification of compliance with current

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 16 of 47 industry standards for quality assurance systems, and continuous improvement through ongoing internal and third-party audits.

4) Maintain and ensure all products received from the time procured from the Canadian supplier until delivery to a designated State agency.

b. The Vendor shall implement all track and trace requirements as stated in the federal DSCSA.

12. Laboratory Testing

1) As required by federal law (Title 21 CFR § 251.16), ensure testing is conducted on sample batches of imported drugs through a qualified laboratory. If approved by the FDA, the Vendor may satisfy the laboratory testing requirements if the certificate of analysis can be obtained by the manufacturer and demonstrates that all required testing was complete.

2) Identify at least two (2) qualifying laboratories that will be used to satisfy testing requirements immediately upon execution of this

3) Ensure testing as needed on samples collected randomly and representatively from each batch of the imported prescription drugs is performed in International Organization for Standardization (ISO) 17025 accredited laboratories (including third party laboratories).

4) Ensure that samples tested are sufficient to provide statistically valid analyses.

5) Ensure that the laboratory testing techniques used to evaluate imported prescription drugs consist of those recommended by the manufacturer sufficient to verify their authenticity.

6) Ensure that the prescription drug meets the active ingredient, identity, strength, purity, sterility, and quality standards of the federal Food, Drug, and Cosmetic Act (FDCA) (such that the prescription drug is not adulterated, counterfeit, damaged, tampered with, or expired) and ensure that it meets the parameters as purported by the labeling of the prescription drug or, where applicable, as established by the United States Pharmacopeia (USP) or other FDA-recognized compendia standards.

7) Provide documentation to the Agency specifying the tests performed on each batch or shipment of imported prescription

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 17 of 47

8) Comply with the frequency of testing as specified in 21 U.S.C. § 384 and shall maintain documentation of all testing that occurred.

9) Have policies and procedures of the steps the Vendor shall take if any of the drugs fail laboratory testing.

10) Document product traceability to the original manufacturer and the manufacturing site, the organization issuing the Certificate of Analysis, and describe the availability of the Certificate of Analysis and testing results when requested.

11) Provide copies of all contracts with qualifying laboratories to the

Agency upon execution.

12) Create a contingency plan if the contracted laboratory is unavailable or cannot meet the established time frames.

13. Relabeling

1) After importation, ensure prescription drugs are relabeled in accordance with federal and State statutes prior to distribution.

The Vendor may delegate this responsibility to the supplier. (21 U.S.C. § 352; 61N-1.032, F.A.C.)

2) Ensure that the relabeler(s) is registered with the FDA and follow the FDA’s unique prescription drug product identifier requirement governing prescription drugs distributed under the DSCSA (i.e., pharmaceutical serialization).

3) Provide information to the Agency regarding the facility where the relabeling will occur for all eligible prescription drug(s) including:

• The facility’s unique facility identifier;

• The facility’s name, address, and establishment identification number;

• The anticipated date the relabeling and any limited repackaging will be completed; and,

• Information about where the relabeled prescription drug will be stored pending distribution, including the FDA establishment identification number of the storage facility, if available.

4) Ensure that the relabeler(s) has appropriate environmental and climate storage controls and implements processes and procedures to prevent mix-ups, contaminations, and cross-allergenicities (e.g., penicillin reactions).

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 18 of 47

14. Immediate Suspension and Recalled Products

a. The Vendor shall comply with federal and State laws related to handling recalls and withdrawals of prescription drugs. The Vendor shall develop and maintain a written procedure to be followed for handling recalls and withdrawals of prescription drugs. Such procedure shall be adequate to deal with recalls and withdrawals due to:

1) Any action initiated at the request of the FDA or any other federal, State, or local law enforcement or other government agency.

2) Any voluntary action by the manufacturer or repackager to remove defective or potentially defective drugs from the market; or

3) Any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design.

b. The Vendor shall subscribe to the Consumer Product Safety News newsletter to monitor and manage any manufacturer recalls of acquired or targeted products.

c. The Vendor shall develop a procedure to ensure that any outdated prescription drugs are segregated from other drugs and returned to the manufacturer or dispositioned. This procedure shall provide for written documentation of the disposition of outdated prescription drugs. This documentation shall be maintained for two (2) years after disposition of the outdated drugs.

d. The Vendor shall have systems in place to respond appropriately to suspect or illegitimate products. For suspect or illegitimate products, the Vendor (in coordination with the Canadian Supplier) shall:

1) Quarantine the suspect or illegitimate products;

2) Investigate whether the prescription drugs are illegitimate products; and

3) Notify the FDA if the investigation finds that the prescription drugs are not suspect or illegitimate products.

e. If the investigation finds that the prescription drugs are illegitimate products, the Vendor shall (in coordination with Canadian Supplier):

1) Notify the FDA within twenty-four (24) hours of determining the illegitimate product status;

2) Quarantine the illegitimate products until dispositioned;

3) Dispose the illegitimate products through disposal or return of the prescription drug(s);

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 19 of 47

4) Provide a report to the Agency specifying the circumstances behind the illegitimate products and recourse to prevent future incidents.

5) Provide reasonable assistance for disposition to parties who have received the illegitimate products, including the payment of refunds as applicable; and,

6) Retain a sample for further physical examination and analysis.

f. The Vendor shall develop a procedure to coordinate the return of recalled imported prescription drugs from State agencies or their designated recipients that accepted delivery.

g. The Vendor shall accept the return of all recalled imported prescription drugs and store them at its facility in Florida until they are determined to be either resaleable or dispositioned.

h. The Vendor shall notify the Agency within seventy-two (72) hours of any recalled or suspended prescription drug(s) imported under the Program.

i. The Vendor, with approval from the Agency, may revoke the suspension of an imported prescription drug if, after investigating, it determines that the public is adequately protected from illegitimate or unsafe drugs being imported into the State.

j. The Vendor shall subscribe to the Consumer Product Safety News newsletter to monitor and manage any manufacturer recalls of acquired or targeted products.

15. Drug Shortages

a. The Vendor shall have policies and procedures for when manufacturers cannot supply drugs, whether it is because they are in backorder or the drugs have been discontinued.

b. Within thirty (30) days of request by the Agency, the Vendor shall submit a contingency plan to the Agency that specifies actions it will take in the event of a Canadian prescription drug shortage(s).

c. The Vendor shall report all shortages of prescription drugs specified under the Program to the Agency within twenty-four (24) hours of becoming alerted to such shortages.

d. The Vendor shall submit a monthly report to the Agency forecasting availability of prescription drugs available under the Program, to anticipate any potential shortages or areas where need will have to be addressed.

e. The Vendor shall monitor prescription drug shortages in Canada and report to the Agency within twenty-four (24) hours of the addition or

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 20 of 47 deletion of a prescription drug to Canada’s Drug Shortages Homepage that is approved for importation under this Program.

16. Implementation Plan

a. The Vendor shall develop and submit to the Agency a draft implementation plan, no-later-than ten (10) business days after Contract execution, outlining steps necessary for the Vendor to be operational by the implementation date as directed by the Agency.

b. The Vendor shall develop and deliver a comprehensive final implementation plan within five (5) calendar days of receiving Agency feedback on the draft implementation plan.

c. The Vendor shall detail the specific time frames, tasks, responsibilities, and key milestones in the final implementation plan that ensure a successful implementation.

d. The Vendor shall include, at a minimum, the following elements in the final implementation plan:

1) Tasks associated with the Vendor’s establishment of project management tools such as Microsoft Project or similar tools that efficiently track changes to the plan and progress toward accomplishing the activities, goals, and objectives set out in the plan;

2) An itemization of activities that the Vendor shall undertake during the implementation period and the implementation of this Contract. These activities shall have established deadlines and time frames listed. These activities, at a minimum, shall include all information technology (IT) requirements;

3) A staffing plan including position types, number of staff per position type, and job description with roles and responsibilities.

The staffing plan shall include the ramp-up and ramp-down phase of the implementation with on-boarding and off-boarding dates for temporary staff as well as details related to Operations staffing;

4) A communication and outreach plan which include communication modality and time frames;

5) A training plan that includes staff numbers by job type, training locations, proposed dates, training times, and training session descriptions;

6) Identification of interdependencies between activities in the implementation plan; and,

7) Identification of Vendor expectations regarding participation by the Agency and/or its agent(s) in the activities in the implementation plan, and dependencies between these activities

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 21 of 47 and implementation activities for which the Agency and/or its agent(s) shall be responsible.

e. The Vendor shall implement the final implementation plan only after

Agency approval.

f. The Vendor shall work with the Agency to develop a final implementation plan. Any changes to the final implementation plan, either increase or decrease of scope must be reviewed and approved with the Agency.

Failure to do so may be regarded by the Agency as a material breach and all remedies provided for in this Contract shall become available to the Agency, except where Agency approval has been provided in writing for reasons beyond the control of the Vendor.

g. The Vendor shall participate in both face-to-face meetings and conference calls with the Agency and relevant parties for purposes of coordinating implementation activities.

17. Outreach and Communications

a. The Vendor shall provide all services related to outreach and communications as identified by the Agency to include email communications, posting messages to the Vendor’s web page, and performing call campaigns as needed to support the implementation and maintenance of the Program.

b. The Vendor shall develop and implement a draft Outreach and

Communication plan to be delivered to the Agency within thirty (30) calendar days of execution of this Contract, which, at a minimum describes:

1) Methods and timing of outreach and communications; and

2) Reporting related to outreach and communications. The Vendor shall identify all outreach and communications activities and report, at a minimum monthly, identifying the subject of the outreach and communication, the modality, and the timing of each outreach and communication.

c. The Vendor shall develop and deliver a comprehensive final Outreach and Communication plan within five (5) business days of receiving Agency feedback on the draft Outreach and Communication plan.

d. The Vendor shall amend or update its outreach plan as directed by the

Agency at no additional cost to the Agency.

e. The Vendor shall develop and deliver a draft training plan for Program participants, to the Agency, within seven (7) calendar days of execution of this Contract.

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 22 of 47

18. Corporate Capability/Office Location

a. The Vendor shall establish an office location(s) where U.S. based duties are fulfilled. The Vendor shall notify the Agency of any changes to the Vendor office location or when any of the Vendor Contractual obligations shall be performed at a different site other than the designated office location. The Vendor shall ensure that staff are available at the designated office location on business days from the hours of 8:00 AM to

6:00 PM, EST.

19. Staffing Requirements

a. The Vendor shall be responsible for the administration and management of all aspects of this Contract, including all subcontracts, employees, agents, and services performed by anyone acting for or on behalf of the Vendor.

b. The Vendor shall have a centralized executive administration, which shall serve as the contact point for the Agency, except as otherwise specified in this Contract.

c. The Vendor shall maintain a sufficient number of staff at its storage and distribution facility in Florida to ensure the safety, timely receipt, and timely delivery of imported prescription drugs.

d. The Vendor shall maintain a sufficient number of qualified staff to comply with all terms of this Contract.

e. The Vendor shall meet all requirements for doing business in the State of Florida.

f. The Vendor shall submit a resume for any candidates to fill any key named position for Agency approval prior to hiring.

g. The Vendor shall ensure that key name positions are not vacant for more than thirty (30) calendar days.

h. The Vendor shall maintain the minimum level of staffing as required in this Contract. If minimum staffing levels fall below the requirements and remain below the minimum staffing levels in this Contract for more than sixty (60) calendar days, the Agency reserves the right to impose Liquidated Damages.

i. The Vendor shall submit a quarterly Organizational Chart by the fifth (5th) calendar day of each reporting quarter. The Vendor shall identify in its Organizational Chart each person by position and shall attest that each employee meets the contract requirement for said position if applicable.

j. Key Staffing Positions:

1) The Vendor shall designate a Contract Manager to work directly with the Agency. The Vendor Contract Manager shall possess at

AHCA Contract No. MED214, Attachment I-B, Update 02/01/23, Page 23 of 47 least two (2) years of contract management experience. The Vendor Contract Manager shall be a full-time employee of the Vendor. The Vendor Contract Manager shall have the authority to administer the day-to-day business activities of this Contract, including revising processes or procedures and assigning additional resources as needed to maximize the efficiency and effectiveness of services required under this…